QuickLinks -- Click here to rapidly navigate through this document
As filed with the Securities and Exchange Commission on September 26, 2003
Registration No. 333-          

SECURITIES AND EXCHANGE COMMISSION
 Washington, D.C. 20549

FORM S-1
 REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

ACORDA THERAPEUTICS, INC.
 (Exact name of registrant as specified in its charter)

Delaware 
(State or other jurisdiction of
incorporation or organization)	 	2836 
(Primary standard industrial
classification code number)	 	13-3831168 
(I.R.S. employer
identification number)	

15 Skyline Drive
Hawthorne, New York 10532
(914) 347-4300 
(Address, including zip code, and telephone number, including
area code, of registrant's principal executive offices)	

Ron Cohen
Chief Executive Officer
15 Skyline Drive
Hawthorne, New York 10532
(914) 347-4300 
(Name, address, including zip code, and telephone number, including
area code, of agent for service)

 Copies To:	
Fran Stoller
Mitchell Nussbaum
Loeb & Loeb LLP
345 Park Avenue
New York, New York 10154
(212) 407-4000	 	Danielle Carbone
Paul Rivett
Shearman & Sterling LLP
599 Lexington Avenue
New York, New York 10022
(212) 848-4000	

         Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.
        If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended (the "Securities Act") check the following box.  o
        If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  o
        If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  o
        If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  o
        If delivery of the prospectus is expected to be made pursuant to Rule 434, check the following box.  o

CALCULATION OF REGISTRATION FEE

Title of Each Class of
Securities to be Registered	 	Amount to
be Registered(1)	 	Proposed Maximum
Offering Price
Per Share	 	Proposed Maximum
Aggregate Offering
Price(2)	 	Amount of
Registration Fee	
	
Common Stock, $0.001 par value per share	 	 	 	$                  	 	$75,000,000	 	$6,067.50	
	
(1)
Includes a maximum of        shares of common stock that may be purchased by the Underwriters to cover over-allotments, if any.
(2)
Estimated solely for the purpose of determining the registration fee pursuant to Rule 457(o) promulgated under the Securities Act of 1933, as amended.

         The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission acting pursuant to said Section 8(a), may determine.

The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and we are not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.                                                                                                                                                                                                                                                                                      
Prospectus
SUBJECT TO COMPLETION, DATED SEPTEMBER 26, 2003
                        Shares
         
Common Stock

        Acorda Therapeutics, Inc. is offering                        shares of common stock. This is our initial public offering, and no public market currently exists for our shares. We anticipate that the initial public offering price will be between $                  and $                  per share. After the offering, the market price for our shares may be outside this range.

        We will apply to list our common stock on The Nasdaq National Market under the symbol "ACRD."

         Investing in our common stock involves a high degree of risk. See "Risk Factors" beginning on page 8.

  	 	Per Share
	 	Total

Offering price	 	$	 	$	
	
Discounts and commissions to underwriters	 	$	 	$	
	
Offering proceeds to Acorda Therapeutics, Inc., before expenses	 	$	 	$	
	
        Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved these securities or determined if this prospectus is accurate or complete. Any representation to the contrary is a criminal offense.
        We have granted the underwriters the right to purchase up to                        additional shares of common stock to cover any over-allotments. The underwriters can exercise this right at any time within 30 days after the offering. The underwriters expect to deliver the shares of common stock to investors on or about                        , 2003.
Banc of America Securities LLC

Lazard
U.S. Bancorp Piper Jaffray
RBC Capital Markets
                       , 2003

          You should rely only on the information contained in this prospectus. We have not, and the underwriters have not, authorized anyone to provide you with different information. We are not making offers to sell or seeking offers to buy these securities in any jurisdiction where the offer or sale is not permitted. You should assume that the information contained in this prospectus is accurate as of the date on the front of this prospectus only. Our business, financial condition, results of operations and prospects may have changed since that date.
         We have registered "Acorda Therapeutics" and our logo as trademarks in the United States. Other trademarks mentioned in this prospectus are the property of their respective owners.

TABLE OF CONTENTS

 	 	Page
	
Summary	 	3	

Risk Factors	
 	
8	

Forward-Looking Statements	
 	
18	

Use of Proceeds	
 	
19	

Dividend Policy	
 	
19	

Capitalization	
 	
20	

Dilution	
 	
21	

Selected Consolidated Financial and Operating Data	
 	
22	

Management's Discussion and Analysis of Financial Condition and Results of Operations	
 	
24	

Business	
 	
35	

Management	
 	
59	

Certain Relationships and Related Transactions	
 	
71	

Principal Stockholders	
 	
73	

Description of Capital Stock	
 	
75	

Shares Eligible For Future Sale	
 	
77	

Underwriting	
 	
79	

Legal Matters	
 	
81	

Experts	
 	
81	

Where You Can Find More Information	
 	
81	

Index to Financial Statements	
 	
F-1	

2

SUMMARY
         This summary highlights information contained elsewhere in this prospectus. This summary is not complete and does not contain all of the information you should consider before investing in our common stock. You should read the entire prospectus carefully, including the "Risk Factors" section and our consolidated financial statements and the related notes included in this prospectus before making an investment decision. References in this prospectus to "Acorda," "the company," "we," "us" and "our" refer to Acorda Therapeutics, Inc.
OUR BUSINESS
  Overview
        Acorda Therapeutics is a late-stage biopharmaceutical company dedicated to the identification, development and commercialization of novel therapies that improve neurological function in people with spinal cord injury, multiple sclerosis and related disorders of the central nervous system, or CNS. Our current product candidates target the treatment of a wide range of disorders affecting individuals with chronic spinal cord injury, referred to as SCI, and multiple sclerosis, referred to as MS, including spasticity, muscle weakness, loss of bowel and bladder control and sexual dysfunction.
        Approximately 500,000 people in the United States suffer from SCI and MS and we believe that the combined annual cost of treatment for these conditions exceeds $9 billion. Our goal is to become a fully integrated biopharmaceutical company commercializing multiple therapeutic products for these large and underserved markets while continuing to augment our product pipeline and to identify new applications for our core technologies.
 
 Our Product Candidates
        Our lead product candidate, Fampridine-SR, is an oral, small molecule drug contained in a sustained release tablet form. Laboratory studies have shown that fampridine, the active molecule of Fampridine-SR, improves impulse conduction in nerve fibers in which the insulating layer of the spinal cord, called myelin, has been damaged. This damage may be caused by physical trauma, in the case of SCI, or by the body's own immune system, in the case of MS. We are developing Fampridine-SR for use by people with SCI or MS.
        Clinical trials of Fampridine-SR are the first, to our knowledge, that have demonstrated improved neurological function in people with chronic SCI or MS. In cooperation with Elan Corporation plc, or Elan, we have conducted a series of clinical trials during the past six years evaluating Fampridine-SR. Approximately 550 people have been treated with Fampridine-SR in 14 clinical trials, including eight clinical trials for SCI and six clinical trials for MS. In Phase 2 clinical trials, treatment with Fampridine-SR has been associated with a variety of neurological benefits in people with SCI or MS.
        We are currently conducting two Phase 3 clinical trials in people with SCI for the reduction of muscle stiffness, referred to as spasticity, and one late Phase 2 clinical trial in people with MS for the improvement of walking speed. Our goals are to submit a New Drug Application, or NDA, to the United States Food and Drug Administration, or the FDA, for Fampridine-SR for the treatment of spasticity in SCI in 2004 and for the treatment of lower extremity motor dysfunction in people with MS in 2005. We plan to commercialize Fampridine-SR ourselves in the United States and Canada and with partners in various other markets throughout the rest of the world. We have received Orphan Drug designation from the FDA for Fampridine-SR for the treatment of both SCI and MS.
        Our second most advanced product candidate is valrocemide, which is currently in Phase 2 clinical trials for the treatment of epilepsy. Valrocemide is a small molecule drug with early Phase 2 clinical evidence of safety and efficacy as an add-on therapy for partial seizures, a type of epilepsy, and pre-clinical evidence of activity in animal models of epilepsy and neuropathic pain. We plan to move valrocemide into late Phase 2 clinical trials for epilepsy and early Phase 2 clinical trials for bipolar disorder in 2004. We may also pursue
3

clinical development of valrocemide for the treatment of neuropathic pain. Valrocemide is being co-developed and co-promoted with Teva Pharmaceutical Industries Ltd., or Teva, and its affiliates in the United States.
        We have a robust pipeline of pre-clinical programs targeting neurological dysfunction. These programs include two distinct myelin restoring therapies, Glial Growth Factor 2, which we refer to as GGF-2, and remyelinating antibodies. GGF-2 has been shown in various published studies to stimulate remyelination in animal models of MS and to have a variety of other effects in neural protection and repair. Our remyelinating antibody program involves monoclonal antibodies that have demonstrated the ability to stimulate repair of myelin in three different animal models of MS. We have also developed a chondroitinase program based on the concept of breaking down scar tissue that forms as a result of injury, which is believed to limit the regeneration of nerve fibers in the CNS. In addition, we have initiated a regenerative antibody program to identify novel approaches to stimulate nerve fiber regeneration in CNS. To support our research and development efforts, we have substantial laboratory capabilities employing both tissue culture methods and predictive animal models of SCI repair. These capabilities allow us to rapidly screen and validate potentially useful therapeutic approaches to SCI.
        Our product development programs include a patent portfolio comprised of 24 U.S. patents and 40 U.S. patent applications and numerous foreign counterparts, of which we are the assignee or have in-licensed.
 
 Our Focus
        Our core initial focus on the development of treatments for SCI has led, and we believe will continue to lead, to the identification and development of therapies applicable to other CNS disorders. Since many of the mechanisms of tissue damage and repair in SCI are shared by other conditions, such as MS, stroke and traumatic brain injury, our core technologies have potentially broad applicability for these and other CNS indications.
        Our strategy is to focus on the identification, development and marketing of a broad range of CNS therapeutics, using our scientific and clinical expertise in SCI as a strategic point of access. In order to implement this strategy, we plan to pursue the following initiatives:
•
complete the clinical development of, and obtain regulatory approval for, Fampridine-SR in SCI, MS and other neurological disorders;

•
complete the clinical development of, and obtain regulatory approval for, valrocemide in epilepsy, bipolar disorder and other neurological disorders;

•
continue to develop and advance our pipeline of other product candidates and programs to treat neurological disorders;

•
continue to in-license preclinical and clinical programs;

•
expand sales and marketing capabilities; and

•
pursue additional commercial alliances.
        To keep us apprised of the latest technological advances and help us identify and evaluate business development opportunities, we have established an advisory team and network of well-recognized scientists, clinicians and opinion leaders in the fields of SCI and MS. In addition, we have recruited 80 SCI rehabilitation centers and 24 MS rehabilitation centers in the United States and Canada to conduct our clinical trials. Our clinical management team has extensive experience in the areas of SCI and MS and works closely with this network.
4

 
 Corporate Information
        We were incorporated in 1995 as a Delaware corporation. Our principal executive offices are located at 15 Skyline Drive, Hawthorne, New York 10532. Our telephone number is (914) 347-4300. Our website is www.acorda.com . The information on our website is not part of this prospectus.
 
THE OFFERING

Common stock offered	 	            shares	
Common stock outstanding after this offering	 	            shares	
Use of proceeds	 	We intend to use the net proceeds of this offering for research and development, including preclinical development and clinical trials, marketing and for general corporate purposes. See "Use of Proceeds."	
Proposed Nasdaq National Market symbol	 	ACRD	
Risk factors	 	See "Risk Factors" and the other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in shares of our common stock.	
        The number of shares of common stock to be outstanding after this offering is based on the number of shares outstanding as of June 30, 2003 and assumes the following:
•
a one-for-12 reverse stock split that we intend to effect on the date of this prospectus;

•
the automatic conversion of all of our outstanding convertible preferred stock and mandatorily redeemable convertible preferred stock into 15,806,617 shares of common stock immediately prior to the consummation of this offering; and

•
no exercise of the underwriters' over-allotment option.
        In the table above, the number of shares of common stock outstanding after this offering excludes:
•
1,662,129 shares of common stock issuable upon the exercise of outstanding options and warrants to purchase our common stock, at a weighted average exercise price of $6.71 per share;

•
361,842 shares of common stock issuable upon conversion of outstanding convertible promissory notes; and

•
95,045 shares of common stock reserved for issuance under our stock option plan.
5

SUMMARY CONSOLIDATED FINANCIAL DATA
        The following table presents a summary of our historical financial information. You should read this information in conjunction with our consolidated financial statements and related notes and the information under "Selected Consolidated Financial Data" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" included elsewhere in this prospectus.

 	 	Year Ended June 30,
	 	Period from
March 17,
1995
(inception) to
June 30, 2003
	 	
 	 	1999
	 	2000
	 	2001
	 	2002
	 	2003
			 	
 	 	($ in thousands, except per share data)
	 	
Statement of Operations Data:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Grant revenue	 	$	1,036	 	$	756	 	$	462	 	$	132	 	$	474	 	$	3,637	 	
 	 		 		 		 		 		 		 	
Operating expenses incurred in the development stage:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	Research and development	 	 	3,083	 	 	4,777	 	 	6,142	 	 	11,146	 	 	17,527	 	 	46,175	 	
 	Research and development—Related party	 	 	1,152	 	 	2,024	 	 	2,223	 	 	4,687	 	 	2,265	 	 	32,351	 	
 	General and administrative	 	 	1,342	 	 	1,406	 	 	3,489	 	 	6,636	 	 	6,388	 	 	22,855	 	
 	 		 		 		 		 		 		 	
 	 	Total operating expenses	 	 	5,577	 	 	8,207	 	 	11,854	 	 	22,469	 	 	26,180	 	 	101,381	 	
 	 		 		 		 		 		 		 	
Operating loss	 	 	(4,541	)	 	(7,451	)	 	(11,392	)	 	(22,337	)	 	(25,706	)	 	(97,744	)	
 	 		 		 		 		 		 		 	
Other income (expense):	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	Interest expense	 	 	—	 	 	—	 	 	—	 	 	—	 	 	(78	)	 	(78	)	
 	Interest expense—Related party	 	 	(425	)	 	(448	)	 	(444	)	 	(408	)	 	(369	)	 	(2,580	)	
 	Interest income	 	 	611	 	 	1,001	 	 	1,824	 	 	984	 	 	393	 	 	5,038	 	
 	Other income	 	 	—	 	 	—	 	 	—	 	 	—	 	 	26	 	 	26	 	
 	 		 		 		 		 		 		 	
 	Total other income (expense)	 	 	186	 	 	553	 	 	1,380	 	 	576	 	 	(28	)	 	2,406	 	
 	 		 		 		 		 		 		 	
Minority interest—Related party	 	 	—	 	 	—	 	 	699	 	 	580	 	 	—	 	 	4,279	 	
 	 		 		 		 		 		 		 	
 	 	Net loss	 	 	(4,355	)	 	(6,898	)	 	(9,313	)	 	(21,181	)	 	(25,734	)	 	(91,059	)	
 	 		 		 		 		 		 		 	
Beneficial conversion feature, accretion of issuance costs, preferred dividends and fair value of warrants issued to convertible preferred stockholders	 	 	(18	)	 	(27	)	 	(36	)	 	(55	)	 	(23,793	)	 	(24,426	)	
 	 		 		 		 		 		 		 	
 	Net loss allocable to common stockholders	 	$	(4,373	)	$	(6,925	)	$	(9,349	)	$	(21,236	)	$	(49,527	)	$	(115,485	)	
 	 		 		 		 		 		 		 	
Net loss per share allocable to common stockholders—basic and diluted	 	$	(18.38	)	$	(29.34	)	$	(39.08	)	$	(86.05	)	$	(198.91	)	 	 	 	
 	 		 		 		 		 		 	 	 	 	
Pro forma net loss per share allocable to common stockholders—basic and diluted (unaudited)(1)	 	 	 	 	 	 	 	 	 	 	 	 	 	($	15.38	)	 	 	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 		 	 	 	 	
Weighted average shares of common stock outstanding used in computing net loss per share allocable to common stockholders—basic and diluted	 	 	232	 	 	236	 	 	239	 	 	247	 	 	249	 	 	 	 	
 	 		 		 		 		 		 	 	 	 	
Weighted average shares of common stock outstanding used in computing pro forma net loss per share allocable to common stock-holders—basic and diluted (unaudited)(1)(2)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	8,321	 	 	 	 	

(1)
The pro forma net loss per share and weighted average shares of common stock used in computing pro forma net loss per share allocable to common stockholders for the year ended June 30, 2003 are calculated as if all our convertible preferred stock and mandatorily redeemable convertible preferred stock were converted into common stock as of the beginning of the year ended June 30, 2003 or from their respective dates of issuance,
6

if issued after the beginning of the year. The pro forma net loss per share allocable to common stockholders has been computed assuming the offering was completed at the beginning of the fiscal year presented and has been adjusted to give effect to the following: (a) recognition of the unamortized portion of a beneficial conversion charge of $78.6 million; (b) recognition of the unamortized portion of issuance costs relating to Series E, Series I and Series J preferred stock of $479,000; and (c) reversal of accrued preferred dividends on Series J preferred stock of $630,000 (see Note 2 to the consolidated financial statements).
(2)
The weighted average shares of our common stock outstanding used in computing the pro forma net loss per share allocable to common stockholders is calculated based on the number of (a) Series A through Series I equivalent shares of common stock from the beginning of the fiscal year; (b) additional equivalent shares of common stock issuable under Series A through Series I, as a result of adjusting the conversion prices as a result of anti-dilution provisions as of the date of adjustment; and (c) Series J equivalent shares of common stock issuable from the date of issuance of the Series J preferred stock.
        The pro forma consolidated balance sheet data below reflects the assumed conversion of our outstanding convertible preferred stock and mandatorily redeemable convertible preferred stock into 15,806,617 shares of our common stock upon completion of this offering. The pro forma as adjusted consolidated balance sheet data below reflects the issuance and sale of            shares of our common stock in this offering at an initial public offering price of $    per share (the midpoint of the estimated initial public offering price range), after deducting the underwriter discounts and commissions and estimated offering expenses.

 	 	June 30, 2003
	
 	 	Actual
	 	Pro Forma
(unaudited)
	 	Pro Forma
as Adjusted
(unaudited)
	
 	 	($ in thousands)
	
Consolidated Balance Sheet Data:	 	 	 	 	 	 	 	 	
Cash and cash equivalents	 	$	48,319	 	$	48,319	 	 	
Restricted cash	 	 	253	 	 	253	 	 	
Short-term investments	 	 	12,250	 	 	12,250	 	 	
Working capital	 	 	58,975	 	 	58,975	 	 	
Total assets	 	 	64,807	 	 	64,807	 	 	
Deferred revenue	 	 	95	 	 	95	 	 	
Current portion of notes payable	 	 	310	 	 	310	 	 	
Non-current portion of notes payable	 	 	612	 	 	612	 	 	
Long-term convertible notes payable—principal amount plus accrued interest, less unamortized debt discount—Related party	 	 	7,907	 	 	7,907	 	 	
Mandatorily redeemable preferred stock	 	 	36,712	 	 	 	 	 	
Total stockholders' equity	 	$	16,803	 	$	53,515	 	 	
7

 RISK FACTORS
         An investment in our common stock involves a high degree of risk. You should carefully read and consider the risks described below before deciding to invest in our common stock. If any of the following risks actually occur, our business, financial condition, results of operation or cash flows could be materially harmed. In any such case, the trading price of our common stock could decline, and you could lose all or part of your investment. When determining whether to buy our common stock, you should also refer to the other information in this prospectus, including our consolidated financial statements and the related notes.
Risks Related To Our Business
We have a history of operating losses and may never be profitable
        As of June 30, 2003, we had an accumulated deficit of approximately $91.1 million. As a result of our significant research and development, clinical development, general and administrative, sales and marketing and business development expenses and the lack of any products to generate revenue, we have generated operating losses since our inception. We expect to continue to incur losses for at least the next several years and expect that our losses will increase as we expand our research and development activities and incur significant clinical testing costs. To date, our working capital has primarily been generated through financing activities consisting of the sale of shares of our preferred stock and the issuance of convertible debt securities.
        Our prospects for achieving profitability will depend on how successful we are in executing our business plan to:
•
obtain FDA approval for our late-stage product candidates;

•
market and commercialize our late-stage product candidates;

•
continue to develop and test our other existing product candidates; and

•
attract in-licensing and other business development opportunities, strategic partnerships and collaborative arrangements.
We cannot assure you when or if we will be successful in executing our business plan. If we are not successful, we may never generate revenues or achieve profitability.
The results of our late stage clinical trials may be insufficient to obtain FDA approval
        Positive results from preclinical studies and early clinical trials do not ensure positive results in more advanced clinical trials. If we are unable to demonstrate that a product candidate will be safe and effective in advanced clinical trials involving larger numbers of patients, we will be unable to submit the NDA, necessary to receive approval from the FDA to commercialize that product.
        Fampridine-SR is currently in Phase 3 clinical trials for the treatment of spasticity in SCI. We expect to have results from the Phase 3 clinical trials by the end of the first quarter of 2004 and expect to file our NDA shortly thereafter. If we fail to achieve the primary endpoints in our Phase 3 clinical trials or the results are ambiguous, we will have to determine whether to redesign our Fampridine-SR in SCI development program and protocols and continue with additional testing, or cease activities in this area. Redesigning the program could be extremely costly and time-consuming. A substantial delay in obtaining FDA approval or termination of the Fampridine-SR SCI program could result in a delay in our ability to generate revenue. We face the same risk of failure to meet our primary endpoints with respect to our Fampridine-SR in MS and valrocemide clinical trial programs.
8

Our product candidates are in various stages of development and may not be successfully developed or commercialized
        We currently do not sell any products. We are subject to the risk that some or all of our product candidates:
•
will be found to be ineffective or unsafe;

•
will not receive necessary regulatory approvals;

•
will be unable to get to market in a timely manner;

•
will not be capable of being produced in commercial quantities at reasonable costs;

•
will not be successfully marketed;

•
will be subject to post-market evaluations resulting in marketing restrictions or withdrawal of our product; or

•
will not be accepted by the patient and physician community.
        We cannot predict whether we will successfully develop and commercialize any of our product candidates, and the failure to do so would result in our inability to generate revenue.
If the FDA does not accept the measure we are using in our clinical trials for Fampridine-SR in MS, FDA approval for treatment of patients with MS will be significantly delayed
        We are using the Timed 25 Foot Walk to measure improvement in walking speed in people taking Fampridine-SR for MS in our Phase 2 clinical trials. To our knowledge, the FDA has not approved a drug based on this measure to date. Although the results of our Phase 2 clinical testing may demonstrate a statistically significant, clinically meaningful benefit to patients when using Fampridine-SR in MS, the FDA may decide that the Timed 25 Foot Walk is an insufficient measure to determine whether this product should receive FDA approval, and may require us to re-design our clinical trials using different measures. If we are required to identify new measures to test our primary endpoints, we will face substantial delays in our current timeline to commercialize and launch Fampridine-SR in MS and will incur additional costs associated with these activities. Any delays in regulatory approval will delay commercialization of Fampridine-SR in MS, which would harm our business prospects.
Our other product candidates are in early stages of development and may never be commercialized
        Research, development and pre-clinical testing are long, expensive and uncertain processes. Other than Fampridine-SR and valrocemide, none of our other product candidates have reached clinical trial testing. Our GGF-2 product candidate and our remyelinating antibodies are in pre-clinical testing. Our chondroitinase and regenerative antibodies programs are in the research stage. Our future success depends, in part, on our ability to complete pre-clinical development of our other product candidates and advance them to the clinical trials.
        Our product development programs may be curtailed, redirected or eliminated at any time for some or all of the following reasons:
•
adverse or ambiguous results;

•
undesirable side effects which delay or extend the trials;

•
inability to locate, recruit and qualify a sufficient number of patients for our trials;

•
regulatory delays or other regulatory actions;

•
difficulties in obtaining sufficient quantities of the particular product candidate or any other components needed for our preclinical testing or clinical trials;
9

•
change in the focus of our development efforts; and

•
re-evaluation of our clinical development strategy.
        If we are unsuccessful in advancing our early stage product candidates into clinical testing for any reason, our business prospects will be harmed.
Our product candidates may not gain market acceptance among physicians, patients and the medical community
        Even if we obtain regulatory approval for our products, market acceptance will depend on our ability to demonstrate to physicians and patients the benefits of our products in terms of safety, efficacy, convenience, ease of administration and cost effectiveness. In addition, we believe market acceptance depends on the effectiveness of our marketing strategy, the pricing of our products and the reimbursement policies of government and third-party payors. Physicians may not prescribe our products, and patients may determine, for any reason, that our product is not useful to them. If any of our product candidates fails to achieve market acceptance our ability to generate revenue will be limited.
If we fail to meet our obligations under our license agreements, or our agreements are terminated for any other reasons, we may lose our rights to in-licensed technologies
        We have licensed the rights for most of our products. We could lose the rights to Fampridine-SR, for example, in certain countries if we fail to file regulatory approvals or launch a product in such countries within specified periods, or if we fail to fulfill our payment obligations under the license agreement. Furthermore, if Elan were to file for bankruptcy in Ireland, there is the possibility that our licensed rights could be transferred, altered or terminated, or we could incur substantial expenses to keep our license effective. If we lose our rights to Fampridine-SR, our business and prospects would be materially harmed.
        Our rights to the development, use and marketing of all of our other product candidates are also governed by license agreements that we entered into with licensors of these technologies. Our failure to achieve milestones, or meet any of our financial or other obligations under these license agreements could result in the loss of our rights to these technologies. If we lose our rights under any of these license agreements, we would be unable to continue our product development programs, which may result in lost revenue and would harm our business prospects.
We depend upon Elan for the manufacture of Fampridine-SR, and other manufacturers for the manufacture of our other product candidates
        Our supply agreement with Elan obligates us to purchase at least 75% of our yearly supply of Fampridine-SR from Elan. We are in the process of qualifying a second manufacturing source in the event that Elan is unable or unwilling, due to financial difficulties or otherwise, to fulfill our manufacturing and supply needs. If we are unable to qualify a second manufacturing source, and Elan ceases to manufacture the product for us, we could experience substantial delays before we are able to qualify another supplier. Any significant delays in product shipments could slow the current progress of our clinical trials and, if we receive approval to commercialize Fampridine-SR, would materially adversely affect our ability to commercialize Fampridine-SR. In addition, if we do not purchase at least 100% of our requirements from Elan under the supply agreement we are required to make certain compensatory payments to Elan which could increase our total manufacturing costs.
        We are also substantially dependent upon Elan to complete the chemistry, manufacturing and controls section of the NDA for Fampridine-SR in SCI. If Elan fails to provide this section in a complete and timely manner we could incur delays in filing our NDA for Fampridine-SR in SCI.
10

        We are also wholly dependent on third parties to manufacture our other product candidates, including valrocemide. If we lose and are unable to replace these manufacturers, we will be unable to continue developing and testing our other product candidates.
If we must obtain the active pharmaceutical ingredient in Fampridine-SR from new suppliers, we may face serious delays in manufacturing Fampridine-SR
        We do not have direct contractual relationships with the suppliers of fampridine, the active pharmaceutical ingredient in Fampridine-SR, which we refer to as API. Currently, we rely on Elan's contracts with third parties to supply API. If Elan or an alternative manufacturer is unable to obtain API supplies from these suppliers for any reason, a new supplier would have to be identified. Although other suppliers of API are readily available, a change to a supplier that was not previously approved in our NDA may require formal approval by the FDA before we could use their API in our product. Any delays in obtaining API to manufacture Fampridine-SR would delay the commercialization of Fampridine-SR.
We do not have an internal sales force, and we will rely on a third party provider to assist us in commercializing Fampridine-SR
        We do not currently have our own internal sales force and will rely on third parties to commercialize Fampridine-SR. We have agreements with Cardinal Health and inChord Communications to use their RxPedite program to commercialize Fampridine-SR in SCI. The RxPedite program involves the development and implementation of a marketing plan to launch Fampridine-SR and provides for a sales force to market the product. We cannot assure you that the commercialization and marketing of our product through the RxPedite program will be successful . If our agreements with Cardinal and inChord are terminated for any reason, it could be time-consuming to identify another party to assist us, and we would be subject to a material disruption in our commercialization and marketing process. Without an active sales force, there could be serious delays in marketing Fampridine-SR. Disruption of the commercialization or marketing of Fampridine-SR would have a material adverse effect on our ability to generate revenues.
Our success in developing our product candidates depends upon the performance of our licensees and collaborative partners
        Our efforts to develop, obtain regulatory approval for and commercialize our existing and any future product candidates depend in part upon the performance of our licensees and collaborative partners. Currently, we have license and collaborative agreements with Elan, Rush-Presbyterian St. Luke's Medical Center, Teva, Canadian Spinal Research Organization, Cornell Research Foundation, Inc., Mayo Clinic Foundation and CeNeS Pharmaceuticals plc. We do not have day-to-day control over the activities of our licensees or collaborative partners and cannot assure you that they will fulfill their obligations to us. Further, our licensees and collaborators may encounter conflicts of interest, changes in business strategy or other business issues, or they may acquire or develop rights to competing products, all of which could limit our ability to commercialize our product candidates.
        Any failure on the part of our licensees or collaborators to perform or satisfy their obligations to us could lead to delays in the development or commercialization of our product candidates and affect our ability to realize product revenues. Disagreements with our licensees or collaborators could require or result in litigation or arbitration, which could be time-consuming and expensive. If we fail to maintain our existing agreements or establish new agreements as necessary, we could be required to undertake development, manufacturing and commercialization activities solely at our own expense. This would significantly increase our capital requirements and may also delay the commercialization of our product candidates.
11

If we fail to manage our growth, our business could be harmed
        If we are unable to manage our growth effectively, our business could be materially adversely affected. For example, pursuant to our agreement with Cardinal, we have an option to acquire the Fampridine-SR dedicated sales force provided by the RxPedite program in the future. Assimilation of this sales force into our operations would require us to assume the administrative burden of managing our own sales operations. Our inability to successfully assimilate this sales force, or manage rapid growth in other areas, could materially adversely affect our business.
The loss of our key management and scientific personnel may hinder our ability to execute our business plan
        As a small company with 68 employees, our success depends on the continuing contributions of our management team and scientific personnel, and maintaining relationships with the members of our Scientific Advisory Board and the network of centers in the United States and Canada that conducts our clinical trials. We are highly dependent on the services of Dr. Ron Cohen, our Chairman, President and Chief Executive Officer, as well as the other principal members of our management and scientific staff. Our success depends in large part upon our ability to attract and retain highly qualified personnel. We face intense competition in our hiring efforts with other pharmaceutical and biotechnology companies, as well as universities and nonprofit research organizations, and we may have to pay higher salaries to attract and retain qualified personnel. The loss of one or more of such individuals, or our inability to attract additional qualified personnel, could substantially impair our ability to implement our business plan.
If we cannot protect our intellectual property, our ability to develop and commercialize our products will be severely limited
        Our success will depend in part on our and our licensors' ability to obtain, maintain and enforce patent protection for each party's technologies, compounds and products, if any, resulting from these technologies. Without protection for the intellectual property we use, other companies could offer substantially identical products for sale without incurring the sizable discovery, development and licensing costs that we have incurred. Our ability to recover these expenditures and realize profits upon the sale of products could be diminished.
        We have patent applications filed and pending in the United States and abroad for our own technologies, and for technologies that we have developed from our in-licensed programs. The process of obtaining patents can be time consuming and expensive with no certainty of success. Even if we spend the necessary time and money, a patent may not issue or it may insufficiently protect the technology it was intended to protect. We can never be certain that we were the first to develop the technology or that we were the first to file a patent application for the particular technology because many U.S. patent applications are confidential until a patent issues, and publications in the scientific or patent literature lag behind actual discoveries. The degree of future protection for our proprietary rights will remain uncertain if our pending patent applications are not approved for any reason or if we are unable to develop additional proprietary technologies that are patentable. Furthermore, third parties may independently develop similar or alternative technologies, duplicate some or all of our technologies, design around our patented technologies or challenge our issued patents or the patents of our licensors.
        In any litigation where our patents or our licensors' patents are asserted, a court may determine that the patents are invalid or unenforceable. Even if the validity or enforceability of these patents is upheld by a court, a court may not prevent alleged infringement on the grounds that such activity is not covered by the patent claims. Any litigation, whether to enforce our rights to use our or our licensors' patents or to defend against allegations that we infringe third party rights, will be costly, time consuming, and may distract management from other important tasks.
12

        As is commonplace in the biotechnology and pharmaceutical industry, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. To the extent our employees are involved in research areas which are similar to those areas in which they were involved at their former employers, we may be subject to claims that such employees and/or we have inadvertently or otherwise used or disclosed the alleged trade secrets or other proprietary information of the former employers. Litigation may be necessary to defend against such claims, which could result in substantial costs and be a distraction to management and which may have a material adverse effect on us, even if we are successful in defending such claims.
        We also rely in our business on trade secrets, know-how and other proprietary information. We seek to protect this information, in part, through the use of confidentiality agreements with employees, consultants, advisors and others. Nonetheless, we cannot assure you that those agreements will provide adequate protection for our trade secrets, know-how or other proprietary information and prevent their unauthorized use or disclosure. To the extent that consultants, key employees or other third parties apply technological information independently developed by them or by others to our proposed products, disputes may arise as to the proprietary rights to such information which may not be resolved in our favor. The risk that other parties may breach confidentiality agreements or that our trade secrets become known or independently discovered by competitors, could adversely affect us by enabling our competitors, who may have greater experience and financial resources to copy or use our trade secrets and other proprietary information in the advancement of their products, methods or technologies.
Our success also depends on our ability to operate and commercialize products without infringing on the patents or proprietary rights of others
        Third parties may claim that we or our licensors or suppliers are infringing their patents or are misappropriating their proprietary information. In the event of a successful claim against us or our licensors or suppliers for infringement of the patents or proprietary rights of others, we may be required to:
•
pay substantial damages;

•
stop using our technologies;

•
stop certain research and development efforts;

•
develop non-infringing products or methods; and

•
obtain one or more licenses from third parties.
A license required under any such patents or proprietary rights may not be available to us, or may not be available on acceptable terms. If we or our licensors or suppliers are sued for infringement we could encounter substantial delays in, or be prohibited from developing, manufacturing and commercializing our product candidates.
Our operations could be curtailed if we are unable to obtain additional financing on favorable terms, if at all
        On June 30, 2003, after giving effect to this offering on a pro forma as adjusted basis, we would have had approximately $            million in cash, cash equivalents and short-term investments. We anticipate this will be sufficient to fund our operations for at least the next 18 months. Our product candidates are in various stages of development, and all will require significant further investment to develop, test and obtain regulatory approval prior to commercialization. We may need to seek additional financing to continue our product development activities, and could require substantial funding to commercialize any of the products that we successfully develop. We do not currently have any funding commitments or arrangements with third parties to provide funding. We may not be able to raise additional capital on favorable terms, if at all.
13

        To the extent that we are able to raise additional capital through the sale of equity securities, the issuance of those securities could result in dilution to our stockholders. In addition, if we incur debt financing, we will be required to make cash payments to the principal and interest on such indebtedness, which could substantially reduce our cash balance. If we are unable to successfully commercialize Fampridine-SR, introduce other product candidates, or otherwise obtain sufficient financing on favorable terms when and if needed, we may be required to reduce, defer or discontinue one or more of our product development programs. Our inability to continue development of any one or more of our product candidates may result in reduced revenue, which could harm our business prospects.
The pharmaceutical industry is subject to stringent regulation, and failure to obtain regulatory approval will prevent commercialization of our products
        Our research, development, preclinical and clinical trial activities and the manufacture and marketing of any products that we may successfully develop are subject to an extensive regulatory approval process by the FDA and other regulatory agencies abroad. The process of obtaining required regulatory approvals for drugs is lengthy, expensive and uncertain, and any such regulatory approvals may entail limitations on the indicated usage of a drug, which may reduce the drug's market potential.
        In order to obtain FDA approval to commercialize any product candidate, an NDA must be submitted to the FDA demonstrating, among other things, that the product candidate is safe and effective for use in humans for each target indication. Our regulatory submissions may be delayed, or we may cancel plans to make submissions for product candidates for a number of reasons, including:
•
negative or ambiguous preclinical or clinical trial results;

•
changes in regulations or the adoption of new regulations;

•
unexpected technological developments; and

•
developments by our competitors that are more effective than our product candidates.
        Consequently, we cannot assure you that we will make our submissions to the FDA in the timeframe that we have planned, or at all, or that our submissions will be approved by the FDA. Even if regulatory clearance is obtained, post-market evaluation of our products, if required, could result in restrictions on our product's marketing or withdrawal of our product from the market as well as possible civil and criminal sanctions.
        Clinical trials are subject to oversight by institutional review boards and the FDA to ensure compliance with the FDA's good clinical practice regulations, as well as other requirements for good clinical practices. We depend, in part, on third-party laboratories and medical institutions to conduct preclinical studies and clinical trials for our products and other third-party organizations to perform data collection and analysis, all of which must maintain both good laboratory and good clinical practices. If any such standards are not complied with in our clinical trials, the FDA may suspend or terminate such trial, which would severely delay our development and possibly end the development of such product candidate. We also currently and in the future will depend upon third party manufacturers of our products to comply with Good Manufacturing Practices. We cannot be certain that our present or future manufacturers and suppliers will comply with current Good Manufacturing Practices. The failure to comply with Good Manufacturing Practices may result in restrictions in the sale of, or withdrawal of the products from the market. Compliance by third parties with these standards and practices are outside of our direct control.
        In addition, we are subject to regulation under state and federal laws, including requirements regarding occupational safety, laboratory practices, environmental protection and hazardous substance control, and may be subject to other local, state, federal and foreign regulation. We cannot predict the impact of such regulation on us, although it could impose significant restrictions on our business and additional expenses to comply.
14

If our competitors develop and market products that are more effective than ours, or obtain marketing approval before we do, our commercial opportunity will be reduced or eliminated
        Competition in the pharmaceutical and biotechnology industries is intense and is expected to increase. Several biotechnology and pharmaceutical companies, as well as academic laboratories, universities and other research institutions, are involved in research and/or product development for various treatments for SCI, MS, epilepsy and bipolar disorder. For example, we are aware that Aventis is developing a sodium/potassium channel blocker, HP 184, with a potential indication in SCI. We believe that HP 184 is now in clinical trials and any resulting product could compete with Fampridine-SR. Many of our competitors have significantly greater research and development capabilities, experience in obtaining regulatory approvals and manufacturing, marketing, financial and managerial resources than we have.
        Our competitors may succeed in developing products that are more effective than the ones we have under development or that render our proposed products or technologies noncompetitive or obsolete. In addition, certain of such competitors may achieve product commercialization before we do. If any of our competitors develop a product that is more effective, or are able to obtain FDA approval for commercialization before we do, we may not be able to achieve significant market acceptance, which would have a material adverse effect on our business.
        Our products will also compete with numerous drugs used to treat symptoms related to SCI and MS. Although the mechanism by which Fampridine-SR works to treat patients is different than current treatments, these treatments are well-known and widely prescribed by health care providers who may be reluctant to prescribe a new product to their patients.
        Valrocemide is a new chemical entity derived from valproic acid, which is a commonly used anti-epileptic drug for the treatment of most seizure types. If valrocemide is not shown to have similar or better efficacy than valproic acid, and a more favorable side effect profile, the commercialization of the product may not be successful.
We face an inherent risk of liability in the event that the use or misuse of our products result in personal injury or death
        The use of our product candidates in clinical trials, and the sale of any approved products, may expose us to product liability claims, which could result in financial losses. Our clinical liability insurance coverage may not be sufficient to cover claims that may be made against us. In addition, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts or scope to protect us against losses. Any claims against us, regardless of their merit, could severely harm our financial condition, strain our management and other resources and adversely impact or destroy the prospects for commercialization of the product which is the subject of any such claim.
If we use biological and hazardous materials in a manner that causes injury, we may be liable for damages
        Our research and development activities involve the controlled use of potentially harmful biological materials, hazardous materials and chemicals, and are subject to federal, state and local laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. We cannot completely eliminate the risk of accidental contamination or injury from the use, storage, handling or disposal of these materials. If we fail to comply with environmental regulations, we could be subject to criminal sanctions and/or substantial liability for any damages that result, and any liability could exceed our resources.
Healthcare reform and restrictions on reimbursements may limit our financial returns
        Our ability to successfully commercialize our products may depend in part on the extent to which government health administration authorities, private health insurers and other third party payors will reimburse consumers for the cost of these products. Third party payors are increasingly challenging both the need for and the price of novel therapeutic drugs and uncertainty exists as to the reimbursement status of newly approved therapeutics. Adequate third party reimbursement may not be available for our drug products to enable us to maintain price levels sufficient to realize an appropriate return on our investments in research and product development, which could restrict our ability to commercialize that particular drug.
15

 Risks Relating To The Offering
Our stock price may be volatile, and you may not be able to resell your shares at or above the initial offering price
        Prior to this offering, there has been no public market for our common stock. We cannot predict the extent to which investor trading will lead to the development of an active and liquid trading market in our common stock. The initial public offering price of our common stock was determined by negotiations between the representatives of the underwriters and us and may not be indicative of future market prices. The market price for our common stock may decline below the initial offering price. Our stock price may experience substantial fluctuations and could fluctuate significantly due to a number of factors, including:
•
sales of substantial amounts of our stock;

•
announcements about us or about our competitors;

•
publicity regarding actual or potential medical results relating to products under development by us or our competitors;

•
conditions or trends in the pharmaceutical or biotechnology industries;

•
litigation and other developments relating to patents or other proprietary rights or those of our competitors;

•
governmental regulation and legislation in the United States and foreign countries;

•
change in securities analysts' estimates of our performance, or our failure to meet analysts' expectations; and

•
variations in our anticipated or actual operating results.
        Many of these factors are beyond our control. In addition, the stock markets in general, and Nasdaq and the market for biotechnological companies in particular, have experienced extreme price and volume fluctuations recently. These fluctuations often have been unrelated or disproportionate to the operating performance of these companies. These broad market and industry factors may adversely affect the market price of our common stock, regardless of our actual operating performance.
As a new investor, you will experience immediate and substantial dilution in the net tangible book value of your investment
        Investors purchasing shares of our common stock in this offering will pay more for their shares than the amount paid by existing stockholders who acquired shares prior to this offering. Accordingly, if you purchase common stock in this offering, you will incur immediate dilution in pro forma net tangible book value of approximately $        per share. If the holders of outstanding options or warrants exercise these options or warrants, you will incur further dilution. See "Dilution."
Future sales of our common stock, or the perception that these sales may occur, could adversely impact our stock price
        Sales of substantial amounts of our common stock in the public market after this offering, including sales of our common stock by existing stockholders pursuant to Rule 144 under the Securities Act and sales of common stock issued upon the exercise of outstanding stock options and warrants, could adversely affect the price of our common stock. After the consummation of this offering, our current stockholders will be subject to a 180-day lock up on the sale of their shares. After the lock-up expires, at least 5,649,379 shares of our common stock will become freely tradable, 10,406,232 shares of common stock will be tradable subject to Rule 144, and holders of 15,806,616 shares of our common stock will have rights to cause us to file a registration statement on their behalf and to include their shares in registration statements that we may file on
16

our behalf or on behalf of other stockholders. By exercising their registration rights, and selling a large number of shares, these holders could cause the price of our common stock to decline.
We will have broad discretion regarding the use of proceeds from this offering
        Our management will have broad discretion in utilizing the proceeds from this offering and may use the proceeds in ways with which you may disagree. We may use the proceeds for corporate purposes that do not immediately enhance our prospects for the future or increase the value of your investment.
Provisions in Delaware law and our charter may prevent or delay a change of control, even if that change of control may be beneficial to our stockholders
        We are subject to the Delaware anti-takeover laws regulating corporate takeovers. These anti-takeover laws prevent Delaware corporations from engaging in business combinations with any stockholder, including all affiliates and associates of the stockholder, who owns 15% or more of the corporations' outstanding voting stock, for three years following the date that the stockholder acquired 15% or more of the corporation's voting stock unless specified conditions are met, as further described in "Description of Capital Stock".
        Following this offering, our charter will provide for a classified board of directors, which may have the effect of preventing or hindering any attempt by our stockholders to replace our current directors. In addition, our charter will authorize us to issue 1,000,000 shares of undesignated preferred stock with such preferences, rights and terms as our board of directors determines. Our board of directors may grant specific rights to future holders of our preferred stock that could be used to hinder a takeover attempt by a third party.
17

FORWARD-LOOKING STATEMENTS
        This prospectus, including the sections entitled "Summary," "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations," and "Business," contains forward-looking statements. These statements relate to future events or to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. In some cases, you can identify forward-looking statements by the use of words such as "may," "could," "expect," "intend," "plan," "seek," "anticipate," "believe," "estimate," "predict," "potential," "continue," or the negative of these terms or other comparable terminology. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could materially affect actual results, levels of activity, performance or achievements. Factors that may cause actual results to differ materially from current expectations, which we describe in more detail elsewhere in this prospectus under the heading "Risk Factors", include, but are not limited to:
•
unfavorable results of our product candidate development efforts;

•
unfavorable results of our pre-clinical testing;

•
delays in obtaining FDA approvals;

•
increased regulation by the FDA and other agencies;

•
the outcome of plans for manufacturing, sales and marketing;

•
the introduction of competitive products;

•
impairment of license, patent or other proprietary rights;

•
failure to achieve market acceptance of our products;

•
the impact of present and future collaborative agreements;

•
failure to implement our strategy; and

•
deteriorating financial performance.
        If one or more of these or other risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary significantly from what we projected. Any forward-looking statement you read in this prospectus reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, growth strategy and liquidity. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
        The safe harbor for forward-looking statements contained in the Securities Litigation Reform Act of 1995 protects companies from liability for their forward looking statements if they comply with the requirements of the Act. The Act does not provide this protection for initial public offerings.
18

USE OF PROCEEDS
        We estimate that we will receive approximately $            million in net proceeds from the sale of our common stock in this offering, or approximately $            million if the underwriters' over-allotment option is exercised in full, based on an assumed initial public offering price of $    per share (the midpoint of the estimated initial public offering price range) after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.
        We intend to use the proceeds of this offering:
•
for research and development, including pre-clinical development, clinical trials and the preparation and submission of the Fampridine-SR NDA;

•
in connection with Fampridine-SR marketing activities; and

•
for general corporate purposes, including working capital and the possible acquisition of pharmaceutical products and businesses that are complementary to our own. Currently, we have no specific plans or commitments with respect to any acquisitions.
        The amount and timing of our actual expenditures will depend on numerous factors, including the progress of our research and development activities, the progress of our clinical trials and regulatory approval process, the number and breadth of our product development programs, our ability to maintain our manufacturing and marketing collaborations and other arrangements, and any in-licensing and acquisition activities. Accordingly, we will retain broad discretion in the allocation and use of the proceeds of this offering.
        Pending application of the net proceeds, we intend to invest them in short-term, investment-grade, interest-bearing instruments.
DIVIDEND POLICY
        We have never declared or paid any cash dividends on our common stock. We currently intend to retain our future earnings, if any, to finance the further development and expansion of our business and do not intend to pay cash dividends for the foreseeable future. Any future determination to pay dividends will be at the discretion of our board of directors and will depend on our financial condition, results of operations, capital requirements, restrictions contained in current or future financing instruments and other factors our board of directors deems relevant.
19

CAPITALIZATION
        The following table sets forth our cash, cash equivalents and short-term investments and capitalization as of June 30, 2003:
•
on an actual basis giving retroactive effect to the one-for-12 reverse stock split;

•
on a pro forma basis to give effect to the automatic conversion of all of our outstanding convertible preferred stock and mandatorily redeemable convertible preferred stock into 15,806,617 shares of common stock upon the closing of this offering; and

•
on a pro forma as adjusted basis to give effect to the net proceeds from the sale of            shares of common stock in this offering at an assumed initial public offering price of $            per share (the midpoint of the estimated initial public offering price range) and after deducting the underwriting discounts and commissions and estimated offering expenses.

 	 	As of June 30, 2003
	
 	 	Actual
	 	Pro Forma
	 	Pro Forma
As Adjusted
	
 	 	($ in thousands, except per
share amounts)
	
Cash, cash equivalents and short-term investments	 	$	60,570	 	$	60,570	 	$	 	
 	 		 		 		
Long-term portion of notes payable	 	 	612	 	 	612	 	$	 	

Long-term convertible notes payable—principal amount plus accrued interest, less unamortized debt discount-Related party	
 	
$	
7,907	
 	
$	
7,907	
 	
$	

Mandatorily Redeemable Convertible Preferred Stock, $.001 par value:
7,472,612 shares of Series E convertible preferred stock authorized, issued and outstanding at June 30, 2003; 10,204,047 shares of Series I convertible preferred stock authorized, issued and outstanding at June 30, 2003; 112,790,246 shares of Series J convertible preferred stock authorized, issued and outstanding at June 30, 2003; 0 shares authorized, issued and outstanding on a pro forma and pro forma as adjusted basis	 	 	36,712	 	 	—	 	 	 	
 	 		 		 		
Stockholders' equity (deficit):	 	 	 	 	 	 	 	 	 	
 	Non-redeemable Convertible Preferred Stock, $.001 par value: 1,306,068 shares of Series A convertible preferred stock; 900,000 shares of Series B convertible preferred stock; 333,333 shares of Series C convertible preferred stock; 0 shares of Series D preferred stock; 2,300,000 shares of Series F convertible preferred stock; 0 shares of Series G preferred stock; 1,575,229 shares of Series H convertible preferred stock; 0 shares issued and outstanding on a pro forma and pro forma as adjusted basis	 	 	6	 	 	—	 	 	 	
 	Common stock, $.001 par value; 260,000,000 shares authorized at June 30, 2003 and 75,000,000 shares authorized on a pro forma and on a pro forma as adjusted basis; 248,994 shares issued and outstanding at June 30, 2003, 16,055,611 on a pro forma basis and            on a pro forma as adjusted basis, respectively	 	 	—	 	 	16	 	 	 	
 	 		 		 		
 	Additional paid-in capital	 	 	107,862	 	 	144,564	 	 	 	
 	 		 		 		
 	Deficit accumulated during the development stage	 	 	(91,059	)	 	(91,059	)	 	 	
 	 		 		 		
 	Other comprehensive loss	 	 	(6	)	 	(6	)	 	 	
 	 		 		 		
 	 	Total stockholders' equity	 	 	16,803	 	 	53,515	 	 	 	
 	 		 		 		
 	 	Total capitalization	 	$	62,034	 	$	62,034	 	$	 	
 	 		 		 		
The table above does not include the following amounts as of June 30, 2003:
•
287,132 shares of common stock issuable upon the exercise of outstanding options and warrants to purchase our common stock, at a weighted average exercise price of $10.69 per share;

•
361,842 shares of common stock issuable upon conversion of outstanding convertible promissory notes; and

•
1,470,042 shares of common stock reserved for issuance under our stock option plan.
20

 DILUTION
        Our pro forma net tangible book value as of June 30, 2003 was approximately $    million, or approximately $    per share based on 16,055,611 shares of common stock outstanding as of June 30, 2003, calculated after giving effect to the automatic conversion of all of our outstanding convertible preferred stock and mandatorily redeemable convertible preferred stock into 15,806,617 shares of common stock upon the closing of this offering. Pro forma net tangible book value per share represents our total tangible assets reduced by our total liabilities and divided by the number of shares of common stock outstanding. Dilution in pro forma net tangible book value per share represents the difference between the amount per share that you pay in this offering and the pro forma as adjusted net tangible book value per share immediately after this offering.
        Our pro forma as adjusted net tangible book value per share as of June 30, 2003 would have been approximately $    million, or approximately $    per share after giving effect to the receipt of the estimated net proceeds from the sale by us of            shares. This represents an immediate increase in net tangible book value of $    per share to existing stockholders and an immediate decrease in net tangible book value per share of $        to you. The following table illustrates the dilution.

Assumed initial public offering price per share	 	 	 	 	$	 	
 	Pro forma net tangible book value per share as of June 30, 2003	 	$	 	 	 	 	
 	Increase in net tangible book value per share attributable to new investors	 	 	 	 	 	 	
 	 		 	 	 	
Pro forma as adjusted net tangible book value per share after the offering	 	 	 	 	 	 	
 	 	 	 	 		
Dilution per share to new investors	 	$	 	 	 	 	
 	 		 	 	 	
        The following table sets forth, as of June 30, 2003, on a pro forma basis, the difference between the holders set forth below with respect to the number of shares of common stock purchased from us, the total consideration paid to us, and the average price per share paid.

 	 	Shares Purchased
	 	Total Consideration
	 	 	
 					 	Average Price
Per Share
	
 	 	Number
	 	%
	 	Amount
	 	%
			
Existing stockholders	 	 	 	 	 	$	 	 	 	%	$	 	
New investors(1)	 	 	 	 	 	 	 	 	 	 	 	 	
Option holders(2)	 	 	 	 	 	 	 	 	 	 	 	 	
 	 		 		 		 		 		
Total	 	 	 	 	%	$	 	 	 	%	 	 	

(1)
Before the underwriters' commissions and our expenses.

(2)
Excludes            shares of our common stock issuable upon exercise of options expected to be granted to our officers, directors and employees in connection with this offering and            shares of our common stock issuable upon the exercise of options previously granted to our officers and directors.
        The foregoing discussion and tables are based upon the number of shares issued and outstanding as of June 30, 2003 and excludes:
•
361,842 shares of common stock issuable upon conversion of outstanding convertible promissory notes; and

•
1,470,042 shares of common stock reserved for issuance under our stock option plan.
        The issuance of additional common stock will result in further dilution to new investors.
        If the underwriters' over-allotment option is exercised in full, the number of shares of our common stock held by existing stockholders will be reduced to          ,       % of the aggregate number of shares of our common stock outstanding after this offering, and the number of shares of common stock held by new investors will be increased to             or      % of the aggregate number of shares of common stock outstanding after this offering.
21

SELECTED CONSOLIDATED FINANCIAL AND OPERATING DATA
        The selected consolidated statement of operations data for the years ended June 30, 2001, 2002 and 2003 and the selected consolidated balance sheet data presented below as of June 30, 2002 and 2003 have been derived from our consolidated financial statements included in this prospectus other than the pro forma financial information, which consolidated financial statements have been audited by KPMG LLP, independent auditors. The selected consolidated statement of operations data presented below for the years ended June 30, 1999 and 2000 and selected consolidated balance sheet data presented below as of June 30, 1999, 2000 and 2001 have been derived from our audited Consolidated Financial Statements not included herein.
        This data should be read in conjunction with our "Management's Discussion and Analysis of Financial Condition and Results of Operations" and our Consolidated Financial Statements and the related notes included elsewhere in this prospectus.

 	 	 	 	 	 	 	 	 	 	 	 	Period from
March 17,
1995
(inception)
to June 30,
2003
	 	
 	 	Year Ended June 30,
			 	
Statement of Operations Data:
	 	1999
	 	2000
	 	2001
	 	2002
	 	2003
			 	
 	 	($ in thousands, except per share data)
	 	
Grant revenue	 	$	1,036	 	$	756	 	$	462	 	$	132	 	$	474	 	$	3,637	 	
 	 		 		 		 		 		 		 	
Operating expenses incurred in the development stage:	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	Research and development	 	 	3,083	 	 	4,777	 	 	6,142	 	 	11,146	 	 	17,527	 	 	46,175	 	
 	Research and development—Related party	 	 	1,152	 	 	2,024	 	 	2,223	 	 	4,687	 	 	2,265	 	 	32,351	 	
 	General and administrative	 	 	1,342	 	 	1,406	 	 	3,489	 	 	6,636	 	 	6,388	 	 	22,855	 	
 	 		 		 		 		 		 		 	
 	 	Total operating expenses	 	 	5,577	 	 	8,207	 	 	11,854	 	 	22,469	 	 	26,180	 	 	101,381	 	
 	 		 		 		 		 		 		 	
Operating loss	 	 	(4,541	)	 	(7,451	)	 	(11,392	)	 	(22,337	)	 	(25,706	)	 	(97,744	)	
 	 		 		 		 		 		 		 	
Other income (expense):	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Interest expense	 	 	—	 	 	—	 	 	—	 	 	—	 	 	(78	)	 	(78	)	
 	 	Interest expense—Related party	 	 	(425	)	 	(448	)	 	(444	)	 	(408	)	 	(369	)	 	(2,580	)	
 	 	Interest income	 	 	611	 	 	1,001	 	 	1,824	 	 	984	 	 	393	 	 	5,038	 	
 	 	Other income	 	 	—	 	 	—	 	 	—	 	 	—	 	 	26	 	 	26	 	
 	 		 		 		 		 		 		 	
 	 	Total other income (expense)	 	 	186	 	 	553	 	 	1,380	 	 	576	 	 	(28	)	 	2,406	 	
 	 		 		 		 		 		 		 	
Minority interest—Related party	 	 	—	 	 	—	 	 	699	 	 	580	 	 	—	 	 	4,279	 	
 	 		 		 		 		 		 		 	
 	 	Net loss	 	 	(4,355	)	 	(6,898	)	 	(9,313	)	 	(21,181	)	 	(25,734	)	 	(91,059	)	
 	 		 		 		 		 		 		 	
Beneficial conversion feature, accretion of issuance costs preferred dividends and fair value of warrants issued to convertible preferred stockholders	 	 	(18	)	 	(27	)	 	(36	)	 	(55	)	 	(23,793	)	 	(24,426	)	
 	 		 		 		 		 		 		 	
 	 	Net loss allocable to common stockholders	 	$	(4,373	)	$	(6,925	)	$	(9,349	)	$	(21,236	)	$	(49,527	)	$	(115,485	)	
 	 		 		 		 		 		 		 	
Net loss per share allocable to common stockholders—basic and diluted	 	$	(18.83	)	$	(29.34	)	$	(39.08	)	$	(86.05	)	$	(198.91	)	 	 	 	
 	 		 		 		 		 		 	 	 	 	
Pro forma net loss per share allocable to common stockholders—basic and diluted (unaudited)(1)	 	 	 	 	 	 	 	 	 	 	 	 	 	$	(15.38	)	 	 	 	
Weighted average shares of common stock outstanding used in computing net loss per share allocable to common stockholders—basic and diluted	 	 	232	 	 	236	 	 	239	 	 	247	 	 	249	 	 	 	 	
 	 		 		 		 		 		 	 	 	 	
Weighted average shares of common stock outstanding used in computing pro forma net loss per share allocable to common stockholders—basic and diluted (unaudited)(1)(2)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	8,321	 	 	 	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 		 	 	 	 	
Footnotes on next page
22

(1)
The pro forma net loss per share and weighted average shares of common stock used in computing pro forma net loss per share allocable to common stockholders for the year ended June 30, 2003 are calculated as if all our convertible preferred stock and mandatorily redeemable convertible preferred stock were converted into common stock as of the beginning of the year ended June 30, 2003 or from their respective dates of issuance, if issued after the beginning of the year. The pro forma net loss per share allocable to common stockholders has been computed assuming the offering was completed at the beginning of the fiscal year presented and has been adjusted to give effect to the following: (a) recognition of the unamortized portion of a beneficial conversion charge of $78.6 million; (b) recognition of the unamortized portion of issuance costs relating to Series E, Series I and Series J preferred stock of $479,000; and (c) reversal of accrued preferred dividends on Series J preferred stock of $630,000 (see Note 2 to the consolidated financial statements).

(2)
The weighted average shares of our common stock outstanding used in computing the pro forma net loss per share allocable to common stockholders is calculated based on (a) Series A through Series I equivalent shares of common stock from the beginning of the fiscal year; (b) additional equivalent shares of common stock issuable under Series A through Series I as a result of adjusting the conversion prices as a result of anti-dilution provisions as of the date of adjustment; and (c) Series J equivalent shares of common stock issuable from the date of issuance of the Series J preferred stock.

 	 	As of June 30,
	
Consolidated Balance Sheet Data:
	 	1999
	 	2000
	 	2001
	 	2002
	 	2003
	
 	 	($ in thousands)
	
Cash and cash equivalents	 	$	16,862	 	$	17,193	 	$	48,083	 	$	27,012	 	$	48,319	
Restricted Cash	 	 	—	 	 	232	 	 	243	 	 	250	 	 	253	
Short-term investments	 	 	—	 	 	—	 	 	—	 	 	2,836	 	 	12,250	
Working capital	 	 	16,873	 	 	15,894	 	 	46,115	 	 	27,097	 	 	58,975	
Total assets	 	 	17,487	 	 	18,260	 	 	50,349	 	 	33,597	 	 	64,807	
Deferred revenue	 	 	—	 	 	—	 	 	—	 	 	—	 	 	95	
Current portion of notes payable	 	 	—	 	 	—	 	 	—	 	 	—	 	 	310	
Non-current portion of notes payable	 	 	—	 	 	—	 	 	—	 	 	—	 	 	612	
Long-term convertible notes payable—principal amount plus accrued interest, less unamortized debt discount—Related party	 	 	6,239	 	 	6,687	 	 	7,131	 	 	7,538	 	 	7,907	
Mandatorily redeemable preferred stock	 	 	19,985	 	 	20,012	 	 	59,604	 	 	59,659	 	 	36,712	
Total stockholders' equity (deficit)	 	 	(9,045	)	 	(10,438	)	 	(19,041	)	 	(36,910	)	 	16,803	
23

 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
        The following discussion and analysis of our consolidated financial condition and results of operations should be read in conjunction with our audited consolidated financial statements and related notes included in this prospectus. This discussion and analysis contains forward-looking statements that are subject to risks, uncertainties and other factors, including, but not limited to, those discussed under "Risk Factors" and elsewhere in this prospectus, that could cause our actual results, performance, prospects or opportunities to differ materially from those expressed in, or implied by, these forward-looking statements. See "Forward-Looking Statements".
Background
        Since we commenced operations in 1995, we have devoted substantially all of our resources to the identification, development and commercialization of novel therapies that improve neurological function in people with SCI, MS and related disorders of the CNS. Our current lead product candidate targets the treatment of a wide range of disorders affecting individuals with SCI and MS, including spasticity, muscle weakness, loss of bowel and bladder control and sexual dysfunction. Our pipeline currently includes one product in Phase 3 clinical trials, two products in Phase 2 clinical trials and multiple pre-clinical products.
Revenue
        We have not generated any revenue from product sales since our inception. If our development efforts result in clinical success, regulatory approval and successful commercialization of our products, we would expect to generate revenue from sales of our products, in-licensed products and from receipt of royalties on sales of out-licensed products. Since our inception, we have recognized $3.6 million in revenue from government grants.
Research and Development Expenses
        Research and development expenses consist primarily of salaries and related expenses for personnel, fees paid to professional service providers in conjunction with independently monitoring our clinical trials and acquiring and evaluating data in conjunction with our clinical trials, costs of contract manufacturing services, costs of materials used in clinical trials and research and development, depreciation of capital resources used to develop our products, costs of facilities and the legal costs of pursuing patent protection of our intellectual property. We expense research and development costs as incurred. We expect our research and development expenses to increase as we continue to develop our product candidates. From inception through June 30, 2003, we spent an aggregate of $78.5 million, including stock-based compensation expenses of $3.1 million, on research and development.
Research and development—Related party
        In cooperation with Elan, we have conducted a series of clinical trials during the past six years evaluating Fampridine-SR. Elan is an Acorda stockholder and is considered to be a related party. Related party research and development expenses have been included as a separate line item in our financial statements. These expenses consist of the contracted development and supply of our lead product candidate, Fampridine-SR.
General and Administrative Expenses
        General and administrative expenses consist primarily of salaries and other related costs for personnel serving executive, finance, sales and marketing, business development, information technology and human resource functions. Other costs include facility costs not otherwise included in research and development expense and professional fees for legal and accounting services. We expect that our general and administrative expenses will increase as we add personnel and become subject to the reporting obligations applicable to public companies. From inception through June 30, 2003, we spent an aggregate of $22.9 million, including stock-based compensation expenses of $2.6 million, on general and administrative expenses.
24

Stock-Based Compensation
        We have accounted for options granted to employees and directors in accordance with SFAS No. 123, Accounting for Stock-Based Compensation , and related interpretations. As such, compensation expense is recorded on stock option grants based on the fair value of the options granted, which is estimated on the date of grant using an option-pricing model and it is recognized on a straight-line basis over the vesting period. Compensation expense for options granted to employees amounted to $643,000, $1.3 million, $1.6 million and $3.8 million for the years ended June 30, 2001, 2002 and 2003 and for the period from March 17, 1995, the date of our inception, to June 30, 2003, respectively. Compensation expense for options granted to employees are classified between research and development and general and administrative expense based on employee job function.
        We have accounted for stock options granted to non-employees on a fair-value basis in accordance with SFAS No. 123, Accounting for Stock-Based Compensation , Emerging Issues Task Force Issue No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services , and FASB Interpretations No. 28, Accounting for Stock Appreciation Rights and Other Variable Stock Option or Award Plans an Interpretation of APB Opinion No. 15 and 25 . As a result, the non-cash charge to operations for non-employee options with vesting or other performance criteria is affected each reporting period by changes in the fair value of our common stock. Compensation expense for options granted to non-employees amounted to $94,000, $75,000, ($6,000) and $1.9 million for the years ended June 30, 2001, 2002 and 2003 and for the period from March 17, 1995, the date of our inception, to June 30, 2003, respectively. The amount of compensation expense to be recorded in the future for options granted to non-employees is subject to change each reporting period based upon changes in the fair value of our common stock, estimated volatility and risk free interest rate until the non-employee completes performance under the option agreement.
        We may record additional deferred stock-based compensation if we grant additional options or change the terms of the options granted to our employees. On September 11, 2003, we granted 1,374,997 stock options, that had been authorized for issuance under the Plan in May 2003, to employees under the stock option plan at an exercise price of $5.88 per share which is below the fair value of our common stock at the date of grant. We will immediately recognize a compensation expense of approximately $8.3 million in the first quarter of fiscal 2004, as a certain number of the options issued will vest immediately, and the balance of $5.2 million will be recognized over the remaining respective vesting periods of the options. In addition, we reduced the exercise price per share of 150,251 stock options issued to employees to $5.88 per share. As a result of this repricing, the Company will recognize an additional compensation charge estimated at approximately $520,000, of which $449,000 will be recognized during the first fiscal quarter of 2004, with the balance to be recognized over the remaining respective vesting periods of the options.
Beneficial Conversion Feature
        In May 2003, we completed a private placement of 112,790,233 shares of Series J convertible preferred stock for an aggregate purchase price of approximately $55.3 million. As a result of this financing, our Series A through Series I preferred stockholders' original conversion price was reduced as a result of anti-dilution adjustments, which resulted in a beneficial conversion of $80.8 million in accordance with EITF No. 98-5, Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios and EITF No. 00-27, Application of Issue No. 98-5 to Certain Convertible Instruments . The beneficial conversion of $20.9 million, recorded as an immediate charge to additional paid-in capital, related to our Series A, Series B, Series C, Series F and Series H convertible preferred stock, which are not mandatorily redeemable and may be converted to common stock at any time at the option of the holders. The remaining beneficial conversion of $59.9 million related to our Series E and Series I convertible preferred stock, which is mandatorily redeemable at any time on or after June 30, 2008, is being accreted ratably over the mandatory redemption period. Such accretion for the year ended June 30, 2003 amounted to $1.7 million and is charged to additional paid-in capital.
25

        In addition, the issuance of our Series J mandatorily redeemable convertible preferred stock resulted in a beneficial conversion of $20.9 million in accordance with EITF No. 98-5. The beneficial conversion is calculated using an estimate of the fair value of our common stock on the date of issuance of Series J preferred stock of approximately $8.16 per share of common stock, which is calculated based on the projected midpoint of the range of the Company's initial public offering price per common and the stock price appreciation in comparable public companies from May 2003 to August 2003. The beneficial conversion is being accreted ratably over the mandatory redemption period. The charge to paid-in capital for the year ended June 30, 2003 amounted to $580,000.
        The unamortized portion of the beneficial conversion at June 30, 2003 was $78.6 million. Upon the closing of this offering, we will recognize a one time non-cash charge to additional paid in capital, reflecting the unamortized portion of the beneficial conversion feature as a result of the automatic conversion of the convertible preferred stock and mandatorily redeemable convertible preferred stock to common stock upon completion of this offering.
Other Income (Expense)
        Interest income consists of interest earned on our cash, cash equivalents and short-term investments. Interest expense consists of interest expense on our GE Capital notes payable. Interest expense—Related party consists of amortization of debt discount and accrued interest on our $7.5 million aggregate principal amount of convertible notes payable to Elan International Services, Ltd., or EIS, an affiliate of Elan. Other income primarily consists of a gain on an option transaction.
Results of Operations
        We have a limited history of operations. We anticipate that our quarterly results of operations will fluctuate for the foreseeable future due to several factors, including the timing and amount of payments made or received pursuant to licensing or collaboration agreements, progress of our research and development efforts, and the timing and outcome of regulatory approvals. Our limited operating history makes predictions of future operations difficult or impossible. Since our inception, we have incurred significant losses. As of June 30, 2003, we had an accumulated deficit of approximately $91.1 million. We anticipate incurring additional losses, which we expect will increase, for the foreseeable future.
Year Ended June 30, 2003 Compared to Year Ended June 30, 2002
Grant Revenue
        Grant revenue for the year ended June 30, 2003 was $474,000 compared to $132,000 for the year ended June 30, 2002. Grant revenue is recognized when the related research expenses are incurred and our performance obligations under the terms of the respective contract are satisfied. To the extent expended, grant revenue related to purchase of equipment is deferred and amortized over the shorter of its useful life or the life of the related contract. For the year ended June 30, 2002, we deferred approximately $95,000 in revenue, as it relates to funding for the purchase of equipment. Since inception, we have recognized grant revenue of approximately $3.6 million of which approximately $3.4 million has been received by us as of June 30, 2003.
Operating Expenses Incurred in the Development Stage
Research and Development
        Research and development expenses for the year ended June 30, 2003 were $17.5 million compared to $11.1 million for the year ended June 30, 2002, an increase of approximately $6.4 million or 57.2%. Total research and development expenses include non-cash stock-based compensation expense of $478,000 for the year ended June 30, 2003, as compared to $455,000 for the year ended June 30, 2002, an increase of approximately $23,000 or 5.0%. The increase in research and development expenses for the year ended June 30, 2003 was primarily attributable to acceleration in patient enrollment in both the Phase 2 clinical trial in MS and two Phase 3 clinical trials in SCI. The SCI study expenses increased from $3.4 million for the
26

year ended June 30, 2002 to $5.7 million for the year ended June 30, 2003, an increase of $2.3 million. The MS study expenses increased from $900,000 for the year ended June 30, 2002 to $2.0 million for the year ended June 30, 2003, an increase of $1.1 million. Expenses related to the clinical study and outside contract work for drug stability testing increased by approximately $1.0 million from the year ended June 30, 2002. Expenses incurred in the development of our remyelinating agents and the associated costs increased by approximately $800,000 from the year ended June 30, 2002. Salaries and benefit costs relating to research and development activities increased by approximately $1.0 million from the year ended June 30, 2002 primarily due to an increase in headcount.
Research and Development—Related party
        The cost of the drug development and supply of Fampridine-SR decreased by $2.4 million, or 51.7%, to $2.3 million for the year ended June 30, 2003 compared to $4.7 million for the year ended June 30, 2002. This decrease in expense is due to reduced development activities by Elan related to Fampridine-SR during the year ended June 30, 2003.
General and Administrative
        General and administrative expenses for the year ended June 30, 2003 were $6.4 million compared to $6.6 million for the year ended June 30, 2002, a decrease of approximately $248,000, or 3.7%. Total general and administrative expenses include non-cash stock based compensation expense of $1.1 million for the year ended June 30, 2003, as compared to $951,000 for the year ended June 30, 2002, an increase of approximately $144,000, or 15.2%. The decrease in general and administrative expenses was primarily due to management's decision to defer spending for market research and medical communications until we had reached a later stage of clinical development of Fampridine-SR.
Other Income (Expense)
Interest Income (Expense) Net
        Interest expense—others for the year ended June 30, 2003 consists of approximately $78,000 on our GE Capital notes payable. Interest expense—Related party decreased $39,000, or 9.5%, to $369,000 for the year ended June 30, 2003 from $408,000 for the year ended June 30, 2002. Interest expense—Related party for the year ended June 30, 2003 primarily consists of accrued interest of $150,000 and approximately $219,000 on amortization of debt discount relating to the EIS convertible promissory notes. Interest income decreased $591,000, or 60.1%, to $393,000 for the year ended June 30, 2003 from $984,000 for the year ended June 30, 2002. The decrease in interest income was attributable to lower average cash balances and lower interest earned on cash balances in the year ended June 30, 2003.
Other Income
        We recorded other income of $26,000 for the year ended June 30, 2003 as compared with $0 for the year ended June 30, 2002. During the first quarter of 2003, we entered into a foreign currency option transaction to sell U.S. dollars to British Pounds amounting to approximately $295,000, with a strike price of $1.4280. The option expiration date was January 31, 2003. The Company's primary purpose for entering into this transaction was to cover an exchange gain or loss on a British Pound denominated contract to be entered into with a foreign company. The gain of $26,000 relating to this option transaction is classified as other income.
Minority Interest
        Minority interest decreased to $0 for the year ended June 30, 2003 as compared with $580,000 for the year ended June 30, 2002. Elan's ownership interest in MS Research and Development Corporation, or MSRD, a joint venture owned approximately 83% by Acorda and approximately 17% by Elan and another minority stockholder, is reflected as minority interest in our consolidated financial statements. In the year ended June 30, 2003, Elan ceased funding its share of the joint venture's expenses, therefore there is no minority interest for the year ended June 30, 2003. The assets of this joint venture have been transferred to us. See "R&D and Product Collaborations, Alliances and License Agreements".
27

Beneficial conversion feature, accretion of issuance costs, preferred dividends and fair value of warrants
issued to convertible preferred stockholders
        Charges related to preferred stock increased from $55,000 for the year ended June 30, 2002 to $23.8 million for the year ended June 30, 2003. For the year ended June 30, 2002 charges were primarily comprised of accretion of issuance costs on Series E and Series I mandatorily redeemable convertible preferred stock (see Note 7 to the consolidated financial statements). For the year ended June 30, 2003 charges were primarily comprised of accretion of issuance costs of $66,000 on Series E, Series I and Series J mandatorily redeemable convertible preferred stock, accrual of preferred dividend of $630,000 on Series J mandatorily redeemable convertible preferred stock, accretion of beneficial conversion feature of $22.5 million on Series A through Series I preferred stock for reset in conversion price and accretion of beneficial conversion feature of $580,000 on Series J preferred stock (see Notes 3 and 7 to the consolidated financial statements).
Year Ended June 30, 2002 Compared to Year Ended June 30, 2001
Grant Revenue
        Grant revenue for the year ended June 30, 2002 was $132,000 compared to $462,000 for the year ended June 30, 2001, a decrease of approximately $331,000, or 71.5%. The decrease is primarily due to lower grants received and recognized for the year ended June 30, 2002.
Operating Expenses Incurred in the Development Stage
Research and Development
        Research and development expenses for the year ended June 30, 2002 were $11.1 million compared to $6.1 million for the year ended June 30, 2001, an increase of approximately $5.0 million, or 81.5%. The research and development expenses include non-cash stock based compensation expense of $455,000 for the year ended June 30, 2002, as compared to $286,000 for the year ended June 30, 2001, an increase of approximately $169,000, or 59.4%, primarily due to options granted to employees. SCI clinical study expenses increased from $1.5 million in fiscal 2001 to $3.5 million for the year ended June 30, 2002, an increase of approximately $2.0 million. This increase was due to the increased clinical trial activity for the year ended June 30, 2002. Expenses incurred for salaries and benefits totaled approximately $2.7 million for the year ended June 30, 2002 as compared with $1.8 million for the year ended June 30, 2001, an increase of approximately $900,000 due to increases in research and development headcount. Other research and development expenses associated with our remyelinating agents and other internal costs totaled $1.0 million for the year ended June 30, 2002 compared with $500,000 for the year ended June 30, 2001, an increase of approximately $500,000. We recognized a non-cash charge of $618,000 in research and development expense for the year ended June 30, 2002 on the estimated fair value of a five-year warrant to purchase 100,000 shares of Series B preferred stock of $321,000 and $296,666 as a beneficial conversion charge on issuance of Series C convertible preferred stock (see Note 10 to the consolidated financial statements).
Research and Development—Related party
        The cost of the drug development and supply of Fampridine-SR increased by $2.4 million, or 110.8%, to $4.7 million for the year ended June 30, 2002 compared to $2.2 million for the year ended June 30, 2001. This increase in expense was due to increased development activities by Elan related to Fampridine-SR for the year ended June 30, 2002.
General and Administrative
        General and administrative expenses for the year ended June 30, 2002 were $6.6 million compared to $3.5 million for the year ended June 30, 2001, an increase of approximately $3.1 million, or 90.2%. Total general and administrative expenses include non-cash stock based compensation expense of $951,000 for the year ended June 30, 2002, as compared to $452,000 for the year ended June 30, 2001, an increase of approximately $499,000, or 110.5%. Expenses incurred for public relations, marketing research, medical
28

communications, salaries, benefits and the other related sales and marketing operating costs totaled $1.9 million in the year ended June 30, 2002 as compared with $325,000 for the year ended June 30, 2001, an increase of approximately $1.6 million, or 492.3%, was primarily due to the creation of the sales and marketing department in the fourth quarter of the year ended June 30, 2001 and the business development department in the year ended June 30, 2002. Expenses incurred for salaries, benefits and other business development operating costs totalled $700,000 for the year ended June 30, 2002.
Other Income (Expense)
Interest Income (Expense) Net
        Interest expense—Related party decreased $36,000, or 8.1%, to $408,000 for the year ended June 30, 2002 from $444,000 for the year ended June 30, 2001. Interest expense—Related party for the year ended June 30, 2002 primarily related to amortization of debt discount of approximately $258,000 and accrued interest of $150,000 relating to the EIS convertible promissory notes. Interest income decreased $840,000, or 46.1%, to $984,000 for the year ended June 30, 2002 from $1.8 million for the year ended June 30, 2001. The decrease in interest income was attributable to lower average cash balances and lower interest earned on cash balances for the year ended June 30, 2002.
Minority Interest
        Minority interest decreased $118,000, or 16.9%, to $580,000 for the year ended June 30, 2002 as compared with $699,000 for the year ended June 30, 2001. The minority interest for the year ended June 30, 2002 represents the 19.9% interest in MSRD owned by Elan and another party.
Liquidity and Capital Resources
        We have incurred annual operating losses since inception, and, as of June 30, 2003, we have incurred an accumulated deficit of approximately $91.1 million, including non-cash charges of $6.7 million related to grants of stock options, warrants, and common stock. Since our inception, we have financed our operations primarily through the proceeds of private placements of our securities and, to a lesser extent, from government grants. From our inception through June 30, 2003, we raised aggregate net proceeds of $136 million through the proceeds of private placements of equity securities. In addition, in fiscal 1997, EIS loaned us an aggregate of $7.5 million pursuant to two convertible promissory notes to partly fund our research and development activities. In fiscal 2003, we financed certain of our fixed assets through two financing agreements with GE Capital in the aggregate amount of approximately $1.2 million.
        At June 30, 2003, cash and cash equivalents and short-term investments were approximately $60.6 million compared to $29.8 million at June 30, 2002. Our cash and cash equivalents consist of highly liquid investments with original maturity of three months or less at date of purchase and consist of time deposits and investments in money market funds with commercial banks and financial institutions and high-quality government and investment grade corporate bonds. Also, we maintain cash balances with financial institutions in excess of insured limits. We do not anticipate any losses with respect to such cash balances. Our short-term investments consist of corporate debt securities with original maturities greater than three months.
        Our future cash requirements include, but are not limited to, supporting our clinical trial efforts and continuing our other research and development programs. Since inception we have entered into various agreements with institutions and contract research organizations to conduct and monitor our current clinical trials. Under these agreements, at June 30, 2003 we have estimated our payments to be approximately $2.6 million over the remaining term of the clinical trials. Through June 30, 2003, approximately $78.6 million has been expensed as research and development expenses in the accompanying consolidated statements of operations, $32.3 million has been paid to Elan and $19.2 million has been paid related to these clinical trials. The timing of our expense recognition and future payments related to these agreements are subject to the enrollment of patients and performance by the applicable institution of certain services. As we expand our clinical trials, we will enter into additional agreements and significant additional expenditures will
29

be required as we complete our clinical trials, apply for regulatory approvals, continue development of our product candidates and expand our operations and bring our products to market. In addition, we have entered into various other research and license agreements which, as of June 30, 2003, upon accomplishment of certain milestones, will require payments by us aggregating up to $15.8 million. Approximately $375,000 of these milestone payments can be taken as credits against earned royalties. Upon regulatory approval, these agreements also require us to make royalty payments as a percentage of product sales.
        Net cash used in operations was $8.1 million, $18.1 million and $24.5 million for the years ended June 30, 2001, 2002 and 2003, respectively. Cash was used by operations for the year ended June 30, 2003 due to a net loss of $25.7 million; a decrease in amounts due to Elan of $593,000, primarily due to lower drug development charges from Elan for the year ended June 30, 2003; an increase in prepaid expenses and other current assets of $402,000 primarily due to an $118,000 increase in prepaid insurance premiums as a result of increases in general liability insurance and product liability insurance associated with the clinical trial programs, a $154,000 increase in interest receivable on our short term investments, and an increase in other receivables of $78,000; and an increase in grant receivable of $214,000 primarily due to an increase in grant revenue during the current fiscal year by approximately $437,000. The cash used in operations for the year ended June 30, 2003 was offset by stock compensation expense of $1.6 million; depreciation and amortization expense of $740,000 and amortization of debt discount relating to our $7.5 million aggregate principal amount convertible notes payable to EIS of $219,000.
        Cash was used by operations for the year ended June 30, 2002 due to a net loss of approximately $21.2 million and minority interest of $580,000. The cash used in operations for the year ended June 30, 2003 was partially offset by stock compensation expenses of $1.4 million; expensing of warrants and beneficial conversion charge on Series C preferred stock issued to Elan on completion of Phase 2 clinical trials of $618,000; an increase in due to Elan of $580,000 primarily due to increased drug development charges from Elan as the program progressed in the year ended June 30, 2002; depreciation and amortization expense of $417,000; amortization of debt discount relating to our $7.5 million aggregate principal amount of convertible promissory notes payable to EIS of $258,000; increase in accounts payable and accrued expenses and other current liabilities of $224,000 due to higher expenses incurred as research and development projects progress.
        Net cash used in investing activities for the year ended June 30, 2003 was $10.2 million and was due primarily to the net reinvestment of $9.4 million of surplus cash into marketable securities. In addition, we purchased property and equipment of $748,000 in fiscal 2003. Net cash used in investing activities for the year ended June 30, 2002 was $5.1 million and was primarily due to purchase of short-term investment of $2.8 million and purchase of purchased property and equipment of $2.2 million in the year ended June 30, 2002. We incurred significant expenses in acquisition of property and equipment in the year ended June 30, 2002 as a result of the expansion of our office and laboratory facilities. We had no material commitments to purchase property and equipment at June 30, 2003.
        Net cash provided by financing activities in the years ended June 30, 2002 and 2003 was $2.1 million and $55.9 million, respectively, and was primarily due to proceeds from issuance of preferred stock. In May 2003, we completed a private placement of 112,790,233 shares of Series J mandatorily redeemable convertible preferred stock at $0.49 per share for an aggregate purchase price of approximately $55.3 million. Issuance costs of $334,000 related to this financing were netted against proceeds received. In the year ended June 30, 2003, we entered into two financing agreements with GE Capital and received aggregate proceeds in the amount of $1.2 million, $241,000 of such proceeds have been repaid in fiscal 2003. In the year ended June 30, 2002, we received proceeds from the issuance of preferred stock of approximately $1.3 million. Proceeds from the issuance of preferred stock primarily consisted of the issuance of 150,000 Series B preferred stock for an aggregate purchase price of $300,000 and 333,333 Series C preferred stock for an aggregate purchase price of $1.0 million to Elan as part of our January 1997 License and Supply Agreement.
        We expect to incur losses from operations for the foreseeable future. We expect to incur increasing research and development expenses, including expenses related to additions to personnel and clinical trials. We expect that our general and administrative expenses will increase in the future as we expand our business
30

development, legal and accounting staff, add infrastructure and incur additional costs related to being a public company, including directors' and officers' insurance, investor relations programs and increased professional fees. Our future capital requirements will depend on a number of factors, including the continued progress of our research and development of product candidates, the timing and outcome of regulatory approvals, payments received or made under collaborative agreements, the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights, the acquisition of licenses to new products or compounds, the status of competitive products, the availability of financing and our success in developing markets for our product candidates. We believe our existing cash and cash equivalents, together with the net proceeds of the Series J preferred stock and this offering, will be sufficient to fund our operating expenses, debt repayments and capital equipment requirements for the next 18 months from the date of this prospectus.
        We have no credit facility or other committed sources of capital. To the extent our capital resources are insufficient to meet future operating requirements, we will need to raise additional capital or incur indebtedness to fund our operations. We cannot assure you that additional debt or equity financing will be available on acceptable terms, if at all. If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate some of our research and development programs, reduce our commercialization efforts or obtain funds through arrangements with collaborative partners or others that may require us to relinquish rights to certain product candidates that we might otherwise seek to develop or commercialize independently. Any future funding may dilute the ownership of our equity investors.
Contractual Obligations and Commitments
        In September 2003, we entered into several agreements with Elan, including an agreement to license Elan's sustained release formulation of aminopyridines, including Fampridine-SR. We are obligated to make milestone payments to Elan, which includes a payment upon approval of an NDA for Fampridine-SR, and royalty payments as a percentage of product sales.
        We entered into various other research, license and collaboration agreements which will also require milestone payments upon the achievement of certain milestones and royalty payments as a percentage of product sales.
        Under the terms of the employment agreement with our Chief Executive Officer and Chief Financial Officer, we are obligated to pay severance under certain circumstances. See "Management—Employment Contracts, Termination of Employment and Change-in-Control Arrangements."
        In August and September 2002, we entered into two financing agreements with GE Capital in the aggregate amount of approximately $1.1 million, bearing annual fixed interest rates of 8.57% and 8.88% to finance purchase of certain property and equipment. Borrowings are secured by security interest in certain of our property and equipment. We are required to pay monthly installments until October 2006. Future payment obligations for each of the four years subsequent to June 30, 2003 are: $379,000 in each of 2004 and 2005, $246,000 in 2006 and $42,000 in 2007.
        EIS loaned us an aggregate of $7.5 million pursuant to two convertible promissory notes. One promissory note in the amount of $5 million bears interest at a rate of 3% beginning on the first anniversary of the note. The unpaid principal is convertible into shares of our Series D preferred stock at a conversion price of $12.50 per share. Principal and interest are repayable, if not converted, ratably over a seven-year period beginning one year after we receive certain regulatory approval for the products to be developed, subject to limitations related to gross margin on product sales. If it is determined by Elan and us that regulatory approval will not likely occur, all principal and interest will be forgiven. If our license and supply agreements with Elan are terminated for any other reason, the principal and interest is repayable ratably over 15 years.
        The other promissory note in the amount of $2.5 million is non-interest bearing. This promissory note is convertible after January 22, 1999 into either shares of Series B preferred stock at a conversion price of $2.00 per share or into an undesignated series of preferred stock at a conversion price equal to 80% of the most recently completed equity financing, as defined, whichever conversion price is greater. This promissory note is repayable by us, if not converted by EIS, ratably over a seven-year period beginning one year after we receive certain regulatory approval for the products to be developed. If it is determined by us and Elan that regulatory approval will not likely occur or if our license and supply agreements with Elan are terminated for any other reason, the note is repayable ratably over 15 years.
31

         The following table summarizes our contractual obligations as of June 30, 2003. This table should be read in conjunction with the accompanying notes to our consolidated financial statements:

Fiscal Year Ending June 30,
	 	Notes Payable(1)
	 	Operating Leases
	
 	 	($ in thousands)

2004	
 	
$   379	
 	
$   642	

2005	
 	
379	
 	
642	

2006	
 	
246	
 	
642	

2007	
 	
42	
 	
642	

2008	
 	
—	
 	
374	

Total	
 	
$1,046	
 	
$2,942	

(1)
The notes payable represents the principal and interest payables on the GE Capital notes payable and does not include the $7.5 million aggregate principal amount of convertible notes payable to EIS as these notes are payable on a contingent event.
Subsequent Events
        For a discussion of material events that have taken place subsequent to June 30, 2003, please refer to Note 13 to our consolidated financial statements included in this prospectus.
Quantitative and Qualitative Disclosures about Market Risk
        Our financial instruments consist of cash and cash equivalents, short-term investments, grant receivable, notes payable, convertible notes payable and accounts payable. The estimated fair values of all of our financial instruments, excluding convertible notes payable to EIS, approximate their carrying amounts at June 30, 2003. The terms of these notes are disclosed at Note 10 to the consolidated financial statements.
        We have cash equivalents and marketable securities at June 30, 2003, which are exposed to the impact of interest rate changes and our interest income fluctuates as our interest rates change. Due to the short-term nature of our investments in money market funds and corporate debt securities, the carrying value of our cash equivalents and marketable securities approximate their fair value at June 30, 2003.
        We maintain an investment portfolio in accordance with our investment policy. The primary objectives of our investment policy are to preserve principal, maintain proper liquidity to meet operating needs and maximize yields. Although our investments are subject to credit risk, our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure from any single issue, issuer or type of investment. Our investments are also subject to interest rate risk and will decrease in value if market interest rates increase. However, due to the conservative nature of our investments and relatively short duration, interest rate risk is mitigated. We do not own derivative financial instruments. Accordingly, we do not believe that there is any material market risk exposure with respect to derivative or other financial instruments.
Effects of Inflation
        Our most liquid assets are cash, cash equivalents and short-term investments. Because of their liquidity, these assets are not directly affected by inflation. Because we intend to retain and continue to use our equipment, furniture and fixtures and leasehold improvements, we believe that the incremental inflation
32

related to replacement costs of such items will not materially affect our operations. However, the rate of inflation affects our expenses, such as those for employee compensation and contract services, which could increase our level of expenses and the rate at which we use our resources.
Critical Accounting Policies and Estimates
        The following discussion of critical accounting policies identifies the accounting policies that require application of management's most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods. It is not intended to be a comprehensive list of all of our significant accounting policies, which are more fully described in Note 2 of the notes to the consolidated financial statements included in this prospectus. In many cases, the accounting treatment of a particular transaction is specifically dictated by generally accepted accounting principles, with no need for management's judgment in their application. There are also areas in which the selection of an available alternative policy would not produce a materially different result. We have identified the following as our areas of critical accounting policies: research and development, income taxes, and stock warrants and option accounting.
Research and Development
        Research and development expenses include the costs associated with our internal research and development activities including, salaries and benefits, occupancy costs, and research and development conducted for us by third parties, such as sponsored university-based research, and clinical trial vendors. In addition, research and development expenses include expenses related to grant revenue and the cost of clinical trial drug supply shipped to our clinical study vendors. We account for our clinical study costs by estimating the total cost to treat a patient in each clinical trial and recognizing this cost as we estimate when the patient receives treatment, beginning when the patient enrolls in the trial. This estimated cost includes payments to the trial site and patient-related costs, including laboratory costs related to the conduct of the trial. Cost per patient varies based on the type of clinical trial, the site of the clinical trial, and the length of the treatment period for each patient. As actual costs become known to us, we adjust our accrual; such changes in estimate may be a material change in our clinical study accrual, which could also materially affect our results of operations.
Income Taxes
        As part of the process of preparing our financial statements we are required to estimate our income taxes in each of the jurisdictions in which we operate. We account for income taxes by the liability method. Under this method, deferred income taxes are recognized for tax consequences in future years of differences between the tax bases of assets and liabilities and their financial reporting amounts at each year-end, based on enacted laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
        We have not recorded any tax provision or benefit for the years ended June 30, 2002 and 2003. We have provided a valuation allowance for the full amount of our net deferred tax assets since realization of any future benefit from deductible temporary differences and net operating loss carry-forwards cannot be sufficiently assured at June 30, 2003. As of June 30, 2003, we had available net operating loss carry-forwards of approximately $75.6 million for federal and state income tax purposes, which are available to offset future federal and state taxable income, if any, and expire between 2009 and 2023. We also have research and development tax credit carry-forwards of approximately $704,000 for federal income tax reporting purposes which are available to reduce federal income taxes, if any, through 2017. Since our inception, we have incurred substantial losses and expects to incur substantial and recurring losses in future periods. The Tax Reform Act of 1986, the Act, provides for a limitation of the annual use of NOL and research and development tax credit carry forwards (following certain ownership changes, as defined by the Act) that could
33

significantly limit our ability to utilize these carry-forwards. We have experienced various ownership changes, as defined by the Act, as a result of past financings. Accordingly, our ability to utilize the aforementioned carry-forwards may be limited. Additionally, because U.S. tax laws limit the time during which these carry forwards may be applied against future taxes we may not be able to take full advantage of these attributes for federal income tax purposes.
Stock Warrants and Options Accounting
        We account for options granted to employees and directors in accordance with Statement of Financial Accounting Standards ("SFAS") No. 123, Accounting for Stock-Based Compensation , and related interpretations. As such, compensation expense is recorded on stock option grants based on the fair value of the options granted, which is estimated on the date of grant using the Black-Scholes option-pricing model and it is recognized on a straight-line basis over the vesting period. We account for stock options granted to non-employees on a fair-value basis in accordance with SFAS No. 123, Emerging Issues Task Force Issue No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services , and FASB Interpretations No. 28, Accounting for Stock Appreciation Rights and Other Variable Stock Option or Award Plans an Interpretation of APB Opinion No. 15 and 25 . As a result, the non-cash charge to operations for non-employee options with vesting or other performance criteria is affected each reporting period by changes in the estimated fair value of our common stock. The two factors which most affect charges or credits to operations related to stock-based compensation are the fair value of the common stock underlying stock options for which stock-based compensation is recorded and the volatility of such fair value. If our estimates of the fair value of these equity instruments change, it would have the effect of changing compensation expenses. Because shares of our common stock have not been publicly traded, we estimate the fair value of our common stock considering, among other factors, the most recent previous sale of convertible preferred stock (convertible on a one-for-one basis, or one-for-twelve post reverse split, into common stock). We do not discount the issuance price of our preferred stock in estimating the fair value of our common stock.
Recent Accounting Pronouncements
        In June 2002, the FASB issued SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities ("SFAS No. 146"). SFAS No. 146 addresses financial accounting and reporting for costs associated with exit or disposal activities and nullifies Emerging Issues Task Force ("EITF") Issue No. 94-3, Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring). SFAS No. 146 became effective January 1, 2003. The adoption of SFAS No. 146 did not impact our consolidated financial statements for the fiscal year ended June 30, 2003.
        In May 2003, the FASB issued SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity ("SFAS No. 150"). SFAS No. 150 revises the accounting for certain financial instruments that, under previous guidance, issuers could account for as equity. SFAS No. 150 requires that those instruments be classified as liabilities in statements of financial position. SFAS No. 150 is effective for financial instruments entered into or modified after May 31, 2003, and otherwise is effective for interim periods beginning after June 15, 2003. The adoption of SFAS No. 150 did not impact our consolidated financial statements for the fiscal year ended June 30, 2003.
34

BUSINESS
Overview
        Acorda Therapeutics is a late-stage biopharmaceutical company dedicated to the identification, development and commercialization of novel therapies that improve neurological function in people with SCI, MS and related disorders of the CNS. Our lead product candidate, Fampridine-SR, which is in Phase 3 clinical trials for SCI and Phase 2 clinical trials for MS, targets the treatment of a wide range of disorders affecting individuals with chronic SCI and MS, including spasticity, muscle weakness, loss of bowel and bladder control and sexual dysfunction. Our other product candidates also target SCI and MS as well as other CNS disorders.
        We estimate that approximately 500,000 people in the United States suffer from SCI and MS and that the combined annual cost of treatment for these conditions exceeds $9 billion. Our goal is to become a fully integrated biopharmaceutical company commercializing multiple therapeutic products for these large and underserved markets, while continuing to augment our product pipeline and identify new applications for our core technologies.
Company Highlights
•
Lead product Fampridine-SR in late stage clinical trials for two conditions. Clinical trials of our lead product candidate, Fampridine-SR, are the first, to our knowledge, that have demonstrated improved neurological function in people with chronic SCI or MS. We are currently conducting two Phase 3 clinical trials in subjects with SCI for the reduction of spasticity and one late Phase 2 clinical trial in subjects with MS for the improvement of walking speed.

•
Broad product pipeline behind Fampridine-SR. In addition to Fampridine-SR, we have a pipeline of clinical and pre-clinical programs. Our second most advanced product candidate is valrocemide, which is currently in Phase 2 clinical trials for the treatment of epilepsy. We also have four pre-clinical programs focused on repairing damaged components of the CNS in patients with SCI and MS.

•
Broad applicability of product candidates. Our core initial focus on the development of treatments for SCI has led, and we believe will continue to lead, to the identification and development of therapies applicable to other CNS disorders. Since many of the mechanisms of tissue damage and repair in SCI are shared by other conditions, such as MS, stroke and traumatic brain injury, our core technologies have potentially broad applicability for these and other CNS indications.

•
Extensive scientific and medical network. We have established an advisory team and network of well recognized scientists, clinicians and opinion leaders in the fields of SCI and MS that keep us apprised of the latest technological advances and help us identify and evaluate business development opportunities. In addition, we have recruited 80 SCI rehabilitation centers and 24 MS rehabilitation centers in the United States and Canada to conduct our clinical trials. Our clinical management team has extensive experience in the areas of SCI and MS and works closely with this network.

•
Extensive SCI animal modeling capability and laboratory testing facility. We have substantial animal laboratory capabilities employing both tissue culture methods and predictive animal models of SCI repair. These capabilities allow us to rapidly screen and validate potentially useful therapeutic approaches to SCI.
Fampridine-SR
        Our lead product candidate, Fampridine-SR, is an oral, small molecule drug, contained in a sustained release tablet form. Laboratory studies have shown that fampridine, the active molecule of Fampridine-SR, improves impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. This damage may be caused by physical trauma, in the case of SCI, or by the body's own immune system, in the case of MS. We are developing Fampridine-SR for the treatment of both SCI and MS. We plan to
35

commercialize Fampridine-SR ourselves in the United States and Canada and with partners in various markets throughout the rest of the world.
        Key attributes of our Fampridine-SR program include:
•
clinical trials of Fampridine-SR in subjects with chronic SCI have demonstrated significant reductions in spasticity and indicated improvements in bladder, bowel and sexual function;

•
clinical trials in subjects with MS have shown improvements in walking speed and leg strength;

•
we believe Fampridine-SR is the first potential therapy in late-stage clinical development for chronic SCI which seeks to improve the function of damaged neurons; and

•
our goals are to submit an NDA for Fampridine-SR for the treatment of spasticity in SCI in 2004, which provides the potential for a market launch in 2005, and to file an NDA for Fampridine-SR for the treatment of lower extremity motor dysfunction in MS in 2005.
Other Products in Our Pipeline
        Our other research and development programs are also focused on novel therapeutics for CNS disorders. Our product candidates include small molecules, antibodies, and other protein therapeutics.
Valrocemide
        We have entered into a collaboration agreement with Teva to co-develop and co-promote valrocemide in the United States. Valrocemide is a small molecule drug with early Phase 2 clinical evidence of safety and efficacy as an add-on therapy for partial seizures, a type of epilepsy, and preclinical evidence of activity in animal models of epilepsy and neuropathic pain. We plan to move valrocemide into late Phase 2 clinical trials for epilepsy and early Phase 2 clinical trials for bipolar disorder in 2004. We may also pursue clinical development of valrocemide for the treatment of neuropathic pain.
Remyelinating Agents
        Our pre-clinical programs include two distinct myelin restoring therapies, Glial Growth Factor 2, which we refer to as GGF-2, and remyelinating antibodies. GGF-2 has been shown in various published studies to stimulate remyelination in animal models of MS and to have a variety of other effects in neural protection and repair. We plan to develop GGF-2 initially for treatment of MS, pending successful completion of preclinical toxicology testing. Our remyelinating antibody program involves monoclonal antibodies that have demonstrated the ability to stimulate repair of myelin in three different animal models of MS. We are currently in the process of final preclinical validation and selection of the lead candidate molecule.
Chondroitinase Program for Scar Matrix Modification
        This novel therapeutic approach to repair the injured brain and spinal cord targets the scar tissue that develops as a result of injury, which is believed to impede nerve fiber regeneration and limit functional recovery. We have initiated a collaborative program to develop this promising technology and we are in the process of building our intellectual property position with respect to this technology.
Regenerative Antibody Program
        Our pre-clinical programs have identified novel approaches to stimulate axon regeneration in CNS. Our primary focus involves antibodies that react with CNS antigens. Our second strategy employs the use of neuronally restricted precursor cells.
36

Background and Market Opportunity
Our Approach to the Market for CNS
        We are focused on identifying, developing and commercializing novel pharmaceutical products that address large and underserved CNS markets. We view SCI as a strategic point of access to a broad range of additional neurological conditions, particularly those resulting from focused cellular damage in the CNS, for the following reasons:
•
the initial cause of traumatic SCI is well understood, it occurs at one defined time, and treatment can usually be initiated shortly after injury is sustained;

•
chronic SCI is usually a stable condition, without ongoing deterioration;

•
good animal models of SCI exist;

•
many of the mechanisms of secondary tissue damage and potential repair in SCI are shared with other conditions, such as MS, stroke and traumatic brain injury, but the structure of the spinal cord is less complex than that of the brain;

•
a treatment that protects the spinal cord from the consequences of injury, regenerates neural connections, or optimizes function of surviving structures in the spinal cord is likely to also be applicable to many conditions affecting the brain; and

•
even relatively small and incremental improvements in CNS function can produce large positive effects on the quality of life for people with SCI and similar chronic neurological conditions.
        MS is a second major focus for the company because, like SCI, it involves critical damage to nerve fibers and their myelin within the CNS. Three of our product candidates, Fampridine-SR, GGF-2, and the remyelinating antibodies, address demyelination. Epilepsy is another rational development focus because it is also often caused by damage to neurons that produces a disturbance of normal control over excitability and communication between nerve cells.
The Challenge of Central Nervous System Disorders
        The spinal cord and brain together comprise the CNS. The billions of nerve cells that make up the CNS, in conjunction with the nerve bundles that run through all parts of the body, which is called the peripheral nervous system, transmit the electrical impulses necessary to sustain, regulate and monitor every aspect of human life. The spinal cord serves as the master link between the brain and the body. Nerve impulses travel between the brain and spinal cord via long, thin fibers, or axons, that transmit information. The spinal cord also acts as a conduit for information that regulates involuntary functions, such as breathing, blood pressure, temperature control, and bladder, bowel and sexual functions. The myelin sheath that surrounds nerve fibers in the brain and spinal cord provides insulation that facilitates the effective transmission of nerve impulses. It is composed of multiple layers of tightly packed cell membrane, and is vulnerable to damage in conditions like SCI and MS. Once damaged, it is often not effectively repaired. Although nerve fibers can survive in a demyelinated state, their ability to conduct nerve impulses may be completely lost or severely compromised.
Spinal Cord Injury
        Approximately 250,000 people in the United States live with the long-term consequences of SCI and approximately 10,000 to 12,000 new spinal cord injuries occur each year, typically in young men. The majority of people with SCI are injured under the age of 30 and live with permanent disability and multiple related medical conditions for more than 40 years. It is estimated by the Center for Disease Control that the annual direct cost to the U.S. healthcare system for people with SCI exceeds $9 billion. The National Spinal Cord Injury Database at the University of Alabama estimates that the average lifetime costs directly attributable to SCI for an individual injured at age 25 would vary from $700,000 to $2.8 million depending on the severity of injury. We believe that the number of patients with SCI outside of the United States is approximately equal to the number in the United States.
        The spinal cord can be injured by physical trauma that bends the neck or body violently, such as vehicular or diving accidents, or by objects that penetrate or impact the spinal cord, such as a bullet or a
37

knife. The spinal cord can also be injured by loss of blood flow due to damage to major blood vessels or during surgical procedures. When an area of the spinal cord is damaged, motor and sensory function are impaired throughout those parts of the body that are below the level of the injury.
        Until recently, SCI was considered an untreatable and incurable condition. Within the last two decades, researchers have shown that the spinal cord is not severed in most people with SCI. Rather, stretching or compression of the cord causes nerve fibers and blood vessels to tear and unleashes a secondary process of bleeding, loss of blood flow and inflammation that causes more tissue damage. The majority of people with spinal cord injury have some axons that survive within or around the site of injury. Because of these surviving axons, approximately 50% of people with SCI have some motor and/or sensory function remaining below the level of the injury and are said to have incomplete SCI. Those with no detectable function below the injury level are said to have complete SCI. Researchers have also shown that many axons that survive trauma are damaged and permanently lose part of their myelin, the insulating sheath that permits electrical impulses to be conducted rapidly down the axon. Loss of myelin insulation in surviving axons can cause nerve impulses to be delayed or lost entirely, resulting in impaired neurological function.
        In addition to the more obvious impact of paralysis on mobility and independence, chronic SCI is associated with several life-altering conditions that vary depending on the individual and the extent of injury. These include spasticity, as well as persistent pain, loss of control of bowel and bladder functions, loss of sexual function, compromised breathing, loss of sensation, and unstable control of blood pressure, heart rate, and body temperature. We believe that novel therapies that offer even an incremental improvement of these conditions would have a meaningful impact on the quality of life for people with SCI.
Current Approaches to the Treatment of SCI
        There is no cure for SCI and no treatment available that is capable of improving neurological function. Currently, there are only treatments for some of the symptoms and conditions associated with SCI. In the early 1990s clinical trials showed that a very high dose of a common steroid, methylprednisolone, MP, resulted in some protection of function after acute SCI. The effect was small, but statistically significant. MP is believed to act as an antioxidant and thus prevents secondary damage to the tissue during the first few hours after injury. Treatment immediately after the injury with MP is the standard of care in the United States, though the benefits have been debated in recent years.
        Treatments for symptoms of SCI are limited. Spasticity is most often treated with muscle relaxants such as baclofen, tizanidine, diazepam and dantrolene sodium. Although these medications appear to help in symptom relief in some people, they are often only partially effective and generally require dosing every two to four hours. In addition, these medications are often associated with unwanted side effects such as sedation, weakness and loss of normal muscle tone, or flaccidity. Treatments focused on maintaining the health of the bladder and kidneys include Ditropan for the relief of bladder spasticity and antibiotics for the treatment of urinary tract infections. Loss of control over bowel function is treated with a number of prescription and non-prescription medications, often combined with a regular regimen of physical manipulation. Male sexual dysfunction may be treated with Viagra, which is useful in improving erectile function in some people. Loss of mobility is almost always accompanied by a loss of sensation leading to a high risk for skin breakdown and ulceration at pressure points. These conditions are treated with physical care and anti-infective drugs. Chronic pain is treated with a range of prescription and non-prescription drugs; however, neuropathic pain, which is common in SCI patients, is usually not relieved by normal pain medications because it is generated by disordered activity in the nervous system rather than by some physical source of tissue injury.
Multiple Sclerosis
        According to The National Institutes of Health, it is believed that approximately 250,000 to 350,000 people in the United States have been diagnosed with MS, and approximately 10,000 people are newly diagnosed annually. MS is more prevalent in Caucasians and women and is generally diagnosed between the ages of 20 and 50. The NIH estimates that the annual economic, social and medical cost of treating MS in the United States exceeds $2.5 billion.
38

        MS is a degenerative CNS disorder, the cause of which is unknown, in which the immune system attacks and damages the insulating myelin sheath around nerve fibers in the brain and spinal cord. As in SCI, this myelin sheath damage blocks or diminishes conduction of electrical impulses. However, the loss of conduction caused by MS can occur at multiple sites in the CNS rather than at a specific point of injury as it does in SCI.
        People with MS may suffer impairments in any number of neurological functions. These impairments vary from individual to individual, and over the course of time, depending on which parts of the brain and spinal cord are affected. Some of these impairments are also common in SCI including loss of sensation, loss of bowel and bladder control, sexual dysfunction, spasticity, neuropathic pain, and muscle paralysis. However, other aspects of MS are not characteristic of SCI, including severe fatigue or lack of stamina, dizziness, tremors, loss or disturbance of vision, and cognitive difficulties. The great majority of people with MS experience general weakness and difficulty walking.
Current Approaches to the Treatment of MS
        Current therapies for MS are focused on the control of symptoms associated with exacerbations and progression of the disease. Many of the symptoms that result from MS are also common in SCI, including spasticity, and issues with bladder, bowel and sexual function. Similar approaches to treating symptoms in SCI are used in treating people with MS, often resulting in the occurrence of the same unwanted side effects. Treatments are defined as relapse management and disease course management.
        Relapse Management.     The majority of neurologists treating people with MS utilize intravenous high-dose corticosteroids for the treatment of a sudden and severe relapses. Generally, people experiencing a severe relapse receive a four-day course of steroids on either an in-patient or out-patient basis. This treatment may shorten the time required for recovery from an acute relapse.
        Disease Course Management.     Drugs that modify the immune reactions associated with nerve damage in MS include Avonex, Betaseron, Copaxone, and Rebif. Other drugs that suppress the immune system include drugs initially approved to treat cancer such as Novantrone and methotrexate. However, these medications produce a slowing of deterioration, rather than a halting or reversal of the disease process. They do not restore lost neurological function.
Epilepsy
        In 1998, the Centers for Disease Control estimated that approximately 180,000 new cases of epilepsy are diagnosed annually in the United States. In 1995, the Epilepsy Foundation Report to the Nation stated that epilepsy and seizures affect approximately 2.3 million Americans of all ages. Both sources estimate annual costs of medical care as approximately $12.5 billion.
        Epilepsy is a condition defined by the presence of recurrent seizures that are not provoked by any immediate clinical cause, such as fever or trauma. Seizures are a manifestation of abnormal and excessive excitation of neurons in an area of the brain. There may be many different underlying causes of epilepsy, including genetic predisposition and localized chemical or mechanical damage to the brain. The cause is often not identified, particularly in children. Epilepsy may develop at any stage of life, but is most likely to develop in childhood, adolescence or in old age.
Current Approaches to the Treatment of Epilepsy
        The diagnosis of a particular seizure type, and of a specific type of epilepsy, or epilepsy syndrome, determines the initial therapy. The decision to treat with anti-epileptic drugs, or AEDs, after an initial seizure is still controversial, although there is growing evidence that repeated seizures in themselves can further damage the affected area of the brain. This makes it important to limit seizure recurrence to the extent possible. The decision to treat is based on a consideration of the individual's risk of relapse and potential consequences of further seizures and of drug treatment, including the potential adverse effects of the available AEDs.
39

        Most cases of epilepsy are managed with a single AED, and the choice of drug and dosage is typically adjusted individually based on the degree of seizure control and the type and degree of adverse responses. For partial onset seizures with secondary generalization, cabamazepine, phenytoin, valproic acid, phenobarbital and primidone have been used for many years. More recently approved drugs include felbamate, gabapentin, lamotrigine, topiramate and tiagabine. The more recent drugs were approved as adjunctive treatment, based on studies in which they were tested as add-on therapy with older compounds. This clinical trial design is required by the ethical consideration of the need to maintain subjects on an established drug, even if it is only partially effective.
        For people with more severe, generalized onset seizures, particularly tonic-clonic, myoclonic, absence, or photosensitive forms, valproic acid is often the drug of choice. The rare but potentially fatal risk of liver toxicity with valproic acid means that ethosuxamide is considered slightly safer, particularly in very young children, who are most at risk for this complication.
        Many AEDs are associated with birth defects, which may be offset with folic acid administration. Also, AEDs tend to affect metabolism of other drugs in the liver and most are metabolized in the liver themselves, which complicates the use of drug combinations, particularly with other AEDs. Some drugs, such as phenytoin and valproic acid are significantly bound to proteins in the blood, which reduces their activity. This means that the effective dose can influence or be influenced by other drugs that affect protein binding, such as common aspirin.
Other Disorders of the Central Nervous System
        Neurological injuries and degenerative diseases of the CNS, including stroke, traumatic brain injury, Parkinson's Disease and Alzheimer's Disease, are among the most devastating and costly of human ailments. These conditions are most often chronic and historically have been extremely difficult to treat.
        These disorders, like SCI and MS, involve damage to nerve cells and nerve fibers and would likely benefit from similar approaches to tissue protection and repair. For example, the inflammation process that occurs naturally after many types of tissue injury may damage both injured and healthy CNS cells. Several of these conditions could benefit from treatments that inhibit aspects of this inflammatory process. As with SCI, these conditions could be treated with interventions that replace nerve cells, stimulate new nerve fiber growth, or increase the adaptability of connections within the nervous system.
Our Strategy
        Our strategy is to become an integrated biopharmaceutical company focused on the identification, development and marketing of a broad range of CNS therapeutics, using our scientific and clinical expertise in SCI as a strategic point of access. In implementing this strategy, we have the following initiatives in place:
•
Complete the clinical development and obtain regulatory approval for Fampridine-SR in SCI, MS and other neurological disorders. We have advanced Fampridine-SR into two Phase 3 clinical trials in people with SCI for spasticity and into one late Phase 2 clinical trial in people with MS for improvement in walking speed. Following our discussion with the FDA, our registration plan for Fampridine-SR in SCI initially addresses spasticity. We have also discussed with the FDA a proposal to seek approval of Fampridine-SR for improvement in walking speed and leg strength in people with MS, and we have designed the current Phase 2 clinical trial to potentially provide the first of two sets of pivotal data. We may also pursue subsequent approvals in additional CNS disorders.

•
Complete the clinical development and obtain regulatory approval for valrocemide in epilepsy, bipolar and other neurological disorders. We have entered a co-development and co-promotion agreement with Teva for valrocemide. Valrocemide is currently in Phase 2 clinical trials for epilepsy. We and Teva plan to continue to develop valrocemide in epilepsy and to initiate Phase 2 clinical trials in bi-polar disorder. In addition, we and Teva may pursue clinical development of valrocemide in neuropathic pain and other CNS disorders.
40

•
Continue to develop and advance our pipeline of other products and programs to treat neurological disorders. We have two pre-clinical programs focused on remyelination, one focused on reducing scar tissue related to CNS injury and one focused on regeneration of nerve axons. In order to advance these programs into clinical trials, we have established dedicated project management teams with experience in commercial therapeutic development, allocated internal laboratory resources and retained outside service providers to establish manufacturing and testing capabilities.

•
Continue to in-license pre-clinical and clinical programs . We plan to leverage our network of scientific advisors to identify additional business development opportunities. We will continue to use our internal animal modeling capability to evaluate these opportunities as potential candidates for in-licensing.

•
Expand sales and marketing capabilities . Building on our existing market analysis and commercialization plan, we plan to hire additional sales and marketing professionals who will be responsible for brand strategy and sales force management. We plan to build a field sales force through the RxPedite program under our contracts with subsidiaries of Cardinal Health and inChord Communications. Under this contract after one year we have the option to offer employment to any or all dedicated Acorda representatives employed by Cardinal, who would then transfer directly to our payroll. Other services will be provided under this agreement with Cardinal Health and inChord Communications, including publications planning, product warehousing, distribution, technical support, professional and consumer advertising, web marketing and promotion, and data analysis.

•
Pursue additional commercial alliances . We intend to leverage our sales capabilities for co-promotion of additional in-licensed products. We also intend to license our products to partners in order to gain incremental revenues from expansion into areas and geographies beyond our current focus. Our selection criteria for co-promotion agreements include strategic fit, market size of the opportunity, our potential partner's level of internal expertise in the field, manufacturing requirements, clinical trial size and complexity and investment considerations.
Our Product Pipeline

Product
	 	Target Condition
	 	Status
	 	Marketing Rights
	
Fampridine-SR	 	SCI	 	Phase 3	 	Worldwide	
 	 	MS	 	Phase 2	 	Worldwide	

Valrocemide	
 	
Epilepsy	
 	
Phase 2	
 	
U.S. co-promotion	
 	 	Bipolar disorder	 	Phase 2 planned	 	U.S. co-promotion	

GGF-2	
 	
MS	
 	
Pre-clinical	
 	
Worldwide	

Remyelinating Antibodies	
 	
MS	
 	
Pre-clinical	
 	
Worldwide	

Chondroitinase	
 	
SCI	
 	
Research	
 	
Worldwide	

Regenerative Antibodies	
 	
SCI	
 	
Research	
 	
Worldwide	
Fampridine-SR for SCI and MS
        Our lead product candidate, Fampridine-SR, is a sustained release, oral tablet formulation of fampridine, suitable for twice daily dosing. It is based on a small molecule drug, fampridine, which acts to block potassium ion channels in nerve cell membranes. We believe that Fampridine-SR represents a fundamental shift in the treatment of both SCI and MS because it may improve neurological function rather than only treating the symptoms or slowing the progression of these diseases. We are currently conducting two Phase 3 clinical trials of Fampridine-SR for chronic SCI, and one Phase 2 clinical trial for MS.
        Recent clinical research using imaging and post-mortem studies has shown that the majority of people with SCI do not have severed spinal cords and maintain some nerve fibers, or axons, that cross the site of injury. However, these surviving axons are often damaged and lose their myelin. In MS, the myelin is damaged by the body's own immune system, rather than by physical trauma. When an axon is demyelinated after injury, large numbers of the specialized potassium channels on the surface of axons that are normally hidden or covered by the myelin sheath are exposed and leak potassium ions, causing the axon to short circuit
41

its electrical impulses. Fampridine is able to block these exposed channels, thereby permitting the axon to transmit nerve impulses again, even in a demyelinated state. Fampridine may also serve to amplify electrical signals at sites of contact or synapses between nerve cells by blocking the same channels in the tips of the nerve fiber, thereby improving the function of surviving tissue in the injured nervous system. Fampridine does not repair damaged nerve fibers or axons, but works to improve impulse conduction and must be given continuously to maintain its effects.
        Fampridine-SR was developed by and is manufactured for us by Elan. We have a worldwide exclusive license from Elan to its patent for the sustained release formulation of aminopyridines, which includes fampridine, for the rights to, among other things, develop, promote, distribute, use and sell Fampridine-SR in all human clinical indications, and to develop, promote, distribute, use and sell other patented sustained-release formulations of the drug. We hold an exclusive license from the Canadian Spinal Research Organization to a patent for the use of fampridine in the treatment of neuropathic pain and spasticity in SCI, as well as an exclusive license from Cornell University to a patent for the use of fampridine in the treatment of anterior horn cell diseases, which include amyotrophic lateral sclerosis, known as Lou Gehrig's disease. We have obtained Orphan Drug designations from the FDA for Fampridine-SR in both incomplete SCI and MS.
        We have performed a series of clinical trials of Fampridine-SR in chronic SCI and MS to establish the pharmacokinetics, safety, and optimal dosing of the drug, as well as to assess its efficacy. Our previous clinical trials have indicated that people with chronic and incomplete SCI experience benefits with Fampridine-SR on a range of measures including improvements in spasticity, bowel and bladder function, and sexual function. We are currently sponsoring two independent Phase 3 clinical trials of Fampridine-SR in SCI, each designed to establish a significant clinical benefit of the drug on spasticity, which is marked by muscle stiffness, and we are preparing a regulatory filing based on this specific indication. These clinical trials also include secondary endpoints related to bowel, bladder and sexual function.
        We believe there are several compelling reasons for the development of Fampridine-SR with a primary indication of spasticity:
•
approximately 75% of people with SCI suffer from spasticity;

•
clinical trials with Fampridine-SR in SCI patients have shown a statistically significant reduction in spasticity;

•
Fampridine-SR has not shown frequent adverse effects of sedation, weakness and flaccidity associated with muscle relaxants which are currently used to treat spasticity; and

•
dosing of Fampridine-SR is twice daily, rather than the inconvenient 3 to 4 times per day required for muscle relaxants.
        We believe there are compelling reasons for the development of Fampridine-SR as a new therapy for MS, with a primary indication of lower extremity motor function:
•
most people with MS eventually experience a decline in their ability to walk, which is one of the most limiting aspects of the disease;

•
clinical trials with Fampridine-SR in MS patients have shown a statistically significant improvement in walking speed and leg strength; and

•
there are no current therapies that improve leg strength or walking ability in people with MS.

Clinical Trials of Fampridine-SR
        In cooperation with Elan we have conducted a series of clinical trials during the past six years evaluating Fampridine-SR. Approximately 550 people have been treated with Fampridine-SR in 14 clinical trials, including eight clinical trials for SCI and six clinical trials for MS. In all the Phase 2 clinical trials, treatment with Fampridine-SR has been associated with a variety of neurological benefits in people with SCI and MS.
42

Fampridine-SR in Spinal Cord Injury
        Phase 3 Clinical Trials.     We are currently conducting two parallel Phase 3 clinical trials of Fampridine-SR in SCI, designated as SCI-F301 and SCI-F302. The protocols for these two clinical trials are identical. They are designed to provide evidence of efficacy of Fampridine-SR sufficient to allow submission of an NDA to the FDA in 2004. Each double-blinded clinical trial enrolled approximately 200 subjects with chronic and incomplete SCI at approximately 40 clinical centers in North America. Subjects entering the clinical trials were randomly assigned to receive a stable dose of either 25 mg of Fampridine-SR or placebo twice a day for 12 weeks. During the 12-week study period, subjects visit the clinic for evaluation once every four weeks. We anticipate that the data produced by these clinical trials should be unblinded and analyzed by the end of March 2004.
        The primary endpoints for these two clinical trials are improvement in spasticity in the legs of the subjects, which is measured by a reduction in the Ashworth score, and improvement in the subject's rating of the effect of treatment, which is measured by a test called the Subject Global Impression. The Ashworth score is assigned by a clinician who measures the stiffness of the affected leg muscles by attempting to move the subject's relaxed leg around the knee joint. The stiffness is rated on a scale of 1, indicating no resistance and no spasticity, to 5, indicating stiffness so complete that the leg cannot be moved around the joint. Spasticity associated with an Ashworth score of 3 or greater is considered to have significantly negative effects on a person's quality of life. Our current Phase 3 clinical trials have required subjects to have average Ashworth scores greater than 2 both at their initial screening visit and after two weeks of placebo treatment. The Subject Global Impression, SGI, is a standard seven-point scale on which subjects rate how they feel about the overall effect of the study drug. In two previous double-blind Phase 2 clinical trials of Fampridine-SR in subjects with chronic SCI, the improvement registered by the SGI was statistically significant, even with relatively small study groups of 30 people or less.
        We discussed the primary endpoints and the other aspects of the design of these clinical trials with the FDA during development of the protocols in order to determine the expected requirements for submission of an NDA. The FDA is familiar with the Ashworth score as a measure of spasticity and has approved two other drugs using it as a primary outcome measure. We have also agreed to use SGI, in addition to the Ashworth score, to avoid potential uncertainty about the degree of change in score that represents a clinically meaningful effect.
        Phase 2 Clinical Trials.     We conducted two double-blind Phase 2 clinical trials, SCI-200 and SCI-F201, and Elan sponsored a double-blind Phase 2 clinical trial, ELN 0295-001US, which was published in the Journal of Neurotrauma in October 1998. These clinical trials involved a total of 177 subjects with SCI. In these three clinical trials there was evidence of benefit across a broad spectrum of neurological functions in subjects treated with Fampridine-SR at doses ranging from 17.5 mg to 25 mg twice per day, compared to placebo. These benefits included improvements in sensory, motor, bowel, bladder and sexual function. The most consistent finding across the clinical trials was a reduction in spasticity in Fampridine-SR treated subjects.
        Unlike the design of our Phase 3 clinical trials, our Phase 2 clinical trials did not require a minimum spasticity level for enrollment. The average Ashworth score at baseline was approximately 2, the mildest level of spasticity on the scale. Therefore in study SCI-F201, for example, although we saw improvement in the entire group treated with 25 mg twice a day, the difference was not quite statistically significant, as shown in Figure 1. A much clearer assessment of effects on spasticity was produced by separately analyzing the measurements for those subjects who had more than minimal spasticity before treatment, with average Ashworth scores greater than 2 at their initial baseline examination. The average improvement for those treated with Fampridine-SR, compared to those treated with placebo, was then both statistically significant and clinically meaningful, at more than half a point improvement to the average Ashworth score. Moreover, subjects whose spasticity at the beginning of the study registered as greater than 3 on the Ashworth scale, showed even larger mean improvements, at more than a full point on the scale, although statistical significance was reduced by the smaller number of subjects that could be included, as shown in Figure 1.
43

 Figure 1: SCI-F201 Phase 2 Ashworth Scores
Post-Treatment with Placebo or Fampridine-SR Treatment vs. Baseline

The illustration depicts Ashworth scores for the placebo group, shown on left, as compared to the Fampridine-SR treatment group, shown on right. The arrows highlight the differences in Ashworth scores between the placebo and Fampridine-SR treatment groups. The Ashworth scores were averaged over four muscle groups in each subject and compared against baseline for the four weekly clinic visits during the stable treatment period. Statistical significance for this clinical trial was established at p<0.025.
        Similar results were derived from our earlier clinical trial, SCI-200, which examined a dose of 20 mg twice a day for one week, compared to placebo. A statistically significant improvement in Ashworth score was also seen in the published Elan-sponsored clinical trial for subjects receiving 17.5 mg of Fampridine-SR twice a day for one week.
        Subjects treated with the 25 mg dose twice daily experienced side effects that were not significantly different from those experienced by subjects receiving the placebo. The number of subjects who discontinued the clinical trial because of side effects was similar between the 25 mg twice a day and placebo groups at approximately 10% and 8%, respectively. Side effects included dizziness, tingling, nervousness, insomnia and pain. This experience was similar to the earlier clinical trials that used lower doses of Fampridine-SR. Side effects were more severe and more frequent in the group treated with 40 mg of Fampridine-SR twice a day, including nausea, tremor, and abnormal thinking. These side effects led 11 of the 30 subjects in this group to discontinue the study, most during the stage of increasing doses at the beginning of the clinical trial. One subject in the 40 mg group experienced a seizure near the end of the designated treatment period. This subject had a prior history of traumatic brain injury and amnesia, combined with spinal cord injury two years earlier, and had been treated with Dilantin for three weeks following possible post-traumatic seizure activity that could not be thoroughly investigated at the time.
         Phase 1 Clinical Trials . A series of earlier clinical trials, called SCI-101, SCI-102 and SCI-103, were designed to measure the concentration of drug achieved in the blood with a wide range of doses, and to relate those levels to side effects and possible clinical benefits. These clinical trials showed that a dose of 25 mg every 12 hours produced peak concentrations of Fampridine-SR in the subjects' blood that were usually in the target effective range of 50 to 100 ng/ml.
        Overall, subject and clinician reports and clinical measures in these non-blinded clinical trials indicated that there was evidence of increasing dose-response through the range of 10 to 25 mg twice a day, but that evidence of increasing efficacy at doses higher than 25 mg twice a day was limited, possibly being offset by increased side effects.
44

         Safety Studies.     As part of our evaluation of safety, we have established extension studies that allow subjects in earlier clinical trials to receive Fampridine-SR on an open-label basis, with their progress followed for at least a year, but with the potential for continuing treatment until the drug is approved. By their open-label design, these studies will allow us to gain some additional knowledge of the longer term efficacy and safety of the drug, albeit limited by the lack of a placebo control group. These studies are intended primarily to gain sufficient subject experience to satisfy the regulatory guidelines for long-term and overall safety assessments. As of September 2003, approximately 90 subjects from Phase 1 and Phase 2 SCI clinical trials have been enrolled in ongoing extension trials. A separate extension study for subjects of the current Phase 3 clinical trials is expected to enroll a total of approximately 350 subjects, beginning in the third quarter of 2003.
        Only limited data are yet available from these ongoing safety studies, since no interim analysis of the data is planned, but there have been three incidences of seizures in subjects enrolled in the SCI-F201 extension. Two of these occurred in subjects taking more than 25 mg twice per day (70 mg/day for 9 months and 80 mg/day for 2 months, respectively). Overall, including the subject in study SCI-F201, this represents 3 seizures in the 115 subjects (2.6%) exposed to doses greater than 50 mg daily, and 1 seizure in the 308 subjects (0.3%) exposed to doses less than or equal to 50 mg daily, the proposed commercial dose for Fampridine-SR in SCI applications. Some currently marketed drugs cite incidence of seizures in clinical trials of 3% or greater. We are carefully monitoring the potential for seizure as a side effect, including the possibility of interaction with other drugs that are known to lower the threshold for seizure in susceptible subjects.
Fampridine-SR in Multiple Sclerosis
        Phase 2 Clinical Trial.     The current late Phase 2 clinical trial, MS-F202, was designed, after extensive consultation with a panel of expert MS neurologists and with the FDA, to provide pivotal data for support of an NDA for the use of Fampridine-SR in MS. The clinical trial is also designed to compare three doses of 10, 15 and 20 mg, twice per day, and to assess their relative safety and efficacy over a treatment period of 12 weeks. The primary endpoint of the study is an improvement in average walking speed using the Timed 25 Foot Walk. The Timed 25 Foot Walk is part of a standardized set of neurological tests, called the Multiple Sclerosis Functional Composite Score, MSFC, and involves timing the subject completing a 25 foot walk. We plan to use these measurements to support an indication for the treatment of lower extremity motor dysfunction, characterized by weakness and walking impairment.
        The clinical trial was initiated early in 2003 and completed enrollment of approximately 200 subjects in 24 major MS centers in July 2003. We expect the data from this clinical trial to be available by the end of March 2004. If the clinical trial is successful, we plan to sponsor a second clinical trial as soon as possible to provide the necessary confirmation. It is also possible that the clinical trial may not provide statistical significance on the primary endpoint but give us a clear indication of dose and group size to inform the design of two subsequent Phase 3 clinical trials that should provide sufficient pivotal data for submission of the MS NDA.
        In 2001, we completed a double-blind Phase 2 clinical trial of Fampridine-SR in Multiple Sclerosis, MS-F201. The clinical trial was designed to determine the optimal dose level of Fampridine-SR and to evaluate possible ways in which to measure the effect of the drug on symptoms of the disease, including motor strength, timed walking, and self-reported fatigue. The clinical trial involved a total of 36 MS subjects in four major academic MS research centers. A total of 25 subjects received Fampridine-SR in doses increasing from 10 mg to 40 mg twice per day over eight weeks of treatment, and 11 subjects were given placebo over the same period. This treatment period was preceded by a series of baseline evaluations over the course of four weeks to allow the subjects to become adjusted to the clinic visits and allow the various measurements to stabilize. A one week blinded treatment with placebo preceded the first drug administration to look for potential placebo effects on the various outcome measures.
45

        The clinical trial demonstrated that doses up to 25 mg twice a day were well tolerated, and were associated with statistically significant improvements in walking speed and leg muscle strength. Most of the improvement in strength and walking speed was apparent within the first three weeks of the Fampridine-SR treatment, at doses from 10 to 25 mg twice a day.
        When we examined the measurements from individual subjects, and looked at the improvement in walking speed between the baseline period and the average over the first four treatment weeks, we found clear differences in the pattern of response between Fampridine-SR and placebo-treated subjects, as shown in Figure 2. The placebo-treated subjects showed some tendency to improve or worsen slightly in walking speed, mostly within 20% of their baseline average. However, the Fampridine-SR treated group showed a marked tendency for improvement in speed, with 9 of 25 subjects improving more than 20% from baseline, and 2 with greater than 50% improvement. These findings were consistent with the results of a small crossover study sponsored by Elan, using doses of 17.5 mg. twice a day for one week, which was published in the journal Neurology in 1997.
Figure 2: Change in Walking Speed During the First Four Weeks of Treatment

The subjects (25 Fampridine-treated and 11 placebo-treated) were placed in order of degree of improvement, from top to bottom. The Fampridine-SR treated group showed a significantly greater improvement in walking speed during the treatment period.
        The side effects experienced by subjects in MS-F201 given Fampridine-SR up to 25 mg twice a day were similar to those in our SCI clinical trials. Two subjects experienced seizures while on doses of 30 to 35 mg twice a day, respectively. This was consistent with previous experience and the expected greater
46

susceptibility of people with MS to seizure, which is thought to be related to the presence of demyelinating damage in the brain.
        Phase 1 Clinical Trials.     Two earlier Phase 1 clinical trials, AN751-101 and AN751-102, sponsored by Elan, addressed the pharmacokinetics of Fampridine-SR in subjects with MS in a manner equivalent to our SCI-101 and SCI-102 clinical trials. The pharmacokinetic characteristics of Fampridine-SR measured in these clinical trials were similar to those established in normal subjects and in people with SCI.
Valrocemide for Epilepsy
        Valrocemide is a new chemical entity derived from valproic acid which is a commonly used AED. Valrocemide was discovered as part of a program to identify a compound with similar or better efficacy than valproic acid, but with a more favorable side effect profile. Valrocemide has been studied by Teva in both animal models and in clinical trials in Europe.
        Based on responses in pre-clinical models of epilepsy and neuropathic pain and on the close relation between valrocemide and valproic acid, we believe this drug may be effective in epilepsy and bipolar disorder, and potentially in neuropathic pain, for which valproic acid is frequently prescribed.
        In pre-clinical studies and clinical trials carried out by Teva, valrocemide appears to have minimal interactions with other drugs, unlike valproic acid which significantly affects liver enzymes that are used to metabolize many compounds. Valrocemide also shows less affinity for binding to proteins in the blood compared to valproic acid, which should simplify dosing. Based on animal toxicology studies the side effects of valrocemide appear to be less significant than those of valproic acid.
        Studies in human volunteers have indicated that the maximum tolerated dose is in the range of 4 grams per day. Teva has completed a 13-week, early Phase 2 clinical trial in Europe involving 22 people with refractory epilepsy, using valrocemide as an add-on therapy with doses increasing up to four grams per day. Side effects were considered mild to moderate. However, one patient reported severe loss of strength, which may have been related to the treatment. All but one subject completed the study, with one leaving the study because of the requirement for multiple blood samples. This was an open-label study and was not designed to demonstrate safety or efficacy, although there were indications of clinical benefit that were consistent with the expectations for the drug. Larger scale clinical trials have yet to be conducted to demonstrate safety and efficacy.
        Together with Teva, we plan to develop valrocemide initially for the treatment of epilepsy, for a number of reasons:
•
the development path is well known;

•
animal studies support efficacy in epilepsy;

•
an initial Phase 2 study in epilepsy has been completed in Europe; and

•
many of the studies needed for an epilepsy development program will also be required for other indications.

We also plan to initiate a clinical program to explore the potential for efficacy in bipolar disorder in 2004. We may also pursue clinical development of valrocemide for neuropathic pain in the future.
Other Research and Development Programs
Remyelination Programs
        We believe that if the myelin sheath can be repaired, we can expect greater improvements in neurological function than those achieved with Fampridine-SR, which addresses a single, although crucial, consequence of demyelination. We licensed two separate groups of patents, one group relating to the neuregulin growth factors and another group relating to a family of remyelinating antibodies, that may provide access to remyelinating therapies via different and potentially complementary routes.
47

Neuregulins/GGF-2
         We are conducting a research and development program directed towards applying a neuregulin growth factor, GGF-2, to stimulate the cells that normally form the myelin sheath. GGF-2 was the subject of a comprehensive discovery program by CeNeS Pharmaceuticals, PLC, previously Cambridge Neuroscience, Inc. In 2002, we obtained an exclusive worldwide license to the neuregulin technology, including GGF-2, from CeNeS. In addition, we licensed cell lines for the production of the molecule from both CeNeS and Bayer AG, which had earlier partnered with CeNeS on the GGF-2 program. We have entered into an agreement with Lonza Biologics, plc for the manufacturing and process development for GGF-2. If our pre-clinical testing is successful, we intend to advance GGF-2 to clinical development by early 2005.
Remyelinating Antibody Program
        Our remyelinating antibody program is based on an exclusive license to patents derived from more than 15 years of research performed at the Mayo Clinic. Our remyelinating antibody program is designed to promote remyelination of affected areas in the brain and spinal cord. In particular, these remyelinating antibodies were found to react with molecules on the surface of the cells that make myelin, and stimulate them in a number of ways, leading to increased activity and remyelination.
        In addition, we are continuing to support pre-clinical studies at the Mayo Clinic to learn more about the ways the antibodies act to stimulate the myelin-forming cells. The development costs of this program will be partially offset by a small business grant of $1.0 million awarded to us in September of 2002 by the NIH.
Regeneration and Plasticity Programs
Chondroitinase Program for Scar Matrix Modification
        We have developed a chondroitinase program around the concept of breaking down scar tissues that develop as a result of an injury. We believe this scar tissue is partly responsible for limiting the regeneration of nerve fibers in the CNS and also the repair of the myelin sheath, because it restricts the movements of the myelinating cells into the area of damage. We believe that some of the molecular components of the scarring reaction are particularly inhibitory to nerve fiber growth.
        Chondroitin sulfate proteoglycans, CSPGs, are a group of large molecules that form a major component of the scar matrix. Proteoglycans are composed of a combination of protein and sugar molecules, producing essentially a sugar-coated protein. Cell culture studies and animal studies have shown that these CSPGs inhibit the growth of nerve fibers and are likely to be key factors in the failure of the spinal cord to regenerate and repair. Cell culture studies have shown that it is possible to reduce the inhibitory activity of CSPG molecules by breaking them down with bacterial enzymes called chondroitinases. These enzymes clip off some of the surface sugar molecules from the protein core of the CSPG, which are responsible for much of the inhibitory action.
Regenerative Antibodies
        During the course of our remyelinating antibody program, for which we evaluated a range of antibodies that react with CNS tissues, we identified another family of antibodies that appear to stimulate growth of nerve fibers. Studies are under way to determine whether these antibodies are effective in promoting regeneration in animal models of SCI.
R&D and Product Collaborations, Alliances and License Agreements
Elan Corporation plc
        In January 1997, we licensed from Elan exclusive worldwide rights to Elan's sustained release formulation of fampridine, Fampridine-SR, for the treatment of SCI. In April 1998, we formed MS Research & Development Corporation, or MSRD, with Elan's subsidiary, Elan International Services, Ltd., or
48

EIS, to develop Fampridine-SR for treatment of MS. At that time, MSRD licensed from Elan exclusive worldwide rights to Fampridine-SR for the treatment of MS.
Termination and Assignment Agreement
        In September 2003, we entered into a termination and assignment agreement with Elan, EIS and MSRD pursuant to which MSRD assigned to us its assets, including the license from Elan for Fampridine-SR for MS. We paid MSRD approximately $11.5 million for all the assets and assumed liabilities of MSRD. MSRD will distribute the purchase price to its shareholders according to their equity ownership interest. We will receive a distribution of approximately $9.5 million as a result of this distribution. We also purchased EIS's shares at par value, and own approximately 88% of MSRD, which now has no assets or liabilities and is inactive.
Amended and Restated License
        In September 2003, we entered into an amended and restated license with Elan, which replaced the two prior licenses for Fampridine-SR in oral sustained release dosage form. Under this agreement, Elan granted us exclusive worldwide rights to Fampridine-SR for all indications, including SCI, MS and all other indications. We agreed to pay Elan milestone payments and royalties based on net sales of the product.
        Elan may terminate our license in the US, the major European markets or Japan if we do not file to obtain regulatory approval or launch the product after regulatory approval in the applicable country within specified periods. If Elan terminates our license in any applicable country, Elan is entitled to license from us our patent rights and know-how relating to the product and to market the product in the applicable country, subject to royalty payments to us.
        Elan is responsible for completing the chemistry, manufacturing and controls section of our NDA and equivalent regulatory applications outside the US. Elan is also supplying us with product for our clinical trials under this agreement.
        Subject to early termination provisions, the Elan license terminates on a country by country basis on the last to occur of fifteen years from the date of the agreement, the expiration of the last to expire Elan patent or the existence of competition in that country.
Supply Agreement
        In September 2003, we entered into a supply agreement with Elan relating to the manufacture and supply of Fampridine-SR by Elan. We agreed to purchase at least 75% of our annual requirements of product from Elan, unless Elan is unable or unwilling to meet our requirements, for a purchase price based on a specified percentage of net sales. In those circumstances where we elect to purchase less than 100% of our requirements from Elan, we agreed to make certain compensatory payments to Elan. Elan agreed to assist us in qualifying a second manufacturer to manufacture and supply us with Fampridine-SR subject to our obligations to Elan.
Teva Pharmaceutical Industries Ltd.
        In September 2003, we entered into a collaboration agreement with Teva under which we were granted a co-exclusive license with Teva to jointly develop and promote in the United States products containing valrocemide as an active ingredient in any formulation and dosage form for any indication for human use, except MS. However, in the event that Teva seeks to develop and promote products containing valrocemide for MS it must provide us with notice and negotiate with us an amendment to the agreement. The agreement provides that Teva will own all right, title and interest in and to all intellectual property jointly developed by the parties while Teva has the sole right and obligation to defend against any infringement claims.
        The agreement further provides that Teva is responsible for seeking and maintaining regulatory approval from the FDA upon the completion of any co-developed product and that Teva will consult with us in
49

preparing the filings to obtain regulatory approval. Teva is also solely responsible for commercializing, manufacturing and supplying all co-developed products.
        We made an initial payment to Teva upon execution of the collaboration agreement and are obligated to make payments to Teva upon achieving certain milestones. We are also responsible for the cost and conduct of the next clinical trial in epilepsy and a toxicology study for valrocemide. We will use commercially reasonable efforts to complete the next clinical trial by the first quarter of 2006 and, if further clinical trials are required after the completion of the next clinical trial, we will share the costs of such trials with Teva. Following the completion of the next clinical trial in epilepsy, we will share in 50% of co-development expenses and co-development profits. We are entitled to receive a royalty, on a country by country basis, on net sales by Teva of valrocemide outside of the United States if the clinical data used to obtain regulatory approval for sale of the product in such country was jointly developed, or independently developed by us, under this Agreement.
        Unless earlier terminated under provisions of the Teva agreement, the agreement will expire on the earlier to occur of (i) September 23, 2009, if the parties have not achieved a statistically significant primary endpoint that is accepted by the FDA for the first pivotal trial in connection with any product, (ii) six months after the first generic version of any product is launched in the United States, or (iii) September 23, 2012, if the parties have not commenced the promotion and/or commercialization of any product under the Teva agreement.
        In addition, if we seek a co-promotion partner for our products containing Fampridine-SR, Teva has a right of first negotiation for the co-development and co-promotion of these products in the United States. Teva's right of first negotiation terminates 60 days after we deliver to Teva the summary results of the completed SCI-F301, SCI-F302 and MS-F202 clinical trials for Fampridine-SR.
Rush-Presbyterian St. Luke's Medical Center
        In 1990, Elan licensed from Rush know-how relating to fampridine for the treatment of MS. We subsequently licensed this know-how from Elan. In September 2003, we entered into an agreement with Rush and Elan terminating the Rush license to Elan and providing for mutual releases. We also entered into a license agreement with Rush in which Rush granted us an exclusive worldwide license to their know-how relating to fampridine for the treatment of MS. Rush has also assigned to us their Orphan Drug Designation for fampridine for the relief of symptoms of MS.
        We agreed to pay Rush a license fee, milestone payments and royalties based on net sales of the product for neurological indications. We also entered into an agreement with Elan relating to the allocation of payments between us and Elan of certain payments to Rush under the Rush license.
        Subject to early termination provisions, the Rush license terminates upon expiration of the royalty obligations, which expire fifteen years from the date of the agreement.
Canadian Spinal Research Organization
        In August 2003, we entered into an Amended and Restated License Agreement with the Canadian Spinal Research Organization, CSRO. Under this agreement we were granted an exclusive and worldwide license under certain patent assets and know-how of CSRO relating to the use of fampridine in the reduction of chronic pain and spasticity in a spinal cord injured patient.
        We are required to pay to CSRO royalties based on a percentage of net sales of any product incorporating the licensed rights, including royalties on the sale of Fampridine-SR for any indication.
        Subject to early termination provisions, the CSRO agreement will expire upon the termination of all royalty or other payment obligations on a country-by-country basis, which will be no longer than the earlier of the expiration of the last to expire licensed patent in such country or ten years from the date of the first commercial sale of the product in such country.
50

Cornell Research Foundation, Inc.
        In February 2003, we entered into a license agreement with Cornell Research Foundation, Inc., pursuant to which we were granted an exclusive license under a patent for the use of fampridine in the treatment of anterior horn cell diseases. In consideration for the license, we paid Cornell an upfront license fee and are required to make payments to Cornell upon the achievement of certain milestones relating to the successful reissuance or reexamination of the patents licensed to us and, the completion of a clinical trial testing the use of Fampridine-SR in amyotrophic lateral sclerosis. We are also obligated to pay Cornell royalties on net sales of Fampridine-SR in any and all indications.
        Under the Cornell agreement, Cornell is responsible for all patent prosecution and maintenance activities relating to the licensed patent, and we are responsible for paying all fees incurred by Cornell in connection therewith. We have the right under this agreement to enforce any patent rights within the licensed patents against infringement by third parties at our own expense.
        Subject to early termination by either of us, the term of the Cornell agreement will continue until the expiration of the last to expire valid claim under the licensed patent.
Mayo Clinic Foundation
        In September 2000, we entered into a license agreement with The Mayo Foundation for Education and Research, or the Mayo Clinic, pursuant to which we were granted an exclusive worldwide license to its patents on remyelinating antibodies. Under this agreement, we have the right to develop, make, use and sell the remyelinating antibody products for the prevention, mitigation and treatment of CNS disorders. We have worked closely with the Mayo Clinic research group on developing and patenting this emerging technology in connection with the therapeutic use of these antibodies, specifically myelination and re-myelination in SCI and MS. The Mayo Clinic has the right to continue researching the antibodies and, in the event it develops other applications related to the licensed patent, which are outside of the scope of our current license, the Mayo Clinic is required to offer rights in these new applications to us before it offers such rights to a third party.
        Under the Mayo Clinic agreement, we are obligated to make milestone payments and pay royalties based on net sales. This license agreement will terminate upon the expiration of the last licensed patent in any such licensed product.
CeNeS Pharmaceuticals plc
        In November 2002, we entered into two license agreements with CeNeS Pharmaceuticals plc. The first agreement relates to an exclusive worldwide sublicense under certain patents, patent applications and know-how to make, have made, use, import, offer for sale and sell protein products composed of GGF-2 and non-protein products developed through the use of material covered by a valid claim in the patents. The license to these patents and the right to sub-license these patents were granted to CeNeS by the Ludwig Institute for Cancer Research.
        Our payment obligations to CeNeS include payment of an upfront license fee, royalties based on annual net sales of the product, if any, as well as payments upon achieving certain milestones in connection with the development, testing and regulatory approval of any protein products. We are obligated to make minimum royalty payments commencing on the third calendar year following the first commercial sale of any licensed product. If we fail to pay any minimum royalty, CeNeS will have the option to convert our license or any sublicense to a non-exclusive license.
        This agreement with CeNeS is effective until the later of November 12, 2017 or the expiration of the last-to-expire valid claim in the licensed patents.
        The second agreement relates to an exclusive worldwide sublicense to us under certain patents, patent applications and know-how to make and have made, use and have used, sell, offer for sale, have sold and import protein products composed of one or more proteins encoded by the growth factor gene nrg -2 and non-protein products developed through the use of material covered by a valid claim of the patents. The license to this patent and the right to sub-license this patent was granted to CeNeS by the President and Fellows of Harvard College.
51

         We have agreed to a timeline to achieve certain milestones relating to the research and development and the clinical testing and filing of regulatory approvals for the products. We are also required to make milestone payments. If we are unable to meet a milestone, CeNeS has agreed to negotiate in good faith with us to agree for a reasonable extension of the time to achieve the milestone up to one year. We are obligated to pay CeNeS a license fee and royalties based on a percentage of net sales of protein products and non-protein products covered under the agreement.
        Subject to early termination provisions, this agreement remains effective until the last patent, patent application or claim included in the licensed patents has expired, been abandoned or been held finally rejected or invalid.
Aeres Biomedical Limited
        In February 2002, we entered into a research collaboration and commercialization agreement with Aeres Biomedical Limited, pursuant to which Aeres will modify our Lym22 and Lym46 antibodies to switch their class from IgM to IgG and create a stable cell line expressing each antibody. We will have all right, title and interest in the DNA and RNA sequences expressing our antibodies, any and all cell lines, and all inventions and all patents and patent applications arising out of the research under this agreement.
        We will pay Aeres for the costs of its research and will make payments to Aeres upon completion of each research milestone. We will also pay Aeres a royalty on our net sales of any product incorporating or derived from an antibody that is produced by Aeres' stable cell line under this agreement for a period of 12 years after commercial introduction of the product in a particular country.
        Unless earlier terminated, the Aeres agreement will expire on a country by country basis until no further payments are due by us to Aeres in such country.
Sales and Marketing
        We plan to market Fampridine-SR for both SCI and MS in the United States and Canada. We believe marketing synergies exist between the planned initial indication of SCI and the follow-on indication of MS. SCI and MS have several symptoms in common, and these symptoms are treated with similar medications prescribed by similar physicians. This concentrated group of physicians may be targeted with a relatively small sales force. We do not intend to build commercial capabilities outside North America at this time, but intend to secure those capabilities through a partner or partners.
        Our sales and marketing efforts in North America will focus on SCI specialists, physiatrists, neurologists, physical therapists and nurse practitioners involved in the treatment of SCI and MS. These health care professionals form a small group, and are located at major medical centers in the U.S. and Canada. We have existing relationships with a majority of these centers already, as a result of extensive interaction throughout the Fampridine-SR clinical testing process.
        We believe that, in general, people with SCI and MS are knowledgeable about their condition, actively seek new treatments, and directly influence their prescriber's evaluation of treatment options. We have existing relationships with the major advocacy groups that focus on SCI and MS. We provide regular updates regarding our development programs, and sponsor or support several SCI and MS educational initiatives.
        We have developed the following three-part strategy for the development and commercialization of our product candidates:
•
Market development and education . We are increasing awareness of Fampridine-SR for SCI and MS within the concentrated network of neurologists and physiatrists who prescribe the majority of therapies to treat these conditions. We plan initially to target those neurologists and physiatrists who prescribe the highest volume of prescriptions and who also are early adopters of new therapeutics. We believe there is considerable overlap between these prescriber groups, such that we will be able to
52

leverage the introduction of Fampridine-SR for SCI into additional indications in MS. In addition, we plan to build on the unusually large role that people with SCI and MS play in the development of their own treatment. This will involve a variety of advocacy initiatives, including consumer education, professional medical seminars, continuing medical education programs, advisory boards and publications. To date, we have presented clinical results at most major medical conferences for physical medicine and rehabilitation as well as neurology.
•
Agreements with Cardinal Health PTS, Inc. and inChord Communications, Inc. We have entered into agreements with subsidiaries of Cardinal Health and inChord Communications to use the product commercialization services available through their RxPedite program to launch Fampridine-SR in SCI. Cardinal Health and inChord have developed the RxPedite program to provide marketing, selling and distribution capabilities to enhance commercialization of their clients' pharmaceutical products. We plan to manage strategic and tactical planning for launching Fampridine-SR in SCI. Under the agreement, Cardinal Health is responsible for providing medical education services, as well as recruiting, hiring and training sales representatives in the United States to target Fampridine-SR to the highly concentrated network of neurologists and physiatrists most active in prescribing therapies for SCI. inChord is responsible for providing marketing communications services, including creating and preparing sales promotion material and other advertising, marketing, and promotional programs for Fampridine-SR, web site development, product branding and data analysis. Under the agreement, we have the right to offer employment to all or any selected member of Cardinal Health's sales force in the RxPedite program. Cardinal will help us transition those members of their sales force who accept our offer to work for us as part of our own direct sales force.

•
Co-development and co-promotion alliances . We intend to develop product candidates jointly with other companies as a means to leverage our sales capabilities, as well as to gain incremental revenues from the expansion of our products into areas beyond our therapeutic focus. In these arrangements, we would expect to pay a share of the research and development costs, retain rights to co-promote or co-market the potential products, and share in the profits from sales. Our criteria for selecting product candidates for co-development include strategic fit, size of the market opportunity, our level of internal expertise related to the field, manufacturing requirements, clinical trial size and complexity, and investment considerations. In cases where we determine that it is worthwhile to invest our capital in a development program for a product candidate, but we do not believe that we can internally meet the development requirements, we will seek a co-development partner.
Manufacturing
        Under our supply agreement with Elan, Elan will manufacture and supply to us, Fampridine-SR. We agreed to purchase at least 75% of our annual requirements of product from Elan, unless Elan is unable or unwilling to meet our requirements, for a purchase price based on a specified percentage of net sales. Except in those circumstances, if we elect to purchase less than 100% of our requirements from Elan, we agreed to make certain additional compensatory payments to Elan. Elan agreed to assist us in qualifying a second manufacturer and supply us with Fampridine-SR subject to our obligations to Elan.
        We have entered into a technical transfer program agreement with Patheon, Inc., pursuant to which Patheon will perform certain manufacturing and analytical services on Fampridine-SR in connection with the contemplated transfer of Elan's Fampridine-SR technology to Patheon. Elan is supporting the technology transfer to Patheon, and if it is successful, we intend to pursue qualifying Patheon as an alternate manufacturer of Fampridine-SR in our NDA filing.
        Fampridine Active Pharmaceutical Ingredient, API, is supplied by third parties directly under contract to Elan. Acorda may or may not have future direct contracts with these API suppliers. We currently participate in quality audits of these API suppliers, and have met with the FDA regarding our plans to submit two alternate suppliers of API.
53

        Teva and its affiliates have the exclusive right to manufacture valrocemide. Commercially reasonable efforts, consistent with good pharmaceutical industry practices, shall be used to manufacture and supply valrocemide.
        We have established the internal capability to manufacture research quantities of antibody and protein drug candidates. In April 2003, we entered into an agreement with Lonza Biologics, pursuant to which it will perform testing and manufacturing development activities for GGF-2. We have also retained the services of Aeres Biomedical for antibody engineering support. As NDA holder we plan to have quality assurance agreements with all manufacturing parties to ensure compliance with regulatory requirements.
Intellectual Property
        We have in-licensed, or are the assignee, of 24 U.S. patents, 40 U.S. patent applications and their numerous foreign counterparts. There are four major families of patents in our portfolio, corresponding to our four current major programs of research and development, i.e., fampridine, remyelinating antibodies, Neuregulins, including GGF-2, and the chondroitinase program.
Fampridine
        We hold an exclusive, worldwide license from CSRO for a Canadian patent application and its foreign counterparts for the use of fampridine in the treatment of spasticity and neuropathic pain in chronic SCI. Foreign counterpart patents have been granted in the U.S. and in a number of other countries worldwide. The U.S. patent expires in 2013.
        We hold an exclusive, worldwide license to three issued U.S. patents from Elan relating to timed delivery formulations of a family of aminopyridine compounds, including fampridine, and which also claim methods of administration and treatment for relevant neurological conditions. Foreign counterparts of these patents are also covered by the license. One of the three U.S. patents expires in 2011 and the other two U.S. patents expire in 2013.
        We also hold an exclusive license from Cornell University for an issued U.S. patent that relates to the use of aminopyridine compositions, including fampridine, for the treatment of diseases of anterior horn cells, including amyotrophic lateral sclerosis, which is known as Lou Gehrig's disease. This patent expires in 2016.
Valrocemide
        Teva owns, has in-licensed or is the assignee of patents related to valrocemide. The U.S. patent for valrocemide expires in 2013.
Remyelinating Antibodies
        We are the exclusive licensee of a portfolio of patents and patent applications related to a series of remyelinating monoclonal antibodies discovered in the laboratory of Dr. Moses Rodriguez at the Mayo Clinic in Minnesota. One U.S. patent has issued. Foreign counterparts of this patent are also issued in Australia, Mexico, and New Zealand, and applications are pending elsewhere, including Europe, Canada, Japan and Korea.
Neuregulins
        We are the exclusive licensee of a worldwide portfolio of patents and patent applications related to products of neuregulin genes, including glial growth factors. These patents claim the use of particular neuregulins to treat various pathophysiological conditions, particularly stimulating myelinating cells in order to treat demyelinating conditions of the central and peripheral nervous system. These patents also claim a number of additional potential applications of neuregulins, including stimulation of growth in mammalian muscle cells and treating peripheral neuropathy and nerve injury.
54

Chondroitinase / Matrix Modification
        We have filed patent applications related to our own research and development program in matrix modification.
Competition
        A number of biotechnology and pharmaceutical companies are engaged in development of therapeutics for a broad range of CNS conditions, though none of them have focused on the spinal cord as a point of access to this field. The current therapies for people with SCI and MS focus on treating symptoms associated with these diseases. Current approaches to symptom management include the use of compounds such as baclofen for spasticity, tricyclic antidepressants for neurological pain, fluoxetine for depression, amantadine or modafinil for fatigue, and oxybutinin for bladder contraction. Although our approach to the treatment of SCI and MS does not focus on treating symptoms, but rather on improving neurological function, our products will compete for market acceptance with these current treatments because they have been accepted and regularly prescribed to people with SCI and MS by health care providers.
        Several biotechnology and pharmaceutical companies, as well as academic laboratories, are involved in research and/or product development for various neurological diseases, including SCI. However, to our knowledge, none has a comprehensive, multi-disciplinary approach for SCI therapeutic product development that is comparable to ours. We are aware that Aventis is developing a sodium/potassium channel blocker, HP 184, with a potential indication in SCI. We believe that HP 184 is now in clinical trials and any resulting product could compete with Fampridine-SR. Many of our competitors have substantially greater financial, research and development, human and other resources than we do. Furthermore, large pharmaceutical companies have significantly more experience than we do in preclinical testing, human clinical trials and regulatory approval procedures.
        Commercially available therapies for MS are centered on immunomodulatory compounds. These treatments reduce the frequency and severity of exacerbations or slow the accumulation of physical disability for people with certain types of MS, though their precise mechanisms of action are not known. Several biotechnology and pharmaceutical companies are engaged in developing products that include novel immunomodulator and cell transplant approaches to remyelination for the treatment of people with MS.
        There are also numerous drugs used to treat epilepsy and bipolar disorder with which our valrocemide product as well as other products we develop in collaboration with Teva may compete.
Government Regulation
FDA Regulation and Product Approval
        The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the clinical development, manufacture and marketing of pharmaceutical products. These agencies and other federal, state and local entities regulate research and development activities and the testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of our product candidates.
        The process required by the FDA before our product candidates may be marketed in the United States generally involves the following:
•
preclinical laboratory and animal tests;

•
submission to the FDA of an Investigational New Drug, or IND, application which must become effective before clinical trials may begin;
55

•
adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed pharmaceutical in our intended use; and

•
submission to the FDA of a New Drug Application that must be approved.
The testing and approval process requires substantial time, effort, and financial resources and we cannot be certain that any approval will be granted on a timely basis, if at all.
        Preclinical studies include laboratory evaluation of the product candidate, its chemistry, formulation and stability, as well as animal studies to assess its potential safety and efficacy. We then submit the results of the preclinical studies, together with manufacturing information and analytical data, to the FDA as part of an IND application, which must become effective before we may begin human clinical trials. The IND automatically becomes effective 30 days after the FDA acknowledges that the filing is complete, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the preclinical trials or the design of the proposed clinical trials as outlined in the IND. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin. Further, an independent Institutional Review Board at each medical center proposing to conduct the clinical trials must review and approve any clinical study.
        Human clinical trials are typically conducted in three sequential phases which may overlap:
•
Phase 1: The drug is initially administered into healthy human subjects or subjects with the target condition and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion.

•
Phase 2: The drug is administered to a limited subject population to identify possible adverse effects and safety risks, to determine the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.

•
Phase 3: When Phase 2 evaluations demonstrate that a dosage range of the drug is effective and has an acceptable safety profile, Phase 3 clinical trials are undertaken to further evaluate dosage, clinical efficacy and to further test for safety in an expanded population at geographically dispersed clinical study sites.
        In the case of product candidates for severe or life-threatening diseases such as MS, the initial human testing is often conducted in affected subjects rather than in healthy volunteers. Since these subjects already have the target condition, these clinical trials may provide initial evidence of efficacy traditionally obtained in Phase 2 clinical trials and thus these clinical trials are frequently referred to as Phase 1b clinical trials.
        The orphan designation process is the mechanism by which sponsors of drugs and biologics for rare diseases qualify for a tax credit and seven-year marketing exclusivity incentives of the Orphan Drug Act. Orphan Drug designations are specific to a product and its FDA-approved indication. Market exclusivity begins at the time of FDA approval of a product for its designated use. We have received Orphan Drug designation for Fampridine-SR for both the treatment of incomplete SCI and MS.
        We cannot be certain that we will successfully complete Phase 1, Phase 2 or Phase 3 testing of our product candidates within any specific time period, if at all. Furthermore, the FDA or the Institutional Review Boards or the sponsor may suspend clinical trials at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk.
        The results of product development, preclinical studies and clinical trials are submitted to the FDA as part of a new drug application for approval of the marketing and commercial shipment of the product candidate. The FDA may deny a new drug application if the applicable regulatory criteria are not satisfied or may require additional clinical data. Even if such data is submitted, the FDA may ultimately decide that the new drug application does not satisfy the criteria for approval. Once issued, the FDA may withdraw product approval if compliance with regulatory standards is not maintained or if problems occur after the product reaches the market. In addition, the FDA may require testing and surveillance programs to monitor the effect
56

of approved products which have been commercialized, and the agency has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs.
        Satisfaction of the above FDA requirements or similar requirements of state, local and foreign regulatory agencies typically takes several years and the actual time required may vary substantially, based upon the type, complexity and novelty of the pharmaceutical product candidate. Government regulation may delay or prevent marketing of potential products for a considerable period of time and to impose costly procedures upon our activities. We cannot be certain that the FDA or any other regulatory agency will grant approval for any of our product candidates on a timely basis, if at all. Success in preclinical or early stage clinical trials does not assure success in later stage clinical trials. Data obtained from preclinical and clinical activities is not always conclusive and may be susceptible to varying interpretations which could delay, limit or prevent regulatory approval. Even if a product candidate receives regulatory approval, the approval may be significantly limited to specific indications. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market. Delays in obtaining, or failures to obtain regulatory approvals would have a material adverse effect on our business. Marketing our product candidates abroad will require similar regulatory approvals and is subject to similar risks. In addition, we cannot predict what adverse governmental regulations may arise from future United States or foreign governmental action.
        Any products manufactured or distributed by us pursuant to FDA clearances or approvals are subject to pervasive and continuing regulation by the FDA, including record-keeping requirements and reporting of adverse experiences with the drug. Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with current Good Manufacturing Practices, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. We cannot be certain that we or our present or future suppliers will be able to comply with the current Good Manufacturing Practices and other FDA regulatory requirements.
        The FDA regulates drug labeling and promotion activities. The FDA has actively enforced regulations prohibiting the marketing of products for unapproved uses. Under the Modernization Act of 1997, the FDA will permit the promotion of a drug for an unapproved use in certain circumstances, but subject to very stringent requirements.
        We and our product candidates are also subject to a variety of state laws and regulations in those states or localities where they are or will be marketed. Any applicable state or local regulations may hinder our ability to market our product candidates in those states or localities.
        The FDA's policies may change and additional government regulations may be enacted which could prevent or delay regulatory approval of our potential products. Moreover, increased attention to the containment of health care costs in the United States and in foreign markets could result in new government regulations which could have a material adverse effect on our business. We cannot predict the likelihood, nature or extent of adverse governmental regulation which might arise from future legislative or administrative action, either in the United States or abroad.
Foreign Regulation and Product Approval
        Outside the United States, our ability to market a product candidate is contingent upon receiving a marketing authorization from the appropriate regulatory authorities. The requirements governing the conduct of clinical trials, marketing authorization, pricing and reimbursement vary widely from country to country. At present, foreign marketing authorizations are applied for at a national level, although within the European Community, or EC, registration procedures are available to companies wishing to market a product in more than one EC member state. If the regulatory authority is satisfied that adequate evidence of safety, quality and efficacy has been presented, a marketing authorization will be granted. This foreign regulatory approval process involves all of the risks associated with FDA clearance discussed above.
57

Other Regulations
        We are also subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances. We may incur significant costs to comply with such laws and regulations now or in the future.
Employees
        As of July 31, 2003, we had 68 employees. Of the 68 employees, 27 perform scientific and research activities and 15 hold advanced degrees.
Facilities
        Our principal executive offices are located in an approximately 30,000 square foot facility in Hawthorne, NY, which houses offices and laboratory space. The current annual rent for this facility is $642,000. We believe that our facility is currently adequate for our purposes and that it will continue to be so for the foreseeable future. The lease for this facility expires in January 2008.
Legal Proceedings
        We are not currently a party to any material legal proceedings.
58

 MANAGEMENT
Executive Officers and Directors
        The following table sets forth information about our directors and executive officers.

Name
	 	Age
	 	Position
	
Ron Cohen, M.D.	 	47	 	President, Chief Executive Officer and Director	
Andrew R. Blight, Ph.D.	 	52	 	Executive Vice President, Research and Development	
Mary Fisher	 	42	 	Vice President, Commercial Operations	
Elliott A. Gruskin, Ph.D.	 	41	 	Vice President, Research and Development	
Mitchell Katz, Ph.D.	 	48	 	Vice President, Clinical Programs	
David Lawrence, M.B.A.	 	47	 	Vice President, Finance	
King Lee, Ph.D.	 	50	 	Vice President, Regulatory Affairs	
Mark R.E. Pinney, M.B.A., C.F.A.	 	49	 	Chief Financial Officer and Director	
Harold Safferstein, Ph.D., J.D.	 	38	 	Vice President, Business Development	
John Friedman(1)(2)(3)	 	50	 	Director	
Sandra Panem, Ph.D.(1)(2)(3)	 	57	 	Director	
Michael Steinmetz, Ph.D.(2)	 	56	 	Director	
Wise Young, Ph.D., M.D.	 	53	 	Director	

(1)
Member of Governance Committee
(2)
Member of Compensation Committee
(3)
Member of Audit Committee
         Ron Cohen, M.D. has served as our President and Chief Executive Officer and a director since he founded Acorda in 1995. Dr. Cohen previously was a principal in the startup of Advanced Tissue Sciences, Inc., a biotechnology company engaged in the growth of human organ tissues for transplantation uses. Dr. Cohen serves as the Chairman of the Board of the New York Biotechnology Association and on the Board of Directors of Ceregene, Inc. He also serves on the Advisory Editorial Board of BioPeople magazine, and as a member of the Columbia-Presbyterian Health Sciences Council. Dr. Cohen received his B.A. degree with honors in Psychology from Princeton University, and his M.D. from the Columbia College of Physicians & Surgeons. He completed a residency in Internal Medicine at the University of Virginia Medical Center, and is Board Certified in Internal Medicine.
         Andrew R. Blight, Ph.D. has served as our Executive Vice President, Research and Development since 2000 and was Vice President from 1998 to 2000. Prior to joining Acorda, Dr. Blight spent approximately 6 years as Professor and Director of the Neurosurgery Research Laboratory at the University of North Carolina at Chapel Hill. Dr. Blight held prior academic positions at Purdue University and New York University. Dr. Blight is a leader in SCI pathophysiology research and has made several important contributions to the field, particularly on the role of demyelination in SCI. He also pioneered the therapeutic application of 4-AP in SCI animal models and in human clinical trials. Dr. Blight is a member of the editorial board of the Journal of Neurotrauma and has served as a member of the NIH NSDA review committee. He was previously Secretary, Treasurer and Vice President of the National Neurotrauma Society. Dr. Blight received his B.S. in Zoology and his Ph.D. in Zoology/Neurobiology from the University of Bristol, U.K.
         Mary Fisher has served as our Vice President, Commercial Operations since September 2003 and was Vice President, Marketing and Strategic Planning since 2000 to 2003. From 1999 to 2000, Ms. Fisher was an independent consultant to various pharmaceutical companies. From 1994 to 1999, Ms Fisher was Vice President, Strategic Healthcare and Commercial Operations for Cephalon, Inc. In that capacity she had responsibility for the company's corporate sales, managed care marketing, pricing, reimbursement, health economics, patient support programs, product planning, commercial manufacturing, distribution and customer service. From 1990 until joining Cephalon, Ms. Fisher was Corporate Communications Manager for Immunex
59

Corporation. Previously, she spent nine years in a variety of line and staff positions, including production planning, purchasing, accounting, and public affairs at Boehringer Ingelheim Pharmaceuticals, Inc. Ms. Fisher currently serves as a director of PharmaMetrics GmbH.
         Elliott A. Gruskin, Ph.D. has served as our Vice President, Research & Development since 2001. From November 1990 until joining Acorda, Dr. Gruskin served as Senior Director of the Life Sciences Division of United States Surgical Corporation where he was responsible for all operations including strategic planning, budgets, corporate development, contracts, external research agreements, intellectual property, research, development and transfer of products to manufacturing. Dr. Gruskin was responsible for two approved wound healing products, has been issued 8 U.S. patents and has published scientific papers in DNA repair enzymology biomaterials, wound healing and tissue engineering. Dr. Gruskin received his B.S. Degree in Biochemistry from the University of Rochester and his Ph.D. in Biochemistry from Vanderbilt University as a Harold Sterling Vanderbilt Scholar and completed his postdoctoral training at MIT in Biophysics.
         Mitchell Katz, Ph.D. has served as our Vice President, Clinical Programs since 2000. Prior to joining Acorda, he served as the Director of Clinical Operations at SCP Communications from 1998 to 2000. He also supported clinical and preclinical operations at several start-up biotechnology companies, and held management positions at R.W. Johnson Pharmaceutical Research Institute, and Schering-Plough. In these prior positions, he participated in four successful NDA applications. He received a B.A. in Biology from CUNY Brooklyn and a Ph.D. in microbiology from Rutgers University Graduate School and served as a postdoctoral research follow in the Department of Microbiology and Immunology at Downstate Medical Center, Brooklyn, New York. Dr. Katz has also published scientific papers in numerous peer-review journals.
         David Lawrence, M.B.A. joined us as Vice President, Finance in 1999. From 1991 to 1999, Mr. Lawrence held several positions for Tel-Air Communications, Inc. including Vice President and Controller. Prior to Tel-Air, he held financial management positions of Controller and Finance Manager for Southwestern Bell and Metromedia Telecommunications respectively. Mr. Lawrence received his undergraduate degree in Accounting from Roger Williams College in Rhode Island, and an M.B.A in Finance from Iona College in New York. Mr. Lawrence is a founding member and currently serves on the Board of Directors as Treasurer of The Brian Ahearn Children's Fund.
         King Lee, Ph.D. R.A.C. joined us in August 2003 as our Vice President of Regulatory Affairs. From 2001 to 2003, Dr. Lee was Executive Director of Regulatory Affairs/Quality Assurance/Quality Control at ATON Pharma, Inc. From 1996 to 2001, Dr. Lee was with VION Pharmaceuticals, Inc., where he had held several management positions, most recently the Senior Director in Regulatory Affairs/Quality Assurance. Prior to VION, Dr. Lee held positions at IBEX, Sterling-Winthrop Research Institute, and Wyeth Pharmaceuticals. Dr. Lee is a member of the Regulatory Affairs Professional Society and has authored over 40 publications. Dr. Lee received his Ph.D. in Pharmacology from the College of Medicine of the University of Kentucky and was certified by the Regulatory Affairs Professionals Board in 1994.
         Mark R. E. Pinney, M.B.A., C.F.A., M.S. has served as our Chief Financial Officer since 2001 and has been a member of the board of directors since the founding of the company in 1995. Prior to joining Acorda, from 2000 to 2001, Mr. Pinney was Chairman of CanDo, Inc., an Internet company that offered product and service solutions to people with disabilities. In 1998, he co-founded and was Chief Executive Officer of LifeWire, Inc., a company developing community-based destination web sites for the disability population. LifeWire merged with CanDo in 2000. Mr. Pinney also co-founded Real Media, Inc., an Internet advertising software and services firm, in 1996, and participated in the start-up of Acorda. From 1984 to 1988, he was Vice President, Corporate Finance for Merrill Lynch Capital Markets and from 1988 to 1992, he was Vice President, Private Transactions at Dillon Read & Co., Inc. Mr. Pinney serves as a Trustee of the Christopher Reeve Paralysis Foundation and currently serves as a director of Healthlink Systems, Inc. He received an undergraduate degree in engineering at the University of Exeter, England, an M.B.A. from the University of Chicago Graduate School of Business, and a masters degree in engineering from Columbia University. He is a Chartered Financial Analyst.
60

         Harold Safferstein, Ph.D., J.D. has served as our Vice President, Business Development since 2001. From 1997 to 2001, Dr. Safferstein spent approximately 5 years at Bristol-Myers Squibb, most recently as Director, Lifecycle Management, Business Development and Strategic Planning for the Diabetes Franchise. Prior to joining Bristol-Myers Squibb, Dr. Safferstein was Director, Technology Transfer at the National Heart, Lung and Blood Institute, Cooperative Venture Manager for the National Institute of Allergy and Infectious Diseases and Chair, PHS Technology Development Coordinators Committee at the National Institutes of Health. Dr. Safferstein was a NIH Post-Doctoral Fellow and Fellow of the Multiple Sclerosis Society. Dr. Safferstein received a B.A. in biochemistry from Rutgers University, a Ph.D. in neurobiology from the University of Louisville, a J.D. from The American University, Washington College of Law and an M.B.A. from Columbia University.
         John Friedman has served as a director of Acorda since May 2003. Mr. Friedman is the founder and principal of Easton Hunt Capital Partners which he founded in 1998. Prior to founding Easton Hunt Capital Partners he was managing director of Easton Capital Corp. from 1993 to 1998, which he also founded. Mr. Friedman was also the founder and Managing General Partner of Security Pacific Capital Investors, a $200-million private equity fund geared towards expansion financings and recapitalizations. Prior to joining Security Pacific, he spent more than eight years at E.M. Warburg, Pincus & Co., Inc., serving last as a Managing Director and Partner. Before joining Warburg, Mr. Friedman was an attorney with Sullivan and Cromwell LLP. He holds a J.D. from Yale Law School and a B.A. degree from Yale College. He currently serves on the boards of directors of Transave, Inc., Renovis, Inc., Conor Med Systems, Comverse Technology Inc., Trellis Bioscience, Assistive Technology, Inc., and ModelWire, Inc., and is on the President's Council at the Cold Spring Harbor Laboratory.
         Sandra Panem, Ph.D. has served as a director of Acorda since 1998. She is currently a partner at Cross Atlantic Partners which she joined in 2000. From 1994 to 1999, Dr. Panem was President of Vector Fund Management, the asset management affiliate of Vector Securities International. Prior thereto, Dr. Panem served as Vice President and Portfolio Manager for the Oppenheimer Global BioTech Fund, a mutual fund that invested in public and private biotechnology companies. Previously, she was Vice President at Salomon Brothers Venture Capital, a fund focused on early and later-stage life sciences and technology investments. Dr. Panem was also a Science and Public Policy Fellow in economic studies at the Brookings Institution, and an Assistant Professor of Pathology at the University of Chicago. She received a B.S. in biochemistry and Ph.D. in microbiology from the University of Chicago. Dr. Panem currently serves on the boards of directors of Martek Biosciences Corp., Bioject Medical Technologies, Inc., AirLogix, Inc. and Confluent Surgical, Inc.
         Michael Steinmetz, Ph.D. joined our board of directors in 1998. Dr. Michael Steinmetz currently serves as a General Partner of MPM Capital, which he joined in 1997. Prior to MPM, he held positions at various academic institutions, including the California Institute of Technology and the Basel Institute for Immunology where he was a permanent member. In 1986, he joined Hoffmann-La Roche and held various leadership positions in R&D, initially in Switzerland and subsequently in the U.S.A. where, as Vice President of Preclinical Research and Development, he was responsible for Roche's drug discovery activities in the U.S.A. and Roche's global biotechnology efforts. Dr. Steinmetz was trained as a chemist and holds a Ph.D. from the University of Munich. He did academic research in the areas of Biochemistry, Molecular Biology and Immunology and published over 130 manuscripts in leading scientific journals. He is currently Chairman of the Board at BioXell SpA and the ISB Accelerator Corporation and a director of Amphora Discovery Corporation, atugen AG, Biovitrum AB, Cellular Genomics, Inc., Epigenomics AG, Intracel Resources, LLC, MacroGenics Inc., and TaiGen Bioscience Corporation.
         Wise Young, Ph.D., M.D. has been a member of the board of directors and of our scientific advisory board since the founding of the company in 1995. Dr. Young has been at Rutger's University since 1997, where he serves as Professor and Chair of the Department of Cell Biology and Neuroscience, Professor II and Director of the Neuroscience Center and founder of the W.M. Keck Center for Neuroscience. Dr. Young is one of the preeminent scientists in the fields of spinal cord injury and neurotrauma, SCI animal models, and the pharmacological therapy of SCI. He was the Principal Investigator for the Multicenter Animal Spinal
61

Cord Injury Study, funded by the National Institutes of Health; is editor-in-chief of Current Concepts in Critical Care and Trauma ; and serves on numerous editorial boards, including those of Experimental Neurology, Journal of Neurotrauma, Brain Research and Stroke . Dr. Young has received the Wakeman Award for Research in Neurosciences, and a Jacob Javits Neuroscience Award from the National Institute of Neurological Disorder and Stroke. He is also a member of the Scientific Advisory Council of the American Paralysis Association and of the National Acute Spinal Cord Injury Study executive committee. Dr. Young received a B.A. in biology and chemistry from Reed College, a Ph.D. in physiology and biophysics from the University of Iowa and an M.D. from Stanford University.
Scientific Advisory Board
        Our Scientific Advisory Board is comprised of the following individuals who are well recognized scientists and academic leaders in the SCI and MS fields, representing multiple areas of expertise, including neuropharmacology, cellular and molecular neurobiology, clinical neurology, SCI animal models, and spinal cord pathophysiology. They provide us with advance access to information and technology within the SCI and MS fields, as well as advise us on particular project needs, perform experiments and write grants that help to support in-house research.
         Michael S. Beattie, Ph.D. holds the Brumbaugh Chair in Brain Research and Teaching, and is Professor of and Chair of the Department of Neuroscience at Ohio State University. In collaboration with Dr. Jacqueline Bresnahan, Dr. Beattie has contributed seminal work in the areas of SCI mechanisms and regeneration, most recently in elucidating the role of programmed cell death in SCI, and he is co-developer of the Beattie-Bresnahan-Basso, or BBB, scale that is now a standard for measurement of behavioral recovery in animals after SCI. He has served on the editorial board of Journal of Neurotrauma, NIH study sections , and has chaired international symposia on neural transplantation and neurotrauma. Dr. Beattie received his B.S. in psychology from the University of California, and his M.A. and Ph.D. in neuropsychology from Ohio State University.
         Jacqueline C. Bresnahan, Ph.D. is Professor of Neuroscience at Ohio State University. In collaboration with Dr. Michael Beattie, Dr. Bresnahan has contributed seminal work in the areas of SCI mechanisms and regeneration, most recently in elucidating the role of apoptosis in SCI, and she is co-developer of the BBB scale that is now a standard for measurement of behavioral recovery in animals after SCI. She is a past President of the Neurotrauma Society, serves on the editorial boards of the Journal of Neurotrauma and the Neurotrauma Society Newsletter , and is a member of the Scientific Advisory Council of the American Paralysis Association. Dr. Bresnahan received her B.A. in psychology and biology from Kent State University, and her M.A. and Ph.D. in physiological psychology from Ohio State University.
         Mary B. Bunge, Ph.D. is Professor of Cell Biology and Anatomy, Neurological Surgery and Neurology at the University of Miami School of Medicine. Dr. Bunge's research focuses on the development and repair of neural tissue, particularly by the application of cultured Schwann cell grafts and various nerve growth factors. She has served on the editorial boards of the Journal of Cell Biology and Journal of Neurocytology . She is the first winner of the Mika Salpeter Women in Neuroscience Lifetime Achievement Award and the recipient of the 1996 Wakeman Award for her seminal contributions to the field of spinal cord injury repair. Dr. Bunge received her B.S. in biology from Simmons College, her M.S. in medical physiology and Ph.D. in zoology/cytology from the University of Wisconsin Medical School, and her Post-Doctoral Fellowship in developmental neurobiology at the Columbia College of Physicians and Surgeons.
         Carl W. Cotman, Ph.D. is Professor of Psychobiology and Neurology at the University of California, Irvine. His research focus is on programmed cell death in the CNS, and on beta amyloid-associated neurotoxicity. Among other honors, Dr. Cotman has received the Bristol Myers Neuroscience Research Award, the Pattison Prize in Neuroscience, and the Camhi Research Award of the American Paralysis Association, or APA. He has published nearly 500 papers in the field of neuroscience and serves on several editorial boards, including the Journal of Neurochemical Research, Journal of Biological Chemistry and Central Nervous
62

System Trauma . Dr. Cotman also is past Chairman of the Scientific Advisory Council of the APA, and continues to serve as a Scientific Advisor. He received his B.A. in chemistry from Wooster College, and his Ph.D. in biochemistry from Indiana University.
         James W. Fawcett, Ph.D. is Merck Company Professor of Experimental Neurology, Cambridge University, and Chairman of the MRC Cambridge Centre for Brain Repair. He is a world authority on regeneration in the nervous system, has published extensively in the field of neural development and repair. He is also edited of a number of books, including the recent Brain Damage and Brain Repair .
         Martin Grumet, Ph.D. is Professor of Cell Biology and Neuroscience in the Division of Life Sciences at Rutgers University and he is Director of the W.M. Keck Center for Neuroscience. He is the discoverer of the Ng-CAM protein, a chick homologue of L1. He is a leading researcher of cell adhesion molecules in the nervous system and their roles in CNS development and regeneration. Dr. Grumet received his B.Sc. in physics and biology from, respectively, The Cooper Union and New York University, his Ph.D. in biophysics at Johns Hopkins University, and did his Post-Doctoral Fellowship in developmental and molecular biology at The Rockefeller University.
         Eugene Johnson, Jr., Ph.D. is Norman J. Stupp Professor of Neurology, and Professor of Molecular Biology and Pharmacology at Washington University School of Medicine, St. Louis. He is preeminent in the field of pharmacologic regulation of nerve growth factors, and in the mechanisms and prevention of programmed nerve cell death. Dr. Johnson has received both a Jacob Javits Neurosciences Investigator Award and a MERIT Award from the National Institutes of Health, and a Decade of the Brain Medal from the American Association of Neurological Surgeons. He serves as the Co-Director of the Washington University Alzheimer's Disease Research Center. His editorial board service includes Neuron, Journal of Neuroscience, Synapse and Journal of Neurotrauma . Dr. Johnson received his B.Sc. in pharmacy, and his Ph.D. in medicinal chemistry from the University of Maryland.
         Mark D. Noble, Ph.D. is Professor of Genetics at the Center for Cancer Biology, University of Rochester Medical Center, Rochester, NY. Dr. Noble is a world leader in the areas of stem cell biology, CNS myelin repair, glial progenitor cells, and CNS regeneration. He is a recipient of the Jean Monnet Prize of the European Neurological Society, and serves on the editorial boards of, among others, Developmental Neuroscience, International Journal of Developmental Neuroscience and Glia . Dr. Noble received his B.A. in Biology and Philosophy from Franklin and Marshall College, and his Ph.D. in Genetics from Stanford University
         Melitta Schachner, Ph.D. is Professor and Director of the Institute for Synthesis of Neural Structures at the University of Hamburg, in Germany. Dr. Schachner is the discoverer of the L1 protein, a promoter of axonal outgrowth, and the L2/HNK-1 carbohydrate, a critical motor neuron guidance factor. Her research focus is on cell adhesion molecules in the nervous system, and their role in nerve cell regeneration. She serves on the editorial boards of numerous scientific journals, including the Journal of Neurobiology, Brain Research, Molecular Brain Research, Journal of Neuroscience and the Journal of Neuroimmunolog y. Dr. Schachner received her undergraduate degree in biochemistry at the University of Tubingen, and her Ph.D. in biochemistry from the Max-Planck Institute in Munich.
         Jerry Silver, Ph.D. is Professor of Neurosciences at Case Western Reserve University. Dr. Silver is a world authority on neuroglial cells, extracellular matrix and nerve regeneration, particularly in relation to spinal cord injury. He is associate editor of Experimental Neurology , and serves on the editorial boards of Glia, The Journal of Neurobiology, and Restorative Neurobiology and Neuroscience . He is a member of the Scientific Committee of the International Spinal Research Trust and the Daniel Heumann Fund. He has served as Chairman of the Workshop on New Developments in Spinal Cord Injury: Acute Interventions and Neural Grafts, sponsored by the U.S. Congress. Dr. Silver received his B.S. in biology from Cleveland State University, and his Ph.D. in anatomy from Case Western Reserve University.
63

         Patrick A. Tresco, Ph.D. is Associate Professor of Bioengineering at the University of Utah. He has performed groundbreaking research in the development of cell encapsulation systems as sustained delivery devices for treatment for CNS disorders. Dr. Tresco holds 11 issued and pending patents relating to this and other bioengineering areas. Dr. Tresco is a regular peer reviewer for Experimental Neurology and Bioengineering and Biotechnology . He received his B.A. in biology from Susquehanna University, his M.S. in pharmacology and toxicology from the University of Rhode Island, and his Ph.D. in medical sciences from Brown University.
         Mark H. Tuszynski, M.D., Ph.D. is Professor of Neurosciences, Director of the Center for Neural Repair, and Attending Neurologist at the University of California, San Diego, or UCSD. Dr. Tuszynski has performed pioneering research in the regeneration of CNS axons by use of genetically modified cell grafts, notably in the areas of SCI and Alzheimer's disease. He holds a Physician Scientist Award from the University of Minnesota, and in 1995 was the first recipient of the Silvio O. Conte Neuroscience Research Award from the American Academy of Neurology. He serves as a reviewer for, among others, the Journal of Neuroscience, Experimental Neurology, Cell Transplantation, and the Journal of Neuroscience Methods . Dr. Tuszynski received his B.A. in biology and his M.D. from the University of Minnesota, and his Ph.D. in neurosciences from UCSD. He completed his neurology residency at Cornell University Medical Center.
         Stephen G. Waxman, M.D., Ph.D. is Chairman of the Department of Neurology, Yale University School of Medicine, and Neurologist-in-Chief, Yale-New Haven Hospital. He also is founder and Director of the PVA/EPVA Neuroscience Research Center. Dr. Waxman is internationally recognized for elucidating the molecular architecture of nerve fibers and glial cells, and mechanisms of injury to nerve fibers in the spinal cord and brain. He has published over 400 scientific papers and has authored three books on neuroscience. He is editor of The Neuroscientist , associate editor of the Journal of Neurological Sciences and Muscle and Nerve , and serves on the editorial boards of numerous other journals. Dr. Waxman is a member of the Institute of Medicine of the National Academy of Sciences; and has served on the Advisory Boards of the American Paralysis Association and the Spinal Cord Research Foundation. A graduate of Harvard College, his honors include the Wartenburg Award of the American Academy of Neurology and the Distinguished Alumnus Award of the Albert Einstein College of Medicine, where he received his MD and Ph.D. degrees.
         Wise Young, Ph.D., M.D. See "Executive Officers and Directors" above.
Board Composition
        Following this offering, our board of directors will consist of six directors divided into three classes, with each class serving for a term of three years. At each annual meeting of stockholders, directors will be elected for a three-year term to succeed the directors whose terms are expiring. Mr. Pinney and Dr. Young will be Class I directors whose terms will expire in 2004; Drs. Panem and Steinmetz will be Class II directors whose terms will expire in 2005 and Dr. Cohen and Mr. Friedman will be Class III directors whose terms will expire in 2006.
Director Compensation
        Commencing on the date of this prospectus, each of our non-employee directors will receive non-qualified stock options to purchase 20,000 shares at the initial public offering price per share, which options will vest in 12 equal quarterly installments commencing 180 days after the date of grant.
        Commencing on the date of this prospectus, each of our directors will receive an annual option grant to purchase 10,000 shares on the date of our annual stockholder meeting. In addition, directors will receive an annual grant of 5,000 options exercisable to purchase shares for each committee on which they serve. Directors will also be reimbursed for expenses incurred in attending meetings.
64

Board Committees
        The board of directors has an audit committee, a compensation committee and a governance committee.
        Our audit committee is responsible for the following functions:
•
approve and retain the independent auditors to conduct the annual audit of our books and records;

•
review the proposed scope and results of the audit;

•
review and pre-approve the independent auditors' audit and non-audit services rendered;

•
approve the audit fees to be paid;

•
review accounting and financial controls with the independent auditors and our financial and accounting staff;

•
review and approve transactions between us and our directors, officers and affiliates;

•
recognize and prevent prohibited non-audit services;

•
establish procedures for complaints received by us regarding accounting matters; and

•
oversee internal audit functions.
        Our compensation committee is responsible for the following functions:
•
review and recommend the compensation arrangements for executives, including the compensation for our president and chief executive officer;

•
establish and review general compensation policies with the objective to attract and retain superior talent, to reward individual performance and to achieve our financial goals; and

•
administer our stock incentive plan and annual bonus pool.
        The governance committee is responsible for identifying potential candidates to serve on our board.
Compensation Committee Interlocks and Insider Participation
        Our Compensation Committee is comprised of three members, Mr. John Friedman and Drs. Sandra Panem and Michael Steinmetz. No member of our Compensation Committee has at any time been an officer or employee of ours, or our subsidiary. No interlocking relationship exists between our board of directors or compensation committee and the board of directors or compensation committee of any other company, nor has any interlocking relationship existed in the past.
        Mr. Friedman, Dr. Panem and Dr. Steinmetz are affiliated with Easton Hunt Capital Partners, Cross Atlantic Partners and MPM/BB Bioventure group, respectively, each of which participated in the sale of our Series J preferred stock in a private placement consummated in May 2003, and MPM/BB Bioventure group also participated in our Series I preferred stock a private placement consummated in March 2001. Pursuant to an amended and restated registration rights agreement among us and certain of our stockholders, including entities affiliated with Mr. Friedman and Drs. Panem and Steinmetz, the parties to the registration rights agreement have demand and piggy-back registration rights. See "Certain Relationships and Related Transactions."
65

Executive Compensation
        The following summary compensation table sets forth the aggregate compensation awarded to, earned by, or paid to the Chief Executive Officer and to our four most highly compensated executive officers whose annual compensation exceeded $100,000 for the fiscal year ended June 30, 2003, for services during the fiscal year ended June 30, 2003:
 
 Summary Compensation Table

 	 	Annual Compensation
	 	Long-Term
Compensation
	 	 	
Name and Principal Position
	 	Year
	 	Salary
	 	Bonus
	 	Other Annual
Compensation
	 	Securities
Underlying Options
	 	All Other
Compensation
	
Ron Cohen, M.D.
President and Chief Executive Officer	 	2003	 	$	285,000	 	$	60,000	 	—	 	—	 	—	

Andrew R. Blight, Ph.D.
Executive Vice President, Research and Development	
 	
2003	
 	
$	
179,500	
 	
$	
28,915	
 	
—	
 	
—	
 	
—	

Mary Fisher
Vice President, Marketing	
 	
2003	
 	
$	
176,000	
 	
$	
28,263	
 	
—	
 	
—	
 	
—	

Mitchell Katz, Ph.D.
Vice President, Clinical Programs	
 	
2003	
 	
$	
187,292	
 	
$	
20,161	
 	
—	
 	
—	
 	
—	

Mark Pinney, M.B.A., C.F.A.(1)
Chief Financial Officer	
 	
2003	
 	
$	
191,250	
 	
$	
33,306	
 	
—	
 	
—	
 	
—	

(1)
A portion of Mr. Pinney's salary in the amount of $91,250, which was paid in September 2003, was deferred as of June 30, 2003.

Option Grants in Last Fiscal Year
        During the fiscal year ended June 30, 2003 no stock option grants were made to the named executive officers. No stock appreciation rights were granted to these individuals during such year.
66

Aggregate Option Exercises in Last Fiscal Year and Fiscal Year-End Option Values
        The following table sets forth information concerning option exercises and option holdings for the fiscal year ended June 30, 2003 with respect to the named executive officers. No stock appreciation rights were exercised during such year or were outstanding at the end of that year.

 	 	 	 	 	 	Number of Securities
Underlying Unexercised
Options at
June 30, 2003
	 	Value of Unexercised
In-the-Money
Options at
June 30, 2003
	
 	 	Shares
Acquired
on Exercise
	 	Value
Realized ($)
					
Name
					 	Exercisable
	 	Unexercisable
	 	Exercisable
	 	Unexercisable
	
Ron Cohen	 	0	 	0	 	39,063	 	19,618	 	$	19,922	 	$	10,005	
Andrew Blight	 	0	 	0	 	18,438	 	2,813	 	 	13,332	 	 	1,433	
Mary Fisher	 	0	 	0	 	4,896	 	3,437	 	 	2,847	 	 	1,870	
Mitchell Katz	 	0	 	0	 	4,531	 	2,552	 	 	2,690	 	 	1,389	
Mark Pinney	 	0	 	0	 	16,111	 	12,854	 	 	8,542	 	 	6,556	

(1)
Based on the estimated fair market value of our common stock at June 30, 2003, less the exercise price payable for such shares. This table gives retroactive effect to a repricing in September 2003 on certain options.
1999 Employee Stock Option Plan
        In June 1999, our board of directors adopted the 1999 Employee Stock Option Plan. We obtained stockholder approval of the plan in August 1999. The plan allows us to issue awards of incentive or nonstatutory stock options for shares of our common stock and stock appreciation rights. Our compensation committee administers the plan, selects those persons who are to be granted awards under the plan and determines the terms and conditions of those awards. Our directors, key employees, officers, independent contractors, agents and consultants are eligible to receive awards under our plan, but only employees and officers may receive incentive stock options. As of June 30, 2003 we reserved a total of 1,658,333 shares of common stock for issuance and have granted options to purchase 188,291 shares under the plan. In September 2003, our board of directors adopted an amendment to the plan, which is subject to approval by our stockholders. The amendment to the plan, which will become effective upon consummation of this offering, provides for automatic annual increases to the share reserve on the first day of each fiscal year by a number of shares equal to the lesser of:
•
2.5% of our then outstanding shares of common stock;

•
647,151 shares; or

•
a number determined by our board of directors.
        The exercise price per share of the incentive stock options awarded under the plan must be at least equal to the fair market value of a share of our common stock on the date of grant. The exercise price per share of nonstatutory stock options awarded under the plan must be equal to the fair market value of a share of our common stock on the date of grant, or such other price than the compensation committee may determine is appropriate. The compensation committee determines the exercise period of the stock options, but in no event will the stock options expire later than ten years from the date of grant. Except as the compensation committee may otherwise determine, upon the voluntary termination or involuntary termination without cause of the option holder, the stock options may be exercised for a period of three months after such termination. In the case of termination of the option holder by reason of retirement or due to disability, the stock options may be exercised at any time to the extent that such stock option was vested, but only within one year of termination in the case of incentive stock options. In the case of termination by death, the option holder's
67

estate, or any person who acquires the stock option by reason of the option holder's death, may exercise the stock option within a period of three years after the option holder's death.
        The compensation committee has the authority to include with any stock option award a progressive stock option, which allows an option holder to exercise their stock option by surrendering shares of common stock and entitles them to receive additional shares of common stock equal to the number of shares surrendered. The compensation committee also has the authority to grant stock appreciation rights in connection with any stock option award, which may be paid in shares of common stock, cash or both, at the discretion of the compensation committee and subject to the requirements of the plan.
        In the event of a tender offer by a person or persons other than us, for all or any part of the outstanding stock, which if upon consummation of the tender offer, the offeror or offerors would, own, beneficially or of record, an aggregate of more than 25% of our outstanding common stock, or in the event of a change of control, the stock options will become immediately exercisable to the extent of the total number of shares subject to the stock options. The compensation committee may authorize payment of cash upon exercise of a stock appreciation right in the event of a tender offer as described above, or a change of control.
        At June 30, 2003, options to purchase an aggregate of 188,291 shares at prices ranging from $4.20 to $24.00 were outstanding under the 1999 option plan. In September 2003, we unilaterally reduced the exercise price of 150,251 of such options to $5.88, the effective common stock price per share at which we sold our Series J preferred stock. Also in September 2003, we granted stock options to purchase an aggregate of 1,374,997 shares of our common stock at $5.88 per share to our officers and employees. These options had been authorized for issuance under the Plan by the board of directors at the closing of the Series J financing in May 2003. The following table sets forth the number of shares underlying such options issued to each of the named executive officers and directors and the number of stock options repriced:

Name
	 	Number of
Shares Underlying
Stock Options Granted
	 	Number of
Stock Options Repriced
	
Ron Cohen	 	740,100	 	58,681	
Andrew Blight	 	102,411	 	21,250	
Mary Fisher	 	39,621	 	8,333	
Mitchell Katz	 	32,570	 	7,083	
Mark Pinney	 	204,508	 	28,965	
401(k) Plan
        Effective September 1, 1999, we adopted a defined contribution 401(k) savings plan covering all of our employees. Participants may elect to defer a percentage of their annual pre-tax compensation to the 401(k) plan, subject to defined limitations. Our board of directors has discretion to match contributions made by our employees. We did not make any matching contributions to the plan in fiscal years 2001, 2002 and 2003.
Employment Contracts, Termination of Employment and Change-in-Control Arrangements
        We are a party to an employment agreement with Dr. Cohen which governs the terms and conditions of his employment as our President and Chief Executive Officer. The employment agreement provides for a base annual salary of $280,000, subject to annual increases and bonuses at the discretion of the board of directors. Dr. Cohen is eligible to receive annual performance-based stock options to purchase common stock in an amount determined by the board of directors based on Dr. Cohen's individual performance and the achievement of our goals and objectives. Dr. Cohen's employment agreement expires in January 2004, but is subject to automatic successive one-year renewal periods unless either Dr. Cohen or we give the other written notice at least 60 days prior to the expiration date that Dr. Cohen or we do not intend to renew the contract. In the event we terminate the agreement with Dr. Cohen without cause, or if Dr. Cohen voluntarily terminates
68

the agreement with good reason, we are obligated to make severance payments equal to one year's base annual salary and COBRA premium payments for the severance period plus a bonus equal to his prior year's bonus pro rated for the number of days worked prior to termination. In such event, all of Dr. Cohen's options will become immediately exercisable and will remain exercisable for 48 months following termination. If Mr. Cohen's employment terminates for death or disability, we are obligated to pay his base salary for three months and COBRA premiums for the COBRA coverage period and 65% of his outstanding options will become immediately vested and remain exercisable for 48 months following such termination. In the event of a change in control, the vesting of Dr. Cohen's options will be governed by the terms of our stock option plan and his stock option agreement, but in no event will less than 65% of Dr. Cohen's then unvested stock options become immediately vested and exercisable. If Dr. Cohen voluntarily terminates his employment without good reason following a change in control, he is entitled to receive the same severance and bonus package described above, however, only 65% of his outstanding options will become immediately vested and remain exercisable for 48 months following termination. Following his termination of employment, Mr. Cohen will remain subject to confidentiality, non-competition and non-solicitation covenants for one year in the case of non-competition and non-solicitation and five years in the case of confidentiality.
        We are a party to an employment agreement with Mr. Pinney which governs the terms and conditions of his employment as our Chief Financial Officer. The employment agreement provides for a base annual salary of $197,500. Mr. Pinney is eligible to receive an annual bonus and to receive annual performance-based stock options to purchase common stock in an amount to be determined by the board of directors based on Mr. Pinney's performance and, in the case of the stock options, upon the achievement of our goals and objectives. Mr. Pinney's employment agreement expires in September 2004, but is subject to automatic successive one-year renewal periods unless either Mr. Pinney or we give written notice to the other at least 60 days prior to the expiration date that either Mr. Pinney or we do not intend to renew the agreement. In the event we terminate the agreement with Mr. Pinney without cause, or if Mr. Pinney voluntarily terminates the agreement with good reason, we are obligated to make severance payments equal to six months base annual salary and COBRA premium payments for the severance period plus a bonus equal to his prior year's bonus pro rated for the number of days worked prior to termination. In such event, all of Mr. Pinney's options will become immediately exercisable and will remain exercisable for 48 months following termination. If Mr. Pinney's employment terminates for death or disability, we are obligated to pay his base salary for three months and COBRA premiums for the COBRA coverage period and 33% of his outstanding options will become immediately vested and remain exercisable for 48 months following such termination. In the event of a change in control, the vesting of Mr. Pinney's options will be governed by the terms of our stock option plan and his stock option agreements, but in no event will less than 33% of Mr. Pinney's then unvested stock options become immediately vested and exercisable. If Mr. Pinney voluntarily terminates his employment without good reason following a change in control, he is entitled to receive the same severance and bonus package described above. However, only 33% of his outstanding options will become immediately vested and remain exercisable for 48 months following termination. Following his termination of employment, Mr. Pinney will remain subject to confidentiality, non-competition and non-solicitation covenants for one year in the case of non-competition and non-solicitation and five years in the case of confidentiality.
Indemnification of Directors and Executive Officers and Limitation on Liability
        Our bylaws currently provide and, upon the closing of this offering our amended and restated bylaws will provide, that we shall indemnify our directors and officers to the fullest extent permitted by Delaware law, provided that, with respect to proceedings initiated by our officers and directors, we are only required to indemnify these persons if the proceeding was authorized by our board of directors. Our bylaws permit us, by action of our board of directors, to indemnify our other employees and agents to the same extent as we are required to indemnify our officers and directors. We are also empowered under our bylaws to enter into indemnification agreements with our directors, officers, employees or agents and to purchase insurance on behalf of any of our director, officer, employee or agent whether or not we are required or permitted to indemnify such persons under Delaware law.
69

        We have entered into indemnification agreements with certain of our directors and executive officers and intend to enter into indemnification agreements with all of our other directors and executive officers prior to the consummation of this offering. Under these agreements, we will indemnify our directors and executive officers against amounts actually and reasonably incurred in connection with actual or threatened proceedings if any of them may be made a party because of their role as one of our directors or officers. We are obligated to pay these amounts only if the officer or director acted in good faith and in a manner that he or she reasonably believed to be in or not opposed to our best interests. For any criminal proceedings, we are obligated to pay these amounts only if the officer or director had no reasonable cause to believe his or her conduct was unlawful. The indemnification agreements also set forth procedures that will apply in the event of a claim for indemnification thereunder.
        In addition, our bylaws provide that our directors will not be personally liable to us or our stockholders for monetary damages for any breach of fiduciary duty as a director, except for liability:
•
for any breach of the director's duty of loyalty to us or our stockholders;

•
for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law;

•
under Section 174 of the Delaware General Corporation Law; or

•
for any transaction from which the director derives an improper personal benefit.
        There is no pending litigation or proceeding involving any of our directors or officers for which indemnification is being sought, nor are we aware of any pending or threatened litigation that may result in claims for indemnification by any director or officer.
70

 CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Sale of Securities
        In March 2001, we consummated a private placement of 10,204,047 shares of Series I preferred stock for an aggregate purchase price of approximately $39,694,000. Except for Michael Steinmetz, who is affiliated with MPM/BB Bioventure, respectively, none of our executive officers or directors purchased any shares of the Series I preferred stock.
        The following table sets forth, with respect to the Series I preferred stock transaction, the purchase price per share, the aggregate shares purchased and the total investment for MPM/BB Bioventure group.

Investor
	 	Purchase Price
per Share of
Series I
Preferred
	 	Aggregate Shares of
Series I Preferred
Purchased
	 	Total Investment in
Series I Preferred
	
MPM/BB Bioventure group	 	$	3.89	 	639,359	 	$	2,487,107	
        In May 2003, we consummated a private placement of 112,790,233 shares of Series J preferred stock for an aggregate purchase price of approximately $55,267,000. Except for Michael Steinmetz, John Friedman and Sandra Panem, who are affiliated with MPM/BB Bioventure group, Easton Hunt Capital Partners and Cross Atlantic Partners, respectively, none of our executive officers or directors purchased any shares of the Series J preferred stock.
        The following table sets forth, with respect to the Series J preferred stock transaction, the purchase price per share, the aggregate shares purchased and the total investment for each of MPM/BB Bioventure group, Easton Hunt Capital Partners and Cross Atlantic Partners:

Investor
	 	Purchase Price
per Share of
Series J
Preferred
	 	Aggregate Shares of
Series J Preferred
Purchased
	 	Total Investment in
Series J Preferred
	
MPM/BB Bioventure group	 	$	0.49	 	15,306,121	 	$	7,500,000	
Easton Hunt Capital Partners	 	$	0.49	 	11,224,490	 	$	5,500,000	
Cross Atlantic Partners	 	$	0.49	 	8,506,256	 	$	4,168,065	
Board Representation and Registration Rights
        Pursuant to an amended and restated registration rights agreement, the above parties have demand and piggy-back registration rights; provided that the board of directors has the right to postpone a demand registration in certain circumstances. However, under the amended and restated registration rights agreement, we are not obligated to register the registrable securities prior to the date that is six months after the effective date of our registration statement for this offering. We have agreed to pay for all expenses in connection with the registration. See "Description of Capital Stock—Registration Rights".
        In addition, if we propose to register any of our securities under the Securities Act, including in this offering, certain of our other stockholders are entitled to notice of the registration and to include their registrable shares in the offering. If the managing underwriter determines that marketing factors require a limitation on the number of shares to be underwritten, the managing underwriters may limit or exclude from such underwriting the registrable securities and other securities of the holders to be so distributed. If we are so advised by the managing underwriter, then all securities other than registrable securities shall first be excluded from the registration. We are required to bear substantially all costs incurred in these registrations, other than underwriting discounts and commissions.
71

Indemnification agreements
        For a description of our indemnification arrangements with our directors and executive officers, see "Management—Indemnification of Directors and Executive Officers and Limitation on Liability".
Agreements with Elan
        In September 2003, we entered into the following agreements with Elan, which holds more than 5% of our outstanding common stock:
•
We entered into a termination and assignment agreement with Elan. Pursuant to the terms of this agreement, we purchased all of the assets of MS Research and Development Corp., our jointly owned subsidiary. See "Business—R&D and Product Collaborations, Alliances and License Agreements".

•
We entered into an amended and restated license agreement with Elan. Pursuant to the terms of the license agreement we were granted an exclusive worldwide license to develop, use and sell Fampridine-SR. We are obligated under the license to make milestone and royalty payments to Elan. See "Business—R&D and Product Collaborations, Alliances and License Agreements".

•
We entered into a supply agreement with Elan. Subject to certain exceptions in the supply agreement, Elan will be our exclusive supplier of Fampridine-SR. See "Business—R&D and Product Collaborations, Alliances and License Agreements".
72

PRINCIPAL STOCKHOLDERS
        The following table contains information about the beneficial ownership of our common stock before and after the consummation of this offering for:
•
each person, or group of persons, who beneficially owns more than 5% of our capital stock;

•
each of our directors;

•
each executive officer named in the summary compensation table; and

•
all directors and executive officers as a group.

        Unless otherwise indicated, the address for each person or entity named below is c/o Acorda Therapeutics, Inc., 15 Skyline Drive, Hawthorne, New York 10532.
        Beneficial ownership is determined in accordance with the rules and regulations of the Securities and Exchange Commission. In computing the number of shares beneficially owned by a person and the percentage ownership of that person, shares of common stock subject to options held by that person that are currently exercisable or exercisable within 60 days of the date hereof are deemed outstanding. Such shares, however, are not deemed outstanding for the purposes of computing the percentage ownership of any other person. Except as indicated in the footnotes to the following table or pursuant to applicable community property laws, each stockholder named in the table has sole voting and investment power with respect to the shares set forth opposite such stockholder's name. The percentage of beneficial ownership is based on 16,055,611 shares of common stock outstanding on the date of this prospectus.

 	 	 	 	Percentage of Common Stock
Outstanding
	
Beneficial Owner
	 	Number of
Shares(1)
	 	Before Offering
	 	After Offering(2)
	
Five Percent Stockholders	 	 	 	 	 	 	
 	MPM/BB Bioventure group(3)	 	2,132,189	 	13.3	%	 	
 	Elan group(4)	 	1,297,115	 	7.9	%	 	
 	Forward Ventures group(5)	 	1,136,061	 	7.1	%	 	
 	Easton Hunt Capital Partners, LP(6)	 	935,374	 	5.8	%	 	
 	MDS/Neuroscience Partners Healthcare(7)	 	876,597	 	5.5	%	 	
 	TVM Life Sciences(8)	 	850,340	 	5.3	%	 	
 	ABN AMRO(9)	 	850,340	 	5.3	%	 	
 	J.P. Morgan(10)	 	850,340	 	5.3	%	 	
 	Cross Atlantic Partners(11)	 	850,339	 	5.3	%	 	

Directors and Executive Officers:	

 	

 	
 	Ron Cohen, M.D.(12)	 	670,240	 	4.0	%	 	
 	Andrew R. Blight, Ph.D.(13)	 	109,985	 	*	 	 	
 	Mary Fisher(14)	 	28,903	 	*	 	 	
 	Elliott A. Gruskin, Ph.D.(15)	 	19,796	 	*	 	 	
 	Mitchell Katz, Ph.D.(16)	 	25,964	 	*	 	 	
 	David Lawrence, M.B.A.(17)	 	22,821	 	*	 	 	
 	King Lee, Ph.D.	 	0	 	*	 	 	
 	Mark R.E. Pinney, M.B.A., C.F.A.(18)	 	147,842	 	*	 	 	
 	Harold Safferstein, Ph.D., J.D.(19)	 	15,293	 	*	 	 	
 	John Friedman(20)	 	935,374	 	5.8	%	 	
 	Sandra Panem, Ph.D.(21)	 	854,556	 	4.4	%	 	
 	Michael Steinmetz, Ph.D.(22)	 	2,132,189	 	13.3	%	 	
 	Wise Young, Ph.D., M.D.(23)	 	24,167	 	*	 	 	
All directors and executive officers as a group (13 persons)(24)	 	4,837,003	 	28.5	%	 	

*
Represents beneficial ownership of less than one percent of the outstanding shares of our common stock.

(1)
Reflects preferred stock on an as converted basis.

(2)
Assumes no shares are purchased in this offering by the listed persons.

(3)
Includes 1,906,058 shares beneficially owned by BB Bioventures LP, 201,610 shares beneficially owned by MPM Bioventures Parallel Fund, L.P., and 9,852 shares beneficially owned by MPM Asset Management
73

Investors 1998 LLC. The address of MPM/BB Bioventures group is c/o MPM Capital Asset Management, 111 Huntington Avenue, 31st Floor, Boston, Massachusetts 02199.
(4)
Includes 361,842 shares of common stock issuable to EIS, upon conversion of convertible promissory notes and 21,930 shares of common stock issuable upon exercise of a warrant to purchase common stock. The address of Elan group is c/o Elan Pharmaceuticals, 345 Park Avenue, New York, NY 10154.

(5)
Includes 1,047,278 shares beneficially owned by Forward Ventures IV, L.P. and 88,783 shares beneficially owned by Forward Ventures IV B. L.P. The address of Forward Ventures group is c/o Forward Ventures, 9393 Towne Center Drive, Suite 200, San Diego, California 92121.

(6)
The address of Easton Hunt Capital Partners, L.P. is 641 Lexington Avenue, 21st Floor, New York, New York 10022.

(7)
Includes 211,002 shares beneficially owned by MDS Life Sciences Technology Fund Limited Partnership, 49,889 shares beneficially owned by MDS Life Sciences Technology Fund USA, L.P., 36,617 shares beneficially owned by MDS Life Sciences Technology Barbados Investment Trust, 473,608 shares beneficially owned by Neuroscience Partners Limited Partnership, 47,090 shares beneficially owned by The Health Care and Biotechnology Venture Fund and 58,391 shares beneficially owned by SC Biotechnology Development Fund. The address for MDS/Neuroscience Partners Healthcare is c/o MDS Capital Corp., 100 International Blvd., Toronto, Ontario M9W6J6.

(8)
The address of TVM Life Sciences is c/o TVM Management Corporation, 101 Arch Street, Boston, MA 02110.

(9)
The address for ABN AMRO is c/o ABN-AMRO Participaties, B.V., Gustav Mahler Loan 10, 1082 PP Amsterdam, The Netherlands.

(10)
The address of JPMorgan is c/o JP Morgan Fleming Investment, 522 Fifth Ave., New York, NY 10036.

(11)
The address of Cross Atlantic is c/o Cross Atlantic Partners, Inc., 551 Madison Ave., New York, NY 10022.

(12)
Includes 536,598 shares of common stock issuable upon exercise of stock options.

(13)
Includes 107,901 shares of common stock issuable upon exercise of stock options.

(14)
Includes 28,903 shares of common stock issuable upon exercise of stock options.

(15)
Includes 19,796 shares of common stock issuable upon exercise of stock options.

(16)
Includes 25,964 shares of common stock issuable upon exercise of stock options.

(17)
Includes 22,821 shares of common stock issuable upon exercise of stock options.

(18)
Includes 133,842 shares of common stock issuable upon exercise of stock options.

(19)
Includes 15,293 shares of common stock issuable upon exercise of stock options.

(20)
Includes 935,374 shares beneficially owned by Easton Hunt Capital Partners, L.P. Mr. Friedman is a founder and principal of Easton Hunt Capital Partners, L.P. and exercises investment and voting power over these shares. Mr. Friedman disclaims beneficial ownership of these shares.

(21)
Includes 3,576 shares of common stock issuable upon exercise of stock options, and 708,854 shares beneficially owned by Cross Atlantic Partners and 141,485 shares beneficially owned by Nordea Bank Delaware A/S. Cross Atlantic Partners has voting and dispository authority over the shares owned by Nordea Bank. Dr. Panem is a partner of Cross Atlantic Partners IV, K/S and exercises investment and voting power over these shares. Dr. Panem disclaims beneficial ownership of these shares.

(22)
Includes 1,906,058 shares beneficially owned by BB Bioventures LP, 201,610 shares beneficially owned by MPM Bioventures Parallel Fund, L.P. and 9,852 shares beneficially owned by MPM Asset Management Investors 1998 LLC. Dr. Steinmetz is a general partner of MPM Capital Asset Management and exercises investment and voting power over these shares. Dr. Steinmetz disclaims beneficial ownership of these shares.

(23)
Includes 7,500 shares of common stock issuable upon exercise of stock options.

(24)
Includes 902,194 shares of common stock issuable upon exercise of stock options.
74

 DESCRIPTION OF CAPITAL STOCK
        Prior to the consummation of this offering and the filing of our amended and restated certificate of incorporation, our authorized capital stock consists of 260,000,000 shares of common stock, $0.001 par value per share, and 140,221,535 shares of preferred stock, $0.001 par value per share. Immediately following the consummation of this offering and the filing of our amended and restated certificate of incorporation, our authorized capital stock will consist of 75,000,000 shares of common stock, $0.001 par value per share, and 1,000,000 shares of preferred stock, $0.001 par value per share. As of September 19, 2003, there were outstanding:
•
229,841 shares of common stock, held of record by 39 stockholders; and

•
136,881,522 shares of preferred stock, held of record by 74 stockholders.
        As of the consummation of this offering, all of the outstanding shares of preferred stock will automatically convert into common stock. After giving effect to the conversion, we will have outstanding 16,055,611 shares of common stock and no shares of preferred stock.
Common stock
        Under our amended and restated certificate of incorporation, the holders of common stock are entitled to one vote per share on all matters to be voted on by the stockholders. After payment of any dividends due and owing to the holders of preferred stock, holders of common stock are entitled to receive dividends declared by the board of directors out of funds legally available for dividends. In the event of our liquidation, dissolution or winding up, holders of common stock are entitled to share in all assets remaining after payment of liabilities and liquidation preferences of outstanding shares of preferred stock. Holders of common stock have no preemptive, conversion, subscription or other rights. There are no redemption or sinking fund provisions applicable to the common stock. All outstanding shares of common stock are, and all shares of common stock to be outstanding upon completion of this offering will be, fully paid and nonassessable.
Preferred stock
        In accordance with our amended and restated certificate of incorporation, our board of directors has the authority, without further action by the stockholders, to issue up to 1,000,000 shares of preferred stock. Our board of directors may issue preferred stock in one or more series and may determine the rights, preferences, privileges, qualifications and restrictions granted to or imposed upon the preferred stock, including dividend rights, conversion rights, voting rights, rights and terms of redemption, liquidation preferences and sinking fund terms, any or all of which may be greater than the rights of the common stock. The issuance of preferred stock could adversely affect the voting power of holders of common stock and reduce the likelihood that common stockholders will receive dividend payments and payments upon liquidation. The issuance of preferred stock could also have the effect of decreasing the market price of the common stock and could delay, deter or prevent a change in control of our company. We have no present plans to issue any shares of preferred stock.
Warrants
        We have outstanding warrants to purchase 38,424 shares of common stock at a weighted average exercise price of $1.47 per share.
Stock options
        1,623,705 shares of common stock are issuable upon the exercise of outstanding stock options to purchase our common stock. After this offering, we intend to file a registration statement on Form S-8 to register the shares of common stock reserved for issuance upon exercise of outstanding options. The registration statement is expected to be filed and become effective approximately six months after the closing
75

of this offering. Accordingly, shares registered under the registration statement will be available for sale in the open market without restriction, except with respect to Rule 144 volume limitations that apply to our affiliates.
Convertible Promissory Notes
        In January 1997, EIS loaned us an aggregate of $7.5 million pursuant to two promissory notes that are convertible into 361,842 shares of our common stock.
Classified Board of Directors
        Our amended and restated certificate of incorporation provides for our board of directors to be divided into three classes, with each class serving for a term of three years. At each annual meeting of stockholders, directors will be elected for a three-year term to succeed the directors whose terms are expiring. Mr. Pinney and Dr. Young will be class I directors whose terms will expire in 2004; Drs. Panem and Steinmetz will be class II directors whose terms will expire in 2005 and Dr. Cohen and Mr. Friedman will be class III directors whose terms will expire in 2006. There will be no cumulative voting with respect to the election of directors.
Registration rights
        Pursuant to an amended and restated registration rights agreement between us and certain of our stockholders, commencing six months after the effective date of our registration statement for this offering, holders of an aggregate of shares of our common stock have demand and piggy-back registration rights. The demand rights may be exercised by holders of 30% of the registrable securities. Additionally, if at any time we propose to register our common stock under the Securities Act for our own account or the account of any of our stockholders or both, the stockholders party to the registration rights agreement are entitled to notice of the registration and to include registrable shares in the offering, provided that the underwriters of that offering do not limit the number of shares included in the registration. We are required to bear substantially all costs incurred in these registrations, other than underwriting discounts and commissions. The registration rights described above could result in substantial future expenses for us and adversely affect any future equity or debt offerings.
Anti-takeover provisions
        We are governed by the provisions of Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits a public Delaware corporation from engaging in a business combination with an interested stockholder for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. A business combination includes mergers, asset sales or other transactions resulting in a financial benefit to the interested stockholder. An interested stockholder is a person who, together with affiliates and associates, owns, or within three years, did own 15.0% or more of the company's voting stock. The statute could delay, defer or prevent a change in control of our company.
Listing
        We will apply to list our common stock on The Nasdaq Stock Market's National Market under the trading symbol "ACRD."
Transfer agent and registrar
        The transfer agent and registrar for our common stock is American Stock Transfer & Trust Company.
76

SHARES ELIGIBLE FOR FUTURE SALE
        Prior to this offering, there has been no market for our common stock. Upon completion of this offering, we will have outstanding an aggregate of             shares of common stock, and if the underwriters exercise their over-allotment option in full, we will have outstanding an aggregate of            shares of our common stock. Of these shares, the shares sold in this offering will be freely tradable without restriction or further registration under the Securities Act, except that any shares purchased by our affiliates, as that term is defined in Rule 144 of the Securities Act, may generally only be sold in compliance with the limitations of Rule 144 described below. Persons who may be deemed to be affiliates generally include individuals or entities that control, are controlled by, or are under common control with, us and may include our directors and officers.
        Sales of substantial amounts of our common stock in the public market could adversely affect the market price of our common stock. We cannot estimate the number of shares of common stock that may be sold by third parties in the future because such sales will depend on market prices, the circumstances of sellers and other factors.
Sales of restricted shares
        16,055,611 shares of our common stock held by existing stockholders as of the date of this prospectus are restricted securities under Rule 144. The number of these shares of common stock available for sale in the public market is limited by restrictions under the Securities Act.
        In general, under Rule 144 as currently in effect, beginning 90 days after the date of this prospectus, a person (or persons whose shares are aggregated), including any of our affiliates, who has beneficially owned restricted shares for at least one year (including the holding period of any prior owner, except if the prior owner was an affiliate) will be entitled to sell, within any three-month period a number of shares that does not exceed the greater of: (a) one percent of the number of shares of common stock then outstanding (which will equal approximately         shares upon completion of this offering); or (b) the average weekly trading volume of our common stock on the Nasdaq National Market during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale. Sales of restricted securities pursuant to Rule 144 are also subject to requirements relating to manner of sale notice and the availability of current public information about us. Under Rule 144(k), a person who is not deemed to have been an affiliate of ours at any time during the three months preceding a sale, and who has beneficially owned the shares proposed to be sold for at least two years (including the holding period of any prior owners except a prior owner who was an affiliate), is entitled to sell its shares without complying with the volume limitation or the manner of sale, notice or current public information provisions of Rule 144. Therefore, unless otherwise restricted, 144(k) shares could be sold immediately upon the completion of this offering. As of the date of this prospectus, an aggregate of approximately 5,649,379 shares qualified as 144(k) shares which are not otherwise restricted.
Lock-up Agreements
        We and our directors, officers and all of our existing stockholders and option holders have entered into lock-up agreements with the underwriters pursuant to which we and those holders of stock and options have agreed not to, directly or indirectly, sell, dispose of or hedge any shares of our common stock or securities convertible into or exchangeable for shares of our common stock without the prior written consent of Banc of America Securities LLC for a period of 180 days after the date of this prospectus. This consent may be given at any time without public notice. In addition, during this 180 day period, we have also agreed not to file any registration for, and each of our officers has agreed not to make any demand for, or exercise any right of, the registration of, any shares of common stock or any securities convertible into or exercisable or exchangeable for shares of our common stock without the prior written consent of Banc of America Securities LLC.
77

Registration rights
        Commencing six months after the effective date of our registration statement for this offering, holders of 15,806,616 shares of our common stock will be entitled to certain rights with respect to the registration of their shares under the Securities Act.
        See "Description of Capital Stock—Registration Rights." Except for shares purchased by affiliates, registration of their shares under the Securities Act would result in these shares becoming freely tradable without restriction under the Securities Act immediately upon the effectiveness of the registration. These stockholders are not permitted to exercise their registration rights for at least six months following this offering.
78

UNDERWRITING
        We are offering the shares of common stock described in this prospectus through a number of underwriters. Banc of America Securities LLC, Lazard Frères & Co. LLC, U.S. Bancorp Piper Jaffray Inc. and RBC Dain Rauscher, Inc. are the representatives of the underwriters. We have entered into a underwriting agreement with the underwriters. Subject to the terms and conditions of the underwriting agreement, we have agreed to sell to the underwriters, and each underwriter has agreed to purchase, the number of shares of common stock listed next to its name in the following table:

Underwriter
	 	Number of Shares
	
Banc of America Securities LLC	 	 	
Lazard Frères & Co. LLC	 	 	
U.S. Bancorp Piper Jaffray Inc.	 	 	
RBC Dain Rauscher, Inc.	 	 	

Total	

 	 		
        The underwriting agreement is subject to a number of terms and conditions and provides that the underwriters must buy all of the shares if they buy any of them. The underwriters will sell the shares to the public when and if the underwriters buy the shares from us.
        The underwriters initially will offer the shares to the public at the price specified on the cover page of this prospectus. The underwriters may allow to selected dealers a concession of not more than $            per share. The underwriters may also allow, and any dealers may reallow, a concession of not more than $            per share to some other dealers. If all the shares of common stock are not sold at the public offering price, the underwriters may change the public offering price and the other selling terms. Our common stock is offered subject to a number of conditions, including:
•
receipt and acceptance of the common stock by the underwriters; and

•
the underwriters' right to reject orders in whole or in part.
        We have granted the underwriters an option to purchase up to                        additional shares of our common stock at the public offering price less the underwriting discounts and commissions. The underwriters may exercise this option solely for the purpose of covering any over-allotments made in connection with this offering. The underwriters have 30 days from the date of this prospectus to exercise this option. If the underwriters exercise this option, they will each purchase additional shares approximately in proportion to the amounts specified in the table above.
        The following table shows the per share and total underwriting discounts and commissions to be paid to the underwriters assuming both no exercise and full exercise of the underwriters' option to purchase additional shares.

 	 	Paid by Us
	
 	 	No Exercise
	 	Full Exercise
	
Per share	 	$	 	 	$	 	
 	 		 		
Total	 	$	 	 	$	 	
 	 		 		
        We estimate that the total expenses of this offering to be paid by us, not including the underwriting discounts and commissions, will be approximately $             million.
        We, our executive officers and directors and our existing stockholders have entered into lock-up agreements with the underwriters. Under these agreements, we and each of these persons may not, without
79

the prior written approval of Banc of America Securities LLC, offer, sell, contact to sell or otherwise dispose of or hedge our common stock or securities convertible into or exchangeable for our common stock. These restrictions will be in effect for a period of 180 days after the date of this prospectus. At any time and without notice, Banc of America Securities LLC may, in its sole discretion, release all or some of the securities from these lock-up agreements.
        We will indemnify the underwriters against various liabilities, including liabilities under the Securities Act. If we are unable to provide this indemnification, we will contribute to payments the underwriters may be required to make in respect of those liabilities.
        We have applied to have our common stock included for quotation on the Nasdaq National Market under the symbol "ACRD."
        In connection with this offering, the underwriters may engage in activities that stabilize, maintain or otherwise affect the price of our common stock, including:
•
stabilizing transactions;

•
short sales;

•
syndicate covering transactions;

•
imposition of penalty bids; and

•
purchases to cover positions created by short sales.
        Stabilizing transactions consist of bids or purchases made for the purpose of preventing or retarding a decline in the market price of our common stock while this offering is in progress. Stabilizing transactions may include making short sales of our common stock, which involves the sale by the underwriters of a greater number of shares of common stock than they are required to purchase in this offering, and purchasing shares of common stock from us or in the open market to cover positions created by short sales. Short sales may be "covered" shorts, which are short positions in an amount not greater than the underwriters' over-allotment option referred to above, or may be "naked" shorts, which are short positions in excess of that amount.
        The underwriters may close out any covered short position either by exercising their over-allotment option, in whole or in part, or by purchasing shares in the open market. In making this determination, the underwriters will consider, among other things, the price of shares available for purchase in the open market compared to the price at which the underwriters may purchase shares pursuant to the over-allotment option.
        A naked short position is more likely to be created if the underwriters are concerned that there may be downward pressure on the price of the common stock in the open market that could adversely affect investors who purchased in this offering. To the extent that the underwriters create a naked short position, they will purchase shares in the open market to cover the position.
        The representatives also may impose a penalty bid on underwriters and selling group members. This means that if the representatives purchase shares in the open market in stabilizing transactions or to cover short sales, the representatives can require the underwriters or selling group members that sold those shares as part of this offering to repay the selling concession received by them.
        As a result of these activities, the price of our common stock may be higher than the price that otherwise might exist in the open market. If the underwriters commence these activities, they may discontinue them at any time. The underwriters may carry out these transactions on the Nasdaq National Market, in the over-the-counter market or otherwise.
        The underwriters do not expect sales to accounts over which they exercise discretionary authority to exceed 5% of the total number of shares of common stock offered by this prospectus.
80

        Prior to this offering, there has been no public market for our common stock. The initial public offering price will be determined by negotiations among us and the representatives of the underwriters. The primary factors to be considered in determining the initial public offering price include:
•
the economic conditions in and future prospects for the industry in which we compete;

•
our past and present operating performance and financial condition;

•
our prospects for future earnings;

•
an assessment of our management;

•
the present state of our development;

•
the prevailing conditions of the equity securities markets at the time of this offering; and

•
current market valuations of publicly traded companies considered comparable to our company.
        At our request, the underwriters have reserved up to 5% of the common stock being offered by this prospectus for sale to our directors, employees, business associates and related persons at the public offering price. The sales will be made by Banc of America Securities LLC through a directed share program. We do not know if these persons will choose to purchase all or any portion of these reserved shares, but any purchases they do make will reduce the number of shares available to the general public. These persons must commit to purchase no later than the close of business on the day following the date of this prospectus. Any directors, employees or other persons purchasing such reserved shares will be prohibited from disposing of or hedging such shares for a period of at least 180 days after the date of this prospectus.
        The underwriters and their affiliates may from time to time engage in future transactions with us and our affiliates and provide services to us and our affiliates in the ordinary course of their business.
LEGAL MATTERS
        The validity of the shares of common stock offered in this prospectus will be passed upon for us by Loeb & Loeb LLP, New York, New York. Shearman & Sterling LLP New York, New York, will pass upon certain legal matters in connection with this offering for the underwriters.
EXPERTS
        The consolidated financial statements of Acorda Therapeutics, Inc. and subsidiary as of June 30, 2002 and 2003, and the related consolidated statements of operations, stockholders' equity and cash flows for each of the years in the three-year period ended June 30, 2003 and for the period from March 17, 1995 (inception) to June 30, 2003, have been included herein and in the registration statement in reliance upon the report of KPMG LLP, independent accountants, appearing elsewhere herein and upon the authority of said firm as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
        We have filed with the SEC a registration statement on Form S-1 under the Securities Act, with respect to the common stock offered by this prospectus. As permitted by the rules and regulations of the SEC, this prospectus, which is a part of the registration statement, omits various information, exhibits, schedules and undertakings included in the registration statement. For further information pertaining to us and the common stock offered under this prospectus, reference is made to the registration statement and the attached exhibits and schedules. Although required material information has been presented in this prospectus, statements contained in this prospectus as to the contents or provisions of any contract or other document referred to in this prospectus may be summary in nature, and in each instance reference is made to the copy of this contract or other document filed as an exhibit to the registration statement, and each statement is qualified in all respects by this reference.
81

        A copy of the registration statement may be inspected without charge at the public reference facilities maintained by the SEC at the Public Reference Room, 450 Fifth Street, N.W., Washington, D.C. 20549. Copies of all or any part of the registration statement may be obtained from the SEC's offices upon the payment of the fees prescribed by the SEC. Please call the SEC at 1-800-SEC-0330 for further information on the operation of the Public Reference facilities. In addition, registration statements and certain other filings made with the commission through its Electronic Data Gathering, Analysis and Retrieval system, including our registration statement and all exhibits and amendments to our registration statement, are publicly available through the SEC's website at www.sec.gov.
        After this offering, we will have to provide the information and reports required by the Securities Exchange Act of 1934, as amended, and we will file periodic reports, proxy statements and other information with the Securities and Exchange Commission. Our SEC filings are also available at the office of The Nasdaq National Market. For further information on obtaining copies of our public filings at The Nasdaq National Market you should call (212) 656-5060.
82

 ACORDA THERAPEUTICS, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

 	 	PAGE
	
Consolidated Financial Statements:	 	 	
 	
Independent Auditors' Report	
 	
F-2	
 	
Consolidated Balance Sheets as of June 30, 2002 and 2003	
 	
F-3	
 	
Consolidated Statements of Operations for the years ended June 30, 2001, 2002 and 2003 and for the period from March 17, 1995 (inception) to June 30, 2003	
 	
F-4	
 	
Consolidated Statements of Stockholders' Equity for the years ended June 30, 2001, 2002 and 2003 and for the period from March 17, 1995 (inception) to June 30, 2003	
 	
F-5	
 	
Consolidated Statements of Cash Flows for the years ended June 30, 2001, 2002 and 2003 and for the period from March 17, 1995 (inception) to June 30, 2003	
 	
F-7	
 	
Notes to Consolidated Financial Statements	
 	
F-8	
F-1

 Independent Auditors' Report
When the transaction referred to in note 13(i) of the notes to the consolidated financial statements has been consummated, we will be in a position to render the following report.
KPMG LLP
The Board of Directors and Stockholders
Acorda Therapeutics, Inc.:
        We have audited the accompanying consolidated balance sheets of Acorda Therapeutics, Inc. and subsidiary (a development stage enterprise) as of June 30, 2002 and 2003, and the related consolidated statements of operations, stockholders' equity (deficit), and cash flows for each of the years in the three-year period ended June 30, 2003 and for the period from March 17, 1995 (inception) to June 30, 2003. These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.
        We conducted our audits in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
        In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Acorda Therapeutics, Inc. and subsidiary (a development stage enterprise) as of June 30, 2002 and 2003, and the results of their operations and their cash flows for each of the years in the three-year period ended June 30, 2003 and for the period from March 17, 1995 (inception) to June 30, 2003, in conformity with accounting principles generally accepted in the United States of America.
September 26, 2003, except as to Note 13(i)
            which is as of            
F-2

 ACORDA THERAPEUTICS, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
Consolidated Balance Sheets

 	 	June 30,
	 	 	 	
 			 	Pro Forma
June 30, 2003
	 	
 	 	2002
	 	2003

(Unaudited)	 	
Assets	 	
Current assets:	 	 	 	 	 	 	 	 	 	 	
 	Cash and cash equivalents	 	$	27,012,412	 	$	48,319,175	 	$	48,319,175	 	
 	Restricted cash	 	 	249,502	 	 	252,997	 	 	252,997	 	
 	Short-term investments	 	 	2,835,526	 	 	12,250,449	 	 	12,250,449	 	
 	Grant receivable	 	 	147,721	 	 	361,607	 	 	361,607	 	
 	Prepaid expenses	 	 	74,128	 	 	244,982	 	 	244,982	 	
 	Other current assets	 	 	87,324	 	 	318,176	 	 	318,176	 	
 	 		 		 		 	
 	 	 	Total current assets	 	 	30,406,613	 	 	61,747,386	 	 	61,747,386	 	
Property and equipment, net of accumulated depreciation	 	 	2,939,968	 	 	2,947,747	 	 	2,947,747	 	
Minority interest—Related party	 	 	110,374	 	 	—	 	 	—	 	
Other assets	 	 	139,816	 	 	111,516	 	 	111,516	 	
 	 		 		 		 	
 	 	 	Total assets	 	$	33,596,771	 	$	64,806,649	 	$	64,806,649	 	
 	 		 		 		 	
Liabilities, Mandatorily Redeemable
Convertible Preferred Stock and Stockholders' Equity (Deficit)	 	
Current liabilities:	 	 	 	 	 	 	 	 	 	 	
 	Accounts payable	 	$	1,454,636	 	$	787,980	 	$	787,980	 	
 	Accounts payable to Related party	 	 	965,435	 	 	173,668	 	 	173,668	 	
 	Accrued expenses and other current liabilities	 	 	825,192	 	 	1,291,775	 	 	1,291,775	 	
 	Due to Related party	 	 	64,394	 	 	113,260	 	 	113,260	 	
 	Deferred revenue	 	 	—	 	 	95,462	 	 	95,462	 	
 	Current portion of notes payable	 	 	—	 	 	310,233	 	 	310,233	 	
 	 		 		 		 	
 	 	 	Total current liabilities	 	 	3,309,657	 	 	2,772,378	 	 	2,772,378	 	
 	 		 		 		 	
Long-term portion of notes payable	 	 	—	 	 	612,087	 	 	612,087	 	
Long-term convertible notes payable—principal amount, plus accrued interest less unamortized debt discount of $636,749 and $417,814 as of June 30, 2002 and 2003, respectively-Related party	 	 	7,538,251	 	 	7,907,186	 	 	7,907,186	 	
Mandatorily Redeemable Convertible Preferred Stock:	 	 	 	 	 	 	 	 	 	 	
 	Series E convertible preferred stock—$0.001 par value. Authorized, issued, and outstanding 7,472,612 shares in 2002 and 2003 (Redemption and liquidation value of $20,176,052 at June 30, 2003)	 	 	20,066,835	 	 	476,478	 	 	—	 	
 	Series I convertible preferred stock—$0.001 par value. Authorized 10,282,777 and 10,204,047 shares in 2002 and 2003, respectively; issued and outstanding 10,204,047 shares in 2002 and 2003 (Redemption and liquidation value of $39,693,743 at June 30, 2003)	 	 	39,591,760	 	 	1,024,149	 	 	—	 	
 	Series J convertible preferred stock—$0.001 par value. Authorized, issued, and outstanding 112,790,246 shares in 2003 (Redemption and liquidation value of $56,003,896 at June 30, 2003)	 	 	—	 	 	35,211,047	 	 	—	 	
Commitments and contingencies	 	 	 	 	 	 	 	 	 	 	
Stockholders' equity (deficit):	 	 	 	 	 	 	 	 	 	 	
 	Series A convertible preferred stock, $0.001 par value. Authorized 1,656,000 and 1,646,068 shares in 2002 and 2003, respectively; issued and outstanding 1,306,068 shares in 2002 and 2003 (liquidation value of $1,306,068 at June 30, 2003)	 	 	1,306	 	 	1,306	 	 	—	 	
 	Series B convertible preferred stock, $0.001 par value. Authorized 2,250,000 shares in 2002 and 2003; issued and outstanding 900,000 shares in 2002 and 2003 (liquidation value of $1,800,000 at June 30, 2003)	 	 	900	 	 	900	 	 	—	 	
 	Series C convertible preferred stock, $0.001. Authorized, issued, and outstanding 333,333 shares in 2002 and 2003 (liquidation value of $999,999 at June 30, 2003)	 	 	333	 	 	333	 	 	—	 	
 	Series D convertible preferred stock, $0.001. Authorized 400,000 shares in 2002 and 2003; issued, and outstanding—none	 	 	—	 	 	—	 	 	—	 	
 	Series F convertible preferred stock, $0.001 par value. Authorized, issued, and outstanding 2,300,000 shares in 2002 and 2003 (liquidation value of $11,999,100 at June 30, 2003)	 	 	2,300	 	 	2,300	 	 	—	 	
 	Series G convertible preferred stock, $0.001. Authorized 1,250,000 shares in 2002 and 2003; issued, and outstanding—none	 	 	—	 	 	—	 	 	—	 	
 	Series H convertible preferred stock, $0.001 par value. Authorized, issued, and outstanding 1,575,229 shares in 2002 and 2003 (liquidation value of $5,119,494 at June 30, 2003)	 	 	1,575	 	 	1,575	 	 	—	 	
 	Common stock, $0.001 par value. Authorized 33,670,451 and 260,000,000 shares in 2002 and 2003, respectively; issued and outstanding 248,994 shares in 2002 and 2003	 	 	249	 	 	249	 	 	16,056	 	
 	Additional paid-in capital	 	 	28,408,252	 	 	107,861,689	 	 	144,563,969	 	
 	Deficit accumulated during the development stage	 	 	(65,324,647	)	 	(91,058,949	)	 	(91,058,949	)	
 	Other comprehensive loss	 	 	—	 	 	(6,078	)	 	(6,078	)	
 	 		 		 		 	
 	 	 	Total stockholders' equity (deficit)	 	 	(36,909,732	)	 	16,803,325	 	 	53,514,998	 	
 	 		 		 		 	
 	 	 	Total liabilities, mandatorily redeemable convertible preferred stock and stockholders' equity (deficit)	 	$	33,596,771	 	$	64,806,649	 	$	64,806,649	 	
 	 		 		 		 	
See accompanying Notes to Consolidated Financial Statements.
F-3

 ACORDA THERAPEUTICS, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
Consolidated Statements of Operations

 	 	 	 	 	 	 	 	Period From
March 17,
1995
(inception)
to June 30,
2003
	 	
 	 	Year ended June 30
			 	
 	 	2001
	 	2002
	 	2003
			 	
Grant revenue	 	$	462,407	 	$	131,592	 	$	473,588	 	$	3,637,117	 	
 	 		 		 		 		 	
Operating expenses incurred in the development stage:	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	Research and development	 	 	6,141,705	 	 	11,146,415	 	 	17,526,656	 	 	46,175,443	 	
 	Research and development—Related party	 	 	2,223,407	 	 	4,686,671	 	 	2,265,233	 	 	32,350,958	 	
 	General and administrative	 	 	3,489,509	 	 	6,636,306	 	 	6,387,999	 	 	22,854,793	 	
 	 		 		 		 		 	
 	 	Total operating expenses	 	 	11,854,621	 	 	22,469,392	 	 	26,179,888	 	 	101,381,194	 	
 	 		 		 		 		 	
Operating loss	 	 	(11,392,214	)	 	(22,337,800	)	 	(25,706,300	)	 	(97,744,077	)	
 	 		 		 		 		 	
Other income (expense):	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	Interest expense	 	 	—	 	 	—	 	 	(77,712	)	 	(77,712	)	
 	Interest expense—Related party	 	 	(443,400	)	 	(407,686	)	 	(368,935	)	 	(2,580,413	)	
 	Interest income	 	 	1,824,050	 	 	983,876	 	 	392,742	 	 	5,037,989	 	
 	Other income	 	 	—	 	 	—	 	 	25,903	 	 	25,903	 	
 	 		 		 		 		 	
 	 	Total other income (expense)	 	 	1,380,650	 	 	576,190	 	 	(28,002	)	 	2,405,767	 	
 	 		 		 		 		 	
Minority interest—Related party	 	 	698,894	 	 	580,467	 	 	—	 	 	4,279,361	 	
 	 		 		 		 		 	
 	 	Net loss	 	 	(9,312,670	)	 	(21,181,143	)	 	(25,734,302	)	 	(91,058,949	)	
 	 		 		 		 		 	
Beneficial conversion feature, accretion of issuance costs, preferred dividends, and fair value of warrants issued to convertible preferred stockholders	 	 	(35,897	)	 	(54,973	)	 	(23,792,769	)	 	(24,426,130	)	
 	 		 		 		 		 	
 	 	Net loss allocable to common stockholders	 	$	(9,348,567	)	$	(21,236,116	)	$	(49,527,071	)	$	(115,485,079	)	
 	 		 		 		 		 	
Net loss per share allocable to common stockholders—basic and diluted	 	$	(39.08	)	$	(86.05	)	$	(198.91	)	 	 	 	
 	 		 		 		 	 	 	 	
Weighted average common shares outstanding used in computing net loss per share allocable to common stockholders—basic and diluted	 	 	239,207	 	 	246,778	 	 	248,994	 	 	 	 	
 	 		 		 		 	 	 	 	
See accompanying Notes to Consolidated Financial Statements.
F-4

 ACORDA THERAPEUTICS, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
Consolidated Statements of Changes in Stockholders' Equity (Deficit)

 	 	Stockholders' Equity (Deficit)
	 	
 	 	Series A convertible
preferred stock
	 	Series B convertible
preferred stock
	 	Series C convertible
preferred stock
	 	Series F convertible
preferred stock
	 	Series H convertible
preferred stock
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 											 	Common Stock
	 	 	 	 	 	Deficit
accumulated
during the
development
stage
	 	Accumulated
other
Comprehensive
Income
(Loss)
	 	 	 	
 													 	 	 	 					 	Total
stockholders'
equity
(deficit)
	 	
 	 	Number
of shares
	 	Par
value
	 	Number
of shares
	 	Par
value
	 	Number
of shares
	 	Par
value
	 	Number
of shares
	 	Par
value
	 	Number
of shares
	 	Par
value
	 	Number
of shares
	 	Par
value
	 	Additional
paid-in
capital
	 	Stock
subscriptions
receivable
							 	
Issuance of common stock in March 1995, $0.12 per share	 	—	 	$	—	 	—	 	$	—	 	—	 	$	—	 	—	 	$	—	 	—	 	$	—	 	216,875	 	$	2,603	 	$	23,422	 	$	(24,750	)	$	—	 	$	—	 	$	1,275	 	
One-for twelve reverse stock split	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	(2,386	)	 	2,386	 	 	—	 	 	—	 	 	—	 	 	—	 	
Issuance of Series A convertible preferred stock in May 1995, $1.00 per share	 	610,000	 	 	610	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	609,390	 	 	—	 	 	—	 	 	—	 	 	610,000	 	
Contribution of services	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	125,000	 	 	—	 	 	—	 	 	—	 	 	125,000	 	
Issuance of detachable warrants with Series A convertible preferred stock	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	44,971	 	 	—	 	 	—	 	 	—	 	 	44,971	 	
Amortization of Series A warrants	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(44,971	)	 	—	 	 	—	 	 	—	 	 	(44,971	)	
Net loss	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	—	 	 	—	 	 	(276,998	)	 	—	 	 	(276,998	)	
 	 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 	
Balance at June 30, 1995	 	610,000	 	 	610	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	216,875	 	 	217	 	 	760,198	 	 	(24,750	)	 	(276,998	)	 	—	 	 	459,277	 	
Issuance of common stock in February through March and June 1996, $1.20 per share	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	4,333	 	 	52	 	 	5,148	 	 	(4,800	)	 	—	 	 	—	 	 	400	 	
Exercise of stock warrants	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	7,500	 	 	90	 	 	810	 	 	—	 	 	—	 	 	—	 	 	900	 	
One-for twelve reverse stock split	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	(130	)	 	130	 	 	—	 	 	—	 	 	—	 	 	—	 	
Issuance of Series A convertible preferred stock in December 1995 and April 1996, $1.00 per share	 	450,000	 	 	450	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	449,550	 	 	—	 	 	—	 	 	—	 	 	450,000	 	
Contribution of services	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	125,000	 	 	—	 	 	—	 	 	—	 	 	125,000	 	
Research and development expense for issuance of stock options to non-employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	155,189	 	 	 	 	 	 	 	 	 	 	 	155,189	 	
Net loss	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	—	 	 	—	 	 	(1,116,738	)	 	—	 	 	(1,116,738	)	
 	 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 	
Balance at June 30, 1996	 	1,060,000	 	 	1,060	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	228,708	 	 	229	 	 	1,496,025	 	 	(29,550	)	 	(1,393,736	)	 	—	 	 	74,028	 	
Issuance of Series A convertible preferred stock in January 1997, $1.00 per share	 	195,000	 	 	195	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	194,805	 	 	—	 	 	—	 	 	—	 	 	195,000	 	
Issuance of Series B convertible preferred stock, net in January 1997, $2.00 per share	 	—	 	 	—	 	750,000	 	 	750	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	1,499,250	 	 	—	 	 	—	 	 	—	 	 	1,500,000	 	
Discount on below-market interest rate convertible notes	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	2,173,127	 	 	—	 	 	—	 	 	—	 	 	2,173,127	 	
Contribution of services	 	—	 	 	—	 	—	 	 	—	 	—	 	 	 	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	70,000	 	 	—	 	 	—	 	 	—	 	 	70,000	 	
Research and development expense for issuance of stock options to non-employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	653,214	 	 	—	 	 	—	 	 	—	 	 	653,214	 	
Issuance of detachable warrants with preferred stock	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	452,141	 	 	—	 	 	—	 	 	—	 	 	452,141	 	
Amortization of warrants	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(452,141	)	 	—	 	 	—	 	 	—	 	 	(452,141	)	
Net loss	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	—	 	 	—	 	 	(6,798,970	)	 	—	 	 	(6,798,970	)	
 	 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 	
Balance at June 30, 1997	 	1,255,000	 	 	1,255	 	750,000	 	 	750	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	228,708	 	 	229	 	 	6,086,421	 	 	(29,550	)	 	(8,192,706	)	 	—	 	 	(2,133,601	)	
Issuance of common stock in September 1997 and June 1998, $1.44 per share	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	2,208	 	 	26	 	 	3,024	 	 	—	 	 	—	 	 	—	 	 	3,050	 	
One-for twelve reverse stock split	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	(24	)	 	24	 	 	—	 	 	—	 	 	—	 	 	—	 	
Issuance of Series F convertible preferred stock in April 1998, $5.22 per share	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	2,300,000	 	 	2,300	 	—	 	 	—	 	—	 	 	—	 	 	11,997,700	 	 	—	 	 	—	 	 	—	 	 	12,000,000	 	
Research and development expense for issuance of stock options to non-employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	342,658	 	 	—	 	 	—	 	 	—	 	 	342,658	 	
Compensation expense for issuance of stock options to employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	1,059	 	 	—	 	 	—	 	 	—	 	 	1,059	 	
Net loss	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	—	 	 	—	 	 	(15,385,329	)	 	—	 	 	(15,385,329	)	
 	 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 	
Balance at June 30, 1998	 	1,255,000	 	 	1,255	 	750,000	 	 	750	 	—	 	 	—	 	2,300,000	 	 	2,300	 	—	 	 	—	 	230,916	 	 	231	 	 	18,430,886	 	 	(29,550	)	 	(23,578,035	)	 	—	 	 	(5,172,163	)	
Issuance of common stock in July 1998, $1.44 per share	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	1,334	 	 	16	 	 	1,834	 	 	—	 	 	—	 	 	—	 	 	1,850	 	
One-for twelve reverse stock split	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	(15	)	 	15	 	 	—	 	 	—	 	 	—	 	 	—	 	
Payments received on notes due from shareholders	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	—	 	 	22,350	 	 	—	 	 	—	 	 	22,350	 	
Research and development expense for issuance of stock options to non-employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	378,814	 	 	—	 	 	—	 	 	—	 	 	378,814	 	
Compensation expense for issuance of stock options to employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	97,349	 	 	—	 	 	—	 	 	—	 	 	97,349	 	
Accretion of issuance costs related to Series E mandatorily redeemable convertible preferred stock	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(18,042	)	 	—	 	 	—	 	 	—	 	 	(18,042	)	
Net loss	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	—	 	 	—	 	 	(4,354,718	)	 	—	 	 	(4,354,718	)	
 	 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 	
Balance at June 30, 1999	 	1,255,000	 	 	1,255	 	750,000	 	 	750	 	—	 	 	—	 	2,300,000	 	 	2,300	 	—	 	 	—	 	232,250	 	 	232	 	 	18,890,856	 	 	(7,200	)	 	(27,932,753	)	 	—	 	 	(9,044,560	)	
Issuance of common stock in November and December 1999, $0.36 per share	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	6,041	 	 	73	 	 	2,227	 	 	—	 	 	—	 	 	—	 	 	2,300	 	
One-for twelve reverse stock split	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	(67	)	 	67	 	 	—	 	 	—	 	 	—	 	 	—	 	
Issuance of Series H convertible preferred stock in August 1999, $3.25 per share	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	1,575,229	 	 	1,575	 	—	 	 	—	 	 	5,117,919	 	 	—	 	 	—	 	 	—	 	 	5,119,494	 	
Payment received on notes due from shareholders	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	—	 	 	4,200	 	 	—	 	 	—	 	 	4,200	 	
Research and development expense for issuance of stock options to non-employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	227,318	 	 	—	 	 	—	 	 	—	 	 	227,318	 	
Compensation expense for issuance of stock options to employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	178,383	 	 	—	 	 	—	 	 	—	 	 	178,383	 	
Accretion of issuance costs related to Series E mandatorily redeemable convertible preferred stock	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(27,337	)	 	—	 	 	—	 	 	—	 	 	(27,337	)	
Net loss	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	—	 	 	—	 	 	(6,898,081	)	 	—	 	 	(6,898,081	)	
 	 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 	
Balance at June 30, 2000	 	1,255,000	 	 	1,255	 	750,000	 	 	750	 	—	 	 	—	 	2,300,000	 	 	2,300	 	1,575,229	 	 	1,575	 	238,291	 	 	238	 	 	24,389,433	 	 	(3,000	)	 	(34,830,834	)	 	—	 	 	(10,438,283	)	
F-5

 ACORDA THERAPEUTICS, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Continued)

 	 	Stockholders' Equity (Deficit)
	 	
 	 	Series A convertible
preferred stock
	 	Series B convertible
preferred stock
	 	Series C convertible
preferred stock
	 	Series F convertible
preferred stock
	 	Series H convertible
preferred stock
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 											 	Common Stock
	 	 	 	 	 	Deficit
accumulated
during the
development
stage
	 	Accumulated
other
Comprehensive
Income
(Loss)
	 	 	 	
 													 	 	 	Stock
sub-
scriptions
receivable
					 	Total
stockholders'
equity
(deficit)
	 	
 	 	Number
of shares
	 	Par
value
	 	Number
of shares
	 	Par
value
	 	Number
of shares
	 	Par
value
	 	Number
of shares
	 	Par
value
	 	Number
of shares
	 	Par
value
	 	Number
of shares
	 	Par
value
	 	Additional
paid-in
capital
									 	
Issuance of common stock in January and June 2001, $0.84 per share	 	—	 	$	—	 	—	 	$	—	 	—	 	$	—	 	—	 	$	—	 	—	 	$	—	 	6,307	 	$	75	 	$	5,115	 	$	—	 	$	—	 	$	—	 	$	5,190	 	
Payment received on notes due from shareholders	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	(68	)	 	68	 	 	3,000	 	 	—	 	 	—	 	 	3,000	 	
Research and development expense for issuance of stock options to non-employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	94,397	 	 	—	 	 	—	 	 	—	 	 	94,397	 	
Compensation expense for issuance of stock options to employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	643,028	 	 	—	 	 	—	 	 	—	 	 	643,028	 	
Accretion of issuance costs related to Series E mandatorily redeemable convertible preferred stock	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(27,337	)	 	—	 	 	—	 	 	—	 	 	(27,337	)	
Accretion of issuance costs related to Series I mandatorily redeemable convertible preferred stock	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(8,560	)	 	—	 	 	—	 	 	—	 	 	(8,560	)	
Net loss	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	—	 	 	—	 	 	(9,312,670	)	 	—	 	 	(9,312,670	)	
 	 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 	
Balance at June 30, 2001	 	1,255,000	 	 	1,255	 	750,000	 	 	750	 	—	 	 	—	 	2,300,000	 	 	2,300	 	1,575,229	 	 	1,575	 	244,598	 	 	245	 	 	25,096,144	 	 	—	 	 	(44,143,504	)	 	—	 	 	(19,041,235	)	
Issuance of Series A convertible preferred stock in May 2002, $1.00 per share	 	51,068	 	 	51	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	22,749	 	 	—	 	 	—	 	 	—	 	 	22,800	 	
Issuance of Series B convertible preferred stock in January 2002, $2.00 per share	 	—	 	 	—	 	150,000	 	 	150	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	299,850	 	 	—	 	 	—	 	 	—	 	 	300,000	 	
Issuance of Series C convertible preferred stock in February 2002, $3.00 per share	 	—	 	 	—	 	—	 	 	—	 	333,333	 	 	333	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	999,666	 	 	—	 	 	—	 	 	—	 	 	999,999	 	
Issuance of common stock in September and October 2001 and February 2002, $4.68 per share	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	4,396	 	 	53	 	 	20,566	 	 	—	 	 	—	 	 	—	 	 	20,619	 	
One-for-twelve reverse stock split	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	(49	)	 	49	 	 	—	 	 	—	 	 	—	 	 	—	 	
Research and development expense for issuance of stock options to non-employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	74,624	 	 	—	 	 	—	 	 	—	 	 	74,624	 	
Compensation expense for issuance of stock options to employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	1,331,911	 	 	—	 	 	—	 	 	—	 	 	1,331,911	 	
Accretion of issuance costs related to Series E mandatorily redeemable convertible preferred stock	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(27,337	)	 	—	 	 	—	 	 	—	 	 	(27,337	)	
Accretion of issuance costs related to Series I mandatorily redeemable convertible preferred stock	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(27,636	)	 	—	 	 	—	 	 	—	 	 	(27,636	)	
Research and development expense for issuance of warrants and Series C preferred stock on obtaining Phase II clinical trial approval	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	617,666	 	 	—	 	 	—	 	 	—	 	 	617,666	 	
Net loss	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	—	 	 	—	 	 	(21,181,143	)	 	—	 	 	(21,181,143	)	
 	 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 	
Balance at June 30, 2002	 	1,306,068	 	 	1,306	 	900,000	 	 	900	 	333,333	 	 	333	 	2,300,000	 	 	2,300	 	1,575,229	 	 	1,575	 	248,994	 	 	249	 	 	28,408,252	 	 	—	 	 	(65,324,647	)	 	—	 	 	(36,909,732	)	
Research and development expense for issuance of stock options to non-employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(6,539	)	 	—	 	 	—	 	 	—	 	 	(6,539	)	
Compensation expense for issuance of stock options to employees	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	1,580,054	 	 	—	 	 	—	 	 	—	 	 	1,580,054	 	
Accretion of issuance costs related to Series E mandatorily redeemable convertible preferred stock	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(27,337	)	 	—	 	 	—	 	 	—	 	 	(27,337	)	
Accretion of issuance costs related to Series I mandatorily redeemable convertible preferred stock	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(27,636	)	 	—	 	 	—	 	 	—	 	 	(27,636	)	
Accretion of issuance costs related to Series J mandatorily redeemable convertible preferred stock	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(10,990	)	 	—	 	 	—	 	 	—	 	 	(10,990	)	
Accrual of preferred dividend on Series J mandatorily redeemable convertible preferred stock	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(629,895	)	 	—	 	 	—	 	 	—	 	 	(629,895	)	
Beneficial conversion feature for reduction in conversion price	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	80,730,286	 	 	—	 	 	—	 	 	—	 	 	80,730,286	 	
Beneficial conversion feature for reduction in conversion price	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(20,860,491	)	 	—	 	 	—	 	 	—	 	 	(20,860,491	)	
Deemed dividends on preferred stock for reduction in conversion price	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(1,656,854	)	 	—	 	 	—	 	 	—	 	 	(1,656,854	)	
Issuance of preferred stock with beneficial conversion feature	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	20,942,405	 	 	—	 	 	—	 	 	—	 	 	20,942,405	 	
Deemed dividends on preferred stock for issuance of preferred stock with beneficial conversion feature	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	(579,566	)	 	—	 	 	—	 	 	—	 	 	(579,566	)	
Comprehensive loss	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Unrealized loss on investment securities	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	—	 	 	—	 	 	—	 	 	(6,078	)	 	(6,078	)	
Net loss	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	—	 	 	—	 	 	—	 	 	—	 	 	(25,734,302	)	 	—	 	 	(25,734,302	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 		 	
Total Comprehensive loss	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	(25,740,380	)	
 	 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 	
Balance at June 30, 2003	 	1,306,068	 	$	1,306	 	900,000	 	$	900	 	333,333	 	$	333	 	2,300,000	 	$	2,300	 	1,575,229	 	$	1,575	 	248,994	 	$	249	 	$	107,861,689	 	$	—	 	 	(91,058,949	)	$	(6,078	)	$	16,803,325	 	
 	 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 		 	
See accompanying Notes to Consolidated Financial Statements.
F-6

 ACORDA THERAPEUTICS, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
Consolidated Statements of Cash Flows

 	 	 	 	 	 	 	 	Period From
March 17,
1995
(inception)
to June 30,
2003
	 	
 	 	Year ended June 30,
			 	
 	 	2001
	 	2002
	 	2003
			 	
Cash flows from operating activities:	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	Net loss	 	$	(9,312,670	)	$	(21,181,143	)	$	(25,734,302	)	$	(91,058,949	)	
 	Adjustments to reconcile net loss to net cash used in operating activities:	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Stock compensation expense	 	 	737,425	 	 	1,406,535	 	 	1,573,514	 	 	6,071,458	 	
 	 	Expensing of warrants and beneficial conversion feature on completing Phase II clinical trial	 	 	—	 	 	617,666	 	 	—	 	 	617,666	 	
 	 	Amortization of note discount	 	 	293,400	 	 	257,686	 	 	218,935	 	 	1,755,313	 	
 	 	Depreciation and amortization expense	 	 	123,449	 	 	417,479	 	 	740,201	 	 	1,378,346	 	
 	 	Minority interest—Related party	 	 	(698,894	)	 	(580,467	)	 	—	 	 	(4,279,361	)	
 	 	Changes in assets and liabilities:	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	 	Decrease (increase) in grant receivables	 	 	143,263	 	 	50,993	 	 	(213,886	)	 	(361,607	)	
 	 	 	(Increase) decrease in prepaid expenses and other current assets	 	 	(119,353	)	 	84,917	 	 	(401,706	)	 	(563,158	)	
 	 	 	(Increase) decrease in other assets	 	 	(110,200	)	 	23,639	 	 	28,300	 	 	(111,516	)	
 	 	 	Increase (decrease) in accounts payable and accrued expenses and other current liabilities	 	 	56,720	 	 	223,984	 	 	(200,072	)	 	2,079,756	 	
 	 	 	Increase (decrease) in amounts due to Related party	 	 	749,846	 	 	579,983	 	 	(592,901	)	 	1,111,928	 	
 	 	 	Deferred revenue	 	 	—	 	 	—	 	 	95,462	 	 	95,462	 	
 	 	 	Restricted cash	 	 	(11,901	)	 	(6,015	)	 	(3,495	)	 	(252,997	)	
 	 		 		 		 		 	
 	 	 	 	Net cash used in operating activities	 	 	(8,148,915	)	 	(18,104,743	)	 	(24,489,950	)	 	(83,517,659	)	
 	 		 		 		 		 	
Cash flows from investing activities:	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	Purchases of property and equipment	 	 	(936,510	)	 	(2,230,916	)	 	(747,981	)	 	(4,326,094	)	
 	Purchases of short-term investments	 	 	—	 	 	(2,835,526	)	 	(18,669,923	)	 	(21,505,449	)	
 	Proceeds from maturities of short-term investments	 	 	—	 	 	—	 	 	9,248,922	 	 	9,248,922	 	
 	 		 		 		 		 	
 	 	 	 	Net cash used in investing activities	 	 	(936,510	)	 	(5,066,442	)	 	(10,168,982	)	 	(16,582,621	)	
 	 		 		 		 		 	
Cash flows from financing activities:	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	Proceeds from issuance of preferred stock, net of issuance costs	 	 	39,555,564	 	 	1,322,799	 	 	54,933,001	 	 	135,652,640	 	
 	Proceeds from sale of interest in subsidiary	 	 	—	 	 	—	 	 	—	 	 	3,000,000	 	
 	Funding received from minority owner	 	 	411,421	 	 	757,566	 	 	110,374	 	 	1,279,361	 	
 	Proceeds received on notes due from shareholders	 	 	3,000	 	 	—	 	 	—	 	 	29,550	 	
 	Proceeds from issuance of common stock	 	 	5,190	 	 	20,619	 	 	—	 	 	35,584	 	
 	Proceeds from issuance of notes payable	 	 	—	 	 	—	 	 	1,163,511	 	 	1,163,511	 	
 	Repayments of notes payable	 	 	—	 	 	—	 	 	(241,191	)	 	(241,191	)	
 	Proceeds from issuance of long-term convertible notes payable	 	 	—	 	 	—	 	 	—	 	 	7,500,000	 	
 	 		 		 		 		 	
 	 	 	 	Net cash provided by financing activities	 	 	39,975,175	 	 	2,100,984	 	 	55,965,695	 	 	148,419,455	 	
 	 		 		 		 		 	
 	 	 	 	Net increase (decrease) in cash and cash equivalents	 	 	30,889,750	 	 	(21,070,201	)	 	21,306,763	 	 	48,319,175	 	
Cash and cash equivalents at beginning of period	 	 	17,192,863	 	 	48,082,613	 	 	27,012,412	 	 	—	 	
 	 		 		 		 		 	
Cash and cash equivalents at end of period	 	$	48,082,613	 	$	27,012,412	 	$	48,319,175	 	$	48,319,175	 	
 	 		 		 		 		 	
Supplemental disclosure:	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	Issuance of common stock for notes receivable	 	$	—	 	$	—	 	$	—	 	$	29,550	 	
 	Discount on below-market interest rate convertible notes	 	$	—	 	$	—	 	$	—	 	$	2,173,127	 	
 	Cash paid for interest	 	$	—	 	$	—	 	$	77,712	 	$	77,712	 	
See accompanying Notes to Consolidated Financial Statements.
F-7

 ACORDA THERAPEUTICS, INC. AND SUBSIDIARY
(A Development Stage Enterprise)

Notes to Consolidated Financial Statements
(1) Organization and Business Activities
        Acorda Therapeutics, Inc. (Acorda or the Company) was incorporated in Delaware on March 17, 1995. The Company is a development stage biopharmaceutical company engaged in the identification, development and commercialization of therapies that improve neurological function in people with spinal cord injury, multiple sclerosis and related disorders of the central nervous system.
        The Company is devoting substantially all of its efforts toward conducting pharmaceutical development, conducting clinical trials, pursuing regulatory approval for products under development and raising needed capital. In the course of its activities the Company has sustained operating losses and expects such losses to continue for the foreseeable future.
        The Company has not generated product revenues and has not achieved profitable operations or positive cash flows from operations. There is no assurance that profitable operations, if ever achieved, could be sustained on a continuing basis. The Company's deficit accumulated during the development stage aggregated $91,058,949, through June 30, 2003, and it expects to incur substantial and increasing losses in future periods. Further, the Company's future operations are dependent on the success of the Company's research and commercialization efforts and, ultimately, upon regulatory approval and market acceptance of the Company's products.
        The Company plans to finance its operations with a combination of public and/or private placement of equity securities, grants, payments from strategic research and development arrangements, and revenues from future product sales. There are no assurances that the Company will be successful in obtaining an adequate level of financing needed for the long-term development and commercialization of its planned products. The Company believes that its current financial resources and sources of liquidity should be adequate to fund operations through December 31, 2004, based on the Company's current projected spending levels.
(2) Summary of Significant Accounting Policies
Principles of Consolidation
        The accompanying consolidated financial statements prepared in accordance with accounting principles generally accepted in the United States of America include the results of operations of the Company and its approximately 83% owned subsidiary (see Note 7). All intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
        The preparation of the consolidated financial statements requires management of the Company to make a number of estimates and assumptions relating to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Significant items subject to such estimates and assumptions include research and development, income taxes, beneficial conversion charge and stock warrants and option accounting. Actual results could differ from those estimates.
Cash and Cash Equivalents
        The Company considers all highly liquid debt instruments with original maturities of three months or less to be cash equivalents. All cash and cash equivalents are held in United States financial institutions and money market funds, which are unrestricted as to withdrawal or use. To date, the Company has not
F-8

experienced any losses on its cash and cash equivalents. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term and liquid nature.
Restricted Cash
        Restricted cash represents a certificate of deposit placed by the Company with a bank for issuance of a letter of credit in the amount of $226,825 to the Company's lessor for office space.
Short-Term Investments
        Short-term investments consist of corporate debt securities with original maturities greater than three months. In accordance with Statement of Financial Accounting Standards ("SFAS") No. 115 ("SFAS 115"), Accounting for Certain Investments in Debt and Equity Securities , the Company classifies its short-term investments as available-for-sale. Available-for-sale securities are recorded at fair value of the investments based on quoted market prices at June 30, 2003. The Company considered all of these investments to be available-for-sale.
        Unrealized holding gains and losses, which are determined to be temporary, on available-for-sale securities are excluded from earnings and are reported as a separate component of other comprehensive loss.
        Premiums and discounts on investments are amortized over the life of the related available-for-sale security as an adjustment to yield using the effective-interest method. Dividend and interest income are recognized when earned. Realized gains and losses are determined on the average cost method. Amortized premiums and discounts, dividend and interest income and realized gains and losses are included in interest income.
Property and Equipment
        Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is computed on the straight-line basis over the estimated useful lives of the various assets, which range from three to seven years. Leasehold improvements are recorded at cost, less accumulated amortization, which is computed on the straight-line basis over the shorter of the useful lives of the asset or the remaining lease term. Expenditures for maintenance and repairs are charged to expense as incurred.
Patent Costs
        Patent application and maintenance costs are expensed as incurred.
Research and Development
        Research and development expenses include the costs associated with internal research and development by the Company and research and development conducted on behalf of the Company by outside advisors, sponsored university-based research agreements, and clinical study vendors. All research and development costs are expensed as incurred. Costs incurred in obtaining technology licenses are charged immediately to research and development expense if the technology licensed has not reached technological feasibility and has no alternative future uses.
F-9

Long-Lived Assets
        In accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets, which the Company adopted on July 1, 2002, the Company monitors events or changes in circumstances that may indicate carrying amounts of its long-lived assets may not be recoverable. When such events or changes in circumstances are present, the Company assesses the recoverability of its assets by determining whether the carrying amount of its assets will be recovered through undiscounted, expected future cash flows. Should the Company determine that the carrying values of specific long-lived assets are not recoverable, the Company would record a charge to operations to reduce the carrying value of such assets to their fair values. The Company considers various valuation factors, principally discounted cash flows, to assess the fair values of long-lived assets.
        Prior to the adoption of SFAS No. 144, the Company accounted for long-lived assets in accordance with SFAS No. 121, Accounting for Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed Of .
Accounting for Income Taxes
        Income taxes are accounted for under the asset and liability method with deferred tax assets and liabilities recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be reversed or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance for the amounts of any tax benefits which, more likely than not, will not be realized.
Revenue Recognition—Grants
        Revenue related to research and development grants is recognized when the related research expenses are incurred and the Company's specific performance obligations under the terms of the respective contract are satisfied. To the extent expended, grant funding related to purchases of equipment is deferred and amortized over the shorter of the equipment's useful life or the life of the related contract. Revenue recognized in the accompanying consolidated financial statements is not subject to repayment. Payments, if any, received in advance of performance under the contract are deferred and recognized as revenue when earned. Since inception, the Company has recognized $3,637,117 in grant revenue, of which $3,370,972 has been received by the Company.
Concentration of Risk
        Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of investments in cash and cash equivalents, restricted cash and debt securities. The Company maintains such financial instruments with approved financial institutions. The Company is exposed to credit risks in the event of default by the financial institutions or issuers of investments in excess of FDIC insured limits. The Company performs periodic evaluations of the relative credit standing of these financial institutions and limits the amount of credit exposure with any institution.
F-10

        The Company is substantially dependent upon Elan Corporation plc ("Elan") for several activities related to the development and commercialization of Fampridine-SR. The Company will rely on Elan to complete the chemistry, manufacturing and controls section of the New Drug Application ("NDA") for Fampridine-SR in SCI. If Elan fails to provide it in a complete and timely manner the Company could incur delays in filing of its NDA for Fampridine-SR in SCI.
        The Company relies upon Elan to manufacture at least 75% of its Fampridine-SR product requirements. In addition, the Company does not have direct contractual relationships with the suppliers of fampridine, the active pharmaceutical ingredient in Fampridine-SR, referred to as API. Currently, the Company is relying on Elan's contracts with third parties to supply API. If Elan or an alternative manufacturer is unable to obtain API supplies from these suppliers for any reason, a new supplier would have to be identified by the Company. Although other suppliers of API are readily available, a change to a supplier, that was not previously approved in the Company's NDA may require formal approval by the Food and Drug Administration ("FDA") before the Company could use the new suppliers' API product. Any delays in obtaining API to manufacture Fampridine-SR would delay the commercialization of Fampridine-SR.
Fair Value of Financial Instruments
        The fair value of a financial instrument represents the amount at which the instrument could be exchanged in a current transaction between willing parties, other than in a forced sale or liquidation. Significant differences can arise between the fair value and carrying amounts of financial instruments that are recognized at historical cost amounts.
        The following methods are used to estimate the Company's financial instruments:
(a)
Cash and cash equivalents, grant receivables, accounts payable and accrued liabilities approximate their fair value due to the short-term nature of these instruments;

(b)
Available-for-sale securities are recorded based on quoted market prices;

(c)
Notes payable carrying value approximate fair value as the interest rates on these notes approximate market rate of interest; and
It is not practical for the Company to estimate the fair value of the convertible notes payable to Elan due to the specific provisions of these notes including the uncertainty of the timing of repayment which is tied to regulatory approval of certain products. The terms of these notes are disclosed at Note 10. In September 2003, the notes were restructured, see Note 13.
Net Loss Per Share
        Net loss per share is computed in accordance with SFAS No. 128, Earnings Per Share , by dividing the net loss allocable to common stockholders by the weighted average number of shares of common stock outstanding. The Company has certain options, warrants, convertible preferred stock and mandatorily redeemable convertible preferred stock (see Notes 3 and 7), which have not been used in the calculation of diluted net loss per share because to do so would be anti-dilutive. As such, the numerator and the denominator used in computing both basic and diluted net loss per share allocable to common stockholders for each year are equal. The Company has reflected the beneficial conversion feature of $23,096,911, accretion of issuance costs of $65,963, and preferred dividend of $629,895 in the 2003 net loss allocable to
F-11

common stockholders (See Notes 3 and 7). The 2001 and 2002 net loss allocable to common stockholders reflect accretion of issuance costs and the beneficial conversion feature on issuance of Series C convertible preferred stock in the net loss allocable to common stockholders (See Note 11).
Stock-Based Compensation
        At June 30, 2003, the Company had various stock-based employee and non-employee compensation plans, which are described more fully in Note 8. The Company accounts for options granted to employees and directors in accordance with the fair value method of SFAS No. 123, Accounting for Stock-Based Compensation , as amended by SFAS No. 148, Accounting for Stock-Based Compensation—Transition and Disclosure an amendment of FASB Statement No. 123 and related interpretations. As such, compensation expense is recorded on stock option grants based on the fair value of the options granted, which is estimated on the date of grant using the Black-Scholes option-pricing model and it is recognized on a straight-line basis over the vesting period. The Company accounts for stock options granted to non-employees on a fair-value basis in accordance with SFAS No. 123, Emerging Issues Task Force Issue ("EITF") No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services, and FASB Interpretation No. 28, Accounting for Stock Appreciation Rights and Other Variable Stock Option or Award Plans an Interpretation of APB Opinion No. 15 and 25 . As a result, the non-cash charge to operations for non-employee options with vesting or other performance criteria is affected each reporting period by changes in the estimated fair value of the Company's common stock. All the stock option grants made by the Company since fiscal 1996 are in the money. The two factors which most affect charges or credits to operations related to stock-based compensation are the fair value of the common stock underlying stock options for which stock-based compensation is recorded and the volatility of such fair value. If the Company's estimates of the fair value of these equity instruments changes, it would have the effect of changing compensation expense. Because shares of the Company's common stock have not been publicly traded, the Company estimates the fair value of its common stock based on the most recent previous sale of convertible preferred stock (convertible on a one-for-one basis (one-for-twelve post reverse split) into common stock). The Company does not discount the issuance price of its preferred stock in estimating for financial reporting purposes the fair value of its common stock.
Segment Information
        The Company is managed and operated as one business. The entire business is managed by a single management team that reports to the chief executive officer. The Company does not operate separate lines of business with respect to any of its product candidates. Accordingly, the Company does not prepare discrete financial information with respect to separate product candidates or by location and does not have separately reportable segments as defined by SFAS No. 131, Disclosures about Segments of an Enterprise and Related Information .
Derivatives
        On July 1, 2001, the Company adopted SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities . This Statement requires the recognition of all derivative instruments as either assets or liabilities in the consolidated balance sheet, and the periodic adjustment of those instruments to fair value. The classification of gains and losses resulting from changes in the fair values of derivatives is dependent on the intended use of the derivative and its resultant designation.
F-12

        During the first quarter of fiscal 2003, the Company entered into a foreign currency option transaction to sell (put option) U.S. dollars to British Pounds amounting to $294,739, with a strike price of $1.4280. The option expiration date was January 31, 2003. The Company's primary purpose for entering into this transaction was to cover an exchange gain or loss on a British Pound denominated contract to be entered into with a foreign company. This contract was not entered into by the Company. During fiscal 2003, the Company recorded a gain of $25,903 related to this option transaction, which is classified as other income in the consolidated statement of operations.
Comprehensive income (loss)
        SFAS No. 130, Reporting Comprehensive Income ("SFAS No. 130") establishes standards for the reporting and display of comprehensive income (loss) and its components in a full set of financial statements. SFAS No. 130 requires that unrealized losses from the Company's investment securities be included in other comprehensive income (loss).
Pro Forma Consolidated Balance Sheet (Unaudited)
        Upon the consummation of the initial public offering contemplated herein, all of the outstanding shares of convertible preferred stock and mandatorily redeemable convertible preferred stock at June 30, 2003 automatically convert into 15,806,617 shares of common stock (see Note 7). The June 30, 2003 unaudited pro forma consolidated balance sheet have been prepared assuming the conversion of the convertible preferred stock and the mandatorily redeemable convertible preferred stock outstanding as of June 30, 2003, into common stock as of June 30, 2003.
Pro Forma Net Loss Per Share (Unaudited)
        The following pro forma basic and diluted net loss per share allocable to common stockholders and shares used in computing pro forma basic and diluted net loss per share allocable to common stockholders have been presented reflecting the automatic conversion into shares of common stock of the convertible preferred stock and mandatorily redeemable convertible preferred stock upon completion of the initial public offering contemplated herein (see Note 7), using the as converted method from their respective dates of issuance. Pro forma adjustments related to the pro forma consolidated statement of operations have been computed assuming the initial public offering was consummated at the beginning of the fiscal year ended June 30, 2003 and include adjustments giving effect to the following: (a) recognition of unamortized portion of beneficial conversion charge of $78,575,780, which is calculated as follows: (x) beneficial conversion feature of $80,730,286 for reset in conversion price (see Note 2), plus (y) beneficial conversion feature of $20,942,405 on issuance of Series J mandatorily redeemable convertible preferred stock (see Note 2), less (z) beneficial conversion feature charged to additional paid-in capital for the year ended June 30, 2003 of $23,096,911 (b) recognition of unamortized portion of issuance costs relating to Series E, Series I and Series J preferred stock charge of $479,457, which is calculated as follows: (x) total issuance costs relating to Series E, Series I and Series J of $681,668 (see Note 7), less (y) accumulated amortization of issuance costs as of June 30, 2003 of $202,211, and (c) reversal of accrued preferred dividend on Series J preferred stock in the amount of $629,895 (see Note 7). Weighted average common shares outstanding used in computing pro forma net less per share allocable to common stockholder is calculated based on (a) Series A through Series I equivalent common shares from the beginning of the fiscal year; (b) additional equivalent common shares
F-13

issuable for Series A through Series I, based on reset to conversion price from the date of reset; and (c) Series J equivalent common shares issuable from the date of issuance of Series J preferred stock.

 	 	Pro Forma Year ended June 30, 2003
	 	
 	 	(unaudited)
	 	
Pro forma net loss per share allocable to common stockholders—basic and diluted	 	$	(15.38	)	
 	 		 	
Weighted average common shares outstanding used in computing pro forma net loss per share allocable to common stockholders—basic and diluted	 	 	8,320,796	 	
 	 		 	
Recent Accounting Pronouncements
        In June 2002, the FASB issued SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities ("SFAS No. 146"). SFAS No. 146 addresses financial accounting and reporting for costs associated with exit or disposal activities and nullifies EITF Issue No. 94-3, Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring). The adoption of SFAS No. 146 did not impact the Company's consolidated financial statements for the fiscal year ended June 30, 2003.
        In May 2003, the FASB issued SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity ("SFAS No. 150"). SFAS No. 150 revises the accounting for certain financial instruments that, under previous guidance, issuers could account for as equity. SFAS No. 150 requires that those instruments be classified as liabilities in statements of financial position. SFAS No. 150 is effective for financial instruments entered into or modified after May 31, 2003, and otherwise is effective for interim periods beginning after June 15, 2003. The adoption of SFAS No. 150 did not impact the Company's consolidated financial statements for the fiscal year ended June 30, 2003.
(3) Beneficial Conversion Feature
        In May 2003, the Company completed a private placement of 112,790,246 shares of Series J mandatorily reedeemable convertible preferred stock at $0.49 per share for an aggregate purchase price of approximately $55,267,000. The terms of the preferred stock are more fully described in Note 7.
        As part of this financing, the original conversion price on the Series A through Series I preferred stock was reduced as a result of anti-dilution adjustments, which resulted in a beneficial conversion amounting to $80,730,286 in accordance with EITF No. 98-5, Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios and EITF No. 00-27, Application of Issue No. 98-5 to Certain Convertible Instruments . The beneficial conversion charge of $20,860,491 related to Series A, Series B, Series C, Series F and Series H convertible preferred stock, which are not mandatorily redeemable and may be converted at any time at the option of the holders to common stock, has been recorded as an immediate charge to additional paid-in capital. The remaining beneficial conversion amount of $59,869,795 related to Series E and Series I convertible preferred stock, which are mandatorily redeemable at any time on or after June 30, 2008, is being accreted ratably over the mandatory redemption period. Such
F-14

accretion for the year ended June 30, 2003 amounted to $1,656,854 and is charged to additional paid-in capital.
        In addition, the issuance of Series J mandatorily redeemable convertible preferred stock resulted in a beneficial conversion amounting to $20,942,405 in accordance with EITF No. 98-5. The beneficial conversion is calculated based on the estimated fair value of the Company's common stock price per share at the date of issuance of Series J preferred stock of approximately $8.16 per share of common stock, which is calculated based on the projected midpoint of the range of the estimated Company's initial public offering price per common share and the stock price appreciation in comparable public companies from May 2003 to August 2003. The beneficial conversion feature is being accreted ratably over the mandatory redemption period, with a charge to additional paid-in capital of $579,566 for the year ended June 30, 2003.
(4) Short-Term Investments
        The Company has accounted for its investments in accordance with SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities , and determined that all of its short-term investments are classified as available-for-sale. Available-for-sale securities are carried at fair value with interest on these securities included in interest income. Available-for-sale securities consisted of the following:

 	 	Amortized
Cost
	 	Gross
unrealized gains
	 	Gross
unrealized losses
	 	Estimated
fair value
	
Corporate debt securities	 	 	 	 	 	 	 	 	 	
 	As of June 30, 2002	 	$	2,835,526	 	—	 	—	 	2,835,526	
 	As of June 30, 2003	 	$	12,256,527	 	518,122	 	(524,200	)	12,250,449	
        The contractual maturities of available-for-sale debt securities at June 30, 2003 are within one year.
        Proceeds from sales and maturities of investment securities available-for-sale during fiscal 2001, 2002 and 2003 and for the period from March 17, 1995 (inception) to June 30, 2003, were $0, $0, $9,255,000 and $9,255,000, respectively. No gains/(losses) were realized on those sales during any of the periods presented. Purchases of investment securities during fiscal 2001, 2002 and 2003 and for the period March 17, 1995 (inception) to June 30, 2003, were $0, $2,835,526, $18,669,923 and $21,505,449, respectively. Short-term investments with original maturity of three months or less have been classified as cash and cash equivalents, and amounted to $24,902,027 and $46,638,611 as of June 30, 2002 and June 30, 2003, respectively.
F-15

(5) Property and Equipment
        Property and equipment consisted of the following as of June 30, 2003 and 2002:

 	 	2002
	 	2003
	 	Estimated
useful lives
	
Laboratory equipment	 	$	1,399,729	 	1,641,423	 	5 years	
Furniture and fixtures	 	 	518,772	 	499,743	 	5 years	
Computer equipement	 	 	315,197	 	474,239	 	3 years	
Leasehold improvements	 	 	1,344,415	 	1,710,688	 	5 to 7 years	
 	 		 		 	 	
 	 	 	3,578,113	 	4,326,093	 	 	
Less accumulated depreciation	 	 	638,145	 	1,378,346	 	 	
 	 		 		 	 	
 	 	$	2,939,968	 	2,947,747	 	 	
 	 		 		 	 	
        Depreciation and amortization expense on property and equipment was $123,449, $417,479, $740,201 and $1,378,346 for the years ended June 30, 2001, 2002 and 2003 and for the period from March 17, 1995 (inception) to June 30, 2003, respectively.
(6) Notes Payable
        In 2003, the Company entered into two financing agreements with General Electric Capital Corporation in the aggregate amount of $1,163,511, bearing annual fixed interest rates of 8.57% and 8.88%, to finance the purchase of certain property and equipment. Borrowings are secured by a security interest in certain property and equipment of the Company. The Company is required to pay monthly installments until October 2006. The aggregate maturities for each of the four years subsequent to June 30, 2003 are: $310,233 in 2004, $338,317 in 2005, $231,937 in 2006 and $41,833 in 2007.
        For Long-term convertible notes payable to related party see Note 11.
(7) Mandatorily Redeemable Convertible Preferred Stock and Convertible Preferred Stock
        The board of directors of the Company has authorized 140,221,535 shares of convertible preferred stock, designated as Series A, B, C, D, E, F, G, H, I and J preferred stock (Series A, Series B, Series C, Series D, Series E, Series F, Series G, Series H, Series I and Series J; collectively, the Preferred Stock). Series E, Series I and Series J are mandatorily redeemable convertible preferred stock (Redeemable Preferred Stock). The terms of the Preferred Stock are as follows:
(a)
Dividends
The Preferred Stock is entitled to noncumulative dividends prior to and in preference to dividends declared or paid on the common stock, at the rate of $0.10 per share per annum for Series A through Series H and at the rate of $0.39 per share per annum for Series I when and if declared by the board of directors. Dividends accrue on each share of Series J Preferred Stock commencing on the date of issuance, whether or not earned or declared at the rate of $0.0392 per share per annum, based on the original issue price of Series J Preferred Stock, prior and in preference to any declaration or payment of any dividend on any other Series of Preferred Stock holders (Series A through Series I). Series J dividends are payable when declared by the Board of Directors or upon liquidation, as defined or upon redemption.
F-16

(b)
Liquidation
The preferred stockholders have liquidation preferences over common stockholders based on the series of Preferred Stock held. In the event of liquidation, dissolution, or winding up of the Company, each holder of shares of Series J Preferred Stock is entitled to be paid in preference to common stockholders and any other Series of Preferred Stock holders (Series A through Series I) an amount equal to the original issue price per share of $0.49, plus all accrued or declared but unpaid dividend, as defined. After payment has been made to Series J Preferred Stock, Series I, Series E, Series F and Series H shall be entitled to receive out of the available assets, on a pro rata basis, an amount per share of $3.89, $1.31, $1.07, $1.09 and $1.36, respectively, plus all declared but unpaid dividends on each such share issued. After payment of the above mentioned preferential amounts have been made by the Company, the holders of Series E, Series F and Series H Preferred Stock shall be entitled to be paid out of the remaining available assets an amount per share equal to $0.26, $0.21 and $0.27, respectively, plus all declared but unpaid dividends. After payment of the above mentioned preferential amounts, the holders of Series A through Series H Preferred Stock shall be entitled to be paid out of remaining available assets an amount per share up to and including such amounts paid in accordance with as mentioned above, equal to $1.00, $2.00, $3.00, $12.50, $3.13, $5.22, the greater of $2.00 and 80% of the closing price per share of the Institutional Financing, as defined, most recently completed by the Company prior to the issuance of the Series G Preferred Stock and $3.25, respectively.
(c)
Conversion
The Preferred Stock is convertible into common stock at the option of the stockholder. The per share conversion price on preferred stock are Series A—$6.97, Series B—$9.12, Series C—$11.26, Series D—$9.12, Series E—$10.62, Series F—$10.62, Series G—the product of (x) the number of Series G Preferred Stock surrendered and (y) the number determined by dividing (i) the greater of $24.0 or 80% of the closing price per share of the most recently completed bona fide equity financing of the Company prior to the issuance of Series G Preferred Stock by (ii) the Series G conversion price in effect, Series H—$11.80, Series I—$13.16 and Series J—$5.88. The Preferred Stock will be automatically converted into common stock upon either the approval by written consent of the holders of a majority of the then outstanding shares of Series A, Series B, Series C, Series D, Series E, Series F, Series G, Series H and Series I voting together as a single class and upon approval by written consent of the holders of a majority of the then outstanding shares of Series J, or upon an Initial Public Offering, provided that (i) the price to the public is not less than $14.76 per share and (ii) the aggregate proceeds are not less than approximately $40 million (see Note 13 for modification of terms).
In the event the convertible promissory notes payable to Elan are converted into common stock, the per share conversion price on the Series I and Series J preferred stock would be adjusted to $12.59 and $5.48, respectively. In the event the Company issues common stock (or securities convertible into common stock) at an effective common stock issuance price of less than $5.88 per share, the conversion price on all convertible preferred stock will be reduced based on anti-dilution provisions.
F-17

(d)
Redemption
Holders of Series E, Series I and Series J Preferred Stock may at any time on or after June 30, 2008, require the Company to redeem all or any portion of such Holders' Redeemable Preferred Stock at a redemption price, as specified below, provided, however, that no holder of Redeemable Preferred Stock may so require such redemption unless and until (i) the holders of not less than a majority of the Redeemable Preferred Stock then issued and outstanding make such election and (ii) the holders of a majority of the Series J Preferred Stock then issued and outstanding make such election prior to September 30, 2008. Redemption price for each share of Redeemable Preferred Stock shall be original issue price plus accrued but unpaid dividends. One half of such aggregate redemption price for all Redeemable Preferred Stock shall be payable in cash on the Redemption Date, as defined and the second half of such aggregate redemption price shall be payable in cash on the first anniversary of the Redemption Date, as defined. For the fiscal year ended June 30, 2003, the Company has accrued preferred dividends in the amount of $629,895 for Series J Preferred Stockholders.
(e)
Voting
Each holder of outstanding Preferred Stock (other than Series F) shall be entitled to the number of votes equal to the number of shares of common stock into which the shares of Preferred Stock so held could be converted. The holders of Series F Preferred Stock shall have no voting rights except as required by Delaware General Corporation Law. The board of directors consist of seven directors: (i) two directors elected by the holders of Series A, Series E and Series H Preferred Stock, voting as a single class; (ii) one director elected by Series I Preferred Stock; (iii) two directors elected by Series J Preferred Stock; (iv) one director elected by holders of common stock; and (v) one director elected by the holders of common stock and Preferred Stock, voting as a single class. The Company's certificate of incorporation includes provisions which restrict the Company from certain actions without the approval of a defined percentage of the preferred stockholders.
Convertible Preferred Stock
        In May 1995, the Company issued 610,000 shares of Series A, at a per share price of $1.00, for aggregate proceeds of $610,000, and granted each purchaser a warrant to purchase one additional share of Series A for every ten Series A shares purchased, at an exercise price of $1 per share. 51,068 of these warrants were exercised in fiscal 2002. The Company estimated the fair value of warrants at approximately $44,971. Such value was determined by the Black-Scholes valuation method, using a risk free interest rate of 6.5%, its contractual life of seven years, an annual volatility of 73% and no expected dividends. Such amount was credited to additional paid-in capital and charged immediately to additional paid-in capital as the warrants were exercisable at any time at the option of the holder. Each warrant was exercised for one share of Series A. Through June 30, 2003, 22,800 of these warrants were exercised on a cash basis and 28,268 were exercised in a cashless exercise resulting in total proceeds of $22,800. The remaining 9,932 of these warrants were not exercised and have expired.
        In fiscal 1996 and 1997, the Company issued 450,000 and 195,000 shares of Series A, at a per share price of $1.00, for aggregate proceeds of $450,000 and $195,000, respectively. In August 1996 and
F-18

January 1997, the Company granted 340,000 warrants to purchase shares of Series A at an exercise price of $1.00. These warrants expire in August 2003 and January 2004, respectively, and the number of Series A shares to be received upon exercise is one share for one warrant. The Company estimated the fair value of warrants at approximately $254,110. Such value was determined by the Black-Scholes valuation method, using a risk free interest rate of 6.5%, the warrant's contractual life of seven years, an annual volatility of 75% and no expected dividends. Such amount was credited to additional paid-in capital and charged immediately to additional paid-in capital as the warrants were exercisable at any time at the option of the holder. In January 1997, the Company issued 750,000 shares of Series B, at a per share price of $2.00, for aggregate proceeds of $1,500,000. In January 2002, the Company issued 150,000 shares of Series B, at a per share price of $2.00, for aggregate proceeds of $300,000 (see Note 10).
        In February 2002, the Company issued to Elan and affiliates 333,333 shares of Series C, at a per share price of $3.00, for aggregate proceeds of $999,999.
        In April 1998, the Company issued to Elan 2,300,000 shares of Series F, at a per share price of approximately $5.22, for aggregate proceeds of approximately $12 million. Also, in April 1998, the Company entered into a joint venture agreement with Elan. The $12 million proceeds from the sale of the Series F was then transferred to MS Research and Development Corp. (MSRD), a joint venture company of which the Company owned approximately 80% and Elan owned 20%, approximately. To purchase its approximate 20% interest, Elan invested an additional $3 million into MSRD. The combined $15 million was subsequently used to license research and development technology from Elan to develop Elan's proprietary oral sustained release formulation of fampridine for the treatment of multiple sclerosis. This purchase is recorded as a license payment expense in the consolidated financial statements for the fiscal year ended June 30, 1998. For the years ended June 30, 2001, 2002 and 2003, and the period from March 17, 1995 (inception) to June 30, 2003, MSRD incurred approximately $2.2 million, $2.9 million, $3.2 million, and $24.6 million, respectively, in research and development expenses, which is included as research and development expense in the accompanying statements of operations, of which Acorda funded 80% and Elan funded 20% until June 30, 2002, in accordance with the terms of the original development agreement. Elan's ownership interest in MSRD is reflected as minority interest in the accompanying statement of operations. The minority interest share of the MSRD losses were being funded by Elan, and through June 30, 2002 the Company received $1,279,361 as a reimbursement of this funding. In fiscal 2003, Elan ceased funding its approximately 20% share of its minority interest in MSRD and the Company ceased recognizing the related minority interest benefit resulting in an increase in the Company's ownership interest to 83% pursuant to the original agreement.
        In August 1999, the Company completed a private placement of 1,575,229 shares of Series H at $3.25 per share, resulting in net proceeds to the Company of $5,119,494 after payment of legal and certain other fees.
        As of June 30, 2003, 340,000 Series A and 100,000 Series B warrants were outstanding with a weighted average exercise price per share of $1.23. The warrants to acquire Series A and Series B Preferred Stock enable the holder to acquire 70,695 shares of common stock.
F-19

Mandatorily Redeemable Convertible Preferred Stock
        The following convertible preferred stock are classified as free standing instruments based on the redemption rights and conversion option as discussed above under terms of the Preferred Stock.
        In July and November 1998, the Company issued 7,472,612 shares of Series E, which are mandatorily redeemable at $2.70 per share for an aggregate purchase price of approximately $20,176,000. The Company incurred issuance costs of $209,270. Such costs are netted against the proceeds of the Series E, and are being amortized over the mandatory redemption period.
        In March 2001, the Company issued 10,204,047 shares of Series I which are mandatorily redeemable at $3.89 per share for an aggregate purchase price of approximately $39,694,000. The Company incurred issuance costs of $138,179. Such costs are netted against the proceeds of the Series I, and are being amortized over the mandatory redemption period.
        In May 2003, the Company issued 112,790,246 shares of Series J which are mandatorily redeemable at $0.49 per share for an aggregate purchase price of approximately $55,267,000. The Company incurred issuance costs of $334,219. Such costs are netted against the proceeds of the Series J, and are being amortized over the mandatory redemption period.
F-20

        The changes in mandatorily redeemable convertible preferred stock since inception are as follows:

 	 	Mandatorily Redeemable Convertible Preferred Stock
	 	
 	 	Series E mandatorily
redeemable convertible
preferred stock
	 	Series I mandatorily
redeemable convertible
preferred stock
	 	Series J mandatorily
redeemable convertible
preferred stock
	 	
 	 	Number of
Shares
	 	Amount
	 	Number of
Shares
	 	Amount
	 	Number of
Shares
	 	Amount
	 	
Balance at June 30, 1998	 	—	 	$	—	 	—	 	$	—	 	—	 	$	—	 	
 	 		 		 		 		 		 		 	
Issuance of Series E mandatorily redeemable convertible preferred stock	 	7,472,612	 	 	19,966,782	 	—	 	 	—	 	—	 	 	—	 	
Accretion of issuance costs	 	—	 	 	18,042	 	—	 	 	—	 	—	 	 	—	 	
 	 		 		 		 		 		 		 	
Balance at June 30, 1999	 	7,472,612	 	 	19,984,824	 	—	 	 	—	 	—	 	 	—	 	
Accretion of issuance costs	 	—	 	 	27,337	 	—	 	 	—	 	—	 	 	—	 	
 	 		 		 		 		 		 		 	
Balance at June 30, 2000	 	7,472,612	 	 	20,012,161	 	—	 	 	—	 	—	 	 	—	 	
Issuance of Series I mandatorily redeemable convertible preferred stock	 	—	 	 	—	 	10,204,047	 	 	39,555,564	 	—	 	 	—	 	
Accretion of issuance costs	 	—	 	 	27,337	 	—	 	 	8,560	 	—	 	 	—	 	
 	 		 		 		 		 		 		 	
Balance at June 30, 2001	 	7,472,612	 	 	20,039,498	 	10,204,047	 	 	39,564,124	 	—	 	 	—	 	
Accretion of issuance costs	 	—	 	 	27,337	 	—	 	 	27,636	 	—	 	 	—	 	
 	 		 		 		 		 		 		 	
Balance at June 30, 2002	 	7,472,612	 	 	20,066,835	 	10,204,047	 	 	39,591,760	 	—	 	 	—	 	
Issuance of Series J mandatorily redeemable convertible preferred stock	 	—	 	 	—	 	—	 	 	—	 	112,790,246	 	 	54,933,001	 	
Accretion of issuance costs	 	—	 	 	27,337	 	—	 	 	27,636	 	—	 	 	10,990	 	
Accrual of preferred dividend on Series J mandatorily redeemable convertible preferred stock	 	—	 	 	—	 	—	 	 	—	 	—	 	 	629,895	 	
Beneficial conversion feature for reduction in conversion price	 	—	 	 	—	 	—	 	 	(39,693,743	)	—	 	 	(20,942,405	)	
Beneficial conversion feature on issuance	 	—	 	 	(20,176,052	)	—	 	 	—	 	—	 	 	—	 	
Deemed dividends on preferred stock for reduction in conversion price	 	—	 	 	558,358	 	—	 	 	1,098,496	 	—	 	 	—	 	
Deemed dividends on preferred stock for issuance of preferred stock with beneficial conversion feature	 	—	 	 	—	 	—	 	 	—	 	—	 	 	579,566	 	
 	 		 		 		 		 		 		 	
Balance at June 30, 2003	 	7,472,612	 	$	476,478	 	10,204,047	 	$	1,024,149	 	112,790,246	 	$	35,211,047	 	
 	 		 		 		 		 		 		 	
(8) Common Stock and Common Stock Options and Warrants
      Upon inception of the Company in March 1995, the founders, directors, and certain employees purchased 216,875 shares of restricted common stock at a per share price of $0.12. Full recourse promissory notes with interest rates of 7.75% were issued for the purchase price and have been received by the Company for 206,250 of these shares. The remaining amounts due were paid during 2001.
        The Company's president began devoting substantial time to the formation and then-operation of the Company in November 1993. Compensation expense and additional paid in capital for the estimated value of his services has been recorded in the amount of $125,000 in both fiscal 1995 and 1996 and $70,000 in fiscal 1997, as his salary was not paid and has been forgiven. The amount recorded in fiscal 1995 includes an amount related to the period prior to incorporation. The Company's president has received a salary since 1997.
F-21

        In fiscal 1996, the Company issued 4,000 shares of common stock at a per share price of $1.20. Promissory notes due and received in fiscal 2001 were for 1,500 of these shares. The remaining promissory notes for 2,500 of these shares were paid in August 2000.
        On June 18, 1999, the Company's board of directors approved the adoption of the Acorda Therapeutics, Inc. 1999 Employee Stock Option Plan (the "Plan"). The Plan reserves 1.7 million shares for issuance through option grants (see Note 13 for changes to stock option plan). All employees of the Company are eligible to participate in the Plan, including executive officers, as well as directors, independent contractors, and agents of the Company. The Plan is administered by the Compensation Committee of the board of directors, which selects the individuals to be granted options and stock appreciation rights, determines the time or times at which options and stock appreciation rights shall be granted under the Plan, determines the number of shares to be granted subject to any option or stock appreciation right under the Plan and the duration of each option and stock appreciation right, and makes any other determinations necessary, advisable, and/or appropriate to administer the Plan. Under the Plan, each option granted expires no later than the tenth anniversary of the date of its grant. No option may be granted pursuant to the Plan more than ten years after the date on which the Plan was adopted by the board of directors and any option granted under the Plan shall, by its terms, not be exercisable more than ten years after the date of grant.
        The effects of applying SFAS No. 123 in a particular year, may not be representative of the effects on reported net income or loss for future years. The fair value of each option granted is estimated on the date of grant using an option-pricing model with the following weighted average assumptions:

 	 	2001
	 	2002
	 	2003
	 	
Employees and directors	 	 	 	 	 	 	 	
 	Estimated volatility	 	104.4	%	97.7	%	94.0	%	
 	Expected life in years	 	5	 	5	 	5	 	
 	Risk free interest rate	 	4.79	%	4.41	%	3.04	%	
 	Dividend yield	 	—	 	—	 	—	 	
        The weighted average fair value per share of options granted to employees for the years ended June 30, 2001, 2002 and 2003 amounted to approximately $33.96, $39.96 and $40.56, respectively. The weighted average fair value per share of options granted to non-employees for the year ended June 30, 2001 amounted to approximately $28.68. No options were granted to non-employees for the years ended June 30, 2002 and 2003. The fair value of each option granted in 2001 to non-employees was calculated at the date of grant using an option-pricing model with the following weighted average assumptions (a) estimated volatility—104.5%; (b) expected life in years—10 years; (c) risk free interest rate—5.11%; and (d) dividend yield—0%.
        The Company estimated volatility for purposes of computing compensation expense on its employee and non-employee options using the volatility of public companies that the Company considered comparable. The expected life used to estimate the fair value of non-employee options is equal to the contractual life of the option granted, which is 10 years.
F-22

        Common stock option and warrant activity from March 17, 1995 (inception) to June 30, 2003 is as follows (this table does not include Warrants to acquire Series A and Series B Preferred stock, which are discussed in Note 7.):

 	 	Shares
	 	Exercise Price
per share
	
March 17, 1995 (inception)	 	—	 	$	—	
Granted	 	5,000	 	 	0.12	
Exercised	 	—	 	 	—	
 	 		 	 	 	
Balance at June 30, 1995	 	5,000	 	 	 	
Granted	 	29,583	 	 	0.12–1.20	
Exercised	 	(7,500	)	 	0.12	
 	 		 	 	 	
Balance at June 30, 1996	 	27,083	 	 	 	
Granted	 	45,417	 	 	1.20–2.40	
Exercised	 	—	 	 	—	
 	 		 	 	 	
Balance at June 30, 1997	 	72,500	 	 	 	
Granted	 	3,500	 	 	2.40–4.20	
Forfeited	 	(500	)	 	2.40	
Exercised	 	(2,209	)	 	1.20–2.40	
 	 		 	 	 	
Balance at June 30, 1998	 	73,291	 	 	 	
Granted	 	24,833	 	 	4.20	
Exercised	 	(1,333	)	 	1.20–4.20	
 	 		 	 	 	
Balance at June 30, 1999	 	96,791	 	 	 	
Granted	 	13,625	 	 	4.20	
Exercised	 	(6,041	)	 	0.12–1.20	
 	 		 	 	 	
Balance at June 30, 2000	 	104,375	 	 	 	
Granted	 	95,709	 	 	4.20–18.0	
Forfeited	 	(1,984	)	 	4.20–18.0	
Exercised	 	(6,308	)	 	0.12–4.20	
 	 		 	 	 	
Balance at June 30, 2001	 	191,792	 	 	 	
Granted	 	56,720	 	 	18.0–24.0	
Forfeited	 	(3,965	)	 	4.20–18.0	
Exercised	 	(4,395	)	 	4.20–18.0	
 	 		 	 	 	
Balance at June 30, 2002	 	240,152	 	 	 	
Granted	 	14,521	 	 	9.60–24.0	
Forfeited	 	(5,965	)	 	4.20–24.0	
 	 		 	 	 	
Balance at June 30, 2003	 	248,708	 	 	 	

F-23

Options and Warrants outstanding
	 	Options and Warrants exercisable
	
Range of
exercise prices
	 	Outstanding
as of June 30,
2003
	 	Weighted average
remaining
contractual life
	 	Weighted
average
exercise price
	 	Exercisable
as of June 30,
2003
	 	Weighted
average
exercise price
	
$0.12–2.40	 	58,333	 	3.19	 	$	1.20	 	58,333	 	$	1.20	
4.20 and 9.60	 	41,579	 	6.67	 	 	5.40	 	30,423	 	 	4.32	
18.0 and 24.0	 	148,796	 	7.93	 	 	18.36	 	79,846	 	 	18.12	
 	 		 		 		 		 		
 	 	248,708	 	6.61	 	$	12.12	 	168,602	 	$	9.72	
 	 		 		 		 		 		
        The Company has granted certain common stock options and warrants. These options and warrants are exercisable for a period of ten years and vest up to four years.
        Compensation expense for options granted to employees amounted to $643,028, $1,331,911, $1,580,054 and $3,831,784 for the years ended June 30, 2001, 2002 and 2003 and for the period from March 17, 1995 (inception) to June 30, 2003, respectively. Compensation expense for options granted to employees are classified between research and development and general and administrative expense based on employee job function.
        Options granted to non-employees vest immediately or over a one to four year period based upon future service requirements. Compensation expense for options granted to non-employees amounted to $94,397, $74,624, ($6,539) and $1,919,675 for the years ended June 30, 2001, 2002 and 2003 and for the period from March 17, 1995 (inception) to June 30, 2003, respectively. The amount of compensation expense to be recorded in the future for options granted to non-employees is subject to change each reporting period based upon changes in the fair value of the Company's common stock, estimated volatility and risk free interest rate until the non-employee completes performance under the option agreement. 1,770 options subject to this treatment remain unvested at June 30, 2003.
(9) Income Taxes
        As of June 30, 2003, the Company had available net operating loss carry-forwards ("NOL") of approximately $75,591,000 for federal and state income tax purposes, which are available to offset future federal and state taxable income, if any, and expire between 2009 and 2023. The Company also has research and development tax credit carryforwards of approximately $704,000 for federal income tax reporting purposes which are available to reduce federal income taxes, if any, and expire in future years through 2017.
F-24

        The tax effect of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities as of June 30, 2002 and 2003, are presented below:

 	 	2002
	 	2003
	 	
Net operating loss carryforwards	 	$	16,320,233	 	32,504,088	 	
Research and development tax credit	 	 	503,000	 	703,500	 	
Property and equipment	 	 	6,000	 	(270,300	)	
Intellectual property	 	 	6,521,667	 	5,948,334	 	
Other temporary differences	 	 	35,482	 	42,061	 	
 	 		 		 	
 	 	 	23,386,382	 	38,927,683	 	
Less valuation allowance	 	 	(23,386,382	)	(38,927,683	)	
 	 		 		 	
 	 	$	—	 	—	 	
 	 		 		 	
        Changes in the valuation allowance for the years ended June 30, 2001, 2002 and 2003 amounted to approximately $5,300,000, $3,853,000 and $15,541,000 respectively. Since inception the Company has incurred substantial losses and expects to incur substantial losses in future periods. The Tax Reform Act of 1986 (the "Act") provides for a limitation of the annual use of NOL and research and development tax credit carryforwards (following certain ownership changes, as defined by the Act) that could significantly limit the Company's ability to utilize these carryforwards. The Company has experienced various ownership changes, as defined by the Act, as a result of past financings. Accordingly, the Company's ability to utilize the aforementioned carryforwards may be limited. Additionally, because U.S. tax laws limit the time during which these carryforwards may be applied against future taxes, the Company may not be able to take full advantage of these attributes for federal income tax purposes. Because of the above mentioned factors and the development stage nature of its operations (see Note 1), the Company has not recognized its net deferred tax assets as of and for all periods presented. Accordingly, the Company has provided a full valuation allowance against its deferred tax assets and no tax benefit has been recognized relative to its pretax losses.
(10) License and Research Agreements
        In January 1997, the Company entered into several agreements with Elan, including a License and Supply Agreement to develop Elan's proprietary oral, sustained-release formulation of Fampridine-SR for treatment of SCI. In return for this exclusive license granted by Elan, the Company paid a license fee of $5 million which was expensed in fiscal 1997. The term of the agreement is equal to the greater of 20 years or the duration of relevant fampridine patent rights. Any mutually agreed to research conducted by Elan will be paid by the Company at cost plus 45%. The Company will be responsible for all clinical trials and regulatory approvals. Elan will have the right to manufacture, subject to certain exceptions, products for the Company upon regulatory approval at specified prices as a percentage of net selling price. In the event Elan does not manufacture the products, it is entitled to a royalty as a stated percentage of the products' net selling price. The Company may recover up to $2.5 million of the license fee by reducing the royalty payable to Elan by stated percentages of the products' net selling price.
        Concurrent with the License and Supply Agreement, the Company entered into a Preferred Stock, Convertible Note and Warrant Purchase Agreement (the "Agreement") with Elan. Under this Agreement, Elan purchased 750,000 shares of the Company's Series B at a per share price of $2.00 and also agreed to purchase 333,333 shares of the Company's Series C at a per share price of $3.00 within 30 days of the
F-25

completion of Phase II clinical trials relating to products to be developed under the License and Supply Agreement. Concurrent with the purchase of Series B, the Company issued to Elan a warrant to purchase an additional 150,000 shares of Series B at a per share exercise price of $2.00 for a period of five years. The Company estimated the fair value of warrants at approximately $198,031. Such value was determined by the Black-Scholes valuation method, using a risk free interest rate of 6.4%, the warrant's contractual life of five years, an annual volatility of 75% and no expected dividends. Such amount was credited to additional paid-in capital and charged immediately to additional paid-in capital as the warrants were exercisable at any time at the option of the holder. Concurrent with the purchase of Series C, described below the Company issued to Elan a warrant to purchase 100,000 shares of Series B at a per share exercise price of $2.00 for a period of five years from the date of issuance.
        Phase II clinical trials relating to products to be developed under the License and Supply Agreement were completed in February 2002 and Elan purchased 333,333 shares of Series C at a per share price of $3.00 resulting in total proceeds of $999,999. Elan also exercised its Series B warrant and the Company issued 150,000 shares of Series B at a per share price of $2.00 resulting in total proceeds of $300,000. The Company also issued an additional five-year warrant to purchase 100,000 shares of Series B on January 4, 2002. The Company estimated the fair value of the five-year warrant to purchase 100,000 shares of Series B at approximately $321,000. Such value was determined by the Black-Scholes valuation method, using a risk free interest rate of 4.3%, the warrant's contractual life of five years, an annual volatility of 102% and no expected dividends. Such amount was credited to additional paid-in capital and charged immediately to research and development expenses as these warrants were issued in connection with the Company completing Phase II clinical trials. In addition, the Company recognized $296,666 as a beneficial conversion feature on issuance of Series C convertible preferred stock and charged this amount to research and development expenses as these shares were issued upon the Company completing Phase II clinical trials pursuant to a previous arrangement.
        Under the Agreement, Elan also loaned to the Company an aggregate of $7.5 million pursuant to two convertible promissory notes. One promissory note in the amount of $5 million bears interest at a rate of 3% beginning on the first anniversary of the note. The unpaid principal is convertible into shares of the Company's Series D at a conversion price of $12.50 per share. Principal and interest are repayable, if not converted, ratably over a seven-year period beginning one year after the Company receives certain regulatory approval for the products to be developed, subject to limitations related to gross margin on product sales. If it is determined by both parties that regulatory approval will not likely occur, all principal and interest shall not be repayable and the note will be cancellable after a defined notice period, if not earlier converted. If the License and Supply Agreement is otherwise terminated, the principal and interest is repayable ratably over 15 years.
        The second promissory note in the amount of $2.5 million is non-interest bearing. This promissory note is convertible after January 22, 1999 into either shares of Series B at a conversion price of $2 per share or into an undesignated series of Preferred Stock at a conversion price equal to 80% of the-then most recently completed equity financing, as defined, whichever conversion price is greater. This promissory note is repayable by the Company, if not converted by Elan, ratably over a seven-year period beginning one year after the Company receives certain regulatory approval for the products to be developed. If it is determined by both parties that regulatory approval will not likely occur or if the License and Supply Agreement is otherwise terminated, the note is repayable ratably over 15 years from the date of determination. Interest on these
F-26

convertible promissory notes has been imputed using 9% on 50% of the $5 million note and 8% on the $2.5 million note. In case of the $5 million note, the Company has not imputed interest on 50% of the $5 million note based on the provision in the License and Supply Agreement which provides for a recovery of up to $2.5 million of the license fee paid, which is dependent upon regulatory approval of the product. If regulatory approval of the product is received, the convertible note would be repayable and the Company would be entitled to recovery of up to $2.5 million based on the aforementioned provision. If the parties determine that regulatory approval will not likely occur, the note shall not be repayable and the Company would not receive recovery of up to $2.5 million of the license fee. The $2,173,127 difference between the $7.5 million principal amount of the notes and the discounted balance is being accreted to interest expense over the estimated term of the notes. Elan is considered to be a related party based on its ownership interest in the Company, significant license agreements entered into and involvement with research and development activities of the Company. In addition, Elan had a right to appoint a representative on the board of directors from January 22, 1997 through May 8, 2003. The aggregate amount of the $7.5 million convertible notes payable are convertible into 361,842 shares of common stock.
        In April 1998, the Company entered into an agreement with Elan to develop Elan's proprietary oral sustained release formulation of fampridine for the treatment of multiple sclerosis (see note 7). Upon approval of a NDA for the product by the FDA in the United States the Company is obligated to pay $2.5 million. In addition, the Company is obligated to pay an additional amount of $2.5 million to Elan, upon the earlier occurrence of the following: (a) first anniversary from the date of approval of NDA approval in the United States, or (b) upon approval of the product by a regulatory authority in Japan, the United Kingdom, Germany, France or Italy.
        The Company has entered into various other research and license agreements which, as of June 30, 2003, upon accomplishment of certain milestones, will require payments by the Company aggregating up to $15.8 million. Approximately $375,000 of these milestone payments can be taken as credits against earned royalties. Upon regulatory approval, these agreements also require the Company to make royalty payments as a percentage of product sales.
(11) Employee Benefit Plan
        Effective September 1, 1999, the Company adopted a defined contribution 401(k) savings plan (the "401(k) plan") covering all employees of the Company. Participants may elect to defer a percentage of their annual pretax compensation to the 401(k) plan, subject to defined limitations. No contributions were made by the Company for the years ended June 30, 2001, 2002 and 2003, respectively.
(12) Commitments and Contingencies
        During 1998, the Company entered into a lease agreement for its facility. During November, 2000 and May, 2001, the Company entered into amendments of the lease for its facility. Under the amendments, the Company increased the total leased space and extended the lease term for its original leased space. Future minimum commitments under the facility leases are as follows:

2004	 	$	641,808	
2005	 	 	641,808	
2006	 	 	641,808	
2007	 	 	641,808	
2008	 	 	374,388	
 	 		
 	 	$	2,941,620	
 	 		
F-27

        Rent expense under these operating leases during the years ended June 30, 2001, 2002, and 2003 was $309,442, $468,309, and $652,339, respectively.
        Under the terms of the employment agreement with the Company's chief executive officer, the Company is obligated to pay severance under certain circumstances. If the employment agreement is terminated by the Company or by the Company's chief executive officer for reasons other than for cause, the Company must pay (i) an amount equal to the base salary for a period of one year following the date of termination, plus (ii) bonus equal to last annual bonus received by chief executive officer multiplied by a fraction, the numerator of which shall be the number of days in the calendar year elapsed as of the termination date and the denominator of which shall be 365.
        The Company has entered into various clinical trial agreements which, as of June 30, 2003, upon accomplishment of certain milestones, will require payments by the Company aggregating up to $5.1 million. Approximately $2.5 million of these milestone payments have been made or accrued in the consolidated financial statements.
        The Company is not a party to any material legal proceedings. It is the Company's policy to accrue for amounts related to legal matters if it is probable that a liability has been incurred and the amount is reasonably estimable.
(13) Subsequent events
(a)
Employment agreement
On September 24, 2003, the Company entered into an employment agreement with the Company's chief financial officer, which was effective September 1, 2003. Under the terms of the agreement the Company is obligated to pay severance under certain circumstances. If the employment agreement is terminated by the Company or by the Company's chief financial officer for reasons other than for cause, the Company must pay (i) an amount equal to the base salary for a period of six months following the date of termination, plus (ii) bonus equal to last annual bonus received by chief financial officer multiplied by a fraction, the numerator of which shall be the number of days in the calendar year elapsed as of the termination date and the denominator of which shall be 365.
(b)
Stock Option Grants
In September 2003, the Company granted 1,374,997 stock options, that had been authorized for issuance under the Plan in May 2003, to employees under the Plan at exercise prices of $5.88 per share, which is below the estimated fair value of the Company's common stock at the date of grant. Compensation expense of approximately $8.3 million will be recognized immediately in the first quarter of fiscal 2004, as a certain number of options issued to employees vested immediately and the balance of $5.2 million will be recognized over the remaining respective vesting periods of the options.
F-28

(c)
Stock options Re-pricing
In September 2003, the Company re-priced 150,251 stock options issued to employees, which had an exercise price per option of more than $5.88, with a new exercise price per share of $5.88. As a result of this re-pricing, the Company will recognize an additional compensation charge estimated at approximately $520,000, of which $449,000 will be recognized during the first quarter of fiscal 2004, with the balance to be recognized over the remaining respective vesting periods of the repriced options.
(d)
R&D and Product Collaborations, Alliances and License Agreements
Elan
In January 1997, the Company licensed from Elan exclusive worldwide rights to Elan's sustained release formulation of fampridine, Fampridine-SR, for the treatment of SCI. In April 1998, the Company formed MS Research & Development Corporation, or MSRD, with Elan and one of its affiliates to develop Fampridine-SR for treatment of MS. At that time, MSR&D licensed from Elan exclusive worldwide rights to Fampridine-SR for the treatment of MS.
Termination and Assignment Agreement. In September 2003, the Company entered into a termination and assignment agreement with Elan, Elan's affiliate, and MSRD pursuant to which MSRD (83% owned by Acorda immediately prior to entering into the agreement) assigned to the Company its assets, including the license from Elan for Fampridine-SR for treatment of MS. The Company paid MSRD approximately $11.5 million for all the assets and liabilities of MSRD. MSRD will distribute the purchase price to its shareholders according to their equity ownership interest. The Company will receive a distribution of approximately $9.5 million as a result of this distribution and the remaining distribution of $2 million will be expensed in the first quarter of fiscal 2004 as acquired in-process research and development. The Company also purchased Elan's affiliate shares at par value and now owns approximately 88% of MSRD, which now has no assets or liabilities and is inactive.
Amended and Restated License. In September 2003, the Company entered into an amended and restated license with Elan, which replaced the two prior licenses for Fampridine-SR. Under this agreement, Elan granted the Company exclusive worldwide rights to Fampridine-SR, as well as Elan's formulation for any other mono- or di-aminopyridines, for all indications, including SCI and MS. The Company agreed to pay Elan milestone payments and royalties based on net sales of the product.
Elan may terminate the Company's license in the United States, the major European markets or Japan if the Company does not file to obtain regulatory approval or launch the product after regulatory approval in the applicable country within specified periods. If Elan terminates the Company's license in any applicable country, Elan is entitled to license from the Company patents rights and know-how relating to the product and to market the product in the applicable country, subject to royalty payments.
F-29

Elan is responsible for completing the chemistry, manufacturing and controls section of the NDA and equivalent regulatory applications outside the United States. Elan is also responsible for supplying the product for clinical trials under this agreement.
Subject to early termination provisions, the Elan license terminates on a country by country basis on the latter to occur of fifteen years from the date of the agreement, the expiration of the last to expire Elan patent or the existence of competition in that country.
Supply agreement. In September 2003, the Company entered into a supply agreement with Elan relating to the manufacture and supply of Fampridine-SR by Elan. The Company agreed to purchase at least 75% of its annual requirements of product from Elan, unless Elan is unable or unwilling to meet its requirements, for a purchase price based on a specified percentage of net sales. In those circumstances, where the Company elects to purchase less than 100% of its requirements from Elan, the Company agreed to make certain compensatory payments to Elan. Elan agreed to assist the Company in qualifying a second manufacturer to manufacture and supply the Company with Fampridine-SR subject to its obligations to Elan.
Securities Amendment Agreement. In September 2003, the Company entered into a securities amendment agreement with Elan to modify certain provisions in some existing agreements between Elan and the Company. These included:
•   The modification of certain transfer restrictions
•   The automatic conversion of the $5 million limited recourse notes into the underlying common shares, if the board of directors of the Company determines that regulatory approval of Fampridine-SR is unlikely to be obtained, subject to Elan's consent.
•   Repayment of the $2.5 million full recourse note will start no later than September 30, 2008, either on a seven year schedule or a 15 year schedule depending on whether the Company deems the market opportunity to be economically significant, unless the Company extends the date because regulatory approval is considered likely in a timely manner, or unless the note had been already converted into common stock.
Teva Pharmaceuticals Industries Ltd.
In September 2003, the Company entered into a collaboration agreement with Teva Pharmaceuticals Industries Ltd. (Teva) under which the Company was granted a co-exclusive license with Teva to jointly develop and promote in the United States products containing valrocemide as an active ingredient in any formulation and dosage form for any indication, except MS. However, in the event that Teva seeks to develop and promote products containing valrocemide for MS it must provide the Company with notice and negotiate an amendment to the agreement. The agreement provides that Teva will own all right, title and interest in and to all intellectual property jointly developed by the parties while Teva has the sole right and obligation to defend against any infringement claims.
The agreement further provides that Teva is responsible for seeking and maintaining regulatory approval from the FDA upon the completion of any co-developed product and that Teva will consult in preparing the filings to obtain regulatory approval. Teva is also solely responsible for the
F-30

commercializing, manufacture and supply of the product, and has the sole responsibility to commercialize the products in the territory.
The Company made an initial payment to Teva upon execution of the collaboration agreement, and is obligated to make payments to Teva upon achieving certain milestones. The Company is also responsible for the payment of costs as well as conducting the next clinical trial of a product for the treatment of therapy. The Company must make the best reasonable efforts to complete the next clinical trial by the first quarter of 2006; if further clinical trials are required after the completion of the next clinical trial, then the costs of such trials will be shared. Such costs will be shared equally with Teva during any calendar quarter based on the net sales of any co-developed product. However, in the event the costs incurred by both parties under the agreement exceed net sales, the Company is obligated to pay Teva a fee equal to 50% of the amount by which the aggregate costs have exceeded net sales. Under the agreement, the Company is entitled to receive a fee on a country by country basis, based on sales by Teva of co-developed products outside the United States, if clinical data used to obtain regulatory approval of sale of the product in such country was jointly developed, or independently by the Company, under this Agreement.
Unless earlier terminated under provisions of the Teva agreement, the agreement will expire on the earlier to occur of (i) September 2009, if parties have not achieved a statistically significant primary endpoint that is accepted by the FDA for the first pivotal trial in connection with any product, (ii) six months after the first generic version of any product is launched in the United States, or (iii) September 2012, if the parties have not commenced the promotion and/or commercialization of any product under the Teva agreement.
In addition, we have granted Teva a right of first negotiation for the co-development and co-promotion of Fampridine-SR in North America.
Rush-Presbyterian St. Luke's Medical Center
In 1990, Elan licensed from Rush know-how relating to fampridine for the treatment of MS. The Company subsequently licensed this know-how from Elan. In September 2003, the Company entered into an agreement with Rush and Elan which terminated the Rush license agreement with Elan. The Company also entered into a license agreement with Rush in which Rush granted the Company an exclusive worldwide license to their know-how relating to fampridine for the treatment of MS. Rush has also assigned to the Company their Orphan Drug Designation for fampridine for the relief of symptoms of MS.
The Company agreed to pay Rush a license fee, milestone payments and royalties based on net sales of the product for neurological indications. The Company also entered into an agreement with Elan relating to the allocation of payments between the Company and Elan of certain payments to Rush under the Rush license.
Subject to early termination provisions, the Rush license terminates upon expiration of the royalty obligations, which expire fifteen years from the date of the agreement.
F-31

In September 2003, the Company also entered into an agreement with Rush and Elan, pursuant to which the Company agreed that the payment of license fees, milestones and royalties to Rush under the license agreement with Rush, will be allocated between Elan and the Company.
Upon entering into the above mentioned R&D and Product Collaborations, Alliances and License agreements, the Company expended approximately $2.1 million. Upon accomplishment of certain milestones, the Company will be required to make payments aggregating up to approximately $30 million.
(e)
Sales and Marketing agreement
In September 2003, the Company entered into two marketing service agreements with inChord Communication, Inc. and Cardinal Health PTC, Inc. for contract sales and marketing services associated with the commercialization of Fampridine-SR in the United States. RxPedite is a program developed by inChord Communications, Inc. and Cardinal Health PTC, Inc. pursuant to which they provide pharmaceutical drug manufacturers and biotech companies with comprehensive outsourced marketing communications, selling and distribution/manufacturing capabilities. The Company will receive the RxPedite services at a discounted market rate in exchange for full repayment of such discounts, if the product achieves 100% of its revenue targets (based on gross sales) through the twelve month period following launch, plus a risk premium in the event that the product exceeds such target revenues. The repayment terms range between no repayment if the product fails to achieve more than 50% of its revenue target in any quarter and full repayment of all discounts plus 200% of such amounts if the product achieves over 130% of its revenue target. The discount from the market rate is to be determined periodically according to a target product profile, which is in the range of 10-28%. The discounts and premiums will be repaid on a quarterly basis beginning six months after product launch and ending eighteen months post launch, with a final reconciliation after the first twelve months of product sales in the event of over/under payment.
A joint commercialization committee, composed of the Company and RxPedite representatives, will coordinate the overall marketing and sales strategies for the product and associated workplans and budgets; however, the Company retains ultimate approval authority over all relevant decisions. The Company is responsible for all regulatory affairs including: filings and approvals, compliance of promotional materials, adverse event reporting, product recalls, and communication with regulatory authorities. Acorda owns all work product developed pursuant to the marketing service agreements unless otherwise agreed in a specific work plan.
The marketing service agreements designate RxPedite as the "agency of record" with respect to the services provided and contain buy-out provisions in the event that the Company enters into a co-promote agreement with a third party and can no longer allocate a substantial amount of the services to RxPedite. The buy-out provision may also be implicated in the event that the Company merges with, or sells the product to, a company that creates a conflict of interest with one of Rxpedite's other clients. In addition to being the "agency of record" with respect to Fampridine-SR, RxPedite is also designated as the "agency of record" for all product related compounds and granted a sixty day right of first negotiation for other molecules developed, licensed or otherwise controlled by the Company.
F-32

Subject to early termination provisions, the agreements expire on the later of five years from the effective date of the agreements or twenty-four months following the program launch in the case of the sales services, or eighteen months following product launch for spinal chord indication in the case of the marketing services.
(f)
Automatic Conversion Terms
In September 2003, the Company obtained approval by the written consent from the holders of Series J preferred stock voting together as a single class and the holders of the Preferred Stock (as defined in note 7), voting separately as a single class on an as if converted basis for a reduction in the price per share of common stock offered to the public in an initial public offering which would trigger automatic conversion of the preferred stock into common stock from an offering price of not less than $14.76 per share to an offering price of not less than $12.00 per share.
(g)
Stock Option Plan
On September 25, 2003, the Company amended the Plan, which will become effective upon consummation of the Company's initial public offering contemplated herein, providing for automatic annual increases to the share reserve under the Plan on the first day of each fiscal year by a number of shares equal to the lessor of: (a) the number that will bring the total reserve to 2.5% of then outstanding shares of common stock; (b) 647,151 shares; (c) or a number determined by the board of directors.
(h)
Initial Public Offering
On September 25, 2003, the Board of Directors authorized the filing of a registration statement with the SEC for the sale of shares of common stock. If the offering is consummated under the terms presently anticipated, all shares of Series A, B, C, E, F, H, I and J preferred stock outstanding as of the Consummation of the Offering will automatically convert into shares of common stock. No dividends will be payable on any of the Series A, B, C, E, F, H, I and J preferred stock.
(i)
Stock-Split

        On September 25, 2003, the Company stockholders approved a one-for-twelve reverse stock split to be effective immediately prior to the effectiveness of the registration statement filed in connection with the initial public offering contemplated herein. The reverse stock split has been retroactively reflected in the accompanying consolidated financial statements.
(j)
Director Compensation
        Upon consummation of an initial public offering, each of the Company non-employee directors will receive non-qualified stock options to purchase 20,000 shares at the initial public offering price per share, which options will vest in 12 equal quarterly installments commencing 180 days after the date of grant.
        Upon consummation of an initial public offering, each of the Company directors will receive an annual option grant to purchase 10,000 shares on the date of the Company annual stockholder meeting. In addition, the Company's directors will receive an annual grant of 5,000 options exercisable to purchase shares for each
F-33

committee on which they serve. Directors will also be reimbursed for expenses incurred in attending meetings.
(k)
Preferred stock
        In accordance with the Company amended and restated certificate of incorporation which we plan to file upon consummation of an initial public offering, the Company board of directors has the authority, without further action by the stockholders, to issue up to 1,000,000 shares of preferred stock. The Company board of directors may issue preferred stock in one or more series and may determine the rights, preferences, privileges, qualifications and restrictions granted to or imposed upon the preferred stock, including dividend rights, conversion rights, voting rights, rights and terms of redemption, liquidation preferences and sinking fund terms, any or all of which may be greater than the rights of the common stock. The issuance of preferred stock could adversely affect the voting power of holders of common stock and reduce the likelihood that common stockholders will receive dividend payments and payments upon liquidation. The issuance of preferred stock could also have the effect of decreasing the market price of the common stock and could delay, deter or prevent a change in control of the company. We have no present plans to issue any shares of preferred stock.
F-34

                    Shares

Common Stock

Prospectus
            , 2003

Banc of America Securities LLC
 Lazard
U.S. Bancorp Piper Jaffray
RBC Capital Markets
        Until                        , 200    , all dealers that buy, sell or trade the common stock may be required to deliver a prospectus, regardless of whether they are participating in this offering. This is in addition to the dealers' obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.

 PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13.    Other expenses of issuance and distribution
        The following table sets forth all expenses payable by Acorda Therapeutics, Inc. (the "Registrant") in connection with the sale of the common stock being registered, other than underwriting commissions and discounts. All amounts are estimates, except for the SEC registration fee, the NASD filing fee and the Nasdaq National Market listing application fee.

 	 	Amount to Be Paid
	
SEC registration fee	 	$	 	
NASD filing fee	 	 	 	
Nasdaq National Market listing application fee	 	 	*	
Blue sky qualification fees and expenses	 	 	20,000	
Printing and engraving expenses	 	 	*	
Legal fees and expenses	 	 	*	
Accounting fees and expenses	 	 	*	
Transfer agent and registrar fees	 	 	*	
Miscellaneous	 	 	*	
 	 		
 	Total	 	$	*	

*
To be completed by amendment.
Item 14.    Indemnification of officers and directors
        Under Section 145 of the Delaware General Corporation Law, the Registrant has broad powers to indemnify its directors and officers against liabilities they may incur in such capacities, including liabilities under the Securities Act of 1933, as amended (the "Securities Act").
        The Registrant's Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws include provisions to (i) eliminate the personal liability of its directors and officers for monetary damages resulting from breaches of their fiduciary duty to the extent permitted by Section 102(b)(7) of the General Corporation Law of Delaware (the "Delaware Law") and (ii) require the Registrant to indemnify its directors and officers to the fullest extent permitted by Section 145 of the Delaware Law, including circumstances in which indemnification is otherwise discretionary. Pursuant to Section 145 of the Delaware Law, a corporation generally has the power to indemnify its present and former directors, officers, employees and agents against expenses incurred by them in connection with any suit to which they are or are threatened to be made, a party by reason of their serving in such positions so long as they acted in good faith and in a manner they reasonably believed to be in or not opposed to, the best interests of the corporation and with respect to any criminal action, they had no reasonable cause to believe their conduct was unlawful. The Registrant believes that these provisions are necessary to attract and retain qualified persons as directors and officers. These provisions do not eliminate the directors' duty of care, and, in appropriate circumstances, equitable remedies such as injunctive or other forms of non-monetary relief will remain available under Delaware Law. In addition, each director will continue to be subject to liability for breach of the director's duty of loyalty to the Registrant, for acts or omissions not in good faith or involving intentional misconduct, for knowing violations of law, for acts or omissions that the director believes to be contrary to the best interests of the Registrant or its stockholders, for any transaction from which the director derived an improper personal benefit, for acts or omissions involving a reckless disregard for the director's duty to the Registrant or its stockholders when the director was aware or should have been aware of a risk of serious injury to the Registrant or its stockholders, for acts or omissions that constitute an unexcused pattern of inattention that amounts to an abdication of the director's duty to the Registrant or its stockholders, for improper transactions between the director and the Registrant and for improper distributions to stockholders and loans to directors and officers. The provision
II-1

also does not affect a director's responsibilities under any other law, such as the federal securities law or state or federal environmental laws.
        The Registrant has entered into indemnification agreements with certain directors and executive officers and intends to enter into indemnification agreements with all of its other directors and executive officers prior to the consummation of the offering. Under these agreements, the Registrant will indemnify its directors and executive officers against amounts actually and reasonably incurred in connection with actual or threatened proceedings if any of them may be made a party because of their role as a director or officer. The Registrant is obligated to pay these amounts only if the officer or director acted in good faith and in a manner that he or she reasonably believed to be in or not opposed to the Registrant's best interests. For any criminal proceedings, the Registrant is obligated to pay these amounts only if the officer or director had no reasonable cause to believe his or her conduct was unlawful. The indemnification agreements also set forth procedures that will apply in the event of a claim for indemnification thereunder.
        At present, there is no pending litigation or proceeding involving a director or officer of the Registrant as to which indemnification is being sought nor is the Registrant aware of any threatened litigation that may result in claims for indemnification by any officer or director.
        The Registrant intends to apply for an insurance policy covering the officers and directors of the Registrant with respect to certain liabilities, including liabilities arising under the Securities Act or otherwise.
        Reference is made to the indemnification and contribution provisions of the Underwriting Agreement filed as an exhibit to this Registration Statement.
Item 15.    Recent sales of unregistered securities
        The following sets forth information regarding sales of the Registrant's unregistered securities during the last three years (giving effect to a one-for-12 reverse stock split to be effected prior to the completion of the offering):
        In March 2001, we consummated a private placement of 10,204,047 shares of our Series I Convertible Preferred Stock to a group of accredited investors at a purchase price of $3.89 per share for aggregate consideration of $39,693,743.
        In May 2003, we consummated a private placement of 112,790,296 shares of our Series J Convertible Preferred Stock to a group of accredited investors at a purchase price of $0.49 per share for aggregate consideration of $55,000,000.
        All of the above-described issuances were exempt from registration pursuant to Section 4(2) of the Securities Act, or Regulation D or Rule 144A promulgated thereunder, as transactions not involving a public offering. With respect to each transaction listed above, no general solicitation was made by either us or any person acting on our behalf; the securities sold are subject to transfer restrictions; and the certificates for the shares contained an appropriate legend stating such securities have not been registered under the Securities Act and may not be offered or sold absent registration or pursuant to an exemption therefrom. No underwriters were involved in connection with the sales of securities referred to in this Item 15.
Item 16.    Exhibits and financial statement schedule
(a)    Exhibits.

1.1*	 	Form of Underwriting Agreement	
3.1	 	Form of Amended and Restated Certificate of Incorporation	
3.2	 	Form of Amended and Restated Bylaws	
3.3	 	Form of Amended and Restated Certificate of Incorporation to be filed after consummation of the Offering	
 	 	 	
II-2

4.1*	 	Specimen Stock Certificate	
5.1*	 	Opinion of Loeb & Loeb LLP	
10.1	 	Acorda Therapeutics 1999 Employee Stock Option Plan	
10.2	 	Proposed Amendment to 1999 Employee Stock Option Plan	
10.3	 	Intentionally left blank	
10.4	 	Fifth Amended and Restated Registration Rights Agreement, dated May 8, 2003, by and among the Registrant and certain stockholders named therein	
10.5	 	Employment Agreement, dated August 11, 2002, by and between the Registrant and Ron Cohen	
10.6	 	Employment Agreement, dated September 24, 2003, by and between the Registrant and Mark Pinney	
10.7	 	Termination and Assignment Agreement, dated September 26, 2003, by and among the Registrant, Elan Corporation plc, Elan International Services Ltd. and MS Research and Development Corporation	
10.8**	 	Amended and Restated License Agreement, dated September 26, 2003, by and between the Registrant and Elan Corporation plc	
10.9**	 	Supply Agreement, dated September 26, 2003, by and between the Registrant and Elan Corporation plc	
10.10**	 	License Agreement, dated September 26, 2003, by and between the Registrant and Rush-Presbyterian-St. Luke's Medical Center	
10.11*	 	Side Agreement, dated September 26, 2003, by and among the Registrant, Rush-Presbyterian-St. Luke's Medical Center, and Elan Corporation plc	
10.12**	 	Payment Agreement, dated September 26, 2003, by and among the Registrant, Rush-Presbyterian-St. Luke's Medical Center, and Elan Corporation plc	
10.13**	 	Amended and Restated License Agreement, dated August 1, 2003, by and between the Registrant and Canadian Spinal Research Organization	
10.14**	 	License Agreement, dated February 3, 2003, by and between the Registrant and Cornell Research Foundation, Inc.	
10.15**	 	License Agreement, dated November 12, 2002, by and between the Registrant and CeNeS Pharmaceuticals, plc	
10.16**	 	License Agreement, dated November 12, 2002, by and between the Registrant and CeNeS Pharmaceuticals, plc	
10.17**	 	Acorda Marketing Services Agreement, dated September 19, 2003, by and between the Registrant and Creative Healthcare Solutions, LLC	
10.18**	 	Acorda Marketing Services Agreement, dated September 19, 2003, by and between the Registrant and Cardinal Health PTS, Inc.	
10.19**	 	Workplan for Detailing Services, dated September 19, 2003, by and between the Registrant and Cardinal Health PTS, Inc.	
10.20**	 	License Agreement, dated September 8, 2000, by and between the Registrant and the Mayo Clinic	
10.21**	 	Research Collaboration and Commercialization Agreement, dated February 27, 2002, by and between the Registrant and AERES Biomedical Limited	
10.22**	 	Collaboration Agreement, dated September 23, 2003, by and between the Registrant and Teva Pharmaceuticals Industries, Ltd., and Letter Agreement, dated September 23, 2003, by and between the Registrant and Teva Pharmaceutical Industries, Ltd.	
10.23	 	Limited Recourse Convertible Promissory Note issued to Elan International Services, Ltd.	
10.24	 	Full Recourse Convertible Promissory Note issued to Elan International Services, Ltd.	

II-3

10.25	 	Securities Amendment Agreement, dated September 26, 2003, by and among the Registrant, Elan Pharmaceutical Investments, Ltd., Elan Pharma International Limited, and Elan International Services, Ltd.	
10.26**	 	Technical Transfer Program Proposal for Commercial Registration, dated February 29, 2003, by and between the Registrant and Patheon, Inc.	
10.27**	 	Agreement, dated April 4, 2003, by and between the Registrant and Lonza Biologics, plc	
21.1	 	List of Subsidiaries of the Registrant.	
23.1	 	Consent of KPMG LLP, Independent Auditors.	
23.2*	 	Consent of Loeb & Loeb LLP. Reference is made to Exhibit 5.1.	
24.1	 	Power of Attorney. Reference is made to page II-5.	

*
To be filed by amendment.

**
Confidential treatment has been requested for portions of this Exhibit, which portions are omitted and filed separately with the Securities and Exchange Commission.
(b)    Financial statement schedules.
        All schedules are omitted because they are not required, are not applicable or the information is included in our financial statements or notes thereto.
Item 17. Undertakings
        The Registrant hereby undertakes to provide to the underwriters at the closing specified in the Underwriting Agreement certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.
        Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
        The undersigned Registrant hereby undertakes that:
        (1) For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this Registration Statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this Registration Statement as of the time it was declared effective.
        (2) For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
II-4

 SIGNATURES
        Pursuant to the requirements of the Securities Act, the Registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of New York, State of New York, on September 26, 2003.

 	 	By:	 	/s/   RON COHEN       

Ron Cohen, Chairman of the Board,
President and Chief Executive Officer	
POWER OF ATTORNEY
        KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Ron Cohen and Mark Pinney, and each of them (with full power of each to act alone), severally, as his or her true and lawful attorneys-in-fact and agent, with full power of substitution and resubstitution, for him or her and in his or her name, place, and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments, exhibits thereto and other documents in connection therewith) to this Registration Statement and any subsequent registration statement filed by the registrant pursuant to Rule 462(b) of the Securities Act of 1933, as amended, which relates to this Registration Statement, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agent, or any of them, or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
        Pursuant to the requirements of the Securities Act of 1933, as amended, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated:

Signature

Title

Date

 	

 	

/s/   RON COHEN       

Ron Cohen, M.D.	
 	
President, Chief Executive Officer and Director
(Principal Executive Officer)	
 	
September 26, 2003	

/s/   JOHN FRIEDMAN       

John Friedman	
 	
Director	
 	
September 26, 2003	

/s/   SANDRA PANEM       

Sandra Panem, Ph.D.	
 	
Director	
 	
September 26, 2003	

/s/   MICHAEL STEINMETZ       

Michael Steinmetz, Ph.D.	
 	
Director	
 	
September 26, 2003	

/s/   WISE YOUNG       

Wise Young, Ph.D., M.D.	
 	
Director	
 	
September 26, 2003	

/s/   MARK R.E. PINNEY       

Mark R.E. Pinney, M.B.A., C.F.A, M.Sc.	
 	
Chief Financial Officer and Director
(Principal Financial Officer)	
 	
September 26, 2003	
II-5

 Exhibit Index

Exhibit No.
	 	Description
	
1.1*	 	Form of Underwriting Agreement	
3.1	 	Form of Amended and Restated Certificate of Incorporation	
3.2	 	Form of Amended and Restated Bylaws	
4.1*	 	Specimen Stock Certificate	
10.7	 	Termination and Assignment Agreement, dated September 26, 2003, by and among the Registrant, Elan Corporation plc, Elan International Services Ltd. and MS Research and Development Corporation	
10.8**	 	Amended and Restated License Agreement, dated September 26, 2003, by and between the Registrant and Elan Corporation plc	
10.9**	 	Supply Agreement, dated September 26, 2003, by and between the Registrant and Elan Corporation plc	
10.10**	 	License Agreement, dated September 26, 2003, by and between the Registrant and Rush-Presbyterian-St. Luke's Medical Center	
10.11*	 	Side Agreement, dated September 26, 2003, by and among the Registrant, Rush-Presbyterian-St. Luke's Medical Center, and Elan Corporation plc	
10.12**	 	Payment Agreement, dated September 26, 2003, by and among the Registrant, Rush-Presbyterian-St. Luke's Medical Center, and Elan Corporation plc	
10.13**	 	Amended and Restated License Agreement, dated August 1, 2003, by and between the Registrant and Canadian Spinal Research Organization	
10.14**	 	License Agreement, dated February 3, 2003, by and between the Registrant and Cornell Research Foundation, Inc.	
10.15**	 	License Agreement, dated November 12, 2002, by and between the Registrant and CeNeS Pharmaceuticals, plc	
10.16**	 	License Agreement, dated November 12, 2002, by and between the Registrant and CeNeS Pharmaceuticals, plc	
10.17**	 	Acorda Marketing Services Agreement, dated September 19, 2003, by and between the Registrant and Creative Healthcare Solutions, LLC	
10.18**	 	Acorda Marketing Services Agreement, dated September 19, 2003, by and between the Registrant and Cardinal Health PTS, Inc.	
10.19**	 	Workplan for Detailing Services, dated September 19, 2003, by and between the Registrant and Cardinal Health PTS, Inc.	
10.20**	 	License Agreement, dated September 8, 2000, by and between the Registrant and the Mayo Clinic	
10.21**	 	Research Collaboration and Commercialization Agreement, dated February 27, 2002, by and between the Registrant and AERES Biomedical Limited	
10.22**	 	Collaboration Agreement, dated September 23, 2003, by and between the Registrant and Teva Pharmaceuticals Industries, Ltd., and Letter Agreement, dated September 23, 2003, by and between the Registrant and Teva Pharmaceutical Industries, Ltd.	
10.23	 	Limited Recourse Convertible Promissory Note issued to Elan International Services, Ltd.	
10.24	 	Full Recourse Convertible Promissory Note issued to Elan International Services, Ltd.	
10.25	 	Securities Amendment Agreement, dated September 26, 2003, by and among the Registrant, Elan Pharmaceutical Investments, Ltd., Elan Pharma International Limited, and Elan International Services, Ltd.	
10.26**	 	Technical Transfer Program Proposal for Commercial Registration, dated February 29, 2003, by and between the Registrant and Patheon, Inc.	

10.27**	 	Agreement, dated April 4, 2003, by and between the Registrant and Lonza Biologics, plc	
21.1	 	List of Subsidiaries of the Registrant.	
23.1	 	Consent of KPMG LLP, Independent Auditors.	
23.2*	 	Consent of Loeb & Loeb LLP. Reference is made to Exhibit 5.1.	
24.1	 	Power of Attorney. Reference is made to page II-5.	

*
To be filed by amendment.

**
Confidential treatment has been requested for portions of this Exhibit, which portions are omitted and filed separately with the Securities and Exchange Commission.

QuickLinks
 Overview
Our Product Candidates
Our Focus
Corporate Information
 Figure 1: SCI-F201 Phase 2 Ashworth Scores Post-Treatment with Placebo or Fampridine-SR Treatment vs. Baseline
 Summary Compensation Table
 ACORDA THERAPEUTICS, INC. AND SUBSIDIARY (A Development Stage Enterprise) Notes to Consolidated Financial Statements
 Exhibit Index
 
Exhibit 3.1
 
CERTIFICATE OF AMENDMENT TO
AMENDED AND RESTATED
 CERTIFICATE OF INCORPORATION OF
ACORDA THERAPEUTICS, INC.
 
Acorda Therapeutics, Inc., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “Corporation”) does hereby certify as follows:
 
1.  The name of the Corporation is Acorda Therapeutics, Inc.  The date of filing of its original Certificate of Incorporation with the Secretary of the State of Delaware was March 17, 1995.
 
2.  Amendments to ARTICLE 4 of the Corporation’s Amended and Restated Certificate of Incorporation, set forth below, were duly adopted in accordance with the provisions of Section 242 of the Delaware General Corporation Law.
 
3.  Section 4.1 of the Corporation’s Certificate of Incorporation is amended to read in its entirety as follows:
 
“4.1  Authorized Capital .  The aggregate number of shares of all classes of stock which the Corporation shall have authority to issue is 400,221,535, such shares being designated as follows: (i) 260,000,000 shares of Common Stock, par value $0.001 per share (the “Common Stock”), and (ii) 140,221,535 shares of Preferred Stock, par value $0.001 per share (the “Preferred Stock”).  Effective as of           , 2003 (the “Effective Date”), every 12 shares of the Corporation’s issued and outstanding Common Stock shall be combined into 1 share of fully paid and nonassessable Common Stock of the Corporation.  No fractional shares of Common Stock of the Corporation shall be issued in connection with the reverse split.  In lieu of any fractional shares to which the holder would otherwise be entitled, the Corporation shall pay cash equal to such fraction multiplied by the fair market value of the Common Stock on such Effective Date as reasonably determined in good faith by the Board of Directors.”
 
4. Section 4.2.4 (b) of the Corporation’s Certificate of Incorporation is amended in part to read as follows:
 
“4.2.4 (b) Automatic Conversion .  All outstanding shares of Preferred Stock shall automatically be converted into shares of Common Stock at the then effective Conversion Rates provided therefor in Section 4.2.4(a) hereof upon the occurrence, contemporaneous or otherwise, of the first of the following:
 
(i)  The consummation of the Corporation’s sale of Common Stock pursuant to a registration statement filed with the Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), in connection with a firm commitment underwritten public offering in the United States by a United States underwriter (a “Public Offering”); provided that (1) the price to the public is to be no less than $1.00 per share (such price to be equitably adjusted in the event of any stock dividend, stock split, combination

 
recapitalization or other similar event) and (2) the aggregate gross proceeds thereof are not less than U.S. $40,000,000.”
 
2

 
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION OF
ACORDA THERAPEUTICS, INC.
 
ARTICLE 1
 
1.1.                               Name . The name of the corporation is Acorda Therapeutics, Inc. (the “Corporation”).
 
ARTICLE 2
 
2.1.                               Registered Agent and Office . The address of the Corporation’s registered office in the State of Delaware is 1209 Orange Street in the City of Wilmington, County of New Castle, Delaware 19808. The name of its registered agent at such address is The Corporation Trust Company.
 
ARTICLE 3
 
3.1.                               Purposes . The purposes for which the Corporation is formed are to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of Delaware (the “DGCL”).
 
ARTICLE 4
 
4.1.                               Authorized Capital . The aggregate number of shares of all classes of stock which the Corporation shall have authority to issue is 400,221,535, such shares being designated as follows: (i) 260,000,000 shares of Common Stock, par value 50.001 per share (the “Common Stock”), and (ii) 140,221,535 shares of Preferred Stock, par value $0.001 per share (the “Preferred Stock”).
 
4.2.                               Preferred Stock .
 
4.2.1.                      Designation of Preferred Stock .
 
(a)                                   The Preferred Stock is divided into ten series as follows: 1,646,068 shares of Preferred Stock are denominated as Series A Preferred Stock (the “Series A Preferred Stock”); 2,250,000 shares of Preferred Stock are denominated as Series B Preferred Stock (the “Series B Preferred Stock”); 333,333 shares of Preferred Stock are denominated as Series C Preferred Stock (the “Series C Preferred Stock”); 400,000 shares of Preferred Stock are denominated as Series D Preferred Stock (the “Series D Preferred Stock”); 1,844,289 shares are denominated as Series E-1 Preferred Stock (the “Series E-1 Preferred Stock”); 5,628,323 shares are denominated as Series E-2 Preferred Stock (the “Series E-2 Preferred Stock”) (collectively, Series E-1 Preferred Stock and Series E-2 Preferred Stock are referred to as the “Series E Preferred Stock”); 2,300,000 shares are denominated as Series F Preferred Stock (the ‘Series F Preferred Stock”); 1,250,000 shares are denominated as Series G Preferred Stock (the “Series G
 
3

 
Preferred Stock”); 1,575,229 shares are denominated as Series H Preferred Stock (the “Series H Preferred Stock”); 10,204,047 shares are denominated as Series I Preferred Stock (the “Series I Preferred Stock”); and 112,790,246 shares are denominated as Series J Preferred Stock (the “Series j Preferred Stock”). The Series A Preferred Stock, Series B Preferred Stock, Series C Preferred stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock and any other series of Preferred Stock hereafter created after the Effective Date (as hereafter defined) which has rights, preferences or privileges junior to those of the Series J Preferred Stock with respect to dividends, distributions, liquidation preference or redemption are sometimes referred to collectively herein as the “Junior Preferred Stock”.
 
(b)                                  Authorized and unissued shares of Series G Preferred Stock may be issued only upon the exercise of the conversion right provided for in Section 3 of the Corporation’s “Full Recourse Convertible Promissory Note” (the “Convertible Note”) dated January 22, 1997 in the principal amount of $2,500,000 made payable to Elan International Services, Ltd., a Bermuda corporation (“EIS”).
 
4.2.2.                      Dividends and Distributions .
 
(a)                                   Holders of shares of Series J Preferred Stock shall be entitled to receive a preferential cumulative dividend, out of any assets legally available therefor, at a rate of $.0392 per share per annum (as adjusted for any stock dividends, combinations or splits with respect to such shares) when, as and if declared by the Board of Directors of the Corporation (the “Board of Directors”), prior and in preference to any declaration or payment of any dividend on any Junior Preferred Stock or the Common Stock. Such dividends shall be deemed to accrue on each share of the Series J Preferred Stock commencing on its issuance date, whether or not earned or declared and whether or not there are profits, surplus or other funds of the Corporation legally available for the payment of dividends but shall be payable only when such dividends are declared by the Board of Directors or upon a Liquidation or redemption as provided herein. Dividends shall be cumulative but not compound. If such dividends in respect of any prior or current dividend period shall not have been declared and paid or if there shall not have been a sum sufficient for the payment thereof set apart for later payment, the deficiency shall first be fully paid before any dividend or other distribution shall be paid or declared and set apart with respect to any class of the Corporation’s capital stock, now or hereafter outstanding.
 
(b)                                  After payment of the dividends required by Section 4.2.2(a), any additional dividends declared shall be distributed among all holders of Common Stock and Preferred Stock in proportion to the number of shares of Common Stock held by each such holder (or with respect to a holder of Preferred Stock the number of shares of Common Stock into which the holder’s Preferred Stock is convertible). No dividends shall be declared or paid on the Common Stock unless and until the holders of Preferred Stock shall have received all declared or accrued but unpaid dividends to which they are entitled under this Section 4.2.2.
 
(c)                                   Notwithstanding anything to the contrary contained herein, in the event the Corporation shall make or issue, or shall fix a record date for the determination of holders of Common Stock entitled to receive, a dividend or other distribution with respect to Common Stock payable in (i) securities of the Corporation other than shares of Common Stock
 
4

 
or (ii) assets, then, and in each such event, the holders of Series J Preferred Stock shall receive prior to and in preference of any such dividend or distribution on the Common Stock securities and assets in amounts equivalent to the cash that would have been required to be distributed pursuant to Section 4.2.2(a), and then the holders of Preferred Stock (including Series J Preferred Stock) shall receive, at the same time distribution is made to the holders of Common Stock, the number of securities or other assets which they would have received had their Preferred Stock been converted into Common Stock, immediately prior to the record date for determining holders of Common Stock entitled to receive such distribution.
 
(d)                                  The Corporation shall not declare or pay any dividends on, or purchase, redeem, retire or otherwise acquire for value, any shares of its capital stock junior to the Preferred Stock (or rights, options or warrants to purchase such shares) now or hereafter outstanding, return any capital or make any distributions of assets to the holders of any capital stock junior to the Preferred Stock, or permit any Subsidiary to do any of the foregoing. “Subsidiary” or “Subsidiaries” means any corporation, partnership, or joint venture or other entity of which the Corporation and/or any of its other Subsidiaries (as herein defined) directly or indirectly owns at the time at least fifty percent (50%) of the outstanding voting shares or similar interests. Notwithstanding the foregoing, Subsidiaries may declare and make payment of cash and stock dividends, return capital and make distributions of assets to the Corporation, and nothing contained in the foregoing shall prevent the Corporation from: (i) effecting a stock split or declaring or paying any dividend consisting of shares of any class of capital stock paid to the holders of shares of such class of capital stock subject to the provisions of this Certificate; (ii) complying with any specific provision of the terms of the Preferred Stock in accordance with its terms; (in) declaring and paying all accrued dividends on the Preferred Stock, or (iv) redeeming or repurchasing any stock of a deceased stockholder out of proceeds of insurance held by the Corporation on that stockholder’s life or redeeming or repurchasing any stock of any director, officer, employee, advisor, consultant or other person or entity, pursuant to a stock repurchase agreement or stock restriction agreement under which the Corporation has the right or obligation to repurchase such shares in the event of death, termination of employment or of the consulting arrangement, or other similar discontinuation of a business relationship.
 
4.2.3.                      Liquidation .
 
(a)                                   The holders of Preferred Stock shall have preferential rights to the assets of the Corporation upon the occurrence of a “Liquidation”. For purposes of this Section 4.2.3, a “Liquidation” means a liquidation, dissolution, or winding up of the Corporation, whether voluntary or involuntary, and shall also be deemed to be occasioned by, and to include (but not be limited to) (i) the Corporation’s sale, license or other disposition of all or substantially all of its assets, (ii) or the merger, share exchange, consolidation or other reorganization or combination of the Corporation with or into another entity (A) resulting in the exchange of the outstanding shares of the Corporation for securities or consideration issued, or caused to be issued, by the other entity or its subsidiary or (B) whereby the Corporation is the surviving entity, but the Corporation’s stockholders immediately prior to the consummation of such merger or consolidation own less than fifty-one percent (51%) of the voting power of the Corporation or the acquiring entity immediately following the consummation of such merger, share exchange, consolidation or reorganization or combination. An event set forth in clauses (A) and (B) of the preceding sentence shall not be treated as a Liquidation if both the holders of a majority of the
 
5

 
Series J Preferred Stock then outstanding voting as a separate class and the holders of a majority of the Junior Preferred Stock voting separately as a class voting on an as if converted to Common Stock basis each elect not to treat the event as a Liquidation.
 
(b)                                  Upon a Liquidation, before any distribution or payment is made to any holders of Junior Preferred Stock or Common Stock, the holders of each share of Series I Preferred Stock shall be entitled to be paid out of the assets of the Corporation available for distribution to holders of the Corporation’s capital stock of all classes, whether such assets are capital, surplus or earnings (“Available Assets”), an amount equal to the greater of:
 
(i)                                      the sum of (A) an amount per share of Series J Preferred Stock equal to the Original Issue Price of the Series J Preferred Stock (subject to equitable adjustment for any stock dividend, stock split, combination, reorganization, recapitalization, reclassification or other similar event involving a change in the capital structure of the Preferred Stock) plus (B) all accrued or declared but unpaid dividends on such share of Series J Preferred Stock, up to and including the date upon which full payment shall be tendered to the holders of Series J Preferred Stock with respect to such Liquidation; provided, however, that the amount payable pursuant to clause (B) shall not exceed the Original Issue Price of the Series J Preferred Stock (subject to equitable adjustment for any stock dividend, stock split, combination, reorganization, reclassification or other similar event involving a change in the capital structure of the Series J Preferred Stock) less the aggregate amount of the dividends paid in cash on such share of Series J Preferred Stock prior to such liquidation event; or
 
(ii)                                   such amount per share of Series J Preferred Stock as would have been payable had each share of Preferred Stock which is convertible into Common Stock (pursuant to Section 4.2.4) been so converted immediately prior to such Liquidation plus all accrued and unpaid dividends on such share up to and including the date on which payment shall be made to the holder of such share with respect to such Liquidation.
 
(iii)                                If upon a Liquidation the Available Assets shall be insufficient to pay the holders of Series J Preferred Stock the fall aforesaid liquidation amounts to which they are entitled, then Available Assets shall be distributed to such holders pro rata in accordance with the number of shares of Series J Preferred Stock held by each such holder.
 
(c)                                   Upon a Liquidation, after payment shall have been made to the holders of Series J Preferred Stock of the full amounts to which they shall be entitled under this Section 4.2.3(b) and prior and in preference to any distribution or payment to any holders of Common Stock but subject to the liquidation rights and preferences of any class or series of Preferred Stock designated in the future to be senior to the Junior Preferred Stock with respect to liquidation preference, the holders of Series I Preferred Stock, Series E Preferred Stock, Series F Preferred Stock and Series H Preferred Stock shall be entitled to receive out of the Available Assets, on a pro rata basis, an amount for each share of Series I Preferred Stock, Series E Preferred Stock, Series F Preferred Stock and Series H Preferred Stock, respectively, held by such holder equal to the sum of (A) (i) $3.89 for each such outstanding share of Series I Preferred Stock, (ii) $1.3069 for each such outstanding share of Series E-l Preferred Stock, (iii) $1.0707 for each such outstanding share of Series E-2 Preferred Stock, (iv) $1.0907 for each such outstanding share of Series F Preferred Stock and (v) $1.3591 for each such outstanding
 
6

 
share of Series H Preferred Stock (in each case as adjusted for any stock dividends, combinations or splits with respect to such shares) and (B) in each case, an amount equal to all declared but unpaid dividends on each such share issued. If upon a Liquidation the remaining Available Assets are insufficient to pay the holders of Series I Preferred Stock, Series E Preferred Stock, Series F Preferred Stock and Series H Preferred Stock the full aforesaid preferential amounts set forth in this Section 4.2.3(c), then the remaining Available Assets shall be distributed ratably among the holders of the Series I Preferred Stock, Series E Preferred Stock, Series F Preferred Stock and Series H Preferred Stock in proportion to the product of the above liquidation preference of each such share set forth in this Section 4.2.3(c) and the number of such shares owned by each such holder.
 
(d)                                  Upon a Liquidation, after payment shall have been made to the holders of Series J Preferred Stock of the full amounts to which they shall be entitled under Section 4.2.3(b) and after payment shall have been made to the holders of the Series E Preferred Stock, Series F Preferred Stock, Series H Preferred Stock and Series I Preferred Stock of the full amounts to which they shall be entitled under Section 4.2.3(c), and prior and in preference to any distribution or payment to any holders of Common Stock but subject to the liquidation rights and preferences of any class or series of Preferred Stock designated in the future to be senior to the Junior Preferred Stock with respect to liquidation preference, the holders of each outstanding share of Series E-1 Preferred Stock, Series E-2 Preferred Stock, Series F Preferred Stock and Series H Preferred Stock shall be entitled to be paid out of remaining Available Assets an amount per share equal to $0.2556, $0.2093, $0.21355 and $0.2659, respectively, (in each case as adjusted for any stock dividends, combinations or splits with respect to such shares) plus an amount equal to all declared but unpaid dividends thereon, as applicable. If upon a Liquidation the remaining Available Assets are insufficient to pay the holders Series E Preferred Stock, Series F Preferred Stock and Series H Preferred Stock to the full aforesaid preferential amounts set forth in this Section 4.2.3(d), then the remaining Available Assets shall be distributed ratably among the holders of the Series E Preferred Stock, Series F Preferred Stock and Series H Preferred Stock in proportion to the product of the above liquidation preference of each such share set forth in this Section 4.2.3(d) and the number of such shares owned by each such holder.
 
(e)                                   Upon a Liquidation, after payment shall have been made to the holders of Series J Preferred Stock of the full amounts to which they shall be entitled under Section 4.2.3(b), after payment shall have been made to the holders of the Series E Preferred Stock, Series F Preferred Stock, Series H Preferred Stock and Series I Preferred Stock of the full amounts to which they shall be entitled under Section 4.2.3(c) and after payment shall have been made to the holders of Series E-1 Preferred Stock, Series E-2 Preferred Stock, Series F Preferred Stock and Series H Preferred Stock of the full amounts to which they are entitled under Section 4.2.3(d), and prior and in preference to any distribution or payment to any holders of Common Stock but subject to the liquidation rights and preferences of any class or series of Preferred Stock designated to be senior to the Junior Preferred Stock with respect to liquidation preference, the holders of each outstanding share of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E-1 Preferred Stock, Series E-2 Preferred Stock, Series F Preferred Stock, Series G Preferred Stock and Series H Preferred Stock shall be entitled to be paid out of remaining Available Assets an amount per share up to and including such amounts paid in accordance with the provisions of subsections (c) and (d) above, equal to $1.00, $2.00, $3.00, $12.50, $3.125, $2.56, $5.217, the greater of $2.00 and 80% of the
 
7

 
closing price per share of the Institutional Financing (as defined below) most recently completed by the Company prior to the issuance of the Series G Preferred Stock (the “Series G Issuance Price”) and $3.25, respectively (in each case as adjusted for any stock dividends, combinations or splits with respect to such shares) (with respect to each class of Preferred Stock, an “Original Price”), plus an amount equal to all declared but unpaid dividends thereon, as applicable. If upon a Liquidation the remaining Available Assets are insufficient to pay the holders of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E-1 Preferred Stock, Series E-2 Preferred Stock, Series F Preferred Stock, Series G Preferred Stock and Series H Preferred Stock the full aforesaid preferential amounts set forth in this Section 4.2.3(e), then the remaining Available Assets shall be distributed ratably, in the proportion to the product of the above liquidation preference of each share and the number of such shares owned by each such holder, in the following order of priority: (i) first, pro rata among (1) the holders of the outstanding shares of Series H Preferred Stock in an amount per share equal to fifty (50%) percent of the Original Price for such outstanding shares, plus declared but unpaid dividends, (2) the holders of the outstanding shares of Series F Preferred Stock in an amount per share equal to twenty five (25%) percent of the Original Price for such shares, plus declared but unpaid dividends, and (3) the holders of the outstanding shares of Series E-1 Preferred Stock and Series E-2 Preferred Stock in an amount per share equal to fifty (50%) of the Original Prices for such outstanding shares, plus declared but unpaid dividends; and (ii) second, pro rata among (1) the holders of the outstanding shares of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock and Series G Preferred Stock, in the same relative proportion as the Original Prices of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock and Series G Preferred Stock, plus declared but unpaid dividends, and (2) the holders of the Series F Preferred Stock in an amount per share equal to fifty percent (50%) of the Original Price for such shares, plus declared but unpaid dividends.
 
(f)                                     Upon conversion of shares of Preferred Stock into Common Stock pursuant to Section 4.2.4, the holders of such Common Stock shall not be entitled to any preferential payment or distribution in case of a Liquidation, but shall share ratably in any distribution of the assets of the Corporation to all holders of Common Stock.
 
(g)                                  In any Liquidation, if the consideration received by the Corporation is other than cash, its value will be deemed its fair market value, as determined in good faith by the Board of Directors of the Corporation or, if the Board so decides, by a committee of independent directors (in either case, the Board or the committee may retain an independent investment banking firm to advise with respect to fair market value); however, if the non-cash consideration is securities, the fair market value shall be determined as follows:
 
(i)                                      if the securities are traded on a securities exchange or through the Nasdaq Stock Market, Inc. (“Nasdaq”), the average of the closing prices of the securities on such exchange or Nasdaq during the thirty-day period ending three (3) days prior to the closing;
 
(ii)                                   if the securities are actively traded over-the-counter but not on Nasdaq, the value shall be deemed to be the average of the closing bid prices over the thirty-day period ending three (3) days prior to closing; and
 
8

 
(iii)                                if there is no active public market for the securities, the fair market value thereof; as mutually determined by the Corporation and the holders of a majority of the Preferred Stock voting as a single class on an as if converted to Common Stock basis.
 
4.2.4.                      Conversion . The holders of the Preferred Stock shall have conversion rights as follows (the “Conversion Rights”):
 
(a)                                   Right to Convert . Each holder of record of shares of Preferred Stock may, without the payment of any additional consideration, at any time, upon surrender to the Corporation of the certificates therefor at the principal office of the Corporation or at such other place as the Corporation shall designate, convert all or any part of such holder’s shares of Preferred Stock into such number of fully paid and non-assessable shares of Common Stock of the Corporation (as such Common Stock shall then be constituted) equal to (i) in the case of the Series A Preferred Stock, the product of (x) the number of shares of Series A Preferred Stock that such holder shall then surrender to the Corporation and (y) the number determined by dividing $1.00 (the “Series A Original Issue Price”) by the Series A Conversion Price (as hereinafter defined) in effect at the time of conversion; (ii) in the case of the Series B Preferred Stock, the product of (x) the number of shares of Series B Preferred Stock that such holder shall then surrender to the Corporation and (y) the number determined by dividing $2.00 (the “Series B Original Issue Price”) by the Series B Conversion Price (as hereinafter defined) in effect at the time of conversion; (iii) in the case of the Series C Preferred Stock, the product of (x) the number of shares of Series C Preferred Stock that such holder shall then surrender to the Corporation and (y) the number determined by dividing $3.00 (the “Series C Original Issue Price”) by the Series C Conversion Price (as hereinafter defined) in effect at the time of conversion; (iv) in the case of the Series D Preferred Stock, the product of (x) the number of shares of Series D Preferred Stock that such holder shall then surrender to the Corporation and (y) the number determined by dividing $2.00 (the “Series D Original Issue Price”) by the Series D Conversion Price (as hereinafter defined) in effect at the time of the conversion; (v) in the case of the Series E- 1 Preferred Stock, the product of (x) the number of shares of Series E-I Preferred Stock that such holder shall then surrender to the Corporation and (y) the number determined by dividing $2.70 (the “Series E-1 Original Issues Price”) by the Series E-1 Conversion Price (as hereinafter defined) in effect at the time of the conversion; (vi) in the case of Series E-2 Preferred Stock, the product of (x) the number of shares of Series E-2 Preferred Stock that such holder shall then surrender to the Corporation and (y) the number determined by dividing $2.70 (the “Series E-2 Original Issue Price”) by the Series E-2 Conversion Price (as hereinafter defined) in effect at the time of the conversion; (vii) in the case of the Series F Preferred Stock, the product of (x) the number of shares of Series F Preferred Stock that such holder shall then surrender to the Corporation and (y) the number determined by dividing $2.70 (the “Series F Original Issue Price”) by the Series F Conversion Price (as hereinafter defined) in effect at the time of the conversion; (viii) in the case of Series G Preferred Stock, the product of (x) the number of shares of Series G Preferred Stock that such holder shall then surrender to the Corporation and (y) the number determined by dividing (1) the greater of $2.00 or 80% of the closing price per share of the most recently completed bona fide equity financing of the Corporation with any institutional or venture capital or similar financing source most recently completed by the Corporation prior to the issuance of the Series G Preferred Stock (the “Series G Original Issuance Price”) by (II) the Series G Conversion Price (as hereinafter defined) in effect
 
9

 
at the time of conversion; (ix) in the case of Series H Preferred Stock, the product of (x) the number of shares of Series H Preferred Stock that such holder shall then surrender to the Corporation and (y) the number determined by dividing $3.25 (the “Series H Original Issue Price”) by the Series H Conversion Price (as hereinafter defined) in effect at the time of the conversion; (x) in the case of the Series I Preferred Stock, the product of (x) the number of shares of Series I Preferred Stock that such holder shall then surrender to the Corporation and (y) the number determined by dividing $3.89 (the “Series I Original Issue Price”) by the Series I Conversion Price (as hereinafter defined) in effect the time of the conversion; and (xi) in the case of the Series J Preferred Stock, the product of (x) the number of shares of Series J Preferred Stock that such bolder shall then surrender to the Corporation and (y) the number determined by dividing $.49 (the “Series J Original Issue Price”) by the Series J Conversion Price (as hereinafter defined) in effect from time to time. The resulting conversion rate applicable from time to time to a particular series shall be referred to hereinafter as the “Conversion Rate.”
 
As of the Effective Date, the Series A Conversion Price shall be $.581 per share, the Series B Conversion Price shall be $.760 per share, the Series C Conversion Price shall be $.938 per share, the Series D Conversion Price shall be $.760 per share, the Series E-1 Conversion Price and the Series E-2 Conversion Price shall each be $.885 per share, the Series F Conversion Price shall be $.885 per share, the Series G Conversion Price shall be the number equal to the Series G Original Issuance Price, the Series H Conversion Price shall be $.983 per share, the Series I Conversion Price shall be $1.097 per share and the Series J Conversion Price shall be $.49 per share.
 
(b)                                  Automatic Conversion . All outstanding shares of Preferred Stock shall automatically be converted into shares of Common Stock at the then effective Conversion Rates provided therefor in Section 4.2.4(a) hereof upon the occurrence of the first of the following:
 
(i)                                      The consummation of the Corporation’s sale of Common Stock pursuant to a registration statement filed with the Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), in connection with a firm commitment underwritten public offering in the United States by a United States underwriter (a “Public Offering”); provided that (1) the price to the public is not less than U.S. $1.23 per share (such price to be equitably adjusted in the event of any stock dividend, stock split, combination recapitalization or other similar event) and (2) the aggregate gross proceeds thereof are not less than U.S. $40,000,000; or
 
(ii)                                   Upon the approval of such conversion by the written consent of the holders of a majority of the then outstanding shares of Series J Preferred Stock voting together as a single class and the holders of a majority of the then outstanding shares of Preferred Stock, voting separately as a single class on an as if converted to Common Stock basis.
 
(c)                                   Mechanics of Conversion . No fractional shares of Common Stock shall be issued upon conversion of the Preferred Stock. In lieu of any fractional shares to which the holder would otherwise be entitled, the Corporation shall pay cash equal to such fraction multiplied by the fair market value of the Common Stock on such conversion date as
 
10

 
reasonably determined in good faith by the Board of Directors. Before any holder of Preferred Stock shall be entitled to convert the same pursuant to Section 4.2.4(a) into full shares of Common Stock, the holder shall surrender the certificate or certificates therefor, duly endorsed, at the office of the Corporation or of any transfer agent for the Preferred Stock, and shall give written notice to the Corporation at such office that the holder elects to convert the same; provided, however, that in the event of an automatic conversion pursuant to Section 4.2.4(b) above, the outstanding shares of Preferred Stock will be converted automatically without any further action by the holders of such shares and whether or not the certificates representing such shares are surrendered to the Corporation or its transfer agent, provided, further, however, that the Corporation shall not be obligated to issue certificates evidencing the shares of Common Stock issuable upon such automatic conversion unless either the certificates evidencing such shares of Preferred Stock are delivered to the Corporation or its transfer agent as provided above, or the holder notifies the Corporation or its transfer agent that such certificates have been lost, stolen, or destroyed and executes an agreement, reasonably satisfactory to the Corporation to indemnify the Corporation from any loss incurred by it in connection with such certificates. The Corporation shall, as soon as practicable after such delivery, or after such agreement and indemnification, issue and deliver to such holder of Preferred Stock, a certificate or certificates for the number of shares of Common Stock to which the holder shall be entitled as aforesaid and a check payable to the holder in the amount of any cash amounts payable as the result of a conversion into fractional shares of Common Stock, plus any declared and unpaid dividends on the converted Preferred Stock; however, no holder of Preferred Stock shall be entitled to any payment by reason of any accrued but undeclared dividends on such Preferred Stock. Such conversion shall be deemed to have been made immediately prior to the close of business on the date of such surrender of the shares of Preferred Stock to be converted in accordance with Section 4.2.4(a) or on the effective date of the approval of the conversion by the holders of the then outstanding shares of Series T Preferred Stock and Preferred Stock (in accordance with Section 4.2.4(b)(ii), above), or upon the date of consummation of a Public Offering satisfying the criteria for automatic conversion (in accordance with Section 4.2.4(b)(i)) and the person or persons entitled to receive the shares of Common Stock issuable upon such conversion shall be treated for all purposes as the record holder or holders of such shares of Common Stock on such date; provided, however, that if the conversion is in connection with a Public Offering, the conversion shall be conditioned upon the closing of the sale of securities pursuant to such offering, in which event the person(s) entitled to receive the Common Stock issuable upon such conversion of the Preferred Stock shall not be deemed to have converted such Preferred Stock until immediately prior to the closing of the sale of such securities.
 
(d)                                  Adjustments to Conversion Price for Diluting Issues .
 
(i)                                      (A) If the Corporation shall after the Effective Date issue any Additional Stock (as hereinafter defined) without consideration or for a consideration per share less than the Series J Conversion Price in effect immediately prior to the issuance of such Additional Stock, the Conversion Price of each series of Preferred Stock in effect immediately prior to each such issuance shall forthwith (except as otherwise provided in
 
(1)                                   The aggregate maximum number of shares of Common Stock deliverable upon exercise of such options to purchase or rights to subscribe for Common Stock shall be deemed to have been issued at the time such options or rights were
 
11

 
issued and for a consideration equal to the consideration (determined in the manner provided in subsections (d)(i)(C) and (d)(i)(D) of this Section 4.2.4), if any, received by the Corporation upon the issuance of such options or rights plus the minimum purchase price provided in such options or rights for the Common Stock covered thereby;
 
(2)                                   The aggregate maximum number of shares of Common Stock deliverable upon conversion of or in exchange for, any such convertible or exchangeable securities or upon the exercise of options to purchase or rights to subscribe for such convertible or exchangeable securities and subsequent conversion or exchange thereof shall be deemed to have been issued at the time such securities were issued or such options or rights were issued and for a consideration equal to the consideration, if any, received by the Corporation for any such securities and related options or rights (excluding any cash received on account of accrued interest or accrued dividends), plus the additional consideration, if any, to be received by the Corporation upon the conversion or exchange of such securities or the exercise of any related options or rights (the consideration in each case to be determined in the manner provided in subsections (d)(i)(C) and (d)(i)(D) of this Section 4.2.4);
 
(3)                                   In the event of any change in the number of shares of Common Stock deliverable upon exercise of such options or rights or upon conversion of or in exchange for such convertible or exchangeable securities, including, but not limited to, a change resulting from the antidilution provisions thereof, the Conversion Price of each series of Preferred Stock in effect at the time shall forthwith be readjusted to such Conversion Price as would have been obtained had the adjustment that was made upon the issuance of such options, rights, or securities not converted prior to such change or the options or rights related to such securities not converted prior to such change been made upon the basis of such change (but not in excess of the Conversion Price immediately before the original adjustment for such options or rights), but no further adjustment shall be made for the actual issuance of Common Stock upon the exercise of any such options or rights or the conversion or exchange of such securities; and
 
(4)                                   Upon the expiration of any such options or rights, the termination of any such rights to convert or exchange, or the expiration of any options or rights related to such convertible or exchangeable securities, the Conversion Price of each series of Preferred Stock shall forthwith be readjusted to such Conversion Price as would have been obtained had the adjustment that was made upon the issuance of such options, rights, or securities or options or rights related to such securities been made upon the basis of the issuance of only the number of shares of Common Stock actually issued upon the exercise of such options or rights, upon the conversion or exchange of such securities or upon the exercise of the options or rights related to such securities.
 
(A)                               In addition to any other adjustments provided for hereunder, the Series I Conversion Price shall be adjusted upon the issuance by the Corporation, after the Effective Date, of any shares of, or warrants or other securities convertible into or exchangeable for, shares of Series B Preferred Stock (not including up to 100,000 shares of Series B Preferred Stock issued upon exercise of warrants issued and outstanding as of the Effective Date) or Series G Preferred Stock (but not upon the conversion of any such shares) (such shares, warrants and other securities, each a “Series I Special Dilutive Issuance”) such that the Series I Conversion Price shall equal the amount obtained by the following calculations: (1)
 
12

 
divide $78,011,386 by the sum of (y) 20,054,341 and (z) the number of shares of Common Stock which would have been issuable upon full exercise and/or conversion of all securities (including shares of Preferred Stock into which such securities are convertible or exercisable) included within such Series I Special Dilutive Issuance, as if such issuance and full exercise and/or conversion had occurred immediately prior to the Effective Date; (2) multiply the result in item (I) by a fraction the numerator of which is the Series I Conversion Price in effect at the time of the Series I Special Dilutive Issuance and the denominator of which is $3.89; (3) subtract the result in item (2) from the Series I Conversion Price in effect at the time of the Series I Special Dilutive Issuance; (4) multiply the result in item (3) by seventy-five percent; and (5) subtract the result in item (4) from the Series I Conversion Price in effect at the time of the Series I Special Dilutive Issuance. The above formula shall be adjusted equitably to account for stock splits, stock dividends, reclassifications, subdivisions, combinations or other such events. This adjustment shall be recalculated upon each Series I Special Dilutive Issuance. Notwithstanding anything herein to the contrary, if an adjustment is made under this Section 4.2.4(d)(i)(F) upon the issuance by the Corporation of any warrant or other security convertible into or exchangeable for Preferred Stock of the Corporation, there shall be no subsequent adjustment under this Section 4.2.4(d)(i)(F) upon the exercise, conversion or exchange of such instrument. No adjustment made pursuant to this Section 4.2.4(d)(i)(F) shall adjust the Conversion Price of any series of Preferred Stock other than Series I Preferred Stock and as provided in Section 4.2.4(d)(i)(G) for the Series I Preferred Stock.
 
(B)                                 In addition to any other adjustments provided for hereunder, the Series J Conversion Price shall be adjusted upon the issuance by the Corporation, after the Effective Date, of any shares of, or warrants or other securities convertible into or exchangeable for, shares of Series B Preferred Stock (not including up to 100,000 shares of Series B Preferred Stock issued upon exercise of warrants issued and outstanding as of the Effective Date), Series D Preferred Stock or Series G Preferred Stock (but not upon the conversion of any such shares) (such shares, warrants and other securities, a “Series J Special Dilutive Issuance”) such that the Series J Conversion Price shall equal the amount obtained by the following calculations: (1) divide $41,105,131 by the sum of (x) 83,888,023, (y) the number of shares of Common Stock which would have been issuable upon full exercise and/or conversion of all securities (including shares of Preferred Stock into which such securities are convertible or exercisable) included within such Series J Special Dilutive Issuance, as if such issuance and full exercise and/or conversion had occurred immediately following the Effective Date; (z) the difference, if any, between the number of shares of Common Stock issuable upon conversion of Series I Preferred Stock immediately following each adjustment made pursuant to Section 4.2.4(d)(i)(F) (if such Series J Special Dilutive Issuance also constitutes a Series I Special Dilutive Issuance) and the number of shares of Common Stock issuable upon conversion of Series I Preferred Stock immediately prior to any such adjustment; (2) multiply the result in item (1) by a fraction the numerator of which is the Series J Conversion Price in effect at the time of the Series J Special Dilutive Issuance and the denominator of which is $.49. The above formula shall be adjusted equitably to account for stock splits, stock dividends, reclassifications, subdivisions, combinations or other such events. This adjustment shall be recalculated upon each Series J Special Dilutive Issuance and upon each adjustment to the Series I Conversion Price required by Section 4.2.4(d)(i)(F). Notwithstanding anything herein to the contrary, if an adjustment is made under this Section 4.2.4(d)(i)(G) upon the issuance by the Corporation of any warrant or other security convertible into or exchangeable for Preferred Stock of the Corporation,
 
13

 
there shall be no subsequent adjustment under this Section 4.2.4(d)(i)(G) upon the exercise, conversion or exchange of such instrument. No adjustment made pursuant to this Section 4.2.4(d)(i)(G) shall adjust the Conversion Price of any series of Preferred Stock other than Series J Preferred Stock.
 
(ii)                                   “Additional Stock” shall mean any shares of Common Stock issued (or deemed to have been issued pursuant to subsection (d)(i)(E) of this Section 4.2.4) by the Corporation after the date of effectiveness of this Amended and Restated Certificate of Incorporation (the “Effective Date”) other than:
 
(A)                               Common Stock issued pursuant to a transaction described in subparagraph (d)(iii) of this Section 4.2.4;
 
(B)                                 Common Stock (or options or warrants therefor) issued or issuable to officers, employees, or directors of, or consultants to, the Corporation pursuant to an equity incentive plan or other arrangement approved by the Board of Directors; provided, however, that the number of shares of Common Stock so issued or issuable shall not exceed 20,522,563 shares;
 
(C)                                 Common Stock issued or issuable upon conversion of any shares of any series of Preferred Stock;
 
(D)                                Up to 340,000 shares of Series A Preferred Stock, up to 100,000 shares of Series B Preferred Stock and up to 40,000 shares of Common Stock issuable upon exercise of warrants outstanding as of the Effective Date;
 
(E)                                  Up to 1,250,000 shares of Series B Preferred Stock and up to 400,000 shares of Series D Preferred Stock issuable upon conversion of any convertible promissory notes outstanding as of the Effective Date;
 
(F)                                  Series G Preferred Stock issuable upon conversion of the Convertible Note;
 
(G)                                 Shares of Common Stock or Preferred Stock issued after the Effective Date, or that becomes issuable pursuant to the exercise of warrants therefor granted after the Effective Date, in connection with any equipment lease, vendor or customer relationship or similar non-equity financing transaction approved by the Board of Directors in accordance with reasonable and customary business practices; provided, however, for purposes of making adjustments to the Conversion Prices of Series E- 1 Preferred Stock, Series E-2 Preferred Stock, Series I Preferred Stock and Series J Preferred Stock, the aggregate number of shares of Common Stock so issued or that are issuable upon the exercise of any such warrants or the conversion of any such Preferred Stock or the exercise of any such warrants to purchase Preferred Stock and the conversion of such Preferred Stock in all such financing transactions shall not exceed at the time of such issuance, and after giving effect thereto and the exercise of any such warrants, one percent (1%) of the “Fully Diluted Common Stock”;
 
(H)                                Series I Preferred Stock; or
 
14

 
(I)                                     Shares of Common Stock issued as consideration in bona fide, arm’s length transactions approved by the Board of Directors involving acquisitions of other persons or assets, strategic licensing transactions and the like.
 
For purposes hereof the term “Fully Diluted Common Stock” means at any time the sum of (x) all shares of Common Stock outstanding at such time, whether or not vested, (y) all shares of Common Stock issuable upon the exercise of any option or warrant therefor, without regard to vesting, and (z) all shares of Common Stock issuable upon the exercise of any conversion or exchange right or right to purchase contained in any obligation or security (other than Common Stock) convertible into or exchangeable for shares of Common Stock, including, without limitation, upon the conversion of shares of any series of Preferred Stock.
 
(iii)                                Adjustments for Subdivisions or Combinations of Common Stock . In the event the outstanding shares of Common Stock shall be subdivided (by stock split or otherwise than a payment of a dividend in Common Stock), into a greater number of shares of Common Stock, the Conversion Price of each series of Preferred Stock in effect immediately prior to such subdivision shall, concurrently with the effectiveness of such subdivision, be proportionately decreased. In the event the outstanding shares of Common Stock shall be combined (by reclassification or otherwise) into a lesser number of shares of Common Stock, the Conversion Price of each series of Preferred Stock in effect immediately prior to such combination shall, concurrently with the effectiveness of such combination, be proportionately increased.
 
(iv)                               Adjustments for Stock Dividends . In the event that the Corporation shall at any time or from time to time after the Effective Date declare or pay, without consideration, any dividend on the Common Stock payable in Common Stock or in any right to acquire Common Stock for no consideration, then such event shall be considered to be a subdivision and the Conversion Price for each series of Preferred Stock in effect immediately prior to such event shall, concurrently with the effectiveness of such event, be proportionately decreased, as appropriate. In the event that the Corporation shall declare or pay, without consideration, any dividend on the Common Stock payable in any right to acquire Common Stock for no consideration then the Corporation shall be deemed to have made a dividend payable in Common Stock in an amount equal to the maximum number of shares issuable upon exercise of such rights to acquire Common Stock.
 
(v)                                  Adjustments for Other Distributions . In the event the Corporation at any time or from time to time makes or fixes a record date for the determination of holders of Common Stock entitled to receive any distribution payable in securities of the Corporation other than shares of Common Stock or property, other than cash and other than as otherwise adjusted in this Section 4.2.4, then and in each such event the holders of each series of Preferred Stock shall receive, concurrent with such distribution, the amount of securities of the Corporation that they would have received had their Preferred Stock been converted into Common Stock on the date of such event.
 
(vi)                               Adjustments for Reclassification Exchange and Substitution . If the Common Stock issuable upon conversion of the Preferred Stock shall be
 
15

 
changed into the same or a different number of shares of any other class or classes of capital stock, whether by capital reorganization, reclassification, or otherwise (other than a subdivision or combination of shares provided for above), the Conversion Price of each series of Preferred Stock then in effect shall, concurrently with the effectiveness of such reorganization or reclassification, be proportionately adjusted such that such Preferred Stock shall be convertible into, in lieu of the number of shares of Common Stock that the holders would otherwise have been entitled to receive, a number of shares of such other class or classes of capital stock equivalent to the number of shares of Common Stock that would have been subject to receipt by the holders upon conversion of any series of Preferred Stock, as the case may be, immediately before such change.
 
(e)                                   No Impairment . The Corporation will not, by amendment of its Certificate of Incorporation or through any reorganization, transfer of assets, merger, dissolution, issue, or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms to be observed or performed hereunder by the Corporation but will at all times in good faith assist in the carrying out of all the provisions of this Section 4.2.4 and in the taking of all such action as may be necessary or appropriate in order to protect the Conversion Rights of the holders of the Preferred Stock against impairment.
 
(f)                                     Certificate as to Adjustments . Upon the occurrence of each adjustment or readjustment of any Conversion Price pursuant to this Section 4.2.4, the Corporation at its expense shall promptly compute such adjustment or readjustment in accordance with the terms thereof and furnish to each holder of each series of Preferred Stock a certificate setting forth such adjustment or readjustment and showing in detail the facts upon which such adjustment or readjustment is based. The Corporation shall, upon the written request at any time of any holder of any series of Preferred Stock, furnish or cause to be furnished to such holder a like certificate setting forth (i) such adjustments and readjustments; (ii) the respective Conversion Price at the time in effect; and (iii) the number of shares of Common Stock and the amount, if any, of other property that at the time would be received upon the conversion of the respective series of Preferred Stock.
 
(g)                                  Notices of Record Date . In the event that this Corporation shall propose at any time:
 
(i)                                      to declare any dividend or distribution upon its Common Stock, whether in cash, property, capital stock, or other securities, whether or not a regular cash dividend and whether or not out of earnings or earned surplus;
 
(ii)                                   to offer for subscription pro rata to the holders of any class or series of its capital stock any additional shares of capital stock of any class or series or other rights;
 
(iii)                                to effect any reclassification or recapitalization of its Common Stock outstanding involving a change in the Common Stock; or
 
16

 
(iv)                               to merge with or into any other corporation, or sell, lease, or convey all or substantially all its property or business, or to liquidate, dissolve, or wind up;
 
then, in connection with each such event, the Corporation shall send to the holders of the Preferred Stock at least twenty (20) days prior written notice of the date on which a record shall be taken for such dividend, distribution, or subscription rights (and specifying the date on which the holders of Common Stock shall be entitled thereto) or for determining rights to vote in respect of the matters referred to in (iii) and (iv) above. Each such written notice shall be given by overnight courier, postage prepaid, addressed to the holders of the Preferred Stock at the address for each such holder as shown on the books of the Corporation.
 
(h)                                  Reservation of Stock Issuable upon Conversion . The Corporation shall at all times reserve and keep available, out of its authorized but unissued shares of Common Stock solely for the purpose of effecting the conversion of the shares of the Preferred Stock, such number of its shares of Common Stock as shall from time to time be sufficient to effect the conversion of all then outstanding shares of the Preferred Stock; and if at any time the number of authorized but unissued shares of Common Stock shall not be sufficient to effect the conversion of all then outstanding shares of each series of Preferred Stock, as applicable, the Corporation will take such corporate action as may, in the opinion of its counsel, be necessary to increase its authorized but unissued shares of Common Stock to such number of shares as shall be sufficient for such purpose.
 
4.2.5.                      Series E. I and J Redemption .
 
(a)                                   Holders’ Election . Holders of the issued and outstanding Series E Preferred Stock, Series I Preferred Stock and Series J Preferred Stock (the “Redeemable Preferred Stock”) may at any time on or after June 30, 2008 require the Corporation to redeem all or any portion of such Holders’ Redeemable Preferred Stock at the redemption price specified in Section 4.2.5(b); provided, however, that no holder of Redeemable Preferred Stock may so require such redemption unless and until (i) the holders of not less than a majority of Redeemable Preferred Stock then issued and outstanding make such election and (ii) the holders of a majority of the Series J Preferred Stock then issued and outstanding make such election (together, the “Majority Election”) prior to September 30, 2008. The foregoing election shall be made by such holders of Redeemable Preferred Stock by delivering to the Corporation written notice of election to redeem, setting forth the number of shares of Redeemable Preferred to be redeemed. The date for such redemption (the “Redemption Date”) shall be thirty (30) days after the Majority Election occurs, but not before June 30, 2008. At least fifteen (15) but no more than thirty (30) days prior to the Redemption Date, the Corporation shall provide written notice to each holder of record (at the close of business on the day preceding the next day on which notice is given) of Redeemable Preferred Stock, at the address last shown on the records of the Corporation for such holder, notifying such holder of the redemption to be effected, specifying the number of shares redeemable by such holder, the Redemption Date, the redemption price for each share of Redeemable Preferred Stock, the place at which payment may be obtained and calling upon such holder to surrender to the Corporation, in the manner and at the place designated, his certificate or certificates representing the shares to be redeemed should such
 
17

 
holder elect to redeem all or some of his Redeemable Preferred Stock (the “Redemption Notice”).
 
(b)                                  Redemption Price . The redemption price for each share of Redeemable Preferred Stock redeemed pursuant to this Section 4.2.5 shall be the Original Issue Price therefor as set forth in Section 4.2.4 hereof, plus accrued but unpaid dividends thereon up to and including the date upon which payment shall be made to the holder of the Redeemable Preferred Stock with respect to such redemption. One half of such aggregate redemption price for all Redeemable Preferred Stock shall be payable in cash in immediately available funds on the Redemption Date and the second half of such aggregate redemption price for all Redeemable Preferred Stock shall be payable in immediately available funds, without interest, on the first anniversary of the Redemption Date; however, all Series J Preferred Stock that have elected to be redeemed shall be redeemed by the Corporation by payment of the full redemption price thereon prior to the Corporation making any redemption payment on any other Redeemable Preferred Stock. Until the full redemption price has been paid in cash for all shares of Redeemable Preferred Stock being redeemed, (A) no dividend whatsoever shall be paid or declared, and no distribution shall be made, on any share of the Corporation’s capital stock, (B) no shares of capital stock of the Corporation (other than Redeemable Preferred Stock in accordance with this Section 4.2.5) shall be purchased, redeemed or acquired by the Corporation and no monies shall be paid into or set aside or made available for a sinking or other analogous fund for the purchase, redemption or acquisition thereof, provided that the Corporation may, to the extent that it may lawfully do so, redeem at their original cost shares of its outstanding equity securities held by departing employees of the Corporation pursuant to the terms of any stock option or purchase plan or arrangement approved by the Board of Directors (other than those of departing executive officers of the Corporation) notwithstanding that all shares of Redeemable Preferred Stock requested to be redeemed hereunder shall not therefor have been redeemed, and (C) the Corporation will not permit any subsidiary or other affiliate to redeem, purchase or otherwise acquire for value, or set apart for any sinking or other analogous fund for the purchase, redemption or acquisition of any shares of the Corporation’s capital stock (other than Series J Preferred Stock in accordance with this Section 4.2.5).
 
(c)                                   Redemption Prohibited . If, at a redemption payment date, the Corporation is prohibited under applicable law from redeeming all shares of Redeemable Preferred Stock requested to be redeemed hereunder, then the Corporation shall redeem shares of Series J Preferred Stock on a pro rata basis among the holders of Series J Preferred Stock in proportion to the number of shares of Series J Preferred Stock being redeemed from each holder and shall redeem the remaining shares of Series J Preferred Stock that it would have been required to redeem on such payment date but for the legal prohibition as soon as the Corporation is not legally prohibited from redeeming all or some of such shares. Any shares of Redeemable Preferred Stock not redeemed shall remain outstanding and entitled to all of the rights and preferences provided in this Article 4. After all Series J Preferred Stock requested to be redeemed has been redeemed by payment in full, then the Corporation shall redeem remaining Redeemable Stock requested to be redeemed; however, if at a redemption payment date the Corporation is prohibited under applicable law from redeeming all such remaining Redeemable Preferred Stock requested to be redeemed hereunder, then the Corporation shall redeem such remaining Redeemable Preferred Stock on a pro rata basis among the holders thereof in proportion to the full respective redemption amounts to which the holders thereof are entitled
 
18

 
hereunder to the extent the Corporation is not so legally prohibited from doing so and shall redeem the remaining shares of Redeemable Preferred Stock requested to be redeemed as soon as the Corporation is not legally prohibited from redeeming all or some of such shares. In the event that the Corporation fails to redeem shares for which redemption is required pursuant to this Section 4.2.5 by reason of a legal prohibition or otherwise, then during the period from the applicable Redemption Date through the date on which such shares are redeemed, the applicable redemption price of such shares shall bear interest at the rate of ten percent (10%) per annum, which interest rate shall increase by an additional one-half percent (0.5%) per annum at the end of each six (6) month period thereafter until the redemption price (as so increased) is paid in full, subject to a maximum interest rate of fifteen percent (15%) per annum and with such interest to be compounded annually. Without limitation of the foregoing, the Corporation shall take such action as shall be necessary or appropriate to remove promptly any impediments to its ability to redeem the Redeemable Preferred Stock under the circumstances contemplated by this Section 4.2.5. Any successor to the Corporation shall agree, as a condition to such succession, to carry out and observe the obligations of the Corporation hereunder with respect to the Redeemable Preferred Stock.
 
(d)                                  Surrender of Certificates . Upon receipt of the applicable redemption price therefor, each holder of shares of Redeemable Preferred Stock so redeemed shall surrender the certificate or certificates representing such shares so redeemed to the Corporation, duly assigned or endorsed for transfer (or accompanied by duly executed stock powers relating thereto), or shall deliver an affidavit or agreement reasonably satisfactory to the Corporation to indemnify the Corporation (without the need to post any bond or other security for such obligation) from any loss incurred by it in connection therewith with respect to such certificates at the principal executive office of the Corporation or the office of the transfer agent for the Redeemable Preferred Stock or such office or offices in the continental United States of an agent for redemption as may from time to time be designated by notice to the holders of Redeemable Preferred Stock, and each surrendered certificate shall be canceled and retired.
 
4.2.6.                      Voting Rights: Directors .
 
(a)                                   General . Each holder of outstanding shares of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series 0 Preferred Stock, Series H Preferred Stock, Series I Preferred Stock and Series J Preferred Stock shall be entitled to the number of votes equal to the number of shares of Common Stock into which the shares of Preferred Stock so held could be converted at the record date for determination of the stockholders entitled to vote, or, if no such record date is established, at the date such vote is taken or any written consent of stockholders is solicited. The holders of Series F Preferred Stock shall have no voting rights except as required by the DGCL. Except as required by law or as otherwise set forth herein, all shares of Preferred Stock and all shares of Common Stock shall vote together as a single class on all matters to come before the stockholders of the Corporation. Fractional votes by the holders of Preferred Stock shall not, however, be permitted, and any fractional voting rights shall (after aggregating all shares into which shares of Preferred Stock held by each holder could be converted) be disregarded.
 
(b)                                  Election of Directors . The Board of Directors shall consist of seven (7) directors elected as follows: (i) two directors shall be elected by the holders of the
 
19

 
Series A Preferred Stock, Series E Preferred Stock and Series H Preferred Stock, voting together as a single class; (ii) one director shall be elected by the holders of the Series I Preferred Stock, (iii) two directors shall be elected by the holders of the Series J Preferred Stock; (iv) one director shall be elected by the holders of Common Stock; and (v) one director shall be elected by the holders of the Common Stock and the Preferred Stock, voting together as a single class. Any vacancy in the Board of Directors occurring because of the death, resignation or removal of a director shall be filled by the vote or written consent of the holders of the class(es) or series entitled to fill such seat as provided in this Section 4.2.6(b). Any amendment to this Section 4.2.6(b) shall require the affirmative vote of (i) a majority of the outstanding Preferred Stock and Common Stock voting together as a single class and (ii) a majority of the outstanding Series J Preferred Stock. Any amendment to this Section 4.2.6(b) that would eliminate the right of the Series I Preferred Stock to elect one director requires the affirmative vote of the holders of a majority of the outstanding Series I Preferred Stock.
 
(c)                                   Protective Provisions .
 
(i)                                      The Corporation shall not, without first obtaining the approval of the holders of at least a majority of the then issued and outstanding shares of Series J Preferred Stock, take any action which (i) changes any of the rights, preferences or privileges of, or adversely affects the rights of, the Series J Preferred Stock including, without limitation, liquidation, redemption, dividend, voting or conversion rights; or (ii) authorizes, creates, reclassifies or issues shares of any class or series of equity securities, including any securities or obligations convertible into or exercisable for such equity securities, ranking senior to or in parity with the Series J Preferred Stock, including without limitation, with respect to any rights, preferences or privileges, including without limitation, relating to dividends, liquidation preference, voting and redemption; or (iii) amends or modifies the rights of the holders of any other series of Preferred Stock to confer on the holders of the shares of any such series of Preferred Stock rights, preferences or privileges that are senior to, in parity with or held by the holders of the Series J Preferred Stock, including without limitation, relating to dividends, liquidation preference, voting and redemption.
 
(ii)                                   The Corporation shall not, without first obtaining the approval of the holders of not less than a majority of the total number of shares of any remaining series of Preferred Stock (other than Series F Preferred Stock) then outstanding, amend the Corporation’s Certificate of Incorporation to alter or change any rights, preferences, or privileges of such series of Preferred Stock so as to materially and adversely affect such series of Preferred Stock.
 
(iii)                                In addition to the approvals required by clauses (i) and (ii) of this Section 4.2.6(c), the Corporation shall not, without first obtaining the approval of the holders of at least 51% of the issued and outstanding shares of Preferred Stock, voting together as a single class, or the approval of its Board of Directors, including at least four of the five directors elected solely by the holders of one or more series of Preferred Stock, if the Board of Directors is authorized under the DGCL to take such action without any stockholder vote, approval or consent, authorize or take any of the following actions:
 
20

 
(A)                               merge, consolidate, reorganize or enter into a share exchange with any other person or engage in any other transaction in which any person or group of persons shall, immediately after giving effect thereto, become or obtain the right to become the beneficial owner, directly or indirectly, of capital securities of the Corporation representing fifty percent (50%) or more of the aggregate voting power represented by all of the Corporation’s issued and outstanding capital securities;
 
(B)                                 make any other distributions upon, or redeem, repurchase or otherwise acquire for value, any of the Corporation’s outstanding equity securities other than (I) conversions of Preferred Stock; (II) purchases at cost from departing employees pursuant to the terms of any stock option or purchase plan or arrangement approved by the Board of Directors (other than those of departing executive officers of the Corporation); (III) redemptions as provided in Section 4.2.5; (IV) distributions upon a Liquidation as provided in Section 4.2.3; and (V) the declaration or payment of dividends (other than cumulative dividends) as contemplated in this Certificate of Incorporation;
 
(C)                                 provide for the voluntary liquidation, dissolution, winding up, recapitalization or reorganization of the Company;
 
(D)                                amend or waive any provision of the Corporation’s Certificate of Incorporation or Bylaws;
 
(E)                                  sell, license, convey or otherwise dispose of or encumber all or substantially all the assets of the Corporation;
 
(F)                                  materially change the business plan of the Corporation as approved by the Corporation’s Board of Directors;
 
(G)                                 change in any material way the nature of the business of the Corporation or the manner in which that business is conducted;
 
(H)                                change in any material way the compensation of senior management;
 
(I)                                     increase expenditures in any year by $1 million or more in the aggregate above the aggregate amount of expenditure set forth in the Corporation’s annual budget for that year, which budget was approved by the Corporation’s Board of Directors prior to the beginning of that year,
 
(J)                                    incur indebtedness for borrowed money in an aggregate amount greater than $500,000; or
 
(K)                                amend in any material manner any existing or approves any new joint venture, material license or similar arrangement.
 
4.2.7.                      Preemptive Rights . The holders of Preferred Stock shall have preemptive rights as set forth in the Amended and Restated Stockholders’ Agreement dated as of May 8, 2003, among the Corporation and the “Holders” identified therein.
 
21

 
4.3.                               Common Stock .
 
4.3.1.                      Dividends . Subject to the rights and preferences applicable to the Preferred Stock outstanding at any time as herein set forth, the holders of shares of Common Stock shall be entitled to receive such dividends, payable in cash or otherwise, as may be declared thereon by the Board of Directors from time to time out of assets of funds of the Corporation legally available therefor; provided, that no dividends shall be declared or paid on any shares of Common Stock until all dividends accrued or declared but unpaid on the Preferred Stock shall have been paid in full; and, provided further, that when and as dividends are declared and paid on shares of Common Stock, the Corporation shall declare and pay at the same time, as provided in Section 4.2.2(b), to each holder of Preferred Stock a dividend equal to the dividend which would have been payable to such holder if the shares of such series of Preferred Stock held by such holder had been converted into Common Stock on the record date for the determination of holders of Common Stock entitled to receive such dividend.
 
4.3.2.                      Voting . Each holder of Common Stock shall have one vote for each share of Common Stock so held and shall be entitled to vote on all matters submitted to a vote of the stockholders of the Corporation, including, subject to Section 4.2.6(b), the election of directors.
 
4.3.3.                      Liquidation . Subject to the rights and preferences applicable to the Preferred Stock outstanding at any time as hereinafter set forth, upon a Liquidation, the holders of shares of Common Stock will be entitled to receive all assets of the Corporation available for distribution to its stockholders.
 
ARTICLE 5
 
5.1.                               Notices . All notices to any party required or permitted to be sent pursuant to this Certificate (“Notices”) shall be contained in a written instrument addressed to such party at such party’s address as it appears on the books of the Corporation or such other address as may hereafter be designated in writing by the addressee to the addressor listing all parties and shall be deemed given (a) when delivered in person; (b) on the next business day after receipt confirming good transmission when sent by facsimile transmission; (c) the earlier of (i) the day of delivery or (ii) four (4) business days after being duly sent by first-class United States mail, postage prepaid and return receipt requested, or (d) the earlier of (i) the day of delivery or (ii) two (2) business days after being duly sent by United States overnight express mail or recognized express courier service.
 
ARTICLE 6
 
6.1.                               Indemnification . The Corporation shall indemnify and hold harmless each person who at any time is, or shall have been, a director or officer of the Corporation and was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he or she is or was a director or officer of the Corporation, or is or was serving at the request of the Corporation as a director, officer, employee, or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees), judgments,
 
22

 
fines and amounts paid in settlement incurred in connection with any such action, suit or proceeding, to the maximum extent permitted by the General Corporation Law of the State of Delaware, as the same exists or may hereafter be amended. In furtherance of and not in limitation of the foregoing, the Corporation shall advance expenses, including attorneys’ fees, incurred by a director or officer of the Corporation in defending any civil, criminal, administrative or investigative action, suit or proceeding in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such director or officer to repay such advances if it shall ultimately be determined that he is not entitled to be indemnified by the Corporation. The foregoing right of indemnification shall in no way be exclusive of any other rights of indemnification to which any such director or officer may be entitled, under any bylaw, agreement, vote of directors or stockholders or otherwise.
 
6.2.                               Limitation on Liability . A Director of the Corporation shall not be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a Director, except for liability (i) for any breach of the Director’s duty of loyalty to the Corporation or its stockholders; (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law; (iii) under Section 174 of the DGCL; or (iv) for any transaction from which the Director derived an improper personal benefit. If the DGCL is amended after the Effective Date to authorize corporate action further eliminating or limiting the personal liability of Directors, then the liability of a Director of the Corporation shall be eliminated or limited to the fullest extent permitted by the DGCL, as so amended.
 
6.3.                               Modification . Any repeal or modification of this Article 6 by either (i) the stockholders of the Corporation or (ii) an amendment to the DGCL, shall not adversely affect any right or protection existing at the time of such repeal or modification with respect to any acts or omissions occurring before such repeal or modification of a person serving as a Director at the time of such repeal or modification.
 
ARTICLE 7
 
7.1.                               Existence . The Corporation is to have perpetual existence.
 
ARTICLE 8
 
8.1.                               Bylaws . Except as otherwise provided by law or this Certificate of Incorporation, the Bylaws of the Corporation may be amended or repealed by the Board of Directors.
 
23

 
Exhibit 3.2
 
AMENDED BY LAWS
 
OF
 
ACORDA THERAPEUTICS, INC.
 
a Delaware Corporation

 
TABLE OF CONTENTS

ARTICLE I	CORPORATE OFFICES	
 	
 	1.1.	REGISTERED OFFICE	
 	1.2.	OTHER OFFICES	
 	
ARTICLE II	MEETINGS OF STOCKHOLDERS	
 	
 	2.1.	PLACE OF MEETINGS	
 	2.2.	ANNUAL MEETING	
 	2.3.	SPECIAL MEETING	
 	2.4.	NOTICE OF STOCKHOLDERS’ MEETINGS	
 	2.5.	ADVANCE NOTICE OF STOCKHOLDER NOMINEES AND STOCKHOLDER BUSINESS	
 	2.6.	MANNER OF GIVING NOTICE; AFFIDAVIT OF NOTICE	
 	2.7.	QUORUM	
 	2.8.	ADJOURNED MEETING: NOTICE	
 	2.9.	VOTING	
 	2.10.	WAIVER OF NOTICE	
 	2.11.	STOCKHOLDER ACTION BY WRITTEN CONSENT WITHOUT A MEETING	
 	2.12.	RECORD DATE FOR STOCKHOLDER NOTICE; VOTING; GIVING CONSENTS	
 	2.13.	PROXIES	
 	2.14.	LIST OF STOCKHOLDERS ENTITLED TO VOTE	
 	2.15.	CONDUCT OF BUSINESS	
 	
ARTICLE III	DIRECTORS	
 	
 	3.1.	POWERS	
 	3.2.	NUMBER	
 	3.3.	ELECTION, QUALIFICATION TERM OF OFFICE OF DIRECTORS	
 	3.4.	RESIGNATION AND VACANCIES	
 	3.5.	PLACE OF MEETING; MEETINGS BY TELEPHONE	
 	3.6.	FIRST MEETINGS	
 	3.7.	REGULAR MEETINGS	
 	3.8.	SPECIAL MEETINGS; NOTICE	
 	3.9.	QUORUM	
 	3.10.	WAIVER OF NOTICE	
 	3.11.	ADJOURNED MEETING; NOTICE	
 	3.12.	CONDUCT OF BUSINESS	
 	3.13.	BOARD ACTION BY WRITTEN CONSENT WITHOUT A MEETING	
 	3.14.	FEES AND COMPENSATION OF DIRECTORS	
 	3.15.	APPROVAL OF LOANS TO OFFICERS	

i

 

 	3.16.	REMOVAL OF DIRECTORS	
 	
ARTICLE IV	COMMITTEES	
 	
 	4.1.	COMMITTEES OF DIRECTORS	
 	4.2.	COMMITTEE MINUTES	
 	4.3.	MEETINGS AND ACTION OF COMMITTEES	
 	
ARTICLE V	OFFICERS	
 	
 	5.1.	OFFICERS	
 	5.2.	ELECTION OF OFFICERS	
 	5.3.	REMOVAL AND RESIGNATION OF OFFICERS	
 	5.4.	CHAIRMAN OF THE BOARD	
 	5.5.	CHIEF EXECUTIVE OFFICER	
 	5.6.	PRESIDENT	
 	5.7.	VICE PRESIDENT	
 	5.8.	SECRETARY	
 	5.9.	CHIEF FINANCIAL OFFICER	
 	5.10.	ASSISTANT SECRETARY	
 	5.11.	AUTHORITY AND DUTIES OF OFFICERS	
 	
ARTICLE VI	INDEMNITY	
 	
 	6.1.	INDEMNIFICATION OF DIRECTORS AND OFFICERS	
 	6.2.	INDEMNIFICATION OF OTHERS	
 	6.3.	INSURANCE	
 	
ARTICLE VII	RECORDS AND REPORTS	
 	
 	7.1.	MAINTENANCE. AND INSPECTION OF RECORDS	
 	7.2.	INSPECTION BY DIRECTORS	
 	7.3.	REPRESENTATION OF SHARES OF OTHER CORPORATIONS	
 	
ARTICLE VIII	GENERAL MATTERS	
 	
 	8.1.	CHECKS	
 	8.2.	EXECUTION OF CORPORATE CONTRACTS AND INSTRUMENTS	
 	8.3.	STOCK CERTIFICATES; PARTLY PAID-SHARES	
 	8.4.	SPECIAL DESIGNATION ON CERTIFICATES	
 	8.5.	LOST CERTIFICATES	
 	8.6.	CONSTRUCTION: DEFINITIONS	
 	8.7.	DIVIDENDS	
 	8.8.	FISCAL YEAR	
 	8.9.	SEAL	
 	8.10.	TRANSFER OF STOCK,	

ii

 

 	8.11.	STOCK TRANSFER AGREEMENTS	
 	8.12.	REGISTERED STOCKHOLDERS	
 	
ARTICLE IX	AMENDMENTS	

ARTICLE X	DISSOLUTION	

ARTICLE XI	CUSTODIAN	
 	
 	11.1.	APPOINTMENT OF A CUSTODIAN IN CERTAIN CASES	
 	11.2.	DUTIES OF CUSTODIAN	
 	
ARTICLE XII	LOANS TO OFFICERS	

iii

 
AMENDED BY LAWS
 
OF
 
ACORDA THERAPEUTICS, INC.
 
ARTICLE I
 
CORPORATE OFFICES
 
1.1.                                                                               REGISTERED OFFICE
 
The registered office of the Corporation shall be in the City of Wilmington, County of New Castle, State of Delaware. The name of the registered agent of the Corporation at such location is The Corporation Trust Company.
 
1.2.                                                                               OTHER OFFICES
 
The board of directors may at any time establish other offices at any place or places where the Corporation is qualified to do business.
 
ARTICLE II
 
MEETINGS OF STOCKHOLDERS
 
2.1.                                                                               PLACE OF MEETINGS
 
Meetings of stockholders shall be held at any place, within or outside the State of Delaware, designated by the board of directors. In the absence of any such designation, stockholders’ meetings shall be held at the registered office of the Corporation.
 
2.2.                                                                               ANNUAL MEETING
 
The annual meeting of stockholders shall be held each year on a date and at a time designated by the board of directors. At the meeting, directors shall be elected and any other proper business may be transacted.
 
2.3.                                                                               SPECIAL MEETING
 
A special meeting of the stockholders may be called at any time by the (i) board of directors, (ii) the chairman of the board, (iii) the president, (iv) the chief executive officer or (v) one or more stockholders holding shares in the aggregate entitled to cast not less than ten percent (10%) of the votes at that meeting.

 
2.4.                                                                               NOTICE OF STOCKHOLDERS’ MEETINGS
 
All notices of meetings with stockholders shall be in writing and shall be sent or otherwise given in accordance with Section 2.6 of these Bylaws not less than 10 nor more than 60 days before the date of the meeting to each stockholder entitled to vote at such meeting. The notice shall specify the place, date and hour of the meeting, and, in the case of a special meeting, the purpose or purposes for which the meeting is called.
 
2.5.                                                                               ADVANCE NOTICE OF STOCKHOLDER NOMINEES AND STOCKHOLDER BUSINESS
 
To be properly brought before an annual meeting or special meeting, nominations for the election of director or other business must be (a) specified in the notice of meeting (or any supplement thereto) given by or at the direction of the board of directors, (b) otherwise properly brought before the meeting by or at the direction of the board of directors, or (c) otherwise properly brought before the meeting by a stockholder. For such nominations or other business to be considered properly brought before the meeting by a stockholder, such stockholder must have given timely notice and in proper form of his intent to bring such business before such meeting. To be timely, such stockholder’s notice must be delivered to or mailed and received by the secretary of the Corporation not less than 90 days prior to the meeting; provided, however, that in the event that less than 100 days notice or prior public disclosure of the date of the meeting is given or made to stockholders, notice by the stockholder to be timely must be so received not later than the close of business on the tenth day following the day on which such notice of the date of the meeting was mailed or such public disclosure was made. To be in proper form, a stockholder’s notice to the secretary shall set forth:
 
(i)                                      the name and address of the stockholder who intends to make the nominations, propose the business, and, as the case may be, the name and address of the person or persons to be nominated or the nature of the business to be proposed;
 
(ii)                                   a representation that the stockholder is a holder of record of stock of the Corporation entitled to vote at such meeting and, if applicable, intends to appear in person or by proxy at the meeting to nominate the person or persons specified in the notice or introduce the business specified in the notice;
 
(iii)                                if applicable, a description of all arrangements or understandings between the stockholder and each nominee and any other person or persons (naming such person or persons) pursuant to which the nomination or nominations are to be made by the stockholder;
 
(iv)                               such other information regarding each nominee or each matter of business to be proposed by such stockholder as would be required to be included in a proxy statement filed pursuant to the proxy rules of the Securities and Exchange Commission had the nominee been nominated, or intended to be nominated, or the matter been proposed, or intended to be proposed by the board of directors; and
 
2

 
(v)                                  if applicable, the consent of each nominee to serve as director of the Corporation if so elected.
 
The chairman of the meeting may refuse to acknowledge the nomination of any person or the proposal of any business not made in compliance with the foregoing procedure.
 
2.6.                                                                               MANNER OF GIVING NOTICE; AFFIDAVIT OF NOTICE
 
Written notice of any meeting of stockholders, if mailed, is given when deposited in the United States mail, postage prepaid, directed to the stockholder at his address as it appears on the records of the Corporation. An affidavit of the secretary or an assistant secretary or of the transfer agent of the Corporation that the notice has been given shall, in the absence of fraud, be prima facie evidence of the facts stated therein.
 
2.7.                                                                               QUORUM
 
The holders of a majority of the stock issued and outstanding and entitled to vote thereat, present in person or represented by proxy, shall constitute a quorum at all meetings of the stockholders for the transaction of business except as otherwise provided by statute or by the certificate of incorporation. If, however, such quorum is not present or represented at any meeting of the stockholders, then either (i) the chairman of the meeting, or (ii) the stockholders entitled to vote thereat, present in person or represented by proxy, shall have power to adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum is present or represented. At such adjourned meeting at which a quorum is present or represented, any business may be transacted that might have been transacted at the meeting as originally noticed.
 
When a quorum is present or represented at any meeting, the vote of the holders of a majority of the stock having voting power present in person or represented by proxy shall decide any question brought before such meeting, unless the question is one upon which, by express provisions of the statutes or of the certificate of incorporation, a different vote is required, in which case such express provision shall govern and control the decision of the question.
 
2.8.                                                                               ADJOURNED MEETING; NOTICE
 
When a meeting is adjourned to another time or place, unless these Bylaws otherwise require, notice need not be given of the adjourned meeting if the time and place thereof are announced at the meeting at which the adjournment is taken. At the adjourned meeting the Corporation may transact any business that might have been transacted at the original meeting. If the adjournment is for more than 30 days, or if after the adjournment a new record date is fixed for the adjourned meeting, a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting.
 
2.9.                                                                               VOTING
 
The stockholders entitled to vote at any meeting of stockholders shall be determined in accordance with the provisions of Sections 2.12 and 2.14 of these Bylaws, subject to the provisions of Sections 217 and 218 of the General Corporation Law of Delaware (relating to
 
3

 
voting rights of fiduciaries, pledgers and joint owners of stock and to voting trusts and other voting agreements).
 
Except as may be otherwise provided in the certificate of incorporation, each stockholder shall be entitled to one vote for each share of capital stock held by such stockholder.
 
2.10.                                                                         WAIVER OF NOTICE
 
Whenever notice is required to be given under any provision of the General Corporation Law of Delaware or of the certificate of incorporation or these Bylaws, a written waiver thereof, signed by the person entitled to notice, whether before or after the time stated therein, shall be deemed equivalent to notice. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person attends a meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Neither the business to be transacted at, nor the purpose of, any regular or special meeting of the stockholders need be specified in any written waiver of notice unless so required by the certificate of incorporation or these Bylaws.
 
2.11.                                                                         STOCKHOLDER ACTION BY WRITTEN CONSENT WITHOUT A MEETING
 
Unless otherwise provided in the certificate of incorporation, any action required by this chapter to be taken at any annual or special meeting of stockholders of a Corporation, or any action that may be taken at any annual or special meeting of such stockholders, may be taken without a meeting, without prior notice, and without a vote if a consent in writing, setting forth the action so taken, is signed by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares entitled to vote thereon were present and voted.
 
Prompt notice of the taking of the corporate action without a meeting by less than unanimous written consent shall be given to those stockholders who have not consented in writing. If the action which is consented to is such as would have required the filing of a certificate under any section of the General Corporation Law of Delaware if such action had been voted on by stockholders at a meeting thereof, then the certificate filed under such section shall state, in lieu of any statement required by such section concerning any vote of stockholders, that written notice and written consent have been given as provided in Section 228 of the General Corporation Law of Delaware.
 
Notwithstanding the foregoing, effective upon the registration of any class of securities of the Corporation pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the stockholders of the Corporation may not take action by written consent without a meeting but must take any such actions at a duly called annual or special meeting.
 
2.12.                                                                         RECORD DATE FOR STOCKHOLDER NOTICE; VOTING; GIVING CONSENTS
 
In order that the Corporation may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment thereof, or entitled to express consent to
 
4

 
corporate action in writing without a meeting, or entitled to receive payment of any dividend or other distribution or allotment of any rights, or entitled to exercise any rights in respect of any change, conversion or exchange of stock or for the purpose of any other lawful action, the board of directors may fix, in advance, a record date, which shall not be more than 60 nor less than 10 days before the date of such meeting, nor more than 60 days prior to any other action.
 
If the board of directors does not so fix a record date, the fixing of such record date shall be governed by the provisions of Section 213 of the General Corporation Law of Delaware.
 
A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the board of directors may fix a new record date for the adjourned meeting.
 
2.13.                                                                         PROXIES
 
Each stockholder entitled to vote at a meeting of stockholders or to express consent or dissent to corporate action in writing without a meeting may authorize another person or persons to act for him by a written proxy, signed by the stockholder and filed with the, secretary of the Corporation, but no such proxy shall be voted or acted upon after 3 years from its date, unless the proxy provides for a longer period. A proxy shall be deemed signed if the stockholder’s name is placed on the proxy (whether by manual signature, typewriting, telegraphic transmission or otherwise) by the stockholder or the stockholder’s attorney-in-fact. The revocability of a proxy that states on its face that it is irrevocable shall be governed by the provisions of Section 212(c) of the General Corporation Law of Delaware.
 
2.14.                                                                         LIST OF STOCKHOLDERS ENTITLED TO VOTE
 
The officer who has charge of the stock ledger of a Corporation shall prepare and make, at least 10 days before every meeting of stockholders, a complete list of the stockholders entitled to vote at the meeting, arranged in alphabetical order, and showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting, during ordinary business hours, for a period of at least 10 days prior to the meeting, either at a place within the city where the meeting is to be held, which place shall be specified in the notice of the meeting, or, if not so specified, at the place where the meeting is to be held. The stock ledger shall also be produced and kept at the time and place of the meeting during the whole time thereof, and may be inspected by any stockholder who is present. The stock ledger shall be the only evidence as to who are the stockholders entitled to examine the stock ledger, the list of stockholders or the books of the Corporation, or to vote in person or by proxy at any meeting of stockholders and of the number of shares held by each such stockholder.
 
2.15.                                                                         CONDUCT OF BUSINESS
 
Meetings of stockholders shall be presided over by the chairman of the board, if any, or in his absence by the president, or in his absence by a vice president, or in the absence of the foregoing persons by a chairman designated by the board of directors, or in the absence of such designation by a chairman chosen at the meeting. The secretary shall act as secretary of the meeting, but in his absence the chairman of the meeting may appoint any person to act as
 
5

 
secretary of the meeting. The chairman of any meeting of stockholders shall determine the order of business and the procedures at the meeting, including such matters as the regulation of the manner of voting and conduct of business.
 
ARTICLE III
 
DIRECTORS
 
3.1.                                                                               POWERS
 
Subject to the provisions of the General Corporation Law of Delaware and any limitations in the certificate of incorporation or these Bylaws relating to action required to be approved by the stockholders or by the outstanding shares, the business and affairs of the Corporation shall be managed and all corporate powers shall be exercised by or under the direction of the board of directors.
 
3.2.                                                                               NUMBER
 
Unless otherwise provided in the certificate of incorporation, the Board of Directors shall consist of the number thereof to be determined from time to time by resolution of the Board of Directors. No reduction of the authorized number of directors shall have the effect of removing any director before that director’s term of office expires.
 
3.3.                                                                               ELEC TION, QUALIFICATION TERM OF OFFICE OF DIRECTORS
 
Except as provided in Section 3.4 of these Bylaws, at each annual meeting of stockholders, directors of the Corporation shall be elected to hold office until the expiration of the term for which they are elected, and until their successors have been duly elected and qualified; except that if any such election shall not be so held, such election shall take place at a stockholders’ meeting called and held in accordance with the Delaware General Corporation Law.
 
Directors need not be stockholders unless so required by the certificate of incorporation or these Bylaws, wherein other qualifications for directors may be prescribed.
 
Elections of directors need not be by written ballot.
 
3.4.                                                                               RESIGNATION AND VACANCIES
 
Any director may resign at any time upon written notice to the Corporation. Subject to Section 3.16 of these Bylaws, Stockholders may remove directors with or without cause. Subject to the following paragraph of this Section 3.4, any vacancy occurring in the board of directors with or without cause may be filled by a majority of the remaining members of the board of directors, although such majority is less than a quorum, or by a plurality of the votes cast at a meeting of stockholders, and each director so elected shall hold office until the expiration of the term of office of the director whom he has replaced.
 
Unless otherwise provided in the certificate of incorporation or these Bylaws:
 
6

 
(i)                                      Vacancies and newly created directorships resulting from any increase in the authorized number of directors elected by all of the stockholders having the right to vote as a single class may be filled by a majority of the directors then in office, although less than a quorum, or by a sole remaining director.
 
(ii)                                   Whenever the holders of any class or classes of stock or series thereof are entitled to elect one or more directors by the provisions of the certificate of incorporation, vacancies and newly created directorships of such class or classes or series may be filled by a majority of the directors elected by such class or classes or series thereof then in office, or by a sole remaining director so elected.
 
If at any time, by reason of death or resignation or other cause, the Corporation should have no directors in office, then any officer or any stockholder or an executor, administrator, trustee or guardian of a stockholder, or other fiduciary entrusted with like responsibility for the person or estate of a stockholder, may apply to the Court of Chancery for a decree summarily ordering an election as provided in Section 211 of the General Corporation Law of Delaware.
 
If, at the time of filling any vacancy or any newly created directorship, the directors then in office constitute less than a majority of the whole board (as constituted immediately prior to any such increase), then the Court of Chancery may, upon application of any stockholder or stockholders holding at least 10% of the total number of the shares at the time outstanding having the right to vote for such directors, summarily order an election to be held to fill any such vacancies or newly created directorships, or to replace the directors chosen by the directors then in office as aforesaid, which election shall be governed by the provisions of Section 211 of the General Corporation Law of Delaware as far as applicable.
 
3.5.                                                                               PLACE OF MEETING; MEETINGS BY TELEPHONE
 
The board of directors of the Corporation may hold meetings, both regular and special, either within or outside the State of Delaware.
 
Unless otherwise restricted by the certificate of incorporation or these Bylaws, members of the board of directors, or any committee designated by the board of directors, may participate in a meeting of the board of directors, or any committee, by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other, and such participation in a meeting shall constitute presence in person at the meeting.
 
3.6.                                                                               FIRST MEETINGS
 
The first meeting of each newly elected board of directors shall be held at such time and place as shall be fixed by the vote of the stockholders at the annual meeting and no notice of such meeting shall be necessary to the newly elected directors in order legally to constitute the meeting, provided a quorum shall be present. In the event of the failure of the stockholders to fix the time or place of such first meeting of the newly elected board of directors, or in the event such meeting is not held at the time and place so fixed by the stockholders, the meeting may be
 
7

 
held at such time and place as shall be specified in a notice given as hereinafter provided for special meetings of the board of directors, or as shall be specified in a written waiver signed by all of the directors.
 
3.7.                                                                               REGULAR MEETINGS
 
Regular meetings of the board of directors may be held without notice at such time and at such place as shall from time to time be determined by the board.’
 
3.8.                                                                               SPECIAL MEETINGS; NOTICE
 
Special meetings of the board of directors for any purpose or purposes may be called at any time by the chairman of the board, the president, any vice president, the secretary or any two directors.
 
Notice of the time and place of special meetings shall be delivered personally or by telephone to each director or sent by first-class mail or telegram, charges prepaid, addressed to each director at that director’s address as it is shown on the records of the Corporation. If the notice is mailed, it shall be deposited in the United States mail at least 4 days before the time of the holding of the meeting. If the notice is delivered personally or by telephone or by telegram, it shall be delivered personally or by telephone or to the telegraph company at least 48 hours before the time of the holding of the meeting. Any oral notice given personally or by telephone may be communicated either to the director or to a person at the office of the director who the person giving the notice has reason to believe will promptly communicate it to the director. The notice need not specify the purpose or the place of the meeting, if the meeting is to be held at the principal executive office of the Corporation.
 
3.9.                                                                               QUOR UM
 
At all meetings of the board of directors, a majority of the authorized number of directors shall constitute a quorum for the transaction of business and the act of a majority of the directors present at any meeting at which there is a quorum shall be the act of the board of directors, except as may be otherwise specifically provided by statute or by the certificate of incorporation.
 
3.10.                                                                         WAIVER OF NOTICE
 
Whenever notice is required to be given under any provision of the General Corporation Law of Delaware or of the certificate of incorporation or these Bylaws, a written waiver thereof, signed by the person entitled to notice, whether before or after the time stated therein, shall be deemed equivalent to notice. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person attends a meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Neither the business to be transacted at, nor the purpose of, any regular or special meeting of the directors, or members of a committee of directors, need be specified in any written waiver of notice unless so required by the certificate of incorporation or these Bylaws.
 
8

 
3.11.                                                                         ADJOURNED MEETING ; NOTICE
 
If a quorum is not present at any meeting of the board of directors, then the directors present thereat may adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum is present.
 
3.12.                                                                         CONDUCT OF BUSINESS
 
Meetings of the board of directors shall be presided over by the chairman of the board, if any, or in his absence by the chief executive officer, or in their absence by a chairman chosen at the meeting. The secretary shall act as secretary of the meeting, but in his absence the chairman of the meeting may appoint any person to act as secretary of the meeting. The chairman of any meeting shall determine the order of business and the procedures at the meeting.
 
3.13.                                                                         BOARD ACTION BY WRITTEN CONSENT WITHOUT A MEETING
 
Unless otherwise restricted by the certificate of incorporation or these Bylaws, any action required or permitted to be taken at any meeting of the board of directors, or of any committee thereof, may be taken without a meeting if all members of the board or committee, as the case may be, consent thereto in writing and the writing or writings are filed with the minutes of proceedings of the board or committee.
 
3.14.                                                                         FEES AND COMPENSATION OF DIRECTORS
 
Unless otherwise restricted by the certificate of incorporation or these Bylaws, the board of directors shall have the authority to fix the compensation of directors. The directors may be paid their expenses, if any, of attendance at each meeting of the board of directors and may be paid a fixed sum for attendance at each meeting of the board of directors or a stated salary as director. No such payment shall preclude any director from serving the Corporation in any other capacity and receiving compensation therefor. Members of special or standing committees may be allowed like compensation for attending committee meetings.
 
3.15.                                                                         APPROVAL OF LOANS TO OFFICERS
 
The Corporation may lend money to, or guarantee any obligation of, or otherwise assist any officer or other employee of the Corporation or of its subsidiary, including any officer or employee who is a director of the Corporation or its subsidiary, whenever, in the judgment of the directors, such loan, guaranty or assistance may reasonably be expected to benefit the Corporation. The loan, guaranty or other assistance may be with or without interest and may be unsecured, or secured in such manner as the board of directors shall approve, including, without limitation, a pledge of shares of stock of the Corporation. Nothing in this section contained shall be deemed to deny, limit or restrict the powers of guaranty or warranty of the Corporation at common law or under any statute.
 
3.16.                                                                         REMOVAL OF DIRECTORS
 
Unless otherwise restricted by statute, by the certificate of incorporation or by these Bylaws, any director or the entire board of directors may be removed, with or without cause, by
 
9

 
the holders of a majority of the shares then entitled to vote at an election of directors. If at any time a class or series of shares is entitled to elect one or more directors, the provisions of this Article 3.16 shall apply to the vote of that class or series and not to the vote of the outstanding shares as a whole.
 
No reduction of the authorized number of directors shall have the effect of removing any director prior to the expiration of such director’s term of office.
 
ARTICLE IV
 
COMMITTEES
 
4.1.                                                                               COMMITTEES OF DIRECTORS
 
The board of directors may, by resolution passed by a majority of the whole board, designate one or more committees, with each committee to consist of one or more of the directors of the Corporation. The board may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee. In the absence or disqualification of a member of a committee, the member or members thereof present at any meeting and not disqualified from voting, whether or not he or they constitute a quorum, may’ unanimously appoint another member of the board of directors to act at the meeting in the place of any such absent or disqualified member. Any such committee, to the extent provided in the resolution of the board of directors or in the Bylaws of the Corporation, shall have and may exercise all the powers and authority of the board of directors in the management of the business and affairs of the Corporation, and may authorize the seal of the Corporation to be affixed to all papers that may require it; but no such committee shall have the power or authority to (i) amend the certificate of incorporation (except that a committee may, to the extent authorized in the resolution or resolutions providing for the issuance of shares of stock adopted by the board of directors as provided in Section 151(a) of the General Corporation Law of Delaware, fix any of the preferences or rights of such shares relating to dividends, redemption, dissolution, any distribution of assets of the Corporation or the conversion into, or the exchange of such shares for, shares of any other class or classes or any other series of the same or any other class or classes of stock of the Corporation), (ii) adopt an agreement of merger or consolidation under Sections 251 or 252 of the General Corporation Law of Delaware, (iii) recommend to the stockholders the sale, lease or exchange of all or substantially all of the Corporation’s property and assets, (iv) recommend to the stockholders a dissolution of the Corporation or a revocation of a dissolution, or (v) amend the Bylaws of the Corporation; and, unless the board resolution establishing the committee, the Bylaws or the certificate of incorporation expressly so provide, no such committee shall have the power or authority to declare a dividend, to authorize the issuance of stock, or to adopt a certificate of ownership and merger pursuant to Section 253 of the General Corporation Law of Delaware.
 
4.2.                                                                               COMMITTEE MINUTES
 
Each committee shall keep regular minutes of its meetings and report the same to the board of directors when required.
 
10

 
4.3.                                                                               MEETINGS AND ACTION OF COMMITTEES
 
Meetings and actions of committees shall be governed by, and held and taken in accordance with, the provisions of Article III of these Bylaws, Section 3.5 (place of meetings and meetings by telephone), Section 3.7 (regular meetings), Section 3.8 (special meetings and notice), Section 3.9 (quorum), Section 3.10 (waiver of notice), Section 3.11 (adjournment and notice of adjournment), Section 3.12 (conduct of business) and 3.13 (action without a meeting), with such changes in the context of those Bylaws as are necessary to substitute the committee and its members for the board of directors and its members; provided, however, that the time of regular meetings of committees may also be called by resolution of the board of directors and that notice of special meetings of committees shall also be given to all alternate members, who shall have the right to attend all meetings of the committee. The board of directors may adopt rules for the government of any committee not inconsistent with the provisions of these Bylaws.
 
ARTICLE V
 
OFF ICERS
 
5.1.                                                                               OFFICERS
 
The officers of the Corporation shall be a chief executive officer, one or more vice presidents, a secretary and a chief financial officer. The Corporation may also have, at the discretion of the board of directors, a chairman of the board, a president, a chief operating officer, one or more executive, senior or assistant vice presidents, assistant secretaries and any such other officers as may be appointed in accordance with the provisions of Section 5.2 of these Bylaws. Any number of offices may be held by the same person.
 
5.2.                                                                               ELECTION OF OFFICERS
 
Except as otherwise provided in this Section 5.2, the officers of the Corporation shall be chosen by the board of directors, subject to the rights, if any, of an officer under any contract of employment. The board of directors may appoint, or empower an officer to appoint, such officers and agents of the business as the Corporation may require (whether or not such officer or agent is described in this Article V), each of whom shall hold office for such period, have such authority, and perform such duties as are provided in these Bylaws or as the board of directors may from time to time determine. Any vacancy occurring in any office of the Corporation shall be filled by the board of directors or may be filled by the officer, if any, who appointed such officer.
 
5.3.                                                                               REMOVAL AND RESIGNATION OF OFFICERS
 
Subject to the rights, if any, of an officer under any contract of employment, any officer may be removed, either with or without cause, by an affirmative vote of the majority of the board of directors at any regular or special meeting of the board or, except in the case of an officer chosen by the board of directors, by any officer upon whom such power of removal may be conferred by the board of directors or, in the case of an officer appointed by another officer, by such other officer.
 
11

 
Any officer may resign at any time by giving written notice to the Corporation. Any resignation shall take effect at the date of the receipt of that notice or at any later time specified in that notice; and, unless otherwise specified in that notice, the acceptance of the resignation shall not be necessary to make it effective. Any resignation is without prejudice to the rights, if any, of the Corporation under any contract to which the officer is a party.
 
5.4.                                                                               CHAIRMAN OF THE BOARD
 
The chairman of the board, if such an officer be elected, shall, if present, preside at meetings of the board of directors and exercise and perform such other powers and duties as may from time to time be assigned to him by the board of directors or as may be prescribed by these Bylaws. If there is no chief executive officer, then the chairman of the board shall also be the chief executive officer of the Corporation and shall have the powers and duties prescribed in Section 5.5 of these Bylaws.
 
5.5.                                                                               CHIEF EXECUTIVE OFFICER
 
The Chief Executive Officer of the Corporation shall, subject to the control of the Board of Directors, have general supervision, direction and control of the business and the officers of the Corporation. He or she shall preside at all meetings of the stockholders and, in the absence or nonexistence of a Chairman of the Board at all meetings of the Board of Directors. He or she shall have the general powers and duties of management usually vested in the chief executive officer of a Corporation, including general supervision, direction and control of the business and supervision of other officers of the Corporation, and shall have such other powers and duties as may be prescribed by the Board of Directors or these Bylaws.
 
The Chief Executive Officer shall, without limitation, have the authority to execute bonds, mortgages and other contracts requiring a seal, under the seal of the Corporation, except where required or permitted by law to be otherwise signed and executed and except where the signing and execution thereof shall be expressly delegated by the Board of Directors to some other officer or agent of the Corporation.
 
5.6.                                                                               PRESIDENT
 
Subject to such supervisory powers as may be given by these Bylaws or the Board of Directors to the Chairman of the Board or the Chief Executive Officer, if there be such officers, the president shall have general supervision, direction and control of the business and supervision of other officers of the Corporation, and shall have such other powers and duties as may be prescribed by the Board of Directors or these Bylaws. In the event a Chief Executive officer shall not be appointed, the President shall have the duties of such office.
 
5.7.                                                                               VICE PRESIDENT
 
In the absence or disability of the president, the vice presidents, if any, in order of their rank as fixed by the board of directors or, if not ranked, a vice president designated by the board of directors, shall perform all the duties of the chief executive officer and when so acting shall have all the powers of, and be subject to all the restrictions upon, the chief executive officer. The vice presidents shall have such other powers and perform such other duties as from time to time
 
12

 
may be prescribed for them respectively by the board of directors, these Bylaws, the chief executive officer or the chairman of the board.
 
5.8.                                                                               SECRETARY
 
The secretary shall keep or cause to be kept, at the principal executive office of the Corporation or such other place as the board of directors may direct, a book of minutes of all meetings and actions of directors, committees of directors, and stockholders. The minutes shall show the time and place of each meeting, whether regular or special (and, if special, how authorized and the notice given), the names of those present at directors’ meetings or committee meetings, the number of shares present or represented at stockholders’ meetings, and the proceedings thereof.
 
The secretary shall keep, or cause to be kept, at the principal executive office of the Corporation or at the office of the Corporation’s transfer agent or registrar, as determined by resolution of the board of directors, a share register, or a duplicate share register, showing the names of all stockholders and their addresses, the number and classes of shares held by each, the number and date of certificates evidencing such shares, and the number and date of cancellation of every certificate surrendered for cancellation.
 
The secretary shall give, or cause to be given, notice of all meetings of the stockholders and of the board of directors required to be given by law or by these Bylaws. He shall keep the seal of the Corporation, if one be adopted, in safe custody and shall have such other powers and perform such other duties as may be prescribed by the board of directors or by these Bylaws.
 
5.9.                                                                               CHIEF FINANCIAL OFFICER
 
The chief financial officer shall keep and maintain, or cause to be kept and maintained, adequate and correct books and records of accounts of the properties and business transactions of the Corporation, including accounts of its assets, liabilities, receipts, disbursements, gains, losses, capital, retained earnings and shares. The books of account shall at all reasonable times be open to inspection by any director.
 
The chief financial officer shall deposit all money and other valuables in the name and to the credit of the Corporation with such depositaries as may be designated by the board of directors. He shall disburse the funds of the Corporation as may be ordered by the board of directors, shall render to the chief executive officer and directors, whenever they request it, an account of all of his transactions as treasurer and of the financial condition of the Corporation, and shall have such other powers and perform such other duties as may be prescribed by the board of directors or these Bylaws.
 
5.10.                                                                         ASSISTANT SECRETARY
 
The assistant secretary, or, if there is more than one, the assistant secretaries in the order determined by the stockholders or board of directors (or if there be no such determination, then in the order of their election) shall, in the absence of the secretary or in the event of his or her inability or refusal to act, perform the duties and exercise the powers of the secretary and shall
 
13

 
perform such other duties and have such other powers as the board of directors or the stockholders may from time to time prescribe.
 
5.11.                                                                         AUTHORITY AND DUTIES OF OFFICERS
 
In addition to the foregoing authority and duties, all officers of the Corporation shall respectively have such authority and perform such duties in the management of the business of the Corporation as may be designated from time to time by the board of directors or the stockholders.
 
ARTICLE VI
 
INDEMNITY
 
6.1.                                                                               INDEMNIFICATION OF DIRECTORS AND OFFICERS
 
The Corporation shall, to the maximum extent and in the manner permitted by the General Corporation Law of Delaware, indemnify each of its directors and officers against expenses (including attorneys’ fees), judgments, fines, settlements, and other amounts actually and reasonably incurred in connection with any proceeding, arising by reason of the fact that such person is or was an agent of the Corporation. For purposes of this Section 6.1, a “director” or “officer” of the Corporation includes any person (i) who is or was a director or officer of the Corporation, (ii) who is or was serving at the request of the Corporation as a director or officer of another Corporation, partnership, joint venture, trust or other enterprise, or (iii) who was a director or officer of a Corporation which was a predecessor Corporation of the Corporation or of another enterprise at the request of such predecessor Corporation.
 
6.2.                                                                               INDEMNIFICATION OF OTHERS
 
The Corporation shall have the power, to the extent and in the manner permitted by the General Corporation Law of Delaware, to indemnify each of its employees and agents (other than directors and officers) against expenses (including attorneys’ fees), judgments, fines, settlements, and other amounts actually and reasonably incurred in connection with any proceeding, arising by reason of the fact that such person is or was an agent of the Corporation. For purposes of this Section 6.2, an “employee” or agent of the corporation (other than a director or officer) includes any person (i) who is or was an employee or agent of the Corporation, (ii) who is or was serving at the request of the Corporation as an employee or agent of another Corporation, partnership, joint venture, trust or other enterprise, or (iii) who was an employee or agent of a Corporation which was a predecessor Corporation of the Corporation or of another enterprise at the request of such predecessor Corporation.
 
6.3.                                                                               INSURANCE
 
The Corporation may purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the Corporation, or is or was serving at the request of the Corporation as a director, officer, employee or agent of another Corporation, partnership, joint venture, trust or other enterprise against any liability asserted against him and incurred by him in any such capacity, or arising out of his status as such, whether or not the Corporation
 
14

 
would have the power to indemnify him against such liability under the provisions of the General Corporation Law of Delaware.
 
ARTICLE VII
 
RECORDS AND REPORT S
 
7.1.                                                                               MAINTENANCE. AND INSPECTION OF RECORDS
 
The corporation shall, either at its principal executive office or at such place or places as designated by the board of directors, keep a record of its stockholders listing their names and addresses and the number and class of shares held by each stockholder, a copy of these Bylaws as amended to date, accounting books, and other records.
 
Any stockholder of record, in person or by attorney or other agent, shall, upon written demand under oath stating the purpose thereof, have the right during the usual hours for business to inspect for any proper purpose the Corporation’s stock ledger, a list of its stockholders, and its other books and records and to make copies or extracts therefrom.  A proper purpose shall mean a purpose reasonably related to such person’s interest as a stockholder. In every instance where an attorney or other agent is the person who seeks the right to inspection, the demand under oath shall be accompanied by a power of attorney or such other writing that authorizes the attorney or other agent to so act on behalf of the stockholder. The demand under oath shall be directed to the Corporation at its registered office in Delaware or at its principal place of business.
 
7.2.                                                                               INSPECTION BY DIRECTORS
 
Any director shall have the right to examine the Corporation’s stock ledger, a list of its stockholders and its other books and records for a purpose reasonably related to his position as a director.  The Court of Chancery is hereby vested with the exclusive jurisdiction to determine whether a director is entitled to the inspection sought. The Court may summarily order the Corporation to permit the director to inspect any and all books and records, the stock ledger, and the stock list and to make copies or extracts therefrom.  The Court may, in its discretion, prescribe any limitations or conditions with reference to the inspection, or award such other and further relief as the Court may deem just and proper.
 
7.3.                                                                               REPRESENTATION OF SHARES OF OTHER CORPORATIONS
 
The chairman of the board, the chief executive officer, any vice president, the chief financial officer, the secretary or assistant secretary of this Corporation, or any other person authorized by the board of directors or the chief executive officer or a vice president, is authorized to vote, represent, and exercise on behalf of this Corporation all rights incident to any and all shares of any other Corporation or Corporations standing in the name of this Corporation. The authority granted herein may be exercised either by such person directly or by any other person authorized to do so by proxy or power of attorney duly executed by such person having the authority.
 
15

 
ARTICLE VIII
 
GENERAL MATTERS
 
8.1.                                                                               CHECKS
 
From time to time, the board of directors shall determine by resolution which person or persons may sign or endorse all checks, drafts, other orders for payment of money, notes or other evidences of indebtedness that are issued in the name of or payable to the Corporation, and only the persons so authorized shall sign or endorse those instruments.
 
8.2.                                                                               EXECUTION OF CORPORATE CONTRACTS AND INSTRUMENTS
 
The board of directors, except as otherwise provided in these Bylaws, may authorize any officer or officers, or agent or agents, to enter into any contract or execute any instrument in the name of and on behalf of the Corporation; such authority may be general or confined to specific instances. Unless so authorized or ratified by the board of directors or within the agency power of an officer, no officer, agent or employee shall have any power or authority to bind the Corporation by any contract or engagement or to pledge its credit or to render it liable for any purpose or for any amount.
 
8.3.                                                                               STOCK CERTIFICATES; PARTLY PAID-SHARE S
 
The shares of a Corporation shall be represented by certificates, provided that the board of directors of the Corporation may provide by resolution or resolutions that some or all of any or all classes or series of its stock shall be uncertificated shares. Any such resolution shall not apply to shares represented by a certificate until such certificate is surrendered to the Corporation. Notwithstanding the adoption of such a resolution by the board of directors, every holder of stock represented by certificates and upon request every holder of uncertificated shares shall be entitled to have a certificate signed by, or in the name of the Corporation by the chairman or vice-chairman of the board of directors, or the president or vice-president, and by the treasurer or an assistant treasurer, or the secretary or an assistant secretary of such Corporation representing the number of shares registered in certificate form. Any or all of the signatures on the certificate may be a facsimile. In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed upon a certificate has to be such officer, transfer agent or registrar before such certificate is issued, it may be issued by the Corporation with the same effect as if he were such officer, transfer agent or registrar at the date of issue.
 
The Corporation may issue the whole or any part of its shares as partly paid and subject to call for the remainder of the consideration to be paid therefor. Upon the face or back of each stock certificate issued to represent any such partly paid shares, upon the books and records of the Corporation in the case of uncertificated partly paid shares, the total amount of the consideration to be paid therefor and the amount paid thereon shall be stated. Upon the declaration of any dividend on fully paid shares, the Corporation shall declare a dividend upon partly paid shares of the same class, but only upon the basis of the percentage of the consideration actually paid thereon.
 
16

 
8.4.                                                                               SPECIAL DESIGNATION ON CERTIFICATES
 
If the Corporation is authorized to issue more than one class of stock or more than one series of any class, then the powers, the designations, the preferences, and the relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and “or rights shall beset forth in full or summarized on the face or back of the certificate that the Corporation shall issue to represent such class or series of stock; provided, however, that, except as otherwise provided in Section 202 of the General Corporation Law of Delaware, in lieu of the foregoing requirements there may be set forth on the face or back of the certificate that the Corporation shall issue to represent such class or series of stock a statement that the Corporation will furnish without charge to each stockholder who so requests the powers, the designations, the preferences, and the relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and” or rights.
 
8.5.                                                                               LOST CERTIFICATES
 
Except as provided in this Section 8.5, no new certificates for shares shall be issued to replace a previously issued certificate unless the latter is surrendered to the Corporation and canceled at the same time. The Corporation may issue a new certificate of stock or uncertificated shares in the place of any certificate theretofore issued by it, alleged to have been lost, stolen or destroyed, and the Corporation may require the owner of the lost, stolen or destroyed certificate, or his legal representative, to give the Corporation a bond sufficient to indemnify it against any claim that may be made against it on account of the alleged loss, theft or destruction of any such certificate or the issuance of such new certificate or uncertificated shares.
 
8.6.                                                                               CONSTRUCTION; DEFINITIONS
 
Unless the context requires otherwise, the general provisions, rules of construction, and definitions in the Delaware General Corporation Law shall govern the construction of these Bylaws.  Without limiting the generality of this provision, the singular number includes the plural, the plural number includes the singular, and the term “person” includes both a Corporation and a natural person.
 
8.7.                                                                               DIVIDENDS
 
The directors of the Corporation, subject to any restrictions contained in the certificate of incorporation, may declare and pay dividends upon the shares of its capital stock pursuant to the General Corporation Law of Delaware. Dividends may be paid in cash, in property, or in shares of the Corporation’s capital stock.
 
The directors of the Corporation may set apart out of any of the funds of the Corporation available for dividends a reserve or reserves for any proper purpose and may abolish any such reserve. Such purposes shall include but not be limited to equalizing dividends, repairing or maintaining any property of the Corporation, and meeting contingencies.
 
17

 
8.8.                                                                               FISCAL YEAR
 
The fiscal year of the Corporation shall be fixed by resolution of the board of directors and may be changed by the board of directors.
 
8.9.                                                                               SEAL
 
The Corporation may adopt a corporate seal, which may be altered at pleasure, and may use the same by causing it or a facsimile thereof to be impressed or affixed or in any other manner reproduced.
 
8.10.                                                                         TRANSFER OF STOCK
 
Upon surrender to the Corporation or the transfer agent of the Corporation of a certificate for shares duly endorsed or accompanied by proper evidence of succession, assignation or authority to transfer, it shall be the duty of the Corporation to issue a new certificate to the person entitled thereto, cancel the old certificate, and record the transaction in its books.
 
8.11.                                                                         STOCK TRANSFER AGREEMENTS
 
The Corporation shall have power to enter into and perform any agreement with any number of stockholders of any one or more classes of stock of the Corporation to restrict the transfer of shares of stock of the Corporation of any one or more classes owned by such stockholders in any manner not prohibited by the General Corporation Law of Delaware.
 
8.12.                                                                         REGISTERED STOCKHOLDERS
 
The Corporation shall be entitled to recognize the exclusive right of a person registered on its books as the owner of shares to receive dividends and to vote as such owner, shall be entitled to hold liable for calls and assessments the person registered on its books as the owner of shares, and shall not be bound to recognize any equitable or other claim to or interest in such share or shares on the part of another person, whether or not it shall have express or other notice thereof, except as otherwise provided by the laws of Delaware.
 
ARTICLE IX
 
AMENDMENT S
 
The original or other Bylaws of the Corporation may be adopted, amended or repealed by the stockholders entitled to vote; provided, however, that the Corporation may, in its certificate of incorporation, confer the power to adopt, amend or repeal Bylaws upon the directors. The fact that such power has been so conferred upon the directors shall not divest the stockholders of the power, nor limit their power to adopt, amend or repeal Bylaws.
 
18

 
ARTICLE X
 
DISSOLUTION
 
If it should be deemed advisable in the judgment of the board of directors of the Corporation that the Corporation should be dissolved, the board, after the adoption of a resolution to that effect by a majority of the whole board at any meeting called for that purpose, shall cause notice to be mailed to each stockholder entitled to vote thereon of the adoption of the resolution and of a meeting of stockholders to take action upon the resolution.
 
At the meeting a vote shall be taken for and against the proposed dissolution. If a majority of the outstanding stock of the Corporation entitled to vote thereon votes for the proposed dissolution, then a certificate stating that the dissolution has been authorized in accordance with the-provisions of Section 275 of the General Corporation Law of Delaware and setting forth the names and residences of the directors and officers shall be executed, acknowledged, and filed and shall become effective in accordance with Section 103 of the General Corporation Law of Delaware. Upon such certificate’s becoming effective in accordance with Section 103 of the General Corporation Law of Delaware, the Corporation shall be dissolved.
 
ARTICLE XI
 
CUSTODIAN
 
11.1.                                                                         APPOINTMENT OF A CUSTODIAN IN CERTAIN CASES
 
The Court of Chancery, upon application of any stockholder, may appoint one or more persons to be custodians and, if the Corporation is insolvent, to be receivers, of and for the Corporation when:
 
(i)                                      at any meeting held for the election of directors the stockholders are so divided that they have failed to elect successors to directors whose terms have expired or would have expired upon qualification of their successors; or
 
(ii)                                   the business of the Corporation is suffering or is threatened with irreparable injury because the directors are so divided respecting the management of the affairs of the Corporation that the required vote for action by the board of directors cannot be obtained and the stockholders are unable to terminate this division; or
 
(iii)                                the Corporation has abandoned its business and has failed within a reasonable time to take steps to dissolve, liquidate or distribute its assets.
 
11.2.                                                                         DUTIES OF CUSTODIAN
 
The custodian shall have all the powers and title of a receiver appointed under Section 291 of the General Corporation Law of Delaware, but the authority of the custodian shall be to continue the business of the Corporation and not to liquidate its affairs and distribute its assets,
 
19

 
except when the Court of Chancery otherwise orders and except in cases arising under Sections 226(a)(3) or 352(a)(2) of the General Corporation Law of Delaware.
 
ARTICLE XII
 
LOANS TO OFFICERS
 
The corporation may lend money to, or guarantee any obligation of, or otherwise assist any officer or other employee of the corporation or of its subsidiaries, including any officer or employee who is a Director of the corporation or its subsidiaries, whenever, in the judgment of the Board of Directors, such loan, guarantee or assistance may reasonably be expected to benefit the corporation. The loan, guarantee or other assistance may be with or without interest and may be unsecured, or secured in such manner as the Board of Directors shall approve, including, without limitation, a pledge of shares of stock of the corporation. Nothing in this Bylaw shall be deemed to deny, limit or restrict the powers of guaranty or warranty of the corporation at common law or under any statute.
 
20

 
Exhibit 3.3
 
AMENDED AND RESTATED
 CERTIFICATE OF INCORPORATION OF
ACORDA THERAPEUTICS, INC.
 
ARTICLE 1
 
1.1                                  Name .  The name of the corporation is Acorda Therapeutics, Inc. (the “Corporation”).
 
ARTICLE 2
 
2.1                                  Registered Agent and Office .  The address of the Corporation’s registered office in the State of Delaware is 1209 Orange Street in the City of Wilmington, County of New Castle, Delaware 19808. The name of its registered agent at such address is The Corporation Trust Company.
 
ARTICLE 3
 
3.1                                  Purposes .  The purposes for which the Corporation is formed are to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of Delaware (the “DGCL”).
 
ARTICLE 4
 
4.1                                  Authorized Capital .  The total number of shares of all classes of stock which the Corporation shall have authority to issue is seventy-six million (76,000,000) shares of which (i) seventy-five million (75,000,000) shares shall be common stock, par value $.001 per share (the “Common Stock”), and (ii) one million (1,000,000) shares shall be preferred stock, par value $.001 per share (the “Preferred Stock”).  Shares of Preferred Stock may be issued in one or more series as may be established from time to time by resolution of the Board of Directors of the Corporation (the “Board of Directors”), each of which series shall consist of such number of shares and have such distinctive designation or title as shall be fixed by resolutions of the Board of Directors prior to the issuance of any shares of such series.  Each such class or series of Preferred Stock shall have such voting powers, full or limited, or no voting powers, and such preferences and relative, participating, optional or other special rights and such qualifications, limitations or restrictions thereof, as shall be stated in such resolutions of the Board of Directors providing for the issuance of such series of Preferred Stock.  The Board of Directors is further authorized to increase or decrease (but not below the number of shares of such class or series then outstanding) the number of shares of any series subsequent to the issuance of shares of that series.
 
B-1

 
ARTICLE 5
 
5.1                                  Indemnification .  The Corporation shall indemnify and hold harmless each person who at any time is, or shall have been, a director or officer of the Corporation and was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he or she is or was a director or officer of the Corporation, or is or was serving at the request of the Corporation as a director, officer, employee, or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement incurred in connection with any such action, suit or proceeding, to the maximum extent permitted by the Delaware General Corporation Law (“DGCL”), as the same exists or may hereafter be amended. In furtherance of and not in limitation of the foregoing, the Corporation shall advance expenses, including attorneys’ fees, incurred by a director or officer of the Corporation in defending any civil, criminal, administrative or investigative action, suit or proceeding in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such director or officer to repay such advances if it shall ultimately be determined that he is not entitled to be indemnified by the Corporation. The foregoing right of indemnification shall in no way be exclusive of any other rights of indemnification to which any such director or officer may be entitled, under any bylaw, agreement, vote of directors or stockholders or otherwise.
 
5.2                                  Limitation on Liability .  A director of the Corporation shall not be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except for liability (i) for any breach of the director’s duty of loyalty to the Corporation or its stockholders; (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law; (iii) under Section 174 of the DGCL; or (iv) for any transaction from which the director derived an improper personal benefit. If the DGCL is amended after the effective date of this Amended and Restated Certificate of Incorporation to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director of the Corporation shall be eliminated or limited to the fullest extent permitted by the DGCL, as so amended.
 
5.3                                  Modification .  Any repeal or modification of this Article 5 by either (i) the stockholders of the Corporation or (ii) an amendment to the DGCL, shall not adversely affect any right or protection existing at the time of such repeal or modification with respect to any acts or omissions occurring before such repeal or modification of a person serving as a director or an officer at the time of such repeal or modification.
 
ARTICLE 6
 
6.1                                  Existence .  The duration of Corporation shall be perpetual.
 
B-2

 
ARTICLE 7
 
7.1                                  Bylaws .  Except as otherwise provided by law or this Amended and Restated Certificate of Incorporation, the bylaws of the Corporation may be amended or repealed by the Board of Directors.
 
ARTICLE 8
 
8.1                                  Number of Directors .  Subject to the rights of the holders of any series of Preferred Stock to elect additional directors under specified circumstances, the authorized number of directors of the Corporation shall be determined from time to time by resolution adopted by the affirmative vote of a majority of the entire Board of Directors at any regular or special meeting of such Board of Directors, within any limits prescribed in the bylaws of the Corporation.
 
8.2                                  Classes of Directors .  The Board of Directors, other than those directors who may be elected by the holders of any series of Preferred Stock under specified circumstances, shall be divided into three classes, designated Class I, Class II and Class III, as nearly equal in number as possible (the exact number of directors in each class being determined by the Board of Directors in the event the aggregate number of directors does not permit each class to have an equal number of directors), and the term of office of directors of one class shall expire at each annual meeting of stockholders, and in all cases as to each director such term shall extend until his or her successor shall be elected and shall qualify or until his or her earlier resignation, removal from office, death or incapacity.  Additional directorships resulting from an increase in number of directors shall be apportioned among the classes as equally as possible (the exact number of directors in each class being determined by the Board of Directors in the event the aggregate number of directors does not permit each class to have an equal number of directors). The initial term of office of directors of Class I shall expire at the annual meeting of stockholders in 2004, the initial term of office of directors of Class II shall expire at the annual meeting of stockholders in 2005 and the initial term of office of directors of Class III shall expire at the annual meeting of stockholders in 2006.  At each annual meeting of stockholders a number of directors equal to the number of directors of the class whose term expires at the time of such meeting (or, if less, the number of directors properly nominated and qualified for election) shall be elected to hold office until the third succeeding annual meeting of stockholders after their election.  Each director shall serve until his or her successor shall have been duly elected and qualified, unless he or she shall resign, become disqualified, disabled or otherwise be removed.
 
At each annual election, directors chosen to succeed those whose terms then expire shall be of the same class as the directors they succeed, unless by reason of any intervening changes in the authorized number of directors, the Board of Directors shall designate one or more directorships whose term then expires as directorships of another class in order to more nearly achieve equality of number of directors among the classes.
 
B-3

 
Notwithstanding the rule that the three classes shall be as nearly equal in number of directors as possible, in the event of any change in the authorized number of directors, each director then continuing to serve as such shall nevertheless continue as a director of the class of which he or she is a member until the expiration of his or her current term, or his or her prior death, resignation or removal.  If any newly created directorship may, consistently with the rule that the three classes shall be as nearly equal in number of directors as possible, be allocated to more than one class, the Board of Directors shall allocate it to the available class whose term of office is due to expire at the earliest date following such allocation.
 
8.3                                  Increase in Directors; Vacancies .  Subject to the rights of the holders of any series of Preferred Stock then outstanding and unless the Board of Directors otherwise determines, and subject to the provisions hereof, newly created directorships resulting from any increase in the authorized number of directors or any vacancies on the Board of Directors resulting from death, resignation, disqualification, removal or another cause may be filled only by the affirmative vote of a majority of the remaining directors then in office, even though less than a quorum of the Board of Directors.  Any director elected in accordance with the preceding sentence shall hold office for the remainder of the full term of the class of directors in which the new directorship was created or in which the vacancy occurred, and until such director’s successor shall have been duly elected and qualified or until his or her earlier resignation, removal from office, death or incapacity.  Subject to the provisions of this Amended and Restated Certificate of Incorporation, no decrease in the number of directors constituting the Board of Directors shall shorten the term of any incumbent director.
 
8.4                                  Removal .  Unless otherwise restricted by statute, by this Amended and Restated Certificate of Incorporation or the bylaws of the Corporation, any director, or all of the directors, may be removed from the Board of Directors, but only for cause and only by the affirmative vote of the holders of a majority of the voting power of the then outstanding shares of capital stock of the Corporation then entitled to vote in the election of directors, voting together as a single class.
 
8.5                                  Election of Directors .  The election of directors need not be by written ballot.
 
B-4

 
ARTICLE 9
 
9.1                                  Amendments and Repeal .  The Corporation reserves the right to amend or repeal any provision contained in this Amended and Restated Certificate of Incorporation in the manner prescribed by the laws of the State of Delaware and all rights conferred upon stockholders are granted subject to this reservation.

 	ACORDA THERAPEUTICS, INC.	

 	 	
 	Name:	
 	Date:	
 
B-5

 
Exhibit 10.1
 
ACORDA THERAPEUTICS, INC.
 
1999 EMPLOYEE STOCK OPTION PLAN
 
SECTION 1.                             PURPOSE
 
The purpose of the Acorda Therapeutics, Inc. 1999 Employee Stock Option Plan (the “Plan”) is to provide an additional incentive to directors, key employees, independent contractors, agents and consultants of Acorda Therapeutics, Inc. (the “Company”) and its subsidiaries, to aid in attracting and retaining directors, employees, independent contractors, agents and consultants of outstanding ability, and to align their interests with those of shareholders.
 
SECTION 2.                             DEFINITIONS
 
Unless the context clearly indicates otherwise, the following terms, when used in this Plan, shall have the meanings set forth in this Section 2.
 
(a)                                   “Board” shall mean the Board of Directors of the Company.
 
(b)                                  “Change in Control”.   A change in control of the Company shall be deemed to have occurred if, over the initial opposition of the then-incumbent Board (whether or not such Board ultimately acquiesces therein), (i) any person or group of persons shall acquire, directly or indirectly, stock of the Company having at least 25% of the combined voting power of the Company’s then-outstanding securities, or (ii) any shareholder or group of shareholders shall elect a majority of the members of the Board in each case after the closing of the initial public offering of the Stock.
 
(c)                                   “Code” shall mean the Internal Revenue Code of 1986 and the rules and regulations thereunder, as it or they may be amended from time to time.
 
(d)                                  “Committee” shall mean the full Board, Compensation Committee of the Board or such other committee as may be designated by the Board.  If less than the full Board, the Committee shall consist of two or more members of the Board who are not eligible to participate in the Plan, and who otherwise are “non-employee directors” under Rule 16b-3.
 
(e)                                   “Date of Exercise” shall mean the earlier of the date on which written notice of exercise, together with payment in full, is received at the office of the Secretary of the Company or the date on which such notice and payment are mailed to the Secretary of the Company at its principal office by certified or registered mail.
 
(f)                                     “Director” shall mean a member of the Board of Directors.
 
(g)                                  “Employee” shall mean any employee or any officer of the Company or any of its Subsidiaries, or any other person, who is an independent contractor, agent or consultant of the Company or any of its Subsidiaries, and excluding any director of the Company who is not

 
otherwise an employee of the Company.  For the purposes of any provision of this Plan relating to Incentive Stock Options, the term “Employee” shall be limited to mean any employee (as that term is defined under Code Section 3401(c)) or officer of the Company or any of its Subsidiaries, but not any person who is merely an independent contractor, agent or consultant of the Company or any of its subsidiaries.
 
(h)                                  “Fair Market Value” of the Stock means, for all purposes of the Plan unless otherwise provided (i) the mean between the high and low sales prices of the Stock as reported on the National Market System or Small Cap Market of the National Association of Securities Dealers, Inc., Automated Quotation System, or any similar system of automated dissemination of quotations of securities prices then in common use, if so quoted, or (ii) if not quoted as described in clause (i), the mean between the high bid and low asked quotations for the Stock as reported by a the National Quotation Bureau Incorporated or such other source as the Committee shall determine, or (iii) if the Stock is listed or admitted for trading on any national securities exchange, the mean between the high and low sales price, or the closing bid price if no sale occurred, of the Stock on the principal securities exchange on which the Stock is listed.  In the event that the method for determining the Fair Market Value of the Stock provided for above shall either be not applicable or not be practical, in the opinion of the Committee, then the Fair Market Value shall be determined by such other reasonable method as the Committee, in its discretion, shall select and apply.
 
(i)                                      “Grantee” shall mean an Employee granted a Stock Option.
 
(j)                                      “Granting Date” shall mean the date on which the Committee authorizes the issuance of a Stock Option for a specified number of shares of Stock to a specified Employee.
 
(k)                                   “Incentive Stock Option” shall mean a Stock Option granted under the Plan which is properly qualified under the provisions of Section 422 of the Code.
 
(l)                                      “Nonstatutory Stock Option” shall mean a Stock Option granted within the Plan which is not an Incentive Stock Option or otherwise qualified under similar tax provisions.
 
(m)                                “Progressive Stock Options” shall mean either Incentive Stock Options or Nonstatutory Stock Options granted pursuant to Section 5(j) of this Plan.
 
(n)                                  “Rule 16b-3” shall mean Rule 16b-3 promulgated by the Securities and Exchange Commission pursuant to the Securities Exchange Act of 1934, as amended, or any rule in replacement thereof.
 
(o)                                  “Stock” shall mean the Common Stock, par value $0.001 per share, of the Company.
 
(p)                                  “Stock Appreciation Right” shall mean a right granted pursuant to the Plan to receive Stock, cash, or a combination thereof, upon the surrender of the right to purchase all or part of the shares of Stock covered by a Stock Option.
 
(q)                                  “Stock Option” shall mean an Incentive Stock Option or Nonstatutory Stock Option granted pursuant to the Plan to purchase shares of Stock.
 
2

 
(r)                                     “Subsidiary” shall mean any subsidiary corporation as defined in Section 424(f) of the Code.
 
SECTION 3.                             SHARES OF STOCK SUBJECT TO THE PLAN
 
Subject to adjustment pursuant to Section 9, 17,558,163 shares of Stock shall be reserved for issuance upon the exercise of Stock Options granted pursuant to this Plan.  Shares delivered under the Plan may be authorized and unissued shares or issued shares held by the Company in its treasury.  If any Stock Options expire or terminate without having been exercised, the shares of Stock covered by such Stock Option shall become available again for the grant of Stock Options hereunder.  Similarly, if any Stock Options are surrendered for cash pursuant to the provisions of Section 7, the shares of Stock covered by such Stock Options shall also become available again for the grant of Stock Options hereunder.  Shares of Stock covered by Stock Options surrendered for Stock pursuant to Section 7, however, shall not become available again for the grant of Stock Options hereunder.
 
SECTION 4.                             ADMINISTRATION OF THE PLAN
 
(a)                                   The Plan shall be administered by the Committee.  Subject to the express provisions of the Plan, the Committee shall have authority to interpret the Plan, to prescribe, amend and rescind rules and regulations relating to it, to determine the terms and provisions of Stock Option grants, and to make all other determinations necessary or advisable for the administration of the Plan.
 
(b)                                  It is intended that the Plan and any transaction hereunder meet all of the requirements of Rule 16b-3 promulgated by the Securities and Exchange Commission, as such rule is currently in effect or as hereafter modified or amended, and all other applicable laws.  If any provision of the Plan or any transaction would disqualify the Plan or such transaction under, or would not comply with, Rule 16b-3 or other applicable laws, such provision or transaction shall be construed or deemed amended to conform to Rule 16b-3 or such other applicable laws or otherwise shall be deemed to be null and void, in each case to the extent permitted by law and deemed advisable by the Committee.
 
(c)                                   Any controversy or claim arising out of or related to this Plan shall be determined unilaterally by and at the sole discretion of the Committee.
 
SECTION 5.                             GRANTING OF STOCK OPTIONS
 
(a)                                   Directors, key Employees, independent contractors, agents and consultants to the Company shall be eligible to receive Stock Options under the Plan.  Only Employees shall be eligible to receive Incentive Stock Options under the Plan.
 
(b)                                  The option price of each share of Stock subject to an Incentive Stock Option shall be at least 100% of the Fair Market Value of a share of the Stock on the Granting Date.
 
(c)                                   The option price of each share of Stock subject to a Nonstatutory Stock Option shall be 100% of the Fair Market Value of a share of the Stock on the Granting Date, or such other price either greater than or less than the Fair Market Value (but in no event less than the
 
3

 
par value of the Stock) as the Committee shall determine appropriate to the purposes of the Plan and to the Company’s total compensation program.
 
(d)                                  The Committee shall determine and designate from time to time those persons who are to be granted Stock Options and whether the particular Stock Options are to be Incentive Stock Options or Nonstatutory Stock Options, and shall also specify the number of shares covered by and the option price per share of each Stock Option.  Each Stock Option granted under the Plan shall be clearly identified as to its status as a Nonstatutory Stock Option or an Incentive Stock Option.
 
(e)                                   The aggregate Fair Market Value (determined at the time the Stock Option is granted) of the Stock with respect to which Incentive Stock Options are exercisable for the first time by any individual during any calendar year (under all plans of the individual’s employer corporation and its parent and subsidiary corporations) shall not exceed $100,000.
 
(f)                                     A Stock Option shall be exercisable during such period or periods and in such installments as shall be fixed by the Committee at the time the Stock Option is granted or in any amendment thereto; but each Stock Option shall expire not later than ten years from the Granting Date.
 
(g)                                  The Committee shall have the authority to grant both transferable Stock Options and nontransferable Stock Options, and to amend outstanding nontransferable Stock Options to provide for transferability.  Each nontransferable Stock Option intended to qualify under Rule 16b-3 or otherwise shall provide by its terms that it is not transferable otherwise than by will or the laws of descent and distribution or, except in the case of Incentive Stock Options, pursuant to a “qualified domestic relations order” as defined by the Code, and is exercisable, during the Grantee’s lifetime, only by the Grantee.  Each transferable Stock Option may provide for such limitations on transferability and exercisability as the Committee may designate at the time a Stock Option is granted or is otherwise amended to provide for transferability.
 
(h)                                  Stock Options may be granted to an Employee or Director who has previously received Stock Options or other options whether such prior Stock Options or other options are still outstanding, have previously been exercised or surrendered in whole or in part, or are canceled in connection with the issuance of new Stock Options.
 
(i)                                      Without in any way limiting the authority of the Committee to make grants of Stock Options under the Plan, and in order to induce persons to retain ownership of Stock, the Committee shall have the authority (but not the obligation) to include within any agreement reflecting a Stock Option a provision entitling the Grantee of such a Stock Option to a further Stock Option (a “Progressive Stock Option”) in the event the Grantee exercises such Stock Option evidenced by such agreement, in whole or in part, by surrendering other shares of Stock in accordance with this Plan and the terms and conditions of such agreement.  Any such Progressive Stock Option shall be for a number of shares of Stock equal to the number of surrendered shares, shall become exerciseable no sooner than six months after the Granting Date of the Stock Option or such longer period as the Committee may establish, shall have an option price per share equal to one hundred percent (100%) of the Fair Market Value of a share of Stock
 
4

 
on the Granting Date of the Progressive Stock Option, and shall be subject to such other terms and conditions as the Committee may determine.
 
(j)                                      Notwithstanding the foregoing, the option price of an Incentive Stock Option in the case of a Grantee who owns more than ten percent of the total combined voting power of all classes of stock of the Company or any of its Subsidiaries, will not be less than one-hundred-ten percent (110%) of the Fair Market Value of the Stock at the Granting date and in the case of such a Grantee, the Incentive Stock Option may be exercised no more than five years after the Granting Date.
 
SECTION 6.                             EXERCISE OF STOCK OPTIONS
 
(a)                                   Except as provided in Section 8, no Stock Option may be exercised at any time unless the Grantee is an Employee on the Date of Exercise and, in the case of holders of Incentive Stock Options, has been an Employee at all times during the period beginning on the Granting Date and ending on the day 3 months before the date of such exercise.
 
(b)                                  The Grantee shall pay the option price in full on the Date of Exercise of a Stock Option in cash, by check, or by delivery of full shares of Stock of the Company, duly endorsed for transfer to the Company with signature guaranteed,  by any combination thereof or by such other mode of payment as the Committee may approve, including payment through a broker in accordance with procedures permitted by rules and regulations of the Federal Reserve Board.  Stock will be accepted at its Fair Market Value on the Date of Exercise.
 
(c)                                   Subject to the approval of the Committee, or of such person to whom the Committee may delegate such authority (“its designee”), and subject further to the applicable regulations of any governmental authority, the Company may loan to the Grantee a sum equal to an amount which is not in excess of 100% of the purchase price of the shares of Stock acquired upon exercise of a Stock Option, such loan to be evidenced by the execution and delivery of a promissory note.  Interest shall be paid on the unpaid balance of the promissory note at such times and at such rate as shall be determined by the Committee or its designee.  Such promissory note shall be secured by the pledge to the Company of shares of Stock having an aggregate purchase price on the date of purchase equal to or greater than the amount of such note.  A Grantee shall have, as to such pledged shares of Stock, all rights of ownership including the right to vote such shares of Stock and to receive dividends paid on such shares of Stock, subject to the security interest of the Company.  Such shares of Stock shall not be released by the Company from the pledge unless the proportionate amount of the note secured thereby has been repaid to the Company; provided, however that shares of Stock subject to a pledge may be used to pay all or part of the purchase price of any other option granted hereunder or under any other stock incentive plan of the Company under the terms of which the purchase price of an option may be paid by the surrender of shares of Stock, subject to the terms and conditions of this Plan relating to the surrender of shares of Stock in payment of the exercise price of an option.  In such event, that number of the newly purchased shares of Stock equal to the shares of Stock previously pledged shall be immediately pledged as substitute security for the pre-existing debt of the Grantee to the Company, and thereupon shall be subject to the provisions hereof relating to pledged shares of Stock.  All notes executed hereunder shall be payable at such times and in such amounts and shall contain such other terms as shall be specified by the Committee or its designee
 
5

 
or stated in the option agreement; provided, however, that such terms shall conform to requirements contained in any applicable regulations which are issued by any governmental authority.
 
SECTION 7.                             STOCK APPRECIATION RIGHTS
 
(a)                                   The Committee may grant to any Employee, Stock Appreciation Rights in connection with any Stock Option.  Stock Appreciation Rights may be granted at the time the related Stock Option is granted or at any time thereafter up to six months prior to the expiration of the related Stock Option.
 
(b)                                  Stock Appreciation Rights shall be exercisable at such times and to the extent that the related Stock Option shall be exercisable and only to the extent the Stock Appreciation Right has a positive value, unless the Committee specifies a more restrictive period.
 
(c)                                   Upon the exercise of a Stock Appreciation Right, the Grantee shall surrender the related Stock Option or a portion thereof and shall be entitled to receive payment of an amount determined by multiplying the number of shares as to which the Stock Option rights are surrendered by the difference obtained by subtracting the exercise price per share of the related Stock Option from the Fair Market Value of a share of Stock on the Date of Exercise of the Stock Appreciation Right.
 
(d)                                  Payment of the amount determined under Section 7(c) shall be made in Stock, in cash, or partly in cash and partly in Stock as the Committee shall determine in its sole discretion.
 
(e)                                   Except as provided in Section 10(b), the exercise of a Stock Appreciation Right for cash may be made only during the period beginning on the third business day following the release of quarterly or annual financial data and ending on the twelfth business day following such date.
 
SECTION 8.                             TERMINATION OF EMPLOYMENT
 
Except as otherwise provided by the Committee at the time the Stock Option is granted or any amendment thereto, if a Grantee ceases to be an Employee then:
 
(a)                                   if termination of employment is voluntary or involuntary without cause, the Grantee may exercise each Stock Option held by the Grantee within three months after such termination (but not after the expiration date of the Stock Option) to the extent of the number of shares subject to the Stock Option which are purchasable pursuant to its terms at the date of termination;
 
(b)                                  if termination is for cause, all Stock Options held by the Grantee shall be canceled as of the date of termination;
 
(c)                                   subject to the provisions of Section 8(d), if termination is (i) by reason of retirement at a time when the Grantee is entitled to the current receipt of benefits under any retirement plan maintained by the Company or any Subsidiary, or (ii) by reason of disability, each Stock Option held by the Grantee may be exercised by the Grantee at any time (but not after
 
6

 
the expiration date of the Stock Option) (within one year of termination in the case of Incentive Stock Options) to the extent of the number of shares subject to the Stock Option which were purchasable pursuant to its terms at the date of termination;
 
(d)                                  if termination is by reason of the death of the Grantee, or if the Grantee dies after retirement or disability as referred to in Section 8(c), each Stock Option held by the Grantee may be exercised by the Grantee’s estate, or by any person who acquires the right to exercise the Stock Option by reason of the Grantee’s death, at any time within a period of three years after death (but not after the expiration date of the Stock Option) to the extent of the total number of shares subject to the Stock Option which were purchasable pursuant to its terms at the date of termination; or
 
(e)                                   if the Grantee should die within three months after voluntary termination of employment or involuntary termination without cause, as contemplated in Section 8(a), each Stock Option held by the Grantee may be exercised by the Grantee’s estate, or by any person who acquires the right to exercise by reason of the Grantee’s death, at any time within a period of one year after death (but not after the expiration date of the Stock Option) to the extent of the number of shares subject to the Stock Option which were purchasable pursuant to its terms at the date of termination.
 
SECTION 9.                             ADJUSTMENTS
 
In the event of any merger, consolidation, reorganization, recapitalization, stock dividend, stock split or other change in the corporate structure or capitalization affecting the Stock, there shall be an appropriate adjustment made by the Committee in the number and kind of shares that may be granted in the aggregate and to Grantees under the Plan, the number and kind of shares subject to each outstanding Stock Option and Stock Appreciation Right and the option prices.
 
SECTION 10.                      TENDER OFFER; CHANGE IN CONTROL
 
(a)                                   A Stock Option shall become immediately exercisable to the extent of the total number of shares subject to the Stock Option in the event of (i) a tender offer by a person or persons other than the Company for all or any part of the outstanding Stock if, upon consummation of the purchases contemplated, the offeror or offerors would own, beneficially or of record, an aggregate of more than 25% of the outstanding Stock, or (ii) a Change in Control of the Company.
 
(b)                                  The Committee may authorize the payment of cash upon the exercise of a Stock Appreciation Right during a period (i) beginning on the date on which a tender offer as described in (a), above, is first published or sent or given to holders of Stock and ending on the date which is seven days after its termination or expiration, or (ii) beginning on the date on which a Change in Control of the Company occurs and ending on the twelfth business day following such date.
 
SECTION 11.                      GENERAL PROVISIONS
 
(a)                                   Each Stock Option shall be evidenced by a written instrument containing such terms and conditions, not inconsistent with this Plan, as the Committee shall approve.
 
7

 
(b)                                  The granting of a Stock Option in any year shall not give the Grantee any right to similar grants in future years or any right to be retained in the employ of the Company or any Subsidiary or interfere in any way with the right of the Company or such Subsidiary to terminate an Employee’s employment at any time.
 
(c)                                   The Company shall have the right to deduct from any payment or distribution under the Plan any federal, state or local taxes of any kind required by law to be withheld with respect to such payments or to take such other action as may be necessary to satisfy all obligations for the payment of such taxes.  In case distributions are made in shares of Stock, the Company shall have the right to retain the value of sufficient shares of Stock to equal the amount of tax to be withheld for such distributions or require a recipient to pay the Company for any such taxes required to be withheld on such terms and conditions prescribed by the Committee.
 
(d)                                  No Grantee shall have any of the rights of a shareholder by reason of a Stock Option until it is exercised.
 
(e)                                   This Plan shall be construed and enforced in accordance with the laws of the State of Delaware (without regard to the legislative or judicial conflict of laws rules of any state), except to the extent superseded by federal law.
 
SECTION 12.                      AMENDMENT AND TERMINATION
 
(a)                                   The Plan shall terminate on June 18, 2009 and no Stock Option shall be granted hereunder after that date, provided that the Board may terminate the Plan at any time prior thereto.
 
(b)                                  The Board may amend the Plan at any time without notice, provided however, that the Board may not, without prior approval by the shareholders, (i) increase the maximum number of shares of Stock for which Stock Options may be granted (except as contemplated by the provisions of Section 9), (ii) materially increase the benefits accruing to participants under the Plan or (iii) materially modify the requirements as to eligibility for participation in the Plan.
 
(c)                                   No termination or amendment of the Plan may, without the consent of a Grantee to whom a Stock Option shall theretofore have been granted, adversely affect the rights of such Grantee under such Stock Option.
 
SECTION 13.                      EFFECTIVE DATE
 
The Plan shall become effective as of the date it is approved by the Company’s stockholders.
 
8

 
Exhibit 10.2
 
PROPOSED AMENDMENT
TO 1999 EMPLOYEE STOCK OPTION PLAN

This amendment (this “Amendment”) dated September     , 2003 amends the 1999 Employee Stock Option Plan (the “Stock Option Plan”) of Acorda Therapeutics, Inc. (the “Company”).
 
WITNESSETH:
 
WHEREAS , the Company intends to complete an initial public offering (the “IPO”); and
 
WHEREAS , the Company wishes to amend the terms of the Stock Option Plan as described below;
 
NOW, THEREFORE , the Stock Option Plan is amended as follows:

1.                  Section 3 of the 1999 Employee Stock Option Plan shall be amended in its entirety to read as follows:
 
“Subject to adjustment pursuant to Section 9, 34,958,163 shares of Stock shall be reserved for issuance upon the exercise of Stock Options granted pursuant to this Plan.  On the first day of each fiscal year, the Stock reserve shall automatically be increased by a number of shares equal to the least of (i) 2.5% of the then outstanding shares of Stock, (ii) 7,765,812 shares, or (iii) a number determined by the Board.  Any shares of Stock from increases in previous years that are not actually issued will continue to be included in the aggregate number of shares available for future issuance.”
 
2.                  Effectiveness . This Amendment shall be deemed effective immediately prior to the consummation of the IPO.

 
Exhibit 10.4
 
FIFTH AMENDED AND RESTATED
REGISTRATION RIGHTS AGREEMENT
 
This Fifth Amended and Restated Registration Rights Agreement (the “Agreement”) is made as of May 8, 2003, by and among Acorda Therapeutics, Inc. , a Delaware corporation (the “Company”), and each of the persons and entities that are parties to the “Prior Agreement” (as hereafter defined), each of the “Purchasers” under the Series J Agreement that becomes a party hereto and each other person or entity that becomes a party hereto pursuant to the terms hereof (all such persons and entities are referred to herein as “Purchasers” and their names and addresses are set forth on the Schedule of Purchasers attached hereto as it may be amended from time to time).
 
Recitals
 
A.                                    In connection with the issuance and sale of shares of its Preferred Stock, the Company has granted, and anticipates that it will continue to grant, registration and other rights to the purchasers of its Preferred Stock or other securities or obligations entitling the holder to acquire directly or indirectly Preferred Stock of the Company on a pari passu basis.
 
B.                                      The Company desires to amend and restate the Fourth Amended and Restated Registration Rights Agreement dated as of December 20, 2000, between the Company and the “Purchasers” identified therein (the “Prior Agreement”) to effect certain changes to the rights and obligations of the parties herein in connection with the completion of an equity financing involving the sale of the Company’s Series J Preferred Stock pursuant to a Series J Preferred Stock Purchase Agreement dated as of the date hereof among the Company and the “Purchasers” identified therein (the “Series J Agreement”).
 
NOW THEREFORE, in consideration of the foregoing, the parties agree as follows:
 
1.                                        Certain Definitions .  As used in this Agreement, the following terms will have the following respective meanings:
 
“Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
 
“Affiliate” of a Holder, as used in Section 2(a) and Section 13,  includes, but is not limited to (a) a general or limited partner of a Holder, (b) a member of a Holder, (c) an officer, director or manager of a Holder, (d) an equity owner of a Holder, (e) if the Holder is a trust, a successor trust or the beneficiaries of the trust, (f) a company controlling, controlled by or under common control with the Holder, (g) a spouse, child, stepchild, parent, stepparent or sibling of a Holder, by way of gift, (h) a revocable trust for the benefit of the Holder or his immediate family via an inter vivos transfer and assignment.
 
“Commission” means the United States Securities and Exchange Commission or any other federal agency at the time administering the Act or the Exchange Act or the Exchange Act.

 
“Conversion Stock” means the shares of the Company’s Common Stock issuable or issued upon conversion or exercise of Preferred Stock.
 
“Convertible Securities” means securities or obligations of the Company entitling the holder to acquire directly or indirectly Preferred Stock pursuant to a stock purchase, warrant, convertible note or related agreement.
 
“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
 
“Holder” means the Purchasers holding Registrable Securities or securities convertible, exercisable or exchangeable into Registrable Securities and any person holding such securities to whom the rights under this Agreement have been transferred in accordance with Section 13 hereof.
 
“Initiating Holders” means any Holder or Holders who in the aggregate hold at least 60% of the Registrable Securities at the time of the relevant event if an initial public offering of Company securities registered under the Act has not taken place or 30% of the Registrable Securities at any other time.
 
“Notes” means any promissory notes issued by the Company that are convertible into or exchangeable for any series of the Preferred Stock or other equity securities of the Company.
 
“Preferred Stock” means, collectively, issued and outstanding shares of the Company’s Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E-1 Preferred Stock, Series E-2 Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock and Series J Preferred Stock and Convertible Securities.
 
The terms “register,” “registered” and “registration” refer to a registration effected by preparing and filing a registration statement in compliance with the Act, and the declaration or ordering of the effectiveness of such registration statement.
 
“Registrable Securities” means (i) the Conversion Stock, (ii) any Common Stock of the Company issued or issuable with respect to the Conversion Stock upon any stock split, stock dividend, recapitalization, or similar event and (iii) any Common Stock delivered to the Holder as full or partial payment in respect of the Notes which are “restricted securities” within the meaning of Rule 144; provided, however, that shares of Common Stock or other securities shall no longer be treated as Registrable Securities after they have been sold to or through a broker or dealer or underwriter in a public distribution or a public securities transaction, whether in a registered offering, pursuant to Rule 144, or otherwise, if in connection with the sale the restrictive legends required pursuant to Section 2(a) have been removed; and provided, further, that if all Company securities of a Purchaser that would be Registrable Securities but for this provision can be sold without any volume or time restrictions under Rule 144(k) and if the Company removes the restrictive legends required by Section 2(a), then those Company securities shall no longer be Registrable Securities.
 
2

 
“Registration Expenses” means all expenses incurred by the Company in complying with Sections 5, 6, and 7 hereof, including, without limitation, all registration, qualification, and filing fees, printing expenses, escrow fees and disbursements of counsel for the Company, blue sky fees and expenses, all accounting fees, including the expense of any special audits incident to or required by such registration, and the reasonable fees and expenses of one counsel for the selling Holders not to exceed $15,000 (but excluding the compensation of regular employees of the Company which shall be paid in any event by the Company).  Registration Expenses will not include expenses of the holders of Registrable Securities to the extent limited or precluded by applicable blue sky laws.  Registration Expenses will not include selling commissions, underwriting discounts, other compensation paid to underwriters or other agents or brokers to effect the sale, stock transfer taxes, or special counsel of any Holder or Holders except as provided in the first sentence of this paragraph.
 
“Restricted Securities” means the securities of the Company required to bear the legend set forth in Section 2 hereof.
 
“Warrants” means any warrants granted by the Company for the purchase of any series of the Preferred Stock.
 
2.                                        Restrictive Legend .  Each certificate representing (i) the Preferred Stock, (ii) the Warrants, (iii) the Conversion Stock, (iv) the Notes, and (v) any other securities issued in respect of the Preferred Stock, the Warrants, or the Conversion Stock or the Notes upon any stock split, stock dividend, recapitalization, merger, consolidation or similar event, shall (unless otherwise permitted by the provisions of Section 4 below) be stamped or otherwise imprinted with a legend in substantially the following form (in addition to any legend required under applicable securities laws of any state or foreign jurisdiction), as and if appropriate.
 
(a)                                   “THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”).  THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, OR HYPOTHECATED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT AS TO THE SECURITIES UNDER THE ACT OR, IF REASONABLY REQUESTED BY THE COMPANY, AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY, THAT SUCH REGISTRATION IS NOT REQUIRED.”
 
(b)                                  “THESE SECURITIES ARE SUBJECT TO CERTAIN RESTRICTIONS ON TRANSFER AS SET FORTH IN AN AGREEMENT BETWEEN THE COMPANY AND THE STOCKHOLDER, A COPY OF WHICH IS ON FILE WITH THE SECRETARY OF THE COMPANY.”
 
(c)                                   Each Holder consents to the Company’s making a notation on its records and giving instructions to any transfer agent of the Restricted Securities, in order to implement the restrictions on transfer established in this Agreement.
 
3.                                        Notice of Proposed Transfers .
 
(a)                                   Each Holder by acceptance of Restricted Securities agrees to comply in all respects with the provisions of this Section 3; provided, however, that the
 
3

 
restrictions on transfer as set forth herein shall be subject to any superseding agreement that may exist between the Holder and the Company.  Prior to any proposed sale, assignment, transfer, or pledge of any Restricted Securities, unless either (i) there is in effect a registration statement under the Act covering the proposed transfer, or (ii) within a reasonable time after sale, assignment, transfer or pledge if made to an Affiliate of a Holder, the Holder thereof gives notice to the Company of such Holder’s intention to effect such transfer, sale, assignment, or pledge (the “Transfer Notice”).  The Transfer Notice shall describe the manner and circumstances of the proposed transfer, sale, assignment, or pledge in sufficient detail, including (i) the number or amount of the Restricted Securities to be sold or transferred, (ii) the price for which the Holder proposes to sell, transfer, or assign the Restricted Securities, and (iii) the name of the proposed purchaser or transferee.  Except for a transfer of Restricted Securities by a Holder to one of its Affiliates, each such notice shall also be accompanied, if requested by the Company and at such Holder’s expense, by a written opinion of legal counsel reasonably satisfactory to the Company, which opinion shall be addressed to the Company to the effect that the proposed transfer of the Restricted Securities may be effected without registration under the Act.  The Company agrees that it will not require such opinions of counsel to the Holder for transfers made pursuant to Rule 144, except in unusual circumstances.
 
(b)                                  Each certificate evidencing the Restricted Securities transferred as provided above (except sales pursuant to a registration statement under the Act) will bear, except if such transfer is made pursuant to Rule 144, the appropriate restrictive legends set forth in Section 2 above, except that such certificate shall not bear the restrictive legend set forth in Section 2(a) if in the opinion of counsel of such Holder and counsel for the Company such legend is not required in order to establish compliance with any provision of the Act.
 
4.                                        Removal of Restrictions on Transfer Securities .  Any legend referred to in Section 2(a) hereof stamped or imprinted on a certificate evidencing the Restricted Securities, and the stock transfer instructions and record notations with respect to such Restricted Securities will be removed and the Company will issue a certificate without such legend to the Holder of such Restricted Securities if (i) such Restricted Securities are registered under the Act or (ii) such Holder provides the Company with (a) an opinion of counsel (which may be counsel for the Company), reasonably satisfactory to the Company, to the effect that a public sale or transfer of such Restricted Securities may be made without registration under the Act or (b) assurances, which may, at the Company’s reasonable discretion, include an opinion of counsel reasonably satisfactory to the Company, that such Restricted Securities can be sold pursuant to an exemption from registration under Section (k) of Rule 144 under the Act.
 
5.                                        Requested Registration .
 
(a)                                   Request for Registration .  In the event the Company shall receive from Initiating Holders a request that the Company effect any registration, qualification, or compliance under the Act with respect to all or any portion of the Registrable Securities the Company will:
 
(i)                                      within twenty days of the Company’s receipt of such notice, give written notice of the proposed registration, qualification, or compliance to all other Holders; and
 
4

 
(ii)                                   as soon as practicable, use its best efforts to effect such registration, qualification, or compliance (including without limitation, filing post-effective amendments, appropriate qualification under applicable blue sky or other state securities laws and appropriate compliance with applicable registrations issued under the Act and any other governmental requirements or regulations) as may be so requested and as would permit or facilitate the sale and distribution of all or such portion of such Registrable Securities as are specified in such request, together with all or such portion of the Registrable Securities of any Holder or such Holders joining in such request as are specified in a written request received by the Company within 20 days after receipt of such written notice from the Company; provided, however, that the Company shall not be obligated to take any action to effect any such registration, qualification, or compliance pursuant to this Section 5:
 
(1)                                   in any particular jurisdiction in which the Company would be required to execute a general consent to service of process in effecting such registration, qualification, or compliance unless the Company is already subject to service in such jurisdiction and except as may be required by the Act; or
 
(2)                                   if the anticipated aggregate offering price of the Registrable Securities proposed to be registered could not be reasonably determined by the Initiating Holders at the time of their request for registration to be at least $5 million; or
 
(3)                                   prior to the earlier of (i) November 1, 2004 or (ii) the date six months immediately following the effective date of any registration statement pertaining to the initial public offering of securities of the Company (other than a registration of securities in a Rule 145 transaction or with respect to an employee benefit plan); or
 
(4)                                   after the Company has effected three such registrations pursuant to this Section 5(a), and such registrations have been declared or ordered effective; or
 
(5)                                   at any time during which the Company is qualified to use Form S-3 for registration of the Registrable Securities, provided the Company treats the Initiating Holders’ request as a request for registration pursuant to Section 7 and promptly proceeds to effect such registration; or
 
(6)                                   if the Company shall furnish to such Holders a certificate signed by the President of the Company stating that in the good faith judgment of the Board of Directors it would be seriously detrimental to the Company or its stockholders for a registration statement to be filed in the near future, whereby the Company’s obligations to use its best efforts to register, qualify or comply under this Section 5(a) shall be deferred for a period of up to 120 days; provided, however, that the Company shall not exercise such right more than once in a twelve-month period.
 
Subject to the foregoing clauses (1) through (6), the Company shall file a registration statement covering the Registrable Securities so requested to be registered as soon as reasonably practicable after receipt of the request or requests of the Initiating Holders.
 
5

 
(b)                                  Underwriting .  If the Initiating Holders intend to distribute the Registrable Securities covered by their request by means of an underwriting, they shall so advise the Company as part of their request made pursuant to Section 5, and the Company shall include such information in the written notice referred to in Section 5(a)(i) above.  The right of any Holder to registration pursuant to Section 5 shall be conditioned upon such Holder’s participation in the underwriting arrangements described by this Section 5(b), and the inclusion of such Holder’s Registrable Securities in the underwriting (unless otherwise mutually agreed by a majority in interest of the Initiating Holders and such Holder with respect to such participation and inclusion) to the extent requested shall be limited to the extent provided herein.  A Holder may elect to include in such underwriting all or any portion of the Registrable Securities he, she or it holds.
 
The Company shall (together with all Holders proposing to distribute their securities through such underwriting) enter into an underwriting agreement in customary form with a managing underwriter of recognized national standing selected for such underwriting by the Company and reasonably acceptable to a majority of the Holders proposing to distribute their securities through such underwriting.  Notwithstanding any other provision of this Section 5, if the managing underwriter advises the Initiating Holders in writing that marketing factors require a limitation of the number of shares to be underwritten, then the Company will so advise all Holders of Registrable Securities, and the number of shares of Registrable Securities that may be included in the registration and underwriting shall be allocated among all such Holders thereof in proportion, as nearly as practicable, to the respective amounts of Registrable Securities held by such Holder; provided, however, that the number of shares of Registrable Securities to be included in such underwriting shall not be reduced unless all other securities are first entirely excluded from the underwriting.  No Registrable Securities excluded from the underwriting by reason of the underwriter’s marketing limitation shall be included in such registration.  To facilitate the allocation of shares in accordance with the above provisions, the Company or the underwriters may round the number of shares allocated to any Holder to the nearest 100 shares.
 
If any Holder of Registrable Securities disapproves of the terms of the underwriting, such Holder may elect to withdraw therefrom by written notice to the Company, the managing underwriter and the Initiating Holders.  The Registrable Securities and/or other securities so withdrawn shall also be withdrawn from registration; provided, however, that if by the withdrawal of such Registrable Securities a greater number of Registrable Securities held by other Holders may be included in such registration (up to the maximum of any limitation imposed by the underwriters), then the Company will offer to all other Holders who have included Registrable Securities in the registration the right to include additional Registrable Securities in the same proportion used in determining the underwriter limitation in this Section 5(b).
 
If the underwriter has not limited the number of Registrable Securities to be underwritten, the Company may include securities for its own account if the underwriter so agrees and if the number of Registrable Securities that would otherwise have been included in such registration and underwriting will not thereby be limited.
 
6

 
6.                                        Company Registration .
 
(a)                                   Notice of Registration .  If at any time or from time to time, the Company shall determine to register any of its securities, either for its own account or the account of any holder of its securities, other than (i) a registration relating solely to employee benefit plans, (ii) a registration relating solely to a Commission Rule 145 transaction, (iii) a registration pursuant to Section 5 hereof, or (iv) a registration pursuant to Section 7 hereof, the Company will :
 
(i)                                      promptly give to each Holder written notice thereof; and
 
(ii)                                   include in such registration (and any related qualification under blue sky laws or other compliance), and in any underwriting involved therein, all the Registrable Securities specified in a written request or requests, made within 20 days after receipt of such written notice from the Company, by any Holder.  Such written request may seek the registration of all or any portion of a Holder’s Registrable Securities.
 
(b)                                  Underwriting .  If the registration of which the Company gives notice is for a registered public offering involving an underwriting, the Company shall so advise the Holders as a part of the written notice pursuant to Section 6(a)(i).  In such event, the right of any Holder to registration pursuant to this Section 6 shall be conditioned upon such Holder’s participation in such underwriting and the inclusion of Holder’s Registrable Securities in the underwriting to the extent provided herein.  All Holders proposing to distribute their securities through such underwriting shall (together with the Company) enter into an underwriting agreement in customary form with the managing underwriter selected for such underwriting by the Company.  Notwithstanding any other provision of this Section 6, if the managing underwriter determines that marketing factors require a limitation of the number of shares to be underwritten, the managing underwriter may (subject to the limitation set forth below) limit or exclude from such underwriting the Registrable Securities and other securities of the Holders to be distributed.  If the Company is so advised by the managing underwriter, then all securities other than Registrable Securities and the securities proposed to be registered by the Company shall first be excluded from the registration.  If additional securities must be eliminated as a consequence of the managing underwriter’s determination, then the Company shall so advise all Holders distributing their Registrable Securities through such underwriting of such limitation or exclusion and, if applicable, the number of shares of Registrable Securities that the managing underwriter determines may be included in the registration and underwriting shall be allocated among all Holders of Registrable Securities in proportion, as nearly as practicable, to the respective amounts of Registrable Securities held by such Holders.  Notwithstanding the foregoing, in no event shall the amount of securities of the selling Holders included in the offering be reduced below thirty percent (30%) of the total amount of securities included in such offering, unless such offering is the initial public offering of the Company’s securities, in which case the selling Holders may be excluded entirely if the underwriters make the determination described above and no other stockholder’s securities are included in such initial public offering.  To facilitate the allocation of shares in accordance with the above provisions, the Company may round the number of shares allocated to any Holder or holder to the nearest 100 shares.
 
7

 
If any Holder of Registrable Securities disapproves of the terms of the underwriting, such Holder may elect to withdraw therefrom by written notice to the Company and the managing underwriter.  If by the withdrawal of such Registrable Securities a greater number of Registrable Securities held by other Holders may be included in such registration (up to the maximum of any limitation imposed by the underwriters), then the Company will offer to all other Holders who have included Registrable Securities in the registration the right to include additional Registrable Securities in the same proportion used in determining the underwriter limitation in this Section 6(b).
 
(c)                                   Right to Terminate Registration .  The Company shall have the right to terminate or withdraw any registration by it under this Section 6 prior to the effectiveness of such registration whether or not any Holder has elected to include securities in such registration.
 
7.                                        Registration on Form S-3 .
 
(a)                                   Subject to the remainder of this Section 7, and unless Rule 144 is available for effecting a proposed transfer of all of the Registrable Securities of a Holder and such transfer would result in the removal of the restrictive legend required by Section 2(a) hereof, in the event that (i) the Company receives from any Holder or Holders a written request that the Company file a registration statement on Form S-3 (or any successor form to Form S-3), or any similar short form registration statement (collectively, “Form S-3”), for a public offering of Registrable Securities, the reasonably anticipated aggregate price to the public of which, net of underwriting discounts and commissions, would exceed $2 million and (ii) the Company is a registrant entitled to use Form S-3 to register the Registrable Securities for such an offering, the Company will promptly give written notice of the proposed registration to all other Holders.  As soon as reasonably practicable thereafter, the Company will use its diligent best efforts to cause all Registrable Securities to be registered as may be so requested for the offering on such form and as would permit or facilitate the sale and distribution of all or such portion of such Registrable Securities as are specified in such request, together with all or such portion of the Registrable Securities of any Holder or Holders joining in such request as are specified in a written request received by the Company within (20) days after receipt of such written notice from the Company.  The provisions of Section 5(b) shall be applicable to each registration initiated under this Section 7.
 
(b)                                  Notwithstanding the foregoing, the Company will not be obligated to take any action pursuant to this Section 7(a):  (i) in any particular jurisdiction in which the Company would be required to execute a general consent to service of process in effectuating such registration, qualification, or compliance unless the Company is already subject to service in such jurisdiction and except as may be required by the Act; (ii) if the Company has previously effected two registrations pursuant to Section 7(a) whose effective dates were within the twelve month period whose last day is the date the Company receives the request; and (iii) if the Company shall furnish to such Holder a certificate signed by the President of the Company stating that, in the good faith judgment of the Board of Directors, it would be seriously detrimental to the Company or its stockholders for registration statements to be filed in the near future or for any disclosure to be made that, in the opinion of the Board of Directors, duly advised by counsel, is required to be made in connection with the sale of Registrable Securities
 
8

 
pursuant to such registration, whereby the Company’s obligation to use its best efforts to file a registration statement shall be deferred for a period not to exceed 120 days from the receipt of the request to file such registration by such Holder; provided however, that the Company shall not exercise such right more than once in any twelve-month period.
 
8.                                        Expenses of Registration .  All Registration Expenses incurred in connection with the registrations pursuant to Sections 5, 6 and 7 shall be borne by the Company.
 
9.                                        Registration Procedures .  Whenever required under this Agreement to effect the registration of any Registrable Securities, the Company will:
 
(a)                                   Prepare and promptly file with the Commission a registration statement with respect to such Registrable Securities and use its best efforts to cause such registration statement to become and remain effective for the greater of (i) one hundred twenty (120) days or (ii) until the distribution described in the registration statement has been completed;
 
(b)                                  Prepare and file with the Commission such amendments and supplements to such registration statements and the prospectus used in connection with such registration statement as may be necessary to comply with the provisions of the Act with respect to the disposition of all securities covered by such registration statement;
 
(c)                                   At least two business days before filing a registration statement or prospectus including Registrable Securities and at least two business days before filing any amendments or supplements thereto, furnish to the counsel of the Holders copies of all documents proposed to be filed for that counsel’s review and approval, which approval shall not be unreasonably withheld or delayed;
 
(d)                                  Furnish to the Holders participating in such registration and to the underwriters of the securities being registered such reasonable number of copies of the registration statement, preliminary prospectus, final prospectus and such other documents as such Holders and underwriters may reasonably request in order to facilitate the public offering of such securities;
 
(e)                                   Furnish, at the request of any Holder requesting registration of Registrable Securities pursuant to this Agreement, on the date that such Registrable Securities are delivered to the underwriters for the sale in connection with a registration pursuant to this Agreement, or, if such securities are not being sold through underwriters, on the date that the registration statement with respect to such securities becomes effective, (i) an opinion, dated such date, of counsel representing the Company for the purposes of such registration, in form and substance as is customarily given to underwriters in an underwritten public offering, addressed to the underwriters, if any, and to the Holders requesting registration of Registrable Securities and (ii) a letter dated such date, from the independent accountants of the Company, in form and substance as is customarily given by independent accountants to underwriters in an underwritten public offering, addressed to the underwriters, if any, and to the Holders requesting registration of Registrable Securities;
 
9

 
(f)                                     In the event of any underwritten public offering, enter into and perform its obligations under an underwriting and other agreements, in usual and customary form, with the managing underwriter of such offering and take all other actions in connection with those agreements reasonably necessary to effect the offer and sale of the Registrable Securities.  Each Holder participating in such underwriting shall also enter into and perform its obligations under such underwriting agreement;
 
(g)                                  Notify each Holder of Registrable Securities covered by such registration statement at any time when a prospectus relating thereto is required to be delivered under the Securities Act of the happening of any event as a result of which the prospectus included in such registration statement, as then in effect, or any document included therein by reference includes an untrue statement of material fact or omits to state a material fact required to be stated therein or necessary to make the statements therein not misleading in the light of the circumstances then existing, and prepare a supplement or amendment to the prospectus or any such document incorporated therein by reference so that thereafter the prospectus will not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading in light of the circumstances then existing;
 
(h)                                  Cooperate with each seller of Registrable Securities and each underwriter or agent participating in the disposition of such Registrable Securities and their respective counsel in connection with any required filings with the National Association of Securities Dealers, Inc.;
 
(i)                                      Cause such Registrable Securities registered pursuant hereunder to be listed on each securities exchange or each inter-dealer quotation system on which similar securities issued by the Company are then listed or quoted;
 
(j)                                      Provide an institutional transfer agent and registrar for all Registrable Securities registered pursuant hereunder and a CUSIP number for all such Registrable Securities, in each case not later than the effective date of such registration;
 
(k)                                   Use its reasonable best efforts to register and qualify the securities covered by such registration statement under such other securities or blue sky laws of such jurisdictions as shall be reasonably requested by the Holders, provided that the Company shall not be required in connection therewith or as a condition thereto to qualify to do business or to file a general consent to service of process in any such states or jurisdictions;
 
(l)                                      Subject to reasonable confidentiality agreements, make available for inspection during business hours on reasonable advance notice by any underwriter participating in any disposition pursuant to a registration statement, and any attorney, accountant or other agent of such underwriter (collectively, the “Inspectors”), financial records, pertinent corporate documents and properties of the Company (collectively, the “Records”) as shall be reasonably necessary to enable them to exercise their due diligence responsibility, and cause the Company’s officers, directors and employees to supply all information reasonably requested by any such Inspector in connection with such registration statement.  Records which the Company determines, in good faith, to be confidential and which it notifies the Inspectors are confidential
 
10

 
shall not be disclosed by the Inspectors unless (i) the disclosure of such Records is necessary to avoid or correct a material misstatement or omission in the registration statement or (ii) the release of such Records is ordered pursuant to a subpoena or other order from a court of competent jurisdiction.  Each Holder selling Registrable Securities further agrees that it will, upon learning that disclosure of such Records is sought in a court of competent jurisdiction, give written notice to the Company, and allow the Company, at the Company’s expense, to undertake appropriate action to prevent disclosure of the Records it deemed confidential.  Each Holder of such Registrable Securities further agrees that information obtained by it as a result of such inspections which is deemed confidential by the Company shall not be used by it, and it shall cause each of its Inspectors not to use such confidential information as the basis for any market transactions in securities of the Company or for any purpose other than any due diligence review with respect to decisions regarding such Holder’s investment in the Registrable Shares, unless and until such information is made generally available to the public; and
 
(m)                                Notify the Holders and the managing underwriters, if any, promptly, and (if requested by any such Person) confirm such advice in writing, (i) when the registration statement, the prospectus or any prospectus supplement or post-effective amendment, has been filed, and, with respect to the registration statement or any post-effective amendment, when the same has become effective, (ii) of the issuance by the Commission of any stop order suspending or threatening to suspend the effectiveness of a registration statement or of any order preventing or suspending the use of any preliminary prospectus or the initiation of any proceedings for that purpose and the Company shall promptly use its best efforts to prevent the issuance of any stop order or to obtain a withdrawal of such stop order should the order be issued and (iii) of the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of a registration statement of any of the Registrable Securities for offer or sale in any jurisdiction, or the initiation or threatening of any proceeding for such purpose.
 
10.                                  Indemnification .  In the event any Registrable Securities are included in a registration statement filed pursuant to this Agreement.
 
(a)                                   To the extent permitted by law, the Company will indemnify each Holder, each of its officers, directors, and partners, and each person controlling such Holder within the meaning of Section 15 of the Act, with respect to which registration, qualification, or compliance has been effected pursuant to this Agreement, and each underwriter, if any, and each person who controls any underwriter within the meaning of Section 15 of the Act, against all expenses, claims, losses, damages, or liabilities (whether joint or several and including actions in respect thereof), including any of the foregoing incurred in settlement of any litigation, commenced or threatened, arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in any registration statement, prospectus, offering circular, or other document, or any amendment or supplement thereto, incident to any such registration, qualification or compliance, or based on any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances in which they were made, not misleading, or any violation by the Company of the Act, the Exchange Act, any federal or state securities law or any rule or regulation promulgated under the Act, the Exchange Act or any federal or state securities law or regulation applicable to the Company in connection with any such registration, qualification, or
 
11

 
compliance, and the Company will reimburse each such Holder, each of its officers, directors, partners, each person controlling such Holder, each such underwriter and each person who controls such underwriter, for any legal and any other expenses reasonably incurred in connection with the investigating, preparing, or defending any such claim, loss, damage, liability, or action; provided that the Company will not be liable in any such case to the extent that any such claim, loss, damage, liability or expense arises out of or is based solely on any untrue statement or omission or alleged untrue statement or omission, made solely in reliance upon and in conformity with written information furnished to the Company by an instrument duly executed by such Holder, controlling person, or underwriter and stated to be specifically for use therein; and provided further, that the Company will not be liable to any underwriter or any person who controls such underwriter for any claim, loss, damage, liability or expense that arises out of or is based upon any untrue statement or omission or alleged untrue statement or omission made in a preliminary prospectus on file with the Securities and Exchange Commission at the time the Registration Statement becomes effective or in the amended prospectus filed with the Securities and Exchange Commission pursuant to Rule 424(b) (the “Final Prospectus”) if a copy of the Final Prospectus was not furnished to the person asserting the claim, loss, damage, liability or expense at or prior to the time such action is required by the Act.
 
(b)                                  To the extent permitted by law, each Holder will, if Registrable Securities held by such Holder are included in the securities as to which such registration, qualification, or compliance is being effected, and each other Company stockholder whose securities are included in the securities as to which such registration, qualification or compliance is being effected (“Other Stockholder”) indemnify the Company, each of its directors and officers, each underwriter, if any, of the Company’s securities covered by such a registration statement, each person who controls the Company or such underwriter within the meaning of Section 15 of the Act, and each other such Holder and Other Stockholder, each of its officers, directors, and partners and each person controlling such Holder and Other Stockholder within the meaning of Section 15 of the Act, against all claims, losses, damages and liabilities (whether joint or several and including actions in respect thereof) arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in any such registration statement, prospectus, offering circular or other document, or any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, and will reimburse the Company, such other Holders, such Other Stockholders, such directors, officers, persons, underwriters, or control persons for any legal or any other expenses reasonably incurred in connection with investigating or defending any such claim, loss, damage, liability or action, in each case to the extent, but only to the extent, that such untrue statement (or alleged untrue statement) or omission (or alleged omission) is made in such registration statement, prospectus, offering circular, or other document in reliance upon and conformity with written information furnished to the Company by an instrument duly executed by such Holder or such Other Stockholder and stated to be specifically for use therein; provided, however, that the indemnity agreement contained in this subsection 10(b) shall not apply to amounts paid in settlement of any such claim, loss, damage, liability or action if such settlement is effected without the consent of the Holder or the Other Stockholder, which consent shall not be unreasonably withheld; and provided further, that, in no event shall any indemnity under this subsection 10(b) exceed the net proceeds (after deducting any discounts or commissions received by any underwriter in connection with such registration) from the offering received by such Holder or such Other Stockholder; and provided further, that any such Holder or such Other
 
12

 
Stockholder will not be liable to any underwriter or any person who controls such underwriter for any claim, loss, damage, liability or expense that arises out of or is based upon any untrue statement or omission or alleged untrue statement or omission made in the Final Prospectus if a copy of the Final Prospectus was not furnished to the person asserting the claim, loss, damage, liability or expense at or prior to the time such action is required by the Act.
 
(c)                                   Each party entitled to indemnification under this Section 10 (the “Indemnified Party”) shall give notice to the party required to provide indemnification (the “Indemnifying Party”) promptly after such Indemnified Party has actual knowledge of any claim as to which indemnity may be sought, and shall permit the Indemnifying Party to assume the defense of any such claim or litigation resulting therefrom, provided that counsel for the Indemnifying Party, who shall conduct the defense of such claim or litigation, shall be approved by the Indemnified Party (whose approval shall not unreasonably be withheld), and the Indemnified Party may participate in such defense at such party’s expense, and provided further that the failure of any Indemnified Party to give notice as provided herein shall not relieve the Indemnifying Party of its obligations under this Agreement except to the extent, but only to the extent, that the failure to give such notice is materially prejudicial to an Indemnifying Party’s ability to defend such action and provided further, that the Indemnifying Party shall not assume the defense for matters as to which there is a conflict of interest or separate and different defenses but shall bear the expense of such defense nevertheless.  No Indemnifying Party, in the defense of any such claim or litigation, shall, except with the consent of each Indemnified Party, consent to entry of any judgment or enter into any settlement which does not include as an unconditional term thereof the giving by the claimant or plaintiff to such Indemnified Party of a release from all liability in respect to such claim or litigation.
 
(d)                                  If the indemnification provided for in this Section 10 is unavailable to or unenforceable by the Indemnified Party in respect of any losses, claims, damages, liabilities or judgments referred to herein, then each such Indemnifying Party, in lieu of indemnifying such Indemnified Party, shall contribute to the amount paid or payable by such Indemnified Party as a result of such losses, claims, damages, liabilities and judgments in such proportions as is appropriate to reflect the relative fault of the Indemnified Party in connection with the actions or inactions which resulted in such losses, claims, damages, liabilities and judgments, as well as any other relevant equitable considerations (including the relative fault and indemnification or contribution obligations of other relevant parties).  The relative fault of the Indemnifying Party on the one hand and of the Indemnified Party on the other shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information supplied by the Indemnifying Party or by the Indemnified Party, and by such party’s relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission.  The Indemnified Persons agree that it would not be just and equitable if contribution pursuant to this Section 10(d) were determined by pro rata allocation or by any other method of allocation which does not take account of the equitable considerations referred to in the immediately preceding paragraph.  No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation.  In no event shall any Holder or Other Stockholder be liable for contribution pursuant to this Section 10(d) to the extent the aggregate payments made by such Holder or Other Stockholder pursuant to Section 10(b) and this Section 10(d)
 
13

 
exceed the net proceeds (after deducting any discounts or commissions received by an underwriter in connection with such registration) from the offering received by such Holder or Other Stockholder.
 
(e)                                   The obligations of the Company and the Holders under this Section 10 shall survive the completion of any offering of Registrable Securities in a registration statement pursuant to this Agreement.
 
11.                                  Information by Holder .  The Holder or Holders of Registrable Securities included in any registration shall furnish to the Company such information regarding such Holder or Holders, the Registrable Securities held by them, and the distribution proposed by such Holder or Holders as the Company may request in writing and as shall be required in connection with any registration, qualification, or compliance referred to in this Agreement.
 
12.                                  Rule 144 Reporting .  With a view to making available the benefits of certain rules and regulations of the Commission which may at any time permit the sale of the Restricted Securities to the public without registration, after such time as a public market exists for the Common Stock of the Company, the Company agrees to use its best efforts to:
 
(a)                                   Make and keep public information available, as those terms are understood and defined Rule 144 under the Act, at all times after the effective date that the Company becomes subject to the reporting requirements of the Act or the Exchange Act.
 
(b)                                  File with the Commission in a timely manner all reports and other documents required of the Company under the Act and the Exchange Act; and
 
(c)                                   So long as a Holder owns any Restricted Securities, to furnish to the Holder forthwith upon request a written statement by the Company as to its compliance with the reporting requirements of said Rule 144 (at any time after 90 days after the effective date of the first registration statement filed by the Company for an offering of its securities to the general public), a copy of the most recent annual or quarterly report of the Company, and such other reports and documents of the Company and other information in the possession of or reasonably obtainable by the Company as a Holder may reasonably request in availing itself of any rule or regulation of the Commission allowing a Holder to sell any such securities without registration.
 
13.                                  Transfer of Registration Rights .  The rights to cause the Company to register securities granted to Holders under Sections 5, 6, and 7 may be assigned to a transferee or assignee in connection with any transfer or assignment of Registrable Securities by a Holder of not less than 100,000 shares of Registrable Securities (subject to the limitations of Section 3), or to any transferee or assignee who is an affiliate or a constituent partner of a Holder or the estate of such constituent partner, provided that such transfer may otherwise be effected in accordance with applicable securities laws, and notice of such transfer is provided promptly to the Company.
 
14.                                  Market Standoff Agreement .  Each Holder agrees in connection with the Company’s initial public offering of securities, upon request of the Company or the underwriters managing such offering of the Company’s securities, not to sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of any Registrable Securities (other
 
14

 
than those Registrable Securities included in the registration and other than transactions with affiliates of the Holder who shall agree to be similarly bound) without the prior written consent of the Company or such underwriters, as the case may be, for such period of time (not to exceed, in any event, one hundred twenty (120) days) from the effective date of such registration as may be requested by the underwriters; provided, however, that the Holders shall have no such obligation under this paragraph 14 unless the officers and directors and all holders of at least one percent (1%) of the Company’s issued and outstanding capital stock shall also agree to such restrictions.
 
15.                                  Limitations on Registration of Resales of Securities .  From and after the date of this Agreement, the Company shall not enter into any agreement with any holder or prospective holder of any securities of the Company giving such holder or prospective holder either (i) the right to require the Company to initiate any registration of any securities of the Company or (ii) the right to have its securities included in a registration by the Company, the Holders pursuant to this Agreement or any other person or entity if such right would permit the securities held by such holder or perspective holder to be registered before all Registrable Securities that have been requested to be included are included.  The Company’s obligations set forth in the preceding sentence shall be for a period of four years (plus the aggregate number of days that the Company has delayed any registrations pursuant to its rights under Section 5(a)(6)) following the effective date of the initial public offering of the Company’s Common Stock registered under the Securities Act.  This Section 15 shall not limit the right of the Company to enter into any agreements with any holder or prospective holder of any securities of the Company giving such holder or prospective holder the right to require the Company, upon any registration of any of its securities (except on initial public offering), to include, among the securities which the Company is then registering, securities owned by such holder so long as they are subject to all cutback and priority limitations of this Agreement.
 
16.                                  Notices, etc.   All notices and other communications required or permitted hereunder shall be in writing and shall be deemed effectively given upon delivery to the party to be notified in person or by courier service or five (5) days after deposit with the United States mail, by registered or certified mail, postage prepaid, addressed (a) if to a Holder of any Registrable Securities, to its address set forth on the Schedule of Purchasers attached hereto or such address as such holder shall have furnished the Company in writing, or (b) if to the Company, to:
 
Acorda Therapeutics, Inc.
15 Skyline Drive
Hawthorne, NY  10532
Attn:  Chief Financial Officer
 
or at such other address as the Company shall have furnished to the Holders in writing.
 
17.                                  Amendment .  Any provision of this Agreement may be amended, waived or modified upon the written consent of (i) the Company and (ii) holders of sixty percent or more of the outstanding shares of Registrable Securities.  Any Holder may waive any of its rights or the Company’s obligations hereunder without obtaining the consent of any other person.
 
15

 
18.                                  Suppression of Earlier Agreement .  This Agreement shall supersede in its entirety the Prior Agreement.  This agreement shall be effective simultaneous with the closing of the initial sale of Series J Preferred Stock by the Company, provided at such time Holders that hold sufficient shares of Preferred Stock and shares of one or more series of Preferred Stock sufficient to amend the Prior Agreement shall have executed and delivered a signed counterpart of this Agreement.
 
19.                                  Counterparts .  This Agreement may be executed in any number of counterparts, each of which shall be an original and all of which together shall constitute one instrument.
 
20.                                  Governing Law .  This Agreement shall be governed by the laws of the State of Delaware.
 
21.                                  Regulated Financial Institutions Compliance Obligations .  Nothing in this agreement shall diminish the continuing obligations of any financial institution to comply with applicable requirements of law that it maintain responsibility for the disposition of, and control over its admitted assets, investments and property, including (without limiting the generality of the foregoing) the provisions of Section 1141(b) of the New York Insurance Law, as amended, and as hereinafter from time to time in effect.
 
22.                                  Listing .  If the Common Stock is listed for trading on any national securities exchange, that listing shall include all Registrable Securities of the Holders (to the extent permitted by the rules of the exchange).
 
23.                                  Severability .  Whenever possible, each provision of this Agreement shall be interpreted in such a manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable law, that provision will be ineffective only to the extent of the prohibition or invalidity, without invalidating the remainder of this Agreement.
 
24.                                  Specific Performance .  Each of the parties agrees that damages for a breach of or default under this Agreement would be inadequate and that in addition to all other remedies available at law or in equity the parties and their successors and assigns shall be entitled to specific performance on injunctive relief, or both, in the event of a breach or a threatened breach of this Agreement.
 
25.                                  Validity of Provisions .  Should any part of this Agreement for any reason be declared by any court of competent jurisdiction to be invalid, that decision shall not affect the validity of the remaining portion, which shall continue in full force and effect as if this Agreement had been executed with the invalid portion eliminated, it being the intent of the parties that they would have executed the remaining portion of the Agreement without including any part or portion that may for any reason be declared invalid.
 
26.                                  Waiver of Breach .  Neither any waiver of any breach of, nor any failure to enforce any term or condition of, this Agreement shall operate as a waiver of any other breach of any term or condition, nor constitute nor be deemed a waiver or release of any other rights, in law or at equity, or claims that any party may have against any other party for anything arising
 
16

 
out of, connected with, or based upon this Agreement.  No waiver shall be enforceable against any party hereto unless set forth in a written instrument or agreement signed by that party.  No waiver shall be deemed to occur as a result of the failure of any party to enforce any term or condition of this Agreement.
 
17

 
IN WITNESS WHEREOF, the undersigned have executed this Fifth Amended and Restated Registration Rights Agreement as of the date first set forth above.

 	 	“Company”	
 	 	 	
 	 	 	Acorda Therapeutics, Inc.
 a Delaware corporation	
 	 	 	
 	 	 	By:	 	
 	 	 	Ron Cohen, M.D., President and CEO	

 	 	“Holders”	

 	 	 	(Print Name of Holder)	

 	 	 	(Signatory)	

 	 	 	(Print Name of Signatory)	

 	 	 	(Title of Signatory)	

18

 
SCHEDULE OF PURCHASERS

Names and Addresses	 	Names and Addresses	

 	 	 	

 
Exhibit 10.5
 
ACORDA
Therapeutics
 
August 11, 2002
 
Dr. Ron Cohen
145 West 58 th Street
New York, NY 10019
 
Dear Ron:
 
We are delighted to present this letter agreement, setting out the terms of your continued employment with Acorda Therapeutics, Inc. (the “Company”) as President, Director and Chief Executive Officer.  If these terms are acceptable, please sign and date the copy of this letter provided herewith and return it to me at your first convenience.  If you accept the terms offered herein, this Agreement shall be deemed to be effective as of January 1, 2002 (the “Effective Date”).
 
1.                                       Employment.
 
You will be employed by the Company, as President and Chief Executive Officer.  As President and Chief Executive Officer you will have overall responsibility for all aspects of the Company’s business.  You will report directly to the Board of the Director’s of the Company (the “Board”).  You will also serve as a member of the Board.
 
2.                                       Base Salary.
 
In consideration for your services under this Agreement, you shall be paid an annual base salary of Two Hundred and Eighty Thousand Dollars ($280,000), to be paid in accordance with the Company’s standard payroll practices. Your base salary shall be reviewed annually by the Board and any increase to your base salary shall be determined by the Board based on your performance and the Company’s overall performance.
 
3.                                       Annual Bonus.
 
You shall be eligible to receive an annual bonus in an amount determined by the Board in its sole discretion based on your performance.
 
4.                                       Benefits; Perquisites; Reimbursement of Expenses.
 
In addition to those payments set forth above, you shall be entitled to the following benefits and payments:
 
(a)                                   Employee Benefit Plans Generally .  You shall be entitled to participate in all employee benefit plans which the Company provides or may establish from time to time for the benefit of its senior executives.
 
(b)                                  Vacation .  You shall be entitled to paid vacation in accordance with the Company’s vacation policy as that policy may be amended from time to time.

 
(c)                                   Perquisites and Reimbursement of Expenses .  You shall be entitled to all perquisites offered to senior executives of the Company.  In addition, you shall be entitled to reimbursement for all ordinary and reasonable out-of-pocket business expenses which are incurred by you in furtherance of the Company’s business, in accordance with the policies adopted from time to time by the Company.
 
(d)                                  Insurance .  You shall be covered by a Directors and Officers Liability Insurance policy that generally covers the directors and officers of the Company, provided by the Company at its expense.  You shall cooperate in all respects with the Company’s efforts to obtain and maintain key person life insurance on your life.
 
(e)                                   Legal Fees .  The Company shall reimburse you for legal fees incurred in connection with the negotiation and drafting of this Agreement, up to a maximum of  Five Thousand Five Dollars ($5,500).
 
5.                                       Stock Options.
 
You shall be eligible to receive annual performance-based stock option grants to purchase shares of the Company’s common stock.  The number of annual options granted shall be determined by the Board, based on the achievement of individual performance objectives and the Company’s achievement of its goals and objectives.  All such options shall be granted pursuant to and in accordance with the terms of the Acorda Therapeutics, Inc. 1999 Employee Stock Option Plan and/or any additional or replacement plan adopted by the Board (the “Plan(s)”) except as such terms may be specifically modified herein.  Unless otherwise provided for in any option agreement, all options granted to you shall vest in 16 equal quarterly installments, beginning with the first day of the quarter next following the date the option is granted.  Unless otherwise limited by IRS rules governing the issuance of incentive options to principal stockholders of the Company, all options shall be exercisable for 10 years following the date of grant.  You shall be eligible to exercise all options granted on a cashless basis, and otherwise in accordance with the terms of the Plan(s).
 
6.                                       Term; Termination.
 
(a)                                   Term .  The term of this Agreement shall continue for a period of one year following the Effective Date, unless earlier terminated as provided herein, and shall be automatically renewed for successive one year terms unless the Company or you provide written notice of its or your determination not to renew this Agreement at least 60 days prior to the expiration of the then current term. A determination by you or the Company not to renew this Agreement based upon Good Reason or Without Cause, as the case may be, shall be deemed a termination of employment for purposes of Section 6(c) and the terms thereof shall apply.
 
2

 
(b)                                  Death or Disability .  Your employment with the Company shall terminate as of the date of your death or the date you are determined to be “Disabled.”  Upon such termination, the following shall apply:
 
(i)                                      The Company shall pay to you or your estate, as the case may be, (A)  all amounts due and owing as of the date of termination and (B) your base salary through the end of the third month following the date your employment is terminated.
 
(ii)                                   If you or your eligible spouse and dependents timely elect health care continuation coverage (“COBRA Coverage”), the Company shall pay the monthly premiums for such coverage for the duration of the applicable COBRA Coverage period.
 
(iii)                                65% of all unvested stock options shall become immediately vested and shall remain exercisable by you or your estate, as the case may be, for 48 months following the termination date.
 
For these purposes, you shall be considered to be Disabled if you are unable to perform the substantial functions of your position for 180 consecutive days or more in a 12 month period, unless a greater period is required by law.  A determination of disability shall be made jointly by a physician of your choice and a physician of the Company’s choice.  If both physicians can not agree on whether you are Disabled, a third physician chosen by the first two shall make the final and binding determination.
 
(c)                                   Termination of Your Employment by the Company Without Cause or Voluntary Termination by You With Good Reason .  If the Company terminates your employment without Cause or if you terminate your employment with Good Reason the following shall apply:
 
(i)                                      The Company shall pay to you your base salary for a period of one (1) year following the date of such termination (the “Severance Period”).  You shall be under no obligation to secure alternative employment during the Severance Period, and payment of your base salary shall be made without regard to any subsequent employment you may obtain.
 
(ii)                                   The Company shall also pay you a bonus equal to the last annual bonus you received multiplied by a fraction, the numerator of which shall be the number of days in the calendar year elapsed as of the termination date and the denominator of which shall be 365.
 
(iii)                                If you or your eligible spouse and dependents timely elect COBRA Coverage, the Company shall pay the monthly premiums for such coverage during the Severance Period; provided that, if you elect coverage under a subsequent employer’s group health insurance plan during the Severance Period, payment of such premiums shall cease.
 
3

 
(iv)                               All stock options granted to you hereunder or under any other agreement shall become immediately and fully vested as of the termination date, and shall remain exercisable for 48 months following such date.
 
(d)                                  Termination of Your Employment by the Company With Cause or by You Without Good Reason .  The Company may terminate your employment with Cause or you may resign at any time.  In such case, you shall be paid all amounts due for services rendered under this Agreement up until the termination date.  Thereafter, no further payments shall be made to you under this Agreement.  All stock options granted to you hereunder or under any other agreement that are fully vested as of the date of your termination shall remain exercisable for ninety (90) days from the termination date.  If you dispute the grounds for your termination, your vested options will remain exercisable until ninety (90) day after the date the dispute is resolved.  All unvested options shall be forfeited.
 
(e)                                   Cause .  As used herein, “Cause” means that you have:
 
(i)                                      committed gross negligence in connection with your duties as set forth herein or otherwise with respect to the business and affairs of the Company, which gross negligence has a material adverse effect on the business of the Company or your ability to perform your duties under this Agreement;
 
(ii)                                   committed fraud in connection with your duties as set forth herein or otherwise with respect to the business and affairs of the Company;
 
(iii)                                engaged in “willful misconduct” with respect to the business and affairs of the Company.  For purposes of this Agreement, “willful misconduct” means misconduct committed with actual knowledge that your actions violate directions and instructions of the Board, which directions and instructions are legal and consistent with the Agreement;
 
(iv)                               materially breached your duties under this Agreement, which breach has a material adverse effect on the business of the Company or your ability to perform your duties under the Agreement; or
 
(v)                                  been found by a court of competent jurisdiction to have committed or plead guilty to an unlawful act whether or not related to the business of the Company if the commission of such act has a material adverse effect either on (a) your ability to perform your duties under the Agreement or (b) the reputation and goodwill of the Company.
 
“Cause” shall be found only by a majority of the full Board and only after you have received notice from the Board, have had an opportunity to
 
4

 
discuss the issues with the Board, have had an opportunity to be heard generally and through counsel, and have been given a 30 day period to cure, where cure is feasible.
 
(f)                                     Good Reason .  As used herein, “Good Reason” means that:
 
(i)                                      the Company has materially breached this Agreement;
 
(ii)                                   you are removed or not appointed as a member the Board;
 
(iii)                                the Company fails to acquire the assignment of this Agreement by an acquiring entity;
 
(iv)                               your position has been materially reduced or you have been assigned duties that are materially inconsistent with your duties as set forth herein or which materially impair your ability to perform the services contemplated hereunder; or
 
(v)                                  the Company relocates its offices more than 60 miles from Hawthorne, New York.
 
(vi)                               Termination for Good Reason may occur only after you have given the Board notice and 30 days to cure, where cure is feasible.
 
7.                                       Change in Control.
 
(a)                                   Subject to the provisions of this Section 7, the vesting of your options upon a Change of Control shall be governed by the terms of the Plans and your option agreements, but in no event shall less than 65% of your then unvested stock options become immediately vested and exercisable.
 
(b)                                  Voluntary Termination by You After a Change in Control Without Good Reason.   If you voluntarily terminate your employment following the effective date of the Change in Control the following shall apply:
 
(i)                                      The Company shall pay to you your base salary for a period of one (1) year following the date of such termination (the “Change in Control Severance Period”).  You shall be under no obligation to secure alternative employment during the Change in Control Severance Period, and payment of your base salary shall be made without regard to any subsequent employment you may obtain;
 
(ii)                                   The Company shall also pay you a bonus equal to the last annual bonus you received multiplied by a fraction, the numerator of which shall be the number of days in the calendar year elapsed as of the termination date and the denominator of which shall be 365.  Should the Company revise its compensation schedule, you will be paid a pro-rata bonus as reasonably determined under the compensation system then in place;
 
5

 
(iii)                                If you or your eligible spouse and dependents timely elect COBRA Coverage, the Company shall pay the monthly premiums for such coverage during the Change in Control Severance Period; provided that, if you elect coverage under a subsequent employer’s group health insurance plan during the Change in Control Severance Period, payment of such premiums shall cease; and
 
(iv)                               65% of all outstanding options shall vest as of the termination date and shall remain exercisable for 48 months following such date.
 
(c)                                   If you voluntarily terminate your employment after a Change in Control with Good Reason, then Paragraph 6(c) shall apply in lieu of Paragraph 7(b).
 
(d)                                  Change in Control Defined .  A Change in Control shall be deemed to have occurred if:
 
(i)                                      there is a consolidation or merger of the Company in which the Company is not the continuing or surviving corporation; or there is any other merger or consolidation if, after such merger or consolidation shareholders of the Company immediately prior to such merger or consolidation hold less than 50% of the voting stock of the surviving entity;
 
(ii)                                   there is a sale or transfer of all or substantially all of the assets of the Company in one or a series of transactions or there is a complete liquidation or dissolution of the Company; or
 
(iii)                                any individual or entity or group acting in concert and affiliates thereof, acquires, directly or indirectly, more than 50% of the outstanding shares of voting stock of the Company; provided that this subsection (iii) shall not apply to an underwritten public offering of the Company’s securities.
 
8.                                       Confidentiality/Noncompetition.
 
(a)                                   During the term of your employment and for an additional period of five years after you are no longer employed by the Company, you will not reveal, divulge or make known to any individual, partnership, joint venture, corporation or other business entity (other than the Company or its affiliates) or use for your own account any customer lists, trade secrets or any confidential information of any kind (“Protected Information”) used by the Company or any of its commonly controlled affiliates in the conduct of the Company’s business and made known to you by reason of your employment with the Company or any of its affiliates (whether or not developed, devised or otherwise created in whole or in part by your efforts); provided , that Protected Information shall not include information that shall become known to the public or the trade without violation of this Section 8(a); and provided , further , that you shall not violate this Section 8(a) if Protected Information is disclosed by you at the direction of the Company or if you are required to provide Protected Information in any legal proceeding or by order of any court.
 
6

 
(b)                                  During the term of your employment and for an additional period of one year after you are no longer employed by the Company, you will not, directly or indirectly, engage in a Competitive Business, including owning or controlling an interest in (except as a passive investor owning less than two percent (2%) of the equity securities of a publicly-owned company), or acting as director, officer or employee of, or consultant to, any individual, partnership, joint venture, corporation or other business entity known to you to be engaged in a Competitive Business. “Competitive Business” shall mean the development of therapeutics for spinal cord injuries, multiple sclerosis and other central nervous system conditions for which the Company is actively seeking to develop therapeutics during the term of this Agreement; provided, however, that notwithstanding the aforesaid, you shall not be prohibited from acting in any of the aforesaid capacities for or with respect to any subsidiary, division, affiliate or unit (each, a “Unit”) of an entity if that Unit itself is not engaged in a Competitive Business, irrespective of whether some other Unit of such entity engages in such competition (as long as you do not engage in a Competitive Business for such other Unit).
 
(c)                                   During the term of your employment and for an additional period of one year after you are no longer employed by the Company, you shall not knowingly employ or solicit, encourage or induce any person (except your spouse, if applicable) who at any time within 90 days prior to the termination of your employment shall have been an employee of the Company or any of its commonly controlled affiliates, to become employed by or associated with any individual, partnership, joint venture, corporation or other business entity other than the Company, and you shall not knowingly approach any such employee for such purpose or authorize or knowingly approve the taking of such actions by any other individual, partnership, joint venture, corporation or other business entity or knowingly assist any such individual, partnership, joint venture, corporation or other business entity in taking such action.
 
(d)                                  You acknowledge that the provisions of this Section 8 are reasonable and necessary for the protection of the Company and that each provision, and the period or periods of time and types and scope of restrictions on the activities specified herein are, and are intended to be divisible.  In the event that any provision of this Agreement, including any sentence, clause or part hereof, shall be deemed contrary to law or invalid or unenforceable in any respect by a court of competent jurisdiction, the remaining provisions shall not be affected, but shall, subject to the discretion of such court, remain in full force and effect and any invalid and unenforceable provisions shall be deemed, without further action on the part of the parties hereto, modified, amended and limited to the extent necessary to render the same valid and enforceable.
 
(e)                                   You acknowledge that the Company will be irrevocably damaged if the covenants contained herein are not specifically enforced.  Accordingly, you agree that, in addition to any other relief to which the Company may be entitled, the Company shall be entitled to seek and obtain injunctive relief from a court of competent jurisdiction for the purposes of restraining you from any actual or threatened breach of such covenants.
 
7

 
9.                                       Miscellaneous Provisions.
 
(a)                                   Notices .  All notices and other communications hereunder between you and the Company shall be in writing, shall be addressed to the receiving party’s address of record (or to such other address as a party may designate by notice hereunder), and shall be either (i) delivered by hand, (ii) made by telecopy, (iii) sent by overnight courier, or (iv) sent by certified mail, return receipt requested, postage prepaid.
 
(b)                                  Modifications and Amendments .  The terms and provisions of this Agreement may be modified or amended only by written agreement executed by the parties hereto.
 
(c)                                   Waivers and Consents .  The terms and provisions of this Agreement may be waived, or consent for the departure therefrom granted, only by written document executed by the party entitled to the benefits of such terms or provisions.  No such waiver or consent shall be deemed to be or shall constitute a waiver or consent with respect to any other terms or provisions of this Agreement, whether or not similar.  Each such waiver or consent shall be effective only in the specific instance and for the purpose for which it was given, and shall not constitute a continuing waiver or consent.
 
(d)                                  Assignment .  This Agreement shall inure to the benefit of and be enforceable by your personal or legal representatives, executors, administrators, successors, heirs, distributes, devisees and legatees.  This Agreement  may not be assigned or pledged by you.  In the event of the merger or consolidation of the Company (whether or not the Company is the surviving or resulting corporation), the transfer of all or substantially all the assets of the Company, or the voluntary or involuntary dissolution of the Company, the surviving or resulting corporation or the transferee or transferees of the Company’s assets shall be bound by this and the Company shall take all actions necessary to ensure that such corporation, transferee or transferees assume and are bound by its provisions.
 
(e)                                   Severability .  The parties intend this Agreement to be enforced as written.  However, if any portion or provision of this Agreement shall to any extent be declared illegal or unenforceable by a duly authorized court of proper jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision of this Agreement shall be valid and enforceable to the fullest extent permitted by law.
 
(f)                                     Choice of Law .  This Agreement and the rights and obligations of the parties hereunder shall be construed in accordance with and governed by the law of the State of New York, without giving effect to the conflict of law principles thereof.
 
(g)                                  Entire Agreement .  This Agreement constitutes the entire agreement of the parties hereto with respect to the subject matter hereof and supersede all prior agreements and understandings of the parties hereto, oral or written, with respect to the subject matter hereof. Notwithstanding the preceding sentence, the provisions of the Acorda Therapeutics, Inc. Restricted Stock Purchase Agreement (dated March 1995) and the Series A Preferred Stock Purchase Agreement shall remain in effect pursuant to their respective terms
 
8

 
(h)                                  Arbitration .  Any dispute or controversy between you and the Company,  arising out of or relating to this Agreement or the breach of this Agreement, shall be settled by arbitration administered by the American Arbitration Association (“AAA”) in accordance with its Employment Disputes Arbitration Rules then in effect, and judgment on the award rendered by the arbitrator may be entered in any court having jurisdiction thereof.  Any arbitration shall be held before a single arbitrator who shall be selected by the mutual agreement of you and the Company, unless the parties are unable to agree to an arbitrator, in which case, the arbitrator will be selected under the procedures of the AAA.  The arbitrator shall have the authority to award any remedy or relief that a court of competent jurisdiction could order or grant, including, without limitation, the issuance of an injunction.  However, either party may, without inconsistency with this arbitration provision, apply to any court having jurisdiction over such dispute or controversy and seek interim provisional, injunctive or other equitable relief until the arbitration award is rendered or the controversy is otherwise resolved.  Except as necessary in court proceedings to enforce this arbitration provision or an award rendered hereunder, to obtain interim relief, as required by law, or the party’s immediate family and legal and financial advisors, neither a party nor an arbitrator may disclose the existence, content or results of any arbitration hereunder without the prior written consent of you and the Company. The Company shall pay all costs and fees associated with such arbitration, including all arbitration fees, the arbitrator’s fees, attorneys’ fees and all costs.
 
If the terms of this Agreement are acceptable to you please sign where indicated below.  It is understood and acknowledged that a fax signature will be considered to be valid as an original.

 	Very truly yours,	
 	 	
 	Acorda Therapeutics, Inc.	
 	 	
 	By:	/s/ Mark Pinney	 	
 	 	
 	Its:	CFO	 	

Agreed to and accepted:	 	
 	 	
/s/ Ron Cohen	 	 	
 	 	
Dr. Ron Cohen	 	
 	 	
Date: 	8/12/02	 	 	

9

 
Exhibit 10.6
 
Mr. Mark Pinney
42 West 15th, Apt. 7
New York, NY   10011
 
Dear Mark:
 
We are delighted to present this letter agreement, setting out the terms of your continued employment with Acorda Therapeutics, Inc. (the “Company”) as Chief Financial Officer.  If these terms are acceptable, please sign and date the copy of this letter provided herewith and return it to me at your first convenience.  If you accept the terms offered herein, this Agreement shall be deemed to be effective as of September 1, 2003 (the “Effective Date”).
 
1.                                        Employment .
 
You will be employed by the Company as Chief Financial Officer of the Company.
 
2.                                        Base Salary .
 
In consideration for your services under this Agreement, you shall be paid an annual base salary of $197,500 to be paid in accordance with the Company’s standard payroll practices. Your base salary shall be reviewed annually by the President and Chief Executive Officer.
 
3.                                        Annual Bonus .
 
You shall be eligible to receive an annual bonus in an amount determined based on your performance.
 
4.                                        Benefits; Perquisites; Reimbursement of Expenses.
 
In addition to those payments set forth above, you shall be entitled to the following benefits and payments:
 
(a)                                   Employee Benefit Plans Generally .  You shall be entitled to participate in all employee benefit plans which the Company provides or may establish from time to time for the benefit of its senior executives.
 
(b)                                  Vacation .  You shall be entitled to paid vacation in accordance with the Company’s vacation policy as that policy may be amended from time to time.
 
(c)                                   Perquisites and Reimbursement of Expenses .  You shall be entitled to all perquisites offered to senior executives of the Company.  In addition, you shall be entitled to reimbursement for all ordinary and reasonable out-of-pocket business expenses which

 
are incurred by you in furtherance of the Company’s business, in accordance with the policies adopted from time to time by the Company.
 
(d)                                  Insurance .   You shall be covered by a Directors and Officers Liability Insurance policy that generally covers the directors and officers of the Company, provided by the Company at its expense, for so long as the Company has such a policy in place.
 
(e)                                   Legal Fees .  The Company shall reimburse you for legal fees incurred in connection with the negotiation and drafting of this Agreement, up to a maximum of Two Thousand Dollars ($2,000).
 
5.                                        Stock Options .
 
You shall be eligible to receive annual performance-based stock option grants to purchase shares of the Company’s common stock.  References to stock options herein may also refer to restricted shares. The number of annual options granted shall be determined based on the achievement of individual performance objectives and the Company’s achievement of its goals and objectives.  All such options shall be granted pursuant to and in accordance with the terms of the Acorda Therapeutics, Inc. 1999 Employee Stock Option Plan and/or any additional or replacement plan adopted by the Board (the “Plan(s)”) except as such terms may be specifically modified herein.  Unless otherwise provided for in any option agreement, all options granted to you shall vest in 16 equal quarterly installments, beginning with the first day of the quarter next following the date the option is granted.  Unless otherwise limited by IRS rules governing the issuance of incentive options to principal stockholders of the Company, all options shall be exercisable for 10 years following the date of grant.  You shall be eligible to exercise all options granted on a cashless basis, and otherwise in accordance with the terms of the Plan(s).
 
6.                                        Term; Termination .
 
(a)                                   Term .  The term of this Agreement shall continue for a period of one year following the Effective Date, unless earlier terminated as provided herein, and shall be automatically renewed for successive one year terms unless the Company or you provide written notice of its or your determination not to renew this Agreement at least 60 days prior to the expiration of the then current term. A determination by you or the Company not to renew this Agreement based upon Good Reason or if Without Cause, as the case may be, shall be deemed a termination of employment for purposes of Section 6(c) and the terms thereof shall apply.
 
(b)                                  Death or Disability .  Your employment with the Company shall terminate as of the date of your death or the date you are determined to be “Disabled.”   Upon such termination, the following shall apply:
 
(i)                                      The Company shall pay to you or your estate, as the case may be, (A) all amounts due and owing as of the date of termination and
 
2

 
(B) your base salary through the end of the third month following the date your employment is terminated.
 
(ii)                                   If you or your eligible spouse and dependents timely elect health care continuation coverage (“COBRA Coverage”), the Company shall pay the monthly premiums for such coverage for the duration of the applicable COBRA Coverage period.
 
(iii)                                33% of all unvested stock options shall become immediately vested and shall remain exercisable by you or your estate, as the case may be, for 48 months following the termination date.
 
For these purposes, you shall be considered to be Disabled if you are unable to perform the substantial functions of your position for 180 consecutive days or more in a 12 month period, unless a greater period is required by law.  A determination of disability shall be made jointly by a physician of your choice and a physician of the Company’s choice.  If both physicians can not agree on whether you are Disabled, a third physician chosen by the first two shall make the final and binding determination.
 
(c)                                   Termination of Your Employment by the Company Without Cause or Voluntary Termination by You With Good Reason .  If the Company terminates your employment without Cause or if you terminate your employment with Good Reason the following shall apply:
 
(i)                                      The Company shall pay to you your base salary for a period of 1/2 year following the date of such termination (the “Severance Period”).  You shall be under no obligation to secure alternative employment during the Severance Period, and payment of your base salary shall be made without regard to any subsequent employment you may obtain.
 
(ii)                                   The Company shall also pay you a bonus equal to the last annual bonus you received multiplied by a fraction, the numerator of which shall be the number of days in the calendar year elapsed as of the termination date and the denominator of which shall be 365.
 
(iii)                                If you or your eligible spouse and dependents timely elect COBRA Coverage, the Company shall pay the monthly premiums for such coverage during the Severance Period; provided that, if you elect coverage under a subsequent employer’s group health insurance plan during the Severance Period, payment of such premiums shall cease.
 
3

 
(iv)                               All stock options granted to you hereunder or under any other agreement shall become immediately and fully vested as of the termination date, and shall remain exercisable for 48 months following such date.
 
 (d)                               Termination of Your Employment by the Company With Cause or by You Without Good Reason .  The Company may terminate your employment with Cause or you may resign at any time.  In such case, you shall be paid all amounts due for services rendered under this Agreement up until the termination date.  Thereafter, no further payments shall be made to you under this Agreement.  All stock options granted to you hereunder or under any other agreement that are fully vested as of the date of your termination shall remain exercisable for ninety (90) days from the termination date.  If you dispute the grounds for your termination, your vested options will remain exercisable until ninety (90) day after the date the dispute is resolved.  All unvested options shall be forfeited.
 
(e)                                   Cause .  As used herein, “Cause” means that you have:
 
(i)                                      committed gross negligence in connection with your duties as set forth herein or otherwise with respect to the business and affairs of the Company, which gross negligence has a material adverse effect on the business of the Company or your ability to perform your duties under this Agreement;
 
(ii)                                   committed fraud in connection with your duties as set forth herein or otherwise with respect to the business and affairs of the Company;
 
(iii)                                engaged in “willful misconduct” with respect to the business and affairs of the Company.  For purposes of this Agreement, “willful misconduct” means misconduct committed with actual knowledge that your actions violate directions and instructions of the CEO, which directions and instructions are legal and consistent with the Agreement;
 
(iv)                               materially breached your duties under this Agreement, which breach has a material adverse effect on the business of the Company or your ability to perform your duties under the Agreement, or
 
(v)                                  been found by a court of competent jurisdiction to have committed or pled guilty to an unlawful act whether or not related to the business of the Company if the commission of such act has a material adverse effect either on (a) your ability to perform your
 
4

 
duties under the Agreement or (b) the reputation and goodwill of the Company.
 
“Cause” shall be found only by a majority of the full Board and only after you have received notice from the Board, have had an opportunity to discuss the issues with the Board, have had an opportunity to be heard generally and through counsel, and have been given a 30 day period to cure, where cure is feasible.
 
(f)                                     Good Reason.  As used herein, “Good Reason” means that:
 
(i)                                      the Company has materially breached this Agreement;
 
(ii)                                   the Company fails to acquire the assignment of this Agreement by an acquiring entity;
 
(iii)                                your position has been materially reduced or you have been assigned duties that are materially inconsistent with your duties as set forth herein or which materially impair your ability to perform the services contemplated hereunder; or
 
(iv)                               the Company relocates its offices more than 60 miles from your home.
 
(v)                                  Termination for Good Reason may occur only after you have given the CEO notice and 30 days to cure, where cure is feasible.
 
7.                                        Change in Control .
 
(a)                                   Subject to the provisions of this Section 7, the vesting of your options upon a Change of Control shall be governed by the terms of the Plans and your option agreements, but in no event shall less than 33% of your then unvested stock options become immediately vested and exercisable.
 
(b)                                  If you voluntarily terminate your employment after a Change in Control with Good Reason, then Paragraph 6(c) shall apply.
 
(c)                                   Change in Control Defined .  A Change in Control shall be deemed to have occurred if:
 
(i)                                      there is a consolidation or merger of the Company in which the Company is not the continuing or surviving corporation; or there is any other merger or consolidation if, after such merger or
 
5

 
consolidation shareholders of the Company immediately prior to such merger or consolidation hold less than 50% of the voting stock of the surviving entity;
 
(ii)                                   there is a sale or transfer of all or substantially all of the assets of the Company in one or a series of transactions or there is a complete liquidation or dissolution of the Company; or
 
(iii)                                any individual or entity or group acting in concert and affiliates thereof, acquires, directly or indirectly, more than 50% of the outstanding shares of voting stock of the Company; provided that this subsection (iii) shall not apply to an underwritten public offering of the Company’s securities.
 
8.                                        Confidentiality/Noncompetition.
 
(a)                                   During the term of your employment and for an additional period of five years after you are no longer employed by the Company, you will not reveal, divulge or make known to any individual, partnership, joint venture, corporation or other business entity (other than the Company or its affiliates) or use for your own account any customer lists, trade secrets or any confidential information of any kind (“Protected Information”) used by the Company or any of its commonly controlled affiliates in the conduct of the Company’s business and made known to you by reason of your employment with the Company or any of its affiliates (whether or not developed, devised or otherwise created in whole or in part by your efforts); provided , that Protected Information shall not include information that shall become known to the public or the trade without violation of this Section 8(a); and provided , further , that you shall not violate this Section 8(a) if Protected Information is disclosed by you at the direction of the Company or if you are required to provide Protected Information in any legal proceeding or by order of any court.
 
(b)                                  During the term of your employment and for an additional period of  one year after you are no longer employed by the Company, you will not, directly or indirectly, engage in a Competitive Business, including owning or controlling an interest in (except as a passive investor owning less than two percent (2%) of the equity securities of a publicly-owned company), or acting as director, officer or employee of, or consultant to, any individual, partnership, joint venture, corporation or other business entity known to you to be engaged in a Competitive Business. “Competitive Business” shall mean the development of therapeutics for spinal cord injuries, multiple sclerosis and other central nervous system conditions for which the Company is actively seeking to develop therapeutics during the term of this Agreement; provided, however, that notwithstanding the foresaid, you shall not be prohibited from acting in any of the aforesaid capacities for or with respect to any subsidiary, division, affiliate or unit (each, a “Unit”) of an entity if that Unit itself is not engaged in a Competitive Business, irrespective of whether some
 
6

 
other Unit of such entity engages in such competition (as long as you do not engage in a Competitive Business for such other Unit).
 
(c)                                   During the term of your employment and for an additional period of one year after you are no longer employed by the Company, you shall not knowingly employ or solicit, encourage or induce any person (except your spouse, if applicable) who at any time within 90 days prior to the termination of your employment shall have been an employee of the Company or any of its commonly controlled affiliates, to become employed by or associated with any individual, partnership, joint venture, corporation or other business entity other than the Company, and you shall not knowingly approach any such employee for such purpose or authorize or knowingly approve the taking of such actions by any other individual, partnership, joint venture, corporation or other business entity or knowingly assist any such individual, partnership, joint venture, corporation or other business entity in taking such action.
 
(d)                                  You acknowledge that the provisions of this Section 8 are reasonable and necessary for the protection of the Company and that each provision, and the period or periods of time and types and scope of restrictions on the activities specified herein are, and are intended to be divisible.  In the event that any provision of this Agreement, including any sentence, clause or part hereof, shall be deemed contrary to law or invalid or unenforceable in any respect by a court of competent jurisdiction, the remaining provisions shall not be affected, but shall, subject to the discretion of such court, remain in full force and effect and any invalid and unenforceable provisions shall be deemed, without further action on the part of the parties hereto, modified, amended and limited to the extent necessary to render the same valid and enforceable.
 
(e)                                   You acknowledge that the Company will be irrevocably damaged if the covenants contained herein are not specifically enforced.  Accordingly, you agree that, in addition to any other relief to which the Company may be entitled, the Company shall be entitled to seek and obtain injunctive relief from a court of competent jurisdiction for the purposes of restraining you from any actual or threatened breach of such covenants.
 
9.                                        Miscellaneous Provisions.
 
(a)                                   Notices .  All notices and other communications hereunder between you and the Company shall be in writing, shall be addressed to the receiving party’s address of record (or to such other address as a party may designate by notice hereunder), and shall be either (i) delivered by hand, (ii) made by telecopy, (iii) sent by overnight courier, or (iv) sent by certified mail, return receipt requested, postage prepaid.
 
(b)                                  Modifications and Amendments .  The terms and provisions of this Agreement may be modified or amended only by written agreement executed by the parties hereto.
 
7

 
(c)                                   Waivers and Consents .  The terms and provisions of this Agreement may be waived, or consent for the departure therefrom granted, only by written document executed by the party entitled to the benefits of such terms or provisions.  No such waiver or consent shall be deemed to be or shall constitute a waiver or consent with respect to any other terms or provisions of this Agreement, whether or not similar.  Each such waiver or consent shall be effective only in the specific instance and for the purpose for which it was given, and shall not constitute a continuing waiver or consent.
 
(d)                                  Assignment .  This Agreement shall inure to the benefit of and be enforceable by your personal or legal representatives, executors, administrators, successors, heirs, distributes, devisees and legatees.  This Agreement may not be assigned or pledged by you.  In the event of the merger or consolidation of the Company (whether or not the Company is the surviving or resulting corporation), the transfer of all or substantially all the assets of the Company, or the voluntary or involuntary dissolution of the Company, the surviving or resulting corporation or the transferee or transferees of the Company’s assets shall be bound by this and the Company shall take all actions necessary to ensure that such corporation, transferee or transferees assume and are bound by its provisions.
 
(e)                                   Severability .  The parties intend this Agreement to be enforced as written.  However, if any portion or provision of this Agreement shall to any extent be declared illegal or unenforceable by a duly authorized court of proper jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision of this Agreement shall be valid and enforceable to the fullest extent permitted by law.
 
(f)                                     Choice of Law . This Agreement and the rights and obligations of the parties hereunder shall be construed in accordance with and governed by the law of the State of New York, without giving effect to the conflict of law principles thereof.
 
(g)                                  Entire Agreement .  This Agreement constitutes the entire agreement of the parties hereto with respect to the subject matter hereof and supersede all prior agreements and understandings of the parties hereto, oral or written, with respect to the subject matter hereof. Notwithstanding the preceding sentence, the provisions of the Acorda Therapeutics, Inc. Restricted Stock Purchase Agreements (dated March 1995 and February 1996) shall remain in effect pursuant to their respective terms.
 
(h)                                  Arbitration .  Any dispute or controversy between you and the Company,  arising out of or relating to this Agreement or the breach of this Agreement, shall be settled by arbitration administered by the American Arbitration Association (“AAA”) in accordance with its Employment Disputes Arbitration Rules then in effect, and judgment on the award rendered by the arbitrator may be entered in any court having jurisdiction thereof.  Any arbitration shall be held before a single arbitrator who shall be selected by
 
8

 
the mutual agreement of you and the Company, unless the parties are unable to agree to an arbitrator, in which case, the arbitrator will be selected under the procedures of the AAA.  The arbitrator shall have the authority to award any remedy or relief that a court of competent jurisdiction could order or grant, including, without limitation, the issuance of an injunction.  However, either party may, without inconsistency with this arbitration provision, apply to any court having jurisdiction over such dispute or controversy and seek interim provisional, injunctive or other equitable relief until the arbitration award is rendered or the controversy is otherwise resolved.  Except as necessary in court proceedings to enforce this arbitration provision or an award rendered hereunder, to obtain interim relief, as required by law, or the party’s immediate family and legal and financial advisors, neither a party nor an arbitrator may disclose the existence, content or results of any arbitration hereunder without the prior written consent of you and the Company. The Company shall pay all costs and fees associated with such arbitration, including all arbitration fees, the arbitrator’s fees, attorneys’ fees and all costs.
 
If the terms of this Agreement are acceptable to you please sign where indicated below.  It is understood and acknowledged that a fax signature will be considered to be valid as an original.

 	Very truly yours,	
 	 	
 	Acorda Therapeutics, Inc.	
 	 	
 	By:	 	 	
 	
 	Its:	 	 	
 	 	
Agreed to and accepted:	 	

 	 	
Mark Pinney	 	
 	 	
Date:	 	 	

9

 
Exhibit 10.7
 
Execution Copy

TERMINATION AND ASSIGNMENT AGREEMENT

ELAN CORPORATION, PLC

ELAN INTERNATIONAL SERVICES, LTD.

!#/2$! 4(%2!0%54)#3  )NC

MS RESEARCH AND DEVELOPMENT CORPORATION

 
INDEX

CLAUSE 1	DEFINITIONS	
 	 	
CLAUSE 2	TERMINATION OF THE MS R&D AGREEMENTS	
 	 	
CLAUSE 3	ASSIGNMENTS	
 	 	
CLAUSE 4	REPRESENTATIONS, WARRANTIES, COVENANTS, CONFIRMATIONS AND INDEMNITIES	
 	 	
CLAUSE 5	INTELLECTUAL PROPERTY	
 	 	
CLAUSE 6	RIGHTS RELATED TO SECURITIES	
 	 	
CLAUSE 7	SALE OF EIS SHARES AND COMPLETION	
 	 	
CLAUSE 8	CONFIDENTIALITY	
 	 	
CLAUSE 9	WAIVER OF ACCRUED RIGHTS/MUTUAL RELEASES	
 	 	
CLAUSE 10	GENERAL	
 
2

 
THIS TERMINATION AND ASSIGNMENT AGREEMENT made this    day of September 2003 (this “ Agreement ”)
 
AMONG:-
 
(1)                                  ELAN CORPORATION, PLC , a public limited company incorporated under the laws of Ireland and having its registered office at Lincoln House, Lincoln Place, Dublin 2, Ireland (“ Elan Corp ”);
 
(2)                                  ELAN INTERNATIONAL SERVICES, LTD., an exempted limited liability company incorporated under the laws of Bermuda, and having its registered office at Clarendon House, 2 Church St., Hamilton, Bermuda, a wholly owned subsidiary of Elan Corp, ( “EIS” );
 
(3)                                  !#/2$! 4(%2!0%54)#3  )NC , a Delaware corporation having its principal place of business at 15 Skyline Drive, Hawthorne, NY 10532, United States of America ( “Acorda” ); and
 
(5)                                  MS RESEARCH AND DEVELOPMENT CORPORATION , a Delaware corporation having its principal place of business at 15 Skyline Drive, Hawthorne, NY 10532, United States of America ( “MS R&D” ).
 
RECITALS
 
A.                                    Certain of the Parties entered into various agreements whereby Elan Corp, EIS and Acorda established MS R&D, and Elan Corp and Acorda each licensed certain intellectual property to MS R&D for a specified field of use.  Specifically:
 
(i)                                      EIS, Acorda and MS R&D entered into a Subscription and Stockholders’ Development Agreement dated as of April 21, 1998 (the “ SSDA ”);
 
(ii)                                   Elan Corp, Acorda and MS R&D entered into a License and Supply Agreement dated as of April 21, 1998 (the “ Elan License Agreement ”);
 
(iii)                                Acorda, EIS and MS R&D entered into an Agreement dated as of April 21, 1998 (the “ MS R&D License Agreement ”);
 
(iv)                               EIS, Acorda and MS R&D entered into a Registration Rights Agreement dated as of April 21, 1998 (the “ MS R&D Registration Rights Agreement ”).
 
B.                                      The SSDA and, the MS R&D License Agreement are together defined in this Agreement as the “ MS R&D Agreements ”.
 
3

 
C.                                      The Parties wish to (i) terminate in full the MS R&D Agreements, (ii) assign the Elan License Agreement and the MS R&D Intellectual Property to Acorda, and (ii) set forth their agreement in relation to certain other matters, as set forth below.
 
D.                                     Simultaneously with the execution of this Agreement:
 
(i)                                      Acorda, Elan and EIS are entering into an Agreement (the “Securities Amendment Agreement” ) to set forth their agreement in relation to certain matters relating to: (i) the securities of Acorda held by Elan, (ii) Elan’s obligations (or lack thereof) with respect to future payments to or in respect of its relationship with Acorda and MS R&D, (iii) amendments to certain finance documents entered into between the Parties; and (iv) Board observation rights in favor of EIS; and
 
(ii)                                   immediately following the effectiveness of the Assignment, Elan Corp and Acorda are entering into (i) an Amended and Restated License Agreement and (ii) a Supply Agreement, pursuant to which, among other things, the parties thereto are amending and restating the Elan License Agreement (collectively the “Restated Elan License” ).
 
IN CONSIDERATION OF THE MUTUAL COVENANTS CONTAINED HEREIN, AND OTHER GOOD AND VALUABLE CONSIDERATION, THE RECEIPT AND ADEQUACY OF WHICH ARE HEREBY ACKNOWLEDGED, IT IS HEREBY AGREED AS FOLLOWS:
 
1                                           DEFINITIONS
 
Capitalized terms used in this Agreement shall have the same meanings assigned to them in the MS R&D Agreements, unless such terms are expressly defined to the contrary in this Agreement.
 
“ Acorda Know-How ” shall mean Acorda Know-How and Acorda Project Know-How (as such terms are defined in the MS R&D License Agreement).
 
“ Acorda Patents ” shall mean Acorda Patent Rights and Acorda Project Patent Rights (as such terms are defined in the MS R&D License Agreement).
 
“ Affiliate” shall mean any corporation or entity controlling, controlled or under the common control of any other corporation or entity.  For the purpose of this definition, (i) “control” shall mean direct or indirect ownership of fifty percent (50%) or more of the equity, partnership interest or voting stock of another entity; and (ii) MS R&D shall not be an Affiliate of Elan Corp, EPIL II or EIS.
 
“Assignments” shall mean the assignments provided for under Clause 3.
 
4

 
“Assignment Consideration” shall mean the amount set forth in Clause 3.
 
“ Balance Sheet ” shall mean the unaudited balance sheet of MS R&D as of the Balance Sheet Date, as set forth in Schedule 4.3.
 
“ Balance Sheet Date ” shall mean June 30, 2003.
 
 “Distribution” shall mean the pro-rata distribution of the Assignment Consideration to be declared and paid by MS R&D ratably to the stockholders thereof in accordance with Schedule 4.10.
 
“ Effective Date ” shall mean the date of this Agreement.
 
“EIS Shares” shall mean the 1,279 shares of MS R&D Common Stock owned by EIS as of the Effective Date.
 
“Elan” shall mean Elan Corp and its Affiliates.
 
“Elan Know-How” shall have the meaning set forth in the Restated Elan License.
 
“Elan Patents” shall mean “Elan Patent Rights” (as such term is defined in the Restated Elan License).
 
“EPIL II” shall mean Elan Pharmaceuticals Investment II, Ltd. an exempted limited liability company incorporated under the laws of Bermuda, a qualified special purpose entity of Elan Corp.
 
“EPIL Shares” shall mean the 2,985 shares of MS R&D Common Stock owned by EPIL II as of the Effective Date.
 
“ Force Majeure ” shall mean causes beyond a Party’s reasonable control, including, without limitation, acts of God, fires, strikes, acts of war, or intervention of a governmental authority.
 
 “ MS R&D Common Stock ” shall mean the common stock, par value $0.001 per share, of MS R&D.
 
“MS R&D Debt” shall mean the estimated outstanding amount of indebtedness owed by MS R&D to Acorda as of the Effective Date and incurred subsequent to the Balance Sheet Date pursuant to the SSDA, as set forth on Schedule 2.4.
 
“ MS R&D Intellectual Property ” shall mean Newco Know How and Newco Patent Rights as defined in the MS R&D License Agreement.
 
5

 
“ Party ” shall mean Elan Corp, EIS, Acorda or MS R&D, as the case may be, and “ Parties ” shall mean all such parties together.
 
“Pro Forma Balance Sheet” shall mean the unaudited pro forma balance sheet attached as Schedule 4.3, giving pro forma effect as of the Balance Sheet Date to the purchase of the EIS Shares and the MS R&D Debt .
 
“ Project ” shall have the meaning set forth in the Elan License Agreement.
 
“Regulatory Filings” shall mean the regulatory filings as set out in Schedule3.6.
 
“ Rush ” shall mean R ush-Presbyterian-St. Luke’s Medical Center.
 
“ Rush Agreements” shall mean (i) the License Agreement by and between Acorda and Rush dated as of the Effective Date and (ii) the Side Agreement dated as of the Effective Date by and among Elan Corp, Acorda and R ush and (iii) the Rush Payment Agreement.
 
“ Rush Payments Agreement” shall mean the Rush Payments Agreement dated as of the Effective Date by and among Elan Corp and Acorda.
 
“Territory” shall mean all of the countries of the world.
 
“United States Dollar” and “US$” and “$” shall mean the lawful currency of the United States of America.
 
2.                                        TERMINATION OF THE MS R & D AGREEMENTS
 
2.1.                               Subject to the provisions of Clause 2.2 and 2.3 hereof, the Parties hereby agree to terminate the MS R&D Agreements, including without limitation, those provisions expressly stated to survive termination, in each case with effect from the Effective Date.
 
All the provisions of the MS R&D Agreements shall terminate forthwith with effect from the Effective Date and be of no further legal force or effect.
 
2.2                                  Notwithstanding anything contained herein to the contrary, the Parties acknowledge that:
 
(i)                                      the provisions originally set forth in Clause 4.5 of the SSDA (the “Co-sale Rights” ), as now set out in full in Schedule 2.2, shall continue in full force and effect as between EPIL II and Acorda as holders of certain shares in MS R&D;
 
6

 
(ii)                                   if and to the extent (A) Elan becomes the owner of shares of MS R&D Common Stock and (B) Acorda is “the party who is not the Selling Stockholder” for purposes of Clause 4.4 of the SSDA, the provisions originally set forth in Clause 4.4 of the SSDA (the “ Rights of First Offer ”), as now set out in full in Schedule 2.2, shall continue in full force and effect with respect to any proposed Transfer (as now defined in Schedule 2.2) of such shares of MS R&D Common Stock by Elan; and
 
(iii)                                the Parties agree that EPIL II is a third party beneficiary of this Clause 2.2 solely as it relates to the Co-Sale Rights, as the holder of the EPIL Shares.
 
2.3                                  For the avoidance of doubt and without prejudice to the generality of the  foregoing Clause 2.1, the Parties hereby acknowledge and agree as follows as of the Effective Date:
 
2.3.1                         EIS Director :
 
(a)                                   by prior agreement of the Parties, the EIS Director, Mike Sember, previously resigned from the board of directors of MS R&D;
 
(b)                                  by prior agreement of the Parties, EIS forfeited the right to designate a director to the board of directors of MS R&D and thereafter no longer had designees on, or the right to designate a director to, the board of directors of MS R&D;  and
 
(c)                                   for the avoidance of doubt, EIS confirms that prior to the Effective Date, it did not at any time assign the right to designate a director to the board of directors of MS R&D.
 
2.3.2                         the nominees of Elan on the Committee (as defined in the Elan License Agreement) have been removed from the Committee by Elan and Elan shall no longer have the right to designate a member of the Committee;
 
2.3.3                         with effect from the Effective Date, Elan shall not have any rights in or to the Acorda Patents, the Acorda Know-How, and/or any other patents, know-how or any other intellectual property rights whatsoever of Acorda;
 
2.3.4                         Elan shall terminate or shall cause to be terminated any and all research and development work being conducted under the MS R&D Agreements;
 
7

 
2.3.5                         Elan shall terminate or cause to be terminated any and all technical services and assistance being conducted under the MS R&D Agreements;
 
2.3.6                         For the avoidance of doubt, the Parties agree that Elan shall not have any obligation to provide Additional Funding, working capital, research or development funding, or other funding or financing of any nature to MS R&D, whether under the MS R&D Agreements, the Elan License Agreement, or otherwise;
 
2.3.7                         For the further avoidance of doubt, the Parties agree that Elan has had no obligation to provide Additional Funding, working capital, research or development funding, or other funding, or other financing or financing of any nature to MS R&D following 30 June 2002;
 
2.3.8                         Elan shall not have any obligation to pay any milestone payment or make any milestone investment to or in MS R&D or Acorda or any of their Affiliates whether relating to the Project , the achievement of any objectives set forth therein or otherwise, except as set forth in the Rush Payments Agreement.
 
2.4                                  Monies owing by MS R&D to Acorda and Elan
 
2.4.1                         Each of the Parties acknowledges and agrees with the other Parties that, as of the Effective Date, no monies are owed or are refundable by any of the Parties to any other Party pursuant to the MS R&D Agreements or the Elan License Agreement, other than the MS R&D Debt and the amount owing to Elan as set forth on Schedule 2.4.
 
2.4.2                         The Parties acknowledge and agree that MS R&D shall pay to Elan the amount owing to Elan (as set out in Schedule 2.4) prior to the Effective Date.
 
2.4.3                         As of the Effective Date, the MS R&D Debt shall be hereby deemed forgiven and extinguished in all respects by Acorda.
 
2.5                                  Franchise Taxes
 
Each of the Parties further acknowledges and agrees with the other Parties that from and after the Effective Date, MS R&D shall be solely responsible for all fees and taxes, including without limitation, franchise taxes owing to the State of Delaware, and all service fees, including without limitation, corporate service fees for corporate filings or
 
8

 
representation as agent for service of process within or without of the State of Delaware.
 
3                                           ASSIGNMENTS
 
In consideration of the payment of $11,541,347 by Acorda to MS R&D (the “Assignment Consideration” ), the receipt of which is hereby acknowledged by MS R&D, the following Assignments shall occur with effect from the Effective Date:
 
3.1                                Assignment of MS R&D Intellectual Property and Regulatory Filings
 
MS R&D, as legal and beneficial owner, hereby irrevocably absolutely and unconditionally assigns, transfers and conveys to Acorda, and Acorda hereby accepts from MS R&D, all of MS R&D’s right, title and interest in and to the MS R&D Intellectual Property including the MS R&D Patent Rights, and the Regulatory Filings.
 
3.2                                Assignment and assumption of Elan License
 
MS R & D hereby irrevocably, absolutely and unconditionally assigns, transfers and conveys to Acorda, and Acorda hereby accepts from MS R & D, the Elan License Agreement and all of MS R & D’s rights and interest throughout the Territory in and under the Elan License Agreement.  Acorda agrees with Elan and MS R&D to assume the rights, interest, obligations, duties and liabilities of MS R&D under the Elan License Agreement.
 
3.3                                Elan consent to Assignments
 
Elan consents to and accepts the assignment referred to in Clauses 3.1 and 3.2 by MS R&D to Acorda and the assumption by Acorda of MS R&D’s rights, interest, obligations, duties and liabilities under the Elan License Agreement.
 
3.4                                  Restated Elan License
 
The Parties acknowledge and agree that immediately following the Assignments, Elan Corp and Acorda will execute and deliver the Restated Elan License, at which time the Elan License Agreement will be superceded by the Restated Elan License.
 
9

 
3.5                                  Advisory Fees
 
Each of the Parties confirms to the other that such Party has not incurred nor shall become liable for any advisory, appraisal or other fee or commission in connection with the transactions contemplated by this Agreement, except that MS R & D intends to pay a fee to Standard & Poor’s Corporate Value Consulting, a division of the McGraw-Hill Companies, Inc..
 
4                   REPRESENTATIONS , WARRANTIES, COVENANTS, CONFIRMATIONS AND INDEMNITIES
 
4.1                                  MS R&D Capitalization :
 
The Parties confirm that, as of the Effective Date, the capitalization of MS R&D is as set out in Schedule 4.1.
 
4.2                                  Sub-licenses:
 
MS R&D represents and warrants to the other Parties that it has not granted any sub-licenses or any other rights of any nature to any third parties pursuant to the Elan License Agreement or the MS R&D License Agreement.
 
4.3                                  Balance Sheet:
 
4.3.1                         MS R&D and Acorda represent and warrant to Elan that the Balance Sheet is accurate and that, since the Balance Sheet Date, there has been no material adverse change in the financial position or prospects of MS R&D except for the MS R&D Debt which amount is to be forgiven as of the Effective Date as set out in Clause 2.4 above.
 
4.3.2                         MS R&D and Acorda represent and warrant to Elan that there are no other liabilities of MS R&D other than as reflected or reserved against on the Balance Sheet and other than as described in Clause 4.3.1 above.
 
4.3.3                         MS R&D and Acorda represent and warrant to Elan that the Pro Forma Balance Sheet accurately reflects the pro forma effect on the Balance Sheet as of the Balance Sheet Date of the purchase of the EIS Shares and the MS R&D Debt.
 
10

 
4.4                                  Third party agreements / Orders / Claims:
 
4.4.1                         Each of the Parties confirms to the other Parties hereto that, as of the Effective Date, to its actual knowledge, MS R&D is not a party to, or bound by, any judgment, order, decree or other directive of or stipulation with any court or any governmental or regulatory authority.
 
4.4.2                         Each of the Parties confirms to the other Parties that MS R&D is not a party to, or bound by, nor is Acorda, or any of its Affiliates, on behalf of MS R&D, nor is Elan or any of its Affiliates, on behalf of MS R&D, a party to or bound by, any agreement with any third party, except for the MS R&D Agreements, other than as set out in Schedule 4.4.2 (“ MS R&D Third Party Agreement(s) ”).
 
4.4.3                         Each of the Parties confirms to the other Parties hereto that, as of the Effective Date, to its actual knowledge, there are no claims, suits or proceedings pending or threatened against MS R&D.
 
4.4.4                         Elan represents and warrants to MS R&D and Acorda that none of Elan, EIS nor any of their Affiliates has any agreement with EPIL that is in conflict with or inconsistent with this Agreement or the transactions contemplated hereby.
 
4.5                                  EIS Shares
 
4.5.1                         Each of Elan and EIS represent, warrant and confirm to the other Parties that:
 
(1)                                   EIS is the legal and beneficial owner of the EIS Shares;
 
(2)                                   EIS has good and valid title to all of the EIS Shares free and clear of all pledges, liens, encumbrances or other claims or charges; and
 
(3)                                   EIS has the unrestricted power and authority to transfer the EIS Shares to Acorda in accordance with the terms of this Agreement.
 
4.5.2                         For the avoidance of doubt, the Parties agree that the EIS Shares and the EPIL Shares represent all of the equity or securities of MS R & D to which Elan or any of its Affiliates was or, as of the Effective Date, is entitled to under any of the MS R & D Agreements.
 
11

 
4.6                                  Regulatory Applications :
 
Each of the Parties confirms to the other Parties that, prior to and as of the Effective Date, no Regulatory Filings have been filed by MS R&D or by any Party with any government authority in any part of the world for any product in relation to the Project (as defined in the Elan License Agreement), except as set out in Schedule 4.6.
 
4.7                                  Exclusion of warranties / liability :
 
EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, ALL OTHER WARRANTIES, CONDITIONS OR REPRESENTATIONS, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED BY THE PARTIES.
 
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, NO PARTY SHALL BE LIABLE TO ANY OTHER PARTY BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL SPECIAL OR INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF CURRENT OR FUTURE PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND WHETHER OCCASSIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR OTHERWISE.
 
4.8                                  Indemnity :
 
4.8.1                         The Parties acknowledge and agree that pursuant to Clause 3.2, Acorda has been assigned and has assumed the indemnification obligations of MS R&D under the Elan License Agreement which, as of the Effective Date, are included in the Restated Elan License.
 
4.8.2                         Prior to the Effective Date, Acorda shall furnish Elan Corp with copies of all policies of comprehensive general liability insurance and/or other insurance coverage (the “ Policies ”) which it holds in respect of any clinical trials as set out in Schedule 1 that were carried out by Acorda on behalf of MS R&D.
 
Acorda shall be obliged to maintain the Policies for a period of 5 years from the Effective Date, maintaining at all times at a minimum, the levels of coverage evidenced in the Policies, noting Elan Corp as an additional insured, and shall, at the reasonable request of Elan Corp from time to time, furnish to Elan Corp evidence that all premiums or other payments on the Policies are fully paid up and the Policies are subsisting. Acorda shall require
 
12

 
the consent of Elan Corp to make any modification to the Policies or to take any action to terminate the Policies, which consent shall not be unreasonably withheld.
 
4.9               Organization and authority: 
 
Each Party hereto represents and warrants that with respect to such Party:
 
4.9.1                         it is a corporation duly organized and validly existing under the laws of its respective jurisdiction of incorporation or organization and such Party has full right, power and authority to enter into this Agreement and each agreement, document and instrument to be executed and delivered by it pursuant to or as contemplated by this Agreement and to carry out the transactions contemplated hereby and thereby;  the execution and delivery of this Agreement and the performance of such Party’s obligations hereunder have been duly authorized by all necessary action of such Party including, if required, by its stockholders, and its board of directors; this Agreement and each agreement, document and instrument to be executed and delivered by such Party hereto pursuant to this Agreement constitute, or will when executed and delivered constitute, valid and binding obligations of such Party, enforceable in accordance with their respective terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium and similar laws affecting creditors’ rights generally, and subject, as to enforceability, to general principles of equity (regardless of whether enforcement is sought in a proceeding, at law or in equity);
 
4.9.2                         the execution, delivery, and performance by each Party of this Agreement and each such agreement, document and instrument contemplated by this Agreement to which it is a party (i) do not violate any provision of the certificate or articles of incorporation or other similar governing instruments or by-laws of such Party; (ii) do not and will not result in a breach of, constitute a default under, accelerate any obligation under, or give rise to a right of termination of any indenture or loan or credit agreement or any other agreement, contract, instrument, mortgage, deed of trust, lien, lease, permit, authorization, order, writ, judgment, injunction, decree, determination or arbitration award to which such Party is a party or by which any material property of such Party is bound or affected, which would have material adverse effect on the business or operations of such Party and its subsidiaries, taken as a whole.
 
13

 
4.10                            Payment of Distribution; Negative Covenant :
 
MS R&D agrees that it shall pay, and Acorda agrees to cause MS R&D to pay, the Distribution in the aggregate amount of the Assignment Consideration, in the pro rata amounts and to the parties set forth on Schedule 4.10 as soon as practicable after the Effective Date .   MS R&D and Acorda hereby agree that, until payment of the Distribution, MS R&D shall not, and Acorda and its Affiliates shall not cause MS R&D to, issue any securities or incur any indebtedness without the prior written consent of EIS.
 
4.11                            Representation and Warranties as of the Effective Date:
 
Except where expressly stated otherwise, each of the representations and warranties in this Agreement are made as of the Effective Date.
 
5                                           INTELLECTUAL PROPERTY
 
5.1                                  Ownership:
 
On and following the Effective Date:
 
5.1.1                         For the avoidance of doubt, the Elan Patents and the Elan Know-How shall remain the sole and exclusive property of Elan.
 
5.1.2                         For the avoidance of doubt, the Acorda Patents and the Acorda Know-How shall remain the sole and exclusive property of Acorda.
 
5.1.3                         All MS R&D Intellectual Property shall be subject to the Assignments.
 
6                                           RIGHTS RELATED TO SECURITIES
 
6.1                                  Nothing contained herein shall constitute a waiver of any right of EPIL II or EIS or any of their respective successors and assigns with respect to their respective ownership of securities in Acorda under any agreements of any kind in existence with Acorda with respect thereto, which agreements shall remain unmodified and in full force and effect, except as set forth in the Securities Amendment Agreement.
 
7                                           SALE OF EIS SHARES AND COMPLETION
 
7.1                                  Subject to the terms of this Agreement, on the Effective Date, EIS shall sell as legal and beneficial owner of, and Acorda shall purchase, free from
 
14

 
all liens, charges, security interests and other encumbrances and together with all rights now or hereafter attaching to them, the EIS Shares, for a purchase price per share equal to $0.001 per share, the par value thereof (the “Per Share Consideration” ), or an aggregate price to be paid by Acorda to EIS for the EIS Shares in the total amount of US$1.28, which giving effect to the other transactions contemplated by this Agreement, the Parties agree is the fair value thereof.
 
7.2                                  Elan and Acorda shall take or (to the extent that the same is within its powers) cause to be taken the following steps prior to or at directors meetings of MS R&D, or such other meetings, as appropriate:
 
7.2.1                         on the Effective Date, the delivery by EIS to Acorda of a stock transfer form or stock power in respect of the EIS Shares duly executed by EIS and endorsed in blank together with the related share certificates;
 
7.2.2                         as soon as practicable after the Effective Date, the modification, as appropriate, by board resolutions of MS R&D of matters such as the removal of EIS as book keeper for MS R&D, the removal of EIS representatives as authorized signatories of MS R&D’s bank account, and any other related matters whatsoever; and
 
7.2.3                         any other steps required by this Agreement.
 
7.3                                  In the event that Elan has the right and power to dispose of the EPIL Shares (other than through a subsidiary that is not consolidated on Elan Corp’s financial statements under U.S. GAAP), Elan shall promptly notify Acorda in writing.  Within ten (10) Business Days after receipt of such notice from Elan, Acorda shall have the right and option to purchase the EPIL Shares from Elan for the Per Share Consideration (in the total amount of $2.99) at a closing to take place within a reasonable time thereafter.  The Parties agree that the Per Share Consideration is the fair value for the EPIL Shares after giving effect to the other transactions contemplated by this Agreement.
 
8                                           CONFIDENTIALITY
 
8.1                                  Confidentiality:
 
8.1.1                         The Parties agree that it may be necessary pursuant to this Agreement, from time to time, to disclose to each other confidential and proprietary information, including without limitation, inventions, trade secrets, specifications, designs, data,
 
15

 
know-how and other proprietary information, processes, services and business of the disclosing Party.
 
The foregoing together with the terms of this Agreement shall be referred to collectively as “ Additional Confidential Information ” .
 
The Parties also agree that it may have been necessary to disclose to each other Confidential Information (as defined in the SSDA) pursuant to the MS R&D Agreements and the Elan License Agreement.
 
Together Additional Confidential Information and Confidential Information shall be referred to collectively as “ Proprietary Information ”.
 
8.1.2                         Save as otherwise specifically provided herein, and subject to Clause 8.2 and 8.3, each Party shall disclose Proprietary Information of another Party only to those employees, representatives and agents requiring knowledge thereof in connection with fulfilling the Party’s obligations under this Agreement, and not to any other third party.
 
Each Party further agrees to inform all such employees, representatives and agents of the terms and provisions of this Agreement relating to Proprietary Information and their duties hereunder and to obtain their agreement hereto as a condition of receiving Proprietary Information.
 
Each Party shall exercise the same standard of care as it would itself exercise in relation to its own confidential information (but in no event less than a reasonable standard of care) to protect and preserve the proprietary and confidential nature of the Proprietary Information disclosed to it by another Party.
 
Each Party shall promptly, upon request of another Party, return all documents and any copies thereof containing Proprietary Information belonging to, or disclosed by, such Party, save that it may retain one copy of the same solely for the purposes of ensuring compliance with this Clause 8.
 
8.1.3                         Any breach of this Clause 8 by any person informed by one of the Parties is considered a breach by the Party itself.
 
8.1.4                         Proprietary Information shall be deemed not to include:
 
16

 
(1)                                   information which is in the public domain;
 
(2)                                   information which is made public through no breach of this Agreement;
 
(3)                                   information which is independently developed by a Party, as evidenced by such Party’s records;
 
(4)                                   information that becomes available to a receiving Party on a non-confidential basis, whether directly or indirectly, from a source other than another Party, which source did not acquire this information on a confidential basis.
 
8.1.5                         The provisions relating to confidentiality in this Clause 8 shall remain in effect for a period of 7 years following the Effective Date of this Agreement.
 
8.1.6                         The Parties agree that the obligations of this Clause 8 are necessary and reasonable in order to protect the Parties’ respective businesses, and each Party agrees that monetary damages may be inadequate to compensate a Party for any breach by another Party of its covenants and agreements set forth herein.
 
The Parties agree that any such violation or threatened violation may cause irreparable injury to a Party and that, in addition to any other remedies that may be available, in law and equity or otherwise, each Party shall be entitled to seek injunctive relief against the threatened breach of the provisions of this Clause 8, or a continuation of any such breach by another Party, specific performance and other equitable relief to redress such breach together with damages and reasonable counsel fees and expenses to enforce its rights hereunder.
 
8.2                                  Announcements:
 
Subject to Clause 8.3, no announcement or public statement concerning the existence, subject matter or any term of this Agreement shall be made by or on behalf of any Party without the prior approval of, if such statement is to be made by Elan or EIS, Acorda, and if such statement is to be made by Acorda or MS R&D, Elan Corp, provided, however, that such approval shall not be unreasonably withheld or delayed and shall not be required if the reference to this Agreement has previously been approved by the applicable Party.
 
The terms of any such announcement shall be agreed in good faith by the Parties.
 
17

 
8.3                                  Permitted Disclosures:
 
8.3.1                         A Party (the “ Disclosing Party ”) will be entitled to make an announcement or public statement concerning the existence, subject matter or any term of this Agreement, or to disclose Proprietary Information that the Disclosing Party is required to make or disclose pursuant to:
 
(1)                                    a valid order of a court or governmental authority provided that if the Disclosing Party becomes legally required to make such announcement, public statement or disclosure hereunder, the Disclosing Party shall give the other Parties prompt notice of such fact to enable the other Parties to seek a protective order or other appropriate remedy concerning any such announcement, public statement or disclosure.
 
The Disclosing Party shall fully co-operate with the other Parties in connection with that other Party’s or Parties’ efforts to obtain any such order or other remedy; or
 
(2)                                    any other requirement of law or any securities or stock exchange, provided that to the maximum extent allowable by such securities or stock exchange rules and regulations, the Parties shall seek to maintain the confidentiality obligations set forth herein and shall redact any confidential information set forth in such filings;
 
(3)                                    to governmental or other regulatory agencies in order to obtain patents relating to Product, or to gain approval to conduct clinical trials or to market Product, but such disclosure may be only to the extent reasonably necessary to obtain such patents or authorizations; or
 
(4)                                    by Acorda to its consultants, Affiliates and/or potential sublicensees for the research and development, manufacturing and/or marketing of the Compound and/or Product (as defined in the Restated Elan License) (or for such parties to determine their interests in performing such activities) on the condition that such third parties agree to be bound by the confidentiality obligations consistent with this Agreement;
 
18

 
8.3.2                         Each of the Parties shall be entitled to provide a copy of this Agreement (and any subsequent amendments hereto) and the MS R&D Agreements to a potential third party purchaser in connection with Clause 10.2.1(2); provided that the relevant third party purchaser or assignee has entered into a confidentiality agreement on terms no less protective than the terms of this Clause 8.
 
9                                           WAIVER OF ACCRUED RIGHTS/MUTUAL RELEASES
 
9.1                                  With effect from the Effective Date, each Party and each of its Affiliates (“ Releasor ”):
 
9.1.2                         waives any accrued rights that Releasor may have accrued against the other Parties and each of its Affiliates, officers, directors, representative, agents and employees and the assigns and successors in interest of any of the foregoing entities (“ Releasees ”), whether known or unknown, foreseen or unforeseen, fixed or contingent, of any nature whatsoever from the beginning of time to the Effective Date under the MS R&D Agreements; and
 
9.1.3                         fully and finally releases and discharges the Releasees from any and all manner of actions, claims, promises, debts, sums of money, demands, obligations, in law or in equity, directly or indirectly, whether known or unknown, foreseen or unforeseen, fixed or contingent, of any nature whatsoever that Releasor may have by reason of any act, omission, matter, provision, cause or thing whatsoever from the beginning of time to the Effective Date under the MS R&D Agreements.
 
9.2                                  For the avoidance of doubt the provisions of this Clause 9 shall not in any way act as a waiver or release by any of the Parties in respect of any of the provisions set forth in this Agreement.
 
10                                     GENERAL
 
10.1                            Governing law and jurisdiction :
 
10.1.1                   This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to conflicts of law principles under the laws of the State of New York.
 
19

 
10.1.2                   For the purposes of this Agreement, the Parties submit to the nonexclusive jurisdiction of the State and Federal Courts of New York.
 
10.2                            Assignment :
 
10.2.1                   Subject to Clause 10.2.2, this Agreement shall not be assigned by any Party without the prior written consent of (i) Elan Corp, if the Party seeking such assignment is Acorda or MS R&D, or (ii) Acorda, if the Party seeking such assignment is Elan Corp or EIS, save that any Party:
 
(1)                                   may assign this Agreement in whole or in part and delegate its duties hereunder to its Affiliate or Affiliates without such consent; and
 
(2)                                   may assign its rights and obligations to a successor (whether by merger, consolidation, reorganization or other similar event) or purchaser of all or substantially all of its assets relating to the Project, provided that such successor or purchaser has agreed in writing to assume all of such Party’s rights and obligations hereunder and a copy of such assumption is provided to the other Parties.
 
10.2.2                   For the avoidance of doubt, nothing in this Clause 10.2 shall affect the provisions governing assignment of securities in the Securities Amendment Agreement.
 
10.3                            Notices :
 
10.3.1                   Any notice to be given under this Agreement shall be sent in writing in English by registered airmail, internationally recognized courier or telefaxed to the following addresses:

If to MS R&D at:	
 	
MS Research and Development Corporation	
15 Skyline Drive	
Hawthorne, NY  10532	
Facsimile:	914 347 4560	
with a copy to Acorda at the address indicated below;	

If to Acorda at:	
 	
Acorda Therapeutics, Inc.	
 
20

 

15 Skyline Drive	
Hawthorne, NY  10532	
Facsimile:	914 347 4560	
Attention:	President	
 	
If to Elan and/or EIS at:	
 	
Elan Corporation, plc	
Elan International Services, Ltd.	
C/o Elan International Services, Ltd.	
102 St. James Court	
Flatts,	
Smiths FL04	
Bermuda	
Attention:	Secretary	
Telephone:	441 292 9169	
Fax:	441 292 2224	
 
or to such other address (es) and telefax numbers as may from time to time be notified by any Party to the others hereunder.
 
10.3.2                   Any notice sent by mail shall be deemed to have been delivered within seven (7) working days after dispatch or delivery to the relevant courier and notice sent by fax shall be deemed to have been delivered upon confirmation receipt.  Notice of change of address shall be effective upon receipt.
 
10.4                            Waiver :
 
No waiver of any right under this Agreement shall be deemed effective unless contained in a written document signed by the Party charged with such waiver, and no waiver of any breach or failure to perform shall be deemed to be a waiver of any future breach or failure to perform or of any other right arising under this Agreement.
 
10.5                            Severability :
 
If any provision in this Agreement is agreed by the Parties to be, or is deemed to be, or becomes invalid, illegal, void or unenforceable under any law that is applicable hereto:
 
10.5.1                   such provision will be deemed amended to conform to applicable laws so as to be valid and enforceable; or
 
10.5.2                   if it cannot be so amended without materially altering the intention of the Parties, it will be deleted, with effect from the date of this
 
21

 
Agreement or such earlier date as the Parties may agree, and the validity, legality and enforceability of the remaining provisions of this Agreement shall not be impaired or affected in any way.
 
10.6                            Further Assurances :
 
At the request of any of the Parties, the other Party or Parties shall (and shall use reasonable efforts to procure that any other necessary parties shall) execute and perform all such documents, acts and things as may reasonably be required subsequent to the signing of this Agreement for assuring to or vesting in the requesting Party the full benefit of the terms hereof.
 
10.7                            Successors :
 
This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns.
 
10.8                            Amendments :
 
No amendment, modification or addition hereto shall be effective or binding on any Party unless set forth in writing and executed by a duly authorized representative of each Party.
 
10.9                            Counterparts :
 
This Agreement may be executed in any number of counterparts, each of which when so executed shall be deemed to be an original and all of which when taken together shall constitute this Agreement.
 
10.10                      Costs :
 
Each Party shall bear its own costs and expenses in connection with the transactions contemplated by this Agreement.
 
10.11                      Force Majeure :
 
No Party to this Agreement shall be liable for failure or delay in the performance of any of its obligations hereunder if such failure or delay results from Force Majeure, but any such failure or delay shall be remedied by such Party as soon as practicable.
 
10.12                      Relationship of the Parties :
 
The Parties are independent contractors under this Agreement.  Nothing herein contained shall be deemed to create or establish an employment,
 
22

 
agency, joint venture, or partnership relationship between the Parties or any of their agents or employees, or any other legal arrangement that would impose liability upon one Party for the act or failure to act of another Party.  No Party shall have any express or implied power to enter into any contracts, commitments or negotiations or to incur any liabilities in the name of, or on behalf of, another Party, or to bind another Party in any respect whatsoever.
 
10.13                      Entire agreement :
 
10.13.1              T his Agreement and the Restated Elan License (together with the Appendices, Schedules and Exhibits hereto and thereto) sets forth all of the agreements and understandings between the Parties with respect to the subject matter hereof.  There are no agreements or understandings with respect to the subject matter hereof, either oral or written, between the Parties other than as set forth in this Agreement and the Restated Elan License.
 
10.13.2             No provision of this Agreement shall be construed so as to negate, modify or affect in any way the provisions of any other agreement between the Parties unless specifically provided herein and only to the extent so specified.
 
THE REMAINDER OF THIS PAGE
HAS BEEN INTENTIONALLY LEFT BLANK.
 
23

 
IN WITNESS WHEREOF the Parties have executed this Agreement.

SIGNED	
 	
BY:	 	 	
for and on behalf of	
Elan Corporation, plc	

SIGNED	
 	
BY:	 	 	
for and on behalf of	
Elan International Services, Ltd.	

SIGNED	
 	
BY:	 	 	
for and on behalf of	
MS Research & Development Corporation	

SIGNED	
 	
BY	 	 	
for and on behalf of	
Acorda Therapeutics, Inc.	
 
24

 
SCHEDULE 1
 
CLINICAL TRIALS
 
Completed Studies:
•                   MS-F200: Randomized, Double-Blind, Placebo-controlled Trial of Sustained-Release Fampridine(4-aminopyridine) in Multiple Sclerosis Patients with Internuclear Ophthalmoplegia (INO)
 
•                   MS-F201: A Double blind, Dose-Ranging Study of Fampridine-SR in Subjects with Multiple Sclerosis
 
Ongoing Studies:
•                   MS-F202: Double-Blind, Placebo-controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of oral Fampridine-SR in subjects with Multiple Sclerosis
 
•                   MS-F202 ext: 12 month ext open label extension study
 
25

 
SCHEDULE 2.2
 
RIGHTS OF FIRST OFFER & CO-SALE RIGHTS
 
The following is a restatement of Section 4.4 and Section 4.5 of the SSDA and relevant definitions:
 
Rights of First Offer
 
4.4                                                                                                                                  (a)  If at any time a Stockholder shall desire to Transfer any Common Stock owned by it (a “Selling Stockholder” ), in any transaction or series of related transactions, then such Selling Stockholder shall deliver prior written notice of its desire to Transfer (a “Notice of Intention” ) to (i) the Company and (ii) the party who is not the Selling Stockholder, and (iii) any Permitted Transferee, as applicable, setting forth such Selling Stockholder’s desire to make such Transfer, the number of shares of Common Stock proposed to be transferred (the “Offered Shares” ) and the proposed form of transaction (the “Transaction Proposal” ), together with any documentation relating thereto and the price at which such Selling Stockholder proposes to Transfer the Offered Shares (the “Offer Price” ).  The “Right of First Offer” provided for in this Section 4.4 shall be subject to any “Co-sale Right” benefiting a Stockholder which may be provided for by Section 4.5, subject to the exceptions set forth therein. The parties shall make such adjustments in the arrangements required by this Section 4.4 as the board of directors shall deem necessary and proper in connection with obtaining material investments from unaffiliated third parties.
 
(b)  Upon receipt of the Notice of Intention, the party who is not the Selling Stockholder shall have the right to purchase at the Offer Price the Offered Shares, exercisable by the delivery of notice to the Selling Stockholder (the “Notice of Exercise” ), with a copy to the Company within 10 business days from the date of receipt of the Notice of Intention.  If no such Notice of Exercise has been delivered by the party who is not the Selling Stockholder within such 10 business-day period, or such Notice of Exercise does not relate to all the Offered Shares covered by the Notice of Intention, then the Selling Stockholder shall be entitled to Transfer the Offered Shares to the intended Transferee.
 
(c)  In the event that the party who is not the Selling Stockholder exercises its right to purchase Offered Shares (in accordance with this Section 4.4), then the Selling Stockholder must sell the Offered Shares to such party, in the amounts set forth in the Notice of Intention, after not less than five business and not more than 15 business days from the date of the delivery of the Notice of Exercise.
 
(d)  The rights and obligations of each of the Stockholders pursuant to the Right of First Offer provided herein shall terminate upon the date that the Company shall have a class of securities registered under Section 12(b) or 12(g) of the Exchange Act.
 
26

 
(e)  At the closing of the purchase of Offered Shares (scheduled in accordance with Section 4.4(c)), the Selling Stockholder shall deliver certificates evidencing the Offered Shares being sold, duly endorsed, or accompanied by written instruments of transfer in form reasonably satisfactory to the party who is not the Selling Stockholder, duly executed by the Selling Stockholder, free and clear of any adverse claims, against payment of the purchase price therefor in cash, and such other customary documents as shall be necessary in connection therewith.
 
Co-sale Rights
 
4.5                                                                                                                                  (a)  Subject to Section 4.5(e), any one Stockholder (the “Transferring Stockholder” ) shall not Transfer (either directly or indirectly), in any one transaction or series of related transactions, to any Person or group of Persons, 5% or more of Common Stock, or options, warrants or any other securities convertible, exercisable or exchangeable for Common Stock ( “Common Stock Equivalents” ), unless the terms and conditions of such Transfer shall include an offer to the other Stockholders (the “Remaining Stockholders” ), at the same price and on the same terms and conditions as the Transferring Stockholder has agreed to sell its Common Stock.
 
(b)  In the event a Transferring Stockholder proposes to Transfer any Common Stock or Common Stock Equivalents in a transaction subject to this Section 4.5, it shall notify, or cause to be notified, the Remaining Stockholders in writing of each such proposed Transfer.  Such notice shall set forth: (i) the name of the transferee and the number of shares of Common Stock proposed to be transferred, (ii) the proposed amount and form of consideration and terms and conditions of payment offered by the transferee (the “Transferee Terms” ) and (iii) that the transferee has been informed of the “Co-sale Right” provided for in this Section 4.5, if such right is applicable, and has agreed to purchase shares of Common Stock from the Transferring Stockholder in accordance with the terms hereof.
 
(c)  The Co-sale Right may be exercised by the Remaining Stockholders by delivery of a written notice to the Transferring Stockholder (the “Co-sale Notice” ) within five business days following receipt of the notice specified in the preceding subsection.  The Co-sale Notice shall state the number of shares of Common Stock owned by the Remaining Stockholder which the Remaining Stockholder wishes to include in such Transfer; provided, however, that without the written consent of the Transferring Stockholder, the number of shares belonging to the Remaining Stockholder included in such Transfer may not be greater than such Remaining Stockholder’s percentage beneficial ownership of Common Stock (on a fully diluted basis) multiplied by the total number of shares of Common Stock (including shares of Common Stock issuable upon the conversion, exercise or exchange of any Common Stock Equivalent) to be sold by both the Transferring Stockholder and all Remaining Stockholders.  Upon receipt of a Co-sale Notice, the Transferring Stockholder shall be obligated to transfer at least the entire number of shares of Common Stock set forth in the Co-sale Notice to the Transferee on the Transferee Terms; provided, however, that the Transferring
 
27

 
Stockholder shall not consummate the purchase and sale of any shares hereunder if the Transferee does not purchase all shares.  If no Co-sale Notice has been delivered to the Transferring Stockholder prior to the expiration of the five-day period referred to above and if the provisions of this Section have been complied with in all respects, the Transferring Stockholder shall have the right for a 60 day calendar day period to Transfer Common Stock to the Transferee on the Transferee Terms without further notice to any other party, but after such 60-day period, no such Transfer may be made without again giving notice to the Remaining Stockholders of the proposed Transfer and complying with the requirements of this Section 4.5.
 
(d) At the closing of any Transfer of Common Stock or Common Stock Equivalent subject to this Section 4.5, the Transferring Stockholder, and the Remaining Stockholder, in the event such Co-sale Right is exercised, shall deliver certificates evidencing such shares of Common Stock as have been Transferred by each, duly endorsed, or accompanied by written instruments of transfer in form reasonably satisfactory to the Transferee, free and clear of any adverse claim, against payment of the purchase price therefor.
 
(e) Notwithstanding the foregoing, this Section 4.5 shall not apply to any sale of Common Stock pursuant to an effective registration statement under the Securities Act in a bona fide public offering, sales made in compliance with Rule 144, or any successor rule under the Securities Act.
 
Definitions:
 
“Stockholders” shall mean EIS together with Acorda; each sometimes referred to herein as a “Stockholder”.
 
“Transfer” shall mean, in each case, directly or indirectly, sell, assign, pledge, encumber, hypothecate, grant a security interest in, or otherwise transfer Common Stock.
 
“Common Stock” shall mean shares of the Company’s common stock (the “Shares” ), par value $. 001 per share.
 
“Company” shall mean MS Research and Development Corporation.
 
“Permitted Transferee” means any Affiliate or Subsidiary of EIS or Acorda, to whom this Agreement may be assigned, pursuant to the terms hereof.
 
“Person” shall mean an individual, partnership, joint venture, corporation, trust or unincorporated organization, a government or any department, agency or political subdivision thereof, or any other entity.
 
28

 
SCHEDULE 2.4
 
AMOUNTS OWING BY MS R&D TO ACORDA AND ELAN

MS R&D Debt:	 	$	721,000	 	
 	 	 	 	
Owing to Elan:	 	$	129,229	 	
 
29

 
SCHEDULE 4.1
 
CAPITALIZATION

Shareholder	 	Common Shares	 	% Shareholding	 	
Acorda	 	20,342	 	82.671	%	
EIS	 	1,279	 	5.198	%	
EPIL II	 	2,985	 	12.131	%	
Total	 	24,606	 	100	%	
 
30

 
SCHEDULE 4.3
 
BALANCE SHEET AND PRO FORMA BALANCE SHEET
 
(expressed in United States dollars)

 	 	June 30,
2003	 	June 30, 2003	 	
 	 	(Unaudited)	 	Pro Forma (Unaudited)	 	
 	 	 	 	 	 	
ASSETS:	 	 	 	 	 	
Current Assets	 	 	 	 	 	
Check/Savings	 	0	 	0	 	
 	 	 	 	 	 	
Total Current Assets	 	0	 	0	 	
 	 	 	 	 	 	
Total ASSETS	 	0	 	0	 	
 	 	 	 	 	 	
LIABILITIES AND EQUITY:	 	 	 	 	 	
Liabilities	 	 	 	 	 	
Current Liabilities:	 	 	 	 	 	
Accounts Payable – Due to Elan	 	113,260	 	129,229	 	
Accounts Payable – Due to Acorda	 	—	 	721,000	 	
Total Accounts Payable	 	113,260	 	850,229	 	
 	 	 	 	 	 	
Total current liabilities	 	113,260	 	850,229	 	
 	 	 	 	 	 	
Total liabilities	 	113,260	 	850,229	 	
 	 	 	 	 	 	
Equity	 	 	 	 	 	
Contributed Surplus	 	 	 	 	 	
Contributed Surplus Acorda	 	8,213,265	 	8,213,265	 	
Contributed Surplus EIS	 	1,279,409	 	1,279,409	 	
 	 	9,492,674	 	9,492,674	 	
 	 	 	 	 	 	
Retained Earnings	 	(24,605,943	)	(25,342,912	)	
 	 	 	 	 	 	
Share Capital	 	 	 	 	 	
Common Shares Acorda	 	20	 	21	 	
Common Shares EPIL II	 	3	 	3	 	
Common Shares EIS	 	1	 	—	 	
 	 	24	 	24	 	
 	 	 	 	 	 	
Share Premium	 	 	 	 	 	
Acorda	 	12,014,988	 	12,014,988	 	
EIS	 	2,984,997	 	2,984,997	 	
 	 	14,999,985	 	14,999,985	 	
 	 	 	 	 	 	
Total liabilities and stockholders’ equity	 	—	 	—	 	
 
31

 
SCHEDULE 4.4.2
 
MS R&D THIRD PARTY AGREEMENTS
 
Agreements to which MS R&D is a party
 
None
 
Agreements to which Elan is a party for the benefit of MS R&D
 
1                                           Confidentiality Agreement dated February 24, 2000 between Elan Corporation plc and Regis Technologies, Inc
 
2                                           Confidentiality Agreement dated May 1, 2002 between Elan Corporation plc and Magellan Laboratories, Inc
 
3                                           Confidentiality Agreement dated April 12, 2000 between Elan Corporation plc and Regulatory Interlinx
 
4                                           Confidentiality Agreement dated December 8, 1997 between Elan Corporation plc and CU Chemie Uetikon GmbH
 
5                                           Supply Agreement dated December 8, 2000 between Elan Pharma Limited and Regis Technologies Inc
 
6                                           Letter Agreement dated June 26, 2000 between Elan Pharmaceutical Operations and CU Chemie Uetikon GmbH
 
Agreements to which Elan and Acorda are parties for the benefit of MS R&D
 
Confidentiality Agreement dated December 5, 2002 between Elan Corporation plc, Patheon Inc. and Acorda Therapeutics, Inc
 
Agreements to which Elan and Acorda are parties for the benefit of MS R&D
 
1                                           Clinical Reference Laboratory dated January 9, 2003
2                                           Jeiven/Almedica dated November 14, 2002
3                                           Pharmanet dated October 25, 2001
4                                           Cardinal Health dated April 1, 2003
5                                           ClinPro, Inc. dated July 30, 2002
6                                           Patheon, Inc. dated February 26, 2003
 
32

 
Clinical Study Agreements*
 
1                                           Catholic Healthcare West dated February 24, 2003
2                                           Charlotte Mecklenberg Hospital Authority dated December 18, 2002
3                                           Cleveland Clinic Foundation dated January 10, 2001 (201); March 17, 2003 (202)
4                                           CMSC/Gimbel MS Center dated December 17, 2002
5                                           Fairview MS Center dated December 20, 2002
6                                           Health Research Association dated July 7, 2003
7                                           Maimonides Medical Center dated January 13, 2003
8                                           Mt. Sinai School of Medicine dated December 19, 2002
9                                           Ohio State University Research Foundation dated January 13, 2003
10                                     Oregon Health & Science University dated January 7, 2003
11                                     Research Foundation SUNY dated January 15, 2003
12                                     Shepherd Center, Inc. dated November 25, 2002
13                                     St. Michael’s Hospital dated March 10, 2003
14                                     Swedish Health Services dated January 13, 2003
15                                     Texas Health Sciences Center at Houston dated January 15, 2003
16                                     Thomas Jefferson University dated January 13, 2003
17                                     Governors of the University of Calgary dated Decemeber 19, 2002
18                                     University of Chicago dated March 21, 2003
19                                     University of Maryland, Baltimore dated December 17, 2002
20                                     Regents of the University of New Mexico dated February 24, 2003
21                                     University of Rochester dated November 22 2000 (201); December 18 2002 (202)
22                                     University of Washington dated March 11, 2003
23                                     Washington University dated February 20, 2001 (201); December 18, 2003 (202)
24                                     Yale University dated January 10, 2001 (201); February 6, 2003 (202)
25                                     University of Texas Southwestern dated May 17, 1999 (200)
 
33

 
SCHEDULE 4.6
 
REGULATORY FILINGS
 
USA
 
Acorda submitted an IND application in the US (IND # 51,333) on 23 August 1996, and has been submitting the IND amendments and IND annual reports since then.
 
Acorda has been submitting the IND amendments and IND annual reports since the acceptance of the transfer of IND# 17,627 from Athena Neurosciences to Acorda on 17 June 1998.
 
Acorda submitted orphan drug application (Application# 97-1044) on 14 March 1997, and has been submitting the annual reports since then.
 
Acorda has been submitting the annual reports since the transfer of sponsorship of orphan drug application (Application# 86-181) from Athena Neurosciences, Inc. on 11 July 1997.

Canada
 
Acorda submitted an IND application in Canada (File # 9427-S1507-21C) on December 11, 1997. (File # later changed to 9427-A1507-21C), and the IND amendments and IND annual reports.
 
34

 
SCHEDULE 4.10
 
DISTRIBUTION
 
The Distribution shall be payable pro rata to the stockholders of MS R&D in the amounts set forth opposite their respective names:

Acorda	 	US$	9,541,347	 	
 	 	 	 	
EIS	 	US$	599,919	 	
 	 	 	 	
EPIL II	 	US$	1,400,081	 	
 
35

 
Exhibit 10.8
 
Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission.
 
EXECUTION COPY
 
Date:     September 2003

ELAN CORPORATION, PLC.
 
AND
 
ACORDA THERAPEUTICS, INC.

AMENDED AND RESTATED LICENSE AGREEMENT

 
INDEX

ARTICLE 1	DEFINITIONS AND INTERPRETATION	
 	 	
ARTICLE 2	THE LICENSE	
 	 	
ARTICLE 3	DEVELOPMENT OF THE PRODUCT	
 	 	
ARTICLE 4	[NOT USED]	
 	 	
ARTICLE 5	FINANCIAL PROVISIONS	
 	 	
ARTICLE 6	REGISTRATION OF THE PRODUCT	
 	 	
ARTICLE 7	[NOT USED]	
 	 	
ARTICLE 8	WARRANTY AND INDEMNITY	
 	 	
ARTICLE 9	[NOT USED]	
 	 	
ARTICLE 10	COMMITTEE	
 	 	
ARTICLE 11	PATENTS	
 	 	
ARTICLE 12	SUNDRY CLAUSES	
 	 	
3#(%$5,%￠	!#/2$! 0!4%.4 2)'(43	
 	 	
3#(%$5,%￠	!33)'.-%.4 !'2%%-%.4	
 	 	
3#(%$5,%￠	%,!. 0!4%.4 2)'(43	
 	 	
3#(%$5,%￠	.$! 4)-%,).%	
 	 	
3#(%$5,%￠	253(!#/2$! ,)#%.3%	
 	 	
3#(%$5,%￠	253( 0!9-%.43 !'2%%-%.4	
 	 	
3#(%$5,%￠	30%#)&)#!4)/.3	
 	 	
3#(%$5,%￠	3500,9 !'2%%-%.4	
 	 	
3#(%$5,%￠	4%#(./,/'9 42!.3&%2 2%30/.3)"),)4%3	

 
THIS AMENDED AND RESTATED LICENSE AGREEMENT is made as of the          day of September 2003
 
"%47%%.
 
(1)                                  Elan Corporation, plc. , a public limited company incorporated under the laws of Ireland, and having its registered office at Lincoln House, Lincoln Place, Dublin 2, Ireland (“ Elan ”); and
 
(2)                                  Acorda Therapeutics, Inc. , a corporation organized under the laws of the State of Delaware and having its principal office at 15 Skyline Drive, Hawthorne, New York 10532, United States of America (“ Acorda ”).
 
2%#)4!,3
 
(A)                               As of April 21, 1998, Elan and Acorda entered into an amended and restated licence and supply agreement relating to SCI (effective as from January 23, 1997) (the “ SCI Agreement ”);
 
(B)                                 Effective as of April 21, 1998, Elan, Acorda and MS R & D entered into a licence and supply agreement relating to MS (the “ MS Agreement ”);
 
(C)                                 Pursuant to the Assignment Agreement (i) MS R & D assigned all of its rights, title, interest and obligations under the MS Agreement to Acorda, and Acorda assumed all of MS R & D’s obligations thereunder; and (ii) Elan, Acorda and MS R & D terminated the MS R & D Agreements (as defined in the Assignment Agreement)
 
(D)                                The Parties desire and agree that certain provisions of the SCI Agreement and the MS Agreement should be amended, clarified and restated to reflect the intentions of the Parties with respect to the development, manufacturing and marketing of the Product in the Territory for the Indications on the terms and conditions set out herein.
 
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties hereby agree that each of the MS Agreement and the SCI Agreement, and all of the terms, conditions and provisions of the MS Agreement and the SCI Agreement, are hereby superceded and replaced and restated in their entirety by this Agreement and the Supply Agreement and the terms, conditions and provisions hereof and thereof, as of the Amendment Date, as follows and as set forth in the Supply Agreement:
 
!24)#,%￠￠￠￠$%&).)4)/.3 !.$ ).4%202%4!4)/.
 
1.1.                                    In the present Agreement and any further agreements based thereon between the Parties hereto, the following definitions shall prevail:
 
1

 
“ Acorda Know-How ” shall mean all knowledge, information, trade secrets, data and expertise relating to the Product which is not generally known to the public that is owned or possessed by Acorda (and/or its Affiliates), or that is developed by Acorda (and/or its Affiliates) during the term of this Agreement relating to the Product, including clinical data, whether or not covered by any patent, copyright, design, trademark or other industrial or intellectual property rights and excluding Elan Intellectual Property. Title to all inventions and other intellectual property made solely by Acorda employees in connection with the Project shall be owned by Acorda.
 
“ Acorda Patent Rights ” shall mean any and all rights under any and all patents and patent applications now existing, currently pending or hereafter filed, owned or acquired or licensed by Acorda (and/or its Affiliates) from a Third Party which would be infringed by the manufacture, use or sale of the Product, the current status of which is set forth in Schedule 1 .   Acorda Patent Rights shall also include all continuations, continuations-in-part, divisionals and re-issues of such patents and patent applications and any patents issuing thereon and extensions of any patents licensed hereunder.  Acorda Patent Rights shall further include any patents or patent applications covering any improved methods of making or using the Product invented or acquired by Acorda (and/or its Affiliates) from a Third Party during the term of this Agreement, and under which Acorda (and/or its Affiliates) has a right to grant a licence hereunder. Acorda Patent Rights shall exclude Elan Intellectual Property.
 
“ Act ” shall mean the United States Federal Food Drug and Cosmetic Act of 1934, and the rules and regulations promulgated thereunder, or any successor act, as the same shall be in effect from time to time.
 
“ Affiliate ” shall mean any corporation or entity controlling, controlled by or under the common control of Elan or Acorda as the case may be.  For the purpose of this Agreement, “control” shall mean the direct or indirect ownership of at least fifty percent (50%) of the outstanding shares or other voting rights of the subject entity to elect directors, or if not meeting the preceding criteria, any entity owned or controlled by or owning or controlling at the maximum control or ownership right permitted in the country where such entity exists.
 
“ Agreement ” shall mean this amended and restated license agreement (which expression shall be deemed to include the Recitals and Appendices and Schedules hereto).
 
“ Alternate Compound ” shall mean any mono- or di-aminopyridine, other than the Compound, as well as the isomers, and the salts thereof.
 
“ Amendment Date ” shall mean      September 2003.
 
“ API ” shall mean any Compound or Alternate Compound, in bulk form, for use as an active ingredient in the manufacture of Product.
 
2

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.

“ Assignment Agreement ” shall mean the Termination and Assignment Agreement entered into by and among Acorda, Elan and MS R & D as of the Amendment Date, a copy of which is attached hereto as Schedule 2 .
 
“ Cardinal Agreement ” shall mean the Laboratory Services Agreement by and between Cardinal Health PTS, Inc. (“Cardinal”) and Acorda dated April 1, 2003 relating to stability testing of oral tablets of Fampridine.
 
“ cGCP ”, “ cGLP ” and “ cGMP ” shall mean current Good Clinical Practises, current Good Laboratory Practises and current Good Manufacturing Practises, respectively, pursuant to the Act and FDA guidance documents.
 
“ CMC Section ” shall mean the chemistry, manufacturing, and controls section of an NDA as defined in 21 CFR Section 314.50 (1) and its equivalent in other registration applications.
 
“ Committee ” shall mean the committee to be established pursuant to Article 10.
 
“ Competition ” shall mean on a country by country basis the sale or distribution by a Third Party of a sustained release oral pharmaceutical formulation of a mono- or di-aminopyridine active agent for administration on a once or twice daily basis for the treatment or amelioration of any neurological condition(s) (including neurogenic conditions) in humans, where the sales or distribution of such formulation by said Third Party for a calendar year are at least [**] of the total sales of the Product in such country in such calendar year expressed in equivalent units.  The determination that Competition exists in any country in any calendar year shall be deemed conclusively if a mutually agreed reputable organization such as IMS has made such determination based on its conduct of a market share study in such country during such year, provided the existence of such level of sales of competing products may also be established by other reasonable evidence.  Once a determination is made that Competition exists for a Product in any country, such determination shall be made again by the Parties each calendar year for so long as the Product is marketed in that country; provided that in the event that Competition has ceased prior to the end of a calendar year and has not resumed, the Competition shall be deemed to have terminated for such year.
 
“ Compound ” shall mean the compound known as 4-aminopyridine as well as the isomers, and the salts thereof.
 
“ Confidential Information ” shall mean (i) any proprietary or confidential information or material in tangible form disclosed hereunder that is marked as “Confidential” at the time it is delivered to the receiving Party, or (ii) proprietary or confidential information disclosed orally hereunder which is identified as confidential or proprietary when disclosed and such disclosure of confidential information is confirmed in writing within thirty (30) days by the disclosing Party.
 
“ Designee ” shall mean a sub-licensee, distributor or any other Third Party authorised by Acorda including those entities or persons appointed by Acorda pursuant to the provisions of Article 2.3.1.
 
3

 
“Development Plan ” shall have the meaning set forth in Article 3.1.
 
“ DMF ” shall mean a Drug Master File, as defined in 21 CFR Section 314.420, as the same may be amended or re-promulgated from time to time, or any successor filing or procedure and/or its equivalent in the other countries of the Territory.
 
“ Dominating Patent ” shall mean an unexpired patent that has not been invalidated by a court or governmental agency which is owned by a Third Party, which covers the Product sold by Acorda or its Designees, under circumstances such that Acorda, including on behalf of its Designees, has no commercially reasonable alternative to obtaining a royalty-bearing licence under such patent in order to practise or exploit the Elan Intellectual Property to develop and/or commercialise the Product.
 
“ EDDI ” shall mean Elan Drug Delivery Inc., a wholly-owned subsidiary of Elan, and the successor to Elan Pharmaceutical Research Corp.
 
“ Elan Intellectual Property ” shall mean the Elan Patent Rights and/or the Elan Know-How.
 
“ Elan Know-How ” shall mean all knowledge, information, trade secrets, data and expertise within Elan’s oral controlled release technology relating to the Product which is not generally known to the public that is owned or possessed by Elan (and/or its Affiliates), or to be developed by Elan (and/or its Affiliates), whether before or during the term of this Agreement, whether or not covered by any patent, copyright, design, trademark or other industrial or intellectual property rights, or developed by or on behalf of Elan (and/or its Affiliates) in connection with the Project, or developed by or on behalf of Elan (and/or its Affiliates) pursuant to the Axogen Agreement. Title to all inventions and other intellectual property made solely by employees of Elan in connection with the Project shall be owned by Elan.
 
Elan Know-How shall exclude:
 
(a)                              any and all know how as of the Amendment Date pertaining to the development or manufacture of transdermal formulations of the Compound and/or other mono- or di-aminopyridines, isomers and salts thereof, other than US patents numbers 5,370,879, 5,540,938 and/or 5,580,580, and any foreign equivalents, divisionals, reissues or continuations and any patents issued thereon, and the know-how described therein; and
 
(b)                             nanoformulation technology to the extent specifically licensed by Elan to Merck pursuant to the Merck Agreement for Indications other than MS or SCI.
 
“ Elan Patent Rights ” shall mean any and all rights under any and all patents and patent applications now existing, currently pending or hereafter filed, owned or acquired or licensed by Elan (and/or its Affiliates) which would be infringed by the manufacture, use or sale of the Product, the current status of which as of the Amendment Date is set forth in Schedule 3 .  Elan Patent Rights shall also include all continuations, continuations-in-part, divisionals and re-issues of such patents and patent applications and any patents
 
4

Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission.
 
issuing thereon and extensions of any patents licensed hereunder.  Elan Patent Rights shall further include any patents or patent applications covering any improved methods of making or using the Product invented or acquired by Elan (and/or its Affiliates) during the term of this Agreement and under which Elan (and/or its Affiliates) has a right to grant a licence hereunder, and Elan’s (and/or its Affiliates) interest in any intellectual property conceived reduced to practice or otherwise developed in connection with the Project.
 
“ EMEA ” shall mean the European Agency for the Evaluation of Medicinal Products based in London (UK), as established by Council Regulation n° 2309/93 of July 22, 1993, as subsequently amended by Commission Regulation 649/98 of March 23, 1998.
 
“ End of Phase 2 Meeting ” shall mean the first end of Phase 2 meeting with the FDA, as defined in 21 CFR Section 312.47, intended to determine the safety of proceeding to Phase 3, evaluate the Phase 3 plan and protocols and identify any additional information necessary to support an NDA for Product.
 
“ EXW ” and “ Ex Works ” shall have the meaning as such term is defined in the ICC Incoterms, 2000, International Rules for the Interpretation of Trade Terms, ICC Publication No. 560.
 
“ Fampridine Product ” shall mean any finished pharmaceutical oral sustained release dosage form containing the Compound, which is in the scope of one or more Valid Claims within the Elan Patent Rights in the country of sale, and/or incorporates Elan Know-How in material part.  The use of the pre-clinical, toxicological, pharmacokinetic, metabolic, formulation, methods, clinical protocols and data developed for and on behalf of Elan, which is included in the Elan Know-How shall constitute incorporation of the Elan Know-How in material part.
 
“ FDA ” shall mean the United States Food and Drug Administration or any other successor agency, whose approval is necessary to market the Product in the United States of America.
 
“ First Commercial Sale ” shall mean the first In Market sale of Product in any country by Acorda or an Acorda Designee for end use or consumption, after all required Regulatory Approvals have been granted by the governing health authority of such country.
 
“ FTE ” means Elan’s full time equivalent charging rate for its appropriate employees or consultants from time to time (based on cost without mark-up) which as of the Amendment Date is US[***] per day.
 
“ GAAP ” shall mean generally accepted accounting principles in the United States consistently applied.
 
“ IND ” shall mean the investigational new drug application and any amendments thereto for the Product filed with the FDA including IND numbers [*****].
 
5

 
 “ Indication ” shall mean any use or indication of Product for treatment of any condition, including SCI and MS.
 
“ Initial Period ” shall have the meaning set forth in Article 12.5.1.1.
 
“ In Market ” shall mean the sale of the Product, whether by Acorda or its Designee, to an unaffiliated Third Party such as a wholesaler, distributor, managed care organisation, hospital or pharmacy and shall exclude the transfer pricing of the Product by Acorda to an Affiliate.
 
“Joint Invention” shall mean all inventions and other intellectual property made jointly by employees of Acorda and Elan in connection with the Project, which inventions and intellectual property shall be jointly owned by Elan and Acorda.
 
“ Launch Stocks ” shall have the meaning set forth in the Supply Agreement.
 
“ License Revenues ” shall mean the monetary amount or non cash consideration (exclusive of any taxes or duties that Acorda may be required by law to pay, but not including income, corporation or similar taxes) paid to Acorda for the granting to any Third Party any of the rights granted to Acorda under this Agreement and shall further include any other on going fees paid to Acorda in respect of such rights, but shall exclude bona fide research or development fees and payments received by Acorda and any payments received by Acorda for the sale of the Product from Elan pursuant to the provisions of Article 2.11.3.  For the avoidance of doubt, it is understood and agreed that License Revenues shall not include and Elan shall not be entitled to receive any share of payments received from a Third Party for the purchase of equity in Acorda, debt financing, the licence of intellectual property other than the Elan Intellectual Property, rights to products other than the Product or the reimbursement of patent or other expenses incurred by Acorda; provided that License Revenues shall include and Elan shall be entitled to receive any share of payments received from a Third Party for the purchase of equity in Acorda where such payments or a portion thereof are referable to the granting of rights to the Elan Intellectual Property for the Product.  The fact that a premium is paid by a Third Party for the purchase of equity in Acorda shall not of itself mean that the premium is referable to the granting of rights to the Elan Intellectual Property for the Product. For the avoidance of doubt, the Parties hereby confirm that the definition of License Revenues does not include royalties calculated as a percentage of NSP or of net In Market sales payable in each case by Designees to Acorda.
 
“Major European Markets” shall mean each of the United Kingdom, France, Germany and Italy.
 
“ Manufacturing Cost ” shall have the same meaning as in the Supply Agreement.
 
“ Merck Agreement ” shall mean the Technology Transfer and License Agreement dated 26 July 1999 between Merck & Co. Inc. (“ Merck ”), Elan, Elan Pharmaceutical Research Corp. (now EDDI) and Elan Pharma International Limited.
 
“ MS ” shall mean multiple sclerosis.
 
6

 
“ MS Field ” shall mean use as an oral prescription medicine for the treatment of MS in humans.
 
“ MS R & D ” shall mean MS Research and Development Corporation, a Delaware corporation, having an office at 15 Skyline Drive, Hawthorne, New York 10532 USA.
 
“ MS Term ” shall mean shall mean the period beginning on 21 April 1998 and ending upon expiry or termination of this Agreement, howsoever arising.
 
“ NDA ” shall mean the new drug application as defined in the Act and applicable regulations promulgated thereunder including any supplements or amendments thereto, which Acorda may file for the Product with the FDA.
 
“ NDA Approval ” shall mean the final approval to market the Product by the FDA as defined under the Act.
 
“ NDA Equivalent ” shall mean any new registration application or submission including any supplements or amendments thereto, such as a foreign counterpart to the NDA, which Acorda may file for the Product with any regulatory authority in any regulatory jurisdiction in the Territory other than the United States that is required to obtain Regulatory Approval in such jurisdiction.
 
“ NDA Timeline ” shall mean the development and regulatory timeline attached hereto as Schedule 4.
 
“ Notional NSP ” shall mean the estimated NSP of Product at the applicable time, which shall on a country-by-country basis be provided by Acorda to the Committee within ninety (90) days prior to commencement of each calendar year (or, for the Launch Year in any country, within ninety (90) days prior to the estimated date of First Commercial Sale in such country); provided, that:
 
(a)                                   for (i) the Launch Year and (ii) if no Statement is due to be produced prior to ninety (90) days prior to the estimated date of First Commercial Sale in such country, the Notional NSP shall be estimated in good faith; and
 
(b)                                  in each subsequent year, Notional NSP shall be calculated by reference to the average NSP in that country as evidenced by the last four Statements (or such lesser number of Statements as have actually been produced in relation to that country).
 
“ NSP ” shall mean that sum determined by deducting from the gross amount billed, however characterized, for the Product, commencing on the date of First Commercial Sale and sold In Market by Acorda or an Acorda Designee, the following:
 
(a)                                   transportation charges or allowances, including freight pick-up allowances, and packaging costs, if any;
 
7

 
(b)                                  trade, quantity or cash discounts, service allowances and independent broker’s or agent’s commissions, if any, allowed or paid;
 
(c)                                   credits or allowances, if any, given or made on account of price adjustments, returns up to ten per cent (10%) of gross sales, off-invoice promotional discounts, rebates, any and all national, federal, state or local government rebates, whether in existence now, or enacted at any time during the term of this Agreement, rejections, recall or Product destruction (voluntarily made or requested or made by an appropriate government agency sub-division or department) for the Product; and
 
(d)                                  any duty, tariff or tax (other than income or corporation tax), excise or governmental charge upon or measured by the production, import, export, sale, transportation, delivery, or use of the Product.
 
In the event that Acorda or its Designee shall sell the Product together with other products to third parties in a particular country and the price attributable to the Product is less than the average price of “arms length” sales of the Product alone in the particular country for the reporting period in which sales occur (such sales to be excluded from the calculation of the average price of “arms length” sales), NSP for any such sales shall be the average price of “arms length” sales by Acorda or its Designee of the Product alone and in the country during the reporting period in which such sales occur.   If the average price of “arms length” sale of the Product cannot be determined in any given country, the NSP will be determined by the value of the Product sold to similar customers in countries with similar pricing and reimbursement structures and for similar quantities.  Any dispute as to the determination of fair market value that cannot be resolved through discussion between the Parties shall be determined by an independent arbitrator in accordance with the provisions of Article 12.14.
 
“ Other Indication Field ” shall mean use as a prescription medicine for the treatment of any condition in humans, excluding the SCI Field and the MS Field, but for the avoidance of doubt including the treatment of SCI and/or MS otherwise than orally.
 
“ Other Indication Term ” shall mean the period beginning on the Amendment Date and ending upon expiry or termination of this Agreement, howsoever arising.
 
“ Party ” shall mean Acorda or Elan, as the case may be.
 
“ Parties ” shall mean Acorda and Elan.
 
“ Patheon Agreement ” shall mean the Technical Transfer Program Proposal for Commercial Registration entered into by and between Patheon, Inc. (“Patheon”) and Acorda dated as of February 26, 2003 relating to the manufacturing of Fampridine tablets.
 
“ Phase 3 Clinical Study ” shall mean a clinical trial conducted after an End of Phase 2 Meeting and conducted on a sufficient number of patients that is designed to establish that the Product is safe and efficacious for its intended Indication and is intended to
 
8

 
define warnings, precautions and adverse reactions that are associated with Product in the dosage range and formulation to be prescribed, and to support Regulatory Approval of Product for such Indication.
 
“ Product ” shall mean any finished pharmaceutical dosage form containing the Compound or an Alternate Compound, which is in the scope of one or more Valid Claims within the Elan Patent Rights in the country of sale, and/or incorporates Elan Know-How in material part.  The use of the pre-clinical, toxicological, pharmacokinetic, metabolic, formulation, methods, clinical protocols and data developed for and on behalf of Elan (except for tests and studies conducted by or on behalf of Acorda as contemplated by this Agreement), which is included in the Elan Know-How shall constitute incorporation of the Elan Know-How in material part.
 
“ Project ” shall mean all activity undertaken by Elan and Acorda in order to develop the Product in accordance with the Development Plan, together with (i) all activity as undertaken by Elan and Acorda to develop the Fampridine Product for SCI prior to the Amendment Date, and (ii) all activity as undertaken by Elan, Acorda and MS R & D to develop the Fampridine Product for MS, prior to the Amendment Date.
 
“ Regulatory Approval ” shall mean (i) NDA approval by the FDA in the United States of America, (ii) in the case of the Major European Markets, approval of the NDA Equivalent by the EMEA in the Major European Markets (and/or the applicable regulatory authorities in such Major European Market not failing to provide or rejecting such approval), or (iii) such approvals as are required in any other country of the Territory to launch the sale of the Product in the normal course of business, as applicable, in each case including any required pricing and reimbursement approvals.
 
“ Research and Development Cost ” shall mean in the case of research and development being conducted by or on behalf of Elan in connection with the Project the costs thereof calculated in accordance with GAAP.
 
“ Rush ” shall mean Rush-Presbyterian-St. Luke’s Medical Center.
 
“ Rush/Acorda License” shall mean the License Agreement entered into as of the Amendment Date by and between Rush and Acorda, and any amendments or supplements thereto, the form of which, including the schedules thereto, is attached hereto as Schedule 5 .
 
“ Rush Payments Agreement ” shall mean the Rush Payments Agreement entered into as of the Amendment Date by and between Elan and Acorda, and any amendments or supplements thereto, in connection with the Rush/Acorda License, a form of which is attached hereto as Schedule 6 .
 
“ Rush Side Agreement ” shall mean the Side Agreement entered into as of the Amendment Date by and between Rush, Acorda, Elan and EDDI, and attached as a schedule to the Rush/Acorda License, and any amendments or supplements thereto.
 
“ SCI ” shall mean spinal cord injury indications.
 
9

 
“ SCI Field ” shall mean use as an oral prescription medicine for the treatment of SCI in humans.
 
“ SCI Term ” shall mean the period beginning on 23 January 1997 and ending upon expiry or termination of this Agreement, howsoever arising.
 
“ SEC ” shall mean the United States Securities and Exchange Commission or any successor agency thereto.
 
“ Specifications ” shall mean the specifications for the Product(s) and API attached as Schedule 7 , as they may be modified from time to time by mutual written agreement of the Parties consistent with the specifications approved by the FDA in the NDA and, outside the United States, any NDA Equivalent.
 
“ Supply Agreement ” shall mean the supply agreement between Elan and Acorda of even date herewith, in the form attached hereto as Schedule 8 .
 
“ Technology Transfer Responsibilities ” shall mean the respective responsibilities of each of Acorda and Elan in connection with the Project relating, as applicable, to the (i) activities being conducted under the Cardinal Agreement; (ii) activities being conducted under the Patheon Agreement, and (iii) procurement of API, as set forth on Schedule 9 hereto, as such responsibilities may be modified from time to time by mutual agreement of the Parties.
 
“ Territory ” shall mean all of the countries of the world.
 
“ Third Party(ies) ” shall mean a person or entity who or which is neither a Party nor an Affiliate of a Party.
 
“ Trademark ” shall mean the trademark(s) as may be selected by Acorda which has been or may be registered by Acorda in one or more countries of the Territory.
 
“ Valid Claim(s) ” shall mean a claim in any patent within the Elan Patents which has not lapsed or become abandoned and which claim has not been declared invalid by an unreversed or an unappealable decision of a court of competent jurisdiction.
 
“ $ ” and “ US$ ” shall mean United States Dollars.
 
1.2.                                    In this Agreement
 
1.2.1                              the singular includes the plural and vice versa, the masculine includes the feminine and vice versa and references to natural persons include corporate bodies, partnerships and vice versa;
 
1.2.2                              any reference to an Article, Exhibit or Schedule shall, unless otherwise specifically provided, be to an Article, Exhibit or Schedule of this Agreement;
 
10

 
1.2.3                              the headings of this Agreement are for ease of reference only and shall not affect its construction or interpretation; and
 
1.2.4                              the expressions “include”, “includes”, “including”, “in particular” and similar expressions shall be construed without limitation.
 
!24)#,%￠ 4(% ,)#%.3%
 
2.1.                                    License Grant :
 
Elan shall remain proprietor of all the Elan Intellectual Property relating to the Product and any trademark licensed by Elan to Acorda, (such as an acronym for the applicable technology applied to the Product), but hereby grants to Acorda an exclusive (even as to Elan) licence under the Elan Intellectual Property in the Territory to package, use, import, export, promote, distribute, offer for sale, sell and otherwise exploit and, solely as permitted in the Supply Agreement, to make and have made:
 
2.1.1                              the Fampridine Product in the SCI Field for the SCI Term;
 
2.1.2                              the Fampridine Product in the MS Field for the MS Term; and
 
2.1.3                              without prejudice to Articles 2.1.1 and 2.1.2, the Product in the SCI Field, MS Field and/or Other Indication Field for the Other Indication Term, subject to any contractual obligations of Elan under the Merck Agreement with respect to a formulation using Nanoformulation technology (as defined in the Merck Agreement) in the Other Indication Field.
 
in each case under the terms and conditions set out herein.
 
2.2.                                    Acceptance; Acorda Non-Competition :
 
Subject to the provisions of the following sentence, Acorda hereby accepts such licence and confirms that Acorda and its Affiliates will not directly or indirectly market as a prescription medicine any other sustained release oral dosage form or transdermal form, containing the Compound or any other mono-or di-aminopyridine active agent, other than Product (“ Acorda Competing Product ”) during the period Acorda retains a licence under the Agreement and for one year thereafter.
 
Should Acorda or its Affiliates market an Acorda Competing Product in the countries of the European Economic Area, Elan reserves as its sole remedy the right to terminate the exclusive licences granted to Acorda solely in the applicable country (ies) in which Acorda or its Affiliates market an Acorda Competing Product, which thenceforth for the remainder of the term of this Agreement shall become non-exclusive in nature in such countries of the European Economic Area, and to stop licensing improvements in such countries of the European Economic Area.
 
11

 
2.3.                                    Sub-licensing :
 
2.3.1                              Acorda may sub-license or otherwise authorise one or more third parties (each a Designee) to use, import, offer for sale, promote, distribute, sell and otherwise exploit the Product in one or more countries of the Territory (but not the rights to manufacture the Product which may only be sub-licensed in accordance with the provisions of the Supply Agreement).  In circumstances where the third party is entitled to, or is likely to be able to obtain, access to the CMC Section, the prior written consent of Elan shall be obtained to any sub-licence or other agreement permitted by this Article 2.3.1 which consent shall not be unreasonably withheld or delayed.  In the event that the Third Party is entitled to access to Confidential Information disclosed by Elan to Acorda, the agreement between the Third Party and Acorda shall contain obligations of confidentiality no less onerous than those set out in this Agreement.  Elan shall be furnished with a copy of the proposed and the executed sub-licence or other agreement contemplated by this Article 2.3.1  Any sub-licence or other agreement permitted by this Article 2.3.1 shall be subject to the terms of this Agreement, but excluding the right to grant a sub-licence.  Acorda shall use its reasonable endeavours to ensure that Elan shall have the same rights of audit and inspection vis a vis a Designee, as Elan has pursuant to this Agreement concerning Acorda.  A sub-licence may be granted by Acorda without any obligation upon the Designee to pay to Acorda or Elan any amounts other than those set out in this Agreement.
 
2.3.2                              Insofar as the obligations owed by Acorda to Elan are concerned, Acorda shall remain responsible for all acts and omissions of any Designee as if such acts and omissions were by Acorda.  Any sub-licence or other agreement permitted by Article 2.3.1 shall automatically and immediately terminate on termination of this Agreement.
 
2.3.3                              For the avoidance of doubt, the Parties hereby confirm that In Market sales of the Product by any Designee shall constitute sales by Acorda for the purposes of Article 5.6.
 
2.4.                                    Use of Data and Improvements :
 
Subject to the provisions of Article 12.1 Elan may use the Elan Intellectual Property and all technical and clinical data or improvements generated by Elan pursuant to this Agreement in connection with Elan’s commercial arrangements for the Product in any country which ceases to be a part of the Territory, or in relation to the Product in the Territory in the event of the termination of this Agreement.
 
2.5.                                    Rush:
 
Each of Elan and Acorda hereby acknowledges and agrees that the licences previously granted to Elan by Rush and the licenses granted to Acorda by Rush pursuant to the Rush/Acorda License do not constitute Elan Patent Rights or Elan Know-How for the purposes of this Agreement.
 
12

 
2.6.                                    Technical Advice:
 
Without prejudice to Article 5.1.2, Elan shall, if requested, advise Acorda in any technical matters as may become necessary for the proper utilisation of the licence to Acorda pursuant to this Agreement and shall provide reasonable advice and assistance to Acorda with respect thereto without additional charge.
 
2.7.                                    Combination Products :
 
In the event that Acorda wishes to develop, market and sell an oral sustained release product for the treatment of SCI which contains the Compound or an Alternate Compound as one of two or more pharmaceutically active ingredients (“ Combination Product ”), Acorda shall seek the consent of Elan to extend the licences granted by Elan to Acorda pursuant to this Agreement, which consent shall not be unreasonably withheld or delayed.  In the event that such consent is furnished, the Parties shall negotiate in good faith the terms of an agreement, including where applicable, such amendments as are appropriate to this Agreement.
 
2.8.                                    Elan Competing Product :
 
For the term of the Agreement, Elan shall not itself or through an Affiliate or Third Party commercialise or, develop in the Territory nor license another party in the Territory to commercialise or develop any other sustained release oral dosage form for prescription use in humans which contains the Compound or any Alternate Compound as an active ingredient for:
 
2.8.1                              the indication of SCI; and/or
 
2.8.2                              the indication of MS; and/or
 
2.8.3                              any other Indications, subject, during the term of the Merck Agreement, to any contractual obligations of Elan under the Merck Agreement with respect to a formulation using Nanoformulation technology (as defined in the Merck Agreement).
 
(each, an “ Elan Competing Product ”).
 
2.9.                                    Trademark:
 
2.9.1                              Acorda shall market the Product in the Territory under a Trademark, whether during the Initial Period or thereafter, which Trademark will be owned by Acorda.
 
2.9.2                              Elan grants to Acorda a non-exclusive royalty free licence in the Territory solely for use in connection with the sale of the Product, for the term of this Agreement to use any trademark which relates to the Elan technology applicable to the Product (“ Elan Trademark ”), such as an acronym for the applicable technology applied to the Product, on the following terms:
 
2.9.2.1                            Acorda shall as soon as it becomes aware of any infringement give to Elan in writing full particulars of any use or proposed use by any other person, firm or company of a trade name or trademark or mode
 
13

 
or promotion or advertising which amounts to or might amount either to infringement of Elan’s rights in relation to the Elan Trademark or to passing off.
 
2.9.2.2                            If Acorda becomes aware that any other person, firm or company alleges that the Elan Trademark is invalid or that the use of the Elan Trademark infringes any rights of another party or that the Elan Trademark is otherwise attacked or attackable, Acorda shall immediately give to Elan full particulars in writing thereof and shall make no comment or admission to any Third Party in respect thereof.
 
2.9.2.3                            Elan shall have the right to conduct all proceedings relating to the Elan Trademark and shall in its sole discretion decide what action, if any, to take in respect of any infringement or alleged infringement of the Elan Trademark or passing-off or any other claim or counter-claim brought or threatened in respect of the use or registration of the Elan Trademark.  Any such proceedings shall be conducted at Elan’s expense and for its own benefit.
 
2.9.2.4                            At no time during or after the term of this Agreement shall Acorda challenge or assist others to challenge the Elan Trademark, or the registration thereof or attempt to register any trademarks, marks, or trade names confusingly similar to the Elan Trademark.
 
2.9.3                              Acorda shall not be obliged to use the Elan Trademark to identify the Product but at Elan’s request shall be obliged to use the Elan Trademark to identify the applicable Elan technology embodied in the Product.  For the avoidance of doubt, the Parties hereby confirm that Acorda shall not be entitled to a licence to use any trademark owned or controlled by Elan which identifies a product, including Neurelan®.
 
2.10.                              When packaged, and to the extent permitted by law, a product label shall include an acknowledgement that the Product is made under licence from or, if applicable, manufactured by Elan.  Such acknowledgement shall take into consideration regulatory requirements and Acorda’s commercial requirements, including any requirement to state that Product is mananufactured by Patheon.  Acorda shall wherever possible give due acknowledgement and recognition to Elan in all printed promotional and other material regarding the Product such as stating that the Product is under licence from, or if applicable, manufactured by, Elan.  Acorda shall consult with and obtain the approval of Elan as to the format and content of the promotional and other material insofar as it relates to a description of, or other reference to, the application of the Elan Intellectual Property.  It shall be presumed that Elan approved of such use unless Elan provides written notice of disapproval of such use to Acorda within thirty (30) days of delivery of such materials to Elan, such approval not to be unreasonably withheld.  The further consent of Elan shall not be required where the format and content of such materials is
 
14

 
substantively materially similar as the materials previously furnished to and approved by Elan.
 
2.11.                              Diligence :
 
2.11.1                        Acorda shall use reasonable efforts consistent with the reasonable standard as would be applied by a bio-pharmaceutical company of similar size, stage of development and assets for a product of the market size and potential of the Product to market and promote the Product throughout the Territory.
 
2.11.2                        Acorda shall effect a national commercial launch of the Product in the United States of America within one hundred and eighty (180) days of NDA Approval, provided that Acorda shall have received the agreed quantities of Launch Stocks ordered pursuant to firm purchase orders at least sixty (60) days in advance of the launch date.  It is agreed that with respect to Japan and the Major European Markets, Acorda will effect a national commercial launch of the Product within one hundred and eighty (180) days after the necessary Regulatory Approvals, provided that Acorda shall have received the agreed quantities of Launch Stocks ordered pursuant to firm purchase orders pursuant to the Supply Agreement at least sixty (60) days in advance of the projected launch date.  In the event that Acorda shall have received the agreed quantities of Launch Stocks ordered pursuant to firm purchase orders pursuant to the Supply Agreement at least sixty (60) days in advance of the projected launch date and Acorda does not make a national commercial launch in one or more of the countries listed above within the one hundred and eighty (180) day period, or such longer period permitted by the provisions of this Article 2.11.2, the licences granted to Acorda hereunder shall with thirty (30) days notice from Elan terminate in the applicable country and Elan shall be entitled to a licence to the Acorda Patent Rights and the Acorda Know-How in the applicable country on the terms set out in Article 2.11.3 and to the Trademark on the terms set out in Article 2.9.  Notwithstanding the above, in the event that the Parties disagree whether or not Acorda has satisfied its obligations under this Agreement in any country listed above, the matter may be submitted to arbitration by either Party, and Acorda’s rights and licences shall remain in effect until and unless the arbitrator makes a decision that Acorda’s right and licence in such country should terminate.
 
2.11.3                        Acorda will use commercially reasonable efforts to file and obtain registration approval in the United States of America, the Major European Markets and Japan as soon as practicable.  In the event of any failure by Elan to perform its obligations under this Agreement or under the Supply Agreement which results in Acorda’s failure to obtain such a Regulatory Approval or any delay thereof, the Parties through the Committee shall make reasonable and appropriate adjustments to the period in which Acorda shall have to file to obtain the applicable Regulatory Approval.  If (x) Acorda fails to file to obtain a Regulatory Approval to commercialise the Product in the United States of America, Japan or the Major European Markets within a commercially reasonable time after completion and receipt of positive data from all pre-
 
15

Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission.
 
clinical and clinical studies required for the related NDA or any NDA Equivalent, as determined by the Committee, or (y) Acorda fails to effect a commercial launch of the Product in the United States of America, Japan or the Major European Markets within the period specified in Article 2.11.2 above then, in such event, provided that Elan has terminated Acorda’s licence as provided in Article 12.5.2.2, Acorda shall, at the option of Elan, license, make available and transfer to Elan all of Acorda’s data, information, applications, approvals and filings to permit Elan to commercialise the Product in the applicable region, in exchange for an initial payment equal to Acorda’s costs of developing such data, information, applications, approvals and filings for such region and [*****] of NSP (for which purpose the definition of NSP as set out in Article 1 shall apply mutatis mutandis) of the Product by Elan and/or its designees (for which purpose the definition of Designee as set out in Article 1 shall apply mutatis mutandis) in such region.  In such event Elan shall be entitled to a licence to the Acorda Patent Rights and the Acorda Know-How to commercialise the Product on the terms set out in this Article 2.11.3 and to the Trademark on the terms set out in Article 2.9.   In the event that Elan is entitled to such licence, the Parties shall enter into a further written licence agreement which shall include customary and reasonable terms relating to, inter alia , the timing of royalty payments to Acorda, reporting obligations regarding net sales, audit rights of Acorda with respect to books and records relating to net sales, sublicense and indemnity provisions, which obligations shall, unless otherwise agreed by the Parties, be substantially similar to those in this Agreement with respect to commercialisation of the Products by Acorda.
 
2.11.4
 
2.11.4.1                      Acorda will use its commercially reasonable efforts to obtain Regulatory Approval to commercialise the Product in the other countries of the Territory that it selects, having regard to the effort and expenditure required to obtain Regulatory Approval for the Product and the commercial opportunities for the Product in such other countries of the Territory.
 
2.11.4.2                      In the event that the Parties disagree whether Acorda has satisfied its obligations under Article 2.11.4.1, with regard to one or more of such other countries of the Territory, the matter may be submitted to the Committee, and if not resolved by the Committee, by arbitration, by either Party, and Acorda’s rights and licences shall remain in effect until and unless the arbitrator makes a decision that Acorda’s right and licence hereunder in such country should terminate.
 
2.11.4.3                      If Acorda (a) indicates to Elan that it does not intend to file to obtain Regulatory Approval and commercialise the Product in a particular country or countries of the Territory, or (b) fails to commence commercialisation in any country in the Territory (other than the United States, the Major European Markets {or, if
 
16

 
commercialization has commenced in the Major European Markets, any other country subject to the jurisdiction of the EMEA, provided that Acorda provides to the Committee a marketing plan for such other countries} or Japan), within one hundred and (180) days after receiving the required Regulatory Approval therefor, provided that Acorda shall have ordered and received the agreed quantities of Launch Stocks ordered pursuant to firm purchase orders pursuant to the Supply Agreement at least sixty (60) days in advance of the projected launch date, Elan shall be entitled to a licence to the Acorda Patent Rights and the Acorda Know-How to commercialise the Product in such countries on the terms set out in Article 2.11.3 and to the Trademark on the terms set out in Article 2.9.
 
ARTICLE 3 DEVELOPMENT OF THE PRODUCT
 
3.1.                                    Subject to the provisions of this Article 3, Acorda shall use its reasonable efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own to conduct such part of the Project as the Parties mutually agree shall be conducted by Acorda.  Subject to the provisions of this Article 3, Elan shall use its reasonable efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own, to conduct such part of the Project as the Parties mutually agree that shall be conducted by Elan. The allocation between the Parties of their respective responsibilities for conducting parts of the Project (i) is set forth in Schedule 9 - Technology Transfer Responsibilities, and (ii) shall be set forth in a development plan (the “ Development Plan ”) to be prepared and updated from time to time by Acorda in consultation with Elan, relating to the development of the Product, the current form of which is attached as Schedule 4 - NDA Timeline , and the Committee shall monitor the progress of such activities.  Elan and Acorda each undertake that it shall carry out the respective studies, testing and activities set forth as Technology Transfer Responsibilities, in the Development Plan, and otherwise undertaken and conducted by it in good faith and in accordance with prevailing cGCP and cGLP and FDA standards and guidelines.
 
3.2.                                    Provided that Elan uses reasonable endeavours to meet its obligations under this Agreement, Elan shall have no liability to Acorda as a result of any failure or delay of the Product to achieve one or more of the milestones set out in the Project and/or to obtain the NDA Approval or the approval of the regulatory authorities in one or more of the other countries of the Territory.  Acorda shall have no liability to Elan as a result of any failure or delay of the Product to obtain the NDA Approval or the approval of the appropriate health regulatory authorities in one or more of the countries of the Territory.
 
3.3.                                    The Parties hereby confirm that each shall undertake its respective part of the Project as a collaborative effort and that the provisions of this Agreement requires that each Party diligently carries out those tasks assigned to it under the Project and as otherwise agreed during the course of the Project.  Each Party shall co-operate with the other in good faith particularly with respect to unknown problems or contingencies and shall perform its
 
17

 
obligations in good faith and in a commercially reasonable, diligent and workmanlike manner.  Each Party will update the other Party on the progress of the Project at meetings of the Committee.
 
3.4.                                    Elan will supply Acorda with Acorda’s reasonable requirements of Product including clinical trial supplies to enable Acorda to carry out the Project.  The Product shall be supplied by Elan EXW at Manufacturing Cost.
 
3.5.                                    Acorda agrees to carry out and complete the Phase III programme in the United States of America to a standard and timeframe that a company of comparable size, stage of development and assets would use for a product of similar size and potential as the Product.
 
3.6.                                    With respect to generating stability data on the oral Product in bulk tablet form, Elan and Acorda acknowledge and agree that (i) under the SCI Agreement and the MS Agreement, Elan had the responsibility for generating such data, (ii) pursuant to the Cardinal Agreement, Cardinal is currently performing such stability testing, (iii) the Technology Transfer Responsibilities shall govern the related responsibilities of the Parties, provided that the data resulting from such stability testing shall be provided to both Acorda and Elan, and Elan shall have the right to and responsibility for providing necessary and appropriate technical assistance and oversight of such stability testing (including having the right at its own expense to arrange for its employees involved in the Project to discuss the stability testing and its results with the technical personnel of Acorda and Cardinal upon reasonable notice and at reasonable times); and (iv) Elan shall incorporate such stability data into the CMC module that it will prepare for delivery to Acorda for inclusion in the NDA or any NDA Equivalent, pursuant to Article 3.8.
 
3.7.                                    For the avoidance of doubt, the Parties hereby confirm that a primary objective of the Project is to generate the NDA and secure NDA Approval for the oral Product.  As of the date of the SCI Agreement, the MS Agreement and the Amendment Date, it is the Parties’ expectation that the body of data so generated in the Project will also support such applications for Regulatory Approval that Acorda shall make in the other countries of the Territory.  In the event however that such expectation proves unfounded or incorrect and further data is required to obtain such other approvals as are pursued by Acorda in the other countries of the Territory, Acorda shall determine the viability of proceeding further with the regulatory application and generation of the further data requirements.  In the event that Acorda elects to continue, the Parties shall update the Development Plan to reflect the allocation between the Parties of conducting such additional activities.   In such event, subject to and in accordance with the provisions of this Article 3, Elan shall be responsible for conducting such further activities and generating such further data as set forth in the Development Plan to allow Acorda to seek such further Regulatory Approvals in the Territory. Notwithstanding the foregoing, it is intended by the Parties that except as otherwise specifically set forth in a Development Plan agreed to by the Parties and subject to compliance with regulatory requirements, Acorda shall have primary responsibility and decision making authority with respect to development and marketing of Product.
 
18

 
3.8.                                    Elan shall be responsible for the preparation and delivery to Acorda of the CMC Section in electronic and hard copy form and the latter in format suitable for inclusion in the NDA and any NDA Equivalent in accordance with applicable law and regulatory standards and as the Parties may mutually agree.  Acorda shall provide Elan as soon as practicable with a copy of any comments received by Acorda from the FDA or any other regulatory authority relating to the CMC Section and Elan shall provide or, at Acorda’s request, cooperate with Acorda to provide, a response to such comments as soon as practicable. In the event that there is a deficiency in the CMC Section attributable to negligence by Elan in the activities conducted by Elan, then Elan shall be responsible for correcting such deficiency, at Elan’s expense, and shall use reasonable efforts to do so as soon as practicable. In the event Elan breaches the foregoing obligation, in addition to any other remedies available to Acorda, Acorda shall have the right to correct such deficiency or arrange to have a Third Party conduct any required activities necessary to correct such deficiency, at Elan’s expense, the cost of which may be offset against any amounts otherwise due Elan under this Agreement.  Acorda shall be responsible for the maintenance of the CMC Section in accordance with applicable law and regulatory standards, at Acorda’s expense, provided that (i) Elan shall cooperate with and provide reasonable assistance to Acorda in connection with such maintenance; and (ii) any revisions, amendments or supplements to the CMC Section required by or resulting from the negligence of Elan in performing its obligations hereunder or under the Supply Agreement, or from any action taken by Elan on its own initiative, or taken by Acorda or any Acorda Designee on behalf of or at the request of Elan, including any changes made by Elan on its own initiative to its manufacturing processes or facilities, shall be at Elan’s expense; and (iii) Elan shall not make any changes to its manufacturing processes or facilities that would require an amendment or supplement to the CMC Section without first notifying Acorda of such changes and preparing and delivering to Acorda any required amendments or supplements to the CMC Section before the implementation of such changes.
 
If Elan is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Elan shall at Acorda’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Acorda shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its license rights under this Agreement.
 
Similarly, if Elan is entitled to market, distribute and sell the Product in a particular country, and Acorda is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Acorda shall at Elan’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Elan shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its rights under this Agreement.
 
!24)#,%￠ ;./4 53%$=
 
19

Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission.
!24)#,%￠ &).!.#)!, 02/6)3)/.3
 
5.1.                                    Research and Development Activities :
 
5.1.1                              In consideration for the research and development of the Product by Elan under this Agreement, Acorda shall pay to Elan the amounts set out in Article 5.1.2.
 
5.1.2                              Research and Development Cost incurred by Elan after the Amendment Date and before commercial launch of the Product shall be invoiced and payable monthly, at a rate of FTE plus [***].
 
5.1.3                              Elan will keep accurate records consistent with its normal business practices, of the efforts expended by it under the Project for which it is charging Acorda, which will include the time spent by each person working on the Project.  Each quarter Elan will send reports to Acorda in order to enable Acorda to monitor Elan’s level of effort to assure Acorda that the committed level of effort is being applied.
 
5.1.4                              If Elan’s development efforts require the use of a Third Party, Elan will, prior to appointing such Third Party, discuss with Acorda the activities to be undertaken by such Third Party and the terms and conditions thereof.  Elan will not proceed with such Third Party without the prior written approval of Acorda, which approval shall not be unreasonably withheld. Elan shall charge Acorda for the time spent by its employees in administering the work conducted by such Third Parties on the basis set out in Article 5.1.2.  Elan shall have the right to charge Acorda for all reasonable out of pocket expenses incurred in the provision of its obligations thereunder.
 
5.2.                                    License Royalties :
 
5.2.1                              In consideration of the rights and licence granted to Acorda to the Elan Patent Rights by virtue of the SCI Agreement, Acorda has paid to Elan $[****]; and
 
5.2.2                              In consideration of the rights and licence granted to MS R & D to the Elan Patent Rights by virtue of the MS Agreement, MS R & D has paid to Elan $[****] –
 
receipt of each of which is hereby acknowledged by Elan.
 
5.3.                                    Milestone Payments :
 
5.3.1                              In further consideration of the rights and license granted to Acorda to the Elan Patent Rights hereunder, Acorda shall pay to Elan the following non-refundable amounts contingent upon occurrence of the specified event, with each milestone payment to be made no more than once with respect to the achievement of such event (but payable the first time such milestone is achieved) for Product:
 
20

Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission.
 
5.3.1.1                [****] 90 (ninety) days after written receipt of NDA Approval of the Product for the first Indication;
 
5.3.1.2                            [***] on the earlier of (a) 90 (ninety) days after written receipt of NDA Approval of the Product for a second Indication or (b) the 2 nd (second) anniversary of NDA Approval of the Product for the first Indication;
 
5.3.1.3                            [***] upon the commencement of a Phase III Clinical Study of the Product for a third Indication;
 
5.3.1.4                            [***] upon acceptance by the FDA for filing of the NDA for a third Indication;
 
5.3.1.5                            [***] upon written receipt of NDA Approval of the Product for a third Indication;
 
5.3.1.6                            [***] upon First Commercial Sale of the Product for a third Indication;
 
5.3.1.7                            [***] upon the commencement of a Phase III Clinical Study of the Product for a fourth Indication;
 
5.3.1.8                            [***] upon acceptance by the FDA for filing of the NDA for a fourth Indication;
 
5.3.1.9                            [***] upon written receipt of NDA Approval of the Product for a fourth Indication; and
 
5.3.1.10                      [***] upon First Commercial Sale of the Product for a fourth Indication –
 
the payments described in Articles 5.3.1.1 to 5.3.1.10 being “ Milestone Payments ”.
 
5.3.2                              The Milestone Payments referred to in Articles 5.3.1.3 through 5.3.1.10 shall be payable within forty five (45) days after achievement of the applicable milestone event.
 
5.3.3                              For the avoidance of doubt, references in this Article 5.3 to an Indication by number are to the number of Indications for which a particular milestone has been achieved.
 
By way of example, the Milestone Payment in Article 5.3.1.9 shall become payable upon NDA Approval for a Indication “E”, where Indications “A”, “B”
 
21

Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission.

and “C” have already received NDA Approval, notwithstanding that commencement of a Phase III Clinical Study of the Product and/or NDA filing for Indication “D” may have occurred before commencement of such studies for Indication “E”.
 
5.3.4                              In respect of each of the third and fourth indication of the Product, in the event that Acorda spends in excess of [***] on Phase III Clinical Studies for such indication, Acorda shall be entitled to credit one half of the excess spend in respect of that indication, over and above [***] per indication, against the respective Milestone Payments for that indication, viz. the Milestone Payments referred to in Articles 5.3.1.4 and 5.3.1.5 for the third indication and the Milestone Payments referred to in Articles 5.3.1.8 and 5.3.1.9 for the fourth indication, up to a maximum of [****] for each indication.
 
5.3.5                              The Milestone Payments shall not be subject to future performance obligations of Elan to Acorda and shall not be applicable against future services provided by Elan to Acorda.
 
5.4.                                    Certain Payments relating to Rush/Acorda License :
 
Elan shall reimburse Acorda in respect of the milestone payments payable from Acorda to Rush pursuant to Section 5.2 of the Rush/Acorda License and Acorda shall pay Elan an additional royalty, each in accordance with and subject to the terms and conditions of the Rush Payments Agreement.
 
5.5.                                    License Revenues :
 
In further consideration of the rights and licence granted to Acorda to the Elan Patent Rights by virtue of this Agreement, Acorda shall pay to Elan [***] of all and any License Revenues.
 
5.6.                                    Royalty on Sales :
 
5.6.1                              Subject to Article 5.6.2 and in further consideration of the rights and license granted to Acorda to the Elan Patent Rights while there is a Valid Claim thereunder, and in consideration of the rights and license granted to Acorda of the Elan Know-How thereafter, Acorda shall additionally pay to Elan a royalty of [***] of the NSP of the Product (the “ Elan Royalty ”). The Elan Royalty shall be payable as follows:
 
5.6.1.1                            In respect of the Elan Royalty, where Elan manufactures and supplies the Product, Elan shall render an invoice in respect of the quantities of Product delivered to Acorda for a sum calculated by reference to [***] of the Notional NSP and the quantity of Product supplied.  For the avoidance of doubt the Parties agree that if for whatever reason the Product supplied by Elan to Acorda which meets the Specifications and the applicable law and regulatory
 
22

Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission.

requirements is not sold by Acorda, payment to Elan for such Product shall nonetheless be effected and the price of the Product shall be determined by reference to the NSP calculated pursuant to the provisions of Article 5.6.1.2.
 
5.6.1.2                            Within forty five (45) days of the end of each calendar quarter, Acorda shall notify Elan of the prevailing NSP for Product sold in the previous quarter.  Acorda shall calculate the total Elan Royalty payable to Elan for the Product supplied by Elan during the previous quarter by reference to [***] of the NSP. The Parties shall adjust their account by Acorda promptly paying to Elan, or by Elan crediting Acorda against the price of Product to be supplied (as the case may be), the difference between the sum paid pursuant to Article 5.6.1.1 and the sum calculated pursuant to this Article 5.6.1.2.
 
5.6.1.3                            In respect of the Elan Royalty, where Elan does not manufacture and supply the Product, within forty five (45) days of the end of each calendar quarter (for the first two years following first commercial sale of the Product in any country of the Territory, within sixty (60) days of the end of each quarter), Acorda shall notify Elan of the prevailing NSP of Product sold in that preceding quarter and of the quantity of Product sourced from third parties.  The Elan Royalty in respect of such Product shall each be payable on the date on the date such report is due.
 
5.6.2                              In countries where there are no Valid Claims covering the Product and if there is no Competition, Acorda shall pay to Elan the applicable Elan Royalty set forth in Article 5.6.1 for sales in such countries; provided, if, and only if, (a) Elan is not manufacturing the Product, (b) there are no Valid Claims covering the Product and (c) there is Competition in any such country, the Elan Royalty due under Article 5.6.1 on Product sales in such country shall be reduced to [***] of NSP provided, however, that in the event there is Competition in any country, the Parties agree to discuss, considering market conditions, further reducing the Elan Royalty.
 
5.6.3                              In the event that Elan or its subcontractor does not manufacture and supply the Product and in the event that Acorda enters into a licence agreement with any Third Party with respect to a Dominating Patent, or to avoid or settle a claim by a Third Party for infringement or misappropriation by any Elan Intellectual Property right relating to the manufacture, use or sale of the Product, Acorda may offset any payments made in accordance with such licence agreements against any royalty amounts (and not amounts in respect of manufacturing) owed by Acorda to Elan, up to a maximum of [***] of the royalty amounts due.  For the purpose of this Article 5.6.3 the Parties hereby confirm that the minimum Elan Royalty payable by Acorda to Elan shall be [***] of the NSP. Any dispute under this Article 5.6.3 (including one as to
 
23

Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission.

whether Acorda should have entered into such agreement) shall be resolved by referring such matter to an independent patent attorney for arbitration, and in the event of such a dispute the offset above shall only take effect prospectively upon an arbitrator’s decision in favour of Acorda.  In such event the procedure set forth in Article  12.14 shall to the extent practicable apply to the conduct of such arbitration.
 
5.6.4                              No more than one royalty payment shall be due with respect to a sale of a particular Product (except any royalty payable under the Rush Payments Agreement).  No multiple payments shall be payable because any Product or its manufacture, sale or use is covered by more than one Valid Claim covering the Product.  No royalty payments shall be payable with respect to Products distributed for use in research and/or development, in clinical trials or as promotional samples.
 
5.6.5                              All payments due hereunder shall be made in United States Dollars in accordance with Article 5.9.
 
5.6.6                              For the avoidance of doubt, the Elan Royalty and any royalty payable under the Rush Payments Agreement shall be payable whether or not Elan is manufacturing and supplying the Product.
 
5.7.                                    Additional Expenses :
 
Acorda shall pay Elan within thirty (30) days of the date of invoicing for any technical assistance requested by Acorda, including travel and subsistence, provided that Elan is not otherwise obliged to provide such assistance pursuant to the terms of the Agreement.  Elan’s charges for such work shall be Research and Development Cost plus [***], as well as reimbursement for out-of pocket expenses incurred by Elan to Third Parties in performing activities under the Development Plan that are not already included in Research and Development Cost.
 
5.8.                                    Non-Refundable Payments :
 
All payments received by Elan from Acorda under Article 5 shall be non-refundable, subject to the provisions of Article 5.9.5.
 
5.9.                                    Payments, Reports and Records :
 
5.9.1                              Acorda shall keep and shall cause its Affiliates and Designees to keep true and accurate records of gross sales of the Product, the items deducted from the gross amount in calculating the NSP, the NSP and the royalties payable to Elan under Article 5 hereof.  Acorda shall deliver to Elan a written statement thereof within forty five (45) days following the end of each calendar quarter (or any part thereof in the first or last calendar quarter of this Agreement) for such calendar quarter.  The said written statements shall set forth on a country-by-country basis, the calculation of the NSP from gross revenues during that calendar quarter, the applicable percentage rate, and a computation of the sums due to Elan (the “ Statement ”).  The Parties’ financial officers shall agree upon the
 
24

 
precise format of the Statement. Acorda shall also provide Elan with preliminary monthly sales reports in a format to be determined by the Committee.
 
5.9.2                              Payments due on NSP of the Product based on sales amounts in a currency other than United States Dollars shall first be calculated in the foreign currency and then converted to United States Dollars on the basis of the exchange rate in effect for the purchase of United States Dollars with such foreign currency quoted in the Wall Street Journal (or comparable publication if not quoted in the Wall Street Journal) with respect to the sale of currency of the country of origin of such payment for the day prior to the date on which the payment by Acorda is being made.  In order to facilitate the payments, the Parties may agree that with respect to a certain country or countries the payments due with regard to Product sales in such country or countries will be paid directly by the Acorda Designee(s) responsible for the marketing of the Product in such country or countries to Elan.  In remitting such royalty payments such Designees(s) will abide by the terms of this Article 5.9.  No such direct payments will be made by any Acorda Designee unless Acorda and Elan have beforehand agreed that such direct royalty payment and such direct payments shall not adversely affect the withholding liability of Elan compared to the payments made by Acorda to Elan.
 
5.9.3                              If laws, rules or regulations require withholding of income taxes or other taxes imposed upon payments set forth in this Article 5, Elan shall provide Acorda, prior to any such payment, once each calendar year or more frequently if required, with all forms or documentation required by any applicable taxation laws, treaties or agreements to such withholding or as necessary to claim a benefit thereunder (including, but not limited to Form W-8BEN or any successor forms).  Any such income or other taxes which Acorda is required by law to pay or withhold on behalf of Elan with respect to royalties and any other monies payable to Elan under this Agreement shall be deducted from the amount of such NSP payments, royalties and other monies due.  Acorda shall furnish Elan with proof of such payments.  Any such tax required to be paid or withheld shall be an expense of and borne solely by Elan.  Acorda shall promptly provide Elan with a certificate or other documentary evidence to enable Elan to support a claim for a refund or a foreign tax credit with respect to any such tax so withheld or deducted by Acorda.  Both Parties will reasonably cooperate in completing and filing documents required under the provisions of any applicable tax treaty or under any other applicable law, in order to enable Acorda to make such payments to Elan without any deduction or withholding.
 
5.9.4                              All payments due hereunder shall be made to the designated bank account of Elan in accordance with such timely written instructions as Elan shall from time to time provide.
 
5.9.5                              For the twenty four (24) month period following the close of each calendar year during the term of the Agreement, Elan and Acorda will provide each other’s independent certified accountants (reasonably acceptable to the other Party) with access, during regular business hours and upon reasonable prior request and
 
25

 
subject to the confidentiality provisions as contained in this Agreement, to such Party’s books and records relating to the Product, solely for the purpose of verifying the accuracy and reasonable composition of the calculations hereunder for the calendar year then ended, including in the case of Elan the sums payable by Acorda to Elan pursuant to Article 5. If such accounting firm concludes that additional royalties were owed during such period then Acorda shall pay the additional royalties within sixty (60) days after the date of delivery of such accounting firm’s written report so concluding.  In the event such accounting firm concludes that amounts were overpaid by Acorda during such period, Elan shall repay Acorda the amount of such overpayment within sixty (60) days after the date of delivery of such accounting firm’s written report so concluding.
 
5.9.6                              In addition, for the twenty four (24) month period following the close of each calendar year, Elan will provide Acorda’s independent certified accountants (reasonably acceptable to Elan) with access, during regular business hours and upon reasonable prior request and subject to the confidentiality provisions as contained in this Agreement, to Elan’s books and records relating to (i) the Manufacturing Cost of the Product; (ii) any activities undertaken by Elan on behalf of Acorda pursuant to Article 3; and (iii) any activities undertaken by Elan on behalf of Acorda pursuant to Article 6, in each case, for the purpose of verifying the reasonable basis of the payments made by Acorda hereunder with respect thereto.
 
5.9.7                              Notwithstanding any other provision of this Agreement, if at any time legal restrictions prevent the prompt remittance of part or all of the payments due to Elan in any country, payment shall be made through such lawful means or methods as Acorda may determine after consultation with Elan.  When in any country the law or regulations prohibit both the transmittal and deposit of royalties on sales in such a country, payments shall be suspended for as long as such prohibition is in effect and promptly after such prohibition ceases to be in effect, all royalties or other payments that Acorda or its Affiliates would have been obligated to transmit or deposit, but for the prohibition, shall be deposited or transmitted, as the case may be, to the extent allowable, less any transactional costs.  If the royalty rate specified in this Agreement should exceed the permissible rate established in any country, the royalty rate for sales in such country shall be adjusted to the highest legally permissible or government-approved rate.
 
!24)#,%￠ 2%')342!4)/. /& 4(% 02/$5#4
 
6.1.                                    As is stated at Article 3.7, a primary objective of the Project is to generate the NDA and to secure NDA Approval.  As of the date of this Agreement, it is the Parties’ expectation that the body of data so generated during the Project will support such applications for Regulatory Approval that Acorda shall make in the other countries of the Territory.
 
26

 
6.2.                                    Subject to the review by the Committee pursuant to Article 10 and to Elan’s preparation and delivery to Acorda of the CMC Section in form and substance acceptable for inclusion in the NDA (as well as any revisions thereto as may be mandated or requested by the FDA), and to the other provisions of this Article 6, Acorda shall have the right and responsibility for filing, shall use its reasonable efforts to prosecute to approval, and shall own the NDA.  It is acknowledged that Elan has assigned the IND to Acorda.  Within ninety (90) days following the completion of the Project as determined by the Committee, Acorda shall submit the NDA for filing with the FDA.
 
6.3.                                    Acorda shall not alter the Specifications or any part of the CMC Section unless (a) by agreement with Elan, or (b) mandated by the FDA or other regulatory authority.  In either case, Acorda shall promptly notify Elan and for changes made after NDA Approval, shall be responsible for Elan’s reasonable expenses associated with required changes to its manufacturing license(s ).
 
6.4.                                    Subject to Elan preparing and delivering to Acorda the CMC Section as set forth in this Agreement, Acorda shall be responsible for obtaining all Regulatory Approvals necessary for Elan to package the Product into final market packaging.  Acorda shall be responsible for obtaining all applicable FDA and other state and local regulatory approvals for the distribution of the Product in the United States of America and elsewhere.  Elan shall co-operate with Acorda in obtaining such approvals.
 
6.5.                                    Acorda shall maintain at its own cost the NDA (and shall bear the cost of any amendments or supplements to the CMC Section, other than those requested by Elan, which costs shall be borne by Elan) with the FDA during the period that Acorda and/or its Designees are marketing the Product.  Acorda shall continue to maintain the NDA with the FDA, at Elan’s request and expense, if Elan acquires the right to a licence in the United States or any other country in which the NDA is relied upon as the primary application for Regulatory Approval pursuant to Article 2.11.3 for such term thereafter during which Elan and/or its designees (for which purpose the definition of Designee as set out in Article 1 shall apply mutatis mutandis) is marketing the Product.  Acorda hereby agrees to provide to Elan a copy of the NDA within thirty (30) days of the submission thereof to the FDA.  Acorda shall also furnish a copy to Elan of all other regulatory filings and other material correspondence with the FDA and other regulatory authorities within thirty (30) days of submission.  The NDA and any NDA Equivalent or application for Regulatory Approval filed in Territory for the Product shall remain the property of Acorda, provided that Acorda shall allow Elan access thereto to enable Elan to fulfil its obligations and exercise its rights hereunder.
 
6.6.                                    During the NDA registration procedure, Acorda shall keep Elan promptly and fully advised of Acorda’s registration activities, progress and procedures during Committee meetings.  Elan and Acorda shall each before proceeding with any FDA filings, meetings or telephone conferences, inform and discuss the participation of the other with respect to any such proposed dealings with the FDA relating to the Product and shall promptly provide to that other copies of all correspondence with, and all documents and applications filed with, or submitted by it to, any regulatory authority with respect to Product; provided, however, that that the Parties acknowledge and agree that Acorda
 
27

 
shall be the primary contact with the FDA and any other regulatory authority in the Territory with respect to Product.
 
6.7.                                    It is hereby acknowledged that there are inherent uncertainties involved in the development and registration of pharmaceutical products with the FDA or any other regulatory body in the United States of America insofar as obtaining approval is concerned and that such uncertainties form part of the business risk involved in undertaking the form of commercial collaboration as set forth in this Agreement. Therefore, save for using its reasonable efforts, neither Party shall have any liability to the other solely as a result of any failure of the Product to achieve the approval of the FDA, or any other regulatory body in the United States of America.
 
6.8.                                    Acorda shall also be responsible for the filing and prosecution at its own cost of the regulatory applications with the regulatory authorities in Japan, the Major European Markets and in such other countries of the Territory as it elects and Elan shall cooperate fully with Acorda in connection with such activities.  The provisions of Articles 6.1 to 6.7 inclusive shall apply, mutatis mutandis, to Acorda’s and Elan’s obligations vis a vis Japan, the Major European Markets and such other countries of the Territory.
 
ARTICLE 7 [NOT USED]
 
ARTICLE 8 WARRANTY AND INDEMNITY
 
8.1.                                    Elan represents and warrants that Elan is the sole and exclusive owner or licensee of, or controls all right, title and interest in the Elan Intellectual Property; Elan has the right to grant the rights and licences granted herein, and the Elan Intellectual Property as it pertains to the Product and the Product is free and clear of any lien, encumbrances, security interest) or restriction on license; Elan will not grant during the term of this Agreement, any right, licence or interest in and to the Elan Intellectual Property or the Product, or any portion thereof, inconsistent with the licence granted to Acorda herein; and there are no pending or, to the knowledge of Elan, threatened, actions, suits, investigations, claims or proceedings in any way related to the Elan Intellectual Property or the Product.  Insofar as such patent rights and know-how constitute Elan Patent Rights or Elan Know-How for the purposes of this Agreement, Elan represents and warrants that it is entitled to grant a licence to such patent rights and know-how as are developed by or on behalf of Elan pursuant to the Axogen Agreement, including any patent rights and non-patented know-how or other information which may be conceived, reduced to practice or otherwise developed by or on behalf of Elan pursuant to the Axogen Agreement.  Elan agrees to hold Acorda harmless from any and all costs, expenses and damages (including reasonable attorneys’ fees) incurred or sustained by Acorda as the result of any Third Party’s challenges to Elan’s right to enter into this Agreement and to grant the rights and licences herein granted to Acorda and the Elan Intellectual Property.
 
8.2.                                    Elan represents and warrants that the execution of this Agreement and the full performance and enjoyment of the rights of Acorda under this Agreement will not breach or in any way
 
28

 
be inconsistent with the terms and conditions of any licence, contract, understanding or agreement, whether express, implied, written or oral between Elan and any Third Party.
 
8.3.                                    Acorda represents and warrants that it has not granted any option, licence, right or interest in or to the Compound or to the Acorda Patent Rights to any Third Party which would conflict with the terms of this Agreement.  Acorda agrees to hold Elan harmless from any and all costs, expenses and damages (including reasonable attorneys’ fees) incurred or sustained by Elan as the result of any Third Party’s challenges to Acorda’s right to enter into this Agreement.
 
8.4.                                    Acorda represents and warrants that the execution of this Agreement will not breach or in any way be inconsistent with the terms and conditions of any licence, contract, understanding or agreement, whether express, implied, written or oral between Acorda and any Third Party.
 
8.5.                                    Each Party represents and warrants that with respect to all data and information generated by it to support regulatory filings seeking to obtain approval of the regulatory authorities shall, to the best of that party’s knowledge, be free from fraud or material falsity and shall be accurate and reliable for purposes of supporting approval of the submissions.  Each Party warrants that all regulatory applications made by that Party have not been and will not be obtained either through bribery or the payment of illegal gratuities, and that no Regulatory Approval shall be obtained with illegal or unethical behaviour of any kind.
 
8.6.                                    Elan represents and warrants that the Product supplied to Acorda by Elan under this Agreement has been and shall be free of any lien, security, interest or other encumbrance on title, conform to the Specifications and in accordance with all regulations and requirements of the FDA and foreign regulatory authorities including, without limitation, the cGMP regulations which apply to the manufacture, storage, packaging and supply of the Product.  Elan represents and warrants that the Product supplied to Acorda under this Agreement has been and shall be free of defects in material and workmanship, shall not be adulterated or mis-branded as defined by the Act (or applicable foreign law) and shall not be a product which would violate any section of such Act if introduced in interstate commerce and shall be fit for use as a pharmaceutical product.  Acorda agrees not to assert its right to rescind this Agreement (if any) in the event of a breach of the representations of Elan contained in this Article 8.6.
 
It is hereby acknowledged for the avoidance of doubt that for the purposes of this Article 8, commercial supplies of Product under the Supply Agreement are not regarded as supplied “under this Agreement”.
 
8.7.                                    Elan and Acorda is each fully cognisant of all applicable statutes, ordinances and regulations of the United States of America with respect to the manufacture of the Product including, but not limited to, the Act and regulations thereunder, cGLP, cGCP and cGMP.  Elan shall manufacture or procure the manufacture the Product under this Agreement in conformity with the Specifications, the relevant portions of the CMC Section and, if applicable, the DMF and in a manner which fully complies with all United States of America and foreign statutes, ordinances, regulations and practices.
 
29

 
8.8.                                    Acorda shall indemnify and hold harmless Elan, its agents and employees from and against all claims, damages, losses, liabilities and expenses to which Elan, its agents, and employees may become subject related to or arising out of Acorda’s bad faith, gross negligence or intentional misconduct in connection with the filing or maintenance of the NDA.  Elan shall indemnify and hold harmless Acorda, its agents and employees from and against all claims, damages, losses, liabilities and expenses to which Acorda, its agents, and employees may become subject related to or arising out of Elan’s bad faith, gross negligence or intentional misconduct in connection with the preparation of the CMC Section.
 
8.9.                                    Elan shall indemnify, defend and hold harmless Acorda and its officers, directors, employees and agents from all actions, losses, claims, demands, damages, costs and liabilities (including reasonable attorneys’ fees) due to Third Party claims to which Acorda is or may become subject insofar as they arise out of or are alleged or claimed to arise out of (i) any breach by Elan of any of its obligations under this Agreement, (ii) any breach of a representation or warranty of Elan made in this Agreement, (iii) any activities conducted by Elan in connection with the Project, (iv) any failure of the Product provided under this Agreement to meet the Specifications, or (v) the manufacture or shipment of the Product provided under this Agreement by Elan, except in each case to the extent due to the negligence or wilful misconduct of Acorda.
 
8.10.                              Acorda shall indemnify, defend and hold harmless Elan and its officers, directors, employees and agents from all actions, losses, claims, demands, damages, costs and liabilities (including reasonable attorneys’ fees) due to Third Party claims to which Elan is or may become subject insofar as they arise out of or are alleged or claimed to arise out of (i) any breach by Acorda of any of its obligations under the Agreement, (ii) any breach of any representation or warranty of Acorda made in this Agreement, and (iii) any activities conducted by Acorda in connection with the Project, except to the extent due to the negligence or wilful misconduct of Elan.
 
8.11.                              Acorda shall indemnify, defend and hold harmless Elan and its officers, directors, employees and agents from all actions, losses, claims, demands, damages, costs and liabilities (including reasonable attorneys’ fees) due to Third Party claims to which Elan is or may become subject insofar as they arise out of or are alleged or claimed to arise out of activities conducted by Acorda or its Designee in the manufacture, transport, packaging, storage, handling, distribution, promotion, marketing or sale of the Product, that was caused by the negligence or wrongful acts or omissions on the part of Acorda or its Designees, except in each case, to the extent covered by Article 8.10 or due to the negligence or wilful misconduct of Elan.
 
8.12.                              Elan represents and warrants that, the manufacture, sale, distribution or use of the Product in the Territory solely because of the use of the Elan Intellectual Property does not, to Elan’s actual knowledge, infringe any patent owned by a Third Party, provided, that Elan represents and warrants that it is not aware of any pending or threatened proceeding or claim of any person or entity pertaining to the Product, that asserts the infringement of any patent owned by a Third Party.  In the event that (I) a claim or proceedings are brought against Acorda and/or Elan by a Third Party alleging that the
 
30

 
manufacture, sale, distribution or use of the Product in the Territory infringes the patent rights of such Third Party, and such alleged infringement results from the use of the Elan Intellectual Property, and (II) Elan was in breach of the foregoing representation and warranty with respect to such Third Party patent rights, Elan’s liability to Acorda with respect to such infringement pursuant to this Article 8.12 (including without limitation, reasonable attorney’s fees and other out of pocket expenses of the litigation, including the fees and expenses incurred by Elan and Acorda) shall be limited to and shall be borne by the Parties in the manner set forth in Article 11.3.1.
 
For purposes of this Article 8, “Elan’s actual knowledge” shall mean the knowledge of representatives of Elan that have been engaged in the Project in a key operational role.
 
8.13.                              Elan has no actual knowledge that (a) the issued and unexpired patents included in the Elan Patent Rights are invalid or unenforceable over any references or prior art known to Elan or its agents, taken alone or in combination, nor (b) that the pending patent applications included in the Elan Patent Rights fail to include patentable subject matter, nor (c) that Elan and its agents have failed to comply with any duty of candor imposed on an applicant for patent before a particular national or regional patent office with respect to the patents, applications and patent offices listed in Schedule 3.
 
8.14.                              Acorda represents and warrants that as of the date of this Agreement to Acorda’s actual knowledge, the development and manufacture of the Product by Elan or Acorda, or the manufacture, sale, distribution or use of the Product in the Territory, solely because of the use of the Acorda Patent Rights or Acorda Know-How will not to the best of Acorda’s belief infringe any patent owned by a Third Party.
 
For purposes of this Article 8, “Acorda’s actual knowledge” shall mean the knowledge of representatives of Acorda that have been engaged in the Project in a key operational role.
 
8.15.                              As a condition of obtaining an indemnity in the circumstances set out above, the Party seeking an indemnity shall:
 
8.15.1                        fully and promptly notify the other Party of any claim or proceeding, or threatened claim or proceeding;
 
8.15.2                        permit the indemnifying Party to take full care and control of such claim or proceeding;
 
8.15.3                        assist in the investigation and defence of such claim or proceeding;
 
8.15.4                        not compromise or otherwise settle any such claim or proceeding without the prior written consent of the other Party, which consent shall not be unreasonably withheld; and
 
8.15.5                        take all reasonable steps to mitigate any loss or liability in respect of any such claim or proceeding.
 
31

 
8.16.                              TO THE FULLEST EXTENT PERMITTED BY LAW, APART FROM THE FOREGOING REPRESENTATIONS, WARRANTIES AND INDEMNITY, ELAN MAKES NO ADDITIONAL REPRESENTATIONS OR WARRANTIES AND HEREBY DISCLAIMS ALL WARRANTIES, REPRESENTATIONS, AND LIABILITIES, WHETHER EXPRESS OR IMPLIED, ARISING FROM CONTRACT OR TORT (EXCEPT FRAUD), IMPOSED BY STATUTE OR OTHERWISE, RELATING TO THE PRODUCT AND/OR ANY PATENTS OR TECHNOLOGY USED OR INCLUDED IN THE PRODUCT, INCLUDING ANY WARRANTIES AS TO MERCHANTABILITY, FITNESS FOR PURPOSE, CORRESPONDENCE WITH DESCRIPTION, OR NON-INFRINGEMENT.
 
8.17.                              EXCEPT IN RESPECT OF EACH PARTY’S LIABILITY TO INDEMNIFY THE OTHER AGAINST CLAIMS MADE BY A THIRD PARTY, NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ELAN AND ACORDA SHALL NOT BE LIABLE TO THE OTHER BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, SPECIAL OR INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF CURRENT OR FUTURE PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR OTHERWISE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, EXCEPT THAT THIS LIMITATION SHALL NOT APPLY TO DAMAGES DIRECTLY OR INDIRECTLY ARISING FROM PERSONAL INJURY OR DEATH CAUSED BY THE DEFECTIVE DESIGN AND/OR MANUFACTURE OF THE PRODUCT.
 
8.18.                              Elan represents and warrants that Elan Corporation plc will provide Elan Pharma Limited or any other subsidiaries with a licence and the rights to manufacture the Product in accordance with the terms of this Agreement and the Supply Agreement.
 
ARTICLE 9 [NOT USED]

ARTICLE 10   COMMITTEE
 
10.1.                              Acorda and Elan shall establish the Committee to provide oversight, review and coordination relating to the development, manufacturing and supply, Regulatory Approval and commercialisation of the Product, and for resolution of disputed issues that may arise between the Parties under this Agreement or the Supply Agreement. Unless otherwise agreed, the Committee shall be comprised of six members, with three members appointed by each of Elan and Acorda.  The operation of the Committee shall be as set forth at Article 10.2 to Article 10.5.  Acorda and Elan each shall appoint a person (a “ Primary Contact ”) to be the primary contact between the Parties with respect to the Project and to coordinate correspondence and communications between the Parties.  Each Party shall notify the other in writing within thirty (30) days after the
 
32

 
Amendment Date of its representatives on the Committee and of the appointment of its Primary Contact and shall notify the other Party as soon as practicable upon changing its Committee representatives or the Primary Contact appointment in accordance with Article 12.12.  The Primary Contact of each Party will be one of its three representatives in the Committee.
 
10.2.                              Except as specifically set forth in this Agreement, the Committee shall be responsible for overseeing the Project, including the following:
 
10.2.1                        reviewing and, if deemed necessary or desirable, updating the Development Plan, the Technology Transfer Responsibilities and the Project budget; and accordingly Elan shall advise the Committee if it believes that the budget for items of the Project has been or is likely to be significantly exceeded;
 
10.2.2                        facilitating the transfer of know-how, regulatory correspondence and communications and other data as contemplated by this Agreement and the Supply Agreement;
 
10.2.3                        reviewing and assessing the progress of development of Product and, to the extent contemplated by this Agreement, evaluating and, if determined by the Committee, approving Technology Transfer Responsibilities and authorizing Elan to perform tasks required in connection with development of and regulatory submissions relating to Product;
 
10.2.4                        discussing objectives for and performance of the Product in the Territory, and the promotional activities and materials associated therewith;
 
10.2.5                        resolving any disputes between the Parties relating to the Project, provided, however, that Acorda shall have the final decision as to all clinical trial protocols and the conduct of all clinical trials and marketing and promotional activities by Acorda or its Designee; and
 
10.2.6                        such other activities as are delegated to the Committee under this Agreement.
 
10.3.                              The Committee shall use its best efforts to resolve any disputed issues, conflicts or differences of opinion between the Parties under this Agreement.  If the Committee is unable to reach a consensus on any issue within thirty (30) days after such issue being presented to the Committee by a Party, notwithstanding the exercise of its best efforts as provided in Article 10, then such issue shall be referred to the chief executive officers of Acorda and Elan Any final decision of the CEOs shall be conclusive and binding on the Parties hereto, and must be reached, if practicable under the circumstances, within thirty (30) days after being referred to the CEO, provided, however, that issues referred to in Article 10.2.5 as being subject to Acorda’s final decision shall be determined finally and conclusively by Acorda in the event that the Committee and/or the CEOs are unable to reach a consensus; provided further, that any such decision shall comply with applicable governmental regulatory requirements. Any matter as to which the CEOs are unable to reach agreement may be submitted by either Party to binding arbitration for final
 
33

 
resolution pursuant to Article  12.14, or as otherwise agreed, except with respect to matters for which Acorda has authority to make final decisions.
 
10.4.                              The Committee shall consist of the Primary Contact from each Party together with such additional business and development personnel from each Party who are deemed necessary to accomplish the work of the Committee.  Unless otherwise agreed, the Committee shall meet at least once each calendar quarter, in person, or by video or telephone conference.  In such instance, the next quarterly meeting will be scheduled.  Meetings shall be chaired by the chief representative of Acorda and such representative shall be responsible for preparing minutes of such meetings.
 
10.5.                              At each meeting, Acorda shall summarize the status of Acorda’s clinical development, regulatory and, if applicable, marketing and promotional activities with respect to Product. Any disclosures of such progress, results, data or know-how in any meeting shall be deemed Confidential Information of Acorda. At and between meetings of the Committee, each Party shall keep the other fully and regularly informed as to its progress with its respective obligations.
 
10.6.                              The Committee shall not be empowered to alter the terms of this Agreement.  The continuation of the Committee shall be at the discretion of the Parties as deemed appropriate to further the registration and commercialisation activities in the Territory.
 
ARTICLE 11   PATENTS
 
11.1.
 
11.1.1                        Acorda shall have the first right to file, prosecute and maintain the Elan Patent Rights in Elan’s name, using patent counsel selected by Acorda, and shall be responsible for the payment of all related patent filing, prosecution and maintenance costs, subject to this Article 11.1.1.  Upon Acorda’s request, Elan shall reasonably cooperate in the filing, prosecution or maintenance of any patent application or patent included in the Elan Patent Rights. If Acorda elects not to file, prosecute or maintain a patent application or patent included in the Elan Patent Rights in any particular country, it shall provide Elan with written advance notice sufficient to avoid any loss or forfeiture, or at least 60 days notice, and Elan shall have the right, but not the obligation, at its sole expense, to file, prosecute or maintain such patent application or patent in such country in Elan’s name. If Elan elects to file, prosecute or maintain a patent or application within the Elan Patent Rights that Acorda has elected not to file, prosecute or maintain, such patent or application in such country shall no longer be deemed an Elan Patent Right for purposes of the license in Article 2 to Acorda.
 
11.1.2                        Acorda shall have the first right to file, prosecute and maintain any patent application(s) or patent(s) arising from Joint Inventions and shall be responsible for the payment of all related patent prosecution and maintenance costs.  Upon Acorda’s request, Elan shall reasonably cooperate in the filing, prosecution or
 
34

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
 
maintenance of any such patent application or patent.  If Acorda elects not to file, prosecute or maintain any such patent application or patent in any particular country, it shall provide Elan with written advance notice sufficient to avoid any loss or forfeiture, or at least 60 days notice, and Elan shall have the right, but not the obligation, at its sole expense, to file, prosecute or maintain such patent application or patent in such country. Thereafter, such patent or patent application in such country shall be deemed solely an Elan Patent Right. In any such case, Acorda shall not grant any Third Party a license under its interest in the applicable Joint Invention without the prior written consent of Elan.
 
11.2.                              Acorda and Elan shall promptly inform the other in writing of any alleged infringement of which it shall become aware by a Third Party of any patents within the Elan Patent Rights and provide each other with any available evidence of infringement. The Parties will thereafter consult and cooperate to determine a course of action, including, without limitation, the commencement of legal action by either party.  However, Acorda shall have the first right to initiate and prosecute such legal action at its own expense and in the name of Elan and Acorda, or to control the defense of any declaratory judgment action relating to Elan Patent Rights and Elan will co-operate with such action at Acorda’s request and expense.  Elan shall receive [*] of any such recovery remaining after the deduction by Acorda of the reasonable expenses (including attorney’s fees and expenses) incurred in relation to such an infringement proceeding.  In the alternative to the foregoing, the Parties may agree to institute such proceedings in their joint names and shall reach agreement as to the proportion in which they will share the proceeds of any such proceedings, and the expense of any costs not recovered, or the costs or damages payable to the Third Party.  Should Acorda decide not to pursue such infringers within six (6) months of acquiring knowledge of such infringement, except with respect to Paragraph IV Certifications, in such case the time of notice shall not exceed 20 days, Elan may do so at its expense provided that Acorda shall receive [*] of any such recovery remaining after the deduction by Elan of the reasonable expenses (including attorney’s fees and expenses) incurred in relation to such an infringement proceeding.  Acorda will co-operate with such action at Elan’s request and expense.  The Party involved in any such claim, suit or proceeding, shall keep the other Party hereto reasonably informed of the progress of any such claim, suit or proceeding. For any such legal action or defense, in the event that any Party is unable to initiate, prosecute, or defend such action solely in its own name, the other Party will join such action voluntarily and will execute all documents necessary for the Party to prosecute, defend and maintain such action.
 
11.3.
 
11.3.1                        In the event that (I) a claim or proceedings are brought against Acorda and/or Elan by a Third Party alleging that the manufacture, sale, distribution or use of the Product in the Territory infringes the patent rights of such Third Party, and such alleged infringement results from the use of the Elan Intellectual Property, and (II) as of the date the Specifications for the Product have been agreed, Elan was or should reasonably have been aware of such Third Party patent rights, the following shall apply as regards the Third Party claim, including without
 
35

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
 
limitation, reasonable attorney’s fees and other out of pocket expenses of the litigation, including the fees and expenses incurred by Elan and Acorda (“ Patent Expenses ”):
 
11.3.1.1                      if Elan or its subcontractor is manufacturing the Product, Acorda shall bear the [**] of Patent Expenses; Elan and Acorda shall bear the remaining Patent Expenses equally;
 
11.3.1.2                      if Elan or its subcontractor is not manufacturing the Product, Acorda shall discharge the Patent Expenses.  Acorda shall be entitled to credit the Patent Expenses from up to [**] of the royalty otherwise payable to Elan pursuant to Article 5.6 and may carry forward any such uncredited Patent Expenses to be credited against up to [**] of the royalty otherwise payable to Elan pursuant to Article 5.6 until fully expended; Elan and Acorda shall bear the remaining Patent Expenses equally.
 
During the term of this Agreement, Acorda shall have the first right but not the obligation to defend the proceedings referred to in this paragraph and Elan will co-operate with such action at Acorda’s request and expense.  In such event Acorda shall keep Elan advised of all material developments in the said proceedings and shall not settle or compromise such proceedings without the consent of Elan which shall not be unreasonably withheld or delayed.  Should Acorda decide not defend such proceedings, Elan may do so and Acorda will co-operate with such action at Elan’s request and expense.  In such event Elan shall keep Acorda advised of all material developments in the said proceedings and shall not settle or compromise such proceedings without the consent of Acorda which shall not be unreasonably withheld or delayed.
 
Any sums payable by Elan to Acorda, or by Acorda to Elan pursuant to this Article 11.3.1 shall be discharged by Elan or Acorda, as the case may be, within thirty (30) days of the appropriate invoice and reasonable supporting documentation being furnished.
 
11.3.2                        In the event that a claim or proceedings are brought against Elan and/or Acorda by a Third Party alleging that the manufacture, sale, distribution or use of the Product in the Territory as a result of the use of the Elan Patent Rights or Elan Know-How infringes the patent rights of such a Third Party and Elan should not reasonably have been aware of such Third Party patent rights, Acorda and Elan shall meet to discuss in what manner the said proceedings should be defended and, the manner in which any award for damages, costs and expenses incurred in respect of or arising out of such a claim or proceedings should be borne as between Elan and Acorda.
 
11.3.3                        Acorda shall reasonably consider taking such action as is reasonable, such as, to re-formulate or modify the applicable Product so as to avoid infringing the
 
36

 
patent rights of a Third Party, or entering into a licence agreement with such Third Party after due consultation with Elan.
 
11.3.4                        Elan shall have no liability to Acorda whatsoever or howsoever arising for any losses incurred by Acorda as a result of having to cease selling Product or having to defer the launch of selling Product, as a result of a court order or settlement entered into pursuant to Article 11.5.
 
11.4.
 
11.4.1                        In the event that a claim or proceedings are brought against Elan by a Third Party alleging that the manufacture, sale, distribution or use of the Product in the Territory infringes the patent rights of such Third Party, and such alleged infringement results from the use of the Acorda Patent Rights or Acorda Know-How, Elan shall promptly advise Acorda of such threat or suit.  Acorda shall indemnify Elan against such a claim, including without limitation, reasonable attorney’s fees and other expenses of the litigation, provided however, that as of the date the Specifications have been agreed, Acorda was or should reasonably have been aware of such Third Party patent rights; and further provided that Elan shall not acknowledge to the Third Party or to any other person the validity of the patent rights of such a Third Party and shall not compromise or settle any claim or proceedings relating thereto without the written consent of Acorda.  At its option, Acorda may elect to take over the conduct of such proceedings from Elan.
 
11.4.2                        In the event that a claim or proceedings are brought against Elan by a Third Party alleging that the manufacture, sale, distribution or use of the Product in the Territory solely as a result of the use of the Acorda Patent Rights or Acorda Know-How infringes the patent rights of such a Third Party and Acorda should not reasonably have been aware of such Third Party patent rights, Acorda and Elan shall meet to discuss in what manner the said proceedings should be defended and, the manner in which any award for damages, costs and expenses incurred in respect of or arising out of such a claim or proceedings should be borne as between Elan and Acorda.
 
11.4.3                        In the event that a claim or proceedings are brought against Elan by a Third Party alleging that the manufacture, sale, distribution or use of the Product in the Territory infringes any patents held by such Third Party and Acorda or its Designee is manufacturing the Product, and the claim or proceeding results from the use of the patent rights or know-how of Acorda or its Designee (and not the Elan Intellectual Property), Elan shall promptly advise Acorda of such threat or suit.  Acorda shall indemnify Elan against such a claim, including without limitation, reasonable attorney’s fees and other expenses of the litigation; provided that Elan shall not acknowledge to the Third Party or to any other person the validity of the patent rights of such a Third Party and shall not compromise or settle any claim or proceedings relating thereto without the written consent of Acorda.  At its option, Acorda may elect to take over the conduct of such proceedings from Elan.
 
37

 
11.5.                              In the event that a claim or proceedings are brought against either Party by a Third Party alleging that the sale, distribution or use of the Product in the Territory as a result of the use of the Joint Inventions infringes the patent rights of such a Third Party, Acorda and Elan shall meet to discuss in what manner the said proceedings should be defended and the manner in which any award for damages, costs and expenses incurred in respect of or arising out of such a claim or proceedings should be borne as between Elan and Acorda, provided, however, that Acorda shall have the first right to control the defense of such action relating to Joint Inventions and Elan will co-operate with such action at Acorda’s request and expense.  Neither Party shall acknowledge to a Third Party or to any other person the validity of the patent rights of such a Third Party, the invalidity of the Elan Patent Rights or the Acorda Patent Rights and shall not compromise or settle any claim or proceedings relating thereto without the written consent of the other Party, such consent not to be unreasonably withheld or delayed.  The Parties shall co-operate in relation to all material aspects of such litigation or other proceedings and shall meet to discuss in what manner the said proceedings should be defended.  If one Party has control of the litigation or other proceeding pursuant to the terms of this Agreement and the other Party wishes to retain separate representation, the latter Party shall bear the costs of such representation.
 
11.6.                              Acorda agrees to mark all Product it sells or distributes pursuant to this Agreement with applicable patent numbers or otherwise in accordance with the applicable statute or regulations in the country or countries of manufacture and sale thereof.
 
!24)#,%￠￠￠￠35.$29 #,!53%3
 
12.1.                              Secrecy :
 
12.1.1                        Any Confidential Information pertaining to the Product that has been or will be communicated or delivered by Elan to Acorda, and any information from time to time communicated or delivered by Acorda to Elan, including, without limitation, trade secrets, business methods, and cost, supplier, manufacturing and customer information, shall be treated by Acorda and Elan, respectively, as Confidential Information, and shall not be disclosed or revealed to any Third Party whatsoever or used in any manner except as expressly provided for herein; provided, however, that such Confidential Information shall not be subject to the restrictions and prohibitions set forth in this section to the extent that such Confidential Information:
 
12.1.1.1                      is available to the public in public literature or otherwise, or after disclosure by one Party to the other becomes public knowledge through no default of the Party receiving such confidential information; or
 
12.1.1.2                      was known to the Party receiving such confidential information prior to the receipt of such confidential information by such Party, whether received before or after the date of this Agreement; or
 
38

 
12.1.1.3                      is obtained by the Party receiving such confidential information from a Third Party not subject to a requirement of confidentiality with respect to such confidential information; or
 
12.1.1.4                      is required to be disclosed pursuant to: (A) any order of a court having jurisdiction and power to order such information to be released or made public; or (B) any lawful action of a governmental or regulatory agency.
 
12.1.2                        Each Party shall take all such precautions with Confidential Information disclosed to it by the other Party as it normally takes with its own confidential information to prevent any improper disclosure of the Confidential Information disclosed to it by the other Party to any Third Party; provided, however, that such confidential information may be disclosed within the limits required to obtain any authorisation from the FDA or any other United States of America or foreign governmental or regulatory agency or, with the prior written consent of the other Party, which shall not be unreasonably withheld, or as may otherwise be required in connection with the purposes of this Agreement.
 
12.1.3                        Notwithstanding the above, each Party hereto may use or disclose Confidential Information disclosed to it by the other Party to the extent such use or disclosure is reasonably necessary in filing or prosecuting patent applications, prosecuting or defending litigation, complying with applicable governmental regulations or otherwise submitting information to tax or other governmental authorities, conducting clinical trials, or making a permitted sub-licence or otherwise exercising its rights hereunder, provided that if a Party is required to make any such disclosure of the other party’s Confidential Information, other than pursuant to a confidentiality agreement, it will given reasonable advance notice to the latter Party of such disclosure and, save to the extent inappropriate in the case of patent applications and regulatory submissions, will use its best efforts to secure confidential treatment of such information prior to its disclosure (whether through protective orders or otherwise).
 
12.1.4                        Each Party agrees that it will not use, directly or indirectly, any Confidential Information disclosed by the other Party pursuant to this Agreement or the Supply Agreement, other than as expressly provided herein or in the Supply Agreement.
 
12.1.5                        Acorda and Elan will not publicise the existence of this Agreement in any way without the consent of the other, which consent shall not be unreasonably withheld or delayed, subject to the disclosure requirements of applicable laws and regulations; provided , however , that it is understood that the Parties or their Affiliates may make disclosure of this Agreement and the terms hereof in any filings required by the SEC, may file this Agreement as an exhibit to any filing with the SEC and may distribute any such filing in the ordinary course of its business, provided , further , that to the maximum extent allowable by SEC rules and regulations, the Parties shall be seek to maintain the confidentiality
 
39

 
obligations set forth herein and shall redact any confidential information set forth in such filings.  In the event that either Party wishes to make an announcement concerning the Agreement, that Party shall seek the consent of the other Party, which consent shall not be unreasonably withheld or delayed and shall not be required to the extent the text of the announcement relating to this Agreement has previously been agreed to by the other Party.  The terms of any such announcement shall be agreed in good faith.
 
12.2.                              Assignments/ Subcontracting :
 
12.2.1                        Subject to the provisions of this Article 12.2, each party be entitled without the consent of the other:
 
12.2.1.1                      to subcontract or delegate the whole or any part of its duties hereunder to its Affiliate(s) (but shall remain responsible for its obligations under this Agreement); and/or
 
12.2.1.2                      to assign this Agreement to its Affiliate, provided that such assignment has no material adverse tax implications for the other party or parties hereto, and provided further that the assigning Party shall remain liable and responsible with such assignee to the other Party for the performance of any obligations, representations or warranties delegated, contracted, assigned or otherwise transferred to any such assignee.
 
12.2.2                        Elan may, but shall not be obliged to, assign its rights and obligations under this Agreement to a Permitted Assignee (as such term is defined in the Supply Agreement) of the Supply Agreement.
 
12.2.3                        Each Party may assign all (but not a portion) of its rights and obligations under this Agreement to an entity that acquires all or substantially all of its business or assets to which this Agreement pertains, whether by merger, reorganisation, acquisition, sale or otherwise.
 
12.2.4                        Except as provided for in this Article 12.2, this Agreement may not be assigned by a party without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed.
 
12.2.5                        Any permitted assignee of a Party under this Article 12.2 shall assume all related obligations of its assignor under this Agreement.
 
12.3.                              Parties bound :
 
This Agreement shall be binding upon and enure for the benefit of Parties hereto, their successors and permitted assigns.
 
40

 
12.4.                              Severability :
 
If any provision in this Agreement is agreed by the Parties to be, or is deemed to be, or becomes invalid, illegal, void or unenforceable under any law that is applicable hereto, (i) such provision will be deemed amended to conform to applicable laws so as to be valid and enforceable or, if it cannot be so amended without materially altering the intention of the Parties, it will be deleted, with effect from the date of such agreement or such earlier date as the Parties may agree, and (ii) the validity, legality and enforceability of the remaining provisions of this Agreement shall not be impaired or affected in any way.
 
12.5.                              Duration and Termination :
 
12.5.1
 
12.5.1.1                      Subject to the other provisions of Article 12.5, this Agreement shall remain in full force and effect for a period commencing as of the date of this Agreement and shall expire on a country by country basis on the latest of:
 
(a)           fifteen (15) years starting from the Amendment Date;
 
(b)          expiry of the last to expire patent included in the Elan Patent Rights in that country; and
 
(c)           the existence of Competition in that country
 
(the “Initial Period ” ) .
 
12.5.1.2                      At the end of the Initial Period, the Agreement may be continued for five (5) year terms by the consent of the Parties, which consent shall not be unreasonably withheld or delayed.  The Party requiring the extension shall serve two (2) years written notice on the other prior to the end of the Initial Period or any additional five (5) year period.
 
12.5.2                        The Agreement shall be subject to earlier termination in accordance with the following provisions:
 
12.5.2.1                      Acorda may terminate this Agreement in its entirety or with respect to any country with thirty (30) days prior written notice to Elan prior to Regulatory Approval, and with ninety (90) days prior written notice to Elan at any time thereafter;
 
12.5.2.2                      subject to the determination in an arbitration that Acorda has breached the applicable provisions, Elan may terminate the Agreement for the applicable region(s) or country or countries of the Territory if Acorda breaches the provisions of Article 2.11.3, or Acorda indicates to Elan pursuant to Article 2.11.4.3, that it does not intend to obtain Regulatory Approval and commercialise the Product, and Elan does not exercise its option to take a licence to the
 
41

 
Acorda Patent Rights and the Acorda Know-How in accordance with Article 2.11.3.
 
12.5.3                        In addition to the rights of early or premature termination provided for elsewhere in this Agreement, in the event that any of the terms or provisions hereof are incurably breached by either Party, the non-breaching Party may immediately terminate this Agreement by written notice.  An incurable breach shall be committed when either Party is dissolved, liquidated, discontinued, becomes insolvent, or when any proceeding is filed or commenced by either Party under bankruptcy, insolvency or debtor relief laws.  In the event of any other breach, the non-breaching Party may terminate this Agreement by the giving of written notice to the breaching Party that this Agreement will terminate on the sixtieth (60th) day from notice unless cure is sooner effected.  If the breaching Party has proposed a course of action to rectify the breach and is acting in good faith to rectify same but has not cured the breach by the sixtieth (60th) day, the said period shall be extended by such period as is reasonably necessary to permit the breach to be rectified.
 
12.5.4                        Upon exercise of those rights of termination as specified in Article 12.5.2, or Article 12.5.3, in any country or countries or the entire Agreement as the case may be, this Agreement shall, subject to the other provisions of the Agreement and Article 12.5.5, automatically terminate forthwith in the applicable country or countries or the entire Agreement as the case may be, and be of no further legal force or effect.
 
12.5.5                        Upon termination of the Agreement:
 
12.5.5.1                      any sums that were due from Acorda to Elan prior to the exercise of the right to terminate this Agreement (including but not limited to, Research and Development Costs and such additional expenses pursuant to Article 5.7 in each case incurred prior to the notice of termination, shall be paid in full within sixty (60) days of termination of this Agreement;
 
12.5.5.2                      all confidentiality provisions set out herein shall remain in full force and effect for a period of five (5) years;
 
12.5.5.3                      all representations and warranties shall insofar are appropriate remain in full force and effect;
 
12.5.5.4                      the rights of inspection and audit shall continue in force for the period referred to in the relevant provisions of this Agreement;
 
12.5.5.5                      termination of this Agreement for any reason shall not release any Party hereto from any liability which, at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such termination nor preclude either
 
42

 
Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement;
 
12.5.5.6                      save and except as is necessary to enable Elan to exercise the licences granted by Acorda to Elan pursuant to Article 2.9 and Article 2.11.3, upon any termination of this Agreement, Acorda and Elan shall promptly return to the other Party all Confidential Information received from the other Party (except one copy of which may be retained for archival purposes); and
 
12.5.5.7                      in the event this Agreement is terminated for any reason, Acorda and its Designees shall have the right for a period of six (6) months from termination to sell or otherwise dispose of the stock of any Product then on hand, which such sale shall be subject to the terms of the Supply Agreement.
 
12.5.5.8                      Article 1, Article 2.2, Article 8, Article 11.1.1, 11.1.2, 11.2, 11.3, 11.4, 11.5, and Article 12 shall survive the termination or expiration of this Agreement for any reason.
 
12.5.6
 
12.5.6.1                      In the event of termination of the licences to the Elan Intellectual Property granted by Elan to Acorda pursuant to Article 2.11.3 as to any country or countries or in the event of the termination of this Agreement by Elan pursuant to Article 12.5.3, Acorda shall at the option of Elan grant a licence to the Acorda Patent Rights and the Acorda Know-How, including the data, information, Regulatory Applications, Regulatory Approvals, pricing and reimbursement approvals to enable Elan to commercialise the Products in such country or countries on the terms set out in Article 2.11.3 and to the Trademark on the terms set out in Article 2.9.
 
12.6.                              Force Majeure :
 
Neither Party to this Agreement shall be liable for delay in the performance of any of its obligations hereunder if such delay results from causes beyond its reasonable control, including, without limitation, acts of God, fires, strikes, acts of war, or intervention of a Government Authority, non availability of raw materials, but any such delay or failure shall be remedied by such Party as soon as practicable.
 
12.7.                              Relationship of the Parties :
 
Nothing contained in this Agreement is intended or is to be construed to constitute Elan and Acorda as partners or joint venturers or either Party as an employee of the other.  Neither Party hereto shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party.
 
43

 
12.8.                              Amendments :
 
No amendment, modification or addition hereto shall be effective or binding on either Party unless set forth in writing and executed by a duly authorised representative of both Parties.
 
12.9.                              Waiver :
 
No waiver of any right under this Agreement shall be deemed effective unless contained in a written document signed by the Party charged with such waiver, and no waiver of any breach or failure to perform shall be deemed to be a waiver of any future breach or failure to perform or of any other right arising under this Agreement.
 
12.10.                        No effect on other agreements :
 
Except as specifically set forth herein, no provision of this Agreement shall be construed so as to negate, modify or affect in any way the provisions of any other agreement between the Parties unless specifically referred to, and solely to the extent provided, in any such other agreement.
 
12.11.                        Applicable Law :
 
This Agreement is construed under and ruled by the laws of the State of New York, excluding its conflict of laws rules.  For the purpose of this Agreement the Parties submit to the jurisdiction of the United States District Court for the State of New York.
 
12.12.                        Notice :
 
12.12.1                  Any notice to be given under this Agreement shall be sent in writing in English by registered airmail or faxed to:

Elan at	
 	
c/o Elan International Services Ltd.	
102 St. James Court	
Flatts,	
Smiths FL04	
Bermuda	
 	
Attention:	 	Secretary	
Fax:	 	+1 441 292 2224	
 	
Acorda at:	
 	
Acorda Therapeutics, Inc.	
15 Skyline Drive	
Hawthorne, New York 10532	
United States of America	
Attention:	 	Chief Executive Officer	
Fax :	 	+1 914.347.4560	
 
44

 
or to such other address (es) and fax numbers as may from time to time be notified by either Party to the other hereunder.
 
12.12.2                  Any notice sent by registered air-mail shall be deemed to have been delivered within seven (7) working days after despatch and any notice sent by fax shall be deemed to have been delivered within twenty four (24) hours of the time of the despatch.  Notice of change of address shall be effective upon receipt.
 
12.13.                        No Implied Rights :
 
No rights or licences are granted or deemed granted hereunder or in connection herewith, other than those rights expressly granted in this Agreement.
 
12.14.                        Arbitration :
 
Any dispute under this Agreement which is not settled by the Committee or the CEOs pursuant to Article 10 or otherwise by mutual consent shall be finally settled by binding arbitration, conducted in accordance with the Commercial Arbitration Rules of the American Arbitration Association by three (3) arbitrators appointed in accordance with said rules.  The arbitration shall be held in New York, New York and at least one of the arbitrators shall be an independent expert in pharmaceutical product development and marketing (including clinical development and regulatory affairs).  The arbitrators shall determine what discovery will be permitted, consistent with the goal of limiting the cost and time which the Parties must expend for discovery; provided the arbitrators shall permit such discovery as they deem necessary to permit an equitable resolution of the dispute.  Any written evidence originally in a language other than English shall be submitted in English translation accompanied by the original or a true copy thereof.  The costs of the arbitration, including administrative and arbitrators’ fees, shall be shared equally by the Parties and each Party shall bear its own costs and attorneys’ and witness’ fees incurred in connection with the arbitration.  A disputed performance or suspended performances pending the resolution of the arbitration must be completed within thirty (30) days following the final decision of the arbitrators or such other reasonable period as the arbitrators determine in a written opinion.  The parties shall use all reasonable efforts to ensure that any arbitration subject to this Article  12.14 shall be completed within one (1) year from the filing of notice of a request for such arbitration.  The arbitration proceedings and the decision shall not be made public without the joint consent of the Parties and each Party shall maintain the confidentiality of such proceedings and decision, subject to any contrary provision of this Agreement or unless otherwise permitted by the other Party.  The Parties agree that the decision shall be the sole, exclusive and binding remedy between them regarding any and all disputes, controversies, claims and counterclaims presented to the arbitrators.  Application may be made to any court having jurisdiction over the Party (or its assets) against whom the decision is rendered for a judicial recognition of the decision and an order of enforcement .
 
12.15.                        Independent Development :
 
Expect as expressly set forth in Article 2.2, nothing in this Agreement will impair Acorda’s right to independently acquire, license, develop for itself, or have others develop for it, intellectual
 
45

 
property and technology performing similar functions as the Elan Intellectual Property or to market and distribute products based on such other intellectual property and technology.
 
12.16.                        Further Assurances :
 
At any time or from time to time on and after the date of this Agreement, each party shall at the request of the other (i) delivery to the other such records, data or other documents consistent with the provisions of this Agreement, (ii) execute, and delivery or cause to be delivered, all such consents, documents or further instruments of transfer or licence, and (iii) take or cause to be taken all such actions, as such party may reasonably deem necessary or desirable in order for such party to obtain the full benefits of this Agreement and the transactions contemplated hereby.
 
12.17.                        Entire Agreement :
 
This Agreement including its Appendices, Schedules and Exhibits, together set forth the entire agreement and understanding of the Parties with respect to the subject matter hereof, and supersedes all prior discussions, agreements and writings in relating thereto, including the letter of agreement of 31 st December 1996, the SCI Agreement, the MS Agreement (as assigned and assumed) and any term sheets or memoranda of understandings relating to any of the foregoing.
 
12.18.                        Counterparts :
 
This Agreement may be executed in two counterparts, each of which shall be deemed an original and which together shall constitute one instrument.
 
***
 
46

 
IN WITNESS THEREOF the Parties hereto have executed this Agreement in duplicate.

SIGNED	

 	 	
 	
for and on behalf of	
ELAN CORPORATION, PLC.	
 	
Name:	 	 	
Title:	 	 	

SIGNED	

 	 	
 	
for and on behalf of	
ACORDA THERAPEUTICS, INC.	
 	
Name:	 	 	
Title:	 	 	

47

 
3#(%$5,%￠￠￠￠!#/2$! 0!4%.4 2)'(43
 
GRANTED PATENT

Country	 	Patent Number	 	Grant Date	 	Status	 	Inventors	
 	 	 	 	 	 	 	 	 	
US	 	5,952,357	 	14-Sept-1999	 	Issued	 	Blass, J. et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  TREATING DISEASES OF THE ANTERIOR HORN CELLS	
 	 	 	
US	 	5,545,648	 	13-Aug-1996	 	Issued	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 	 	 	 	 	 	 	 	 	
AU	 	676,251	 	03-June-1997	 	Granted	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 	 	 	 	 	 	 	 	 	
CZ	 	28441	 	20-Dec-1993	 	Granted	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 	 	 	 	 	 	 	 	 	
EP	 	0626848	 	04-June-2003	 	Granted	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 	 	 	 	 	 	 	 	 	
HU	 	219583	 	19-Mar-2001	 	Granted	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 
48

 

KP	 	31250	 	25-Aug-1997	 	Granted	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 	 	 	 	 	 	 	 	 	
KR	 	301415	 	25-June-2001	 	Granted	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 	 	 	 	 	 	 	 	 	
NO	 	308.644	 	25-June-2001	 	Granted	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 	 	 	 	 	 	 	 	 	
NZ	 	258844	 	22-Sept-1997	 	Granted	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 	 	 	 	 	 	 	 	 	
RU	 	2160590	 	23-May-2000	 	Granted	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 	 	 	 	 	 	 	 	 	
SK	 	280922	 	20-Dec-1993	 	Granted	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 
49

 
PENDING PATENT APPLICATIONS

BG	 	99047	 	20-Dec-1993	 	Pending	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 	 	 	 	 	 	 	 	 	
CA	 	2,085,785	 	20-Dec-1993	 	Pending	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 	 	 	 	 	 	 	 	 	
JP	 	6-514637	 	20-Dec-1993	 	Pending	 	Hansebout, R, et al.	
 	 	 	 	 	 	 	 	 	
 	 	Title:  THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION	
 
50

 
3#(%$5,%￠ ￠￠￠!33)'.-%.4 !'2%%-%.4
 
The remainder of this page is intentionally blank.  The pages of this Schedule are numbered out of sequence.
 
51

Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission.

SCHEDULE 3   ELAN PATENT RIGHTS

1806	 	Formulations and their use in the treatment of neurological diseases	 	Pending :
Canada
Ireland
Japan	 	
2054822
3952/90
349324/1991	
 	 	 	 	 	 	 	
 	 	 	 	Issued :
Australia
Europe
New Zealand
South Africa
United States	 	
657706
484186
240439
91/8711
5370879
5540938
5580580	
 	 	 	 	 	 	 	
[***]	 	[***]	 	Pending:
[***]	 	
[***]	
 
52

Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission.

3#(%$5,%￠￠￠￠.$! 4)-%,).%
 
[*******]
 
53

 
3#(%$5,%￠￠￠￠253(!#/2$! ,)#%.3%
 
The remainder of this page is intentionally blank.  The pages of this Schedule are numbered out of sequence.
 
54

 
3#(%$5,%￠￠￠￠253( 0!9-%.43 !'2%%-%.4
 
The remainder of this page is intentionally blank.  The pages of this Schedule are numbered out of sequence.
 
55

Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission.

3#(%$5,%￠￠￠￠30%#)&)#!4)/.3
 
Current Analytical Methods and Specifications For Finished Product Contained in
the US Drug Master File
 
[****]
 
56

 
SCHEDULE 8   SUPPLY AGREEMENT
 
The remainder of this page is intentionally blank.  The pages of this Schedule are numbered out of sequence.
 
57

 
SCHEDULE 9   TECHNOLOGY TRANSFER RESPONSIBILITES
 
ELAN & ACORDA RESPONSIBILITIES IN CONNECTION WITH FAMPRIDINE DRUG
PRODUCT TECHNOLOGY TRANSFER TO PATHEON, FAMPRIDINE STABILITY
PROGRAM AT CARDINAL (FORMERLY MAGELLAN) & FOR API
MANUFACTURERS
 
ELAN RESPONSIBILITIES DURING TECHNOLOGY TRANSFER TO PATHEON
 
•                                      Elan will send to Patheon API, standards and samples of drug product batches required to successfully transfer the drug substance and drug product methods
 
•                                      Elan will test and release API lots for the Patheon technology transfer studies
 
•                                      Elan will send copies to Patheon of methods, specifications, method validation reports, batch formulae, component specifications, tablet tooling drawings, and process information as needed, to initiate method and process technology transfer
 
•                                      Elan will review and approve method and process technology transfer protocols prepared by Patheon
 
•                                      Elan will approve methods and process technology transfer reports
 
•                                      Elan will consult with Patheon on issues as they arise during the method and process technology transfer; if required, an Elan analyst or process chemist will travel to Patheon to provide on-site assistance and training on the methods
 
•                                      Elan will review analytical data and executed batch records generated from Patheon’s technology transfer work in connection with batch release by Patheon
 
58

 
ACORDA RESPONSIBILITIES DURING TECHNOLOGY TRANSFER TO PATHEON
 
•                                      Acorda will manage Patheon project timelines
 
•                                      Acorda will provide project management and technology assessment review support during method and process technology transfer
 
•                                      Acorda will manage and approve the budget for the Patheon technology transfer work
 
•                                      Acorda will consult with Patheon on issues as they arise during the method and process technology transfer; if required, an Acorda representative will travel to Patheon to participate in technical/project team meetings
 
ELAN RESPONSIBILITIES FOR PATHEON AFTER SUCCESSFUL TECHNOLOGY TRANSFER
 
•                                      Elan will provide technical support and guidance to Patheon if technical issues arise
 
•                                      Elan will perform release testing and regulatory release of API lots for the Patheon process validation studies if validation occurs prior to NDA approval
 
ACORDA RESPONSIBILITIES FOR PATHEON AFTER SUCCESSFUL TECHNOLOGY TRANSFER
 
•                                      Acorda will review batch record and quality control documentation in connection with regulatory release by Patheon of process validation batches
 
•                                      Acorda will manage the Patheon project
 
•                                      Acorda will be responsible for compliance oversight of Patheon
 
59

 
•                                      Acorda will review and approve all validation protocols and final reports generated by Patheon, as needed
 
•                                      Acorda will review analytical data and batch records generated by Patheon in connection with regulatory release by Patheon
 
•                                      Acorda will provide project management and technology assessment oversight and review support to Patheon
 
•                                      Acorda will prepare the CTD Quality section for the NDA as it pertains to Patheon
 
ELAN RESPONSIBILITIES FOR CARDINAL (FORMERLY MAGELLAN) STABILITY PROGRAM
 
•                                      Elan will review and approve Cardinal stability protocols
 
•                                      Elan will review data generated from Cardinal’s analytical testing as needed
 
•                                      Elan will review stability data tables generated from the Cardinal stability studies
 
•                                      Elan will notify Acorda of any out-of-specification results reported to them by Cardinal or discovered during the Elan review of stability data
 
•                                      Elan will consult with Cardinal on issues as they arise during the stability studies; if required, an Elan analyst will travel to Cardinal to provide on-site assistance and training on the methods
 
•                                      Elan will audit Cardinal and will be responsible for compliance oversight during the Cardinal stability studies
 
•                                      Elan will participate and provide technical support during product-specific PAI activities at Cardinal as needed
 
60

 
ACORDA RESPONSIBILITIES FOR CARDINAL (FORMERLY MAGELLAN) STABILITY PROGRAM
 
•                                      Acorda will participate in discussions with Cardinal and Elan on technical and project management issues
 
•                                      Acorda will review stability protocols and final stability reports from the Cardinal studies
 
•                                      Acorda will manage and approve the budget for the Cardinal stability studies
 
•                                      Acorda will consult with Cardinal and Elan on issues as they arise during stability studies; if required, an Acorda representative will travel to Cardinal to participate in technical/project team meetings
 
•                                      Acorda may participate in technical meetings with Cardinal and/or compliance audits that pertain to fampridine stability studies
 
ELAN RESPONSIBILITIES FOR PROCUREMENT OF FAMPRIDINE API
 
•                                      Elan will provide technical advice to API manufacturers (Regis and Uetikon)
 
•                                      Elan will perform regulatory release testing and will release batches for all incoming lots of API to be used in routine production at Elan and through process validation at Patheon (if validation takes place prior to NDA approval)
 
•                   Elan will oversee and review process validation activities at the API manufacturers
 
•                                      Elan will participate and provide technical support during product-specific PAI activities at the API manufacturers as needed
 
•                                      Elan will review API manufacturer’s regulatory documentation in connection with DMF submission by the API manufacturers in connection with NDA submission
 
•                                      Elan will notify Acorda of any out-of-specification results reported to them by API manufacturers
 
•                                      Elan will be responsible for auditing and assuring cGMP compliance at the API API manufacturers
 
•                                      Elan will purchase API and manage supply chain logistics in connection with API to be used in Elan drug product production
 
61

 
•                                      Elan will purchase and manage supply chain logistics in connection with API to be used in Patheon drug product only prior to NDA approval (in connection with technology transfer work and through process validation if validation occurs before NDA approval)
 
ACORDA RESPONSIBILITIES FOR PROCUREMENT OF FAMPRIDINE API
 
•                                      Acorda will participate in discussions with API manufacturers on technical and project timeline issues
 
•                                      Acorda will provide technical review support in connection with preparation of technical reports, regulatory documentation and validation documentation in connection with commercial scale-up and process optimization activities at the API manufacturers
 
•                                      Acorda will participate in compliance audits of API manufacturers
 
•                                      Acorda will review and advise Elan on budget matters in connection with API manufacturing and development
 
•         Acorda will consult with Elan and API manufacturers on issues as they arise during development; if required, an Acorda representative will travel to the API manufacturers to participate in technical/project team meetings
 
•                   Acorda will be responsible for purchasing API to be used in commercial production of Patheon drug product
 
62

 
Exhibit 10.9
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission
 
EXECUTION COPY
 
Date:        September 2003

ELAN CORPORATION, PLC.
 
AND
 
ACORDA THERAPEUTICS, INC.

SUPPLY AGREEMENT

Fampridine SR

 
INDEX

CLAUSE 1	PRELIMINARY	
 	 	
CLAUSE 2	EXCLUSIVE SUPPLY	
 	 	
CLAUSE 3	REGULATORY MATTERS	
 	 	
CLAUSE 4	FORECASTS AND ORDERS	
 	 	
CLAUSE 5	SUPPLY OF THE PRODUCT	
 	 	
CLAUSE 6	DISPUTES AS TO SPECIFICATION	
 	 	
CLAUSE 7	SECOND SOURCE	
 	 	
CLAUSE 8	ADVERSE EVENTS AND PRODUCT RECALL	
 	 	
CLAUSE 9	FINANCIAL PROVISIONS	
 	 	
CLAUSE 10	PAYMENTS, REPORTS AND AUDITS	
 	 	
CLAUSE 11	DURATION AND TERMINATION	
 	 	
CLAUSE 12	CONSEQUENCES OF TERMINATION	
 	 	
CLAUSE 13	REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION	
 	 	
CLAUSE 14	MISCELLANEOUS PROVISIONS	
 	 	
SCHEDULE 1	MANUFACTURING COST	

 
THIS SUPPLY AGREEMENT is made the            September 2003
 
BETWEEN:
 
(1)                                       Elan Corporation, plc. , a public limited company incorporated under the laws of Ireland, and having its registered office at Lincoln House, Lincoln Place, Dublin 2, Ireland (“ Elan ”); and
 
(2)                                       Acorda Therapeutics, Inc. , a corporation organized under the laws of the State of Delaware and having its principal office at 15 Skyline Drive, Hawthorne, New York 10532, United States of America (“ Acorda ”).
 
RECITALS:
 
(A)                                    Elan and Acorda have entered into a Licence Agreement concerning the Product (as each of those terms are defined below).
 
(B)                                      Elan is prepared to manufacture and supply the Product to Acorda for onward commercial supply.
 
(C)                                      Elan and Acorda are desirous of entering into this Agreement to give effect to the arrangements described at Recitals (A) and (B).
 
NOW IT IS HEREBY AGREED AS FOLLOWS:

CLAUSE 1                   PRELIMINARY
 
1.1.                                    Definitions :
 
“ Act ” shall mean the United States Federal Food Drug and Cosmetic Act of 1934, and the rules and regulations promulgated thereunder, or any successor act, as the same shall be in effect from time to time.
 
“ Affiliate ” shall mean any corporation or entity controlling, controlled or under  common control with Elan or Acorda, as the case may be.  For the purposes of this Agreement, “control” shall mean the direct or indirect ownership of more than 50% of the issued voting shares or other voting rights of the subject entity to elect directors, or if not meeting the preceding criteria, any entity owned or controlled by or owning or controlling at the maximum control or ownership right permitted in the country where such entity exists.
 
“ Agreement ” shall mean this supply agreement (which expression shall be deemed to include the Recitals and Schedules hereto).
 
1

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission
 
“ Batch ” shall mean a specific quantity of Product that is produced according to a single manufacturing order during the same cycle of manufacture, which quantity shall be agreed in the Technical Agreement.
 
“ cGMP ” shall mean current Good Manufacturing Practice as defined in the Act and FDA guidance documents; or as applicable current Good Manufacturing Practice under applicable regulations in the European Union.
 
“ EEA ” shall mean the countries comprising the European Economic Area, as the same may change from time to time .
 
“ Effective Date ” shall mean the date of this Agreement.
 
“ Elan’s Facility ” shall mean Monksland, Athlone, Co. Westmeath, Ireland or such other facility as Elan may use to perform its obligations hereunder and is in compliance with the NDA and other regulatory requirements.
 
“ Elan Territory ” shall mean any country or countries in which Elan, or any licensee of Elan other than Acorda, is permitted to commercialise the Product, by virtue of termination of the License Agreement in that country or the grant of a license by Acorda to Elan pursuant to Article 2.11.3 of the License Agreement.
 
“ EXW ” or “ Ex Works ” shall have the meaning as such term is defined in the ICC Incoterms, 2000, International Rules for the Interpretation of Trade Terms, ICC Publication No. 560.
 
“ Force Majeure ” shall mean any cause or condition beyond the reasonable control of the party obliged to perform, including acts of God, acts of government (in particular with respect to the refusal to issue necessary import or export licenses), fire, flood, earthquake, war, riots or embargoes, strikes or other labour difficulties affecting a party, or either party’s inability to obtain supplies of components of the Product howsoever arising.
 
“ FTE ” means Elan’s full time equivalent charging rate for its appropriate employees or consultants from time to time (based on cost without mark-up) which as of the Amendment Date is [***] per day.
 
“ Governmental Authority ” shall mean the FDA and /or all other governmental and regulatory bodies, agencies, departments or entities, whether or not located in the Territory, which regulate, direct or control commercial and other related activities in or with the Territory.
 
“ Launch Stocks ” shall mean the quantities of stocks of the Product required by Acorda in relation to the launch of the Product following Regulatory Approval in a Major Market, as more fully described in Clause 4.7.
 
“ Launch Year ” shall mean the period commencing on the date of First Commercial Sale and expiring on the last day of the month that is the twelfth (12 th ) month following the
 
2

 
date in which the First Commercial Sale occurs. For example, if the First Commercial Sale occurs on March 15 of any year, the Launch Year shall commence on March 15 of such year and expire on March 31 of the following year.
 
“ Licence Agreement ” shall mean that certain Amended and Restated Licence Agreement between Elan and Acorda of even date herewith.
 
“ Major Market(s) ” shall mean the US, the UK, France, Germany, Italy and Japan.
 
“ Manufacturing Cost ” shall mean the costs described in Schedule 1 as they relate to the Product, PROVIDED THAT if Elan is manufacturing the Product for sale in an Elan Territory, in no event shall Manufacturing Cost exceed Elan’s own costs for such manufacture, as calculated based on GAAP.
 
“ Maximum Capacity ” shall mean Elan’s maximum quarterly manufacturing capacity for the Product from time to time, as agreed in, or determined pursuant to, the Technical Agreement.
 
“ Minimum Elan Requirements ” shall mean for any Year, at least seventy five percent (75%) of Acorda’s total requirements of the Product .
 
“ Minor Deficiencies ” shall mean shortfalls or delays that are not inconsistent with industry accepted standards, which standards applicable to the Product shall be clarified in the Technical Agreement.
 
“ Permitted Elan Assignee ” shall mean any entity that purchases all or substantially all of the assets of Elan’s Facility and has entered into a written agreement with Elan for the benefit of Acorda whereby (inter alia) it represents to Acorda that it is (i) reasonably experienced in the field of pharmaceutical manufacturing (including the existing management of Elan’s Facility), (ii) in possession of sufficient financial resources and liquidity to perform the obligations of Elan under this Agreement and (iii) in good standing with the FDA.
 
A Permitted Elan Assignee shall also include any entity that has been formed for the purpose of acquiring Elan’s Facility, and shall, following such acquisition, be under the management of individuals reasonably experienced in pharmaceutical manufacturing (including the said existing management), in possession of sufficient financial resources and liquidity to perform the obligations of Elan under this Agreement, and none of which are debarred individuals or entities within the meaning of 21 U.S.C. section 335(a) or (b) and have the capacity of being in good standing with the FDA.
 
“ Product ” shall mean the oral product developed pursuant to the Project, in final packaged and labelled form for commercial sale or for distribution as promotional samples and as defined in the approved NDA or NDA Equivalent.
 
“ Recall ” means a company’s removal or correction of a marketed Product that the FDA or equivalent Governmental Authority considers to be in violation of law and against
 
3

 
which such agency might reasonably be expected to initiate legal action (e.g., a seizure). A Recall does not include market withdrawal for other reasons, or a stock recovery.
 
“ Serious Failure to Supply ” shall mean that in a period of a Year, for reasons other than Force Majeure or the default of Acorda, Elan fails on at least two occasions to supply Acorda’s properly forecasted and ordered requirements of the Product in accordance with the terms of this Agreement, except for Minor Deficiencies, and the cumulative shortfall for such Year attributable to such failure(s) is at least 25% of the aggregate amount properly forecasted and ordered from Elan for delivery in such Year.
 
“ Term ” shall mean the term of this Agreement, as set out in Clause 11.
 
“ $ ” and “ US$ ” shall mean United States Dollars.
 
“ Year ” means each consecutive four Calendar Quarters.
 
1.2.                                    Further Definitions :
 
In addition, the following definitions have the meanings in the Clauses corresponding thereto, as set forth below:

Definition	 	Clause	
 	 	 	
“Discount”	 	9.4	
“First Approval”	 	4.1.1	
“Manufacturer”	 	7.1	
“Resumption Quarter”	 	7.6.1	
“Second Source”	 	7.1	
“Second Source Quantity”	 	7.2.1	
“Supply Price”	 	9.3.1	
“Technical Agreement”	 	5.5	
 
1.3.                                    Definitions in Licence Agreement :
 
Except as otherwise defined in this Agreement, all capitalised terms used in this Agreement shall have the same meaning as in the Licence Agreement.
 
1.4.                                    Interpretation :
 
In this Agreement:
 
1.4.1                              the singular includes the plural and vice versa, the masculine includes the feminine and vice versa and references to natural persons include corporate bodies, partnerships and vice versa.
 
4

 
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission
 
1.4.2                              any reference to a Clause or Schedule, unless otherwise specifically provided, shall be respectively to a Clause or Schedule of this Agreement.
 
1.4.3                              the headings of this Agreement are for ease of reference only and shall not affect its construction or interpretation.
 
1.4.4                              the expressions “include”, “includes”, “including”, “in particular” and similar expressions shall be construed without limitation.

CLAUSE 2                   EXCLUSIVE SUPPLY
 
2.1.                                    Subject to the terms and conditions of this Agreement, during the Term, Acorda shall purchase its Minimum Elan Requirements of the Product in the Territory from Elan, except as provided in Clause 2.3.
 
2.2.                                    Subject to the terms and conditions of this Agreement, during the Term, Elan shall not supply the Product to:
 
2.2.1                              any person other than Acorda outside the Elan Territory; or
 
2.2.2                              any person other than Acorda in the Elan Territory who intends, to the actual knowledge of Elan, to sell the Product outside the Elan Territory –
 
except as requested by Acorda, PROVIDED THAT to extent required by applicable law, Elan shall be permitted to:
 
(a)                                        sell the Product to a person in a country which is both part of the Elan Territory and within the EEA, notwithstanding that such person may re-sell the Product in another part of the EEA which is not part of the Elan Territory; and
 
(b)                                       if any country of the EEA is part of the Elan Territory, sell the Product to a person in another country of the EEA which is not part of the Elan Territory, provided further that Elan shall not actively solicit any such sales.
 
2.3.                                    Elan shall not have the obligation to use commercially reasonable efforts to supply the Product where [***] of Manufacturing Cost would exceed the Supply Price, subject to Clauses 2.4 and 2.5
 
2.4.                                    In the event that either party is of the opinion that the circumstances in Clause 2.3 apply or may shortly apply, it shall promptly notify the other.  In such event the parties shall meet to discuss, inter alia , the manner in which Manufacturing Cost is calculated by Elan and Acorda’s commercialisation plans.
 
2.5.                                    If after such discussions Elan is of the opinion that if it continues to supply the Product to Acorda, the circumstances in Clause 2.3 will apply, Elan shall promptly formally so notify Acorda.  In such event
 
5

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission
 
2.5.1                              Elan shall use commercially reasonable efforts to supply Acorda with Product the subject of binding orders issued prior to Acorda’s receipt of such notification, provided that such orders relate to Product scheduled for delivery in the period of three (3) months after the date of the purchase orders, and that such Product shall be invoiced at the applicable price under Clause 9.2 or 9.3; and
 
2.5.2                              After the expiration of the period referred to in Clause 2.5.1, Acorda shall have no further obligation to purchase Product under this Agreement, provide, however, that Acorda may at its option place further purchase orders for delivery during up to a six (6) month period immediately following the period referred to in Clause 2.5.1, subject always to Clause 4 and Clause 5, provided, further, that (i) any such purchase orders are placed not later than three (3) months from the date of Elan’s notice under this Clause 2.5; and (ii) any such Product ordered shall be invoiced at a price equal to Manufacturing Cost plus [**].
 
If following the period referred to in Clause 2.5.2, Acorda wishes to continue to purchase the Product from Elan and Elan is prepared to supply the same, the Parties shall negotiate in good faith the terms of any such supply and purchase.
 
As from the time of Elan’s notice, Acorda shall be entitled to purchase the Product from the Second Source, but without prejudice to binding purchase orders already placed with Elan and subject to the foregoing paragraph.

CLAUSE 3                   REGULATORY MATTERS
 
3.1.                                    Elan shall be responsible, at Elan’s expense, for filing for and maintaining all license and permits pertinent to Elan’s Facility, as distinct from the Regulatory Approvals specific to the Product, without prejudice to Elan’s responsibilities under the Licence Agreement in respect of preparation and delivery to Acorda for incorporation into the NDA or any NDA Equivalent, of the CMC Section.
 
3.2.                                    Upon Elan’s prior written notice, Acorda shall permit Elan or any Affiliate to have access to the NDA and any NDA Equivalent and Regulatory Approvals and to take photocopies of same, as required by Elan to fulfil reporting requirements or as otherwise may reasonably be required by Elan in connection with this Agreement.
 
3.3.                                    Inspections or Inquiries by Governmental Authorities . With respect to Product supplied by it, Elan shall be responsible for all process and equipment validation and quality control tests and procedures required by any Governmental Authority and shall take all steps necessary to pass inspection by any Governmental Authorities in the Major Markets, but without prejudice to Article 6.3 of the License Agreement. Elan shall:
 
3.3.1                              notify Acorda as soon as possible, but in any event within the time period to be set forth in the Technical Agreement, of any notification received by Elan from a Governmental Authority to conduct an inspection of its manufacturing or other
 
6

 
facilities used in the development, manufacturing, packaging, storage or handling of the Product;
 
3.3.2                              without delay make available to Acorda a copy of any inspection report received by Elan resulting from any inspection of any of such facilities by such Governmental Authority to the extent such report relates to Product, the formulation, manufacture, testing, storage and delivery of the Product or any premises used by Elan in performing Elan’s obligations under this Agreement;
 
3.3.3                              provide Acorda with a written copy of any proposed response(s) thereto at least three Business Days prior to submitting such response to any Governmental Authority as well as a copy of the response actually submitted.
 
Representatives of Acorda or its Designee shall have the right to be present during the inspection and/or during the close-out session with the inspectors.  Any Form 483 observations or warning letter related to the Product shall be provided promptly to Acorda, which shall have the right to review and discuss the proposed written response to such 483 observations or warning letter, and a copy of the response actually submitted shall be promptly provided to Acorda. Copies of all other correspondence with any Governmental Authority relating to that any party’s  activities under this Agreement will be provided to the other party within forty-eight (48) hours.
 
3.4.                                    Inspection by Acorda / Governmental Authority .  Elan shall make (i) any licenses and permits relating to Elan’s Facility; and (ii) that portion of Elan’s facility where the Product is manufactured, packaged, tested or stored, including all record and reference samples, available for inspection:
 
3.4.1                              by Acorda’s duly qualified employee or Designee or, with the consent of Elan, by Acorda’s agent or contractor; or
 
3.4.2                              by the relevant Governmental Authority.
 
An inspection under Clause 3.4.1 shall be limited to determining whether there is compliance with cGMP and other requirements of applicable law, including production or quality issues relating to the Product.  Any consent required under this Clause 3.4 shall not be unreasonably withheld or delayed.
 
3.5.                                    Preservation Samples/Retained Samples .  Pursuant to all applicable laws, rules and regulations and to the Specifications, Elan shall assign and apply lot numbers and shall take from each lot of (i) the API used to manufacture Product pursuant to this Agreement; (ii) inactive ingredients used in the manufacture of Product pursuant to this Agreement; and (iii) the Product shipped to Acorda or its designee pursuant to this Agreement, preservation samples/retained samples. Elan shall retain and store the particular lot of API, other ingredients or Product, as applicable, in accordance with FDA and other applicable regulations, which currently provide for a period expiring no earlier than two years after the expiration of the shelf life of the particular lot of Product shipped to Acorda or its Designee pursuant to this Agreement.  Preservation samples/retained
 
7

 
samples, as referred to herein, do not include samples retained for purposes of stability testing.
 
3.6.                                    Elan shall at its option be entitled to change the manufacturing process or site for manufacture of the Product, provided that (a) Elan provides Acorda with all required information in form and substance necessary to file any related amendments or supplements to the NDA or any NDA Equivalent or, if applicable, Elan files with applicable regulatory authorities any required amendments or supplements to any DMF; (b) no such change shall take effect until all requisite regulatory approvals have been obtained, and (c) Elan shall be responsible for the costs associated with such change.  Acorda shall reasonably co-operate with Elan in obtaining any such changes requested.

CLAUSE 4                   FORECASTS AND ORDERS
 
4.1.                                    Forecasts .   Acorda shall provide Elan with bona fide written forecasts of its estimated Minimum Elan Requirements of the Product as follows:
 
4.1.1                              within eighteen (18) months prior to the anticipated date of first Regulatory Approval in any Major Market (“ First Approval ”), Acorda shall provide Elan with an eighteen (18) month forecast, broken down on a quarterly basis, for the period beginning with the anticipated date of First Commercial Sale in such Major Market (which date shall be specified in the forecast);
 
4.1.2                              thereafter, every three months until First Approval, Acorda shall provide Elan with an updated forecast on a quarterly basis;
 
4.1.3                              within thirty (30) days of First Approval, and thereafter each calendar month not later than the 23 rd of the month, a rolling 18 month forecast, broken down on a month-by-month and country-by-country basis, for the period commencing at the beginning of the following month; and
 
4.1.4                              not later than 1 August in each year, a five (5) year forecast, broken down on an annual basis.
 
Except as otherwise provided herein, all forecasts made hereunder shall be made to assist Elan in planning its production and Acorda in planning marketing and sales, shall not be binding purchase orders, and shall be without prejudice to Acorda’s subsequent firm orders for the Product in accordance with the terms of this agreement. Each forecast provided by Acorda shall supercede any previous forecast and may be expressed in a reasonable range. After receiving Acorda’s forecasts, Elan shall notify Acorda within five (5) days if Elan becomes aware that it will be unable to supply Acorda’s forecasted requirements of Product and, in such event, the provisions of Clause 4.6 shall be applicable.
 
4.2.                                    Purchase Requirements . Subject to the agreement between the Parties relating to Launch Stocks under Clause 4.7, Acorda shall be bound to order one hundred percent
 
8

 
(100%) of the forecasted quantities of the Product for each month of the first  three (3) months of the most recent rolling forecast referred to in Clause 4.1.3, but otherwise forecasts shall not be binding.
 
4.3.                                    Forecasts and orders shall not increase or decrease by more than 25% in the aggregate amount of Product required in a calendar quarter compared to the previous calendar quarter, except for Launch Stocks or unless otherwise agreed by Elan.  However, Elan shall use reasonable efforts to fulfil Acorda’s requirements in excess of duly forecasted and ordered amounts.
 
4.4.                                    Forecasts and orders shall not exceed the Maximum Capacity during the applicable quarterly period.
 
4.5.                                    Firm Orders .   Acorda or its Designee shall provide Elan with purchase orders on the standard purchase order forms of Acorda or its Designee (without prejudice to Clause 5.4) of its Elan Minimum Requirements at least ninety (90) days before it requires each delivery of Product (subject to Clause 4.7 with respect to Launch Stocks), specifying the required delivery date in each purchase order and specifying the quantity of Product requested for commercial use and the quantity of Product for promotional and sample use.
 
4.6.                                    Shortages .   Elan agrees that it will use commercially reasonable efforts to prevent an interruption of supply to Acorda and shall immediately notify Acorda of any problems or unusual production situations which may adversely affect production or quality of Product or its Specifications or its timely delivery to Acorda or its designee.  If, at any time during the term of this Agreement, Elan becomes aware that it will not be able to satisfy Acorda’s forecasts or ordered requirements for Product, then Elan shall:  (i) give Acorda prompt notice thereof, (ii) take all commercially reasonable steps to enable Acorda to procure adequate quantities of Product from the Second Source in accordance with the applicable provisions of Clause 7 and (iii) if such inability is partial, Elan shall fulfill firm orders with such quantities of Product as are available. and shall continue to use its commercially reasonable efforts to fulfill orders on a timely basis.
 
4.7.                                    Launch Stocks . Within six months prior to an anticipated Regulatory Approval in a Major Market, the parties shall discuss and agree upon the manufacture and purchase of specific quantities of Launch Stocks for launch of the Product in  the applicable Major Market.
 
4.7.1                              Launch Stocks shall be ordered not later than 20 Business Days from receipt by Acorda of an approval letter, from the FDA or equivalent Governmental Authority in respect of the NDA or an NDA Equivalent in another Major Market.
 
4.7.2                              Acorda may use the validation batches of the Product as Launch Stocks, subject to compliance with applicable laws, the Licence Agreement and other provisions of this Agreement, provided that in such event, any amounts previously paid by
 
9

 
Acorda to Elan for such validation batches shall be credited against the applicable price for Launch Stocks under Clause 9.1.

CLAUSE 5                   SUPPLY OF THE PRODUCT
 
5.1.                                    Save as otherwise provided in this Agreement, Elan shall use commercially reasonable efforts to produce and supply to Acorda its entire Elan Minimum Requirements of the Product as set forth in and in response to firm purchase orders, within ninety (90) days of the purchase order, or one hundred and fifty (150) days for Launch Stocks or samples (subject to any required extension due to the lead times of specific components of samples).
 
5.2.                                    Elan shall have no obligation to supply Product:
 
5.2.1                              For any period, in excess of Acorda’s properly forecast requirements for such period (but Elan will nevertheless use its commercially reasonable efforts to fulfil Acorda’s requirements in excess of such amounts, having regard to its manufacturing capacity);
 
5.2.2                              for less than a minimum order of one Batch, or such other minimum quantity as may be agreed in the Technical Agreement;
 
5.2.3                              in partial Batches;
 
5.2.4                              where Clause 2.3 applies; or
 
5.2.5                              pursuant to an order which does not conform in all material respects to the provisions of Clause 4 and this Clause 5; provided that if Elan does supply pursuant to such an order in its absolute discretion, that fulfilment shall not affect Elan’s right to refuse to fulfil any subsequent order which does not comply in all material respects with those provisions.
 
5.3.                                    The Product supplied by Elan to Acorda shall:
 
5.3.1                              be delivered in finished packaged form in the dosages and configurations as set forth in the Specifications and agreed by the parties and included in the NDA and any NDA Equivalent;
 
5.3.2                              be shipped EXW Elan’s Facility;
 
5.3.3                              be delivered with a certificate of analysis and certificate of release in respect of the Product, in a form reasonably acceptable to Acorda (and Acorda shall be entitled to rely upon such certificate of analysis without the necessity of performing additional testing), in accordance with the terms of the Technical Agreement, cGMPs and the NDA or any NDA Equivalent; and
 
10

 
5.3.4                              have a shelf life to be determined in the Technical Agreement.
 
5.4.                                    The terms of this Agreement are hereby incorporated by reference into each order of Product submitted by Acorda and accepted by Elan.  In the event of any conflict between an order or other written instructions and this Agreement, the terms of this Agreement shall prevail.
 
5.5.                                    Not less than eighteen (18) months before the anticipated First Approval, or such later date as may be determined by the Committee, the parties shall negotiate in good faith to conclude a detailed technical agreement (the “ Technical Agreement ”) regulating the parties’ respective obligations from a technical and quality perspective for the supply of the Product by Elan to Acorda, subject in all cases to compliance with cGMPs, the requirements and commitments of the NDA and any NDA Equivalent and any other applicable laws or regulations governing manufacture and supply of Product.  Such agreement will include commercially reasonable terms as to:
 
5.5.1                              the precise procedures regulating the alleged failure of any shipment of the Product to conform to the Specifications as a result of an alleged latent defect and the procedures to be adopted for the return and replacement of such Product;
 
5.5.2                              the inspection and testing for compliance with specifications of API to be conducted by Elan prior to incorporation into Product, the testing and quality analysis of Product to be conducted by Elan prior to shipment of the Product and the format of the certificate of analysis and certificate of release to be furnished by Elan to Acorda as well as any quality analysis to be conducted by Acorda or its Designee;
 
5.5.3                              the batch manufacturing records and other documentation to be prepared and maintained by Elan and delivered with each shipment to Acorda to show compliance with cGMP as well as other applicable United States of America and foreign laws and regulations;
 
5.5.4                              the agreed shelf life of the Product as of the date of shipment;
 
5.5.5                              the quantity of Product constituting a Batch and minimum Batch size of each shipment of the Product;
 
5.5.6                              the manner in which Elan may provide Acorda with assistance in relation to field alerts, recalls, complaints and adverse events;
 
5.5.7                              the notification of change by both parties;
 
5.5.8                              the responsibility to collate and write annual product review and annual reports;
 
5.5.9                              technical agreements with any subcontracted parties;
 
5.5.10                        the stability commitments in NDA or amendments thereto;
 
11

 
5.5.11                        active drug substance, excipient and component supplier agreements, including audits/inspections of related manufacturing facilities;
 
5.5.12                        procedures for determining and monitoring the marginal unit variable element of Manufacturing Cost for purposes of Clause 9.5.1;
 
5.5.13                        such other matters relating to the manufacturing and supply of Product, including any amendments to any of the terms of this Agreement, any matters that this Agreement refers to be included in the Technical Agreement or any other matters that the Parties may mutually agree to or as may be required by the NDA or any NDA Equivalent.

CLAUSE 6                   DISPUTES AS TO SPECIFICATION
 
6.1.                                    All claims for failure of any delivery of the Product to conform to the Specifications must be made by Acorda in writing within sixty (60) days  following delivery of Product to Acorda or its Designee except in the case of latent defects.  Acorda shall promptly upon Elan’s request provide reasonable details of the alleged non-conformance and supporting evidence, and shall upon request permit Elan to re-test the Product.  If Elan does not agree with Acorda’s determination of non-conformance, then Elan shall provide Acorda with a written notice of such disagreement within twenty (20) days of receipt of the non-conformance notice (adjusted for any delay in providing appropriate details or permitting re-testing), responding to Acorda’s claim.  The Parties shall use commercially reasonable efforts to resolve such disagreement within ten (10) Business Days of Acorda’s receipt of Elan’s notice of disagreement.
 
6.2.                                    Claims for latent defects, not discovered during the routine testing protocol (to be agreed in the Technical Agreement) shall be made in accordance with the Technical Agreement in writing within thirty (30) days of discovery.  Failure to make timely claims in the manner to be prescribed in the Technical Agreement shall constitute acceptance of the delivery.
 
6.3.                                    In the event that the Product supplied by Elan is not in compliance with the Specifications, or is otherwise adulterated, misbranded or defective, Elan shall, in addition to any other applicable remedies:
 
6.3.1                              be responsible, at the sole cost and expense of Elan, for re-analysis, sampling, processing, return, disposal or destruction, including certification of destruction, of such non-conforming Product; and
 
6.3.2                              at its cost, replace the nonconforming Product with Product meeting the Specifications as soon as reasonably practicable.
 
6.4.                                    In the event that the nonconformity was due to a fault of Acorda, then, according to Elan’s orders, the Product shall either be destroyed by Acorda, or returned to Elan for
 
12

 
destruction by Elan, at Acorda’s expense.  In such an event Acorda will not be entitled to any credit as to the non-conforming Product.
 
6.5.                                    In the event of an unresolved dispute as to:
 
6.5.1                              conformity of the Product with Specifications; or
 
6.5.2                              whether defects in the Product are attributable to the negligent acts or omissions of Elan,
 
the parties shall within 30 days after expiration of the ten (10) Business Day period referred to in Clause 6.1 appoint an independent laboratory to undertake the relevant testing and its findings shall be conclusive and binding upon the parties.
 
All costs relating to this process shall be borne solely by the party whose testing was in error.
 
If the parties are unable to agree as to the independent laboratory to be used, the matter shall be referred to arbitration in accordance with Article 12.14 of the License Agreement.

CLAUSE 7                   SECOND SOURCE
 
7.1.                                    Process Transfer to Second Source :
 
Acorda shall be entitled to qualify  the facility of Patheon Inc. at 2100 Syntex Court, Mississauga, Ontario as a second source of the Product (“ Second Source ”), subject to Patheon, Inc. (the “ Manufacturer ”) undertaking to Elan to protect the confidentiality of Elan’s manufacturing processes related to Product and not use them for any other purpose, in terms reasonably satisfactory to Elan provided that Elan hereby acknowledges that the Manufacturer is in the process of being qualified as a Second Source Manufacturer.
 
At Acorda’s request, Elan shall use commercially reasonable efforts to assist in qualifying the Second Source as an alternative site of manufacture of the Product.  Pursuant to this obligation, Elan shall:
 
7.1.1                              provide Acorda or the Manufacturer (at Acorda’s request) with any information necessary to manufacture the Product;
 
7.1.2                              provide to Acorda or the Manufacturer (at Acorda’s request) the documentation constituting the required material support, more particularly practical performance advice, shop practice, specifications as to materials to be used and control methods;
 
7.1.3                              assist Acorda and/or the Manufacturer (at Acorda’s request) with the working up and use of the technology and with the training of Manufacturer’s personnel to
 
13

 
the extent which may reasonably be necessary in relation to the manufacture of the Product by the Manufacturer.  In this regard, Elan will receive the Acorda’s and/or Manufacturer’s scientific staff, as applicable, in its premises for certain periods, the term of which will be agreed by the parties; and
 
7.1.4                              comply with the other obligations and responsibilities of Elan relating to technology transfer to Patheon, as set forth in the Technology Transfer Responsibilities Schedule.
 
Acorda shall comply with its obligations and responsibilities relating to technology transfer to Patheon, as set forth in the Technology Transfer Responsibilities Schedule.
 
7.2.                                    Supply of Product from Second Source:
 
Acorda may purchase the following quantities of Product from the Second Source and, accordingly, if so purchased, Acorda shall have no obligation to purchase such quantities from Elan and Elan shall have no obligation to supply such quantities to Acorda:
 
7.2.1                              In any Year, up to twenty five percent (25%) of Acorda’s total requirements of Product for such Year, subject to Clauses 7.3.2 and 9.5 (the “ Second Source Quantity ”);
 
7.2.2                              quantities of the Product which Elan is not obligated to, and declines to, supply pursuant to Clause 2.3;
 
7.2.3                              quantities of Product in addition to the Second Source Quantity required to make up any portion of a valid purchase order which is either (i) not delivered by Elan by its due date for delivery (regardless of the cause of late or short delivery), except for Minor Deficiencies, or (ii) by reason of Force Majeure, to the extent not capable of being delivered by its due date for delivery, for so long as the Force Majeure continues;
 
7.2.4                              where there is a Serious Failure To Supply, its entire requirements of the Product, subject to Clause 7.6.
 
7.3.                                    Notification of Supply from Second Source; Equitable Purchase of Samples :
 
7.3.1                              If Acorda purchases Product from the Second Source, the amount of the same, together with the quantity so purchased as samples, shall be notified to Elan in the applicable Statement.
 
7.3.2                              Acorda shall purchase from the Second Source at least the same proportion of samples of the Product  to commercial supply of Product as the proportion of samples to commercial supply purchased by Acorda from Elan.
 
14

 
7.4.                                    No Supply Restrictions On Second Source :
 
Acorda shall not place or attempt to place any restriction on supply from the Second Source to Elan or its licensees for sale in the Elan Territory, except to the extent of the restrictions on supply by Elan under Clause 2.2.  In particular, Acorda shall not place or attempt to place any restriction on supplies from the Second Source to Elan for sale in the Elan Territory or its licensees after the end of the Term.
 
7.5.                                    Responsibility for Second Source :
 
Assuming compliance by Elan with Clause 7.1, Acorda shall be solely responsible for:
 
7.5.1                              all process and equipment validation in the Second Source required by applicable law or regulations and shall take all steps reasonably necessary to pass inspection by the Governmental Authority;
 
7.5.2                              Product supplied to Acorda or its Designees by the Second Source.
 
7.6.                                    Resumption of Elan Supply :
 
7.6.1                              In the event that Product is being purchased from a Second Source as a result of Serious Failure To Supply, at such time as Elan has remedied the situation that caused it and is once again able to fulfil its obligations to supply Product pursuant to the terms and conditions of this Agreement, Elan shall so notify Acorda.  Commencing on the first calendar quarter beginning after the date of such notice (the “ Resumption Quarter ”), Acorda shall resume purchasing and Elan shall resume its obligations to supply the Minimum Elan Quantities from Elan, subject to the provisions of Clause 7.6.2.
 
7.6.2                              Acorda shall be entitled to:
 
7.6.2.1                         honor its binding purchase commitments from the Second Source, incurred reasonably and consistently with its practice of ordering from Elan and for delivery within three (3) months of the date of such commitments, prior to the notice referred to in Clause 7.6.1; and
 
7.6.2.2                         subsequent to the commencement of the Resumption Quarter, in addition to the Second Source Quantity, purchase from the Second Source up to twenty five percent (25%) of Minimum Elan Requirements, to the exclusion of Elan, for two consecutive calendar quarters in order to be satisfied of Elan’s ability to fulfil its obligations in respect of the supply of Product pursuant to the terms and conditions of this Agreement.
 
7.6.3                              The Technical Agreement shall contain terms applicable to the resumption of supply where the cessation is by reason of Force Majeure, which shall be not less favourable to Elan than the provisions of Clauses 7.6.1 and 7.6.2 applicable to resumption following Serious Failure to Supply.
 
15

 
7.7.                                    No Termination Right :
 
Absent Elan’s failure to use commercially reasonable efforts to supply Product in accordance with the terms of this Agreement, Acorda shall have no right to terminate this Agreement by reason of failure to supply, except as otherwise expressly provided herein.
 
7.8.                                    Have Made License :
 
The Parties acknowledge and confirm that:
 
(a)                                   to the extent that Acorda is permitted hereunder to purchase the Product from Patheon; and
 
(b)                                  following termination of this Agreement, and until termination of the License Agreement –
 
Acorda is regarded for the purposes of Article 2.1 of the License Agreement as being permitted to have the Product made by Patheon at the Second Source (subject always to the terms and conditions of this Agreement) and that the license grant under such Article 2.1 to make and have made Product extends accordingly.

CLAUSE 8                   ADVERSE EVENTS AND PRODUCT RECALL
 
8.1.                                    Each party shall give the other prompt notice, which shall be promptly confirmed in writing, of any occurrence that involves:
 
8.1.1                              any material complaint about the safety or effectiveness of a Product, including a claim for death or injury following administration of such Product (that is plausibly related to the administration of such Product); and
 
8.1.2                              any other matter arising out of this Agreement that must be reported to a Governmental Authority.
 
In the case of Acorda reporting to Elan matters described in Clause 8.1.2, reporting quarterly, or in such other timescale as may be agreed in the Technical Agreement, shall be considered “prompt”.
 
For the avoidance of doubt, Acorda shall have overall responsibility for adverse event reporting and medical complaints.
 
8.2.                                    If a party:
 
8.2.1                              is notified by a Governmental Authority that a Recall of a Product is required, requested or otherwise advisable as being probably needed; or
 
8.2.2                              establishes a need to Recall a Product for non-conformities with the Specifications –
 
16

 
Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission
 
it shall promptly give to the other party written notice of the same with full details.
 
8.3.                                    Unless otherwise agreed, after consultation with Elan, Acorda shall take the lead role in any Recall, market withdrawal, stock recovery or any other corrective action related to Product in a commercially reasonable manner and Elan shall afford all reasonable assistance.  A final report shall be completed by Acorda and delivered promptly to Elan.
 
8.4.                                    If the Recall, market withdrawal, stock recovery or other corrective action relating to a Product arises from Elan’s negligent acts or omissions in manufacturing the Product, or failure of the Product to conform to Specifications, the costs, including the cost of replacement quantities of Products, of such Recall, market withdrawal, stock recovery or other corrective action relating to a Product shall be borne by Elan provided that Acorda could not have discovered the said act(s) or omission(s) prior to the sale of the Product by exercising reasonable diligence.  In all other circumstances, such costs shall be borne by Acorda. For purposes of this Agreement, such costs shall include the expenses of notification and destruction or return of the Recalled Product and all other documented out-of-pocket costs incurred in connection with such Recall, market withdrawal, stock recovery or other corrective action relating to a Product, but shall not include lost profits or opportunity costs of either Party.
 
In the event that Elan should bear the costs of any recall hereunder, Elan shall be entitled but not obliged to take over and perform the recall of the Product and Acorda shall provide Elan at no cost with all such reasonable assistance as may be required by Elan.

CLAUSE 9                   FINANCIAL PROVISIONS
 
9.1.                                    Price of Launch Stocks :
 
Elan shall invoice Acorda for Launch Stocks at a price equivalent to Manufacturing Cost plus [**], subject to reconciliation pursuant to Clause 9.3.3.
 
9.2.                                    Price of Samples :
 
The price to be charged to Acorda for Product intended for distribution as free-of-charge promotional samples in its marketing and promotion of the Product shall be equivalent to Manufacturing Cost plus [***] which price shall apply to Product supplied EXW Elan’s Facility to Acorda.  For the avoidance of doubt, the Parties confirm that if Acorda requires the samples to be supplied in sample packaging, Manufacturing Cost shall include all costs referable to such packaging.
 
9.3.                                    Price of Product (General) :
 
9.3.1                              Except for Product referred to in Clauses 9.1 and 9.2, the price of the Product manufactured by Elan to be charged to Acorda under this Agreement shall be equivalent to [***] of the NSP as determined by the provisions of Clause 9.3.3 (the “ Supply Price ”), less the Discount to the extent applicable, and
 
17

 
Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission
 
subject to Clause 2.5. The foregoing price shall apply to Product supplied EXW Elan’s Facility packaged and labelled in final market form and consistent with the NDA.
 
9.3.2                              For the avoidance of doubt the Parties agree that if for whatever reason the Product supplied by Elan to Acorda which meets the Specifications and the applicable law and regulatory requirements is not sold by Acorda, payment to Elan for such Product shall nonetheless be effected and the price of the Product shall be determined by reference to the NSP calculated pursuant to the provisions of Clause 9.3.3.
 
9.3.3                              Upon supply, Elan shall render an invoice in respect of the quantities of Product delivered to Acorda for a sum calculated by reference to [***] of then-applicable Notional NSP.  The Parties shall adjust their account as of the end of each calendar quarter during such calendar year by Acorda paying to Elan, or by Elan crediting Acorda (as the case may be), the difference between the sum paid pursuant to the previous sentence and the actual Supply Price calculated each calendar quarter pursuant by reference to actual NSP in such quarter, within the period specified in Clause 9.6.
 
9.4.                                    Discount :
 
Where Acorda purchases from Elan for delivery in any Year more than [***] tablets of the Product, Acorda shall be entitled to a discount (the “ Discount ”) in respect of the excess equal to [***] of Elan’s Manufacturing Cost for such excess tablets.
 
The Discount is without prejudice to Clause 2.3.
 
9.5.                                    Compensating Payment :
 
9.5.1                              In respect of all Product purchased from the Second Source pursuant to Clause 7.2.1 and 7.6.2.2 , Acorda shall make a compensating payment to Elan calculated per unit as X – Y, where “X” is the unit price that would have applied if the Product were purchased from Elan, under Clause 9.2 or 9.3 as applicable; and “Y” is the marginal unit variable element of Elan’s Manufacturing Cost applicable to such Product.
 
9.5.2                              Such compensating payment shall be made in respect of a particular quarter at the time of provision of the Statement, based on the then Notional NSP and estimated Manufacturing Cost.  The Parties shall adjust their account as of the end of each calendar year by Acorda paying to Elan, or by Elan crediting Acorda (as the case may be), the difference between the sum paid pursuant to Clause 9.5.1 and the actual payment calculated on the basis of actual applicable NSP and actual Manufacturing Cost calculated at the end of the calendar year, or such other period as may be specified in the Technical Agreementwithin sixty (60) days after the end of the calendar year.
 
18

 
Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission
 
9.6.                                    Time For Payment :
 
For the first two years following First Commercial Sale of the Product in any country of the Territory, payment for the Product supplied to Acorda shall be effected in $ within sixty (60) days of the date of the relevant invoice issued on supply by Elan pursuant to Clause 9.3.3.  Thereafter, payment shall be effected by Acorda in $ within thirty (30) days of the date of the relevant invoice issued on supply by Elan pursuant to Clause 9.3.3.
 
The adjusting payments referred to in Clause 9.3.3 shall be made on provision of the relevant Statement.
 
For the avoidance of doubt, in respect of Product ordered for a particular country prior to Regulatory Approval in that country, Acorda shall be responsible for the price of such Product as from its readiness for delivery, notwithstanding that applicable law or regulations may prevent such Product from being supplied before Regulatory Approval.
 
9.7.                                    Process Transfer Costs :
 
Except as otherwise set forth in this Agreement, in respect of the establishment, qualification and operation of the Second Source, Acorda shall be solely responsible for:
 
9.7.1                              Acorda’s own costs and expenses;
 
9.7.2                              all third party costs and expenses, including out of pocket expenses incurred by Elan, for products or services previously approved by the Committee; and
 
9.7.3                              work conducted by Elan, its Affiliates, and their employees and consultants, under the Technology Transfer Responsibilities schedule, or as may otherwise be agreed to by the Parties, at the rate of FTE plus [***].
 
9.8.                                    VAT :
 
All prices for the Product and other amounts in this Agreement are exclusive of any applicable value added or any other sales tax, for which Acorda will be additionally liable, if payable, subject to Clause 10.

CLAUSE 10            PAYMENTS, REPORTS AND AUDITS
 
Article 5.9 of the Licence Agreement is hereby incorporated by reference herein as if restated in its entirety herein.

CLAUSE 11            DURATION AND TERMINATION
 
11.1.                              This Agreement shall be deemed to have come into force on the Effective Date and will expire upon expiry or termination of the Licence Agreement, howsoever arising.
 
19

 
11.2.                              In addition to the rights of termination provided for elsewhere in this Agreement, either party will be entitled forthwith to terminate this Agreement by written notice to the other party if:
 
11.2.1                        that other party commits any breach of any of the provisions of this Agreement or the Licence Agreement, and in the case of a breach capable of cure, fails to cure the same within 60 days after receipt of a written notice giving full particulars of the breach and requiring it to be remedied; provided, that if the breaching party has proposed a course of action to cure the breach and is acting in good faith to cure same but has not cured the breach by the 60th day, such period shall be extended by such period as is reasonably necessary to permit the breach to be cured, provided that such period shall not be extended by more than 90 days, unless otherwise agreed in writing by the parties;
 
11.2.2                        that other party goes into liquidation (except for the purposes of amalgamation or reconstruction and in such manner that the company resulting therefrom effectively agrees to be bound by or assume the obligations imposed on that other party under this Agreement);
 
11.2.3                        an encumbrancer takes possession or a receiver is appointed over any of the property or assets of that other party;
 
11.2.4                        any proceedings are filed or commenced by that other party under bankruptcy, insolvency or debtor relief laws or anything analogous to any of the foregoing under the laws of any jurisdiction occurs in relation to that other party.
 
11.3.                              For the purposes of Clause 11.2, a breach will be considered capable of cure if the party in breach can comply with the provision in question in all respects other than as to the time of performance (provided that time of performance is not of the essence).
 
11.4.                              Elan may terminate this Agreement by giving twelve (12) months’ written notice to do so to Acorda.

CLAUSE 12            CONSEQUENCES OF TERMINATION
 
12.1.                              Upon exercise of those rights of termination specified in Clause 11 or elsewhere in this Agreement, this Agreement shall, subject to the provisions of the Agreement which survive the termination of the Agreement and Clause 12.2 automatically terminate forthwith and be of no further legal force or effect, provided, however, that if the Agreement is terminated by Elan under Clause 11.4 such termination shall not be effective until the expiration of such twelve (12) month period
 
12.2.                              Upon termination of this Agreement by either party, the following shall be the consequences:
 
20

 
12.2.1                        any sums that were due from Acorda to Elan under the provisions of Clause 9 or otherwise prior to the exercise of the right to terminate this Agreement as set forth herein shall be paid in full forthwith provided , that Elan has delivered Product in accordance with the Specifications and cGMP;  and Elan shall not be liable to repay to Acorda any amount of money paid or payable by Acorda to Elan up to the date of the termination of this Agreement;
 
12.2.2                        all confidentiality provisions set out herein shall remain in full force and effect for a period of 7 years from the date of termination of this Agreement;
 
12.2.3                        all representations and warranties shall insofar are appropriate remain in full force and effect;
 
12.2.4                        the rights of inspection and audit shall continue in force for the period referred to in the relevant provisions of this Agreement; and
 
12.2.5                        if Elan terminates the Agreement under Clause 11.4, Acorda shall be entitled to purchase all of Acorda’s requirements of Product from the Second Source as from termination becoming effective.

CLAUSE 13            REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION
 
13.1.                              The following clauses of the License Agreement are hereby incorporated by reference herein as if stated herein in their entirety, except that for purposes of this Agreement, all references in such clauses to “the Agreement” or “this Agreement” shall be deemed to mean this Supply Agreement: Articles 8.2, 8.3, 8.4, 8.5, and 8.7.
 
13.2.                              Elan represents and warrants that the Product supplied to Acorda by Elan under this Agreement shall be free of any lien, security, interest or other encumbrance on title, conform to the Specifications and all applicable laws and regulations and requirements of the FDA and other Governmental Authorities including, without limitation, the cGMP regulations which apply to the manufacture, storage, packaging and supply of the Product.  Elan represents and warrants that the Product supplied to Acorda under this Agreement shall be free of defects in material and workmanship, shall not be adulterated or mis-branded as defined by the Act (or applicable foreign law) and shall not be a product which would violate any section of such Act if introduced in interstate commerce and shall be fit for use as a pharmaceutical product. Acorda agrees not to assert its right to rescind this Agreement in the event of a breach of the representations of Elan contained in this Clause 13.2.
 
13.3.                              Elan shall indemnify, defend and hold harmless Acorda and its officers, directors, employees and agents from all actions, losses, claims, demands, damages, costs and liabilities (including reasonable attorneys’ fees) due to Third Party claims to which Acorda is or may become subject insofar as they arise out of or are alleged or claimed to arise out of (i) any breach by Elan of any of its obligations under this Agreement, (ii) any breach of a representation or warranty of Elan made in this Agreement, (iii) any failure of
 
21

 
the Product provided under this Agreement to meet the Specifications, or (iv) the manufacture or shipment of the Product provided under this Agreement by Elan, except in each case to the extent due to the negligence or wilful misconduct of Acorda.
 
13.4.                              Acorda shall indemnify, defend and hold harmless Elan and its officers, directors, employees and agents from all actions, losses, claims, demands, damages, costs and liabilities (including reasonable attorneys’ fees) due to Third Party claims to which Elan is or may become subject insofar as they arise out of or are alleged or claimed to arise out of (i) any breach by Acorda of any of its obligations under this Agreement, (ii) any breach of any representation or warranty of Acorda made in this Agreement, (iii) damages for personal injury (including death) and/or for costs of medical treatment, caused by or attributed to the Product, or (iv) the acts or omissions of any sub-licensee appointed pursuant to the Licence Agreement, except in each case to the extent due to the negligence or wilful misconduct of Elan or to the relative extent that Elan is obliged to indemnify Acorda pursuant to Clause 13.3.
 
13.5.                              The party seeking an indemnity shall:
 
13.5.1                        fully and promptly notify the other party of any claim or proceedings, or threatened claim or proceedings;
 
13.5.2                        permit the indemnifying party to take full control of such claim or proceedings, with counsel of the indemnifying party’s choice, provided that the indemnifying party shall reasonably and regularly consult with the indemnified party in relation to the progress and status of such claim or proceedings;
 
13.5.3                        co-operate in the investigation and defence of such claim or proceedings; and
 
13.5.4                        take all reasonable steps to mitigate any loss or liability in respect of any such claim or proceedings.
 
The indemnifying party may settle a Claim on terms which provide only for monetary relief and do not include any admission of liability.  Save as aforesaid, neither the indemnifying party nor the party to be indemnified shall acknowledge the validity of, compromise or otherwise settle any Claim or proceedings without the prior written consent of the other, which shall not be unreasonably withheld.
 
13.6.                              TO THE FULLEST EXTENT PERMITTED BY LAW, APART FROM THE FOREGOING REPRESENTATIONS, WARRANTIES, COVENANTS AND INDEMNITIES, AND THOSE SET FORTH IN THE LICENSE AGREEMENT ELAN MAKES NO ADDITIONAL REPRESENTATIONS OR WARRANTIES AND HEREBY DISCLAIMS ALL WARRANTIES, REPRESENTATIONS, AND LIABILITIES, WHETHER EXPRESS OR IMPLIED, ARISING FROM CONTRACT OR TORT (EXCEPT FRAUD), IMPOSED BY STATUTE OR OTHERWISE, RELATING TO THE PRODUCTS AND/OR ANY PATENTS OR TECHNOLOGY USED OR INCLUDED IN THE PRODUCTS, INCLUDING ANY WARRANTIES AS
 
22

 
TO MERCHANTABILITY, FITNESS FOR PURPOSE, CORRESPONDENCE WITH DESCRIPTION, OR NON-INFRINGEMENT.
 
13.7.                              NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ELAN AND ACORDA SHALL NOT BE LIABLE TO THE OTHER BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, SPECIAL OR INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF CURRENT OR FUTURE PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR OTHERWISE.
 
13.8.                              Elan and Acorda shall each maintain comprehensive general liability insurance, insuring against all liability, including product liability, personal injury, physical injury and property damage in respective  amounts deemed reasonable in the industry for companies of their respective size and engaged in their respective activities under this Agreement for the duration of this Agreement and for a period of 5 years thereafter.
 
Each party shall provide the other party with a certificate from the insurance company verifying the above and shall notify the other party in writing at least 30 days prior to the expiration or termination of such coverage.

CLAUSE 14            MISCELLANEOUS PROVISIONS
 
14.1.                              Secrecy and Confidentiality .  Article 12.1 of the License Agreement is hereby incorporated by reference herein as if stated herein in its entirety.
 
14.2.                              Licence to Elan :
 
Acorda hereby grants to Elan and Elan hereby accepts for the Term a non-exclusive royalty-free license to use such Acorda Patent Rights and Acorda Know-How as are necessary or useful for the purpose of manufacturing the Product.  Such rights shall be sub-licensable by Elan to its Affiliates and sub-contractors, for the sole purpose of manufacturing the Product in accordance with this Agreement.
 
14.3.                              Assignment :
 
14.3.1                        Subject to the provisions of this Clause 14.3, each party be entitled without the consent of the other:
 
14.3.1.1               to subcontract or delegate the whole or any part of its duties hereunder to its Affiliate(s) (but shall remain responsible for its obligations under this Agreement); and/or
 
23

 
14.3.1.2                      to assign this Agreement to its Affiliate, provided that such assignment has no material adverse tax implications for the other Party or Parties hereto, and provided further that the assigning Party shall remain liable and responsible with such assignee to the other Party for the performance of any obligations, representations or warranties delegated, contracted, assigned or otherwise transferred to any such assignee.
 
14.3.2                        In the event that Elan agrees to sell all or substantially all of the assets of Elan’s Facility, Elan shall so notify Acorda.  In such event, Elan may (a) terminate this Agreement by ninety (90) days’ written notice to Acorda; or (b) assign all (but not, subject to the following sentences, a portion) of its rights and obligations under this Agreement to a Permitted Elan Assignee, provided that such transfer or assignment has no adverse tax implications for Acorda.
 
14.3.3                        Each Party may assign all (but not a portion) of its rights and obligations under this Agreement to an entity that acquires all or substantially all of its business or assets to which this Agreement pertains, whether by merger, reorganisation, acquisition, sale or otherwise, provided, that in the case of an assignment by Elan, the assignee is a Permitted Elan Assignee.
 
14.3.4                        Except as provided for in this Clause 14.3, this Agreement may not be assigned by a party without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed.
 
14.3.5                        Any permitted assignee of a Party under this Clause 14.3 shall assume all related obligations of its assignor under this Agreement.
 
14.4.                              Parties bound :
 
This Agreement shall be binding upon and enure for the benefit of parties hereto, their successors and permitted assigns.
 
14.5.                              Severability :
 
If any provision in this Agreement is deemed to be, or becomes invalid, illegal, void or unenforceable under applicable laws:
 
14.5.1                        such provision will be deemed amended to conform to applicable laws so as to be valid and enforceable; or
 
14.5.2                        if it cannot be so amended without materially altering the intention of the parties, it will be deleted the validity, legality and enforceability of the remaining provisions of this Agreement shall not be impaired or affected in any way.
 
24

 
14.6.             Force Majeure :
 
14.6.1                        Neither party to this Agreement shall be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure results from Force Majeure.
 
14.6.2                        If Force Majeure prevents or delays the performance by a party of any obligation under this Agreement, then the party claiming Force Majeure shall promptly notify the other party thereof in writing.  The parties shall thereafter as soon as practicable discuss how best to continue their operations in accordance with this Agreement and shall thereafter continue such discussions on a regular basis while Force Majeure continues.
 
14.6.3                        Where a party claims Force Majeure, the other party’s obligations under this Agreement shall be suspended for the period while Force Majeure continues, but only to the extent reasonably required by the Force Majeure.
 
14.6.4                        The party claiming Force Majeure shall use all reasonable efforts to avoid, minimise or remove the cause of such non-performance and to mitigate its effects and shall continue performance with due dispatch whenever such causes are removed.
 
14.6.5                        Where Force Majeure continues for a period of six (6) months the other party shall have the right to terminate this Agreement, provided that it has complied with its obligations under this Clause 14.6.
 
14.7.                              Relationship of the parties :
 
14.7.1                        Nothing contained in this Agreement is intended or is to be construed to constitute any of the parties hereto as partners or members of a joint venture or any party as an employee of another party.
 
14.7.2                        No party hereto shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of any other party or to bind another party to any contract, agreement or undertaking with any third party.
 
14.8.                              Amendments :
 
No amendment, modification or addition hereto shall be effective or binding on any party hereto unless set forth in writing and executed by a duly authorised representative of all parties hereto.
 
14.9.                              Waiver :
 
No waiver of any right under this Agreement shall be deemed effective unless contained in a written document signed by the party charged with such waiver, and no waiver of any breach or failure to perform shall be deemed to be a waiver of any future breach or failure to perform or of any other right arising under this Agreement.
 
25

 
14.10.                   Entire Agreement :
 
14.10.1                  Each of the parties hereto hereby acknowledges that in entering into this Agreement it has not relied on any representation or warranty except as expressly set forth herein or in the License Agreement or in any other document referred to herein.
 
14.10.2                  This Agreement and the Licence Agreement, together with the exhibits and schedules hereto and thereto, together set forth all of the agreements and understandings between the parties with respect to the subject matter hereof, and supersede and terminate all prior agreements and understandings between the parties with respect to the subject matter hereof, including the SCI Agreement and the MS Agreement.
 
14.10.3                  Nothing in this Clause 14.10 shall exclude any liability which any party would otherwise have to the other party or any right which either of them may have to rescind this Agreement for fraud.
 
14.11.                        Governing law and jurisdiction :
 
14.11.1                  This Agreement shall be governed by and construed in accordance with the laws of the State of New York , excluding its conflict of laws rules.
 
14.11.2                  Article 12.14 of the License Agreement is hereby incorporated by reference herein as if stated herein in its entirety.
 
14.12.                        Notices :
 
14.12.1                  Any notice to be given under this Agreement shall be sent in writing in English by registered or recorded delivery post, reputable overnight courier or fax to:

Elan at	
 	
c/o Elan Pharma Ltd.	
Monksland	
Athlone	
Co. Westmeath	
Ireland	
Attention:	General Manager	
Fax:	+353 906 492427	
 	
Acorda at	
 	
15 Skyline Drive	
Hawthorne, New York 10532	
United States of America	
Attention:	President	
Fax:	914.347.4560	
 
26

 
or to such other address(es) and fax numbers as may from time to time be notified by either party to the other hereunder.
 
14.12.2                  Any notice sent by mail shall be deemed to have been delivered within 7 working days after despatch or delivery to the relevant courier and any notice sent by fax shall be deemed to have been delivered upon confirmation of receipt.  Notice of change of address shall be effective upon receipt.
 
14.13.                        Further assurances :
 
At the request of any of the parties, the other party or parties shall (and shall use reasonable efforts to procure that any other necessary third parties shall) execute and do all such documents, acts and things as may reasonably be required subsequent to the signing of this Agreement for assuring to or vesting in the requesting party the full benefit of the terms hereof.
 
14.14.                        Counterparts :
 
This Agreement may be executed in any number of counterparts, each of which when so executed shall be deemed to be an original and all of which when taken together shall constitute this Agreement.
 
14.15.                        Set-off :
 
Each of the parties will be entitled but not obliged to set-off against any amount of money payable to it by the other party hereunder, any amount of money payable by it to the other party hereunder.
 
IN WITNESS WHEREOF the parties have executed this Agreement on the day and date appearing at the top of page 1.
 
27

 
SCHEDULE 1   MANUFACTURING COST
 
“Manufacturing Cost” shall mean fully absorbed cost of manufacture (including packaging) which shall be determined on the basis of the following elements:
 
(a)                         Direct material, labour and overhead cost; and
 
(b)                        Such indirect labour, factory, laboratory and other overhead costs properly allocable.  Overhead allocations shall include, but not be limited to, expenses of plant maintenance and engineering, plant management, receiving and warehousing, disposal and treatment of waste, building occupancy, quality control, costs of services provided to manufacturing and insurance provided to manufacturing.
 
Such allocations shall be in a manner consistent with GAAP from time to time and in a manner consistent with expenses and overhead allocated to other products manufactured by Elan or its Affiliates.
 
Where some part(s) of the manufacture or packaging is/are conducted by unaffiliated third party(ies), Manufacturing Cost shall be the amount paid to such third party(ies) plus any of the aforementioned costs incurred by Elan or its Affiliates in completing the manufacture, packaging or delivery of the Product.
 
28

 

SIGNED	 	

 	 	
for and on behalf of	 	
ELAN CORPORATION, PLC.	 	
 	 	
Name:	 	 	 	
Title:	 	 	 	

SIGNED	 	

 	 	
for and on behalf of	 	
ACORDA THERAPEUTICS, INC.	 	
 	 	
Name:	 	 	 	
Title:	 	 	 	

29

 
Exhibit 10.10

 
LICENSE AGREEMENT
 
by and between
 
RUSH-PRESBYTERIAN-ST. LUKE’S MEDICAL CENTER
 
and
 
ACORDA THERAPEUTICS, INC.
 
1

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.
Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
 
THIS LICENSE AGREEMENT effective as of September 26, 2003 (“Effective Date”), by and between RUSH-PRESBYTERIAN-ST. LUKE’S MEDICAL CENTER, an Illinois not-for-profit corporation and having its principal office at 1725 W. Harrison St. Chicago, Ill. 60612 (“RUSH”) and ACORDA THERAPEUTICS, INC. , a corporation organized and existing under the laws of the State of Delaware and having its principal office at 15 Skyline Drive, Hawthorne, New York 10532 (“ACORDA”).
 
W I T N E S S E T H:
 
WHEREAS, RUSH has conducted investigations of the compound known as 4-aminopyridine for treatment of the symptoms of multiple sclerosis and has accordingly developed know-how in relation thereto;
 
WHEREAS, RUSH has received a notice of designation (the “Rush Orphan Designation”) from the FDA stating that the Licensed Product (as defined herein) “qualifies for orphan designation for the relief of symptoms of multiple sclerosis;”
 
WHEREAS, RUSH’s right and title to the Rush Orphan Designation for the Licensed Product has been assigned to ACORDA and RUSH has consented to such assignment;
 
WHEREAS, RUSH has the right to grant licenses in respect of the RUSH Know-How (as defined herein) and has granted no licenses thereto except (i) the option agreement, dated September 7, 1990 (the “Option Agreement”), between RUSH and Elan Pharmaceutical Research Corp. (“EPRC”), a predecessor corporation of Elan Drug Delivery Inc., a wholly-owned subsidiary of Elan Corporation plc (“ELAN”) and (ii) the license agreement dated November 13, 1990 (the “Rush/Elan License”), between RUSH and EPRC, (the Option Agreement and the Rush/Elan License being collectively referred to herein as the “Rush/Elan Agreements”);
 
WHEREAS, pursuant to the Side Agreement, as defined below, RUSH and ELAN and EPRC have, among other things terminated the Rush/Elan Agreements as of the Effective Date;
 
WHEREAS, ACORDA desires to obtain exclusive license rights, with a right to grant sublicenses, under and to the RUSH Know-How (as defined herein), and RUSH desires to grant such license to ACORDA, upon the terms and conditions set forth herein; and
 
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties hereby agree as follows:
 
2

 
ARTICLE I
DEFINITIONS
 
Unless specifically set forth to the contrary herein, the following terms, where used in the singular or plural, shall have the respective meanings set forth below:
 
1.1.                               “ Act ” shall mean the Federal Food Drug and Cosmetic Act of 1934, and the rules and regulations promulgated thereunder, or any successor act, as the same shall be in effect from time to time.
 
1.2.                               “ Affiliate ” shall mean (i) any corporation or business entity of which more than fifty percent (50%) of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by a Party; (ii) any corporation or business entity which, directly or indirectly, owns, controls or holds more than fifty percent (50%) (or the maximum ownership interest permitted by law) of the securities or other ownership interests representing the equity, voting stock or general partnership interest of a Party or (iii) any corporation or business entity of which a Party has the right to acquire, directly or indirectly, at least fifty percent (50%) of the securities or other ownership interests representing the equity, voting stock or general partnership interest thereof.
 
1.3.                               “ Base Royalty Term ” shall mean, in any country in the Territory, the period beginning with the date of the First Commercial Sale in such country and continuing until the earlier of (i) expiration of the last to expire Elan Patent in such country; or (ii) ten (10) years from the date of First Commercial Sale in such country; provided however, that, in the event that ACORDA receives Regulatory Approval in the United States for Licensed Product with an Orphan Designation for the treatment of multiple sclerosis, then the Base Royalty Term in the United States shall not be less than seven years from the date of First Commercial Sale in the United States.  In the event that RUSH’s further development of the RUSH Know-How results in the issuance to RUSH of a patent in any country or additional Orphan Drug Designation following the effective date of this Agreement that provides for a greater period of market exclusivity of the Product in such country, the Base Royalty Term in such country will continue for that period of market exclusivity provided by such patent or Orphan Drug Designation.
 
1.4.                               “ Business Day(s) ” shall mean any day that is not a Saturday or a Sunday or a day on which the New York Stock Exchange is closed.
 
1.5.                               “ Calendar Quarter ” shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
 
1.6.                               “ Calendar Year ” shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31.
 
1.7.                               “ Compound ” shall mean the chemical compound known as  4-aminopyridine, as diagrammed on Schedule 1.7 hereto.
 
1.8.                               “ CFR ” shall mean the United States Code of Federal Regulations.
 
1.9.                               “ Effective Date ” shall mean the date first above written.
 
3

 
1.10.                         “ Elan/Acorda License ” shall mean the Amended and Restated License Agreement effective as the Effective Date        by and between ACORDA and ELAN.
 
1.11.                         “ Elan Patent ” shall mean any patent included in the Elan Patent Rights as set forth on Schedule 1.11 hereto
 
1.12.                         “ End of Phase 2 Meeting ” shall mean the first end of Phase 2 meeting with the FDA, as defined in 21 CFR Section 312.47, intended to determine the safety of proceeding to a  Phase 3 Clinical Trial, evaluate the Phase 3 plan and protocols and identify any additional information necessary to support the NDA.
 
1.13.                         “ FDA ” shall mean the United States Food and Drug Administration and any successor agency having substantially the same functions.
 
1.14.                         “ First Commercial Sale ” shall mean the first commercial sale of Product by ACORDA, its Affiliate or its sublicensees in a country, for end use or consumption, after all required Regulatory Approvals have been granted by the governing health authority of such country. Sales for test marketing, clinical trial purposes, research and development, or compassionate or similar use where Acorda does not receive revenue from the sale other than cost recovery, shall not be deemed to constitute a commercial sale.
 
1.15.                         “ GAAP ” shall mean generally accepted accounting principles in the United States, consistently applied.
 
1.16.                         “ Improvement ” shall mean any and all improvements and enhancements, patentable or otherwise, related to the Compound or Product including, without limitation, in the manufacture, formulation, ingredients, preparation, presentation, means of delivery or administration, dosage, indication, use or packaging of Compound or Product.
 
1.17.                         “ Licensed Product ” shall mean any Product that utilizes or exploits the RUSH Know-How in the treatment of multiple sclerosis.
 
1.18.                         “ NDA ” shall mean a new drug application as defined in the Act and applicable regulations promulgated thereunder that is filed with the FDA to obtain Regulatory Approval of Licensed Product in the United States.
 
1.19.                         “ Neurological Indications ” shall mean indications concerning disorders and conditions of the neuromuscular system, central, peripheral and autonomic nervous systems, the neuromuscular junction and/or muscle.  Such indications shall include, but not be limited to, multiple sclerosis and spinal cord injury.
 
1.20.                         “ Net Sales ” shall mean the gross amount invoiced for commercial sales of Product in the Territory by ACORDA or its Affiliates to Third Parties commencing upon the date of First Commercial Sale in any country in the Territory, after deducting the following:
 
(i)                                      trade, cash and quantity discounts;
 
4

 
(ii)                                   credits and allowances on account of returned or rejected Product, including allowance for breakage or spoilage, recalls or Product destruction (whether voluntarily made or requested or made by a Regulatory Authority)
 
(iii)                                chargebacks, rebates or similar payments granted to customers, including, but not limited to, managed health care organizations, wholesalers, distributors, buying groups, retailers, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations or other institutions or health care organizations or to federal, state/provincial, local and other governments, their agencies and purchasers and reimbursers;
 
(iv)                               sales or excise taxes, VAT or other taxes, and transportation, freight, postage, shipping and insurance charges and additional special transportation, custom duties, and other governmental charges;
 
(v)                                  retroactive price reductions; and
 
(vi)                               write-offs or allowances for bad debts, to the extent permitted by GAAP.
 
Sales or other transfers between ACORDA and its Affiliates shall be excluded from the computation of Net Sales and no payments will be payable on such sales or transfers except where such Affiliates are end users, but Net Sales shall include the subsequent sales to Third Parties by such Affiliates.
 
1.21.                         “ Orphan Designation ” shall mean the designation of a drug as a drug for a rare disease or condition pursuant to Section 526 of the Act.
 
1.22.                         “ Party ” shall mean RUSH or ACORDA.
 
1.23.                         “ Phase 3 Clinical Trial ” shall mean a clinical trial in patients with multiple sclerosis conducted after an End of Phase 2 Meeting and conducted on a sufficient number of patients that is designed to establish that Licensed Product is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with Licensed Product in the dosage range to be prescribed, and supporting  Regulatory Approval of Licensed Product in the treatment of multiple sclerosis.
 
1.24.                         “ Product ” shall mean any finished pharmaceutical formulation for prescription use for the treatment of any human Neurological Indications which contains Compound as the therapeutically active ingredient.
 
1.25.                         “ Proprietary Information ” shall mean any and all scientific, clinical, regulatory, marketing, financial and commercial information or data, whether communicated in writing, orally or by any other means, which is owned and under the protection of one
 
5

 
Party and is being provided by that Party to the other Party in connection with this Agreement.
 
1.26.                         “ Reduced Royalty Term ” shall mean, in any country in the Territory, the period of time beginning with the date following the expiration of the Base Royalty Term in such country and continuing until the fifteenth anniversary of the Effective Date.
 
1.27.                         “ Regulatory Authority ” shall mean the FDA in the U.S., the EMEA or any agency in the European Union and any health regulatory authority(ies) in any country(ies) in the Territory that holds responsibility for granting Regulatory Approval for a Product in such country(ies), and any successor(s) agency thereto having substantially the same functions.
 
1.28.                         “ Regulatory Approval” shall mean all approvals (including pricing and reimbursement approvals required for marketing authorization), product and/or establishment licenses, registrations or authorizations of all regional, federal, state or local regulatory agencies, departments, bureaus or other governmental entities, necessary for the manufacture, use, storage, import, export, transport and sale of Product in a regulatory jurisdiction.
 
1.29.                         “ Royalty Year ” shall mean, (i) for the year in which the First Commercial Sale occurs (the “First Royalty Year”), the period commencing with the first day of the Calendar Quarter in which the First Commercial Sale occurs and expiring on the last day of the Calendar Year in which the First Commercial Sale occurs; and (ii) for each subsequent year commencing after the end of the First Royalty Year, each successive Calendar Year.
 
1.30.                         “ RUSH Know-How ” shall mean all information and materials, including but not limited to, discoveries, information, Improvements, processes, formulas, data, inventions, know-how and trade secrets, patentable or otherwise, which as of the Effective Date or at any time during the term of this Agreement:
 
(a)                                   relate to Compound or Product; and
 
(b)                                  were developed by or on behalf of RUSH, are owned by RUSH or are in RUSH’s possession or control.
 
Such know-how shall include, without limitation, all chemical, pharmaceutical, toxicological, preclinical, clinical, assay control, regulatory submissions, designations  and approvals, and any other information used or useful for the development, manufacturing and/or regulatory approval of Compound or Product, including such rights which RUSH may have to information developed by Third Parties.
 
1.31.                         “ Side Agreement ” shall mean the Side Agreement by and among RUSH, ACORDA and ELAN executed as of the Effective Date, a copy of which is attached hereto as Exhibit 1.31 .
 
1.32.                         “ Territory ” shall mean all of the countries in the world.
 
1.33.                         “ Third Party(ies) ” shall mean a person or entity who or which is neither a Party nor an Affiliate of a Party.
 
6

 
ARTICLE II
LICENSE; SUBLICENSES
 
2.1.                               License Grant .  RUSH hereby grants to ACORDA an exclusive (even as to RUSH) license, including the right to grant sublicenses, under the RUSH Know-How, to develop, make, have made, use, import, offer for sale, market, commercialize, distribute and sell and otherwise dispose of Product in the Territory and to use and practice the RUSH Know-How.  Notwithstanding the foregoing grant, Rush is expressly permitted to use its 4-AP know how for internal development and research efforts; provided, however, that (i) such use is for non-commercial academic purposes only, and (ii) that RUSH shall promptly notify ACORDA of any intellectual property, discovery or invention, once conceived and/or reduced to practice by RUSH in the course of conducting or performing such non-commercial activity, which shall be deemed RUSH Know-How for purposes of this Agreement.
 
2.2.                               Improvements by ACORDA .  All rights and title to and interest in any Improvement developed or discovered by ACORDA in connection with the license granted under Section 2.1 above or ACORDA’s activities hereunder shall be vested solely in ACORDA.  Notwithstanding the provisions of 2.2, Acorda will continue to have royalty obligations set forth in Article V, to the extent applicable, with respect to any Product that contains an Improvement and which includes the Compound as the primary therapeutically active ingredient.
 
2.3.                               Sublicenses.   ACORDA shall have the right to grant sublicenses of the licenses granted to it under Section 2.1 of this Agreement to Affiliates or any Third Party. ACORDA shall provide written notice to RUSH of any such sublicenses.
 
ARTICLE III
DEVELOPMENT AND COMMERCIALIZATION
 
3.1.                               Exchange of Information .  Following execution of this Agreement, RUSH shall utilize good faith reasonable efforts to disclose to ACORDA in English and in writing, all Rush Know-How not previously available or made available to ACORDA, in electronic format, where available, and hard copies (or, upon ACORDA’s request, originals), with the intention to make such information available to ACORDA as soon as reasonably practicable  Throughout the term of this Agreement, and in addition to the other communications required under this Agreement, RUSH shall also promptly disclose to ACORDA in English and in writing on an ongoing basis all Rush Know-How, and any and all additions or revisions thereto.  To the extent not previously assigned to ACORDA, RUSH hereby conveys, assigns and transfers to ACORDA, free and clear of all claims, liens and encumbrances and contractually imposed restrictions, all right, title and interest in and to the Rush Orphan Designation.  RUSH shall assist and cooperate with ACORDA in the submission of any letters or other documents to the FDA required or requested in connection with the change in ownership of the Rush Orphan Designation from RUSH to ACORDA. RUSH shall notify ACORDA promptly of any request for, or
 
7

 
any expression of interest in using, Compound for research or any other purpose and shall refer any such requests or expressions of interest directly to ACORDA. RUSH shall also promptly notify ACORDA of any intellectual property, discovery or invention, once conceived and/or reduced to practice by RUSH or any employee or agent of RUSH, in the course of conducting or performing any activity relating to Compound or Product.
 
3.2.                               Development and Commercialization .  ACORDA shall use commercially reasonable efforts to develop and commercialize Licensed Product. As used herein, “commercially reasonable efforts” shall mean efforts and resources normally used by ACORDA for a product owned by it or to which it has exclusive rights, which is of similar market potential at a similar stage in its development or product life, taking into account issues of safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory and reimbursement structure involved, the profitability of the applicable products, and other relevant factors.  ACORDA shall provide RUSH with an annual written report summarizing the status of ACORDA’S clinical development and regulatory activities with respect to Licensed Product, with the delivery to RUSH of the summary of the annual report to an IND submitted by ACORDA to the FDA in connection with the periodic reporting requirements of the IND to be in satisfaction of the foregoing requirement.  The obligations set forth in this Section 3.2 are expressly conditioned upon the absence of any serious adverse conditions or event relating to the safety or efficacy of Compound or Product including the absence of any action by any regulatory authority limiting the development or commercialization of Compound or Product.
 
3.3.                               Regulatory Matters .
 
(a)                                   ACORDA shall own, control and retain primary legal responsibility for the preparation, filing and prosecution of all filings and regulatory applications required to obtain Regulatory Approvals.  ACORDA shall notify RUSH upon the receipt of Regulatory Approvals and of the date of First Commercial Sale.
 
(b)                                  Upon ACORDA’S request, RUSH shall consult and cooperate with ACORDA in connection with obtaining Regulatory Approval of Product.
 
3.4.                               Trademark. ACORDA shall select, own and maintain trademarks for Product in the Territory.
 
ARTICLE IV
CONFIDENTIALITY AND PUBLICITY
 
4.1.                               Non-Disclosure and Non-Use Obligations .  All Proprietary Information disclosed by one Party to the other Party hereunder shall be maintained in confidence and shall not be disclosed to any Third Party or used for any purpose except as expressly permitted herein without the prior written consent of the Party that disclosed the Proprietary Information to the other Party during the term of this Agreement.  The foregoing non-disclosure and non-use obligations shall not apply to the extent that such Proprietary Information:
 
8

 
(a)                                   is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by business records;
 
(b)                                  is or becomes properly in the public domain or knowledge;
 
(c)                                   is subsequently disclosed to a receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or
 
(d)                                  is developed by the receiving Party independently of Proprietary Information received from the other Party, as documented by research and development records.
 
4.2.                               Permitted Disclosure of Proprietary Information .  Notwithstanding Section 4.1, a Party receiving Proprietary Information of another Party may disclose such Proprietary Information:
 
(a)                                   by ACORDA to governmental or other regulatory agencies in order to obtain patents or to gain approval to conduct clinical trials or to market Product;
 
(b)                                  by ACORDA or its agents, consultants, Affiliates, sublicensees and/or other Third Parties for the research and development, manufacturing and/or marketing of the Compound and/or Product (or for such parties to determine their interests in performing such activities) on the condition that such Third Parties agree to be bound by the confidentiality obligations consistent with this Agreement; or
 
(c)                                   if required to be disclosed by law or court order, provided that notice is promptly delivered to the non-disclosing Party in order to provide an opportunity to challenge or limit the disclosure obligations; provided, however, without limiting any of the foregoing, it is understood that ACORDA or its Affiliates may make disclosure of this Agreement and the terms hereof in any filings required by the Securities and Exchange Commission (“SEC”) or any other governmental agency, may file this Agreement as an exhibit to any filing with the SEC or such agency and may distribute any such filing in the ordinary course of its business.
 
4.3.                               Publication                                     Neither RUSH nor any Affiliate or employee of or consultant to RUSH shall make any publication relating to Compound or Product without the prior consent of ACORDA. If RUSH proposes to submit for written or oral publication any manuscript, abstract or the like relating to Compound or Product, it shall first deliver the proposed publication to ACORDA at least thirty (30) Business Days prior to planned submission. At the request of ACORDA, the submission of such publication may be delayed for up to fourteen (14) days in addition to the said thirty Business Days, including for issues of patent protection or other matters relating to the development of Compound or Product. If ACORDA requests modifications to the publication, RUSH shall edit such publication as
 
9

 
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.
Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
 
reasonably necessary to prevent disclosure of trade secret or proprietary business information prior to submission of the publication or presentation.
 
ARTICLE V
PAYMENTS; ROYALTIES AND REPORTS
 
5.1.                               Up-front License Fee . In consideration of the rights granted by RUSH hereunder, ACORDA shall pay RUSH an up-front license fee of $[* *] within five (5) Business Days after the Effective Date.
 
5.2.                               Milestone Payments . In further consideration of the rights granted by RUSH hereunder, ACORDA or its designees shall pay RUSH the following milestone payments, contingent upon occurrence of the specified event, with each milestone payment to be made no more than once with respect to the achievement of such milestone (but payable the first time such milestone is achieved) for Licensed Product:
 
(a)                                   US $[* *] upon the commencement (first dosing of the first patient) of the first Phase 3 Clinical Trial;
 
(b)                                  US $[* *] upon the completion of the first Phase 3 Clinical Trial;
 
(c)                                   US $[* *] upon the FDA’s acceptance for filing of the NDA; and
 
(d)                                  US $[* *] upon receipt of first written Regulatory Approval of the NDA for marketing in the United States by the FDA.
 
ACORDA shall notify RUSH in writing within thirty (30) Business Days after the achievement of each milestone and such notice shall be accompanied by the appropriate milestone payment. The milestone payments described in this Section 5.2 shall be payable only upon the initial achievement of each milestone, and no amounts shall be due hereunder for any subsequent or repeated achievement of such milestones, regardless of the number of Licensed Products for which such milestone may be achieved.
 
5.3.                               Royalties and Other Payments.
 
5.3.1.                      Royalties
 
(a)                                   Subject to the terms and conditions of this Agreement, and in further consideration of the rights granted by RUSH hereunder, ACORDA or its designees shall pay to RUSH royalties during the Base Royalty Term in an amount equal to (i) [* *] of Net Sales in each Royalty Year in the United States; and (ii) [* *] of Net Sales in each Royalty Year in each country in the Territory other than the United States. Royalties on Net Sales at the rates set forth in this Section 5.3.1(a) shall accrue as of the date of First Commercial Sale of Product in the applicable country and shall continue and accrue on Net Sales on a country-by-country basis until the expiration of the Base Royalty Term in such country. Thereafter, ACORDA shall be relieved of any royalty payment under this Section 5.3.1(a).
 
10

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.
Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
 
(b)                                  Subject to the terms and conditions of this Agreement, and in further consideration of the rights granted by RUSH hereunder, ACORDA or its designees shall pay to RUSH royalties during the Reduced Royalty Term in an amount equal to (i) [* *]  of Net Sales in each Royalty Year in the United States; and (ii) [* *] of Net Sales in each Royalty Year in each country in the Territory other than the United States.  Royalties on Net Sales at the rates set forth in this Section 5.3.1(b) shall accrue as of the commencement of the Reduced Royalty Term in the applicable country and shall continue and accrue on Net Sales on a country-by-country basis until the expiration of the Reduced Royalty Term in such country. Thereafter, ACORDA shall be relieved of any royalty payment under this Agreement.
 
(c)                                   The payment of royalties set forth above shall be subject to the following conditions:
 
(A)                               only one payment shall be due with respect to the same unit of Product;
 
(B)                                 no royalties shall accrue on the disposition of Product by ACORDA, Affiliates or sublicensees as samples (promotion or otherwise) or as donations (for example, to non-profit institutions or government agencies) or to clinical trials or for research and and/or development or for compassionate or similar use where ACORDA does not receive revenue other than cost recovery; and
 
(C)                                 RUSH shall be responsible for payment of any royalties or other obligations owed by RUSH to any Third Party.
 
5.3.2.                      Affiliate and Sublicensee Sales .  In the event that ACORDA transfers Compound or Product to one of its Affiliates or sublicensees, there shall be no royalty due at the time of transfer.  Subsequent sales of Product by the Affiliates or sublicensees to Third Parties such as patients, hospitals, medical institutions, health plans or funds, wholesalers (which are not sublicensees), pharmacies or other retailers, shall be reported as Net Sales hereunder. 
 
5.3.3.                      Third Party Licenses .  If one or more licenses from a Third Party or Third Parties are obtained by ACORDA in order to develop, make, have made, use, sell or import Compound or Product in a particular country, [* *]  of any royalties or other payments paid under such Third Party patent licenses by ACORDA in such country for such Calendar Quarter shall be creditable against the royalty or other payments payable to RUSH by ACORDA in such country; provided, however, that the amount credited in any Calendar Quarter shall not exceed [* *]  of the royalties that would have otherwise been payable to RUSH for such Calendar Quarter.
 
5.3.4.                      Combination Product .  Notwithstanding the provisions of Section 5.3.1, in the event a Product is sold as a combination product with other biologically active components, Net Sales, for purposes of royalty payments on the combination product, shall be calculated by multiplying the Net Sales of that combination product by the
 
11

 
fraction A/B, where A is the gross selling price of the Product sold separately and B is the gross selling price of the combination product.  If no such separate sales are made, Net Sales for royalty determination shall be calculated by multiplying Net Sales of the combination product by the fraction C/(C+D), where C (excluding the fully allocated cost of the other biologically active component in question) is the fully allocated cost of the Compound and D is the fully allocated cost of such other biologically active components.
 
5.4.                               Reports; Payment of Royalty .  During the term of the Agreement for so long as royalty payments are due, ACORDA shall furnish to RUSH a written report for each Calendar Quarter showing the Net Sales of all Products subject to royalty payments during the reporting period and the calculation of the royalties payable to RUSH under this Agreement, including deductions from Net Sales.  Reports shall be due on the forty-fifth (45 th ) day following the close of each Calendar Quarter.  Royalties shown to have accrued by each royalty report, if any, shall be due and payable on the date such report is due.  ACORDA shall keep complete and accurate records in sufficient detail to enable the royalties hereunder to be determined.  ACORDA shall retain such records for twenty-four (24) months after submission of the corresponding report.
 
5.5.                               Audits . Upon the written request of RUSH and not more than once during the twelve (12) month period next following the expiration of each Royalty Year during the term of the Agreement, ACORDA shall, at RUSH’s expense, permit an independent certified public accounting firm selected by RUSH and reasonably acceptable to ACORDA to have access during normal business hours, upon thirty (30) days prior notice to ACORDA, to such of the records of ACORDA as may be reasonably necessary to verify the accuracy of the royalty reports hereunder for any Royalty Year ending not more than twenty-four (24) months prior to the date of such request.  The accounting firm shall provide a written report as soon as practicable, which shall disclose only whether the royalty reports are correct or incorrect and the specific details concerning any discrepancies.  This Section 5.5 shall survive the expiration or termination of this Agreement for a period of two years.
 
5.5.1.                      If such accounting firm concludes that additional royalties were owed during such period, ACORDA shall pay the additional royalties within sixty (60) days of the date RUSH delivers to ACORDA such accounting firm’s written report so concluding; provided however, that, in the event that ACORDA shall not be in agreement with the conclusion of such report (a) ACORDA shall not be required to pay such additional royalties and (b) such matter shall be resolved pursuant to the provisions of Section 9.6 herein.  In the event such accounting firm concludes that amounts were overpaid by ACORDA during such period, such over payment will be credited against future royalties; provided, however, that, in the event that RUSH shall not be in agreement with the conclusion of such report (x) such matter shall be resolved pursuant to the provisions of Section 9.6 herein and (y) in the event that the overpayment to RUSH exceeds royalties due and owing to Rush over the term of the agreement, RUSH shall reimburse ACORDA within 60 days for any remaining overpayment.  The fees charged by such accounting firm shall be paid by RUSH; provided, however, that if an error in favor of RUSH of more than five percent (5%) of the royalties due hereunder for the period being reviewed is discovered, then
 
12

 
ACORDA shall pay the reasonable fees and expenses charged by such accounting firm.
 
5.5.2.                      Upon the expiration of twenty-four (24) months following the end of any Royalty Year (subject to tolling of such period during the pendency of an audit relating to such period under Section 5.5.1 above) the calculation of royalties payable with respect to such year shall be binding and conclusive upon RUSH, and ACORDA shall be released from any liability or accountability with respect to royalties for such year.
 
5.5.3.                      RUSH shall treat all financial information subject to review under this Section 5.5 in accordance with the confidentiality provisions of this Agreement.
 
5.6.                               Payment Exchange Rate .  All payments to RUSH under this Agreement shall be made in United States dollars.  In the case of sales outside the United States, the rate of exchange to be used in computing Net Sales shall be calculated monthly in accordance with the conversion rates published in the Wall Street Journal, Eastern edition (if available).
 
5.7.                               Tax Withholding .  If laws, rules or regulations require withholding of income taxes or other taxes imposed upon payments set forth in this Article V, RUSH shall provide ACORDA, prior to any such payment, annually or more frequently if required, with all forms or documentation required by any applicable taxation laws, treaties or agreements to such withholding or as necessary to claim a benefit thereunder (including, but not limited to Form W-8BEN or any successor forms) and ACORDA shall make such withholding payments as required and subtract such withholding payments from the payments set forth in this Article V. ACORDA will use commercially reasonable efforts consistent with its usual business practices and cooperate with RUSH to ensure that any withholding taxes imposed are reduced as far as possible under the provisions of the current or any future taxation treaties or agreements between foreign countries.
 
5.8.                               Exchange Controls . Notwithstanding any other provision of this Agreement, if at any time legal restrictions prevent the prompt remittance of part or all of the royalties with respect to Net Sales in any country, payment shall be made through such lawful means or methods as ACORDA may determine.  When in any country the law or regulations prohibit both the transmittal and deposit of royalties on sales in such a country, royalty payments shall be suspended for as long as such prohibition is in effect (and such suspended payments shall not accrue interest), and promptly after such prohibition ceases to be in effect, all royalties or other payments that ACORDA or its Affiliates would have been obligated to transmit or deposit, but for the prohibition, shall be deposited or transmitted, as the case may be, to the extent allowable (with any interest earned on such suspended royalties which were placed in an interest-bearing bank account in that country, less any transactional costs).  If the royalty rate specified in this Agreement should exceed the permissible rate established in any country, the royalty rate for sales in such country shall be adjusted to the highest legally permissible or government-approved rate.
 
13

 
ARTICLE VI
REPRESENTATIONS AND WARRANTIES
 
6.1.                               RUSH Representations and Warranties .  RUSH represents and warrants to ACORDA that as of the Effective Date:
 
(a)                                   Each of this Agreement and the Side Agreement has been duly executed and delivered by RUSH and constitutes legal, valid, and binding obligations enforceable against RUSH in accordance with their respective terms;
 
(b)                                  no approval, authorization, consent, or other order or action of or filing with any court, administrative agency or other governmental authority is required for the execution and delivery by RUSH of this Agreement or the Side Agreement or the consummation by RUSH of the transactions contemplated hereby or thereby except such consents or filings as are contemplated by this Agreement;
 
(c)                                   RUSH has the full corporate power and authority to enter into and deliver this Agreement and the Side Agreement, to perform and to grant the licenses granted under Article II hereof and to consummate the transactions contemplated hereby and by the Side Agreement;  all corporate acts and other proceedings required to be taken to authorize such execution, delivery, and consummation have been duly and properly taken and obtained;
 
(d)                                  With the exception of the Rush/Elan Agreements, which have terminated in their entirety pursuant to the Side Agreement, RUSH has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Compound or Product or the RUSH Know-How or entered into any agreement with any Third Party which is in conflict with the rights granted to ACORDA pursuant to this Agreement;
 
(e)                                   RUSH is the sole and exclusive owner of the RUSH Know-How, all of which are free and clear of any security interests, liens, charges, encumbrances or restrictions on license, and no Third Party has any claim of ownership or other rights with respect to the RUSH Know-How, whatsoever, except that RUSH agrees and acknowledges that the Orphan Designation has been assigned to ACORDA;
 
(f)                                     RUSH has the sole and exclusive authority to grant the rights and licenses granted under Article II and, with the exception of the Rush/Elan Agreements, which have terminated in their entirety pursuant to the Side Agreement,  RUSH has not previously granted, and will not grant, or engage in any discussions to grant, during the term of this Agreement, any right, license or interest in and to the Compound or Product or the RUSH
 
14

 
Know-How, or any portion thereof, inconsistent with the license granted to ACORDA herein;
 
(g)                                  there are no claims, judgments or settlements against or owed by RUSH or pending or, to the best of its knowledge, threatened claims or litigation relating to the Compound or the Rush Know-How;
 
(h)                                  RUSH will use reasonable efforts to disclose to ACORDA all relevant information known by it regarding the Rush Know-How reasonably related to the activities contemplated under this Agreement to the extent such Rush know-how has not previously been disclosed;
 
(i)                                      in connection with development of the Rush Know-How, RUSH has complied in all material respects with applicable U.S. laws and regulations;
 
(j)                                      RUSH has not filed and is not the owner in any country in the Territory of any patents or patent applications or of any certificates of invention or applications for certificates of invention, relating to Compound or Product; and
 
(k)                                   With the exception of the Rush/Elan Agreements, which have terminated in their entirety pursuant to the Side Agreement, there are no contracts, agreements or any other arrangements between RUSH and any Third Party relating to the research, development or commercialization of the Compound or Product.
 
6.2.                               ACORDA Representations and Warranties .  ACORDA represents and warrants to RUSH that as of the Effective Date:
 
(a)                                   Each of this Agreement and the Side Agreement have been duly executed and delivered by it and constitutes legal, valid, and binding obligations enforceable against ACORDA in accordance with their respective terms;
 
(b)                                  it has full corporate power and authority to execute and deliver this Agreement and the Side Agreement and to consummate the transactions contemplated hereby and thereby.  All corporate acts and other proceedings required to be taken to authorize such execution, delivery, and consummation have been duly and properly taken and obtained;
 
(c)                                   no approval, authorization, consent, or other order or action of or filing with any court, administrative agency or other governmental authority is required for the execution and delivery by it of this Agreement or the Side Agreement or the consummation by it of the transactions contemplated hereby or thereby.
 
15

 
ARTICLE VII
 
7.1.                               Indemnification .  ACORDA shall defend, indemnify and hold harmless RUSH from and against any and all loss, cost and liability, including RUSH’s reasonable attorneys fees and costs (“Losses”), arising in connection with claims made by Third Parties respecting the manufacture, sale or use of any Product by such Third Party (“Claims”). RUSH shall give ACORDA prompt notice of any such Loss or claim, shall cooperate in its defense, and shall give ACORDA full authority to defend and settle such claim on RUSH’s behalf.
 
7.2.                               The indemnity obligation set forth in Section 7.1 above shall not apply in the case of Losses or Claims caused by or based on (i) RUSH’s gross negligence or willful misconduct; (ii) any breach of this Agreement by RUSH; or (iii) any violation of RUSH’s representations or warranties hereunder.
 
ARTICLE VIII
TERM AND TERMINATION
 
8.1.                               Term and Expiration .  This Agreement shall be effective as of the Effective Date and unless terminated earlier pursuant to Section 8.2 below, the term of this Agreement shall continue in effect until expiration of all royalty or other payment obligations hereunder.
 
8.2.                               Termination .
 
8.2.1                         Termination for Cause .  Either Party may terminate this Agreement by notice to the other Party at any time during the term of this Agreement as follows:
 
(a)                                   if the other Party is in breach of any material obligation hereunder by causes and reasons within its control, or has breached, in any material respect, any representations or warranties set forth in Article VI, and has not cured such breach within ninety (90) days after notice requesting cure of the breach, provided, however, that if the breach is not capable of being cured within ninety (90) days of such written notice, the Agreement may not be terminated so long as the breaching Party commences and is taking commercially reasonable actions to cure such breach as promptly as practicable; or
 
(b)                                  upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party; provided, however , in the case of any involuntary bankruptcy, reorganization, liquidation, receivership or assignment proceeding such right to terminate shall only become effective if the Party consents to the involuntary proceeding or such proceeding is not dismissed within ninety (90) days after the filing thereof.
 
16

 
8.2.2                         Licensee Rights Not Affected.
 
All rights and licenses granted pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code.  The Parties agree that ACORDA and RUSH shall retain and may fully exercise all of their respective rights, remedies and elections under the Bankruptcy Code.   The Parties further agree that, in the event of the commencement of a bankruptcy or reorganization case by or against a Party under the Bankruptcy Code, the other Party shall be entitled to all applicable rights under Section 365 (including 365(n)) of the Bankruptcy Code.  Upon rejection of this Agreement by a Party or a trustee in bankruptcy for such Party, pursuant to Section 365(n), the other Party may elect (i) to treat this Agreement as terminated by such rejection or (ii) to retain its rights (including any right to enforce any exclusivity provision of this Agreement) to intellectual property (including any embodiment of such intellectual property) under this Agreement and under any agreement supplementary to this Agreement for the duration of this Agreement and any period for which this Agreement could have been extended by such other Party, subject, however, to the continued payment of all amounts owing under Section 5.3 of this Agreement, all of which amounts shall be deemed to be royalties for purposes of Section 365(n) of the Bankruptcy Code.  Upon written request to the trustee in bankruptcy or bankrupt Party, the trustee or Party, as applicable, shall (i) provide to the other Party any intellectual property (including such embodiment) held by the trustee or the bankrupt Party and shall provide to the other Party a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property and (ii) not interfere with the rights of the other Party to such intellectual property as provided in this Agreement or any agreement supplementary to this Agreement, including any right to obtain such intellectual property (or such embodiment or duplicates thereof) from a Third Party.
 
8.3.                               Effect of Expiration or Termination .  Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. ACORDA and its Affiliates and sublicensees shall have the right to sell or otherwise dispose of the stock of any Product subject to this Agreement then on hand or in process of manufacture and ACORDA will continue to pay Rush royalties pursuant to Article V after the expiration or termination of this Agreement for any such Product sold.  In addition to any other provisions of this Agreement which by their terms continue after the expiration of this Agreement, the provision of Article IV shall survive the expiration or termination of this Agreement and shall continue in effect for five (5) years from the date of expiration or termination and the provisions of Article IX shall survive the expiration or termination of this Agreement.  Upon any termination of this Agreement, each party shall promptly return to the other party all Proprietary Information received from the other party (except one copy of which may be retained for archival purposes).  In addition, any other provision required to interpret and enforce the Parties’ rights and obligations under this Agreement shall also survive, but only to the extent required for the full observation and performance of this Agreement. Any expiration or early termination of this Agreement shall be without prejudice to the rights of any Party against the other
 
17

 
accrued or accruing under this Agreement prior to termination. In the event ACORDA breaches any of the financial provisions contained in this Agreement, in lieu of any other remedy that may be available, RUSH shall be entitled to pursue its remedies at law, but shall not be entitled to injunctive relief.
 
ARTICLE IX
MISCELLANEOUS
 
9.1.                               Right to Develop Independently .  Nothing in this Agreement will impair ACORDA’s right to independently acquire, license, develop, or have others develop for it, products similar to or performing functions similar to Product, or similar technology performing similar functions to the Products or to market and distribute products based on other technology.
 
9.2.                               Force Majeure .  Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached the Agreement for failure or delay in fulfilling or performing any term of the Agreement during the period of time when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including, but not limited to, fire, flood, embargo, war, acts of war (whether war be declared or not), insurrection, riot, civil commotion, strike, lockout or other labor disturbance, act of God or act, omission or delay in acting by any governmental authority or the other Party.  The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practicable.
 
9.3.                               Assignment .  The Agreement may not be assigned or otherwise transferred without the prior written consent of the other Party; provided, however, that ACORDA may assign this Agreement to an Affiliate or in connection with the transfer or sale of its business or all or substantially all of its assets related to Compound or Product or in the event of a merger, consolidation, change in control or similar corporate transaction. Any permitted assignee shall assume all obligations of its assignor under this Agreement.
 
9.4.                               Severability .  In the event that any of the provisions contained in this Agreement are held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affect the substantive rights of the Parties.  In such event, the Parties shall replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
 
9.5.                               Notices .  All notices or other communications which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
 
18

 
if to ACORDA to:
 
ACORDA THERAPEUTICS, INC.
15 Skyline Drive
Hawthorne, New York 10532
 
Attention:  : President
Fax No.:  914.347.4560

if to RUSH to:
 
RUSH-PRESBYTERIAN-ST. LUKE’S MEDICAL CENTER
1725 W. Harrison Street
Chicago, Illinois 60612
Attention: Intellectual Property Office/General Counsel’s Office
Fax No.: 312-942-2055
 
or to such other address as the Party to whom notice is to be given may have furnished to the other Parties in writing in accordance herewith.  Any such communication shall be deemed to have been given when delivered if personally delivered or sent by facsimile on a Business Day, upon confirmed delivery by nationally-recognized overnight courier if so delivered and on the third Business Day following the date of mailing if sent by registered or certified mail.
 
9.6.                               Applicable Law and Dispute Resolution .  The Agreement shall be governed by and construed in accordance with the laws of the United States of America and State of New York without reference to any rules of conflict of laws.
 
(a)                                   The Parties agree to attempt initially to solve all claims, disputes, or controversies arising under, out of, or in connection with this Agreement (a “Dispute”) by conducting good faith negotiations.  Any Disputes which cannot be resolved by good faith negotiation within twenty (20) Business Days, shall be referred, by written notice from either Party to the other, to the Chief Executive Officer of each Party. Such Chief Executive Officers shall negotiate in good faith to achieve a resolution of the Dispute referred to them within twenty (20) Business Days after such notice is received by the Party to whom the notice was sent. If the Chief Executive Officers are unable to settle the Dispute between themselves within twenty (20) Business Days, they shall so report to the Parties in writing. The Dispute shall then be referred to mediation as set forth in the following subsection (b).
 
(b)                                  Upon the Parties receiving the Chief Executive Officers’ report that the Dispute referred to them pursuant to subsection (a) has not been resolved, the Dispute shall be referred to mediation by written notice from either Party to the other. The mediation shall be conducted pursuant to the American Arbitration Association (“AAA”) procedures.  The place of the mediation shall be Chicago, Illinois.  If the Parties have not reached a settlement within twenty (20) Business Days of the date of the notice of mediation, the Dispute shall be referred to arbitration pursuant to subsection (c) below.
 
19

 
(c)                                   If after the procedures set forth in subsections (a) and (b) above, the Dispute has not been resolved, a Party shall decide to institute arbitration proceedings, it shall give written notice to that effect to the other Party.  The Parties shall refrain from instituting the arbitration proceedings for a period of sixty (60) days following such notice.  During such period, the Parties shall continue to make good faith efforts to amicably resolve the dispute without arbitration.  If the Parties have not reached a settlement during that period the arbitration proceedings shall go forward and be governed by the AAA rules then in force. Each such arbitration shall be conducted by a panel of three arbitrators: one arbitrator shall be appointed by each of RUSH and ACORDA and the third arbitrator, who shall be the Chairman of the tribunal, shall be appointed by the two-Party appointed arbitrators. Any such arbitration shall be held in Chicago, Illinois, USA.
 
The arbitrators shall have the authority to direct the Parties as to the manner in which the Parties shall resolve the disputed issues, to render a final decision with respect to such disputed issues, or to grant specific performance with respect to any such disputed issue.  Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be. Nothing in this Section shall be construed to preclude either Party from seeking provisional remedies, including but not limited to, temporary restraining orders and preliminary injunctions, from any court of competent jurisdiction, in order to protect its rights pending arbitration, but such preliminary relief shall not be sought as a means of avoiding arbitration.   In no event shall a demand for arbitration be made after the date when institution of a legal or equitable proceeding based on such claim, dispute or other matter in question would be barred by the applicable statute of limitations.  Each Party shall bear its own costs and expenses incurred in connection with any arbitration proceeding and the Parties shall equally share the cost of the mediation and arbitration levied by the AAA.
 
Any mediation or arbitration proceeding entered into pursuant to this Section 9.6 shall be conducted in the English language. Subject to the foregoing, for purposes of this Agreement, each Party consents, for itself and its Affiliates, to the jurisdiction of the courts of the State of New York, county of New York and the U.S. District Court for the Southern District of New York.
 
9.7.                               Entire Agreement .  This Agreement, together with the exhibits and schedules hereto, contains the entire understanding of the Parties with respect to the subject matter hereof and supersedes all previous writings and understandings between the Parties.  This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by all Parties hereto.
 
9.8.                               Independent Contractors .  It is expressly agreed that the Parties shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture or agency. Neither Party shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior consent of such other Party.
 
20

 
9.9                                  Waiver .  The waiver by a Party hereto of any right hereunder or the failure to perform or of a breach by another Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise.
 
9.10.                         Further Assurances .  At any time or from time to time on and after the Effective Date, RUSH shall at the request of ACORDA (i) deliver to ACORDA such records, data or other documents consistent with the provisions of this Agreement, (ii) execute, and deliver or cause to be delivered, all such consents, documents or further instruments of transfer or license, and (iii) take or cause to be taken all such actions as ACORDA may reasonably deem necessary or desirable in order for ACORDA to obtain the full benefits of this Agreement and the transactions contemplated hereby.
 
9.11.                         Headings .  The captions to the several Articles and Sections hereof are not a part of the Agreement, but are merely guides or labels to assist in locating and reading the several Articles and Sections hereof.
 
9.12.                         Counterparts .  The Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
 
9.13.                         Use of Names . Except as otherwise provided in this Agreement, neither Party shall not use the name of the other Party  in relation to this transaction in any public announcement, press release or other public document without the consent of the other Party (which consent shall not be unreasonably withheld or delayed), except as may be required by applicable law.
 
9.14.                         LIMITATION OF LIABILITY .  NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INDIRECT CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY.
 
21

 
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first set forth above.

RUSH-PRESBYTERIAN-ST. LUKE’S MEDICAL CENTER

By:	 	 	 	
 	Name:	 	
 	Title:	 	

ACORDA THERAPEUTICS, INC.	 	

By:	 	 	 	
 	Name:	 	
 	Title:   President and Chief Executive Officer	 	
 
22

 
SCHEDULE 1.7
 
DIAGRAM OF COMPOUND

 
23

 
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.
Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
 
SCHEDULE 1.11
 
ELAN PATENT RIGHTS
 
For purposes of this Agreement, Elan Patent Rights shall mean any and all rights under any and all patents and patent applications now existing, currently pending or hereafter filed, owned or acquired or licensed by Elan (and/or its Affiliates) which would be infringed by the manufacture, use or sale of the Product, the current status of which is set forth below.  Elan Patent Rights shall also include all continuations, continuations-in-part, divisionals and re-issues of such patents and patent applications and any patents issuing thereon and extensions of any patents licensed hereunder.  Elan Patent Rights shall further include any patents or patent applications covering any improved methods of making or using the Product invented or acquired by Elan (and/or its Affiliates) during the term of the Elan/Acorda Agreement and under which Elan (and/or its Affiliates) has a right to grant a licence under the Elan/Acorda Agreement, and Elan’s (and/or its Affiliates) interest in any intellectual property conceived reduced to practice or otherwise developed in connection with the Project (as defined in the Elan/Acorda Agreement).

1806	 	Formulations and their use in the treatment of neurological diseases	 	Pending :
Canada
Ireland
Japan	 	[* *]
[* *]
[* *]	 	
 	 	 	 	 	 	 	 	
 	 	 	 	Issued :	 	 	 	
 	 	 	 	Australia
Europe
New Zealand
South Africa
United States	 	657706
484186
240439
91/8711
5370879
5540938
5580580	 	
 
24

 
EXHIBIT 1.31
 
SIDE AGREEMENT
 
25

 
Exhibit 10.12
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
RUSH PAYMENTS AGREEMENT
REFERENCE IS MADE to (i) the License Agreement effective  as of September 26, 2003, by and between RUSH-PRESBYTERIAN-ST. LUKE’S MEDICAL CENTER , an Illinois not-for-profit corporation and having its principal office at 1725 W. Harrison St. Chicago, Ill. 60612 (“Rush”), and ACORDA THERAPEUTICS, INC. , a corporation organized and existing under the laws of the State of Delaware and having its principal office at 15 Skyline Drive, Hawthorne, New York 10532 (“Acorda”), including the Side Agreement attached thereto as Exhibit 1.31 by and among Rush, Acorda and Elan (as defined below) (the “ Side Agreement ”), a copy of which is attached as Exhibit A hereto (the “ Rush/Acorda License ”); and (ii) the Amended and Restated License Agreement effective as of September 26, 2003 by and between Acorda and ELAN CORPORATION, PLC. , a public limited company incorporated under the laws of Ireland and having its registered office at Lincoln House, Lincoln Place, Dublin 2, Ireland (“Elan”) (the “ Elan/Acorda License ”). The Rush/Acorda License and the Elan/Acorda License are sometimes collectively referred to herein as the “Novation Agreements” and Elan and Acorda are sometimes referred to herein as the “Parties”.
WHEREAS, in connection with and in consideration of the Novation Agreements, Acorda and Elan have agreed to enter into this Rush Payments Agreement with the intention to set forth the respective allocation between the Parties of certain amounts payable under the Rush/Acorda License and certain other rights and obligations of the Parties.
NOW THEREFORE, in consideration of the premises and the mutual covenants hereinafter recited and set forth in the Novation Agreements and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties agree as follows:
1.             With respect to the US $[**] license fee set forth in Section 5.1 of the Rush/Acorda License, each of Acorda and Elan shall be responsible for [**] of such license fee. Accordingly, on the Effective Date, Elan shall pay Acorda US$[**] as Elan’s [**] share of such payment.
2.             With respect to milestone payments that become payable under Section 5.2 of the Rush/Acorda License, the following shall be applicable:
(a)           Each of Acorda and Elan shall be responsible for [**] of any milestone payments payable to Rush under Section 5.2 (a) or 5.2 (b) of the Rush/Acorda License. Accordingly, if the milestone events set forth in either Section 5.2 (a) or Section 5.2 (b) of the Rush/Acorda License are achieved, (x) Acorda shall so advise Elan in writing upon achievement of the applicable milestone event, and (y) Elan shall pay Acorda an amount equal to [**] of the applicable milestone payment upon receipt of such notice as Elan’s share of such payment; and
(b)           Elan shall be responsible for [**] of any milestone payments payable to Rush under Section 5.2 (c) of the Rush/Acorda License. Accordingly, if the milestone event set forth in Section 5.2 (c) of the Rush/Acorda License is achieved, Acorda shall so advise Elan in writing upon achievement of the applicable milestone event and Elan shall pay Acorda an amount equal to [**] of the applicable milestone payment upon receipt of such notice.
 
1

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
3.             In addition, Acorda shall pay to Elan an additional royalty of:
(i)                                      [**] of NSP of the Product sold outside the US during the Base Royalty Term (as such term is defined in the Rush/Acorda License);
(ii)                                   [**] of NSP of the Product sold outside the US during the Reduced Royalty Term (as such term is defined in the Rush/Acorda License);
(iii)                                during the Reduced Royalty Term, [**] of the difference between (a) the royalty that would have been payable by Acorda to Rush during the Base Royalty Term and (b) the royalty payable by Acorda to Rush during the Reduced Royalty Term under Section 5.3.1 of the Rush/Acorda License on such sales of Product in the applicable country; and/or
(iv)                               after termination or expiration of Acorda’s royalty obligations to Rush under the Rush/Acorda License in any country, [**] of NSP of the Product in such country; (with the amounts payable under the foregoing subparagraphs (i), (ii) (iii) and/or (iv), as applicable, referred to as  the “Additional Royalty”);
provided, however, that  in the event the provisions of Clause 5.6.2 or Clause 5.6.3 of the Elan/Acorda License are applicable, any Additional Royalty payable shall be limited to [**] of NSP of Product. All payments of the Additional Royalty shall be made in accordance with the provisions of Clauses 5.6.4, 5.6.5 and 5.6.6 of the Elan/Acorda License, and Article 5.9 of the Elan/Acorda License, to the extent applicable.
4.             In the event that Elan breaches any of its financial obligations and undertakings under Paragraph 2 of this Rush Payments Agreement, Acorda may offset and credit the amount of the unpaid financial obligation, together with accrued interest thereon, against any amounts payable from Acorda to Elan under the Elan/Acorda License including, without limitation, amounts payable under Section 3.4 of the Elan/Acorda License. In the event that it is determined that Acorda has incorrectly offset or credited any amounts pursuant to this Paragraph 4, Acorda shall promptly pay the incorrectly offset or credited amount, together with accrued interest thereon, to Elan.
5.             In the event that Acorda has breached any financial or other curable obligation under the Rush/Acorda License which breach would give Rush the right, pursuant to the Section 8.2.1 of the Rush/Acorda License, to terminate the Rush/Acorda License and, pursuant to the terms of the Side Agreement, Elan has the right to and remedies such breach (provided, however, that Elan shall not have the right to remedy such breach if such breach has been consented to by Elan or is primarily due to the fault of Elan or if Elan is in breach of the terms of this Rush Payments Agreement or the Elan/Acorda License), Elan may charge Acorda an amount equal to the amount so paid by Elan to Rush to remedy such breach on behalf of Acorda. In the event that it is determined that Elan has incorrectly charged any amounts to Acorda pursuant to this
 
2

 
Paragraph 5 and Acorda has paid such amounts, Elan shall promptly repay to Acorda the incorrectly charged and paid amount, together with accrued interest thereon.
6.             In the event that Rush terminates the Rush/Acorda License pursuant to Section 8.2.1 thereof as a result of a breach by Acorda and, pursuant to the terms of the Side Agreement, Elan has the right to and elects to assume the rights and obligations of Acorda under the Rush/Acorda License (provided, however, that Elan shall not have the right to assume such rights and obligations if such breach has been consented to by Elan, is primarily due to the fault of Elan or if Elan is in breach of the terms of this Rush Payments Agreement or the Elan/Acorda License), Elan may charge Acorda an amount equal to any amounts or financial obligations so paid or incurred by Elan to Rush pursuant to Elan’s assumption of Acorda’s obligations under the Rush/Acorda License.
7.             Acorda agrees to indemnify Elan from and against any losses and liability arising from any claims made by Rush against Elan after the Effective Date resulting primarily from any acts or omissions of Acorda under the Rush/Acorda License.  Elan shall give Acorda prompt notice of any such loss or liability, shall cooperate in its defense, and shall give Acorda full authority to defend and settle such claim on Elan’s behalf. This indemnity obligation shall not apply in the case of losses primarily caused by or based on (i) Elan’s acts or omissions; or (ii) any breach of this Rush Payments Agreement, the Side Agreement or the Elan/Acorda License by Elan.
In the event Elan has the right to and elects to cure any Acorda breach of, or assumes the rights and obligations of Acorda under the, Rush/Acorda License in accordance with the terms of the Side Agreement and this Rush Payments Agreement, Elan agrees to indemnify Acorda from and against any losses and liability arising from any claims made by Rush against Acorda resulting from any acts of Elan after the date that Elan cures  such breach or assumes Acorda’s obligations under the Rush/Acorda License.  Acorda shall give Elan prompt notice of any such loss or liability, shall cooperate in its defense, and shall give Elan full authority to defend and settle such claim on Acorda’s behalf. This indemnity obligation shall not apply in the case of losses primarily caused by or based on (i) Acorda’s acts or omissions; or (ii) any breach of this Rush Payments Agreement, the Side Agreement or the Elan/Acorda License by Acorda.
8.             All notices or other communications which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

if to Acorda to:	ACORDA THERAPEUTICS, INC..	
 	15 Skyline Drive	
 	Hawthorne, New York 10532	
 	Attention:  President	
 	Fax No.: 914.347.4560	
 
3

 

if to Elan to:	ELAN CORPORATION, PLC.	
 	c/o Elan International Services Ltd.	
 	102 St. James Court	
 	Flatts,	
 	Smiths FL04 Bermuda	
 	Attention: Secretary	
 	Fax No: +1 441 292 2224	
9.             This Rush Payments Agreement shall be effective as of  the date set forth below  (“Effective Date”), and shall be governed by the laws of the State of New York without reference to any rules of conflict of laws.  Any disputes under this Agreement shall be governed by the dispute resolution provisions of Article 12.14 of the Elan/Acorda License.
10.           This Rush Payments Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties have executed this Rush Payments Agreement as of September____, 2003.

ACORDA THERAPEUTICS, INC.	
 	
By:	 	 	
 	Name:	 	
 	Title:	President and Chief Executive Officer	
 	
ELAN CORPORATION, PLC.	
 	
By:	 	 	
 	Name:	 	
 	Title:	 	

 
4

 
EXHIBIT A
RUSH/ACORDA LICENSE
 
5

 
Exhibit 10.13
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
AMENDED AND RESTATED LICENSE AGREEMENT
 
by and between
 
CANADIAN SPINAL RESEARCH ORGANIZATION
 
and
 
ACORDA THERAPEUTICS, INC.

 
THIS AMENDED AND RESTATED LICENSE AGREEMENT made as of  August 1, 2003  (the “Restatement Date”), by and between CANADIAN SPINAL RESEARCH ORGANIZATION, a not-for-profit corporation organized and existing under the laws of Ontario and having its principal office at 120 Newkirk Road, Unit 2, Richmond Hill, Ontario, L4C 9S7 (“CSRO”) and ACORDA THERAPEUTICS, INC. , a corporation organized and existing under the laws of the State of Delaware and having its principal office at  16 Skyline Drive, Hawthorne, New York 10532 (“ACORDA”).
 
W I T N E S S E T H:
 
WHEREAS, CSRO owns or has rights to certain Patent Assets and Know How (each as defined herein) relating to the use of 4-aminopyridine (“4-AP”) in the reduction of chronic pain and spasticity in a spinal cord injured patient;
 
WHEREAS, CSRO, Purdue and McMaster have entered into that certain Inter-Institutional Agreement, effective as of October 18, 1993 (the “Inter-Institutional Agreement”), pursuant to which CSRO acquired the sole authority to license rights to any patents included in the Patent Assets;
 
WHEREAS, pursuant to the Assignments, CSRO obtained an Assignment from the Inventors of the Patent Assets (all as defined herein);
 
WHEREAS, pursuant to a License Agreement (the “1995 Agreement”), effective August 9, 1995 (the “1995 Agreement Effective Date”), between CSRO and ACORDA, CSRO granted ACORDA an exclusive license under the Patent Assets; and
 
WHEREAS, the Parties agree that the 1995 Agreement should be amended and restated to reflect the intentions of the Parties, effective as of the 1995 Agreement Effective Date, except where indicated to be effective as of the Restatement Date;
 
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties hereby agree that the 1995 Agreement, and all of the terms, conditions and provisions of the 1995 Agreement, are hereby superceded and replaced in their entirety by this Agreement and the terms, conditions and provisions hereof, effective as of the 1995 Agreement Effective Date, as follows:
 
ARTICLE I
DEFINITIONS
 
Unless specifically set forth to the contrary herein, the following terms, where used in the singular or plural, shall have the respective meanings set forth below:
 
1.1.                               “ Affiliate ” shall mean (i) any corporation or business entity of which more than fifty percent (50%) of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by a Party; (ii) any corporation or business entity which, directly or indirectly,
 
2

 
owns, controls or holds more than fifty percent (50%) (or the maximum ownership interest permitted by law) of the securities or other ownership interests representing the equity, voting stock or general partnership interest of a Party or (iii) any corporation or business entity of which a Party has the right to acquire, directly or indirectly, at least fifty percent (50%) of the securities or other ownership interests representing the equity, voting stock or general partnership interest thereof.
 
1.2.                               “ Assignment(s)” shall mean the Assignments from the Inventors to CSRO of the Patent Assets dated October 16 and October 20, 1996 and filed with the United States Patent and Trademark Office on or about November 11, 1996 in the forms attached hereto as Exhibit 1.2.
 
1.3.                               “ Business Day(s) ” shall mean any day that is not a Saturday or a Sunday or a day on which the New York Stock Exchange is closed.
 
1.4.                               “ Calendar Quarter ” shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
 
1.5.                               “ Calendar Year ” shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31.
 
1.6.                               “ Compound ” shall mean the chemical compound known as 4-aminopyridine, as diagrammed on Schedule 1.6 hereto, and any other compounds disclosed, covered or included in the Patent Assets.
 
1.7.                               “ CSRO Intellectual Property ” shall mean the Patent Assets and Know-How.
 
1.8.                               “ Know-How ” shall mean all information and materials, including but not limited to, discoveries, information, Improvements, processes, formulas, data, inventions, know-how and trade secrets, patentable or otherwise, which
 
(a)                                   relate to Compound or Product; and
 
(b)                                  are owned by CSRO or are in CSRO’s possession or control and as to which CSRO has the right to license or sublicense to Third Parties.
 
Such know-how shall include, without limitation, all chemical, pharmaceutical, toxicological, preclinical, clinical, assay control, regulatory, and any other data or information used or useful for the development, manufacturing and/or regulatory approval of Compound or Product, including such rights which CSRO may have to data or information developed by Third Parties.
 
1.9.                               “ Effective Date ” shall mean the 1995 Agreement Effective Date.
 
1.10.                         “ First Commercial Sale ” shall mean the first sale of Product by ACORDA, its Affiliate or its sublicensees in a country, for end use or consumption, after all required Regulatory Approvals have been granted by the governing health authority of such country. Sales for
 
3

 
 test marketing, clinical trial purposes or compassionate or similar use shall not be deemed to constitute a First Commercial Sale.
 
1.11.                         “ GAAP ” means United States generally accepted accounting principles, consistently applied.
 
1.12.                         “ Improvement ” shall mean any and all improvements and enhancements, patentable or otherwise, related to the Compound or Product including, without limitation, in the manufacture, formulation, ingredients, preparation, presentation, means of delivery or administration, dosage, indication, use or packaging of Compound or Product.
 
1.13.                         “ Inventors” shall mean Robert R. Hansebout and Andrew R. Blight.
 
1.14.                         “ Net Sales ” shall mean the gross amount invoiced for commercial sales of Product in the Territory by ACORDA, its Affiliates or its sublicensees to Third Parties commencing upon the date of First Commercial Sale in any country in the Territory, after deducting, in accordance with GAAP, the following:
 
(i)                                                   reasonable and customary trade, cash and quantity discounts and rebates;
 
(ii)                                                recalls, credits and allowances on account of returned or rejected Product, including allowance for breakage or spoilage;
 
(iii)                                             legally allowed chargebacks, rebates or similar payments granted to customers, including, but not limited to, managed health care organizations, wholesalers, distributors, buying groups, retailers, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations or other institutions or health care organizations or to federal, state/provincial, local and other governments, their agencies and purchasers and reimbursers;
 
(iv)                                            sales or excise taxes, VAT or other taxes, and transportation, freight, shipping and insurance charges and additional special transportation, custom duties, and other governmental charges;
 
(v)                                               retroactive price reductions; and
 
(vi)                                            write-offs or allowances for bad debts.
 
Sales or other transfers between ACORDA and its Affiliates or sublicensees shall be excluded from the computation of Net Sales and no payments will be payable on such sales or transfers except where such Affiliates are end users, but Net Sales shall include the subsequent sales to Third Parties by such Affiliates or sublicensees.
 
1.15.                         “ Party ” shall mean CSRO or ACORDA.
 
4

 
1.16.                         “ Patent Assets ” shall mean the patents and patent applications which as of the Effective Date or at any time during the term of this Agreement
 
(a)                                   are owned or controlled by CSRO or which CSRO through license or otherwise has or acquires rights from a Third Party, and
 
(b)                                  relate to Compound, Product or any Improvement, including but not limited to methods of their development, manufacture, use, or otherwise relate to Know-How, including all certificates of invention and applications for certificates of invention, substitutions, divisions, continuations, continuations-in-part, patents issuing thereon or reissues or reexaminations or extensions thereof and any and all foreign patents and patent applications corresponding thereto, supplementary protection certificates or the like of any such patents and current and future patent applications, including but not limited to the patents and patent applications listed on Schedule 1.16 hereto and the patents and patent applications included in the definition of Patent Rights under the Inter-Institutional Agreement, and any counterparts thereof which have been or may be filed in other countries.
 
1.17.                         “ Product ” shall mean any product in final form for commercial sale (or, where the context so indicates, the product being tested in clinical trials), which contains Compound as at least one of the therapeutically active ingredients in all dosage forms and package configurations for any indication.
 
1.18.                         “Proprietary Information” shall mean any and all scientific, clinical, regulatory, marketing, financial and commercial information or data, whether communicated in writing, orally or by any other means, which is owned and under the protection of one Party and is being provided by that Party to the other Party in connection with this Agreement.
 
1.19.                         “ Regulatory Approval ” means all approvals (including pricing and reimbursement approvals required for marketing authorization), product and/or establishment licenses, registrations or authorizations of all regional, federal, state or local regulatory agencies, departments, bureaus or other governmental entities, necessary for the manufacture, use, storage, import, export, transport and sale of Product in a regulatory jurisdiction.
 
1.20.                         “ Royalty Year ” shall mean, (i) for the year in which the First Commercial Sale occurs (the “First Royalty Year”), the period commencing with the first day of the Calendar Quarter in which the First Commercial Sale occurs and expiring on the last day of the Calendar Year in which the First Commercial Sale occurs and (ii) for each subsequent year, each successive Calendar Year.
 
1.21.                         “ Territory ” shall mean all of the countries in the world.
 
1.22.                         “ Third Party(ies) ” shall mean a person or entity who or which is neither a Party nor an Affiliate of a Party.
 
5

 
1.23.                         “ Valid Claim ” means a claim of an issued and unexpired patent included within the Patent Assets, which has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, and which has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.
 
ARTICLE II
LICENSE; SUBLICENSES
 
2.1.                               License Grant .  CSRO hereby grants to ACORDA an exclusive (even as to CSRO) license under the CSRO Intellectual Property, including the right to grant sublicenses, to develop, make, have made, use, import, offer for sale, market, commercialize, distribute and sell and otherwise dispose of Compound and Product in the Territory.  CSRO reserves the right to practice the Patent Assets for its own internal research and educational purposes; provided, however, that such use is for non-commercial academic purposes only and for no other purpose.
 
2.2.                               Improvements by ACORDA.  All rights and title to and interest in any Improvement developed or discovered by ACORDA in connection with the license granted under Section 2.1 above or ACORDA’s activities hereunder shall be vested solely in ACORDA.
 
2.3.                               a. Sublicenses.  ACORDA shall have the right to grant sublicenses of the licenses granted to it under Section 2.1 of this Agreement to Affiliates or any Third Party. ACORDA shall advise CSRO, on a confidential basis, of any sublicense granted by it.
 
ARTICLE III
EXCHANGE OF INFORMATION; REGULATORY MATTERS
 
3.1.                               Exchange of Information .  Throughout the term of this Agreement, and in addition to the other communications required under this Agreement, CSRO shall promptly disclose to ACORDA in writing on an ongoing basis all CSRO Intellectual Property related to the Compound or Product, and any and all additions or revisions thereto. ACORDA shall provide CSRO with an annual written report summarizing the status of ACORDA’s clinical development and regulatory activities with respect to Compound and Product by delivering to CSRO the summary of the annual report to the investigational new drug application relating to the use of Compound and Product submitted by ACORDA to the U.S. Food and Drug Administration in connection with the periodic reporting requirements of such investigational new drug application. Any disclosures contained in such reports shall be deemed Proprietary Information and shall remain the intellectual property of ACORDA.
 
3.2.                               Regulatory Matters.
 
(a)                                   ACORDA shall own, control and retain primary legal responsibility for the preparation, filing and prosecution of all filings and regulatory applications required to obtain Regulatory Approvals. ACORDA shall
 
6

 
promptly notify CSRO upon the receipt of Regulatory Approvals and of the date of First Commercial Sale.
 
(b)                                  Upon ACORDA’s request, CSRO shall consult and cooperate with ACORDA in connection with obtaining Regulatory Approval of Product.
 
3.3.                               Trademark . ACORDA shall select, own and maintain trademarks for Product in the Territory.
 
ARTICLE IV
CONFIDENTIALITY AND PUBLICITY
 
4.1.                               Non-Disclosure and Non-Use Obligations .  All Proprietary Information and Know-how disclosed by one Party to the other Party hereunder shall be maintained in confidence and shall not be disclosed to any Third Party or used for any purpose except as expressly permitted herein without the prior written consent of the Party that disclosed the Proprietary Information to the other Party during the term of this Agreement.  The foregoing non-disclosure and non-use obligations shall not apply to the extent that such Proprietary Information:
 
(a)                                   is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by business records;
 
(b)                                  is or becomes properly in the public domain or knowledge;
 
(c)                                   is subsequently disclosed to a receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or
 
(d)                                  is developed by the receiving Party independently of Proprietary Information received from the other Party, as documented by research and development records.
 
4.2.                               Permitted Disclosure of Proprietary Information .  Notwithstanding Section 4.1, a Party receiving Proprietary Information of another Party may disclose such Proprietary Information:
 
(a)                                   to governmental or other regulatory agencies in order to obtain patents pursuant to this Agreement, or to gain approval to conduct clinical trials or to market Product, but such disclosure may be only to the extent reasonably necessary to obtain such patents or authorizations
 
(b)                                  by ACORDA or its agents, consultants, Affiliates, sublicensees and/or other Third Parties for the research and development, manufacturing and/or marketing of the Compound and/or Product (or for such parties to determine their interests in performing such activities) on the condition
 
7

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
that such Third Parties agree to be bound by the confidentiality obligations consistent with this Agreement; or
 
(c)                                   if required to be disclosed by law or court order, provided that notice is promptly delivered to the non-disclosing Party in order to provide an opportunity to challenge or limit the disclosure obligations.
 
4.3.                               Publication .    In the event CSRO or any Affiliate of or consultant to CSRO wishes to make a publication relating to Compound or Product, it shall deliver to ACORDA a copy of the proposed publication or an outline of the oral disclosure at least sixty (60) Business Days prior to submission or presentation, such that any issue of patent protection can be resolved in accordance with the terms of this Agreement.
 
4.4.                               Confidential Terms .    Except as expressly provided herein, each Party agrees not to disclose any terms of this Agreement to any Third Party without the consent of the other party, except as required by securities or other applicable laws, to prospective investors to such party’s accountants, attorneys and other professional advisors.  Without limiting any of the foregoing, it is understood that ACORDA or its Affiliates may make disclosure of this Agreement and the terms hereof in any filings required by the Securities and Exchange Commission (“SEC”) or any other governmental agency, may file this Agreement as an exhibit to any filing with the SEC or such agency and may distribute any such filing in the ordinary course of its business.
 
ARTICLE V
 ROYALTIES AND REPORTS
 
5.1.                               Royalties .
 
5.1.1                         Royalty Payments.
 
(i)                                                                                      Subject to the terms and conditions of this Agreement, and in consideration of the rights granted by CSRO hereunder, ACORDA shall pay to CSRO royalties in an amount equal to [**] of Net Sales in each country in the Territory where the manufacture, use or sale of Product would, absent the license granted hereunder, infringe one or more Valid Claims in such country.
 
(ii)                                                                                   Royalties on Net Sales at the rate set forth in (i) above shall accrue as of the date of First Commercial Sale of Product in the applicable country and shall continue and accrue on Net Sales on a country-by-country basis until the earlier of (A) the expiration of the last to expire Patent Asset in such country or (B) ten (10) years following the date of First Commercial Sale of Product in such country.  Thereafter, ACORDA shall be relieved of any royalty payment under this Agreement.
 
(iii)                                                                                The payment of royalties set forth above shall be subject to the following conditions:
 
8

 
(A)                                                                               only one payment shall be due with respect to the same unit of Product;
 
(B)                                                                                 no multiple royalties shall be payable because any Product, or its manufacture, sale or use is covered by more than one Valid Claim;
 
(C)                                                                                 no royalties shall accrue on the disposition of Product by ACORDA, Affiliates or sublicensees as samples (promotion or otherwise) or as donations (for example, to non-profit institutions or government agencies) or to clinical trials or for research and and/or development; and
 
(D)                                                                                CSRO shall be responsible for payment of any royalties or other obligations owed by CSRO to any Third Party, including without limitation, pursuant to the Inter-Institutional Agreement.
 
5.1.2                         Affiliate and Sublicensee Sales .  In the event that ACORDA transfers Compound or Product to one of its Affiliates or sublicensees, there shall be no royalty due at the time of transfer.  Subsequent sales of Product by the Affiliates or sublicensees to Third Parties such as patients, hospitals, medical institutions, health plans or funds, wholesalers (which are not sublicensees), pharmacies or other retailers, shall be reported as Net Sales hereunder.
 
5.1.3                         Compulsory Licenses .  If a compulsory license is granted to a Third Party with respect to Product in any country in the Territory with a royalty rate lower than the royalty rate provided by Section 5.1.1, then the royalty rate to be paid by ACORDA on Net Sales in that country under Section 5.1.1 shall be reduced to the rate paid by the compulsory Third Party licensee.
 
5.1.4                         Combination Product .  Notwithstanding the provisions of Section 5.1.1, in the event a Product is sold as a combination product with other biologically active components, Net Sales, for purposes of royalty payments on the combination product, shall be calculated by multiplying the Net Sales of that combination product by the fraction A/B, where A is the gross selling price of the Product sold separately and B is the gross selling price of the combination product.  If no such separate sales are made by ACORDA or its Affiliates or sublicensees, Net Sales for royalty determination shall be calculated by multiplying Net Sales of the combination product by the fraction C/(C+D), where C (excluding the fully allocated cost of the other biologically active component in question) is the fully allocated cost of the Compound and D is the fully allocated cost of such other biologically active components.
 
5.2.                               Reports; Payment of Royalty .  During the term of the Agreement for so long as royalty payments are due, ACORDA shall furnish to CSRO a written report for each Calendar Quarter showing the Net Sales of all Products subject to royalty payments during the
 
9

 
reporting period and the royalties payable to CSRO under this Agreement.  Reports shall be due on the forty-fifth (45 th ) day following the close of each Calendar Quarter.  Royalties shown to have accrued by each royalty report, if any, shall be due and payable on the date such report is due.  ACORDA shall keep complete and accurate records in sufficient detail to enable the royalties hereunder to be determined.  ACORDA shall retain such records for twenty-four (24) months after the submission of the corresponding report.
 
5.3.                               Audits .  Upon the written request of CSRO and not more than once during the twelve (12) month period next following the expiration of each Royalty Year during the term of the Agreement, ACORDA shall, at CSRO’s expense, permit an independent certified public accounting firm selected by CSRO and reasonably acceptable to ACORDA to have access during normal business hours, upon thirty (30) days prior notice to ACORDA, to such of the records of ACORDA as may be reasonably necessary to verify the accuracy of the royalty reports hereunder for any Royalty Year ending not more than twenty-four (24) months prior to the date of such request.  The accounting firm shall disclose to CSRO only whether the royalty reports are correct or incorrect and the specific details concerning any discrepancies.  This Section 5.3 shall survive the expiration or termination of this Agreement for a period of two years.
 
5.3.1                         If such accounting firm concludes that additional royalties were owed during such period, ACORDA shall promptly pay the additional royalties within sixty (60) days of the date CSRO delivers to ACORDA such accounting firm’s written report so concluding; provided however, that, in the event that ACORDA shall not be in agreement with the conclusion of such report (a) ACORDA shall not be required to pay such additional royalties and (b) such matter shall be resolved pursuant to the provisions of Section 10.7 herein.  In the event such accounting firm concludes that amounts were overpaid by ACORDA during such period, CSRO shall repay ACORDA the amount of such overpayment within sixty (60) days of the date CSRO delivers to ACORDA such accounting firm’s written report so concluding, provided, however, that, in the event that CSRO shall not be in agreement with the conclusion of such report (a) CSRO shall not be required to repay such overpayment and (b) such matter shall be resolved pursuant to the provisions of Section 10.7 herein. The fees charged by such accounting firm shall be paid by CSRO; provided, however, that if an error in favor of CSRO of more than the greater of (i) $100,000 or (ii) ten percent (10%) of the royalties due hereunder for the period being reviewed is discovered, then the fees and expenses of the accounting firm shall be paid by ACORDA. Payments of additional royalties under this Section 5.3.1 shall be made with interest from the date such amounts were due, at the prime rate reported by Chase Manhattan Bank, New York, New York.
 
5.3.2                         Upon the expiration of twenty-four (24) months following the end of any Royalty Year the calculation of royalties payable with respect to such year shall be binding and conclusive upon CSRO, and ACORDA shall be released from any liability or accountability with respect to royalties for such year.
 
10

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
5.3.3                         CSRO shall treat all financial information subject to review under this Section 5.3. in accordance with the confidentiality provisions of this Agreement.
 
5.4.                               Payment Exchange Rate .  All payments to CSRO under this Agreement shall be made in United States dollars.  In the case of sales outside the United States, the rate of exchange to be used in computing Net Sales shall be calculated monthly in accordance with the conversion rates published in the Wall Street Journal, Eastern edition (if available).
 
5.5.                               Tax Withholding .  If laws, rules or regulations require withholding of income taxes or other taxes imposed upon payments set forth in this Article V, CSRO shall provide ACORDA, prior to any such payment, annually or more frequently if required, with all forms or documentation required by any applicable taxation laws, treaties or agreements to such withholding or as necessary to claim a benefit thereunder (including, but not limited to Form W-8BEN or any successor forms) and ACORDA shall make such withholding payments as required and subtract such withholding payments from the payments set forth in this Article V. ACORDA will use commercially reasonable efforts consistent with its usual business practices and cooperate with CSRO to ensure that any withholding taxes imposed are reduced as far as possible under the provisions of the current or any future taxation treaties or agreements between foreign countries.
 
5.6.                               Exchange Controls . Notwithstanding any other provision of this Agreement, if at any time legal restrictions prevent the prompt remittance of part or all of the royalties with respect to Net Sales in any country, payment shall be made through such lawful means or methods as ACORDA may determine.  When in any country the law or regulations prohibit both the transmittal and deposit of royalties on sales in such a country, royalty payments shall be suspended for as long as such prohibition is in effect (and such suspended payments shall not accrue interest), and promptly after such prohibition ceases to be in effect, all royalties or other payments that ACORDA or its Affiliates would have been obligated to transmit or deposit, but for the prohibition, shall be deposited or transmitted, as the case may be, to the extent allowable (with any interest earned on such suspended royalties which were placed in an interest-bearing bank account in that country, less any transactional costs).  If the royalty rate specified in this Agreement should exceed the permissible rate established in any country, the royalty rate for sales in such country shall be adjusted to the highest legally permissible or government-approved rate.
 
5.7.                               Other Payments .  The parties hereto acknowledge that, in further consideration of the rights granted by CSRO hereunder, ACORDA had issued to CSRO on the Effective Date warrants, dated August 9, 1995, to purchase up to an aggregate of [**] shares of common stock of ACORDA which warrants have since been exercised in full.
 
ARTICLE VI
REPRESENTATIONS AND WARRANTIES
 
6.1.                               CSRO Representations and Warranties .  CSRO represents and warrants to ACORDA that as of the Restatement Date:
 
11

 
(a)                                   this Agreement has been duly executed and delivered by CSRO and constitutes legal, valid, and binding obligations enforceable against CSRO in accordance with its terms;
 
(b)                                  no approval, authorization, consent, or other order or action of or filing with any court, administrative agency or other governmental authority is required for the execution and delivery by CSRO of this Agreement or the consummation by CSRO of the transactions contemplated hereby;
 
(c)                                   CSRO has the full corporate power and authority to enter into and deliver this Agreement, to perform and to grant the licenses granted under Article II hereof and to consummate the transactions contemplated hereby;  all corporate acts and other proceedings required to be taken to authorize such execution, delivery, and consummation have been duly and properly taken and obtained;
 
(d)                                  the issued patents included in the Patent Assets are valid and enforceable over any references or prior art known to CSRO or its agents, taken alone or in combination;
 
(e)                                   CSRO has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the CSRO Intellectual Property or entered into any agreement with any Third Party which is in conflict with the rights granted to ACORDA pursuant to this Agreement;
 
(f)                                     CSRO is the sole owner of the CSRO Intellectual Property, all of which is free and clear of any security interests, liens, charges, encumbrances or restrictions on license, and no other person, corporate or other private entity, or governmental or university entity or subdivision thereof, including without limitation, McMaster or Purdue, has any claim of ownership with respect to the CSRO Intellectual Property, whatsoever; the Assignments are valid and in full force and effect as of the Restatement Date and CSRO is not aware of any claims challenging the validity of the Assignments;
 
(g)                                  CSRO  has disclosed to ACORDA the complete texts of all Patent Assets as well as all information received by CSRO concerning the institution or possible institution of any interference, opposition, re-examination, reissue, revocation, nullification, or any official proceeding involving a Patent Asset, and that it will continue such disclosure with respect to new events during the term of the Agreement;
 
(h)                                  CSRO has the sole and exclusive authority to grant the rights and licenses granted under Article II and CSRO has not previously granted, and will not grant, or engage in any discussions to grant, during the term of this Agreement, any right, license or interest in and to the CSRO Intellectual
 
12

 
Property, or any portion thereof, inconsistent with the license granted to ACORDA herein;
 
(i)                                      Schedule 1.16 is a complete and accurate list of all patents and patent applications in the Territory relating to Compound or Product owned by CSRO or to which CSRO has the right to license;
 
(j)                                      there are no claims, judgments or settlements against or owed by CSRO or pending or, to the best of its knowledge, threatened claims or litigation relating to the Patent Assets;
 
(k)                                   CSRO has disclosed to ACORDA all relevant information known by it regarding the CSRO Intellectual Property reasonably related to the activities contemplated under this Agreement;
 
(l)                                      no contract research organization, corporation, business entity or individual which have been involved in any studies conducted for the purpose of obtaining regulatory approvals have been debarred individuals or entities within the meaning of 21 U.S.C. section 335(a) or (b);
 
(m)                                in connection with development of Compound and Product, CSRO has complied in all material respects with applicable U.S. laws and regulations;
 
(n)                                  CSRO has not entered into any contracts, agreements and other arrangements with any Third Parties relating to the research, development or commercialization of the Compound or Product; and
 
(o)                                  Attached as Exhibit 6.1(o) is a true and complete copy of the Inter-Institutional Agreement, including all supplements thereto and modifications or amendments thereof.  CSRO is not, and to the best of its knowledge, neither Purdue or McMaster is, in default under or in breach of any terms or provisions of the Inter-Institutional Agreement and such agreement is in full force and effect as of the date hereof.  During the term of this Agreement, CSRO shall not amend, modify, terminate or cause a default under the Inter-Institutional Agreement. In the event that CSRO receives notice from either Purdue or McMaster or any other Third Party that CSRO has committed a breach of its obligations under the Inter-Institutional Agreement, or if CSRO anticipates such breach, or any other claim that may give rise to a right by any Third Party to terminate or otherwise diminish CSRO’s rights to the Patent Assets and/or otherwise diminish CSRO’s ability to perform its obligations under this Agreement, CSRO shall immediately notify ACORDA of such situation, and CSRO shall promptly cure such breach.  However, if CSRO is unable to cure such breach, CSRO shall, to the extent possible, permit ACORDA to cure such breach and to negotiate directly with Purdue or McMaster or any other such Third Party.
 
13

 
6.2.                               ACORDA Representations and Warranties .  ACORDA represents and warrants to CSRO that as of the Effective Date and the Restatement Date:
 
(a)                                   this Agreement has been duly executed and delivered by it and constitutes legal, valid, and binding obligations enforceable against it in accordance with its terms;
 
(b)                                  it has full corporate power and authority to execute and deliver this Agreement and to consummate the transactions contemplated hereby.  All corporate acts and other proceedings required to be taken to authorize such execution, delivery, and consummation have been duly and properly taken and obtained; and
 
(c)                                   no approval, authorization, consent, or other order or action of or filing with any court, administrative agency or other governmental authority is required for the execution and delivery by it of this Agreement or the consummation by it of the transactions contemplated hereby.
 
ARTICLE VII
PATENT MATTERS
 
7.1.                               Filing, Prosecution and Maintenance of Patent Applications or Patents . ACORDA shall file, prosecute and maintain the Patent Assets in CSRO’s name and shall be responsible for the payment of all patent prosecution and maintenance costs. Upon ACORDA’s request, CSRO shall reasonably cooperate in the filing, prosecution or maintenance of such patent application or patent. If ACORDA elects not to file, prosecute or maintain a patent application or patent included in the Patent Assets, it shall provide CSRO with written advance notice sufficient to avoid any loss or forfeiture, and CSRO shall have the right, but not the obligation, at its sole expense, to file, prosecute or maintain such patent application or patent in CSRO’s name. Thereafter, ACORDA’s royalty obligations related to that Patent Asset shall terminate and such patent or patent application shall no longer be deemed a Patent Asset. The responsible Party under this Section 7.1 shall solicit the other Party’s review of the nature and text of such patent applications and important prosecution matters related thereto in reasonably sufficient time prior to filing thereof, and the responsible Party shall take into account the other Party’s reasonable comments related thereto.  ACORDA shall inform CSRO of any significant developments in the prosecution of pending patent applications included in the Patent Assets, including the issuance of any final office actions, allowance of claims, or grant of any domestic or foreign patent based thereon.
 
7.2.                               Patent Office Proceedings .  Each Party shall inform the other Party of any request for, filing, or declaration of any proceeding before a patent office seeking to protest, oppose, cancel, reexamine, declare an interference proceeding, initiate a conflicts proceeding, or analogous process involving a patent application or patent included in the Patent Assets.  ACORDA shall have the option to conduct any such proceedings relating to the Patent Assets, and may offset any expenses incurred therein against royalties due to CSRO
 
14

 
under this Agreement. Each Party thereafter shall cooperate with the other with respect to any such patent office proceedings.
 
7.3.                               Enforcement and Defense.
 
(a)                                   Each Party shall promptly give the other Party notice of any infringement in the Territory of any patent application or patent included in the Patent Assets that comes to such Party’s attention.  The Parties will thereafter consult and cooperate fully to determine a course of action, including, without limitation, the commencement of legal action by any Party.  However, ACORDA shall have the first right to initiate and prosecute such legal action and in the name of CSRO and ACORDA, or to control the defense of any declaratory judgment action relating to Patent Assets.  The initiation and prosecution of such legal action will be at ACORDA’s expense; provided, however, that ACORDA shall be entitled to offset fifty percent (50%) of amounts expended in connection with such action against royalties due to CSRO under this Agreement.  ACORDA shall promptly inform CSRO if ACORDA elects not to exercise such first right, and CSRO thereafter shall have the right either to initiate and prosecute such action or to control the defense of such declaratory judgment action in the name of CSRO and, if necessary, ACORDA.  In no event shall ACORDA be obligated to enforce or defend any of the Patent Assets.
 
(b)                                  If ACORDA elects not to initiate and prosecute an infringement or defend a declaratory judgment action in any country in the Territory as provided in Subsection 7.3 (a), and CSRO elects to do so, the cost of any agreed-upon course of action, including the costs of any legal action commenced or any declaratory judgment action defended, shall be borne solely by CSRO.
 
(c)                                   For any such legal action or defense, in the event that any Party is unable to initiate, prosecute, or defend such action solely in its own name, the other Party will join such action voluntarily and will execute all documents necessary for the Party to prosecute, defend and maintain such action.  In connection with any such action, the Parties will cooperate and will provide each other with any information or assistance that either reasonably may request.
 
(d)                                  Any recovery obtained by ACORDA or CSRO shall be shared as follows:
 
(i)                                     the Party that initiated and prosecuted, or maintained the defense of, the action shall recoup all of its costs and expenses (including reasonable attorneys’ fees) incurred in connection with the action, whether the recovery is by settlement or otherwise;
 
15

 
(ii)                                  the other Party then shall, to the extent possible, recover its costs and expenses (including reasonable attorneys’ fees) incurred in connection with the action;
 
(iii)                               if CSRO initiated and prosecuted, or maintained the defense of, the action, the amount of any recovery remaining then shall be retained by CSRO; and
 
(iv)                              if ACORDA initiated and prosecuted, or maintained the defense of, the action, the amount of any recovery remaining shall be retained by ACORDA, except that CSRO shall receive a portion equivalent to the royalties it would have received in accordance with the terms of this Agreement if such amount were deemed Net Sales.
 
(e)                                   If the practice by ACORDA of the license granted herein results in any allegation or claim of infringement of an intellectual property right of a Third Party against ACORDA, ACORDA shall have the exclusive right but not the obligation to defend such claim, suit or authority to settle such suit; provided, however, CSRO shall cooperate with ACORDA’s reasonable request, in connection with the defense of such claim or suit.  ACORDA shall be entitled to offset any amounts expended in connection with such proceeding, including attorneys’ fees and professional fees, against any royalties it would otherwise owe CSRO under this Agreement, up to a maximum of fifty percent (50%) of the royalties due.
 
(f)                                     CSRO shall inform ACORDA of any certification regarding any Patent Assets it has received pursuant to either 21 U.S.C. §§ 355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or under Canada’s Patented Medicines (Notice of Compliance) Regulations Article 5 and shall provide ACORDA with a copy of such certification within five (5) days of receipt.  CSRO’s and ACORDA’s rights with respect to the initiation and prosecution, or defense, of any legal action as a result of such certification or any recovery obtained as a result of such legal action shall be allocated as defined in Subsections 7.3(d) (i) through (iv); provided, however, that ACORDA shall exercise the first right to initiate and prosecute, or defend, any action and shall inform CSRO of such decision within fifteen (15) days of receipt of the certification, after which time, if ACORDA has not advised CSRO of its intention to initiate and prosecute, or defend, such action, CSRO shall have the right to initiate and prosecute, or defend, such action.
 
7.4.                               Patent Term Extensions or Restorations and Supplemental Protection Certificates .  The Parties shall cooperate with each other in obtaining patent term extensions or restorations or supplemental protection certificates or their equivalents in any country in the Territory where applicable and where desired by ACORDA.  If elections with respect to obtaining such extension or supplemental protection certificates are to be made, ACORDA shall have the right to make the election and CSRO shall abide by such election. CSRO shall
 
16

 
notify ACORDA of (a) the issuance of each U.S. patent included within the Patent Assets, giving the date of issue and patent number for each such patent, and (b) each notice pertaining to any patent included within the Patent Assets pursuant to the United States Drug Price Competition and Patent Term Restoration Act of 1984 (hereinafter called the “1984 Act”), including notices pursuant to §§ 101 and 103 of the 1984 Act from persons who have filed an abbreviated new drug application (“ANDA”).  Such notices shall be given promptly, but in any event within five (5) calendar days of each such patent’s date of issue or receipt of each such notice pursuant to the 1984 Act, whichever is applicable.  The Party responsible for filing shall notify the other Party of each filing for patent term extension or restoration under the 1984 Act, any allegations of failure to show due diligence and all awards of patent term restoration (extensions) with respect to the Patent Assets.  Likewise, the responsible Party shall inform the other Party of patent extensions in the rest of the world regarding any Product.
 
ARTICLE VIII
INDEMNIFICATION
 
8.1.                               ACORDA Indemnification.  ACORDA shall indemnify, defend and hold CSRO harmless from and against any and all liabilities, damages, losses, costs or expenses (including reasonable attorney’s and professional fees and other expenses of litigation and/or arbitration) (collectively, “Losses”) resulting from (i) a claim, suit or proceeding brought by a Third Party against CSRO, arising from, or occurring as a result of, activities performed by ACORDA or its sublicensees in connection with the use, development, manufacture or sale of any Product or Compound, except to the extent caused by the negligence or willful misconduct of CSRO; or (ii) a breach of ACORDA’s representations and warranties contained in Article VI.  CSRO shall promptly notify ACORDA of any Loss for which CSRO intends to claim such indemnification, and cooperate fully with ACORDA in the investigation, conduct and defense of any claim covered by this Section 8.1 and provide full information with respect thereto.
 
8.2.                               CSRO Indemnification .  CSRO shall indemnify, defend and hold ACORDA harmless from and against any and all Losses resulting from the negligence or willful misconduct of CSRO or a breach of CSRO’s representations and warranties contained in Article VI.  ACORDA shall promptly notify CSRO of any Loss for which CSRO intends to claim such indemnification, and cooperate fully with ACORDA in the investigation, conduct and defense of any claim covered by this Section 8.2 and provide full information with respect thereto.
 
ARTICLE IX
TERM AND TERMINATION
 
9.1.                               Term and Expiration .  This Agreement shall be effective as of the Effective Date and unless terminated earlier pursuant to Section 9.2 and 9.3 below, the term of this Agreement shall continue in effect until expiration of all royalty or other payment obligations hereunder.   Expiration of this Agreement shall not preclude ACORDA from continuing to make, use or sell Product in the Territory without further compensation to CSRO.
 
17

 
9.2.                               Termination by Notice .  Notwithstanding anything contained herein to the contrary, ACORDA shall have the right to terminate this Agreement at any time by giving thirty (30) days advance written notice to CSRO.  Except as set forth in this Agreement, in the event of such termination, (i) the rights and obligations hereunder, excluding any payment obligation that has accrued as of the termination date and excluding rights and obligations relating to confidentiality, shall terminate immediately, and (ii) the provisions of Section 9.4 shall be applicable.
 
9.3.                               Termination .
 
9.3.1                         Termination for Cause .  Either Party may terminate this Agreement by notice to the other Party at any time during the term of this Agreement as follows:
 
(a)                                   if the other Party is in breach of any material obligation hereunder by causes and reasons within its control, or has breached, in any material respect, any representations or warranties set forth in Article VI, and has not cured such breach within ninety (90) days after notice requesting cure of the breach, provided, however, that if the breach is not capable of being cured within ninety (90) days of such written notice, the Agreement may not be terminated so long as the breaching Party commences and is taking commercially reasonable actions to cure such breach as promptly as practicable; or
 
(b)                                  upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party; provided, however, in the case of any involuntary bankruptcy, reorganization, liquidation, receivership or assignment proceeding such right to terminate shall only become effective if the Party consents to the involuntary proceeding or such proceeding is not dismissed within sixty (60) days after the filing thereof.
 
9.3.2                         Licensee Rights Not Affected .
 
(a)                                   In the event ACORDA terminates this Agreement under Section 9.3.1(b), or this Agreement is otherwise terminated under Section 9.3.1(b), or CSRO is a debtor in a bankruptcy proceeding, whether voluntary or involuntary, all rights and licenses granted pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of 11 U.S.C. §101 et seq. (the “Bankruptcy Code”), licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code.  The Parties agree that ACORDA and CSRO shall retain and may fully exercise all of their respective rights, remedies and elections under the Bankruptcy Code.  The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against CSRO under the Bankruptcy Code, ACORDA shall be entitled to all applicable rights under Section 365 of the Bankruptcy Code, including but
 
18

 
not limited to, entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property upon written request therefor by ACORDA.
 
(b)                                  In the event ACORDA is a debtor in a bankruptcy proceeding, whether voluntary or involuntary, all rights and licenses granted pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365 of the Bankruptcy Code, executory contracts.  The Parties agree that applicable law does not excuse CSRO from accepting performance by, or rendering performance under this Agreement and all rights and licenses granted hereunder to, a person or entity other than ACORDA.
 
9.4.                               Effect of Expiration or Termination.   Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. ACORDA, its Affiliates and its sublicensees shall have the right to sell or otherwise dispose of the stock of any Product subject to this Agreement then on hand or in process of manufacture.  In addition to any other provisions of this Agreement which by their terms continue after the expiration of this Agreement, the provisions of Article IV shall survive the expiration or termination of this Agreement and shall continue in effect for five (5) years from the date of expiration or termination and the provisions of Articles VIII and X shall survive the expiration or termination of this Agreement.  Upon any termination of this Agreement, each party shall promptly return to the other party all Proprietary Information received from the other party (except one copy of which may be retained for archival purposes). In addition, any other provision required to interpret and enforce the Parties’ rights and obligations under this Agreement shall also survive, but only to the extent required for the full observation and performance of this Agreement. Any expiration or early termination of this Agreement shall be without prejudice to the rights of any Party against the other accrued or accruing under this Agreement prior to termination.  Except as expressly set forth herein, the rights to terminate as set forth herein shall be in addition to all other rights and remedies available under this Agreement, at law, or in equity, or otherwise.
 
ARTICLE X
 
MISCELLANEOUS
 
10.1.                         Right to Develop Independently .  Nothing in this Agreement will impair ACORDA’s right to independently acquire, license, develop, or have others develop for it, similar technology performing similar functions to the Products or to market and distribute products based on other technology.
 
10.2.                         Force Majeure .  Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached the Agreement for failure or delay in fulfilling or performing any term of the Agreement during the period of time when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including, but not limited to, fire, flood, embargo, war, acts of war
 
19

 
(whether war be declared or not), insurrection, riot, civil commotion, strike, lockout or other labor disturbance, act of God or act, omission or delay in acting by any governmental authority or the other Party.  The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practicable.
 
10.3.                         Assignment .  The Agreement may not be assigned or otherwise transferred without the prior written consent of the other Party; provided, however, that ACORDA may assign this Agreement to an Affiliate or in connection with the transfer or sale of its business or all or substantially all of its assets related to Compound or Product or in the event of a merger, consolidation, change in control or similar corporate transaction. Any permitted assignee shall assume all obligations of its assignor under this Agreement.
 
10.4.                         Severability .  In the event that any of the provisions contained in this Agreement are held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affect the substantive rights of the Parties.  In such event, the Parties shall replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
 
10.5.                         Notices .  All notices or other communications which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
 
if to ACORDA to:
 
ACORDA THERAPEUTICS, INC.
16 Skyline Drive
Hawthorne, New York 10532
Attention: Ron Cohen
Fax No.: (914) 347-4560
 
if to CSRO to:
 
CANADIAN SPINAL RESEARCH ORGANIZATION
120 Newkirk Road, Unit 2
Richmond Hill, Ontario L4C 9S7
Attention: Barry Munro
Fax No.: (905) 508-4002
 
or to such other address as the Party to whom notice is to be given may have furnished to the other Parties in writing in accordance herewith.  Any such communication shall be deemed to have been given when delivered if personally delivered or sent by facsimile on a Business Day, upon confirmed delivery by nationally-recognized overnight courier if so
 
20

 
delivered and on the third Business Day following the date of mailing if sent by registered or certified mail.
 
10.6.                         Applicable Law .  The Agreement shall be governed by and construed in accordance with the laws of the United States of America and State of New York without reference to any rules of conflict of laws.
 
10.7.                         Dispute Resolution .
 
(a)                                   The Parties agree to attempt initially to solve all claims, disputes, or controversies arising under, out of, or in connection with this Agreement (a “Dispute”) by conducting good faith negotiations.  Any Disputes which cannot be resolved by good faith negotiation within twenty (20) Business Days, shall be referred, by written notice from either Party to the other, to the Chief Executive Officer of each Party. Such Chief Executive Officers shall negotiate in good faith to achieve a resolution of the Dispute referred to them within twenty (20) Business Days after such notice is received by the Party to whom the notice was sent. If the Chief Executive Officers are unable to settle the Dispute between themselves within twenty (20) Business Days, they shall so report to the Parties in writing. The Dispute shall then be referred to mediation as set forth in the following subsection
 
(b)                                  Upon the Parties receiving the Chief Executive Officers’ report that the Dispute referred to them pursuant to subsection (a) has not been resolved, the Dispute shall be referred to mediation by written notice from either Party to the other. The mediation shall be conducted pursuant to the American Arbitration Association (“AAA”) procedures.  The place of the mediation shall be New York, New York.  If the Parties have not reached a settlement within twenty (20) Business Days of the date of the notice of mediation, the Dispute shall be referred to arbitration pursuant to subsection (c) below.
 
(c)                                   If after the procedures set forth in subsections (a) and (b) above, the Dispute has not been resolved, a Party shall decide to institute arbitration proceedings, it shall give written notice to that effect to the other Party.  The Parties shall refrain from instituting the arbitration proceedings for a period of sixty (60) days following such notice.  During such period, the Parties shall continue to make good faith efforts to amicably resolve the dispute without arbitration.  If the Parties have not reached a settlement during that period the arbitration proceedings shall go forward and be governed by the AAA rules then in force. Each such arbitration shall be conducted by a panel of three arbitrators: one arbitrator shall be appointed by each of ACORDA and CSRO and the third arbitrator, who shall be the Chairman of the tribunal, shall be appointed by the two-Party appointed arbitrators. Any such arbitration shall be held in New York, New York, USA.
 
21

 
(d)                                  The arbitrators shall have the authority to direct the Parties as to the manner in which the Parties shall resolve the disputed issues, to render a final decision with respect to such disputed issues, or to grant specific performance with respect to any such disputed issue.  Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be. Nothing in this Section shall be construed to preclude either Party from seeking provisional remedies, including but not limited to, temporary restraining orders and preliminary injunctions, from any court of competent jurisdiction, in order to protect its rights pending arbitration, but such preliminary relief shall not be sought as a means of avoiding arbitration.   In no event shall a demand for arbitration be made after the date when institution of a legal or equitable proceeding based on such claim, dispute or other matter in question would be barred by the applicable statute of limitations.  Each Party shall bear its own costs and expenses incurred in connection with any arbitration proceeding and the Parties shall equally share the cost of the mediation and arbitration levied by the AAA.
 
Any mediation or arbitration proceeding entered into pursuant to this Section 10.6 shall be conducted in the English language. Subject to the foregoing, for purposes of this Agreement, each Party consents, for itself and its Affiliates, to the jurisdiction of the courts of the State of New York, county of New York and the U.S. District Court for the Southern District of New York.
 
10.8.                         Entire Agreement .  This Agreement contains the entire understanding of the Parties with respect to the subject matter hereof and supersedes all previous writings and understandings, including without limitation, the 1995 Agreement. The Parties agree that the 1995 Agreement is hereby terminated, and notwithstanding anything contained therein to the contrary,  is of no further force or effect.  This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by all Parties hereto.
 
10.9.                         Independent Contractors .  It is expressly agreed that the Parties shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture or agency.  Neither Party shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior consent of such other Party.
 
10.10.                   Waiver .  The waiver by a Party hereto of any right hereunder or the failure to perform or of a breach by another Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise.
 
10.11.                   Further Assurances .  At any time or from time to time on and after the Effective Date, CSRO shall at the request of ACORDA (i) deliver to ACORDA such records, data or other documents consistent with the provisions of this Agreement, (ii) execute, and deliver or cause to be delivered, all such consents, documents or further instruments of
 
22

 
transfer or license, and (iii) take or cause to be taken all such actions as ACORDA may reasonably deem necessary or desirable in order for ACORDA to obtain the full benefits of this Agreement and the transactions contemplated hereby.
 
10.12.                   Headings .  The captions to the several Articles and Sections hereof are not a part of the Agreement, but are merely guides or labels to assist in locating and reading the several Articles and Sections hereof.
 
10.13.                   Counterparts .  The Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
 
10.14.                   Use of Names Except as otherwise provided in this Agreement, neither Party shall use the name of the other Party in relation to this transaction in any public announcement, press release or other public document without the consent of such other Party, which consent shall not be unreasonably withheld or delayed; provided, however, that either Party may use the name of the other Party in any document required to be filed to obtain Regulatory Approval or to comply with applicable laws, rules or regulations.
 
10.15.                   LIMITATION OF LIABILITY .  NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY.
 
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first set forth above.

CANADIAN SPINAL RESEARCH ORGANIZATION	
 	
By:	 	 	
 	Name:	Barry Munro	
 	Title:	President	

A CORDA THERAPEUTICS, INC.	
 	
By:	 	 	
 	Name:	 	
 	Title:	 	

23

 
EXHIBIT 1.2
 
ASSIGNMENTS
 
24

 
SCHEDULE 1.6
 
DIAGRAM OF 4-AP
 
4-aminopyridine (“4-AP”), C5H6N2, MW 94

 
25

 
SCHEDULE 1.16
PATENT ASSETS
Case Number:                         A01

Title:	USE OF 4-AMINOPYRIDINE IN THE REDUCTION OF CHRONIC
PAIN AND SPASTICITY IN A SPINAL CORD INJURED PATIENT	Inventor(s):	
 	Hansebout, Robert R.
Blight, Andrew R	
Client:	Acorda Therapeutics Inc.	 	
Owner:	Canadian Spinal Research Organization	 	
Disclosure Status:	Filed	 	
Disclosure Date:	 	 	
Attorney(s):	MF	 	

Country	 	Sub Case	 	Case Type	 	Status	 	Application Number	 	Filing Date	 	Patent Number	 	Issue Date	 	Expiration Date	 	
Australia	 	 	 	PCT	 	Granted	 	56911/94	 	20-Dec-1993	 	676251	 	06-Mar-1997	 	18-Dec-2012	 	
Austria	 	 	 	PCT	 	Granted	 	1993094902578	 	20-Dec-1993	 	0241981	 	15-Jun-2003	 	20-Dec-2013	 	
Bulgaria	 	 	 	PCT	 	Granted	 	99047	 	20-Dec-1993	 	62272	 	12-Nov-1998	 	20-Dec-2013	 	
Canada	 	 	 	PCT	 	Pending	 	2085785	 	20-Dec-1993	 	 	 	 	 	18-Dec-2012	 	
Czech Republic	 	 	 	ORD	 	Granted	 	PV2254-94	 	20-Dec-1993	 	284441	 	11-Nov-1998	 	20-Dec-2013	 	
European Patent Convention	 	 	 	PCT	 	Granted	 	94902578.7	 	20-Dec-1993	 	0626848	 	04-Jun-2003	 	20-Dec-2013	 	
France	 	 	 	EPC	 	Granted	 	94902578.7	 	20-Dec-1993	 	0626848	 	04-Jun-2003	 	20-Dec-2013	 	
Germany, Federal Republic of	 	 	 	EPC	 	Granted	 	94902578.7	 	20-Dec-1993	 	69333014	 	04-Jun-2003	 	20-Dec-2013	 	
Hungary	 	 	 	PCT	 	Granted	 	P94-02647	 	20-Dec-1993	 	219583	 	02-Aug-2001	 	20-Dec-2013	 	
Ireland	 	 	 	EPC	 	Granted	 	94902578.7	 	20-Dec-1993	 	0626848	 	04-Jun-2003	 	20-Dec-2013	 	
Italy	 	 	 	EPC	 	Granted	 	94902578.7	 	20-Dec-1993	 	0626848	 	04-Jun-2003	 	20-Dec-2013	 	
Japan	 	 	 	PCT	 	Granted	 	6-514637	 	20-Dec-1993	 	8504772	 	21-May-1996	 	20-Dec-2013	 	
Korea, Democratic People’s Republic of	 	 	 	PCT	 	Granted	 	P-94-354	 	20-Dec-1993	 	31250	 	30-Aug-1997	 	20-Dec-2013	 	
Korea, Republic of	 	 	 	PCT	 	Granted	 	94-702838	 	20-Dec-1993	 	10-301415	 	25-Jun-2001	 	20-Dec-2013	 	
Liechtenstein	 	 	 	EPC	 	Granted	 	94902578.7	 	20-Dec-1993	 	0626848	 	04-Jun-2003	 	20-Dec-2013	 	
Netherlands	 	 	 	EPC	 	Granted	 	94902578.7	 	20-Dec-1993	 	0626848	 	04-Jun-2003	 	20-Dec-2013	 	
New Zealand	 	 	 	PCT	 	Granted	 	258844	 	20-Dec-1993	 	258844	 	09-Oct-2000	 	20-Dec-2013	 	
Norway	 	 	 	PCT	 	Granted	 	1994 3049	 	20-Dec-1993	 	308.644	 	09-Oct-2000	 	20-Dec-2013	 	
Russian Federation	 	 	 	PCT	 	Granted	 	94041207.00	 	20-Dec-1993	 	2160590	 	20-Oct-2000	 	20-Dec-2013	 	
Singapore	 	 	 	PCT	 	Granted	 	9705418-3	 	19-Apr-1996	 	48615	 	20-Jul-1999	 	19-Apr-2016	 	
Slovakia	 	 	 	PCT	 	Granted	 	PV-0969-94	 	20-Dec-1993	 	280922	 	24-May-2000	 	20-Dec-2013	 	
Spain	 	 	 	EPC	 	Granted	 	94902578.7	 	20-Dec-1993	 	0626848	 	04-Jun-2003	 	20-Dec-2013	 	
Sweden	 	 	 	EPC	 	Granted	 	94902578.7	 	20-Dec-1993	 	0626848	 	04-Jun-2003	 	20-Dec-2013	 	
United Kingdom	 	 	 	EPC	 	Granted	 	94902578.7	 	20-Dec-1993	 	0626848	 	04-Jun-2003	 	20-Dec-2013	 	
United States of America	 	 	 	ORD	 	Granted	 	08/290757	 	13-Sep-1994	 	5545648	 	13-Aug-1996	 	13-Sep-2014	 	
 
Abstract:  A method of reducing chronic pain and spasticity in a spinal cord injured patient in need of such treatment comprising administering an effective amount of 4-aminopyridine to said patient.
 
26

 
EXHIBIT 6.1(o)
 
INTER-INSTITUTIONAL AGREEMENT
 
i

 
Exhibit 10.14
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
LICENSE AGREEMENT
 
THIS LICENSE AGREEMENT (the “ Agreement ”) is made and entered into as of this                  day of                  , 2003 (the “ Effective Date ”) by and between ACORDA THERAPEUTICS, INC. , a corporation organized and existing under the laws of the state of Delaware having a principal place of business at 15 Skyline Drive, Hawthorne, New York 10532 (“ Acorda ”) and CORNELL RESEARCH FOUNDATION, INC. , a non-profit corporation organized and existing under the laws of the state of New York having an office at 20 Thornwood Drive, Suite 105, Ithaca, NY  14850 (“ Foundation ”). Each of Acorda and Foundation may be referred to herein individually as a “ Party ” and collectively, as “ Parties .”
 
RECITALS
 
WHEREAS , Foundation owns all right, title and interest in U.S. Patent No. 5,952,357; and
 
WHEREAS, Foundation is a wholly owned subsidiary of Cornell University (“Cornell”) and holds the ownership interests of patents, know-how, and biological materials made by Cornell’s employees and administers licenses in a manner consistent with the policies of Cornell; and
 
WHEREAS, Acorda desires to obtain and Foundation wishes to grant to Acorda, an exclusive license to U.S. Patent No. 5,952,357, including all intellectual property rights therein, for the development and commercialization of pharmaceutical products for all purposes; and
 
WHEREAS, the work leading to the Licensed Patents was supported in part by an agency of the U.S. Government, and Foundation is obligated to comply with U.S. OMB Circular A-124 and 37 CFR Part 401; and as such, this license is subject to the applicable terms of U.S. Government regulations concerning Government funded inventions.
 
NOW, THEREFORE , for and in consideration of the mutual covenants and the premises herein contained, the Parties, intending to be legally bound, hereby agree as follows:
 
ARTICLE 1
 
DEFINITIONS
 
The following terms as used herein shall have the following meanings:
 
1.1          “Affiliate” shall mean any corporation or non-corporate business entity which controls, is controlled by, or is under common control with a Party to this Agreement.  A corporation or non-corporate business entity shall be regarded as in control of another corporation if it owns, or directly or indirectly controls, at least fifty (50%) percent of the voting stock of the other corporation, or (a) in the absence of the ownership of at least fifty (50%) percent of the voting stock of a corporation or (b) in the case of a non-corporate business entity, or non-profit corporation, if it possesses, directly or indirectly, the power to direct or cause the

 
direction of the management and policies of such corporation or non-corporate business entity, as applicable.
 
1.2          “Clinical Trial” shall mean one of those trials on sufficient number of subjects that are designed to establish that a pharmaceutical product is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product or label expansion of such pharmaceutical product.
 
1.3          “Dollars” shall mean United States dollars.
 
1.4          “Earned Royalties” shall mean royalties payable to Foundation by Acorda for the Sale of a Royalty-Bearing Product, as provided in Section 3.2.
 
1.5          “FDA” shall mean the United States Food and Drug Administration or successor entity.
 
1.6          “Licensed Patents” shall mean U.S. Patent No. 5,952,357, together with any and all substitutions, extensions, divisionals, continuations, or continuations-in-part of such patent (or its parent application), including reexamined and reissued patents, and all foreign counterparts of any of the foregoing.
 
1.7          “Licensed Product” shall mean any product or process that is covered by, or the manufacture or use of which is covered by, a Valid Claim.
 
1.8          “Licensed Territory” shall mean the world.
 
1.9          “Net Sales” shall mean the actual amounts received by Acorda or an Affiliate or sublicensee of Acorda for the Sale of Royalty-Bearing Products to a Third Party purchaser less the following deductions to the extent that such amounts are actually accrued or incurred as to such sales: (a) freight, packaging and insurance costs incurred in transporting the Royalty-Bearing Product to such customers; (b) quantity, cash and other trade discounts or rebates actually allowed and taken, including without limitation, discounts or rebates granted to managed health care organizations or to any governmental agency or branch thereof; (c) customs duties, surcharges, taxes and other governmental charges incurred in connection with the exportation or importation of such Royalty-Bearing Products; and (d) amounts repaid or credited by reason of rejections, recalls or retroactive price reductions.
 
1.10        “Regulatory Approval” shall mean the approvals, registrations or authorizations of the FDA or other applicable regulatory agency necessary for the manufacture, distribution, use or sale of a pharmaceutical or diagnostic product in the United States.
 
1.11        “Royalty-Bearing Product” shall mean the product known as Fampridine-SR for all indications.
 
1.12        “Sale” or “Sold” shall mean the sale, transfer, exchange, or other commercial disposition of Royalty-Bearing Products by Acorda, its Affiliates or sublicensees.  In case of doubt, Sales of Royalty-Bearing Products shall be deemed consummated no later than receipt of
 
2

 
payment from a Third Party for the applicable transaction involving such Royalty Bearing Product.
 
1.13        “Third Party” shall mean any entity or individual other than Acorda, Foundation or an Affiliate of either of them.
 
1.14        “Valid Claim” shall mean: (a) an issued claim of any unexpired patent included among the Licensed Patents, which patent has not been (i) held unenforceable, unpatentable or invalid by a decision of a court or governmental body of competent jurisdiction that is not further appealable, (ii) rendered unenforceable through reexamination, reissue, disclaimer or otherwise, (iii) lost through an interference proceeding or (iv) abandoned; or (b) a claim of a pending application within the Licensed Patents, provided that not more than five (5) years have elapsed from the date the claim takes priority for filing purposes.
 
ARTICLE 2
 
GRANT OF LICENSE
 
2.1          License.   Subject to the terms and conditions of this Agreement and to the rights of and obligations to the U.S. Government as set forth in U.S. Office of Management & Budget Circular A-124 or 37 CFR Part 401 et seq., Foundation hereby grants to Acorda and its Affiliates and Acorda hereby accepts an exclusive, fully sublicenseable license under the Licensed Patents to practice the inventions claimed therein and to research, develop, make, have made, use, sell, offer for sale, have sold, import and otherwise exploit Licensed Products in the Licensed Territory during the term of this Agreement.
 
2.2          Retained License.   The license granted in Section 2.1 above are further subject to a right and license retained by Foundation and Cornell to practice the Licensed Patents and any improvements thereto for non-commercial academic research and education purposes only.
 
2.3          Sublicenses.   Acorda may grant sublicenses to Third Parties under the license in Section 2.1 to practice Licensed Patents and to research, develop, make, have made, use, sell, offer for sale, have sold, import or otherwise exploit Licensed Products upon prior written approval by Foundation, such approval not to be unreasonably withheld or delayed.  If Acorda fails to obtain the prior written consent of Foundation to a sublicense agreement, Foundation shall have the right to either terminate this Agreement pursuant to Section 10.3 or require that the sublicense be terminated.  Any such sublicense shall contain all the provisions of this Agreement which are protective of and beneficial to Foundation and Acorda shall be responsible to Foundation for the payment of Earned Royalties on Net Sales made by such sublicensees as though they were Net Sales made by Acorda.
 
2.4          No Implied License.   The license and rights granted in this Agreement shall not be construed to confer any rights upon Acorda by implication, estoppel, or otherwise as to any technology not specifically identified in this Agreement as Licensed Patents.
 
2.5          Government Regulations.  Acorda shall alone have the obligation to ensure that any Licensed Product it makes, uses, or sells, leases, or otherwise disposes of is not defective,
 
3

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
that any Licensed Product satisfies all applicable government regulations and that any export of any Licensed Product satisfies export requirements.
 
ARTICLE 3
 
COMPENSATION
 
3.1          License Execution Fee.   Within ten (10) days of the Effective Date, Acorda shall pay Foundation a license execution fee of [**].
 
3.2          Earned Royalties on Royalty-Bearing Products.  For Sales of Royalty-Bearing Product in the Licensed Territory, Acorda shall pay or cause to be paid to Foundation Earned Royalties equal to the following percentages of the aggregate annual Net Sales of such Royalty-Bearing Product by Acorda, its Affiliates and its sublicensees:
 
(a)           for the portion of such aggregate annual Net Sales of such Royalty-Bearing Product less than [**] in any calendar year, [**] of such Net Sales;
 
(b)           for the portion of such aggregate annual Net Sales of such Royalty-Bearing Product between [**] and up to [**] in any calendar year, [**] of such Net Sales; and
 
(c)           for the portion of such aggregate annual Net Sales of such Royalty-Bearing Product greater than [**] in any calendar year, [**] of such Net Sales.
 
3.3          Annual Minimum Royalty .
 
(a)           Subject to Section 3.3(b), if Acorda’s annual Earned Royalties payment for the Royalty-Bearing Product to Foundation pursuant to Section 3.2 after the first full calendar year anniversary following the date of Regulatory Approval for the Royalty-Bearing Product, or in any calendar year thereafter, is less than [**] (the “ Minimum Royalty ”), Acorda shall make or cause to be made a payment to Foundation within sixty (60) days after the end of such applicable calendar year equal to the difference between the Minimum Royalty and the total Earned Royalties payment to Foundation for all Royalty-Bearing Products for that calendar year, together with the applicable report in accordance with Article 4.
 
(b)           If during a given calendar year, the Earned Royalties payment to Foundation pursuant to Section 3.2 for Royalty-Bearing Products exceeds the Minimum Royalty for such year pursuant to Section 3.3(a), Acorda shall have satisfied the requirements of Section 3.3(a) for such year without any additional payment needed.
 
3.4          Milestone Payments.  Acorda shall pay Foundation a milestone payment in the amount specified below no later than [***] days after the occurrence of Milestone 1 and [***] days after the occurrence of Milestone 2, both milestones as defined below.
 
4

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

Event	 	Milestone Payment	 	
 	 	 	 	
(i) The effective date of a successful reissuance or reexamination of the Licensed Patents (“ Milestone 1 ”).	 	$	[**]	 	
 	 	 	 	 	
(ii) The date of completion of a Clinical Trial testing the use of Fampridine-SR in Amyotrophic Lateral Sclerosis (ALS), provided that such Clinical Trial shall be initiated at Acorda’s discretion and a negative or non-statistically significant trial would not trigger this milestone (“ Milestone 2 ”).	 	$	[**]	 	
 
No milestone payment shall be paid more than once to Foundation pursuant to this Section 3.4.  Milestone 1 and Milestone 2 are independent of each other and Milestone 2 may occur prior to Milestone 1.  In any event, Acorda shall pay the specified milestone payment only upon the occurrence of the corresponding milestone event, regardless of the order of occurrence of the milestone events.
 
3.5          Research Support.   Pursuant to a sponsored research agreement to be negotiated by the Parties, Acorda shall pay Foundation [**] per year for research support for two (2) years beginning the first full calendar year of commercial sales for the Royalty-Bearing Product, Fampridine-SR.  Such sponsored research agreement shall include commercially reasonable terms and conditions as are typical for sponsored research agreements of similar nature in the biotechnology industry as discussed and agreed upon in good faith by the Parties, and further, shall provide that the payment for the first year shall be due within sixty (60) days after the commencement of commercial sales for the Royalty-Bearing Product while the second payment shall be due within sixty (60) days after the first anniversary of commercial sales for the Royalty-Bearing Product.
 
ARTICLE 4
 
REPORTS, PAYMENTS AND ACCOUNTING
 
4.1          Earned Royalties Reports and Records.   During the term of this Agreement, Acorda shall furnish, or cause to be furnished to Foundation, quarterly written reports governing each of Acorda and its Affiliates and sublicensees for each fiscal quarter showing, as applicable:
 
(a)           the gross sales of all Royalty Bearing Products Sold by Acorda, its Affiliates and sublicensees, in the Licensed Territory during the reporting period, together with the calculations of Net Sales in accordance with Section 1.9;
 
(b)           the Earned Royalties payable in Dollars, which shall have accrued hereunder in respect to such Net Sales;
 
(c)           the exchange rates, if any, in determining the amount of Dollars; and
 
5

 
(d)           the occurrence of any event triggering a milestone payment obligation in accordance with Section 3.4.
 
4.2          Payment Terms.  Acorda shall provide Foundation with quarterly written reports of all sales, or other dispositions of Licensed Products by Acorda and its Affiliates and sublicensees.  In order to minimize Acorda’s time spent on royalty reports, a brief one-page report form (a “ Royalty Report Form ”), substantially the same as the form attached in Appendix A, will satisfy Foundation’s reporting requirements under this Section 4.2.  The report shall be made within forty-five (45) days after the end of each calendar quarter; provided, however , that if an Acorda sublicense provides that the sublicensee can submit its respective reports to Acorda forty-five (45) days or more after the end of each calendar quarter, Acorda may then delay submitting its royalty report under this Section 4.2 to Foundation with respect to such sublicensee until sixty (60) days after the end of each calendar quarter.  Foundation agrees to keep the information in these reports confidential, except as may be necessary to maintain an action against Acorda for breach of this Agreement.  Royalty payments for Net Sales of the Licensed Products invoiced during a calendar quarter shall accompany the Royalty Report Form for that quarter.  The Royalty Report Form shall be submitted regardless of whether or not royalties are owed.  Payments shall be made in Dollars.  Conversion from foreign currencies, if any, shall be based upon the conversion rate published in The Wall Street Journal on the last day of the particular quarterly accounting period (or on the last business day on which The Wall Street Journal is published during said quarterly period) for which royalties are due.  Royalty checks shall be made payable to Cornell Research Foundation Inc. and mailed to the address specified in Section 12.11.
 
4.3          Minimum Royalty Calculation .  Acorda shall provide in the Royalty Report Form for the last quarter in each calendar year, the total Earned Royalties paid by Acorda to the Foundation for such calendar year and if such total is less than the Minimum Royalty, Acorda shall pay Foundation an amount equal to the difference between the total Earned Royalties paid in such calendar year and the Minimum Royalty.
 
4.4          Right to Audit.   Foundation shall have the right, upon prior written notice to Acorda, not more than once in each Acorda fiscal year, to engage an independent nationally-certified auditing firm selected by Foundation and acceptable to Acorda, which acceptance shall not be unreasonably withheld or delayed, to have access during normal business hours of Acorda as may be reasonably necessary to verify the accuracy of the Earned Royalties reports required to be furnished by Acorda pursuant to Section 4.1 of the Agreement.  If such audit by Foundation shows any underpayment of Earned Royalties by Acorda, its Affiliates or sublicensees, then, within thirty (30) days after Acorda’s receipt of such report, Acorda shall remit or shall cause its sublicensees to remit to Foundation:
 
(a)           the amount of such underpayment; and
 
(b)           if such underpayment exceeds five percent (5%) of the total Earned Royalties owed for the fiscal year then being reviewed, the reasonably necessary fees and expenses of such auditing firm performing the audit.  Otherwise, such fees and expenses shall be borne solely by Foundation.  Any overpayment of Earned Royalties shall be fully creditable against future Earned Royalties payable in any subsequent royalty period.
 
6

 
4.5          Confidentiality of Records.   All information subject to review under this Article 4 shall be deemed Acorda’s Confidential Information (as defined in Section 9.1). The independent nationally-certified auditing firm shall not disclose to Foundation or to any Third Party any such Confidential Information, except for any Confidential Information showing a discrepancy in amount owed to Foundation, and Foundation shall not use any such information for any purpose other than determining and enforcing its rights under this Agreement.  Foundation agrees to hold such records confidential, except as may be necessary to maintain an action against Acorda for breach of this Agreement.
 
4.6           The records required under Article 4 shall be maintained and available for inspection for a period of five (5) years following the calendar quarter to which they pertain.  This Section 4.6 shall survive termination of this Agreement.
 
4.7           Payments due under this Agreement that are more than the sixty (60) days late shall be subject to a twenty percent (20%) per annum interest charge.
 
4.8           Acorda shall keep Foundation appropriately informed about Acorda’s development and commercialization efforts with respect to Licensed Products.  Without limiting the generality of the foregoing, Acorda shall provide Foundation with written notice of significant development, regulatory approval and commercialization plans, activities and results with respect to Licensed Products.  In addition, on each anniversary of the Effective Date during the term of this Agreement (commencing with the first (1 st ) anniversary thereof), Acorda shall provide Foundation with a written annual report summarizing Acorda’s efforts and progress in developing and commercializing Licensed Products during the immediately preceding twelve (12) months.
 
ARTICLE 5
 
PATENTS AND PATENT COSTS
 
5.1          Prosecution and Maintenance of Licensed Patents.  Foundation shall be primarily responsible for all patent prosecution and maintenance activities pertaining to Licensed Patents.  Foundation shall keep Acorda reasonably informed of its activities relating to the filing, prosecution and maintenance of Licensed Patents, including providing copies of all filings and correspondence with patent authorities, in a timely manner, so as to give Acorda an opportunity to comment thereon.  Foundation shall use good faith efforts to accommodate all such comments.  Without limiting the generality of the foregoing, Foundation shall work collaboratively with Acorda to secure the reissuance or reexamination of the Licensed Patents in a manner acceptable to Foundation and Acorda.  Acorda agrees to keep any documentation received under this Section 5.1 confidential in accordance with Article 9 herein.
 
5.2          Future Patent Costs.  Acorda shall pay all fees and out-of-pocket costs incurred by Foundation pursuant to its activities under Section 5.1 after the Effective Date for on-going patent prosecution and maintenance activities for the Licensed Patents (the “ Future Patent Costs ”).  Acorda shall reimburse Foundation, no later than thirty (30) days after receipt of an invoice from Foundation for such Future Patent Costs.
 
7

 
5.3          Acorda’s Payment Obligation.   Acorda’s obligation, pursuant to Section 5.2 to pay for domestic and foreign patent filing, prosecution, and maintenance costs for Licensed Patents shall continue for so long as this Agreement remains in effect, provided, however, that Acorda may terminate its obligations with respect to any given patent application or patent in the Licensed Patents in any particular country or jurisdiction upon thirty (30) days written notice to Foundation, provided, further, that Acorda’s rights under such patent applications or patents in such countries, for which it has terminated its payment obligations pursuant to this Section 5.3, shall terminate.  Patent costs already committed to prior to the date of the termination notice and which are not cancelable, shall be the responsibility of Acorda and shall survive termination of this Agreement.
 
ARTICLE 6
 
INFRINGEMENT
 
6.1          Enforcement of Patents.  If either Acorda or Foundation becomes aware of a product made, used or sold in the Licensed Territory, which it believes infringes a Valid Claim, the Party obtaining such knowledge shall promptly advise the other Party of all relevant facts and circumstances pertaining to the potential infringement.  Acorda shall have the first right, but not the obligation, to enforce any patent rights within the Licensed Patents against such infringement, at its own expense.  Foundation shall cooperate with Acorda in such effort, at Acorda’s expense, including being joined as a Party to such action, if necessary.  Any damages or costs recovered in connection with any action filed by Acorda hereunder which exceed Acorda’s out-of-pocket costs and expenses of litigation, shall be deemed to be the proceeds of Sales of Royalty-Bearing Products in the fiscal quarter received by Acorda, and Earned Royalties shall be payable by Acorda to Foundation thereon in accordance with the terms of this Agreement.
 
6.2          Backup Enforcement Right of Foundation.   If Acorda fails within one hundred twenty (120) days after receiving notice from Foundation of a potential infringement, or providing Foundation with notice of such infringement, to either (a) terminate such infringement or (b) institute an action to prevent continuation thereof and, thereafter to prosecute such action diligently, or if Acorda notifies Foundation that it does not plan to terminate the infringement or institute such action, then Foundation shall have the right to do so at its own expense; provided however, that Foundation first consults with Acorda and gives due consideration to Acorda’s reasons for not instituting actions to terminate or otherwise prevent continuation of such infringement.  If Foundation decides to pursue such infringement, Acorda shall cooperate with Foundation in such effort including being joined as a Party to such action if necessary.  Foundation shall be entitled to retain all damages or costs awarded to Foundation in such action.
 
8

 
ARTICLE 7
 
REPRESENTATIONS AND WARRANTIES; EXCLUSION OF WARRANTIES
 
7.1          Foundation Representations and Warranties.
 
(a)           Foundation represents and warrants that it has the right to enter into this Agreement.  Foundation warrants that it has the right to convey to Acorda the rights granted under this Agreement.
 
(b)           Foundation warrants that it is the sole owner of Licensed Patents prior to the effective date of this Agreement, and has not granted any license or other rights to any third party under the Licensed Patents which rights are still in existence, subject to U.S. government regulations concerning government funded inventions.
 
(c)            Foundation makes no representation or warranty that Licensed Patents will be reissued.
 
(d)            Foundation makes no representations or warranties concerning the validity or scope of any Licensed Patents.
 
(e)            Foundation does not warrant that any Licensed Product made, used, sold, leased or otherwise disposed of under the license of this Agreement is or will be free from infringement of patents of third parties.
 
(f)             Nothing herein shall be construed as granting by implication, estoppel, or otherwise any licenses or rights under patents or other rights of Foundation or Cornell or other persons other than Licensed Patents, regardless of whether such patents or other rights are dominant or subordinate to any Licensed Patents.
 
(g)            Foundation is under no obligation to furnish any technology or technological information other than the Licensed Patents.
 
(h)            Nothing herein shall be construed to grant Acorda rights under any applications or patents other than Licensed Patents.
 
(i)             Foundation does not make any representations, extend any warranties of any kind, express or implied, or assume any responsibility whatever concerning the manufacture, use, or sale, lease or other disposition by Acorda or its vendees or transferees of Licensed Products.
 
(j)             Except as expressly set forth in this Agreement, FOUNDATION MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE LICENSED PRODUCTS WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER RIGHTS OR ANY OTHER EXPRESS OR IMPLIED WARRANTIES.
 
7.2          Acorda Representations and Warranties.   Acorda represents, warrants and covenants to Foundation that:
 
(a)           this Agreement is a legal and valid obligation of, binding upon, and enforceable against Acorda in accordance with the terms of this Agreement;
 
9

 
(b)           Acorda has the right to enter into this Agreement and perform the obligations set forth in this Agreement; and
 
(c)           the execution, delivery and performance of this Agreement does not conflict with, constitute a breach of, or in any way violate any arrangement, understanding or agreement to which Acorda is a party or by which Acorda is bound.
 
ARTICLE 8
 
INDEMNIFICATION; LIMITATION OF LIABILITY
 
8.1          Indemnification by Acorda.  Acorda shall defend, indemnify and hold harmless Foundation and Cornell and their respective trustees, officers, directors, employees, agents and students (the “ Foundation Indemnitees ”), from and against any and all losses, liabilities, expenses or damages (including reasonable attorneys’ fees) (collectively, the “ Losses ”) resulting from claims made or legal proceedings instituted, made or brought against Foundation and/or Cornell by a Third Party arising or alleged to arise by reason of, or in connection with, any and all personal injury (including death) and property damage caused or contributed to, in whole or in part, by the manufacture, testing, design, use, Sale or labeling of any Licensed Products by Acorda, its Affiliates, contractors, agents, or sublicensees, except to the extent of any Losses that arise from the negligence or intentional misconduct of Foundation Indemnitees.
 
8.2          In the event Foundation is found to be in breach of Sections 7.1(a) and/or 7.1(b) of this Agreement, Foundation shall use its best efforts to remedy such breach within ninety (90) days of receipt by Foundation of written notification that such a breach has occurred.  If Foundation is unable to remedy such breach within ninety (90) days after receiving such written notification of a breach, Foundation shall use its best efforts to obtain the right to grant, and to grant to Acorda, a non-exclusive, fully sublicenseable license under the Licensed Patents to practice the inventions claimed therein and to research, develop, make, have made, use, sell, offer for sale, have sold, import and otherwise exploit Licensed Products in the Licensed Territory pursuant to a new license agreement, the terms of which will be negotiated in good faith by the Parties (which terms shall be no less favorable to Acorda than the terms of this Agreement).  Foundation shall not be liable for any indirect, special, consequential, or other damages whatsoever, whether grounded in tort (including negligence), strict liability, contract or otherwise. Foundation shall not have any responsibilities or liabilities whatsoever with respect to Licensed Products.
 
8.3          Indemnification Procedure.   To be indemnified hereunder, the Foundation shall provide Acorda with prompt notice of the claim giving rise to the indemnification obligation pursuant to this Article 8 and the exclusive ability to defend (with the reasonable cooperation of Foundation) or settle any such claim provided however , that Acorda shall not enter into any settlement for damages other than monetary damages without the Foundation’s written consent, such consent not to be unreasonably withheld or delayed.  The Foundation shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by Acorda.
 
10

 
8.4          Insurance.   Acorda shall maintain commercially reasonable levels of insurance or other adequate forms of protection to satisfy its indemnification obligations under this Agreement.
 
ARTICLE 9
 
CONFIDENTIALITY
 
9.1          Nondisclosure of Confidential Information.   Except as otherwise provided hereunder, during the term of this Agreement and for a period of five (5) years thereafter, Acorda and Foundation each agrees to retain in strict confidence, use only for the purposes of this Agreement, and not disclose any written information or data supplied by one Party to the other under this Agreement and marked as proprietary or confidential without the prior written consent of the disclosing Party.  For purposes of this Agreement, all such information and data which a Party is obligated to retain in confidence shall be “ Confidential Information .”
 
9.2          Permitted Disclosure.   It shall not be a breach of this Article 9 if the recipient Party is required to disclose the other Party’s Confidential Information pursuant to an order of the government or a court of competent jurisdiction, provided that the recipient Party (a) provides the other Party with adequate notice of the required disclosure, (b) cooperates with the other Party’s efforts to protect its Confidential Information with respect to such disclosure and (c) takes all reasonable measures requested by the other Party to challenge or to modify the scope of such required disclosure.  To the extent that it is reasonably necessary to fulfill its obligations or exercise its rights under this Agreement, or any rights which survive termination or expiration hereof, the recipient Party may disclose Confidential Information of the other Party to its Affiliates, sublicensees, consultants, outside contractors and clinical investigators provided that such entities or persons are bound by obligations of confidentiality and non-use as strict as the obligations in this Agreement and agree to use the Confidential Information only for such purposes as the recipient Party is authorized to use the Confidential Information.
 
9.3          Exceptions.   The obligation under Section 9.1 not to use or disclose Confidential Information shall not apply to any part of such Confidential Information that the recipient Party can establish by competent written proof:
 
(a)           is or becomes patented, published or otherwise part of the public domain, other than by unauthorized acts of the recipient Party obligated not to disclose such Confidential Information, its Affiliates or sublicensees in contravention of this Agreement;
 
(b)           is disclosed to the recipient Party, its Affiliates or sublicensees by a Third Party having the right to disclose it;
 
(c)           prior to disclosure under this Agreement, was already in the possession of the recipient Party, its Affiliates or sublicensees, as proven through contemporaneous documentation;
 
(d)           results from the research and development by the recipient Party, its Affiliates or sublicensees, independent of disclosures from the disclosing Party of this
 
11

 
Agreement, provided that the persons developing such information have not had exposure to the Confidential Information received from the disclosing Party; or
 
(e)           Acorda and Foundation agree in writing may be disclosed.
 
9.4          Publication.   It is the policy of Foundation and Cornell to promote and safeguard free and open inquiry by faculty, students and others.  To further this policy, Foundation and Cornell shall retain the right to publish the technology described in Licensed Patents.  Foundation and Cornell shall use reasonable efforts to furnish Acorda with a copy of any proposed publication relating to the Licensed Products at least sixty (60) days in advance of the publication date.  Within this sixty (60) day period, Acorda shall review such proposed publication to determine whether Acorda desires to file patent applications on subject matter contained therein and if it is determined that a patent application should be filed, such patent application shall be filed within this sixty (60) day period.
 
ARTICLE 10
 
TERM AND TERMINATION
 
10.1        Term.   Unless sooner terminated as otherwise provided in this Agreement, the term of this Agreement shall commence on the Effective Date hereof and shall continue in full force and effect until the expiration of the last to expire Valid Claim.
 
10.2        Termination by Acorda.   Acorda may terminate this Agreement at any time upon forty five (45) days prior written notice to Foundation.
 
10.3        Termination for Material Breach.   If either Party breaches a material obligation under this Agreement, the other Party shall have the right to give the breaching Party written notice describing the alleged breach.  If the breaching Party does not cure such breach within sixty (60) days after receipt of such notice, the notifying Party may, in addition to any other rights it may have under this Agreement, terminate this Agreement effective immediately.  However, if there is a dispute between the Parties as to termination under this Section 10.3, no termination shall be effected until such dispute is resolved pursuant to Section 12.1.
 
10.4        Upon termination of this Agreement for any reason, including the end of term as specified above, all rights and obligations under this Agreement shall terminate, except those that have accrued prior to termination and except as specified in the Agreement.
 
ARTICLE 11
 
ASSIGNMENT
 
Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other, except a Party may make such an assignment without the other Party’s written consent to an Affiliate or to a successor to all, or substantially all, of the business to which this Agreement relates of such Party, whether in a merger, sale of stock, sale of assets or other transaction. Any permitted successor or assignee of rights and/or obligations hereunder shall, in writing to the other Party, expressly assume
 
12

 
performance of such rights and/or obligations.  Any permitted assignment shall be binding on the successors of the assigning Party.  Any assignment or attempted assignment by either Party in violation of the terms of this Article 11 shall be null and void and of no legal effect.
 
ARTICLE 12
 
MISCELLANEOUS
 
12.1        Dispute Resolution.   If any disputes, controversies or claims arise out of, or in connection with, this Agreement (each, a “ Dispute ”), the Parties shall notify each other in writing of such Dispute and will use good faith efforts to resolve the Dispute.  If the Parties are unable to resolve such Dispute within ten (10) business days of a Party receiving notification from the other Party and requesting resolution of such Dispute, then either Party may, for a period of thirty (30) days thereafter, request in writing that such Dispute be resolved through arbitration, and such arbitration shall be conducted under the auspices of the American Arbitration Association pursuant to that organization’s rules for commercial arbitration.  If neither Party requests to resolve the Dispute through arbitration within such thirty (30) day period, then either Party may pursue resolution through any court of competent jurisdiction in accordance with Section 12.7.  Notwithstanding the foregoing, either Party may apply to a court of competent jurisdiction for a temporary restraining order, a preliminary or permanent injunction, or other equitable relief.
 
12.2        Notwithstanding Section 12.1, Foundation reserves the right and power to proceed with direct judicial remedies against Acorda without conciliation, mediation, mediation, arbitration or disputer resolution for breach of the royalty and/or milestone payments and sales reporting provisions of this Agreement after giving written notice of such breach to Acorda followed by an opportunity period of sixty (60) days in which to cure such breach.  In collecting overdue royalty and milestone payments and securing compliance with reporting obligations, Foundation may use all judicial remedies available.
 
12.3        Legal Compliance.   Acorda shall comply with all laws and regulations relating to its manufacture, use, Sale, labeling or distribution of Licensed Products and shall not take any action which would cause Foundation or Acorda to violate any applicable laws or regulations.
 
12.4        Independent Contractor.   Acorda’s relationship to Foundation shall be that of a licensee only.  Neither Party shall be considered to be an employee or agent of the other, nor shall this Agreement constitute, create or in any way be interpreted as a joint venture, partnership or formal business organization of any kind.  In that respect, neither Party shall have the authority to execute any agreement on behalf of the other Party, nor shall either Party have any authority to negotiate any agreement, except as the other Party may expressly direct in writing.
 
12.5        Patent Marking.   Acorda agrees to mark the appropriate patent number or numbers on all Licensed Products made or Sold in the Licensed Territory in accordance with all applicable governmental laws, rules and regulations, and to requires its sublicensees to do the same.
 
13

 
12.6        Use of Names.   Acorda shall  not use, nor shall Acorda permit sublicensees to use, the names, trademarks, logos or symbols of Foundation or Cornell University, or their respective employees, students and faculty members for any commercial purpose, except as required to comply with law, regulation or court order, without the prior written approval of Foundation. Foundation shall obtain the prior written approval of Acorda prior to making use of the name, trademarks, logos or symbols of Acorda for any commercial purpose, except as required to comply with law, regulation or court order.
 
12.7        Governing Law.  This Agreement and all amendments, modifications, alterations, or supplements hereto, and the rights of the Parties hereunder, shall be construed under and governed by the laws of the State of New York, U.S.A (without regard to its laws regarding choice of law) and the United States of America.  Only federal or state courts located in the State of New York, U.S.A., shall have jurisdiction to hear and decide any controversy or claim between the Parties arising under or relating to this Agreement.
 
12.8        Entire Agreement.   This Agreement and the Appendices attached hereto and incorporated herein constitutes the entire, final and exclusive agreement between the Parties hereto and supercedes and terminates all prior agreements and understandings between the Parties with respect to the subject matter hereof.  No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.
 
12.9        Survival.   Articles 7, 8, 9, and 12 and Section 4.6 shall survive termination of this Agreement for any reason.
 
12.10      Severability.   All rights and restrictions contained herein may be exercised and shall be applicable and binding only to the extent that they do not violate any applicable laws and are intended to be limited to the extent necessary so that they will not render this Agreement illegal, invalid or unenforceable.  If any provision or portion of any provision of this Agreement, not essential to the commercial purpose of this Agreement, shall be held to be illegal, invalid or unenforceable by a court of competent jurisdiction, it is the intention of the Parties that the remaining provisions or portions thereof shall constitute their agreement with respect to the subject matter hereof, and all such remaining provisions, or portions thereof, shall remain in full force and effect.  To the extent legally permissible, any illegal, invalid or unenforceable provision of this Agreement shall be replaced by a valid provision which shall implement the commercial purpose of the illegal, invalid, or unenforceable provision.  In the event that any provision essential to the commercial purpose of this Agreement is held to be illegal, invalid or unenforceable and cannot be replaced by a valid provision which will implement the commercial purpose of this Agreement, the Party who is the beneficiary of such illegal, invalid or unenforceable provision has the right to terminate this Agreement upon written notice, effective upon receipt, to the other Party.
 
12.11      Notices .  Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement and shall be deemed to have been sufficiently given for all purposes if mailed by first class certified or registered mail, postage prepaid, express delivery service or personally delivered.  Unless otherwise specified in writing, the mailing addresess of the Parties shall be as described below.
 
14

 

For Acorda:	 	Acorda Therapeutics, Inc.
15 Skyline Drive
Hawthorne, New York 10532
Attention: Harold Safferstein
Title: Vice President, Business Development	
 	 	 	
For Foundation:	 	 	

Payments to Foundation shall be sent to:	 	 	

 	 	Cornell Research Foundation, Inc.
20 Thornwood Drive, Suite 105
Ithaca, NY 14850
Attn:      Accounting
Phone:   607-257-1081
Fax:       607-257-1015	
All other communications to Foundation shall be sent to:	

 	 	Cornell Research Foundation, Inc.
418 E. 71 st Street, Suite 61
New York, NY 10021
Attn:Brian J. Kelly, Vice President
Phone:   212-746-6186
FAX:     212-746-6662	
 
12.12      Force Majeure.  Any delays in, or failure of, performance of any Party to this Agreement shall not constitute a default hereunder, or give rise to any claim for damages, if and to the extent caused by occurrences beyond the control of the Party affected, including, but not limited to, acts of God, acts of terrorism, strikes or other concerted acts of workmen, civil disturbances, fires, floods, earthquakes, explosions, riots, war, rebellion, sabotage, acts of governmental authority or failure of governmental authority to issue licenses or approvals which may be required.
 
15

 
12.13      No Waiver.   The failure by either Party, at any time, or for any period of time, to enforce any of the provisions of this Agreement, shall not be construed as a waiver of such provisions or as a waiver of either Party’s rights thereafter to enforce each and every such provision of this Agreement.
 
12.14      Counterparts.   This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which shall constitute one and the same instrument.
 
IN WITNESS WHEREOF, Acorda and Foundation have caused this Agreement to be signed, under seal, by their duly authorized representatives below.

ACORDA THERAPEUTICS, INC.	CORNELL RESEARCH FOUNDATION, INC.	

By:	 	 	By:	 	 	
 	 	
Name:	 	 	Name:	 	 	
 	 	
Title:	 	 	Title:	 	 	

16

 
TABLE OF CONTENTS

ARTICLE 1	DEFINITIONS	
 	 	
ARTICLE 2	GRANT OF LICENSE	
 	 	
ARTICLE 3	COMPENSATION	
 	 	
ARTICLE 4	REPORTS, PAYMENTS AND ACCOUNTING	
 	 	
ARTICLE 5	PATENTS AND PATENT COSTS	
 	 	
ARTICLE 6	INFRINGEMENT	
 	 	
ARTICLE 7	REPRESENTATIONS AND WARRANTIES; EXCLUSION OF WARRANTIES	
 	 	
ARTICLE 8	INDEMNIFICATION; LIMITATION OF LIABILITY	
 	 	
ARTICLE 9	CONFIDENTIALITY	
 	 	
ARTICLE 10	TERM AND TERMINATION	
 	 	
ARTICLE 11	ASSIGNMENT	
 	 	
ARTICLE 12	MISCELLANEOUS	
 
i

 
APPENDIX A - ROYALTY REPORT
 
Report royalty payment information to the Cornell Research Foundation, Inc (CRF) using the report format or facsimile attached to these instructions.  This minimal information must be provided in order to correctly record royalty related events required by your license agreement with CRF.
 
Use a separate report to record royalty information for each license agreement.  For each licensee agreement, report royalty sales by CRF docket number, which identifies the technology.  List each contributing technology if more than one technology is used to produce a royalty generating process/product.  This level of detail permits evaluation of the use of each technology under license with your company.
 
Submit this information along with appropriate payment to:
 
Cornell Research Foundation, Inc.
ATTN:  Finance and Accounting
20 Thornwood Drive, Suite 105
Ithaca, NY  14850
(607) 257-1081
www.crf.cornell.edu
 
For your convenience, payments may be made by FEDWIRE or ACH to:
Tompkins Trust Company
The Commons     
Ithaca, NY  14851
(607) 273-3210
www.tompkinstrust.com
 
Account:  01-101-007353, ABA: 021302648

 
ROYALTY REPORT – [licensee NAME]

LICENSEE NAME:	CRF LICENSE NUMBER:	
 
REPORTING PERIOD:
 
Individual to contact concerning this information:

Name:	Phone # or email ID:	
 
For each product/item subject to a royalty payment provision, provide the following information as applicable.
 
PRODUCT/ITEM:

CRF Docket Number	 	Country	 	Number of
Units/Products Sold	 	Gross Sales By
Country	 	Net Sales By
Country	 	Royalty Rate	 	Less Minimum Royalty
Payment Made	 	Net Royalty
Payment Due	 	

 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	

 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	 	 	 	 	Total Payment	 	 	 	
 
3

 
Exhibit 10.15
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
LICENSE AGREEMENT
 
THIS LICENSE AGREEMENT (the “Agreement”) is made and entered into as of November 12, 2002 (the “Effective Date”), by and between Acorda Therapeutics, Inc., a corporation organized and existing under the laws of the State of Delaware and having a principal place of business at 15 Skyline Drive, Hawthorn, New York, USA 10532 (“Acorda”), and CeNeS Pharmaceuticals, PLC, a corporation organized and existing under the laws of the United Kingdom and having a principal place of business at Compass House, Vision Park, Chivers Way, Histon, Cambridge CB4 9ZR, England (“CeNeS”).
 
WHEREAS, CeNeS is the exclusive licensee of certain intellectual property rights pursuant to that certain agreement, as amended, entered into by and between the Ludwig Institute for Cancer Research (“Ludwig”) and Cambridge Neuroscience Research, Inc. dated October 26, 1989 (the “Ludwig Agreement”);
 
WHEREAS, CeNeS and Acorda are parties to that certain License Option Agreement dated as of April 3, 2002, as amended, (the “License Option Agreement”), pursuant to which CeNeS granted Acorda the option to take a sublicense of certain rights licensed to CeNeS under the Ludwig Agreement; and
 
WHEREAS, Acorda desires to exercise such option and to take a sublicense of such rights as set forth herein,
 
NOW, THEREFORE, intending to be legally bound and upon the terms, conditions and mutual covenants hereinafter set forth, the parties agree as follows:

 
Part 1 - Definitions
 
1.1                                  “ Affiliate ” means any corporation, company, partnership, joint venture and/or firm which controls, is controlled by, or is under common control with a party to this Agreement.  As used in this Paragraph, the term “control” means (a) in the case of corporate entities, - direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management policies of such non-corporate entities.
 
1.2                                  “ Licensed Know-How ” means all unpatented know-how, trade secrets, information, data, methods, materials, techniques, reagents, cell lines, protein sequences or segments, and monoclonal antibodies, including without limitation, materials as described generally in Schedule B hereto, owned or controlled by CeNeS at any time during the term of the Agreement that is necessary or useful to practice the Patent Rights or to research, develop, make, use or sell Licensed Products.
 
1.3                                  “ Licensed Products ” means Protein Products and Non-Protein Products that are covered by one or more Valid Claims under the Patent Rights.
 
1.4                                  “ Materials ” means the cell lines and related biological materials that are in CeNeS’ possession or control as of the Effective Date of this Agreement and are directly related to the production of the protein GGF-2.
 
1.5                                  “ NDA ” means New Drug Application or a foreign equivalent.
 
1.6                                  “ Net Sales ” means the amount billed, invoiced, or received (whichever occurs first) for Sales, leases, or other transfers of Licensed Products, less:
 
(a)                                   customary trade, quantity and cash discounts or rebates, and non-affiliated brokers’ or agents’ commissions actually allowed and taken;
 
2

 
(b)                                  amounts repaid or credited by reason of rejection, recall or return;
 
(c)                                   to the extent separately stated on purchase orders, invoices, or other documents of sale, taxes levied on and/or other governmental charges made as to production, sale, transportation, delivery or use and paid by Acorda or a Sublicensee; and
 
(d)                                  reasonable charges for freight, packaging and insurance costs incurred in the delivery or transportation of Licensed Products provided by third parties, if separately stated.
 
Net Sales also includes the fair market value of any non-cash consideration received by Acorda or Sublicensees for the Sale, lease, or transfer of Licensed Products.  The fair market value will be no less than the standard selling price for the applicable Licensed Products, each unit multiplied by the quantity of such Licensed Products delivered in exchange for such non-cash consideration.
 
1.7                                  “ Non-Protein Product ” means a product that is discovered, identified or developed through the use of material that is claimed or covered by a Valid Claim in the Patent Rights, as a target in a screening tool or otherwise, exclusive of Protein Products.
 
1.8                                  “ Patent Rights ” means the patents and patent applications listed on Schedule A attached hereto, including without limitation, the inventions described and/or claimed therein, and any divisionals, continuations, continuations-in-part (to the extent that a claim of such continuation-in-part is entitled to the priority date of at least one of the patents or patent applications identified in Schedule A), patents issuing thereon and reissues and reexaminations thereof, and any and all foreign patents and patent applications corresponding thereto, all to the extent that CeNeS has an ownership or an interest in such Patent Rights.
 
1.9                                  “ Phase II Clinical Trial ” means one of those trials on sufficient numbers of subjects that are designed to establish that a pharmaceutical product is safe and efficacious for its
 
3

 
intended use, and to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed.  A Phase II Clinical Trial shall be deemed to have commenced upon the date of the first dosing of the first subject in such trial.
 
1.10                            “ Phase III Clinical Trial ” means one of those trials on sufficient numbers of subjects that are designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed, and to support Regulatory Approval of a pharmaceutical product or label expansion of such pharmaceutical product.  A Phase III Clinical Trial shall be deemed to have commenced upon the date of the first dosing of the first subject in such trial.
 
1.11                            “ Proceeds ” means the royalties actually received by Acorda from its Sublicensees for Net Sales of Licensed Products that are Non-Protein Products.
 
1.12                            “ Protein Product ” means a product that is, in whole or in part, composed of one or more proteins encoded by the growth factor gene GGF-2, or a fragment thereof, in whatever form including any mutants, analogues, homologues or derivative forms thereof, that is covered by a Valid Claim in the Patent Rights.
 
1.13                            “ Regulatory Approval ” means the approvals, registrations or authorizations of the United States Food and Drug Administration (the “ FDA ”) or successor entity, or other applicable regulatory agency necessary for the manufacture, distribution, use or sale of a pharmaceutical or diagnostic product in the United States or a foreign equivalent in a major market country such as the United Kingdom, Canada, Japan or Germany.
 
1.14                            “ Sold ” or “ Sale ” means the sale, transfer, exchange or other commercial disposition of Licensed Products by Acorda, its Affiliates or Sublicensees.  In case of doubt,
 
4

 
Sales of Licensed Products shall be deemed consummated no later than receipt of payment from a third party for the applicable transaction involving such Licensed Product.
 
1.15                            “ Sublicense ” means a grant by Acorda, either directly or indirectly (i.e., through multiple tiers of sublicenses) to a third party of a sublicense to practice any of the rights granted to Acorda hereunder in accordance with this Agreement.  Such third party shall be referred to as a “Sublicensee” under this Agreement.
 
1.16                            “ Territory ” means all countries and territories worldwide.
 
1.17                            “ USD ” means United States dollars.
 
1.18                            “ Valid Claim ” means (a) a pending claim of a patent application within the Patent Rights, which (i) has been pending under examination for less than seven (7) years, (ii) has been asserted in good faith, and (iii) has not been abandoned or finally rejected without the possibility of appeal or refiling; or (b) a claim of an issued, or granted and unexpired patent within the Patent Rights, which has not been held unenforceable, unpatentable or invalid by a decision of a court or governmental body of competent jurisdiction, which can no longer be appealed (i.e., within the time allowed for appeal), which has not been rendered unenforceable through disclaimer or otherwise, which has not been abandoned, or which has not been lost through an interference proceeding.  A Valid Claim shall be defined as of each calendar half year ending June 30 and December 31.
 
Part 2 - License Grant
 
2.1                                  CeNeS hereby grants to Acorda, and Acorda accepts, an exclusive license under the Patent Rights and Licensed Know-How to practice the same and to make, have made, use, import, offer for sale and sell Licensed Products throughout the Territory during the term of this Agreement.
 
5

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
2.2                                  Acorda hereby acknowledges that CeNeS is obligated to pay Ludwig certain royalties with respect to Sales by Acorda and Acorda hereby agrees to be amenable to suit by Ludwig in the event of non-payment of royalties due CeNeS hereunder by Acorda.  If Ludwig is required to bring suit against Acorda for any material breach of this Agreement that remains uncured pursuant to Section 9.3(a), Acorda will pay all reasonable out-of-pocket costs incurred by Ludwig in connection therewith, including without limitation, reasonable attorneys fees and costs.
 
2.3                                  Acorda shall have the right to grant sublicenses to third parties with respect to any rights conferred upon Acorda under this Part 2, provided, however, that any sublicense shall be subject in all respects to the conditions (e.g., payment), restrictions, exceptions and termination provisions contained in this Agreement.  Acorda shall provide written notice to CeNeS within sixty(60) days of the grant of any sublicense in accordance with this Section 2.3.
 
Part 3 - Royalties
 
3.1                                  Acorda shall pay to CeNeS a non-refundable license fee in the sum of [**] within ten (10) days after the Effective Date of this Agreement.
 
3.2                                  For the license granted to Acorda hereunder, Acorda shall pay CeNeS the following running royalties:
 
(a)                                   Acorda shall pay to CeNeS the following running royalty based on annual Net Sales of Protein Products by Acorda or its Affiliates:

Annual Net Sales in USD	 	Royalty Rate	 	
 	 	 	 	
[**]	 	[**]	 	
 	 	 	 	
[**]	 	[**]	 	
 	 	 	 	
[**]	 	[**]	 	
 	 	 	 	
[**]	 	[**]	 	
 
6

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
(b)                                  If Acorda is required to pay a running royalty to a third party for a license to make, use, offer for sale, sell or import any Protein Product, then Acorda shall have the right to offset up to [**] of such royalties actually paid to such third party against royalties otherwise due under the foregoing Paragraph 3.2(a); provided, however, that such right of offset shall be limited such that - the royalty due under Paragraph 3:2(b) shall not be less than [**] of annual Net Sales of Protein Products and provided further that the amount of the offset which is not available due to such [**] cap cannot be carried-forward for application against future royalties due under Paragraph 3.2(a).
 
(c)                                   In the event a Licensed Product is sold in the form of a combination product containing one or more active ingredients in addition to the Licensed Product active ingredient (hereinafter “Combination Licensed Product”), then Net Sales for such Combination Licensed Product, for purposes of calculating royalties due hereunder, will be adjusted by multiplying actual Net Sales of such Combination Licensed Product by the applicable fraction, determined as follows:
 
(i)                                      Unless Section 3.2(c)(ii), 3.2(c)(iii) or 3,2(c)(iv) applies below, the fraction A/(A+B) where A is the invoice price of the Licensed Product, if sold separately, and B is the sum of the invoice price(s) of any other active component or components in the combination, if sold separately.
 
(ii)                                   If, on a country-by-country basis, the other active component or components in the Combination Licensed Product are not sold separately in said country, the
 
7

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
fraction shall be A/C where A is the invoice price of the Licensed Product if sold separately, and C is the invoice price- of the Combination Licensed Product.
 
(iii)                                If, on country by-country basis, the Licensed Product is not sold separately in said country, the fraction shall be [1-(B/C)] where B is the invoice price sum of any other active components or components in the combination, if sold separately and C is the invoice price of the Combination Licensed Product.
 
(iv)                               If, on a country-by-country basis, neither the Licensed Product nor the other active component or components of the Combination Licensed Product is sold separately in said country, the fraction shall be negotiated in good faith by the parties with the intention of agreeing upon a fair and equitable formula that reasonably reflects the relative value contributed by the Licensed Product to the total value of the combination in the Combination ; Licensed Product, as compared to the other active ingredients therein.
 
(d)                                  Acorda shall pay to CeNeS a royalty of [**] of annual Net Sales of Protein Products by Sublicensees.
 
(e)                                   Acorda shall pay to CeNeS a royalty of [**] of annual Net Sales by Acorda of Non-Protein Products, and [**] of the Proceeds actually received by Acorda from its Sublicensees on their Sales of Non-Protein Products.
 
(f)                                     Minimum Annual Royalty.  To the extent that cumulative annual royalties paid to CeNeS with respect to each Licensed Product during any calendar year, commencing with the third calendar year following first commercial sale of any Licensed Product, are less than [**], a minimum annual royalty with respect to such Licensed Product in the amount of such shortfall shall be payable by Acorda.  If Acorda fails to pay any such minimum royalty for a Licensed Product, CeNeS shall have the option of converting the
 
8

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
license or any sublicense granted hereunder with respect to such Licensed Product to a nonexclusive license by giving Acorda written notice thereof.
 
3.3                                  Acorda shall pay to CeNeS the following non-refundable milestone payments for every Protein Product in respect of which Acorda, an Affiliate or Sublicensee achieves any or all of the milestone events indicated below.  Should a Protein Product be abandoned by Acorda, Its Affiliate or Sublicensee for any reason following completion of any of the first five milestones but prior to the Approval of a NDA and Acorda commences development of a subsequent Protein Product, then Acorda shall resume the milestone payments for such subsequent Protein Product starting at the event subsequent to the event for which a milestone payment had already been paid.  Each such milestone payment shall be paid within thirty (30) days of the achievement of the relevant milestone event.  For clarity, each milestone payment shall be paid only once for each Protein Product and Acorda shall pay milestones on a Protein Product only if its active pharmaceutical ingredient (the “API”), is different from the API of any other Protein Product for which Acorda has already made milestone payments.

Milestone Event	 	Milestone Payment	 	
 	 	 	 	
Satisfactory completion of animal toxicology studies necessary to enter into Phase I clinical studies in accordance with the International Conference of Harmonization (ICH) guidelines provided by the US Food and Drug Administration*	 	$	[**]	 	
Issuance of an Investigational New Drug Application (or foreign equivalent**)	 	$	[**]	 	
Enrollment of the first subject in a Phase II clinical trial (or foreign equivalent**)	 	$	[**]	 	
Enrollment of the first subject in a Phase III clinical trial (or foreign equivalent**)	 	$	[**]	 	
Filing of a New Drug Application (or foreign equivalent**)	 	$	[**]	 	
Approval of a New Drug Application (or foreign equivalent**)	 	$	[**]	 	

*             “Completion of animal toxicology studies” shall mean the completion of all analysis of data generated in such study and delivery of the final report thereon.
 
**      “Foreign equivalent” shall mean the completion of the milestones in a foreign major market country such as the United Kingdom, Japan, Germany, Canada, etc.
 
9

 
3.4                                  (a)                                   All amounts due hereunder shall be payable in United States Dollars.  Royalty payments shall be made within sixty (60) days following the end of each calendar quarter.  Each such payment shall include royalties which shall have accrued during the calendar quarter immediately preceding and shall be accompanied by a report setting forth separately the Net Sales of all Licensed Products sold during said calendar quarter.  Any royalty payment required to be made to CeNeS under Paragraph 3.2(e) shall be made in U.S. Dollars on or before January 31st of following the calendar year to which such payment relates.
 
(b)                                  Royalties shall be payable only once (at the highest - applicable rate) with respect to the same unit of Licensed Product regardless of the number of claims of Patent tights pertaining to same.  Royalties shall apply to any Sale of Licensed Product to , a third party from which Acorda, its Affiliate or Sublicensee derives revenue.  On any transfer or disposal of Licensed Product among Acorda, its Affiliates or Sublicensees, royalties shall become payable only upon further transfer to a third party.
 
(c)                                   The remittance of royalties payable on the Net Sales of Licensed Product outside the U.S. shall be made to CeNeS in U.S. Dollars a the official rate of exchange of the currency of the country from which the royalties are payable (as quoted by Citibank N.A. for the last business day of the calendar quarter in which the royalties are payable) less any withholding or transfer taxes which are applicable.  Acorda or a Sublicensee shall supply CeNeS with proof of payment of such taxes paid on CeNeS’s behalf and shall cooperate with CeNeS in obtaining credit or refund of any such taxes.
 
10

 
(d)                                  No royalties for Sales outside the U.S. shall be payable with respect to any Sales as to which conversion cannot be made of the currency billed in U.S. Dollars until such conversion can be legally made, at which time royalties shall be paid in U.S. Dollars at the rate of exchange quoted by Citibank, N.A., for the business day immediately preceding the date on which the restriction on conversion was lifted.  However, CeNeS shall have the right to have the royalties payable by Acorda, its Affiliates or Sublicensees deposited in CeNeS’s name in the blocked currency in an interest bearing account in a bank designed by CeNeS in the foreign country in question.  In the event CeNeS cannot arrange to have the blocked currency transferred out of the foreign country within twelve (12) months after deposit, CeNeS shall notify Acorda in writing and Acorda shall as soon as possible thereafter cause such royalties (plus earnings thereon during the period of deposit) to be paid to CeNeS in U.S. Dollars at the rate of exchange quoted by Citibank, N.A. on the day the blocked currency was deposited in the bank designated by CeNeS.  Upon receipt of the payment, CeNeS shall release to Acorda from the bank in the foreign country in question the blocked currency in accordance with Acorda’s instructions.
 
(e)                                   Acorda, its Sublicensees and Affiliates shall keep and maintain records of sales of Licensed Products for a period of three (3) years after the royalty period to which such records relate.  Such records shall be open to inspection upon at least fifteen (15) business days’ prior written notice at any reasonable time during normal business hours not more often than once each calendar quarter by an independent Certified Public Accountant selected by CeNeS, to whom Acorda or, if applicable, its Affiliates or Sublicensees, have no reasonable objection, who shall have the right to examine and make abstracts of the records kept pursuant to this Agreement and report findings of said examination of records to CeNeS insofar as it is necessary to evidence any mistake or impropriety on the part of Acorda.  Said independent Certified Public Accountant
 
11

 
shall treat as confidential and shall not use or disclose to any third party any information acquired during the course of such examination, except information which shall be made available to CeNeS or Ludwig pursuant to any provision of this Agreement.
 
(f)                                     Acorda’s obligation to pay royalties with respect to Net Sales of Licensed Product in my country shall continue for so long as CeNeS owns or holds exclusive rights to a valid and enforceable issued patent within the Patent Rights covering such Licensed Product in Such country.  If Acorda’s obligation to pay royalties is based solely on the practice of the Patent Rights to discover or develop a Non-Protein Product, said obligation shall continue until fifteen (15) years from the Effective Date of this Agreement.
 
Part 4 - Patent Matters
 
4.1                                  Upon execution of this Agreement, Acorda shall assume responsibility and control, at its expense, during the Term for the preparation, filing, prosecution and maintenance of any and all patent applications and patents included in Patent Rights.  Notwithstanding the previous sentence, Acorda shall furnish to CeNeS copies of all material documents pertaining to such preparation, filing, prosecution or maintenance, including filings and correspondence with patent authorities, in a timely manner, so as to give CeNeS an opportunity to comment thereon and Acorda shall use good faith efforts to accommodate any such comments.
 
4.2                                  Ludwig, CeNeS, and Acorda shall cooperate fully in the preparation, filing, prosecution and maintenance of Patent Rights and of all patents and patent applications licensed to Acorda hereunder, executing all papers and instruments or requiring members of Ludwig and/or CeNeS to execute such papers and instruments so as to enable Acorda to apply for, to prosecute and to maintain patent applications and patents in Ludwig’s name in any country.  Each party shall provide to the other prompt notice as to all matters which come to its attention
 
12

 
and which may affect the preparation, filing, prosecution or maintenance of any such patent applications or patents.
 
4.3                                  Acorda may elect to surrender its rights under the Patent Rights on a patent-by-patent basis in any country upon sixty (60) days written notice to CeNeS.  CeNeS may elect thereafter to continue prosecution and maintenance of such patents at its own expense.
 
Part 5 - Patent Infringement
 
5.1                                  Enforcement by Acorda.  If either CeNeS or Acorda becomes aware of a product made, used or sold in the Territory, or any other activities, which it believes infringes a Valid Claim, the party obtaining such knowledge shall promptly advise the other patty of all relevant facts and circumstances pertaining to the potential infringement.  Acorda shall have the first right, but not the obligation, to enforce any patent rights against such infringement, at its own expense.  CeNeS and Ludwig shall cooperate with Acorda in such effort, at Acorda’s expense, including being joined as a party to such action, if necessary.  Any damages or costs recovered in connection with any action filed by Acorda hereunder which exceed Acorda’s out-of-pocket costs and expenses of litigation, shall be deemed to be Net Sales of Protein Products in the fiscal quarter received by Acorda, and royalties shall be payable by Acorda to CeNeS thereon in accordance with the terms of this Agreement.
 
5.2                                  Backup Enforcement Right by CeNeS.  If Acorda fails within one hundred twenty (120) days after receiving notice from CeNeS of a potential infringement, or providing CeNeS with notice of such infringement, to either (a) terminate such infringement or (b) institute an action to prevent continuation thereof and, thereafter to prosecute such action diligently, or if Acorda notifies CeNeS that it does not plan to terminate the infringement or institute such action, then CeNeS shall have the right to do so at its own expense; provided however, that CeNeS first
 
13

 
consults with Acorda and gives due consideration to Acorda’s reasons for not instituting actions to terminate or otherwise prevent continuation of such infringement.  If CeNeS decides to pursue such infringement, Acorda shall cooperate with CeNeS in such effort including being joined as a party to such action if necessary.  CeNeS shall be entitled to retain all damages or costs awarded to CeNeS in such action.
 
5.3                                  In the event that Acorda, its Affiliate or Sublicensee is sued by a third party charging infringement of a patent resulting from the manufacture, use or sale by Acorda, its Affiliate or Sublicensee of a Licensed Product, Acorda shall promptly notify CeNeS.  During the period in which any such suit is pending, Acorda shall have the right to apply up to fifty percent (50%) of the royalties due CeNeS against Acorda’s litigation expenses of any such suit.
 
Part 6 - Diligence
 
6.1                                  Acorda agrees to use all reasonable efforts to effect introduction of Licensed Products into the commercial market as soon as practicable, consistent with sound and reasonable business practices and judgment.
 
Part 7 - Indemnification and Insurance
 
7.1                                  Acorda hereby indemnifies CeNeS, Ludwig and their respective directors, officers, employees and agents (collectively, the “ CeNeS Indemnitees ”) and agrees to be solely responsible and to hold CeNeS Indemnitees harmless from any third party claim, demands, suits or causes of action, including all judgments, damages, and costs (including reasonable attorneys’ fees) resulting therefrom, arising out of the use, manufacture, sale, storage or advertising of any Licensed Product except to the extent of such judgments, damages and costs that arise from the negligence or willful misconduct of CeNeS Indemnitees.
 
14

 
7.2                                  CeNeS hereby indemnifies Acorda, its Affiliates, directors, officers, agents, contractors, Sublicensees and employees (collectively, the “ Acorda Indemnitees ”) and agrees to be solely responsible and to hold Acorda Indemnitees harmless from any third party claim demands, suits or causes of action, including all judgments, damages, and costs (including reasonable attorneys’ fees) resulting therefrom, arising out of any breach of Section 8.1 except to the extent of such judgments, damages and costs that arise from the negligence or willful misconduct of Acorda Indemnitees.
 
7.3                                  To be eligible to be indemnified hereunder, the indemnified party shall provide the indemnifying party with prompt notice of the claim giving rise to the indemnification obligation pursuant to this Part 7 and the exclusive ability to defend (with the reasonable cooperation of the indemnified party) or settle any such claim; provided, however , that the indemnifying party shall not enter into any-settlement for damages other than monetary damages without the indemnified party’s written consent, such consent not to be unreasonably withheld or delayed.  The indemnified party shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the indemnifying party.
 
7.4                                  Prior to commencing human use of any Licensed Product hereunder, Acorda shall obtain and maintain thereafter comprehensive general liability insurance (to include advertisers’ liability and product liability) written by a reputable insurer or insurers approved by CeNeS and shall list CeNeS as an additional named insured thereunder and shall require thirty (30) days written notice to be given to CeNeS prior to any cancellation or material change thereof.  The limits for such insurance shall not be less than ten million dollars (USD 10,000,000) per occurrence for personal injury and property damage, adjusted for inflation every year based on
 
15

 
the U.S. Consumer Price Index in effect on the first day of such year.  Acorda shall provide CeNeS with certificates of insurance evidencing the same upon written request by CeNeS.
 
Part 8 - Representations and Warranties
 
8.1                                  CeNeS Representations and Warranties.  CeNeS represents and warrants that:
 
(a)                                   its obligations under this Agreement are not in conflict with any prior commitments or obligations to any third party; that it has all requisite power and authority to enter into this Agreement; and that all corporate action necessary to authorize its execution and delivery of this Agreement has been duly taken;
 
(b)                                  it has the right to grant the rights granted in this Agreement and perform the obligations set forth herein;
 
(c)                                   it and its Affiliates have not granted to any third party any license, option or other rights under the Patent Rights, and to its knowledge, the Ludwig License is in full force and effect;
 
(d)                                  to its knowledge, there are no facts or circumstance which would render any of the Patent Rights invalid or unenforceable;
 
(e)                                   to its knowledge, there is no interference action, opposition, reissue or reexamination proceeding, or any intellectual property litigation pending before any patent office or court concerning any of the Patent Rights; and
 
(f)                                     Cambridge Neuroscience Research, Inc. has assigned all its rights and obligations in the Ludwig Agreement to CeNeS.
 
8.2                                  Acorda Representations and Warranties.  Acorda represents and warrants that its obligations under this Agreement are not in conflict with any prior commitments or obligations to any third party; that it has all requisite power and authority to enter into this Agreement; and
 
16

 
that all corporate action necessary to authorize its execution and delivery of this Agreement has been duly taken.
 
Part 9 - Term and Early Termination
 
9.1                                  Unless sooner terminated as herein provided, this Agreement shall continue in full force and effect commencing on the Effective bate of this Agreement and continuing until the later of fifteen (15) years thereafter or the expiration of the last-to-expire Valid Claim in the Patent Rights.
 
9.2                                  Acorda may terminate this Agreement at any time for any reason, upon thirty (30) days prior written notice to CeNeS.
 
9.3                                  (a)                                   A party may terminate this Agreement and the license herein granted upon the breach of any material obligation herein by the other party upon sixty (60) days written notice; provided that if during such sixty (60) day period the party so notified cures such material breach, then this Agreement shall continue in full force and effect.
 
(b)                                  If this Agreement is terminated as provided in Paragraphs 9.2 or 9.3(a), Acorda shall promptly make an accounting to CeNeS of the inventory of Licensed Products which it and its Affiliates and Sublicensees have on hand as of the effective date of such termination, if applicable.  Acorda, its Affiliates and Sublicensees shall then have the right, for a period of six (6) months after said termination, to sell such inventory provided that the Net Sales thereof shall be subject to the royalty rates payable to CeNeS as set forth above.
 
9.4                                  The license to Acorda set forth in Section 2.1 shall continue after any termination or expiration of this Agreement as set forth in this Section 9.4.  If this Agreement expires pursuant to Section 9.1, then Acorda shall thereafter retain a nonexclusive, perpetual, royalty-free, worldwide license, with the full right to sublicense, under the Patent Rights and Licensed
 
17

 
Know-How to practice such technology and rights for all purposes.  If this Agreement is terminated by Acorda pursuant to Section 9.3, then Acorda, in its sole discretion, may elect to retain the exclusive license granted in Section 2.1, subject to the payment of the royalties otherwise due under Section 3.2.
 
Part 10 - Confidentiality
 
10.1                            Treatment of Confidential Information.  Except as otherwise provided hereunder, during the term of this Agreement and for a period of five (5) years thereafter:
 
(a)                                   CeNeS, its Affiliates and Sublicensees shall retain in confidence and use only for purposes of this Agreement, any written information and data supplied by Acorda to CeNeS under this Agreement and marked as proprietary or confidential; and
 
(b)                                  Acorda shall retain in confidence and use only for purposes of this Agreement, any written information and data supplied by CeNeS to Acorda under this Agreement and marked as proprietary or confidential.
 
For purposes of this Agreement, all such information and data which a party is obligated to retain in confidence shall be called “ Information .”  Any written information, materials or data relating to GGF-2 disclosed by one party to the other party pursuant to the License Option Agreement and the Confidentiality Agreement entered into as of July 23, 2001 shall be deemed Information under this Agreement.
 
10.2                            Permitted Disclosure.  To the extent that it is reasonably necessary to fulfill its obligations or exercise its rights under this Agreement, or any rights which survive termination or expiration hereof, each party may disclose Information to its Affiliates, sublicensees, consultants, outside contractors and clinical investigators on condition that such entities or persons agree:
 
18

 
(a)                                   to keep the Information confidential for at least the same time periods and to the same extent as each party is required to keep the Information confidential and
 
(b)                                  to use the Information only for such purposes as such parties are authorized to use the Information.
 
Each party, its Affiliates or sublicensees may disclose Information to regulatory authorities to the extent that such disclosure is necessary for the prosecution and enforcement of patents, authorizations to conduct clinical trials or commercialization of Licensed Products, provided that such party is otherwise entitled to engage in such activities under this Agreement.  Each party, its Affiliates or sublicensees may disclose Information to the government or a court of competent jurisdiction, provided that such disclosing party (a) provides the other party with adequate notice of the required disclosure, (b) cooperates with the other party’s efforts to protect its Information with respect to such disclosure and (c) takes all reasonable measures requested by the other party to challenge or to modify the scope of such required disclosure.  CeNeS may disclose Information to Ludwig to the extent such disclosure is required pursuant to CeNeS’ obligations under the Ludwig Agreement.
 
10.3                            The obligation under Section 10.1 not to use or disclose Information shall not apply to any part of such Information that the recipient party can establish by competent written proof:
 
(a)                                   is or becomes patented, published or otherwise part of the public domain, other than by unauthorized acts of the party obligated not to disclose such Information (for purposes of this Part 10 (the “ Receiving Party ”), its Affiliates or Sublicensees in contravention of this Agreement;
 
19

 
(b)                                  is disclosed to the Receiving Party, its Affiliates or Sublicensees by a third party provided that such Information was not obtained by such third party directly or indirectly from the other party under this Agreement;
 
(c)                                   prior to disclosure under this Agreement, was already in the possession of the Receiving Party, its Affiliates or Sublicensees, provided that such Information was not obtained directly or indirectly from the other patty under this Agreement;
 
(d)                                  results from the research and development by the Receiving Party, its Affiliates or Sublicensees, independent of disclosures from the other party of this Agreement, provided that the persons developing such information have not had exposure to the Information received from the disclosing party; or
 
(e)                                   CeNeS and Acorda agree in writing may be disclosed.
 
10.4                            Confidential Nature of the Terms of Agreement.  Except as expressly provided herein, CeNeS and Acorda each agrees not to disclose any terms of this Agreement to any third party without the consent of the other party; provided, however, that disclosures may be made as required by securities or other applicable laws, or to actual or prospective investors or corporate partners, or to a party’s accountants, attorneys, and other professional advisors who agree to appropriate confidentiality provisions to protect such terms from disclosure or improper use.
 
Part 11 - General Provisions
 
11.1                            Except as required by law, neither CeNeS nor Acorda shall originate any publicity, news release, or other public announcement, written or oral, whether to the public press, to stockholders, or otherwise, relating to this Agreement to any amendment thereto or to performance hereunder or the existence of an arrangement between the parties without the prior written approval of the other party, not to be unreasonably withheld; provided that, no such
 
20

 
consent shall be required for non-public communications between Acorda and its current, or potential stockholders, investors, acquiring parties, merger partners or Sublicensees.  Acorda shall not use the name Ludwig, or CeNeS (or any variant thereof) or any related organization in any advertising, packaging (except for customary technical references) or other promotional material in connection with the sale of Licensed Products referred to in this Agreement.
 
11.2                            Acorda acknowledges that it has certain duties and obligations under Part 379 of the Export Administration Regulations of the U.S. Department of Commerce (as presently promulgated or hereafter modified or amended) concerning the export and reexport of technical data.  Acorda will be solely responsible for any breach of such Regulations by Acorda, its Affiliates or Sublicensees and will defend and hold Indemnitees harmless in the event of a suit or action involving any such breach.
 
11.3                            Neither party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other, such consent not to be unreasonably withheld, and except that a party may make such an assignment without the other party’s consent to an Affiliate or to a successor to all, or substantially all, of the business and assets to which this Agreement relates of such party, whether in a merger, sale of stock, sale of assets or other transaction of the division or divisions of Acorda involved in the development and sale of Licensed Products.  Any permitted successor or assignee of rights and/or obligations hereunder shall, in a writing to the other party, expressly assume performance of such rights and/or obligations.  Any permitted assignment shall be binding on the successor of the assigning party.
 
11.4                            All notices required to be given by one party to the other hereunder shall be sufficient if signed by such party (or such party’s attorney) and either:  (a) delivered in person; (b) mailed certified mail, postage prepaid, return receipt requested; or (b) faxed to the other party
 
21

 
provided that the sender receives acknowledgement that such notice has been received by the party to be notified and promptly sends the original by ordinary mail; in any event, to the following addresses:

If to Acorda:	
 	
 	Acorda Therapeutics, Inc,	
 	15 Skyline Drive	
 	Hawthorne, NY 10532	
 	Attn: President and Chief Executive Officer	
 	 	
with a copy to:	
 	 	
 	Acorda Therapeutics, Inc.	
 	15 Skyline Drive	
 	Hawthorne, NY 10532	
 	Attn: Harold Safferstein, Vice President, Business Development	
 	 	
If to CeNeS:	
 	 	
 	CeNeS Pharmaceuticals plc	
 	Compass House	
 	Vision Park	
 	Clovers Way	
 	Histon, Cambridge CI4 9ZR	
 	England	
 	Attn: Neil Clark, Chief Operating Officer and Finance Director	
 
By such notice either party may change their address for future notices.  Notices delivered in person shall be deemed given on the date delivered.  Notices sent by fax shall be deemed given on the date faxed.  Notices mailed shall be deemed given two (2) days after the date postmarked on the envelope.
 
11.5                            This Agreement constitutes the entire agreement between the parties and supersedes all written or oral prior agreements or understandings with respect to the subject matter hereof except that any confidential information disclosed pursuant to the License Option
 
22

 
Agreement shall be deemed Information of this Agreement.  No variation or modification of the terms or provisions of this Agreement shall be valid unless in writing and signed by the patties hereto.
 
11.6                            No right or license is granted by CeNeS under this Agreement to Acorda, or by Acorda to CeNeS, either expressly or by implication, except those specifically set forth herein.
 
11.7                            Waiver by Acorda or CeNeS of any single default or breach or succession of defaults or breaches by the other shall not deprive CeNeS or Acorda of any right to terminate this Agreement arising out of any subsequent default or breach nor shall it be construed as a waiver of either party’s rights thereafter to enforce each and every provision of this Agreement.
 
11.8                            All matters affecting the interpretation, validity, and performance of this Agreement shall be governed by the laws of the State of New York applicable to agreements made and to be performed wholly within New York, but the scope and validity of Patent Rights shall be governed by the applicable laws of the country granting the patent in question.
 
11.9                            Acorda’s relationship with CeNeS shall be that of a licensee only.  Neither party shall be considered to be an employee or agent of the other, nor shall this Agreement constitute, create or in any way be interpreted as a joint venture, partnership or formal business organization of any kind.  In that respect, neither party shall have the authority to execute any agreement on behalf of the other party, nor shall either party have any authority to negotiate any agreement, except as the other party may expressly direct in writing.
 
11.10                      Parts 7, 8, and 10 and Sections 9.3(b), 9.4 and 11.10 shall survive termination of this Agreement for any reason.
 
11.11                      This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which shall constitute one and the same instrument.
 
23

 
11.12                      The captions herein are solely for convenience of reference and shall not affect the construction or interpretation of this Agreement.
 
IN WITNESS WHEREOF, CeNeS and Acorda have caused this Agreement to be executed in duplicate by their respective duty authorized officers.

CeNeS PHARMACEUTICALS, PLC	ACORDA THERAPEUTICS, INC.	
 	 	
By:	/s/ Neil Clark	 	By:	/s/ Harold T. Safferstein	 	
 	 	 	 	 	 	
Print Name:	Neil Clark	 	Print Name:	Harold T. Safferstein	 	
 	 	 	 	 	 	
Title:	Finance Director	 	Title:	VP Business Development	 	

24

 
SCHEDULE A
 
PATENT RIGHTS
 
Granted Patent List

Matter
Number	 	Country	 	Patent
Number	 	Grant
Date	 	Filing
Date	 	Status	 	Inventors	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002AU5	 	Australia	 	688270	 	02-Jul-1998	 	29-Jun-1993	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002AU6	 	Australia	 	709968	 	23-Dec-1999	 	25-May-1995	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002AUX	 	Australia	 	703772	 	15-Jul-1999	 	09-Oct-1996	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002EP1	 	Europe	 	0579640	 	24-Jul-2002	 	03-Apr-1992	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002KR1	 	Korea	 	274305	 	08-Sep-2000	 	03-Apr-1992	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002KR5	 	Korea	 	307943	 	25-Aug-2001	 	29-Jun-1993	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002KR6	 	Korea	 	265928	 	09-Jun-2000	 	25-May-1995	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002KR7	 	Korea	 	297680	 	24-May-2001	 	25-May-1995	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002KR8	 	Korea	 	344006	 	28-Jun-2002	 	29-Jun-1993	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002PT1	 	Portugal	 	100344	 	02-May-1999	 	03-Apr-1992	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002PT5	 	Portugal	 	101297	 	07-Jul-1999	 	30-Jun-1993	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002005	 	United States	 	5,530,109	 	25-Jun-1996	 	24-Mar-1993	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002006	 	United States	 	5,716,930	 	10-Feb-1998	 	26-May-1994	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002007	 	United States	 	5,621,081	 	15-Apr-1997	 	06-Jun-1995	 	Granted	 	Andrew D.J. Goodearl et al.	

 

Matter
Number	 	Country	 	Patent
Number	 	Grant
Date	 	Filing
Date	 	Status	 	Inventors	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002009	 	United States	 	5,606,032	 	25-Feb-1997	 	06-Jun-1995	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-00200A	 	United States	 	5,792,849	 	11-Aug-1998	 	06-Jun-1995	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-00200G	 	United States	 	5,602,096	 	11-Feb-1997	 	06-Jun-1995	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-00200J	 	United States	 	6,204,241	 	20-Mar-2001	 	22-Oct-1996	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-00200L	 	United States	 	6,194,377	 	27-Feb-2001	 	22-Oct-1996	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-00200P	 	United States	 	5,854,220	 	29-Dec-1998	 	22-Oct-1996	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002ZA1	 	South Africa	 	92/2001	 	25-Nov-1992	 	01-Apr-1992	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-002ZA5	 	South Africa	 	93/4711	 	31-Aug-1994	 	30-Jun-1993	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-039AU1	 	Australia	 	713384	 	16-Mar-2000	 	27-Mar-1996	 	Granted	 	Thomas A. Reh et al.	
Title:  METHODS OF TREATING DISORDERS OF THE EYE	

Matter
Number	 	Patent
Country	 	Grant
Number	 	Grant
Date	 	Filing
Date	 	Status	 	Inventors	
 	 	 	 	 	 	 	 	 	 	 	 	 	
04585-04AU1	 	Australia	 	707599	 	28-Oct-1999	 	16-Nov-1995	 	Granted	 	David I. Gwynne et al.	
Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR COMMUNICATION	
 	
04585-041001	 	United States	 	6,087,323	 	11-Jul-2000	 	17-Nov-1994	 	Granted	 	David I. Gwynne et al.	
Title: USE OF NEUREGULIN AS MODULATORS OF CELLULAR COMMUNICATION	
 	
04585-043AU2	 	Australia	 	727037	 	15-Mar-2001	 	12-Nov-1996	 	Granted	 	Mark Marchionni et al.	
Title:  METHODS OF TREATING DISORDERS OF NON-VISUAL SENSORY EPITHELIA	
 	
04585-048AU2	 	Australia	 	745324	 	21-Mar-2002	 	08-Oct-1998	 	Natl Phase	 	R. McBurney et al.	
Title:  THERAPEUTIC METHODS COMPRISING USE OF A NEUREGULIN	
 	
04585-051001	 	United States	 	5,594,114	 	14-Jan-1997	 	17-Aug-1992	 	Granted	 	Andrew D.J. Goodearl et al.	
Title:  SCHWANN CELL MITOGENIC FACTOR, ITS PREPARATION AND USE	
 
2

 
Pending Patent Application List

Matter
Number	 	Country	 	Application
Number	 	Filing
Date	 	Status	 	Inventors	
 	 	 	 	 	 	 	 	 	 	 	
04585-002CA1	 	Canada	 	2,108,199	 	03-Apr-1992	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-002CA5	 	Canada	 	2,139,136	 	29-Jun-1993	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-002CA6	 	Canada	 	2,191,085	 	25-May-1995	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-002CN6	 	China	 	95 1 9320X	 	25-May-1995	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-002EP5	 	Europe	 	93 918139.2	 	29-Jun-1993	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-002EP6	 	Europe	 	95922145.8	 	25-May-1995	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-002IE1	 	Ireland	 	921062	 	03-Apr-1992	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-002MX6	 	Mexico	 	965812	 	25-May-1995	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-002PH5	 	Philippines	 	44157	 	03-Apr-1992	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-002008	 	United States	 	08/470,339	 	06-Jun-1995	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-00200E	 	United States	 	08/469,549	 	06-Jun-1995	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-00200F	 	United States	 	08/471,833	 	06-Jun-1995	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-00200H	 	United States	 	08/472,065	 	06-Jun-1995	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-00200I	 	United States	 	08/734,665	 	22-Oct-1996	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-00200M	 	United States	 	08/735,010	 	13-May-1999	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 
3

 

Matter
Number	 	Country	 	Application
Number	 	Filing
Date	 	Status	 	Inventors	
 	 	 	 	 	 	 	 	 	 	 	
04585-00200N	 	United States	 	08/736,070	 	22-Oct-1996	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-00200Q	 	United States	 	08/736,019	 	22-Oct-1996	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-00200R	 	United States	 	08/734,592	 	22-Oct-1996	 	Pending	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-002WO1	 	PCT	 	GB92/00595	 	03-Apr-1992	 	Natl Phase	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-002WO5	 	PCT	 	US93/06228	 	29-Jun-1993	 	Natl Phase	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-002WO6	 	PCT	 	US95/06846	 	25-May-1995	 	Natl Phase	 	Andrew D.J. Goodearl et al.	
Title:  GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE	
 	 	 	 	 	 	 	 	 	 	 	
04585-028001	 	United States	 	08/209,204	 	08-Mar-1994	 	Pending	 	Robert Sklar et al.	
Title:  METHODS FOR TREATING MUSCLE DISEASES AND DISORDERS	
 	 	 	 	 	 	 	 	 	 	 	
04585-028002	 	United States	 	08/461,097	 	05-Jun-1995	 	Pending	 	Robert Sklar et al.	
Title:  METHODS FOR TREATING MUSCLE DISEASES AND DISORDERS	
 	 	 	 	 	 	 	 	 	 	 	
04585-028004	 	United States	 	08/468,731	 	06-Jun-1995	 	Pending	 	Robert Sklar et al.	
Title:  METHODS FOR TREATING MUSCLE DISEASES AND DISORDERS	
 	 	 	 	 	 	 	 	 	 	 	
04585-030CA1	 	Canada	 	2,162,262	 	06-May-1994	 	Pending	 	Robert Sklar et al.	
Title:  METHODS FOR TREATING MUSCLE DISEASES AND DISORDERS	
 	 	 	 	 	 	 	 	 	 	 	
04585-030EP1	 	Europe	 	94916690.4	 	06-May-1994	 	Pending	 	Robert Sklar et al.	
Title:  METHODS FOR TREATING MUSCLE DISEASES AND DISORDERS	
 	 	 	 	 	 	 	 	 	 	 	
04585-030JP1	 	Japan	 	525593/1994	 	06-May-1994	 	Pending	 	Robert Sklar et al.	
Title:  METHODS FOR TREATING MUSCLE DISEASES AND DISORDERS	
 	 	 	 	 	 	 	 	 	 	 	
04585-030WO1	 	PCT	 	US94/05083	 	06-May-1994	 	Natl Phase	 	Robert Sklar et al.	
Title:  METHODS FOR TREATING MUSCLE DISEASES AND DISORDERS	
 	 	 	 	 	 	 	 	 	 	 	
04585-039CA1	 	Canada	 	2,215,330	 	27-Mar-1996	 	Pending	 	Thomas A. Reh et al.	
Title:  METHODS OF TREATING DISORDERS OF THE EYE	
 	 	 	 	 	 	 	 	 	 	 	
04585-039EP1	 	Europe	 	96910617.8	 	27-Mar-1996	 	Pending	 	Thomas A. Reh et al.	
Title:  METHODS OF TREATING DISORDERS OF THE EYE	
 	 	 	 	 	 	 	 	 	 	 	
04585-039JP1	 	Japan	 	8-529635	 	27-Mar-1996	 	Pending	 	Thomas A. Reh et al.	
Title:  METHODS OF TREATING DISORDERS OF THE EYE	
 
4

 

Matter
Number	 	Country	 	Application
Number	 	Filing
Date	 	Status	 	Inventors	
 	 	 	 	 	 	 	 	 	 	 	
04585-041CA1	 	Canada	 	2,204,850	 	16-Nov-1995	 	Pending	 	David I. Gwynne et al.	
Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR COMMUNICATION	
 	 	 	 	 	 	 	 	 	 	 	
04585-041EP1	 	Europe	 	95940728.9	 	16-Nov-1995	 	Pending	 	David I. Gwynne et al.	
Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR COMMUNICATION	
 	 	 	 	 	 	 	 	 	 	 	
04585-041JP1	 	Japan	 	8-516986	 	16-Nov-1995	 	Pending	 	David I. Gwynne et al.	
Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR COMMUNICATION	
 	 	 	 	 	 	 	 	 	 	 	
04585-041004	 	United States	 	09/069,784	 	20-Mar-2001	 	Pending	 	David I. Gwynne et al.	
Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR COMMUNICATION	
 	 	 	 	 	 	 	 	 	 	 	
04585-041005	 	United States	 	09/366,886	 	04-Aug-1999	 	Pending	 	David I. Gwynne et al.	
Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR COMMUNICATION	
 	 	 	 	 	 	 	 	 	 	 	
04585-041WO1	 	PCT	 	US95/14974	 	16-Nov-1995	 	Natl Phase	 	David I. Gwynne et al.	
Title:  USE OF NEUREGULIN AS MODULATORS OF CELLULAR COMMUNICATION	
 	 	 	 	 	 	 	 	 	 	 	
04585-043CA2	 	Canada	 	2,237,400	 	12-Nov-1996	 	Pending	 	Mark Marchionni et al..	
Title:  METHODS OF TREATING DISORDERS OF NON-VISUAL SENSORY EPITHELIA	
 	 	 	 	 	 	 	 	 	 	 	
04585-043EP2	 	Europe	 	96940360.9	 	12-Nov-1996	 	Pending	 	Mark Marchionni et al..	
Title:  METHODS OF TREATING DISORDERS OF NON-VISUAL SENSORY EPITHELIA	
 	 	 	 	 	 	 	 	 	 	 	
04585-043JP2	 	Japan	 	518966/97	 	12-Nov-1996	 	Pending	 	Mark Marchionni et al..	
Title:  METHODS OF TREATING DISORDERS OF NON-VISUAL SENSORY EPITHELIA	
 	 	 	 	 	 	 	 	 	 	 	
04585-043WO2	 	PCT	 	US96/18031	 	12-Nov-1996	 	Natl Phase	 	Mark Marchionni et al..	
Title:  METHODS OF TREATING DISORDERS OF NON-VISUAL SENSORY EPITHELIA	
 	 	 	 	 	 	 	 	 	 	 	
04585-044AU2	 	Australia	 	49744/00	 	20-Apr-2000	 	Natl Phase	 	Mark Marchionni et al..	
Title:  METHODS OF TREATING CONGESTIVE HEART FAILURE	
 	 	 	 	 	 	 	 	 	 	 	
04585-044CA2	 	Canada	 	2,368,357	 	20-Apr-2000	 	Natl Phase	 	Mark Marchionni et al..	
Title:  METHODS OF TREATING CONGESTIVE HEART FAILURE	
 	 	 	 	 	 	 	 	 	 	 	
04585-044EP2	 	Europe	 	00931938.5	 	20-Apr-2000	 	Natl Phase	 	Mark Marchionni et al..	
Title:  METHODS OF TREATING CONGESTIVE HEART FAILURE	
 	 	 	 	 	 	 	 	 	 	 	
04585-044JP2	 	Japan	 	2000-613391	 	20-Apr-2000	 	Natl Phase	 	Mark Marchionni et al..	
Title:  METHODS OF TREATING CONGESTIVE HEART FAILURE	
 	 	 	 	 	 	 	 	 	 	 	
04585-044KR2	 	Korea	 	2001-7013409	 	20-Apr-2000	 	Natl Phase	 	Mark Marchionni et al..	
Title:  METHODS OF TREATING CONGESTIVE HEART FAILURE	
 	 	 	 	 	 	 	 	 	 	 	
04585-044001	 	United States	 	09/298,121	 	23-Apr-2000	 	Pending	 	Mark Marchionni et al..	
Title:  METHODS OF TREATING CONGESTIVE HEART FAILURE	
 
5

 

Matter
Number	 	Country	 	Application
Number	 	Filing
Date	 	Status	 	Inventors	
 	 	 	 	 	 	 	 	 	 	 	
04585-044WO2	 	PCT	 	US00/10664	 	20-Apr-2000	 	Published	 	Mark Marchionni et al..	
Title:  METHODS OF TREATING CONGESTIVE HEART FAILURE	
 	 	 	 	 	 	 	 	 	 	 	
04585-048CA2	 	Canada	 	2,306,228	 	08-Oct-1998	 	Natl Phase	 	R. McBurney et al.	
Title:  THERAPEUTIC METHODS COMPRISING USE OF NEUREGULIN	
 	 	 	 	 	 	 	 	 	 	 	
04585-048EP2	 	Europe	 	98949803.5	 	08-Oct-1998	 	Natl Phase	 	R. McBurney et al.	
Title:  THERAPEUTIC METHODS COMPRISING USE OF NEUREGULIN	
 	 	 	 	 	 	 	 	 	 	 	
04585-048JP2	 	Japan	 	2000-515608	 	08-Oct-1998	 	Natl Phase	 	R. McBurney et al.	
Title:  THERAPEUTIC METHODS COMPRISING USE OF NEUREGULIN	
 	 	 	 	 	 	 	 	 	 	 	
04585-048KR2	 	Korea	 	2000-7003972	 	08-Oct-1998	 	Natl Phase	 	R. McBurney et al.	
Title:  THERAPEUTIC METHODS COMPRISING USE OF NEUREGULIN	
 	 	 	 	 	 	 	 	 	 	 	
04585-048002	 	United States	 	09/530,884	 	29-Aug-2000	 	Natl Phase	 	R. McBurney et al.	
Title:  THERAPEUTIC METHODS COMPRISING USE OF NEUREGULIN	
 	 	 	 	 	 	 	 	 	 	 	
04585-048WO2	 	PCT	 	US98/21349	 	18-Oct-1998	 	Pending	 	R. McBurney et al.	
Title:  THERAPEUTIC METHODS COMPRISING USE OF NEUREGULIN	
 
6

 
Exhibit 10.16
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
LICENSE AGREEMENT
 
This License Agreement (the “AGREEMENT”) is entered into this 12th day of November, 2002 (the “EFFECTIVE DATE”), by and between CeNes Pharmaceuticals, plc, a corporation organized and existing under the laws of the United Kingdom and having a principal place of business at Compass House, Vision Park, Chivers Way, Histon, Cambridge CB4 9ZR, England (hereinafter “CeNeS”) and Acorda Therapeutics, Inc., a corporation organized and existing under the laws of the State of Delaware and having a principal place of business at 15 Skyline Drive, Hawthorne, NY  10532 (hereinafter “Acorda” or “LICENSEE”).
 
WHEREAS, CeNeS, by its acquisition of Cambridge NeuroScience, Inc., has exclusive rights under that certain license agreement, as amended, (the “Harvard License”) by and between Cambridge NeuroScience, Inc. and President and Fellows of Harvard College (“Harvard”), acting on its behalf and, pursuant to an inter-institutional agreement (the “Inter-Institutional Agreement”), acting on behalf of the Leland Stanford Junior College (“STANFORD”) pursuant to which Harvard licensed certain rights to Cambridge NeuroScience, Inc.;
 
WHEREAS, CeNeS and Acorda are parties to that certain license option agreement, as amended, pursuant to which CeNeS granted an option to Acorda to, among other things, obtain a sublicense of the rights granted by Harvard to Cambridge NeuroScience, Inc. pursuant and subject to the Harvard License (the “LICENSE OPTION AGREEMENT”)
 
WHEREAS, Acorda desires to exercise such option and to acquire a sublicense of such rights as set forth herein; and
 
WHEREAS, CeNeS desires to grant a sublicense of such rights as set forth herein.
 
NOW THEREFORE, in consideration of the foregoing premises and of other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:
 
ARTICLE I
DEFINITIONS
 
As used in this AGREEMENT, the terms below shall have the following meanings:
 
1.1            “AFFILIATE” means any corporation, company, partnership, joint venture and/or firm that controls, is controlled by, or is under common control with either party.  As used in this Paragraph, the term “control” means (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%)

 
of the equity interest with the power to direct the management policies of such non-corporate entities.
 
1.2            “BIOLOGICAL MATERIALS” means the materials identified in Appendix B, attached hereto, together with any progeny, mutants, or derivatives thereof which are either supplied by CeNeS or are created by LICENSEE and are covered by a VALID CLAIM.
 
1.3            “IND” means an Investigational New Drug application as defined in the US. Food, Drug and Cosmetics Act and the regulations promulgated thereunder.
 
1.4            “LICENSED KNOW-HOW” means all unpatented know-how, trade secrets, information, data, methods, materials, techniques, reagents, cell lines, protein sequences or segments, and monoclonal antibodies, including without limitation, materials as described generally in Appendix C hereto, owned or controlled by CeNeS at any time during the term of the AGREEMENT that is necessary or useful to practice the PATENT RIGHTS or to research, develop, make, use or sell LICENSED PRODUCTS.
 
1.5            “LICENSED PRODUCTS” means: (a) PROTEIN PRODUCTS and NON-PROTEIN PRODUCTS that are covered by one or more VALID CLAIM(S) under the PATENT RIGHTS and (b) PROTEIN PRODUCTS and NON-PROTEIN PRODUCTS that incorporate some portion of BIOLOGICAL MATERIALS.
 
1.6            “NDA” means a New Drug Application as defined in the U.S. Food, Drug and Cosmetics Act and the regulations promulgated thereunder.
 
1.7            “NET SALES” means the amount billed, invoiced, or received (whichever occurs first) for SALES, leases or other transfers of LICENSED PRODUCTS, less:
 
(a)            customary trade, quantity and cash discounts or rebates and non-affiliated brokers’ or agents’ commissions actually allowed and taken;
 
(b)            amounts repaid or credited by reason of rejection, recall or return;
 
(c)            to the extent separately stated on purchase orders, invoices, or other documents of sale, tax levied on and/or other governmental charges made as to production, sale, transportation, delivery or use and paid by LICENSEE or a SUBLICENSEE; and
 
(d)            reasonable charges for freight, packaging and insurance costs incurred in the delivery of transportation or LICENSED PRODUCTS provided by third parties, if separately stated.
 
NET SALES also includes the fair market value of any non-cash consideration received by LICENSEE or SUBLICENSEES for the SALE, lease, or transfer of LICENSED PRODUCTS.
 
2

 
1.8            “NON-COMMERCIAL RESEARCH PURPOSES” means the use of PATENT RIGHTS and/or BIOLOGICAL MATERIALS for academic research or other not-for-profit scholarly purposes which are undertaken at a non-profit or governmental institution that does not use the PATENT RIGHTS and/or BIOLOGICAL MATERIALS in the production of manufacture of products for sale or the performance of services for a fee.  Such use shall not include (i) the right to use the subject matter of the PATENT RIGHTS in the production or manufacture of products for sale or for the performance of services for a fee, or (ii) the right to use the subject matter of the PATENT RIGHTS pursuant to a research funding or other agreement or collaboration with a third party entity as a consequence of which such third party entity is granted rights to commercialize products or services under the PATENT RIGHTS.
 
1.9            “NON-PROTEIN PRODUCTS” means products that are discovered, identified or developed through the use of material that is claimed or covered by a VALID CLAIM in the PATENT RIGHTS, as a target in a screening tool or otherwise, exclusive of PROTEIN PRODUCTS.
 
1.10          “PATENT RIGHTS” means the patents and patent applications listed on Appendix A attached hereto, including without limitation United States Serial No. 08/525,864, filed September 9, 1995, now United States Patent No. 5,912,326, along with the inventions described and/or claimed therein, and any divisionals, continuations, continuations-in-part (to the extent that a claim of such continuation-in-part is entitled to the priority date of at least one of the patents, applications, or disclosures identified in Appendix A), patents issuing thereon and reissues and reexaminations thereof, and any and all foreign patents and patent applications corresponding thereto, all to the extent that Harvard and/or STANFORD has an ownership or an interest in such PATENT RIGHTS.
 
1.11          “PROCEEDS” means the royalties actually received by Acorda from its SUBLICENSEES for NET SALES of LICENSED PRODUCTS that are NON-PROTEIN PRODUCTS.
 
1.12          “PROTEIN PRODUCT” means a product that is in whole or in part, composed of one or more proteins encoded by the growth factor gene nrg -2, or a fragment thereof, in whatever form including mutants, analogues, homologues or derivative forms thereof, that is covered by a VALID CLAIM in the PATENT RIGHTS.
 
1.13          “PUBLIC LAWS” means the US laws referred to as “Public Law 96-517” and “Public Law 98-620” and includes all amendments to such statutes.
 
1.14          “SOLD” and “SALE” means the sale, transfer, exchange or other commercial disposition of LICENSED PRODUCTS by LICENSEE, its AFFILIATES or SUBLICENSEES.  In case of doubt, SALES of LICENSED PRODUCTS shall be deemed consummated no later than receipt of payment from a third party for the applicable transaction involving such LICENSED PRODUCT.
 
3

 
1.15          “SUBLICENSE” means a grant by LICENSEE, either directly or indirectly (i.e., through multiple tiers of sublicenses) to a third party of sublicense to practice any of the rights granted to LICENSEE hereunder in accordance with this AGREEMENT.  Such third party shall be referred to as a “SUBLICENSEE” under this AGREEMENT.
 
1.16          “TERRITORY” means all countries and territories worldwide.
 
1.17          ‘VALID CLAIM” means (a) a pending claim of a patent application within the PATENT RIGHTS, which (i) has been pending under examination for less than seven (7) years, (ii) has been asserted in good faith, and (iii) has not been abandoned or finally rejected without the possibility of appeal or refiling; or (b) a claim of an issued or granted and unexpired patent within the PATENT RIGHTS, which has not been held unenforceable unpatentable or invalid by a decision of a court or governmental body of competent jurisdiction, which can no longer be appealed (i.e., within the time allowed or appeal), which has not been rendered, unenforceable through disclaimer or otherwise, which has not been abandoned, or which has not been lost through an interference proceeding.  A VALID CLAIM shall be defined as of each calendar half year ending June 30 and December 31.
 
ARTICLE II
Grant of Rights
 
2.1            CeNeS hereby grants to LICENSEE and LICENSEE accepts, subject to the terms an conditions hereof, an exclusive sublicensee under the PATENT RIGHTS and LICENSED KNOW-HOW in the TERRITORY to make and have made, use and have used, sell, offer for sale, have sold and import LICENSED PRODUCTS for the life of the PATENT RIGHTS.  Such sublicense shall include the right to grant further sublicenses through multiple tiers of sublicenses.
 
2.2            The granting and exercise of this license is subject to the following conditions:
 
(a)            Harvard’s “Statement of Policy in Regard to Inventions, Patents and Copyrights,” dated August 10, 1998 the PUBLIC LAWS, the Harvard’s obligations under the sponsored research agreement(s) referenced as Grant Nos. EY08397 and NS14506 from the National Institutes of Health.  Any right granted in this AGREEMENT greater than that permitted under the PUBLIC LAWS shall be subject to modification as may be required to conform to the provisions of those statutes.
 
(b)            Harvard’s reservation of the right to make and use, and to grant to not-for-profit third parties, non-exclusive licenses to use the subject matter described and claimed in the PATENT RIGHTS solely where the rights conferred by such non-exclusive license are explicitly limited to use that is for NON-COMMERCIAL RESEARCH PURPOSES, provided, that , in all such non-exclusive licenses granted under this paragraph 2.2(b),
 
4

 
Harvard shall include such limitation of use as provided in subparagraphs 2.9(i) and 2.9(ii) of the Harvard License, as amended.
 
(c)            LICENSEE shall use its best efforts to bring the subject matter of this AGREEMENT into commercial use as quickly as is reasonably possible.  This AGREEMENT is subject and subordinate to the terms and conditions of the Harvard License.
 
(d)            For as long as the sublicense rights granted in this AGREEMENT remain exclusive in the United States, LICENSEE shall cause any LICENSED PRODUCT produced for sale in the United States to be manufactured substantially in the United States.
 
2.3            All rights reserved to the United States Government and others under the Public Laws shall remain and shall in no way be affected by this AGREEMENT.
 
ARTICLE III
Diligence
 
3.1            LICENSEE shall, itself or through its AFFILIATES or SUBLICENSEES, use diligent efforts to effect introduction of LICENSED PRODUCTS into the commercial market as soon as practicable, consistent with sound and reasonable business practice and judgment; thereafter, until the expiration of this Agreement, LICENSEE shall endeavor to keep LICENSED PRODUCTS reasonably available to the public.  LICENSEE, its AFFILIATES or SUBLICENSEES shall make such efforts in the form of the actions (a) - (d) of this Section 3.1 (hereinafter referred to as “Diligence Milestones”).
 
(a)            within twenty-four (24) months of the EFFECTIVE DATE, commence exploratory studies leading to the validation of a specific therapeutic area of use for the growth factor gene nrg -2, therapeutic study areas may include, but are not limited to, central nervous system indications, congestive heart failure and cardiotoxicity secondary to chemotherapy with tyrosine kinase anti-neoplastic agents, and submit to CeNeS a due diligence report describing the exploratory studies;
 
(b)            within fifty-four (54) months of the EFFECTIVE DATE, file an IND for a LICENSED PRODUCT and shall provide written notice to CeNeS of such filing;
 
(c)            within eighty-four (84) months of the EFFECTIVE DATE, initiate human clinical trials for a LICENSED PRODUCT and shall provide written notice to CeNeS of such initiation; and
 
(d)            within one hundred twenty (120) months of the EFFECTIVE DATE, file a NDA for a LICENSED PRODUCT.
 
5

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
3.2            In the event of a failure by LICENSEE, its AFFILIATES or SUBLICENSEES to meet a Diligence Milestone set forth above, and LICENSEE can demonstrate to CeNeS that it has made reasonable efforts to meet such milestone, CeNeS and LICENSEE shall negotiate in good faith and agree upon a reasonable extension for such milestone; provided that such extension shall be no less than twelve (12) months.  Additional extensions to the same Diligence Milestone may be granted, if needed, based upon the progress that has been made by LICENSEE to meet the unmet Diligence Milestone.
 
ARTICLE IV
Royalties
 
4.1            LICENSEE shall pay to CeNes a non-refundable license royalty fee in the sum of [**] within ten (10) days after execution date of this AGREEMENT.
 
4.2            (a)            LICENSEE shall pay to CeNeS during the term of this AGREEMENT a royalty of [**] of NET SALES of PROTEIN PRODUCTS by LICENSEE and its AFFILIATES and a royalty of [**] of the NET SALES of PROTEIN PRODUCTS by each SUBLICENSEE.
 
(b)            LICENSEE shall pay to CeNeS during the term of this AGREEMENT a royalty of [**] of NET SALES of NON-PROTEIN PRODUCTS by LICENSEE or its AFFILIATES.  In the case of SUBLICENSES, LICENSEE shall pay to CeNeS [**] of PROCEEDS received by LICENSEE from each such SUBLICENSEE in connection with NON-PROTEIN PRODUCTS.
 
(c)            The obligation to pay royalties to CeNeS under this AGREEMENT shall be imposed only once with respect to the same unit of LICENSED PRODUCT regardless of the number of pending or issued claims of the PATENT RIGHTS covering the applicable LICENSED PRODUCT or the amount of subject matter of the PATENT RIGHTS used in the development, manufacture or use thereof.
 
(d)            LICENSEE shall not be obligated to make any further royalty payments in a country for any LICENSED PRODUCT after the end of the period commencing on the date of the first commercial sale of the LICENSED PRODUCT in such country by LICENSEE, its AFFILIATEs or SUBLICENSEEs and ending on the date of expiration of the last VALID CLAIM of the PATENT RIGHTS covering the LICENSED PRODUCT actually used to make such LICENSED PRODUCT, in such country.
 
4.3            In the event a LICENSED PRODUCT is sold in the form of a combination product containing one or more active ingredients in addition to the LICENSED PRODUCT active ingredient (hereinafter “COMBINATION LICENSED PRODUCT”), then the applicable NET SALES for such COMBINATION
 
6

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
LICENSED PRODUCT, for purposes of calculating royalties due thereunder, will be adjusted by multiplying actual NET SALES of such COMBINATION LICENSED PRODUCT by the applicable fraction, determined as follows:
 
(a)            Unless Section 4.3(b), 4.3(c) or 4.3(d) applies below, the fraction A/(A+B) where A is the invoice price of the LICENSED PRODUCT, if sold separately, and B is the sum of the invoice price(s) of any other active component or components in the combination, if sold separately.
 
(b)            If, on a country-by-country basis, the other active component or components in the COMBINATION LICENSED PRODUCT are not sold separately in said country, the fraction shall be A/C where A is the invoice price of the LICENSED PRODUCTS if sold separately, and C is the invoice price of the COMBINATION LICENSED PRODUCT.
 
(c)            If, on country-by-country basis, the LICENSED PRODUCT is not sold separately in said country, the fraction shall be [1-(B/C)] where B is the invoice price sum of any other active components or components in the combination, if sold separately and C is the invoice price of the COMBINATION LICENSED PRODUCT.
 
(d)            If, on a country-by-country basis, neither the LICENSED PRODUCT nor the other active component or components of the COMBINATION LICENSED PRODUCT is sold separately in said country, the fraction shall be negotiated in good faith by the parties with the intention of agreeing upon a fair and equitable formula that reasonably reflects the relative value contributed by the LICENSED PRODUCT to the total value of the combination in the COMBINATION LICENSED PRODUCT, as compared to the other active ingredients therein.
 
4.4            For SALES between LICENSEE and its AFFILIATEs or SUBLICENSEEs for resale, the royalty shall be paid once on the NET SALEs of such resale to a third party by the AFFILIATE or SUBLICENSEE.
 
4.5            No later than January 1 of each calendar year after the EFFECTIVE DATE of this AGREEMENT, LICENSEE shall pay to CeNeS the following non-refundable license maintenance royalty and/or advance on royalties.  Such payments may be credited against the royalties due for that calendar year and Royalty Reports (as defined in Section 5.3(a)) shall reflect such a credit.  Such payments shall not be creditable against royalties due for any subsequent calendar year.  The first three (3) of such payments shall not be creditable against milestone payments but subsequent payments thereafter may be creditable against milestone or royalty payments.

January 1, 2003	 	$	[**]	 	
 	 	 	 	 	
January 1, 2004	 	$	[**]	 	
 	 	 	 	 	
January 1, 2005	 	$	[**]	 	
 	 	 	 	 	
January 1 of each additional year prior to the first to occur of (i) the termination date of this AGREEMENT; or (ii) expiration of the PATENT RIGHTS	 	$	[**]	 	
 
7

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
4.6            LICENSEE shall pay to CeNeS the following non-refundable milestone payments upon achievement by LICENSEE, an AFFILIATE or SUBLICENSEE of the milestone events indicate below:
 
(a)            Upon the EFFECTIVE DATE:  $[**];
 
(b)            Upon initiation of the first human clinical trial of a LICENSED PRODUCT that is a PROTEIN PRODUCT:  $[**];
 
(c)            Upon initiation of the first Phase III human clinical trial of a LICENSED PRODUCT that is a PROTEIN PRODUCT:  $[**];
 
(d)            Upon filing the first New Drug Application (“NDA”) with the U.S. Food and Drug Administration for a LICENSED PRODUCT that is a PROTEIN PRODUCT:  $[**];
 
(e)            Upon being granted the first approval to market commercially a LICENSED PRODUCT that is a PROTEIN PRODUCT in the United States:  $[**]; and
 
(f)             Upon being granted the first approval to market commercially a LICENSED PRODUCT that is a PROTEIN PRODUCT in a country chosen from the group consisting of the United State, Canada, the United Kingdom, France, Germany, Italy, Spain, and Japan:  $[**].  For avoidance of doubt, in the event the first approval to market commercially a LICENSED PRODUCT that is a PROTEIN PRODUCT occurs in the United States, then LICENSEE shall nevertheless be obligated to pay both milestones (e) and (f) for a total payment of $[**] in connection with such approval.
 
For clarity, should a PROTEIN PRODUCT be abandoned by LICENSEE, its AFFILIATE or SUBLICENSEE for any reason following completion of any of milestones (b) through (e) but prior to completion of milestone (f), and LICENSEE commences development of a subsequent PROTEIN PRODUCT, then LICENSEE shall resume the milestone payments for such subsequent PROTEIN PRODUCT starting at the event subsequent to the event for which a milestone payment had already been paid.  Each milestone payment shall be paid only once by LICENSEE.
 
8

 
ARTICLE V
REPORTING
 
5.1            Diligence Milestones shall be reported according to the provisions of Section 3.1 of this AGREEMENT.
 
5.2            LICENSEE shall report to CeNeS the date of first Sale of each LICENSED PRODUCT in each country within thirty (30) days of occurrence.
 
5.3            (a)            LICENSEE shall submit to CeNeS within sixty (60) days after each calendar half year ending June 30 and December 31, a royalty report (“Royalty Report”) setting forth for such half year at least the following information:
 
(i)                   the number of LICENSED PRODUCTS sold by Licensee, its AFFILIATES And SUBLICENSEEs in each country;
 
(ii)                  total billings for such LICENSED PRODUCTS;
 
(iii)                 deduction applicable to determine the NET SALES thereof;
 
(iv)                 the amount of NET SALES by SUBLICENSEEs and PROCEEDS received by LICENSEE; and
 
(v)                  the amount of royalty due thereon, or, if no royalties are due to CeNeS for any reporting period, the statement that no royalties are due.
 
Each such Royalty Report shall be certified as correct by an officer of LICENSEE to the best of such officer’s knowledge, and shall include a detailed listing of all deductions from royalties.
 
(b)            LICENSEE shall pay to CeNeS with each such Royalty Report the amount of royalty due with respect to such half year.  If multiple technologies are covered by the license granted thereunder, LICENSEE shall specify which PATENT RIGHTS are practiced for each LICENSED PRODUCT included in the Royalty Report.
 
(c)            All payments due hereunder shall be deemed received when funds are credited to CeNeS’s bank account and shall be payable by check or wire transfer in United States dollars.  Conversion of foreign currency to U.S. dollars shall be made at the conversion rate existing in the United States (as reported the Wall Street Journal, Eastern Edition) on the last working day of each royalty period.  No transfer, exchange, collection or other charges shall be deduced from such payments.
 
(d)            All such reports shall be considered trade secrets of LICENSEE, and shall be maintained in confidence by CeNeS, except solely as required by law or by the terms of the Harvard License.
 
(e)            Late payments shall be subject to a charge of one and one-half percent (1.5%) per month, or $250, whichever is greater.
 
9

 
ARTICLE VI
Record Keeping
 
6.1            LICENSEE shall keep, and shall require its AFFILIATEs and SUBLICENSEEs to keep, accurate records (together with supporting documentation) of LICENSED PRODUCTS made, used or sold under this AGREEMENT, appropriate to determine the amount of royalties due to CeNeS hereunder.  Such records shall be retained for at least three (3) years following the end of the reporting period to which they relate.  They shall be available upon at least fifteen (15) business days’ prior written notice at any reasonable time during normal business hours not more often than once each calendar quarter for examination by an independent accountant selected by CeNeS, to whom Acorda or, if applicable, its AFFILIATEs or SUBLICENSEEs, have no reasonable objection, for the sole purpose of verifying reports and payments hereunder.  In conducting examinations pursuant to this Section, CeNeS’ independent accountant shall have access to all records that CeNeS reasonably believes to be relevant to the calculation of royalties under Article IV.  Such independent accountant an CeNeS shall treat as confidential and shall not use or disclose to any third party (except Harvard and STANFORD) any information acquired during the course of such examination.
 
6.2            Such examination by CeNeS’s independent accountant shall be at CeNeS’ expense, except that if such an examination shows an underreporting or underpayment in excess of five percent (5%) for any twelve (12) month period, then LICENSEE shall pay the cost of such examination as well as any additional sum that would have been payable to CeNeS had the LICENSEE reported correctly, plus interest on said sum at the rate of one and one-half percent (1.5%) per month.  If the independent account determines that there had been an overpayment by LICENSEE, LICENSEE shall be entitled to either a refund in the amount of such overpayment or a credit against any future payments to be made by LICENSEE under this AGREEMENT.
 
ARTICLE VII
DOMESTIC AND FOREIGN PATENT FILING AND MAINTENANCE
 
7.1            Upon execution of this AGREEMENT, LICENSEE shall be primarily responsible for the preparation, filing, prosecution and maintenance of any and all patent applications and patents included in PATENT RIGHTS, at its expense.  Notwithstanding the previous sentence, LICENSEE shall promptly furnish to CeNeS copies of all material documents pertaining to such preparation, filing, prosecution or maintenance, and CeNeS shall be given and opportunity to consult with LICENSEE as to the preparation, filing, prosecution and maintenance.
 
7.2            Harvard and LICENSEE shall cooperate fully in the preparation, filing, prosecution and maintenance of PATENT RIGHTS and of all patents and patent
 
10

 
applications licensed to LICENSEE hereunder, executing all papers and instruments or requiring members of Harvard and/or STANFORD to execute such papers and instruments so as to enable LICENSEE to apply for, to prosecute and to maintain patent applications and patents in Harvard’s and STANFORD’s name in each country.  Each party shall provide to the other prompt notice as to all matters which come to its attention and which may affect the preparation, filing, prosecution or maintenance of any such patent applications or patents.
 
7.3            LICENSEE may elect to surrender its rights under the PATENT RIGHTS on a patent-by-patent basis in any country upon sixty-(60) days written notice to CeNeS.
 
ARTICLE VIII
ENFORCEMENT AND DEFENSE OF THE PATENT RIGHTS
 
8.1            With respect to any PATENT RIGHTS that are exclusively licensed to LICENSEE pursuant to this AGREEMENT, LICENSEE shall have the right to prosecute and defend its own name and at its own expense any infringement of a patent within PATENT RIGHTS, or any other type of litigation involving the subject matter of the PATENT RIGHTS.  CeNeS agrees to notify LICENSEE promptly of each infringement of such patents of which CeNeS is or becomes aware, and of each challenge to such patents of which CeNeS is or becomes aware.
 
8.2            (a)            If LICENSEE commences an action In accordance with Section 8.1 above, Harvard may to the extent permitted by law, and shall to the extent required by law so as to enable LICENSEE to enforce the exclusive rights granted to it by this AGREEMENT, join as a part in that action. Regardless of whether Harvard joins as a party, both Harvard and CeNeS shall cooperate fully with LICENSEE in connection with any such action.
 
(b)            If Harvard elects to join as a party pursuant to Section 8.2(a), Harvard shall jointly control the action with LICENSEE.
 
(c)            LICENSEE shall reimburse Harvard for any costs Harvard incurs, including reasonable attorneys’ fees, as part of an action brought by LICENSEE, whether or not Harvard becomes a party to such action.
 
8.3            If LICENSEE elects to commence an action as described above, LICENSEE may deduct from its royalty payments to CeNeS with respect to the patent(s) subject to suit an amount not exceeding fifty percent (50%) of LICENSEE’s expenses and costs of such action, including reasonable attorney’s fees and any reimbursements provided for under Section 8.2(c); provided, however, that such reduction shall not exceed fifty percent (50%) of the total royalty due to CeNeS with respect to the patent(s) subject to suit for each calendar year.  If such fifty percent (50%) of LICENSEE’s expenses and costs exceeds the amount of royalties deducted by LICENSEE for any calendar year, LICENSEE may to that extent reduce the
 
11

 
royalties due to CeNeS from LICENSEE in succeeding calendar years, but never by more than fifty percent (50%) of the total royalty due in any one year with respect to the patent subject to suit.
 
8.4            No settlement, consent judgment or other voluntary final disposition of the suit may be entered into without the prior written consent of Harvard, and without the prior written consent of LICENSEE,  which consent shall not be unreasonably withheld by either of them.
 
8.5            Recoveries or reimbursements, from actions commenced pursuant to this Article VIII shall be distributed as follows: (i) each party shall first be reimbursed for any expenses and litigation costs incurred in the action (including any reimbursement provided by LICENSEE to Harvard pursuant to Section 8.2(c) to the extent not deducted from royalties pursuant to Section 8.3) and then to reimburse CeNeS for royalties deducted by LICENSEE pursuant to in Section 8.3; (ii) as to any remaining ordinary damages, LICENSEE shall deem such remaining damages as NET SALES in the fiscal quarter receives by LICENSEE and royalties on such amount shall be payable by LICENSEE to CeNeS accordingly; and (iii) as to any remaining special or punitive damages, LICENSEE shall receive an amount equal to 50% of its external expenses incurred in the action and the remainder of such special or punitive award shall be shared equally between the parties.
 
8.6            If LICENSEE elects not to exercise its right to prosecute an infringement of the . PATENT RIGHTS pursuant to this Article VIII within one hundred twenty (120) days after notification by CeNeS pursuant to Section 8.1 of any such infringement, CeNeS may do so at its own expense, controlling such action and retaining all recoveries therefrom. Notwithstanding the foregoing, CeNeS shall first consult with LICENSEE and give due consideration to LICENSEE’s reasons for not instituting actions to prosecute an infringement of the PATENT RIGHTS. If CeNeS decides to pursue such infringement, LICENSEE shall cooperate fully with CeNeS in connection with any such action.
 
8.7            If a declaratory judgment action is brought naming LICENSEE as a defendant and alleging invalidity of any of the PATENT RIGHTS, CeNeS may elect to join such action at its own expense; in all other respects such action shall be conducted as if it had been brought by LICENSEE pursuant to Sections 8.1, 8.2, 8.3 and 8.4 of this Article VIII.
 
ARTICLE IX
TERMINATION OF AGREEMENT
 
9.1            This AGREEMENT, unless earlier terminated as provided herein, shall remain in effect until the last patent, patent application, or claim included in PATENT RIGHTS has expired, been abandoned or been held finally rejected or invalid (the “TERM”).
 
12

 
9.2            Except as provided in paragraphs 9.3(a) and 9.3(b) below, either party shall have the right to terminate this AGREEMENT if the other party defaults in the performance of a material obligation under this AGREEMENT and the default has not been remedied within ninety (90) days after the date of notice in writing of such default by the party specifying such breach and seeking termination.
 
9.3            CeNeS may terminate this AGREEMENT immediately under the following circumstances:
 
(a)            If LICENSEE defaults in its obligations under Sections 11.6(a) and 11.6(b), provided, that CeNeS provides written notice to LICENSEE of the default and LICENSEE fails to cure such default within thirty (30), days; or
 
(b)            if CeNeS determines that the AGREEMENT should be terminated due to the failure of LICENSEE to meet a Diligence Milestone by the expiration of an extension pursuant to Section 3.2, and if, in CeNeS’ reasonable judgment, a further extension pursuant to Section 3.2 would be unlikely to result in LICENSEE being able to meet such Diligence Milestone.
 
9.4            If Harvard terminates the Harvard License because CeNeS becomes insolvent, makes an assignment for the benefit of creditors, or has a petition in bankruptcy filed for or against it, Harvard shall, upon LICENSEE’s written request, enter into a direct license with LICENSEE for the PATENT RIGHTS under the same terms as those in this AGREEMENT.
 
9.5            This AGREEMENT shall, at LICENSEE’s written request, be assigned to Harvard upon termination of the Harvard License. CeNeS shall provide prompt written notice to LICENSEE if Harvard gives notice that it intends to terminate the Harvard License for breach, and LICENSEE may engage in actions to cure such breach to avoid such termination or else may effect an assignment of this AGREEMENT to Harvard upon termination of the Harvard License.
 
9.6            LICENSEE shall have the right to terminate this AGREEMENT upon ninety (90) days advance written notice of termination to CeNeS, such termination to be effective on the last of such ninety (90) days (the “Termination Date”).  LICENSEE shall submit a final Royalty Report to CeNeS, and pay any and all amounts due hereunder, including, without limitation, all royalty payments and unreimbursed patent expenses, within thirty (30) days following the Termination Date.
 
9.7            The license to LICENSEE set forth in Section 2.1 shall continue after any termination or expiration of this AGREEMENT as set forth in this Section 9.7.  If this AGREEMENT expires pursuant to Section 9.1, then LICENSEE shall thereafter retain a nonexclusive, perpetual, royalty-free, worldwide license, with the full right to sublicense, under the PATENT RIGHTS and LICENSED KNOW-HOW to practice such technology and rights for all purposes. If this
 
13

 
AGREEMENT is terminated by LICENSEE pursuant to Section 9.2, then LICENSEE, in its sole discretion, may elect to retain the exclusive license granted in Section 2.1, subject to the payment of the royalties otherwise due under Section 4.2.
 
9.8            Articles I and X, and Sections 2.3, 5.3(e), 9.7, 9.8, 11.1, 11.2, 11.4, 11.5, 11.7 and 11.9 of this AGREEMENT shall survive termination.
 
ARTICLE X
CONFIDENTIALITY
 
10.1          Treatment of Confidential Information.  Except as otherwise provided hereunder, during the term of this AGREEMENT and for a period of five (5) years thereafter:
 
(a)            CeNeS, its AFFILIATES and SUBLICENSEES shall retain in confidence and use only for purposes of this AGREEMENT, any written information and data supplied by LICENSEE to CeNeS under this AGREEMENT and marked as proprietary or confidential; and
 
(b)            LICENSEE shall retain in confidence and use only for purposes of this AGREEMENT, any written information and data supplied by CeNeS to LICENSEE under this AGREEMENT and marked as proprietary or confidential.
 
For purposes of this AGREEMENT, all such information and data which a party is obligated to retain in confidence shall be called “Information.”   Any written information, materials or data relating to NRG-2 disclosed by one party to the other party pursuant to the LICENSE OPTION AGREEMENT and the Confidentiality Agreement entered into as of July 23, 2001 shall be deemed Information under this AGREEMENT.
 
10.2          Permitted Disclosure. To the extent that it is reasonably necessary to fulfill its obligations or exercise its rights under this AGREEMENT, or any rights which survive termination or expiration hereof, each party may disclose Information to its AFFILIATES, SUBLICENSEES, consultants, outside contractors and clinical investigators on condition that such entities or persons agree:
 
(a)            to keep the Information confidential for at least the same time periods and to the same extent as each party is required to keep the Information confidential and
 
(b)            to use the Information only for such purposes as such parties are authorized to use the Information.
 
Each party, its AFFILIATES or SUBLICENSEES may disclose Information to regulatory authorities to the extent that such disclosure is necessary for the prosecution and enforcement of patents, authorizations to conduct clinical trials or commercialization of LICENSED PRODUCTS, provided that such party is
 
14

 
otherwise entitled to engage in such activities under this AGREEMENT. Each party, its AFFILIATES or SUBLICENSEES may disclose Information to the government or a court of competent jurisdiction, provided that such disclosing party (a) provides the other party with adequate notice of the required disclosure, (b) cooperates with the other party’ s efforts to protect its Information with respect to such disclosure and (c) takes all reasonable measures requested by the other party to challenge or to modify the scope of such required disclosure. CeNeS may disclose Information to Harvard and Stanford to the extent such disclosure is required pursuant to CeNeS’ s obligations under the Harvard License.
 
10.3          The obligation under Section 10.1 not to use or disclose Information shall not apply to any part of such Information that the recipient party can establish by competent written proof:
 
(a)            is or becomes patented, published or otherwise part of the public domain, other than by unauthorized acts of the party obligated not to disclose such Information (for purposes of this Article 10 (the “ Receiving Party ”), its AFFILIATES or SUBLICENSEES in contravention of this AGREEMENT;
 
(b)            is disclosed to the Receiving Party, its AFFILIATES or SUBLICENSEES by a third party provided that such Information was not obtained by such third party directly or indirectly from the other party under this AGREEMENT;
 
(c)            prior to disclosure under this AGREEMENT, was already in the possession of the Receiving Party, its AFFILIATES or SUBLICENSEES, provided that such Information was not obtained directly or indirectly from the other party under this AGREEMENT;
 
(d)            results from the research and development by the Receiving Party, its AFFILIATES or SUBLICENSEES, independent of disclosures from the other party of this AGREEMENT, provided that the persons developing such information have not had exposure to the Information received from the disclosing party; or
 
(e)            CeNeS and LICENSEE agree in writing may be disclosed.
 
10.4          Confidential Nature of the Terms of Agreement. Except as expressly provided herein, CeNeS and LICENSEE each agrees not to disclose any terms of this AGREEMENT to any third party without the consent of the other party; provided, however, that disclosures may be made as required by securities or other applicable laws, or to actual or prospective investors, corporate partners or acquirers, or to a party’s accountants, attorneys, and other professional advisors who agree to appropriate confidentiality provisions to protect such terms from disclosure or improper use.
 
15

 
ARTICLE XI
GENERAL
 
11.1          CeNeS Representations and Warranties. CeNeS represents and warrants that;
 
(a)            (a) its obligations under this AGREEMENT are not in conflict with any prior commitments or obligations to any third party; that it has all requisite power and authority to enter into this AGREEMENT; and that all corporate action necessary to authorize its execution and delivery of this AGREEMENT has been duly taken;
 
(b)            it has the right to grant the rights granted in this AGREEMENT and perform the obligations set forth herein;
 
(c)            it and its Affiliates have not granted to any third party any license, option or other rights under the Patent Rights and to its knowledge, the Harvard License is in full force and effect;
 
(d)            to its knowledge, there are no facts or circumstance which would render any, of the Patent Rights invalid or unenforceable; and
 
(e)            to its knowledge, there is no interference action, opposition, reissue or reexamination proceeding, or any intellectual property litigation pending before any patent office or court concerning any of the Patent Rights.
 
11.2          CeNeS does not warrant the validity of the PATENT RIGHTS licensed hereunder and makes no representations whatsoever with regard to the scope of the licensed PATENT RIGHTS or that such PATENT RIGHTS may be exploited by LICENSEE, an AFFILIATE or SUBLICENSEE without infringing other patents.
 
11.3          Acorda Representations and Warranties. Acorda represents and warrants that its obligations under this AGREEMENT are not in conflict with any prior commitments or obligations to any third party; that it has all requisite power and authority to enter into this AGREEMENT; and that all corporate action necessary to authorize its execution and delivery of this AGREEMENT has been duly taken.
 
11.4          CeNeS EXPRESSLY DISCLAIMS ANY AND ALL IMPLIED OR EXPRESS WARRANTIES AND MAKES NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE PATENT RIGHTS, INFORMATION SUPPLIED BY CeNeS OR LICENSED PRODUCTS CONTEMPLATED BY THIS AGREEMENT.
 
11.5          Indemnification by LICENSEE.
 
(a)            LICENSEE shall indemnify, defend and hold harmless CeNeS, Harvard and STANFORD and their current or former directors, governing board members, trustees, officers, faculty, medical and professional staff, employees, students, and agents and their respective successors, heirs and
 
16

 
assigns (collectively, the “CeNeS Indemnitees”), against any liability, damage, loss or expenses (including reasonable attorneys’ fees and expenses of litigation) incurred by or imposed upon the CeNeS Indemnitees or any of them in connection with any third party claims, suits, actions, demands or judgments arising out of any theory of product liability (including, but not limited to, actions in the form of tort, warranty, or strict liability) concerning any product, process or service made, used or sold by LICENSEE, its AFFILIATES or SUBLICENSEES pursuant to any right or license granted under this AGREEMENT.
 
(b)            CeNeS shall indemnify, defend and hold harmless LICENSEE, its AFFILIATES, directors, officers, agents, contractors, SUBLICENSEES and employees (collectively, the “LICENSEE Indemnitees”); against any -liability, damage, loss or expenses (including reasonable attorney’s fees and expenses of litigation) incurred by or imposed upon the LICENSEE Indemnitees or any of them in connection with (1) any third party claims, suits, actions, demands or judgments arising out of any breach of Section 11.1 by CeNeS or (ii) LICENSEE’S actions pursuant to Section 9.5.
 
(c)            LICENSEE shall, at its own expense, provide attorneys reasonably acceptable to CeNeS, Harvard and STANFORD to defend against any actions brought or filed against any Indemnitee hereunder with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought.
 
11.6          (a)            Beginning at the time any such product, process or service is being commercially distributed or sold (other than for the purpose of obtaining regulatory approvals) by LICENSEE, its AFFILIATE, SUBLICENSEE or agent of LICENSEE, LICENSEE shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less than $2,000,000 per incident and $2,000,000 annual aggregate and naming the CeNeS Indemnitees as additional insureds. During clinical trials of any such product, process or service, LICENSEE shall, at its sole cost and expense, procure and maintain commercial general liability insurance in such equal or lesser amount as CeNeS, Harvard or STANFORD shall require, naming the CeNeS Indemnitees as additional insureds. Such commercial general liability insurance shall provide: (i) product liability coverage; and (ii) broad form contractual liability coverage for LICENSEE’s indemnification under this AGREEMENT. If LICENSEE elects to self-insure all or part of the limits described above (including deductibles or retentions which are in excess of $250,000 annual aggregate) such self-insurance program must be acceptable to CeNeS, Harvard and the Risk Management Foundation of the Harvard Medical Institutions, Inc. in their sole discretion. The minimum amounts of insurance coverage required shall not be construed to create a limit of LICENSEE’s liability with respect to its indemnification under this AGREEMENT.
 
17

 
(b)            LICENSEE shall provide CeNeS and Harvard with written evidence of such insurance upon request of CeNeS or Harvard. LICENSEE shall provide CeNeS with written notice at least fifteen (15) days prior to the cancellation, non-renewal or material change in such insurance; if LICENSEE does not obtain replacement insurance providing comparable coverage within such fifteen (15) day period, CeNeS and/or Harvard shall have the right to terminate this AGREEMENT on written notice.
 
(c)            LICENSEE shall maintain such commercial general liability insurance beyond the expiration or termination of this AGREEMENT during: (i) the period that any product, process, or service, relating to, or developed pursuant to, this AGREEMENT is being commercially distributed or sold by LICENSEE, SUBLICENSEE, AFFILIATE or agent of LICENSEE; and (ii) a reasonable period after the period referred to in Subsection (c)(i) above which in no event shall be less than ten (10) years.
 
11.7          Use of Name. LICENSEE shall not use CeNeS’s, Harvard’s nor STANFORD’s name or insignia, nor any adaptation thereof, nor the name of any of Harvard’s or STANFORD’s inventors, in any advertising, promotional or sales literature without the prior written approval of CeNeS, Harvard or STANFORD, respectively.
 
11.8          This AGREEMENT may not be transferred without the prior written consent of CeNeS and Harvard in each instance, which consent shall not be unreasonably withheld or delayed. The preceding sentence notwithstanding, Licensee shall have the right to transfer or assign this AGREEMENT and the rights granted hereunder in whole or in part to any person or corporation succeeding to its business as a result of sale, consolidation, reorganization, or otherwise, provided such assignee, person, or corporation shall, without delay, accept in writing the provisions of this AGREEMENT and agree to become in all material respects bound thereby in the place and stead of LICENSEE.  This AGREEMENT shall be binding upon the respective successors, legal representatives and assignees of CeNeS, Harvard and of LICENSEE.
 
11.9          The interpretation and application of the provisions of this AGREEMENT shall be governed by the laws of the state of New York and the United-States of America.
 
11.10        LICENSEE shall comply with all applicable laws and regulations in connection with the exercise of its rights hereunder. In particular, it is understood and acknowledged that the transfer of certain commodities and technical data is, subject to United States laws and regulations controlling the export of such. commodities and technical data, including all Export Administration Regulations of the United States Department of Commerce. These laws and regulations among other things, prohibit or require a license for the export of certain types of technical data to certain specified countries. LICENSEE hereby agrees and gives written assurance that it will comply with all United States laws and regulations
 
18

 
controlling the export of commodities and technical data, that it will be solely responsible for any violation of such by LICENSEE or its AFFILIATES or sublicensees, and that it will defend and hold CeNeS, Harvard and STANFORD harmless in the event of any legal action of any nature occasioned by such violation.
 
11.11        LICENSEE agrees: (i) to use reasonable efforts to obtain all regulatory approvals required for the manufacture and sale of LICENSED PRODUCTS; and (ii) to utilize appropriate patent marking on such LICENSED PRODUCTS. LICENSEE also agrees to register or record this AGREEMENT as is required by law or regulation in any country where the license is in effect.
 
11.12        Any notices to be given here under shall be sufficient if signed by the party (or, party’s attorney)giving same and either: (i) delivered in person; (ii) mailed certified mail, postage prepaid, return receipt requested; or (iii) faxed to other party if the sender has evidence of successful transmission and if the sender promptly sends the original by ordinary mail, in any event to the following addresses:
 
If to Acorda:
 
Acorda Therapeutics, Inc.
15 Skyline Drive
Hawthorne, NY 10532
Attn: President and Chief Executive Officer
 
with a copy to:
 
Acorda Therapeutics, Inc.
15 Skyline Drive
Hawthorne, NY 10532
Attn. Harold Safferstein, Vice President, Business Development
 
If to CeNeS:
 
CeNeS Pharmaceuticals plc
Compass House
Vision Park
Chivers Way
Histon, Cambridge CB4 9ZR
England
Attn: Neil Clark, Chief Operating Officer and Finance Director
 
By such notice either party may change their address for future notices. Notices delivered in person shall be deemed given on the date delivered. Notices sent by fax shall be deemed given on the date faxed. Notices mailed shall be deemed given on the date postmarked on the envelope.
 
19

 
11.13        Should a court of competent jurisdiction later hold any provision of this AGREEMENT to be invalid, illegal, or unenforceable, and such holding is not reversed on appeal, it shall be considered severed from this AGREEMENT. All other provisions, rights and obligations shall continue without regard to the severed provision, provided that the remaining provisions of this AGREEMENT are in accordance with the intention of the parties.
 
11.14        This AGREEMENT constitutes the entire understanding between the parties and supersedes all written and prior agreements or understandings with regards to the subject matter hereof except that any confidential information disclosed pursuant to the LICENSE OPTION AGREEMENT shall be deemed Information of this AGREEMENT. Neither party shall be obligated by any condition or representation other than those expressly stated herein or as may be subsequently agreed to by the parties hereto in writing.
 
11.15        LICENSEE’S relationship with CeNeS shall be that of a licensee only. Neither party shall, be considered to be an employee or agent of the other, nor shall this Agreement constitute, create or in any way be interpreted as a joint venture, partnership or formal business organization of any kind. In that respect, neither party shall have the authority to execute any agreement on behalf of the other party, nor shall, either party have any authority to negotiate any agreement, except as the other party may expressly direct in writing.
 
11.16        This AGREEMENT maybe executed in one or more counterparts, each of which shall be deemed an original, but all of which shall constitute one and the same instrument:
 
IN WITNESS WHEREOF, the parties hereto have caused this AGREEMENT to be executed by their duly authorized representatives.

CeNeS Pharmaceuticals PLC	Acordia Therapeutics, Inc.	

By:	/s/ Neil Clark	 	By:	/s/ Harold T. Safferstein	 	
 	 	 	 	 	 	
Print Name:	Neil Clark	 	Print Name:	Harold T. Safferstein	 	
 	 	 	 	 	 	
Title:	Finance Director	 	Title:	VP Business Development	 	

20

 
APPENDIX A
 
LAHIVE AND, COCKFIELD CASES
 
•       US Patent Application serial number 08/525,864 filed September 8,1995 entitled “Cerebellum-Derived Growth Factors and Uses Related Thereto”
 
•       PCT Patent Application serial number PCT/US96/14484 filed September 9,1996 entitled “Cerebellum-Derived Growth Factors, and Uses Related Thereto,”. designating Australia, Canada, EPO, Japan and South Korea
 
•       U.S. Patent Number 5,912,326
Cerebellum-Derived Growth Factors
Inventor: Han Chang
Filed September 8, 1995
Issued June 15, 1999
 
•       European Patent Application Number 96 93 2981.2
Cerebellum-Derived Growth Factors. and Uses Related Thereto
Filed September 9,1996
 
•       Canadian Patent Application Number 2,228,590
Cerebellum-Derived Growth Factors and Uses Related Thereto
Filed September 9,1996
 
•       Australian Patent Application Number 71563/96
Cerebellum-Derived Growth Factors and Uses Related Thereto
Filed September 9, 1996
 
•       Japanese Patent Application Serial Number 9-511448
Cerebellum-Derived Growth Factors and Uses Related Thereto
Filed September 9, 1996
 
•       South Korean Patent Application Serial Number 701775/98
Cerebellum-Derived Growth Factors and Uses. Related Thereto
Filed September 9,1996
 
CLARK & ELBING CASES
 
•       United States. Patent Application Serial Number 60/206,495
nrg-Z nucleic acid Molecules, polypeptides, and diagnostic and therapeutic methods
Filed 23-May-2000
 
•       United States Patent Application Serial Number 09/864,675
nrg-2 nucleic acid molecules, polypeptides, and diagnostic and therapeutic methods
Filed May 23.2001.
 
•       PCT Patent Application Serial Number US01/16896
nrg-2 nucleic add molecules, polypeptides, and diagnostic and therapeutic methods
Filed May 23 2001.
 
21

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
APPENDIX B
 
The following. comprise BIOLOGICAL MATERIALS supplied by Stanford:
 
[**]
 
22

 
Exhibit 10.17
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
RXPEDITE
ACORDA MARKETING SERVICES AGREEMENT
 
This Marketing Services Agreement (the “Agreement”) is made effective as of September 19, 2003 (the “Effective Date”), by and between Creative Healthcare Solutions, LLC, an Ohio limited liability corporation with offices at 500 Olde Worthington Road, Westerville, Ohio 43082 (“CHS”) and Acorda Therapeutics, Inc., a Delaware corporation having its principal place of business at 15 Skyline Drive, Hawthorne, New York 10532 (“Client”).
 
Background Information
 
A.                          CHS is a subsidiary of inChord Communications, Inc. (“inChord”) specializing in strategic consulting and advertising services (through its “Palio” division).  CHS will serve as inChord’s lead contact in connection with this Agreement with Client.  Certain of the Services to be performed hereunder will be provided by other CHS affiliates, including without limitation Blue Diesel, LLC (interactive applications and website development); Y Brand Outlook, LLC (branding services); and Health Process Management, LLC (data analytics).
 
B.                          inChord and Cardinal Health 401, Inc. (“Cardinal Health”) have together developed the RxPedite Program, pursuant to which they are able to provide pharmaceutical drug manufacturers with comprehensive outsourced marketing communications, selling and distribution/manufacturing capabilities to facilitate and enhance the commercialization of clients’ pharmaceutical products.
 
C.                          Client is currently developing a product known as Fampridine SR, a therapy to improve neurological function in spinal cord injuries (the “Product”), and wishes to outsource certain commercialization services available under the RxPedite Program, as set forth in this Agreement.
 
Statement of Agreement
 
The parties hereby acknowledge the accuracy of the Background Information and agree as follows:
 
§1.                                Appointment/Exclusivity .
 
(a)                                   CHS will provide marketing communications services to Client with respect to the Product as may be requested from time-to-time by Client and agreed to by CHS (collectively, the “Services”), which may include strategic consulting, advertising, promotion, contract marketing, market research, interactive applications and website development, data analytics, branding, and relationship marketing.  For clarity, booking sales of the Product will not be included in the Services to be provided by CHS hereunder, and Client will be solely responsible for booking all sales of the Product.  Client hereby appoints CHS as the exclusive “Agency of Record” for marketing communications services relating to the Product and agrees that during the Term (as defined in Section 14(a)) it will not grant any other person or entity
 
1

 
marketing communications rights to the Product anywhere in the United States; subject, however, to Section 1(b) below.
 
(b)                                   The parties acknowledge and agree that, notwithstanding any other provision of this Agreement, Client may enter into one or more collaboration or partnership agreements or other similar arrangements with third parties (exclusive of third party marketing services organizations) during the Term with respect to the development and commercialization of the Product (each, a “Partnering Agreement”).  In any such event, Client will exercise reasonable efforts to cause CHS to be selected as the vendor of choice for all or substantially all Services with respect to the Product, to the extent that such Services are outsourced.  If CHS is selected as the vendor for all or any portion of such Services, the parties will, if necessary, modify any then-current Workplans (as defined in Section 3(a)) including the Budgets therein, to reflect the modified Services as a result of such Partnering Agreement.  If, as a result of a Partnering Agreement and despite the exercise by Client of reasonable efforts to cause CHS to be selected as the vendor of choice, CHS is not selected to be the vendor of a substantial portion of the Services with respect to the Product in the United States, then CHS will no longer be the Agency of Record for Services relating to the Product, and either party may terminate this Agreement in accordance with the provisions of Sections 14(d) and 14(f).
 
§2.                                Services .
 
(a)                                   CHS will, from time-to-time and/or upon request by Client during the Term, prepare and provide to Client one or more proposed workplans (each, a “Proposed Workplan”) outlining the specific Services that CHS proposes to perform on Client’s behalf or that Client requests CHS to perform on its behalf.  Such Services may include, but are not limited to, the following:  (i) developing and submitting for Client’s approval advertising, marketing, and promotional programs for the Product, (ii) after approval by Client, developing advertising and communications materials for the Product for professional, trade, and consumer print, broadcast, and other media, (iii) after approval by Client, creating and preparing sales promotion material such as sales aids, detail aids, point-of-sale, direct mail, leaflets, inserts, catalogs, brochures, sales films, training films, sales manuals, interactive and on-line materials, (iv) checking all media vehicles carrying out communications for the Product for proper placement, reproduction, and rates, (v) purchasing all materials and services necessary for the production of finished advertisements and commercials as approved by Client, and (vi) providing design services including packaging, trademarks, and corporate identity programs.
 
(b)                                   Each Proposed Workplan provided to Client pursuant to Section 2(a) will include, at a minimum, a detailed summary of the specific Services to be provided by CHS and CHS’s good faith estimate of the anticipated fees and costs (a “Budget”) associated with all projects (“Projects”) to be undertaken by CHS under such Proposed Workplan.  Client may request additional information to be included in a Proposed Workplan and CHS will use all reasonable efforts to provide such additional information.  Each Proposed Workplan will be submitted for Client’s approval under the procedures described in Section 3 below.
 
(c)                                   Following approval by both parties of a Proposed Workplan for one or more Projects (as provided in Section 3), CHS will, subject to Client’s direction and instruction or any amendment of the approved Workplan in accordance with Section 7, perform or
 
2

 
coordinate the performance of those Services that are included in such Workplan.  CHS will exercise reasonable efforts to perform the Services on a timely basis and within the Budget, and Client will exercise reasonable efforts to assist CHS in doing so by making available to CHS all information pertaining to the Product that is necessary for CHS’s performance of such Services and cooperating with CHS in expediting its review of all materials submitted by CHS for Client’s approval.
 
(d)                                   During the Term, CHS and those of its affiliates performing Services for Client agree to refrain from providing Services for any product that competes against the Product and has substantially the same indication as the Product, without first obtaining Client’s written consent, which consent shall not be unreasonably withheld.
 
§3.                                Client Approval .
 
(a)                                   Each Proposed Workplan submitted to Client by CHS in Section 2 is subject to the review and written approval of Client prior to the time CHS or any of its affiliates incur liability to third parties in connection with the Projects contained in such Proposed Workplan.  Once a Proposed Workplan is approved by both parties, such approved workplan shall be referred to as a “Workplan,” and it shall govern the performance for Client of the Services covered by such Workplan.  For clarity, neither CHS nor its affiliates will perform any Services or incur any expenses with respect to such Services, and Client will not be obligated to pay for any Services, except in accordance with a Workplan that has been approved by Client.
 
(b)                                   All drafts of any proposed journal advertisements, training materials, media copy, advertisements or other promotional material used to promote the Product (collectively, the “Promotional Material”) will be submitted to Client for review at least two (2) weeks prior to publication or use, whenever practicable, provided, however, that the parties understand and agree that such two (2) week period will necessarily be shortened from time-to-time to reflect special deadlines and circumstances not within the reasonable control of CHS.  Client will be solely responsible for reviewing and approving the content of all Promotional Material and related Services prior to use of such Promotional Material and performance of related Services to make certain that all content in such Promotional Material and any and all related Services comply with all federal, state and local laws and all applicable industry standards and practices generally applicable to CHS’s and Client’s industry, including, without limitation, any applicable research guidelines, ethics and standards established by the American Medical Association, the Food and Drug Administration (“FDA”), the standards and guidelines outlined in the PhRMA Code, the standards and guidelines outlined in the Office of Inspector General (OIG) Guidance, and the Federal Food, Drug and Cosmetic Act and the regulations promulgated pursuant thereto (collectively, “Laws”).  Client hereby acknowledges that CHS will not conduct a legal review of the content of Promotional Material and/or related Services and that CHS is relying solely on Client to make certain that the content of Promotional Material and related Services comply with all Laws.  CHS will ensure that the content of the final copy of Promotional Material and related Services is identical to the draft content of such Promotional Material and related Services as approved by Client.
 
(c)                                   Client will have the right to make any editorial changes it desires prior to publication or use, with any charge for such change to be consistent with the Budget procedures
 
3

 
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.
Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
 
outlined in Section 3(d), below; provided, however, that Client must notify CHS in writing of either its approval or disapproval and/or required editing of Promotional Material as promptly as practicable, but in no event less than forty-eight (48) hours prior to the planned publication or use.
 
(d)                                   The initial Budget for a specific Project included in a Workplan will necessarily include fee and cost estimates based upon initial concepts and preliminary estimates, and CHS will be authorized to commence work and incur expenses on that particular Project based upon Client’s approval of the Workplan containing such initial Budget and up to an amount not to exceed [* * *] of the fees and costs in such approved Budget.  CHS will submit a revised Budget to Client at any time during performance of a Project if fees and costs for such Project are anticipated to exceed the initial Budget by more than [* * *], and this revised estimate must be approved by Client in writing before work on such Project continues.  Once final concepts for a Project are approved and final fee and cost estimates can be obtained, CHS will submit a final Budget for Client’s written approval if the initial Budget needs to be increased by more than [* * *] as a result of such final cost estimates.  CHS will use all reasonable efforts to complete the Services within the approved Budget.  In the case where, despite such efforts, cost estimates to complete the Services exceed the initial Budget by more than [* * *], CHS agrees to negotiate with Client in good faith a revised Budget that is acceptable to both parties.  In any event, Client’s written approval is required prior to any increase of the Budget for a Project by more than [* * *] from the initial Budget and for any further increases thereafter.
 
§4.                                Joint Commercialization Committee .  Promptly following the Effective Date, a joint commercialization committee (the “Committee”) will be formed consisting of an equal number of representatives, such number to be mutually agreed by the parties, from each of Client, CHS, and Cardinal Health.  Each party may replace any of its representatives at any time, and from time to time, by giving written notice to the other party. The Committee will be chaired by a Client representative, and the Committee will meet at such locations as reasonably determined by the chair to discuss and coordinate the overall marketing and sales strategy for the Product, relevant Workplans and Budgets therein associated with the Product, and any other relevant topics relating to the commercialization of the Product.  The Committee will convene at least four (4) times annually or more frequently as the parties deem necessary and meetings may be held by audio or video teleconference, with the consent of each party; provided that at least one (1) meeting per calendar year shall be held in person.  The parties agree that the purpose of the Committee is solely to provide a forum for the parties to discuss, monitor and coordinate activities and communications relating to the performance of the Services and provide recommendations relating thereto to the parties.  The Committee does not have the authority to approve or modify Workplans or Budgets, or to amend this Agreement.
 
§5.                                CHS Compensation .  In consideration for the Services that are rendered to Client under this Agreement, CHS will invoice Client and Client will pay CHS as follows:
 
(a)                                   As compensation for performance by CHS and its affiliates of the Services, Client will pay a fee (the “Agency Fee”) for each Project as specified in the approved Budget for such Project, whether relating to advertising and promotional, strategic consulting, interactive applications and website development, data analytics, branding, relationship
 
4

 
marketing, or other similar services.  Such Agency Fee for the Services performed in a particular month will be determined as follows:
 
(i)                                     Total fees for such Services shall be calculated based on the applicable CHS and its affiliates’ rates as set forth in the applicable Budget;
 
(ii)                                 Such total fees then shall be reduced by the amount (if any) of the pre-determined discount amount to which Client is entitled (any such discount, a “Discount Amount”), where such Discount Amount will be determined as described in the Discount Matrix attached as Exhibit A, and such discounted fees shall be the “Agency Fee” for such Project for such month.
 
(b)                                   The Agency Fee for each Project will be invoiced to Client by CHS on a monthly basis promptly after the beginning of each month as specified in the approved Budget, and Client will pay each such invoice within thirty (30) days of receipt thereof.  Each such invoice will specify with reasonable detail all the charges for Services, and the basis for any Discount Amount used in arriving at the Agency Fee.
 
(c)                                   All Discount Amounts actually allowed will be aggregated and, if applicable, paid to CHS by Client in accordance with the terms and conditions contained in the Discount Payment Matrix attached as Exhibit B.
 
(d)                                   Client will reimburse CHS for actual, verifiable costs incurred for obtaining from third parties any printing, photography, market research, selling aids, direct mail, reference material, color graphic reproductions, exhibit panels, honoraria, conference/meeting expenses and other products, services and supplies purchased by CHS on behalf of Client for a Project under this Agreement (“Client Reimbursable Expenses”) plus CHS’ standard mark-up of 4%; provided, however, that the aggregate costs for such Client Reimbursable Expenses are included in the Budget of the relevant Workplan approved in advance by Client and is subject to the provisions of Section 3(d) with respect to any increase in such costs.  Fifty percent (50%) of the estimated Client Reimbursable Expenses for each Workplan (as set forth in the applicable Budget) will be invoiced by CHS upon Client’s approval of the Workplan, and the balance of the Client Reimbursable Expenses will be invoiced on a monthly basis after such initial advance payment has been fully credited against actual costs incurred (as shown by invoices provided and credits shown), as such expenses are incurred by CHS, or as otherwise agreed to by the Parties as specified in the Budget.  Client will pay each such invoice within thirty (30) days of receipt thereof.
 
(e)                                   Client will reimburse CHS for its reasonable, verifiable travel expenses (including, without limitation, transportation, lodging and meals), fax, photocopying, telephone, overnight or other delivery, postage, shipping and other expenses associated with the performance of Services under this Agreement (“Out-of-Pocket Expenses”), without any CHS mark-up.  An estimate of the Out-of-Pocket Expenses for each Project shall be included in the Budget of the relevant Workplan approved in advance by Client and is subject to the provisions of Section 3(d) with respect to any increase in such expenses.  Out-of-Pocket Expenses will be invoiced by CHS on a monthly basis, as incurred, and Client will pay each such invoice within thirty (30) days of receipt thereof.
 
5

 
(f)                                     When CHS contracts with broadcast or print media for Services performed under this Agreement (“Media Buys”), CHS will, wherever practicable, contract on behalf of Client in a format substantially similar to that promulgated by the American Association of Advertising Agencies (“AAAA”).  CHS will use all reasonable efforts to guard against loss to Client through failure of media suppliers to properly execute their commitments.  However, notwithstanding anything to the contrary contained elsewhere in this Agreement, CHS will not be responsible for any failure on the part of media suppliers to perform.  Estimated costs for Media Buys will be included in the Budget of the relevant Workplan, subject to CHS’s standard mark-up, and will be invoiced by CHS upon issuance of the insertion order.  Client will pay each such invoice for Media Buys within thirty (30) days of receipt thereof. For clarity, CHS will not place any advertising in any media for Client without Client’s prior written approval.
 
(g)                                  Sales, use and other taxes will be included in the Budget and reimbursed by Client in a similar manner to other expenses associated with each Project; provided, however, that CHS will be responsible for all federal, state and local taxes imposed on CHS’s income or in connection with the employment of CHS’s full or part-time employees.
 
§6.                                Payment Terms .  CHS will submit invoices to Client on a monthly basis or as otherwise agreed by the parties in writing.  Payment terms will be net thirty (30) days from the date of the receipt, with interest accruing on any late payment at the rate of one and one-half percent (1.5%) per month until paid.  CHS will provide, upon the request of Client, appropriate supporting detail to allocate expenses by Project and the specific activities undertaken in such Project.  All payments due under Section 5 will be made payable to:  Creative Healthcare Solutions, LLC and mailed to the address as set forth for notices in Section 19, unless otherwise specified by CHS in writing.  Client and CHS will meet quarterly to review projected fees and costs compared to actual fees and costs on all Projects, and appropriate adjustments will be made to Workplans as necessary from time to time to reflect mutually approved changes in the scope of the work to be performed.
 
§7.                                Amending Workplans .  Subject to the terms of this Section 7, Client reserves the right to modify or cancel any previously approved Workplan.   In such event, CHS will promptly take all reasonable steps necessary or appropriate to carry out Client’s instructions; provided, however, that Client will continue to be responsible for paying CHS for (a) all work performed and expenses incurred prior to CHS’s receipt of notification of such change, provided that such work and expenses were incurred by CHS on Client’s behalf in accordance with the relevant Workplan approved by Client, (b) all non-cancelable commitments incurred by CHS prior to its receipt of notification of such change, provided that such commitments were incurred by CHS on Client’s behalf in accordance with the relevant Workplan approved by Client, (c) all expenses incurred by CHS in carrying out Client’s revised instructions, and (d) any other cancellation or other similar fees specifically agreed to by the parties in a Workplan, if any. Notwithstanding the foregoing, Client may not modify or cancel Projects in a fashion that would be inconsistent with Agency’s role as the exclusive “Agency of Record” under Section 1.
 
§8.                                Ownership of Technology; Work Made For Hire .  Client will maintain ownership and maintenance of the NDA, all clinical/scientific data and any other information related to the Product.
 
6

 
(a)                                   Work Product.   CHS agrees and acknowledges that, unless otherwise agreed to by the parties in a Workplan, Client will own all right, title and interest in and to all ideas, artwork, illustrations, audiovisual works, audio recordings, images, photographs, video, graphics, multimedia works, on-line products, sounds, text, notes, sketches, drawings, reports, inventions and Promotional Material, whether patentable or copyrightable, or other copyrightable works conceived or created by CHS or CHS’s affiliates or third party subcontractors in the course of performing the Services pursuant to this Agreement and which are accepted and paid for by Client (collectively, the “Work Product”).  Such Work Product will be deemed “works made for hire,” and CHS hereby assigns and shall assign to Client, and shall cause its affiliates and subcontractors (as applicable) to assign to Client, all right, title and interest in and to such Work Product and all intellectual property rights related thereto.  If Work Product is lost, damaged, or destroyed while in CHS’s custody or control, CHS will be liable to Client for the replacement cost of such Work Product.  Upon Client’s request at any time during the Term or thereafter, CHS will promptly transfer all Work Product to Client.
 
(b)                                   Brand Features.   Subject to retained third party rights disclosed to Client in advance in accordance with Section 9, all trademark(s), trade name(s), logo(s), slogan(s), and advertising plan(s) that are created by CHS and/or its affiliates for Client and which are accepted and paid for by Client under this Agreement (the “Brand Features”) will be the property of Client and regarded as “works made for hire.” CHS will not adopt, suggest or recommend the use of any Promotional Material or Brand Feature of which CHS knows, or in the exercise of reasonable diligence, should know, is identical to or confusingly similar to that being used by a third party.  CHS hereby assigns to Client, and shall cause its affiliates and subcontractors (as applicable) to assign to Client, all of its rights, title and interest to such items, together with all of the goodwill associated therewith, subject only to reserved third party rights.
 
(c)                                   Further Acts .  CHS and its affiliates shall cooperate with Client or its designee(s), both during and after the Term, to execute such documents and take such other actions as Client deems necessary for Client to obtain ownership and to apply for, secure, and maintain copyright, trademark or other proprietary protection of Work Product and Brand Features in the United States and/or worldwide.  CHS will not be responsible for initiating any such application, but will cooperate with Client as reasonably requested.  Client will pay or reimburse CHS for any out-of-pocket expenses associated with such cooperation.  If Client is unable  for any reason to secure CHS’s signature to any document required to apply for or execute any copyright, trademark or other applications with respect to any Work Product or Brand Features, CHS hereby irrevocably designates and appoints Client and its duly authorized officers and agents as its agents and attorneys in fact to act for and on CHS’s behalf to execute and file any such application and to do all other lawfully permitted acts to further the issuance of copyrights, trademarks or other rights thereon with the same legal force and effect as if executed by CHS.
 
(d)                                   CHS Proprietary Material.   Project tracking software, algorithms, and other intellectual property owned by CHS and/or one or more CHS affiliates and used by Client in connection with the Services (“CHS Proprietary Material”) will remain the sole property of CHS at all times.  Client agrees to discontinue the use and return to CHS all CHS Proprietary Material promptly following termination of this Agreement.
 
7

 
§9.                                Third Party Approvals .
 
(a)                                   CHS will be responsible for obtaining appropriate consents, authorizations and approvals from third parties for use of approved Promotional Material prepared by CHS in connection with the Services; provided, however, that Client will maintain its own medical affairs personnel (including physicians and staff) to review and support the marketing and sales efforts (including Promotional Material) on behalf of the Product and will be responsible for obtaining and providing all appropriate consents, authorizations and approvals in connection with materials provided to CHS for inclusion in the Promotional Materials and for scientific or medical papers or scientific consultation required in connection with the Promotional Material and the Services rendered by CHS.  Client will have sole and exclusive authority for managing all regulatory affairs associated with the Product including, but not limited to: (i) all necessary government filings and approvals for the Product; (ii) adverse event reporting to the FDA; (iii) product recalls; (iv) all clinical development associated with the Product; and (v) communications with regulatory authorities.  Client will promptly communicate to CHS all regulatory and other information relevant to CHS’s performance of Services in connection with the Product.
 
(b)                                   Certain Promotional Material may contain the intellectual property of third parties that CHS has the right to use pursuant to a license granted to CHS (or its affiliates), or other arrangement between a third party and CHS (or its affiliates).  Such license or other arrangement between a third party and CHS (or its affiliates) may permit Client to use such intellectual property only in connection with a specific Project or campaign, and would require additional payments for any different or extended use by Client.  CHS will obtain approval from the relevant third party as required under the relevant license or arrangement for use of such third party intellectual property in specific Projects for Client.  CHS will notify Client prior to use of any such third party intellectual property in a specific Project of any material conditions or limitations relating to such use, including but not limited to any conditions or limitations which, if breached, will obligate Client to pay additional fees or charges.  Client will be solely responsible for any fees or other charges associated with its different or extended use of intellectual property so licensed from a third party in breach of the applicable conditions or limitations of such use; provided that Client will not be responsible for such fees or charges if CHS fails to notify Client in writing in advance of its use of any third party intellectual property and the conditions and limitations related thereto.  CHS makes no representations with regard to use of Promotional Material outside of the United States; however, CHS will use all reasonable efforts to obtain such rights for Client if requested to do so.
 
§10.                         Right of First Negotiation .
 
(a)                                   Product Related Compounds. If Client controls or materially influences decisions regarding use of Services and is not restricted by a Partnering Agreement, Client agrees during the Term that CHS will be designated as the Agency of Record and perform those Services required by Client with respect to any future indications for the Product.
 
(b)                                   Other Compounds.   If Client controls or materially influences decisions regarding use of Services with respect to a molecule, compound or product described at the end of this Section 10(b), and is not restricted by a Partnering Agreement with respect to such
 
8

 
molecule, compound or product, Client agrees during the Term to provide CHS with an exclusive right of negotiation for a period of sixty (60) days following delivery to CHS of a request for proposal and related background materials (“RFP”) to provide Services, provided that such Services are necessary and will be outsourced.  The molecules, compounds or products that are subject of the foregoing rights are:  (i) products resulting from Client’s other molecules or compounds in development, (ii) products resulting from molecules or compounds which Client purchases, licenses or otherwise assumes rights from a third party, or (iii) any pharmaceutical human therapeutic product that Client purchases, licenses or otherwise assumes commercialization rights from a third party.
 
§11.                         Indemnification .  Each party will indemnify the other as follows:
 
(a)                                   CHS will indemnify, defend and hold Client and its officers, directors, agents, employees and affiliates (collectively, the “Client Group”) harmless from and against any liabilities, damages, losses or expenses, including reasonable attorneys’ fees, any of them may sustain or incur as a result of any claim, suit or proceeding (“Claim”) made, brought or threatened by third parties and based upon or resulting from (i) CHS’s or its affiliates’ negligence, willful misconduct or breach of this Agreement, including but not limited to, CHS’s breach of its representations and warranties under this Agreement and (ii) any Work Product or Brand Features that are alleged to constitute plagiarism, idea misappropriation, or that infringe third party intellectual property rights.  CHS’s obligations under this section include all time charges and expenses (including reasonable attorneys’ fees) incurred in connection with any subpoena, discovery demand or other directive having the force of law or any governmental inquiry served upon Client that relates to CHS or its business.  The provisions of this paragraph will not apply to a Claim to the extent that such Claim arises as a result of the negligence or willful misconduct of Client or any member of the Client Group or Client’s breach of this Agreement.
 
(b)                                   Client will indemnify, defend and hold CHS and its officers, directors, agents, employees and affiliates (collectively, the CHS Group”) harmless from and against any Claim made, brought or threatened by third parties and based upon or resulting from (i) Client’s or its affiliates’ negligence, willful misconduct or breach of this Agreement, including but not limited to, Client’s breach of its representations and warranties under this Agreement; (ii) any product liability or other Claim based upon the use or efficacy of any Product; (iii) content of Promotional Material that has been provided by Client or approved by Client in advance of publication; and (iv) any use of Promotional Material by Client outside the scope of any third party license of which CHS has notified Client in accordance with Section 9(b).  Client’s obligations under this section include all time charges and expenses (including reasonable attorneys’ fees) incurred in connection with any subpoena, discovery demand or other directive having the force of law or any governmental inquiry served upon CHS that relates to Client or its business.  The provisions of this paragraph will not apply to a Claim to the extent such Claim arises as a result of the negligence or willful misconduct of CHS or any member of the CHS Group or any CHS Group member’s breach of this Agreement.
 
9

 
(c)                                   Each party’s agreement to indemnify, defend and hold the other party harmless is conditioned on the indemnified party (i) providing prompt written notice to the indemnifying party of any Claim subject to indemnification under this Section 11; (ii) permitting the indemnifying party to assume full responsibility to investigate, prepare for and defend against any such Claim, (iii) assisting the indemnifying party, at the indemnifying party’s reasonable expense, in the investigation of, preparation for and defense of any Claim, and (iv) not compromising or settling such Claim without the indemnifying party’s written consent.
 
§12.                         Confidential Information .  Neither party will, during the Term and for a period of five (5) years thereafter, without the other party’s prior written consent, disclose to any third party any of the other party’s Confidential Information, except that either party may disclose the other party’s Confidential Information to its affiliates, Cardinal Health and Cardinal Health affiliates solely as necessary for their performance of the Services, provided that the party conveying the other party’s Confidential Information will inform each recipient of the confidential nature of such information and will use all reasonable efforts to cause each recipient to receive and hold such information in accordance with the terms of this Agreement.  Each party will, during the Term and for a period of five (5) years thereafter, keep the other party’s Confidential Information secret and confidential, will use reasonable efforts to cause its affiliates, employees, representatives and agents to keep such Confidential Information secret and confidential, and will take reasonable precautions to prevent any use or disclosure of such Confidential Information except in the performance of the Services in accordance with the terms of this Agreement.
 
(a)                                   For purposes of this Agreement, “Confidential Information” means information disclosed hereunder by, or on behalf of, CHS or Client to the other party, whether of a technical, business or other nature, including but not limited to non-public information which relates to CHS’s (including its affiliates) or Client’s trade secrets, product or service offerings, proprietary rights or business affairs and identified as “confidential.”
 
(b)                                   Exceptions to Confidential Information .  Confidential Information does not include any information that, as evidenced by competent written proof: (i) was known to the receiving party prior to its disclosure by the disclosing party; (ii) is lawfully obtained by the receiving party from a third party, as a matter of right and without restriction on disclosure; (iii) is disclosed in public literature or becomes generally available to the public through no violation of this Agreement by the receiving party; or (iv) was independently developed or obtained by the receiving party without violation of this Agreement.
 
(c)                                   Permitted Disclosures. Notwithstanding the foregoing, a party may disclose Confidential Information of the other party to third parties to the extent such disclosure is required by order of a court, government agency or the like having competent jurisdiction; provided that, in the event such information is required to be disclosed pursuant to this Section 12(c), the party required to make such disclosure will promptly notify the other party prior to such disclosure, will disclose only what is reasonably necessary to comply with such order, and will use reasonable efforts to cooperate with such other party to allow assertion of whatever exclusions, exemptions or confidential treatment that may be available to it under applicable law or regulation.
 
10

 
(d)                                   It is understood and agreed that CHS may list Client as one of its RxPedite clients when furnishing proposals to other prospective clients or in client listings in trade publications and directories.
 
§13.                         Force Majeure .  Neither party will be liable to the other for failure to perform when and as specified in this Agreement (exclusive of payment obligations) if such failure to perform is caused by war, fire, flood, strike, labor dispute, public disaster, accident, serious illness, act of God, act of terrorism, act of governmental authority (including rule or regulation), or other similar contingencies (a “Force Majeure”) beyond the reasonable control of the non-performing party and which materially interferes with such party’s ability to perform its obligations hereunder.  In the event of such a Force Majeure, the party so affected will be excused from performance hereunder for the period of time attributable to the Force Majeure; provided that such party uses and continues to use all reasonable efforts to overcome such Force Majeure.
 
§14.                         Termination .
 
(a)                                   The term of this Agreement will commence on the Effective Date and continue for a period equal to the longer of: (i) five (5) years, or (ii) eighteen (18) months following the launch date of the Product for spinal cord indication, unless terminated earlier pursuant to the termination provisions below, or extended by written agreement of the parties.  As used herein, “Term” will mean the term of this Agreement as specified above.
 
(b)                                   Either party will have the right to effect an early termination of this Agreement if the other party breaches any material obligation of this Agreement and fails to cure such breach as provided herein.  Following a material breach, the non-breaching party will provide the breaching party with written notice of the specific reason or reasons for the non-breaching party’s intention to terminate the Agreement early, and will provide the breaching party with (i) sixty (60) days to correct any non-performance or breach other than non-payment, or (ii) thirty (30) days to correct such breach in the case of non-payment.  If the breaching party fails to correct the specified non-performance or breach within the time period specified in the foregoing sentence (or, in the case of a breach other than non-payment, if such breach is not reasonably capable of cure within sixty (60) days, the breaching party fails to commence cure of the specified non-performance within sixty (60) days and diligently pursue completion of the cure thereafter), then the non-breaching party may immediately effect an early termination of this Agreement upon written notice to the breaching party.
 
(c)                                   Either party may terminate this Agreement effective upon written notice to the other party, if the other party becomes insolvent or admits in writing its inability to pay its debts as they become due, files a petition for bankruptcy, makes an assignment for the benefit of its creditors or has a receiver, trustee or other court officer appointed for its properties or assets.
 
(d)                                   Either party may terminate this Agreement under the circumstances described in Section 1(b) upon sixty (60) days prior written notice to the other party.
 
(e)                                   Upon termination of this Agreement for any reason, CHS will cease work on all Projects and will give to Client a written report on the status of all  Services.  Each party
 
11

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
will cooperate with the other and make all reasonable efforts to facilitate a smooth and efficient transition of all pending Projects to Client or a successor agency designated by Client.  Client will promptly pay CHS for all work performed and expenses incurred prior to the effective date of termination of this Agreement and for all non-cancelable commitments incurred by CHS prior to such time.  Any funds previously paid to CHS by Client which are in excess of compensation and/or expenses to which CHS is entitled through the termination of this Agreement will be promptly returned to Client.
 
(f)                                     Upon termination of this Agreement pursuant to Section 14(d), Client will pay to CHS the following amounts:  (i) if such termination is effected by Client prior to Product launch or within six (6) months thereafter, then the sum of (1) the Aggregate Discount Amounts (as such term is defined in Exhibit A) actually given by CHS, and (2) a premium payment in the amount of [***] of the Aggregate Discount Amounts actually given by CHS and (ii) if such termination is effected by Client at any time more than six (6) months after the date of Product launch, then the sum of (1) the Aggregate Discount Amounts actually given by CHS and not already repaid in accordance with the Repayment Rate set forth in Exhibit B and (2) a premium payment in the amount of [***] of the Aggregate Discount Amounts actually given by CHS.  Client will pay the total amount due under this Section 14(f) in four (4) equal quarterly installments, the first of which is due on the first day of the calendar quarter immediately following the effective date of termination under Section 14(d).
 
§15.                         Records and Audit .  For a period of two (2) years following the termination of this Agreement, each party will maintain records, in commercially reasonable form, detail, and accuracy, relating to the Services, Product revenues, and other information reasonably relevant to the calculation of the Agency Fees and Discount Amounts.  During the Term and for a period of two (2) years thereafter, each party agrees that it will provide relevant information and access to relevant records to an independent third party accountant upon reasonable prior notice and during normal business hours for the purpose of inspection, examination and audit.  All examinations of records will take place at the site at which the records are regularly kept and will be at the examining party’s sole expense.
 
§16.                         Limitation of Liability .  IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, INCIDENTAL, INDIRECT, CONSEQUENTIAL OR SIMILAR DAMAGES (INCLUDING BUT NOT LIMITED TO DAMAGES FOR INDIRECT LOSS OF PROFITS, LOSS OF BUSINESS REPUTATION OR THE LIKE) ARISING DIRECTLY OR INDIRECTLY OUT OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT.
 
§17.                         Insurance .
 
(a)                                   CHS.  CHS will, at its own cost and expense, obtain and maintain in full force and effect the following insurance during the Term: (i) Commercial General Liability insurance with per-occurrence and general aggregate limits of not less than one million dollars ($1,000,000); (ii) Workers’ Compensation and Employer’s Liability Insurance with statutory limits for Workers’ Compensation and Employer’s Liability insurance limits of not less than one million dollars ($1,000,000); (iii) Professional Services Errors & Omissions Liability Insurance with per claim and aggregate limits of not less than ten million dollars ($10,000,000).  In the
 
12

 
event that any of the required policies of insurance are written on a claims made basis, then such policies will be maintained during the entire Term and for a period of not less than three (3) years following the termination or expiration of this Agreement.  CHS will obtain a waiver from any insurance carrier with whom CHS carries Workers’ Compensation insurance releasing its subrogation rights against Client.  Client will be named as an additional insured under the Commercial General Liability insurance policies.  CHS will furnish certificates of insurance for all of the above noted policies and required additional insured status to Client as soon as practicable after the Effective Date of the Agreement and upon renewal of any such policies.  Each insurance policy that is required under this Section will be obtained from an insurance carrier with an A.M. Best rating of at least A- VII.
 
(b)                                   Client Insurance.  Client will, at its own cost and expense, obtain and maintain in full force and effect the following insurance during the Term: (i) Products and Completed Operations Liability Insurance with per-occurrence and general aggregate limits of not less than ten million dollars ($10,000,000); and (ii) Workers’ Compensation and Employer’s Liability Insurance with statutory limits for Workers’ Compensation and Employer’s Liability insurance limits of not less than one million dollars ($1,000,000).  In the event that any of the required policies of insurance are written on a claims made basis, then such policies will be maintained during the entire Term and for a period of not less than three (3) years following the termination or expiration of this Agreement.  Client will obtain a waiver from any insurance carrier with whom Client carries Workers’ Compensation insurance releasing its subrogation rights against CHS.  CHS will be named as additional insureds under the Products and Completed Operations Liability insurance policies.  Client will furnish certificates of insurance for all of the above noted policies and required additional insured status to CHS as soon as practicable after the Effective Date of the Agreement and upon renewal of any such policies.  Each insurance policy that is required under this Section will be obtained from an insurance carrier with an A.M. Best rating of at least A- VII.
 
§18.                         Representations and Warranties.
 
(a)                                   Mutual Representations and Warranties.   Each party hereby represents and warrants that:
 
(i)                                     such party is duly organized and validly existing under the laws of the state of its organization and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
 
(ii)                                 such party is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder;
 
(iii)                             this Agreement is a legal and valid obligation binding upon such party and enforceable in accordance with its terms;
 
(iv)                                the execution, delivery and performance of this Agreement by such party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound; and
 
13

 
(v)                                    such party will perform its obligations herein in conformance with applicable federal, state and local laws and regulations including, but not limited to, the regulations and guidelines of the Food, Drug and Cosmetic Act.
 
(b)                                   CHS Representations and Warranties.    CHS hereby represents and warrants that:
 
(i)                                     all Work Product and Brand Features will be original works of CHS, its affiliates or its third party subcontractors;
 
(ii)                                 CHS and its affiliates will obtain all rights and licenses to any toolsets or other software embedded in Work Product, which rights shall extend to Client (subject to Section 9(b));
 
(iii)                             CHS and its affiliates will not create Work Product or Brand Features that CHS knows or reasonably should have known, infringes the intellectual property rights of a third party;
 
(iv)                                CHS and its affiliates will not grant, directly or indirectly, any rights or interest to third parties whatsoever in Work Product or Brand Features without the prior written approval of Client;
 
(v)                                    CHS and its affiliates (1) are not currently involved in any litigation, and is unaware of any pending litigation proceedings, relating to its role in the provision of marketing communications services for any third party with respect to a pharmaceutical product; and (2) have not received any warnings from the FDA (or any regulatory body in a country other than the United States) relating to services it has provided to third parties with respect to a pharmaceutical product; and
 
(vi) CHS and its affiliates will not employ, contract with or retain any person in any capacity to perform Services under this Agreement if such a person is debarred by the FDA under 21 U.S.C. § 335(a) or disqualified as described in 21 C.F.R. §812.119.
 
§19.                         Notice .  All notices required or permitted to be given under this Agreement must be in writing and will be addressed to the appropriate party at the address specified below or  such other address as may be specified by a party in writing in accordance with this Section 19, and will be deemed to have been duly given (a) when received, if hand-delivered or sent by a reputable overnight courier service, (b) five (5) business days after mailing, if mailed by first-class certified or registered mail, postage prepaid, return receipt requested, or (c) when received as evidenced by confirmation of transmission, if sent by facsimile, provided that the sender calls and notifies the recipient prior to sending such facsimile.
 
Creative Healthcare Solutions, LLC
500 Olde Worthington Road
Westerville, Ohio 43082-8913
Attention: Chief Financial Officer
 
14

 
Tel (614) 543-6471
Fax (614) 848-3477
 
Acorda Therapeutics, Inc.
15 Skyline Drive
Hawthorne, NY 10532
Attention: Director of Contracts and Grants
Tel (914) 347-4300
Fax (914) 347-4560
 
§20.                         Complete Agreement .  This Agreement, including the exhibits attached hereto and each Workplan, contain the entire agreement between the parties and supersede all prior or contemporaneous discussions, negotiations, representations, or agreements relating to the subject matter herein.  No changes to this Agreement will be made or be binding on any party unless made in writing and signed by an authorized representative of each party to this Agreement. If and to the extent there are inconsistencies between this Agreement and any one or more Workplans, the terms of this Agreement shall govern.
 
§21.                         Alternate Dispute Resolution .  If a dispute, controversy or disagreement (“Dispute”) arises between the parties in connection with this Agreement, then the Dispute will be presented to the respective designated executives of CHS and Client for their consideration and resolution.  If such executives cannot reach a resolution of the Dispute within forty-five (45) days of such referral, then such Dispute will be resolved by binding Alternative Dispute Resolution in accordance with the then-existing commercial arbitration rules of The CPR Institute for Dispute Resolution (“CPR”), 366 Madison Avenue, New York, NY 10017.  Arbitration will be conducted in New York, New York.
 
§22.                         Jurisdiction .  This Agreement will be governed by the laws of the State of New York without regard to conflicts of laws principles.
 
§23.                         No Benefit to Others .  The representations, warranties, covenants and agreements contained in this Agreement are for the sole benefit of the parties hereto and their affiliates, successors and assigns, and they shall not be construed as conferring any rights on any other persons.
 
§24.                         Severability .  Any provision of this Agreement which is invalid or unenforceable in any jurisdiction shall be ineffective to the extent of such invalidity or unenforceability without invalidating or rendering unenforceable the remaining provisions hereof, and any such invalidity or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction.  To the extent legally permissible, the parties shall use good faith efforts to agree to replace any invalid or unenforceable provision of this Agreement with a valid provision that shall implement as much as permitted the commercial intent of the invalid or unenforceable provision.
 
§25.                         Subcontractors .  CHS will be permitted to enter into subcontracts for the provision of portions of the Services to be supplied under this Agreement with the prior written approval by Client (subject to Section 28, and with such approval not to be unreasonably
 
15

 
withheld), provided that such right to subcontract will not remove or limit CHS’s duties, rights, obligations, or liabilities to Client under this Agreement.  Any agreements entered into by CHS with third party subcontractors for the performance of Services under this Agreement shall, at a minimum, provide for ownership and allocation of intellectual property rights with respect to Work Product and Brand Features and for obligations of confidentiality and non-use of Confidential Information that are consistent with the intent and terms of this Agreement.   CHS will ensure that each subcontractor who has contributed to Work Product or Brand Features will execute an assignment to CHS of all of such subcontractor’s right, title and interest in and to such Work Product or Brand Features to enable compliance by CHS with the assignment obligations of Section 8 with respect thereto.
 
§26.                         Successors and Assigns .  Neither party will be permitted to assign or transfer its rights, duties or obligations under this Agreement without the prior written consent of the other party, which consent will not be unreasonably withheld.  Notwithstanding the foregoing, upon the occurrence of a sale of the Product, merger, consolidation or other similar corporate transaction affecting either party (a “Special Event”), the benefits and obligations of this Agreement shall automatically pass to the successor entity without prior written consent of the other party; provided, however, that if, following a Special Event affecting Client, (a)CHS’s continued performance of Services would result in an impermissible conflict, as defined in Section 2(d), with one or more of its other clients, CHS may effect an early termination of this Agreement without penalty upon delivery to Client  of written notice specifying in detail such impermissible
 conflict, in which case, the provisions of Section 14(e) will apply, or (b) Client may terminate this Agreement in accordance with the provisions of Sections 14(d) and 14(f).
 
§27.                         Publicity .  Except as provided in Section 12, neither party will make any press release or other public disclosure regarding this Agreement or the transactions contemplated hereby without the other party’s express prior written consent, except as required under applicable law or by any governmental agency, in which case the party required to make the press release or public disclosure will use commercially reasonable efforts to obtain the approval of the other party as to the form, nature and extent of the press release or public disclosure prior to issuing the press release or making the public disclosure.
 
§28.                         Performance by Affiliates .  CHS may have certain of its affiliates perform certain Services on its behalf, and CHS hereby covenants that its affiliates, including but not limited to, Blue Diesel, LLC, Y Brand Outlook, LLC, and Health Process Management, LLC, which will be providing certain of the Services under this Agreement are bound by this Agreement and guarantees the performance by such CHS affiliates of obligations assigned to CHS under this Agreement, and shall cause such CHS affiliates to comply with the terms and conditions of this Agreement in connection with such performance.  Any breach by such affiliates of any of CHS’s obligations under this Agreement shall be deemed a breach by CHS, and Client may proceed directly against CHS without any obligation to first proceed against such affiliates.
 
§29.                         No Implied Rights or Licenses.   The parties agree that neither party transfers to the other party by operation of this Agreement any patent right, copyright right, trademark right or other proprietary right (including any right with respect to the Product), except as specifically provided herein.
 
16

 
§30.                         Survival.   Sections 8, 11 (as to any Claims arising from the parties’ performance during the Term), 12, 14(e), 14(f), 15, 16, 21, 22, 26, 28 and 30 shall survive termination of this Agreement.
 
§31.                         Miscellaneous .
 
(a)                                   This Agreement may be executed in two (2) or more counterparts, each of which shall be binding as of the date first written above, and all of which shall constitute one and the same instrument.  Each such copy shall be deemed an original, and it shall not be necessary in making proof of this Agreement to produce or account for more than one such counterpart.
 
(b)                                   CHS is retained by Client only for the purposes and to the extent provided for under this Agreement, and CHS will for all purposes under this Agreement be deemed an independent contractor and not an employee, partner or joint venturer with Client or Cardinal Health.
 
(c)                                   No covenant or condition of this Agreement will be waived except by written consent of Client and CHS. The omission, or delay, by either party at any time to enforce any right or remedy reserved to it, or to require performance of any of the terms, covenants or provisions hereof, by the other party, shall not be a waiver of any such right or remedy to which the party is entitled.  Any waiver by a party of the breach by the other party of this Agreement shall not operate or be construed as a waiver of any subsequent breach by either party.
 
[ Remainder of page intentionally left blank. ]
 
17

 
IN WITNESS WHEREOF, the parties to this Agreement, each by a duly authorized representative, have executed this Agreement as of the Effective Date.

CHS:	 	CLIENT:	
Creative Healthcare Solutions, LLC	 	Acorda Therapeutics, Inc.	

By:	 	 	 	By:	 	 	
 	 	 	
Print Name:	 	 	 	Print Name:	 	 	
 	 	 	
Title:	 	 	 	Title:	 	 	

18

 
Exhibit A
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
DISCOUNT MATRIX
 
•                   In determining the Agency Fees for Services performed during “Period 1” of the Agreement beginning as of the Effective Date and continuing through the First Milestone, Client will be entitled to a Discount Amount of [**] of the total amount charged for such Services in accordance with the applicable Budget.  As used herein, the First Milestone will be the completion of the Product’s Phase III pivotal Trial 1 for spinal cord injuries (“SCI”).  As used in this Exhibit A, the term “completion” of a clinical trial means completion of conducting the trial, analyzing all data and results of such trial, and preparing the final and complete report of such analyzed data.  Period 1 is currently estimated to include the period from the Effective Date through [***].
 
•                   In determining the Agency Fees for Services performed during “Period 2” of the Agreement beginning as of the end of Period 1 and continuing through the Second Milestone, Client will be entitled to a Discount Amount within the range of [***] of the total amount charged for such Services in accordance with the applicable Budget, where the actual percentage within this range will be based on the study findings relative to those identified parameters of promotional success for the Product as described in the Target Product Profile (“TPP”) attached as Exhibit C.  As used herein, the Second Milestone will be the completion of the Product’s Phase III pivotal Trial 2 for SCI.  Period 2 is currently estimated to include the period from [***].
 
•                   In determining the Agency Fees for Services performed during “Period 3” of the Agreement beginning as of the end of Period 2 and continuing through the Third Milestone, Client will be entitled to a Discount Amount within the range of [***] of the total amount charged for such Services in accordance with the applicable Budget, where the actual percentage within this range will be based on the TPP study findings as described in Exhibit C.  As used herein, the Third Milestone will be the NDA submission for SCI. Period 3 is currently estimated to include the period from [***].
 
•                   In determining the Agency Fees for Services performed during “Period 4” of the Agreement beginning as of the end of Period 3 and continuing through the Fourth Milestone, Client will be entitled to a Discount Amount within the range of [***] of the total amount charged for such Services in accordance with the applicable Budget, where the actual percentage within this range will be based on the TPP study findings as described in Exhibit C. As used herein, the Fourth Milestone will be FDA approval of the Product for the SCI indication.  Period 4 is currently estimated to include the period from [***].
 
•                   In determining the Agency Fees for Services performed during “Period 5” of the Agreement beginning as of the end of Period 4 and continuing through the Fifth Milestone, Client will be entitled to a Discount Amount within the range of [***]
 
19

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
of the total amount charged for such Services in accordance with the applicable Budget, where the actual percentage within this range will be based on the TPP study findings as described in Exhibit C.  As used herein, the Fifth Milestone will be the six-month anniversary of the Product’s launch for SCI indication.  Period 5 is currently estimated to include the period from [***] .
 
•                   In determining the Agency Fees for Services performed during “Period 6” of the Agreement beginning as of the end of Period 5 and continuing through the end of the Term, Client will pay as Agency Fees the total amount charged for such Services in accordance with the applicable Budget and will not be entitled to any Discount Amount from such fees.  Period 6 is currently estimated to include the period from [***] through the end of the Term.
 
“Aggregate Discount Amount” means the total aggregate amount of all Discount Amounts actually allowed by CHS during Period 2 through Period 5.  The Aggregate Discount Amount will be “at risk.”  Such amount will be earned by and payable to CHS at the Repayment Rate described in the Discount Payment Matrix in Exhibit B, such rate will be based on the Product’s quarterly revenue performance during the twelve (12) month period following the Product’s launch.
 
20

 
Exhibit B
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
DISCOUNT PAYMENT MATRIX
 
Contract Exhibit B
 
DISCOUNT PAYMENT DESCRIPTION
 
The “Actual Prescription Targets” means actual filled prescriptions of the Product, as measured by IMS, and the Repayment Rate will be based on comparing the actual filled prescriptions of the Product during the particular time period(s) with the Actual Prescription Target(s) during such period(s). The Actual Prescription Target for the period is [***] prescriptions.
 
Client agrees to make certain repayments to CHS, as percentages of the Aggregate Discount Amount, based on the actual filled prescriptions of the Product during the four quarterly periods immediately following the launch of the Product (such consecutive three month periods referred to as “Q1,” “Q2,” “Q3,” and “Q4.”), and the applicable Repayment Rate.  Such repayments by Client to CHS shall be made, using the applicable Repayment Rate determined as above, in four quarterly installments, with the first such payment occurring on the six month anniversary of the Product launch and with subsequent payments made on the ninth, twelfth, and fifteenth month anniversaries of the launch of the Product, in accordance with the following procedure:
 
(1)   The first such payment will be determined by applying the Q1 Repayment Rate (the “Q1 Rate”) – which is determined by comparing the actual filled prescriptions of the Product made during Q1, with Actual Prescriptions Target for Q1 – to one quarter of the Aggregate Discount Amount, according to the following formula. The Actual Prescription Target for Q1 is [***] prescriptions.
1 st Repayment = (1/4)(Aggregate Discount Amount)(Q1 Rate)
 
(2)   The second such payment will be determined by applying the Q2 Repayment Rate (the “Q2 Rate”) – which is determined by comparing the aggregate actual filled prescriptions of the Product made during Q1 and Q2, with sum of the Actual Prescriptions Targets for Q1 and Q2 – to one half of the Aggregate Discount Amount, less the 1 st Repayment, according to the following formula. The Actual Prescription Target for Q2 is [***] prescriptions.
2 nd Repayment = (1/2)(Aggregate Discount Amount)(Q2 Rate) – 1 st Repayment; In the event the 2 nd Repayment is negative, then CHS will pay Client the amount of the 2nd Repayment.
 
(3)   The third such payment will be determined by applying the Q3 Repayment Rate (the “Q3 Rate”) – which is determined by comparing the aggregate actual filled prescriptions of the Product made during Q1, Q2, and Q3 with sum of the Actual Prescriptions Targets for Q1, Q2, and Q3 – to three quarters of the Aggregate Discount Amount, less the 1 st Repayment and the 2 nd Repayment, according to the following formula. The Actual Prescription Target for Q3 is [***] prescriptions.
3 rd Repayment = (3/4)(Aggregate Discount Amount)(Q3 Rate) – 1 st Repayment –2 nd Repayment; In the event the 3rd Repayment is negative, then CHS will pay Client the amount of the 3rd Repayment.
 
(4)   The fourth and final such payment will be based on applying the Q4 Repayment Rate (the “Q4 Rate”) – which is determined by comparing the aggregate actual filled prescriptions of the Product made during Q1, Q2, Q3, and Q4, with sum of the Actual Prescriptions Targets for Q1, Q2, Q3, and Q4 – to the total Aggregate Discount Amount, less the 1 st Repayment, 2 nd Repayment and 3 rd Repayment, according to the following formula. The Actual Prescription Target for Q4 is [***] prescriptions.
4 th Repayment = (Aggregate Discount Amount)(Q4 Rate) – 1 st Repayment –2 nd Repayment – 3 rd Repayment; In the event the 4th Repayment is negative, then CHS will pay Client the amount of the 4th Repayment.
 
21

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Contract Exhibit B

 	 	RANGE	 	 	 	DISCOUNTS	 	
Milestone	 	Low	 	High	 	Fees	 	Low	 	High	 	
1st Phase 3*	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
2nd Phase 3	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
NDA Filing	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
NDA Approval	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
Launch + 6	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
TOTAL	 	 	 	 	 	 	 	[****]	 	[****]	 	
 	 	 	 	 	 	 	 	 	 	 	 	
Low Discount	 	 	 	 	 	 	 	 	 	 	 	
 	 	Quarterly	 	Cumulative	 	% of Target	 	Repayment %	 	Repayment $	 	
Q1	 	[***]	 	[***]	 	[***]	 	[***]	 	[***]	 	
Q2	 	[***]	 	[***]	 	[***]	 	[***]	 	[***]	 	
Q3	 	[***]	 	[***]	 	[***]	 	[***]	 	[***]	 	
Q4	 	[***]	 	[***]	 	[***]	 	[***]	 	[***]	 	
TOTAL	 	[***]	 	 	 	 	 	 	 	[***]	 	
 	 	 	 	 	 	 	 	 	 	 	 	
High Discount	 	 	 	 	 	 	 	 	 	 	 	
 	 	Quarterly	 	Cumulative	 	% of Target	 	Repayment %	 	Repayment $	 	
Q1	 	[***]	 	[***]	 	[***]	 	[***]	 	[***]	 	
Q2	 	[***]	 	[***]	 	[***]	 	[***]	 	[***]	 	
Q3	 	[***]	 	[***]	 	[***]	 	[***]	 	[***]	 	
Q4	 	[***]	 	[***]	 	[***]	 	[***]	 	[***]	 	
TOTAL	 	[***]	 	 	 	 	 	 	 	[***]	 	
 
22

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

Low	 	High	 	Payment	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
 
23

 
Exhibit C
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
TARGET PRODUCT PROFILE MATRIX
 
[*****]
 
24

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

[*****]
 
25

 
Exhibit 10.18
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
RXPEDITE
ACORDA MARKETING SERVICES AGREEMENT
 
This Marketing Services Agreement (the “Agreement”) is made effective as of September 19, 2003 (the “Effective Date”), by and between Cardinal Health PTS, Inc., a corporation with offices at 7000 Cardinal Place, Dublin, Ohio 43017 (“Cardinal Health”) and Acorda Therapeutics, Inc., a Delaware corporation having its principal place of business at 15 Skyline Drive, Hawthorne, New York 10532  (“Client”).
 
Background Information
 
A.                                     Cardinal Health and its affiliates are engaged in the business of providing contract marketing, promotion, communication, sales and other related services to the pharmaceutical industry.  Cardinal Health may perform such services directly or through one of its affiliates.
 
B.                                     Cardinal Health 401, Inc. and inChord Communications, Inc. (“inChord”) have together developed the RxPedite Program, pursuant to which they are able to provide pharmaceutical drug manufacturers with comprehensive outsourced marketing communications, selling and distribution/manufacturing capabilities to facilitate and enhance the commercialization of clients’ pharmaceutical products.
 
C.                                     Client is currently developing a product known as Fampridine SR , a therapy to improve neurological function in spinal cord injuries (the “Product”), and wishes to outsource certain commercialization services available under the RxPedite Program, as set forth in this Agreement.
 
Statement of Agreement
 
The parties hereby acknowledge the accuracy of the Background Information and agree as follows:
 
§1.                                Appointment/Exclusivity .
 
(a)                                   Cardinal Health will provide medical education and sales force services to Client with respect to the Product as may be requested from time-to-time by Client and agreed to by Cardinal Health (collectively, the “Services”).  Client hereby appoints Cardinal Health as the exclusive “Agency of Record” for medical education and sales force services relating to the Product and agrees that during the Term (as defined in Section 14(a)) it will not grant any other person or entity the right to provide medical education and sales force services relating to the Product anywhere in the United States; subject, however, to Section 1(b) below.  In the event Client desires other commercialization services offered by Cardinal Health, such as drug development, manufacturing, storage, distribution, product return or recall, analytical or packaging services, the parties will negotiate the terms of such services in good faith.
 
(b)                                   The parties acknowledge and agree that, notwithstanding any other provision of this Agreement, Client may enter into one or more collaboration or partnership agreements or other similar arrangements with third parties during the Term with respect to the
 
1

 
development and commercialization of the Product (each, a “Partnering Agreement”).  In any such event, Client will exercise all reasonable efforts to cause Cardinal Health to be selected as the vendor of choice for all or substantially all Services, with respect to the Product, to the extent that such Services are outsourced.  If Cardinal Health is selected as the vendor for all or any portion of such Services, the parties will, if necessary, modify any then-current Workplans (as defined in Section 3(a)) including the Budgets therein, to reflect the modified Services as a result of such Partnering Agreement. If, despite the exercise by Client of all reasonable efforts to cause Cardinal Health to be selected as the vendor of choice, Cardinal Health is not selected to be the vendor of a substantial portion of the Services with respect to the Product in the United States as a result of the Partnering Agreement, then Cardinal Health will no longer be the Agency of Record for the Services relating to the Product, and either party may terminate this Agreement in accordance with the provisions of Sections 14(d) and 14(f).
 
§2.                                Services .
 
(a)                                   Cardinal Health will, from time-to-time and/or upon request by Client during the Term, prepare and provide to Client, one or more proposed workplans (each, a “Proposed Workplan”) outlining the specific Services that Cardinal Health proposes to perform on Client’s behalf or that Client requests Cardinal Health to perform on its behalf.  Such Services may include, but are not limited to:  (i) recruiting and hiring specialty sales representatives appropriately qualified with the level of education and experience necessary for promoting the Product, (ii)  training and maintaining specialty sales representatives for the Product, (iii) establishing a sales force of specialty sales representatives in the United States to promote the Product (the “Sales Force”), and (iv)  providing medical education services.
 
(b)                                   Each Proposed Workplan provided to Client pursuant to Section 2(a) will include, at a minimum, a detailed summary of the specific Services to be provided by Cardinal Health and Cardinal Health’s good faith estimate of the anticipated fees and costs (a “Budget”) associated with all projects (“Projects”) to be undertaken by Cardinal Health under such Proposed Workplan.  Client may request additional information to be included in a Proposed Workplan and Cardinal Health will use all reasonable efforts to provide such additional information.  Each Proposed Workplan will be submitted for Client’s approval under the procedures described in Section 3 below.
 
(c)                                   Following approval by both parties of a Proposed Workplan for one or more Projects (as provided in Section 3(a)), Cardinal Health will, subject to Client’s direction and instruction or any amendment of the approved Workplan in accordance with Section 7, perform or coordinate the performance of those Services that are included in such Workplan. Cardinal Health will exercise all reasonable efforts to perform the Services on a timely basis and within the Budget, and Client will exercise all reasonable efforts to assist Cardinal Health in doing so by making available to Cardinal Health all information pertaining to the Product that is necessary for Cardinal Health’s performance of such Services and cooperating with Cardinal Health in expediting its review of all materials submitted by Cardinal Health for Client’s approval.
 
(d)                                   Cardinal Health will perform the Services under this Agreement through various affiliates of Cardinal Health.  During the Term, Cardinal Health agrees that the specific
 
2

 
Cardinal Health affiliates providing Services to Client under this Agreement will refrain from providing medical education and sales force services for any product that competes against the Product and has substantially the same indication as the Product, without first obtaining Client’s written consent, which shall not be unreasonably withheld.  For purposes of clarification, the foregoing restriction shall not restrict any Cardinal Health affiliate which is not providing Services to Client under this Agreement from providing medical education and sales force services to any other customer for products that compete against the Product.
 
§3.                                Client Approval .
 
(a)                                   Each Proposed Workplan submitted to Client by Cardinal Health in Section 2 is subject to the review and written approval of Client prior to the time Cardinal Health or any of its affiliates incur liability to third parties in connection with the Projects contained in such Proposed Workplan.  Once a Proposed Workplan is approved by both parties, such approved workplan shall be referred to as a “Workplan,” and it shall govern the performance for Client of the Services covered by such Workplan.  For clarity, neither Cardinal Health nor its affiliates will perform any Services or incur any expenses with respect to such Services, and Client will not be obligated to pay for any Services, except in accordance with a Workplan that has been approved by Client.
 
(b)                                   All drafts of any proposed journal advertisements, training materials, media copy, advertisements or other promotional material used to promote the Product (collectively, the “Promotional Material”) will be submitted to Client for review at least two (2) weeks prior to publication or use whenever practicable ; provided, however, that the arties understand and agree that such two (2) week period will necessarily be shortened from time to time to reflect special deadlines and circumstances not within the reasonable control of Cardinal Health.  Client shall be solely responsible for reviewing and approving the content of all Promotional Material and related Services prior to use of such Promotional Material and performance of related Services to make certain that all content in such Promotional Material and any and all related Services comply with all federal, state and local laws and all applicable industry standards and practices generally applicable to Cardinal Health’s and Client’s industry, including, without limitation, any applicable research guidelines, ethics and standards established by the American Medical Association, the Food and Drug Administration (“FDA”), the standards and guidelines outlined in the PhRMA Code, the standards and guidelines outlined in the Office of Inspector General (OIG) Guidance, and the Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder (collectively, “Laws”).  Client hereby acknowledges that Cardinal Health shall not conduct a legal review of the content of the Promotional Materials and/or related Services and that Cardinal Health is relying solely on Client to make certain that the content of Promotional Material and related Services comply with all Laws.  Cardinal Health will ensure that the content of the final copy of Promotional Material and related Services is identical to the draft content of such Promotional Material and related Services as approved by Client.
 
(c)                                   Client will have the right to make any editorial changes it desires prior to publication or use, with any charge for such change to be consistent with the budget procedures outlined in Section 3(d) below; provided, however, that Client must notify Cardinal Health in writing of either its approval or disapproval and/or required editing of Promotional Material as
 
3

 
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.
Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
 
promptly as practicable, but in no event less than forty-eight (48) hours prior to the planned publication or use.
 
(d)                                   The initial Budget for a specific Project included in a Workplan will necessarily include fee and cost estimates based upon initial concepts and preliminary estimates, and Cardinal Health will be authorized to commence work and incur expenses on that particular Project based upon Client’s approval of the Workplan containing such initial Budget and up to an amount not to exceed [* * *] of the fees and costs in such approved Budget.  Cardinal Health will submit a revised Budget to Client at any time during performance of a Project if fees and costs for such Project are anticipated to exceed the initial Budget by more than [* * *], and this revised estimate must be approved by Client in writing before work on such Project continues.  Once final concepts for a Project are approved and final fee and cost estimates can be obtained, Cardinal Health will submit a final Budget for Client’s written approval if the initial Budget needs to be increased by more than [* * *] as a result of such final cost estimates.  Cardinal Health will use all reasonable efforts to complete the Services within the approved Budget.  In the case where, despite such efforts, cost estimates to complete the Services exceed the initial Budget by more than [* * *], Cardinal Health agrees to negotiate with Client in good faith a revised Budget that is acceptable to both parties.  In any event, Client’s written approval is required prior to any increase of the Budget for a Project by more than [* * *] from the initial Budget and for any further increases thereafter.
 
§4.                                Joint Commercialization Committee .  Promptly following the Effective Date, a joint commercialization committee (the “Committee”) will be formed consisting of an equal number of representatives, such number to be mutually agreed by the parties, from each of Client, Cardinal Health, and inChord.  Each party may replace any of its representatives at any time, and from time to time, by giving written notice to the other party.  The Committee will be chaired by a Client representative, and the Committee will meet at such locations as reasonably determined by the chair to discuss and coordinate the overall marketing and sales strategy for the Product, relevant Workplans and Budgets therein associated with the Product, and any other relevant topics relating to the commercialization of the Product.  The Committee will convene at least four (4) times annually or more frequently as the parties deem necessary and meetings may be held by audio or video teleconference, with the consent of each party; provided that at least one (1) meeting per calendar year shall be held in person.  The parties agree that the purpose of the Committee is solely to provide a forum for the parties to discuss, monitor and coordinate activities and communications relating to the performance of the Services and provide recommendations relating thereto to the parties.  The Committee does not have the authority to approve or modify Workplans or Budgets, or to amend this Agreement.
 
§5.                                Cardinal Health Compensation .  In consideration for the Services that are rendered to Client under this Agreement, Cardinal Health will invoice Client and Client will pay Cardinal Health as follows:
 
(a)                                   As compensation for performance by Cardinal Health and its affiliates of the Services, Client will pay a fee (the “Cardinal Health Fee”) for each Project as specified in the approved Budget for such Project.  Such Cardinal Health Fee for the Services performed in a particular month will be determined as follows:
 
4

 
(i)                                     Total fees for such Services shall be calculated based on the applicable Cardinal Health and its affiliates’ rates as set forth in the applicable Budget; and
 
(ii)                                 Such total fees then shall be reduced by the amount (if any) of the pre-determined discount amount to which Client is entitled (any such discount, a “Discount Amount”), where such Discount Amount will be determined as described in the Discount Matrix attached as Exhibit A, and such discounted fees shall be the “Cardinal Health Fee” for such Project for such month.
 
(b)                                   The Cardinal Health Fee for each Project will be invoiced to Client by Cardinal Health on a monthly basis promptly after the beginning of each month as specified in the approved Budget, and Client will pay each such invoice within thirty (30) days of receipt thereof.  Each such invoice will specify with reasonable detail all the charges for Services, and the basis for any Discount Amount used in arriving at the Cardinal Health Fee.
 
(c)                                   All Discount Amounts actually allowed will be aggregated and, if applicable, paid to Cardinal Health by Client in accordance with the terms and conditions contained in the Discount Payment Matrix attached as Exhibit B.
 
(d)                                   Client will reimburse Cardinal Health for actual, verifiable costs incurred for obtaining from third parties any printing, photography, market research, selling aids, direct mail, reference material, color graphic reproductions, exhibit panels, honoraria, conference/meeting expenses and other products, services and supplies purchased by Cardinal Health on behalf of Client for a Project under this Agreement (“Client Reimbursable Expenses”) without Cardinal Health mark-up, provided, however, that the aggregate costs for such Client Reimbursable Expenses are included in the Budget of the relevant Workplan approved in advance by Client and is subject to the provisions of Section 3(d) with respect to any increase in such costs. Fifty percent (50%) of the estimated Client Reimbursable Expenses for each Workplan (as set forth in the applicable Budget) will be invoiced by Cardinal Health upon Client’s approval of the Workplan, and the balance of the Client Reimbursable Expenses will be invoiced on a monthly basis after such initial advance payment has been fully credited against actual costs incurred (as shown by invoices provided and credits shown), as such expenses are incurred by Cardinal Health, or as otherwise agreed to by the parties as specified in the Budget.  Client will pay each such invoice within thirty (30) days of receipt thereof.
 
(e)                                   Client will reimburse Cardinal Health for its reasonable, verifiable travel expenses (including, without limitation, transportation, lodging and meals), fax, photocopying, telephone, overnight or other delivery, postage, shipping and other expenses associated with the performance of Services under this Agreement (“Out-of-Pocket Expenses”), without any Cardinal Health mark-up.  An estimate of the Out-of-Pocket Expenses for each Project shall be included in the Budget of the relevant Workplan approved in advance by Client and is subject to the provisions of Section 3(d) with respect to any increase in such expenses. Out-of-Pocket Expenses will be invoiced by Cardinal Health on a monthly basis, as incurred, and Client will pay each such invoice within thirty (30) days of receipt thereof.
 
(f)                                     Sales, use and other taxes will be included in the Budget and reimbursed by Client in a similar manner to other expenses associated with each Project; provided, however,
 
5

 
that Cardinal Health will be responsible for all federal, state and local taxes imposed on Cardinal Health’s income or in connection with the employment of Cardinal Health’s full or part-time employees.
 
§6.                                Payment Terms .  Cardinal Health will submit invoices to Client on a monthly basis or as otherwise agreed by the parties in writing.  Payment terms will be net thirty (30) days from the date of the receipt, with interest accruing on any late payment at the rate of one and one-half percent (1.5%) per month until paid.  Cardinal Health will provide Client with appropriate supporting detail with each invoice to allocate expenses by Project and the specific activities undertaken in such Project.  All payments due under Section 5 will be made payable to: the Cardinal Health entity named on the relevant invoice and mailed to the address set forth on such Cardinal Health invoice.  Client and Cardinal Health will meet periodically to review projected fees and costs compared to actual fees and costs on all Projects, and appropriate adjustments will be made to Workplans as necessary from time to time to reflect mutually approved changes in the scope of the work to be performed.
 
§7.                                Amending Workplans .  Subject to the terms of this Section 7, Client reserves the right to modify or cancel any previously approved Workplan.  In such event, Cardinal Health will promptly take all reasonable steps necessary or appropriate to carry out Client’s instructions; provided, however, that Client will continue to be responsible for paying Cardinal Health for (a) all work performed and expenses incurred prior to Cardinal Health’s receipt of notification of such change, provided that such work and expenses were incurred by Cardinal Health on Client’s behalf in accordance with the relevant Workplan approved by Client, (b) all non-cancelable commitments incurred by Cardinal Health prior to its receipt of notification of such change, provided that such commitments were incurred by Cardinal Health on Client’s behalf in accordance with the relevant Workplan approved by Client, (c) all expenses incurred by Cardinal Health in carrying out Client’s revised instructions, and (d) any other cancellation or other similar fees specifically agreed to by the parties in a Workplan, if any.  Notwithstanding the foregoing, Client may not modify or cancel Projects in a fashion that would be inconsistent with Agency’s role as the exclusive “Agency of Record” under Section 1.
 
§8.                                Ownership of Technology; Work Made For Hire .  Client will maintain ownership and maintenance of the NDA, all clinical/scientific data  and any other information related to the Product.
 
(a)                                   Work Product.   Cardinal Health agrees and acknowledges that, unless otherwise agreed to by the parties in a Workplan, Client will own all right, title and interest in and to all ideas, artwork, illustrations, audiovisual works, audio recordings, images, photographs, video, graphics, multimedia works, on-line products, sounds, text, notes, sketches, drawings, reports, inventions and Promotional Material, whether patentable or copyrightable, or other copyrightable works conceived or created by Cardinal Health or Cardinal Health’s affiliates or third party subcontractors in the course of performing the Services pursuant to this Agreement and which are accepted and paid for by Client (collectively, the “Work Product”).  Such Work Product will be deemed “works made for hire,” and in any event, Cardinal Health hereby assigns to Client, and shall cause its affiliates and subcontractors (as applicable) to assign to Client, all right, title and interest in and to such Work Product and all intellectual property rights related thereto.  If Work Product is lost, damaged, or destroyed while in Cardinal Health’s custody or
 
6

 
control, Cardinal Health will be liable to Client for the replacement cost of such Work Product.  Upon Client’s request at any time during the Term or thereafter, Cardinal Health will promptly transfer all Work Product to Client.
 
(b)                                   Brand Features.   Subject to retained third party rights disclosed to Client in advance in accordance with Section 9, all trademark(s), trade name(s), logo(s), slogan(s), and advertising plan(s) that are created by Cardinal Health and/or its affiliates for Client and which are accepted and paid for by Client under this Agreement (the “Brand Features”) will be the property of Client and regarded as “works made for hire.” Cardinal Health will not adopt, suggest or recommend the use of any Promotional Material or Brand Feature of which Cardinal Health knows, or in the exercise of reasonable diligence, should know, is identical to or confusingly similar to that being used by a third party.  Cardinal Health hereby assigns to Client, and shall cause its affiliates and subcontractors (as applicable) to assign to Client, all of its rights, title and interest to such items, together with all of the goodwill associated therewith, subject only to reserved third party rights.
 
(c)                                   Further Acts.   Cardinal Health and its affiliates shall cooperate with Client or its designee(s), both during and after the Term, to execute such documents and take such other actions as Client deems necessary for Client to obtain ownership and to apply for, secure, and maintain copyright, trademark or other proprietary protection of Work Product and Brand Features in the United States and/or worldwide.  Cardinal Health will not be responsible for initiating any such application, but will cooperate with Client as reasonably requested.  Client will pay or reimburse Cardinal Health for any out-of-pocket expenses associated with such cooperation.  If Client is unable  for any reason to secure Cardinal Health’s signature to any document required to apply for or execute any copyright, trademark or other applications with respect to any Work Product or Brand Features, Cardinal Health hereby irrevocably designates and appoints Client and its duly authorized officers and agents as its agents and attorneys in fact to act for and on Cardinal Health’s behalf to execute and file any such application and to do all other lawfully permitted acts to further the issuance of copyrights, trademarks or other rights thereon with the same legal force and effect as if executed by Cardinal Health.
 
(d)                                   Cardinal Health Proprietary Material.   Project tracking software, algorithms, and other intellectual property owned by Cardinal Health and/or one or more Cardinal Health affiliates and used by Client in connection with the Services (“Cardinal Health Proprietary Material”) will remain the sole property of Cardinal Health at all times.  Cardinal Health shall, prior to the use of any Cardinal Health Proprietary Material in the course of providing the Services, notify Client of such use.  Client agrees to discontinue the use and return to Cardinal Health all Cardinal Health Proprietary Material promptly following termination of this Agreement.
 
§9.                                Third Party Approvals .
 
(a)                                   Cardinal Health will be responsible for obtaining appropriate consents, authorizations and approvals from third parties for use of approved Promotional Material prepared by Cardinal Health in connection with the Services; provided, however, that Client will maintain its own medical affairs personnel (including physicians and staff) to review and support the marketing and sales efforts (including Promotional Material) on behalf of the Product and
 
7

 
will be responsible for obtaining and providing all appropriate consents, authorizations and approvals in connection with materials provided to Cardinal Health for inclusion in the Promotional Materials and for scientific or medical papers or scientific consultation required in connection with the Promotional Material and the Services rendered by Cardinal Health.  Client will have sole and exclusive authority for managing all regulatory affairs associated with the Product including, but not limited to: (i) all necessary government filings and approvals for the Product; (ii) adverse event reporting to the FDA; (iii) product recalls; (iv) all clinical development associated with the Product; and (v) communications with regulatory authorities. Client will promptly communicate to Cardinal Health all regulatory and other information relevant to Cardinal Health’s performance of Services in connection with the Product.
 
(b)                                   Certain Promotional Material may contain the intellectual property of third parties that Cardinal Health has the right to use pursuant to a license granted to Cardinal Health (or its affiliates), or other arrangement between a third party and Cardinal Health (or its affiliates).  Such license or other arrangement between a third party and Cardinal Health (or its affiliates) may permit Client to use such intellectual property only in connection with a specific Project or campaign, and would require additional payments for any different or extended use by Client.  Cardinal Health will obtain approval from the relevant third party as required under the relevant license or arrangement for use of such third party intellectual property in specific Projects for Client.  Cardinal Health will notify Client prior to use of any such third party intellectual property in a specific Project of any material conditions or limitations relating to such use, including but not limited to any conditions or limitations which, if breached, will obligate Client to pay additional fees or charges.  Client will be solely responsible for any fees or other charges associated with its different or extended use of intellectual property so licensed from a third party in breach of the applicable conditions or limitations of such use; provided that Client will not be responsible for such fees or charges if Cardinal Health fails to notify Client in writing in advance of its use of any third party intellectual property and the conditions and limitations related thereto.  Cardinal Health makes no representations with regard to use of Promotional Material outside of the United States; however, Cardinal Health will use all reasonable efforts to obtain such rights for Client if requested to do so.
 
§10.                         Right of First Negotiation .
 
(a)                                   Product Related Compounds.   If Client controls or materially influences decisions regarding Services and is not restricted by a Partnering Agreement, Client agrees during the Term that Cardinal Health will be designated as the Agency of Record and perform those Services required by Client with respect to future indications for the Product.
 
(b)                                   Other Compounds.   If Client controls or materially influences decisions regarding use of Services with respect to a molecule, compound or product described at the end of this Section 10(b) and is not restricted by a Partnering Agreement with respect to such molecule, compound or product, Client agrees during the Term to provide Cardinal Health with an exclusive right of negotiation for a period of sixty (60) days following delivery to Cardinal Health of a request for proposal and related background materials (“RFP”) to provide Services, provided that such Services are necessary and will be outsourced.  The molecules, compounds or products that are subject of the foregoing rights are: (i) products resulting from Client’s other molecules or compounds in development, (ii) products resulting from molecules or compounds
 
8

 
which Client purchases, licenses or otherwise assumes rights from a third party, or (iii) any pharmaceutical human therapeutic product that Client purchases, licenses or otherwise assumes commercialization rights from a third party.
 
§11.                         Indemnification .  Each party will indemnify the other as follows:
 
(a)                                   Cardinal Health will indemnify, defend and hold Client and its officers, directors, agents, employees and affiliates (collectively, the “Client Group”) harmless from and against any liabilities, damages, losses or expenses, including reasonable attorneys’ fees, any of them may sustain or incur as a result of any claim, suit or proceeding (“Claim”) made, brought or threatened by third parties and based upon or resulting from (i) Cardinal Health’s or its affiliate’s negligence, willful misconduct or breach of this Agreement, including but not limited to, Cardinal Health’s breach of its representations and warranties under this Agreement or any Workplan and (ii) any Work Product or Brand Features that are alleged to constitute plagiarism, idea misappropriation, or that infringe third party intellectual property rights.  Cardinal Health’s obligations under this section include all time charges and expenses (including reasonable attorneys’ fees) incurred in connection with any subpoena, discovery demand or other directive having the force of law or any governmental inquiry served upon Client that relates to Cardinal Health or its business.  The provisions of this paragraph will not apply to a Claim to the extent that such Claim arises as a result of the negligence or willful misconduct of Client or any member of the Client Group or Client’s breach of this Agreement.
 
(b)                                   Client will indemnify, defend and hold Cardinal Health and its officers, directors, agents, employees and affiliates (collectively, the Cardinal Health Group”) harmless from and against any Claim made, brought or threatened by third parties and based upon or resulting from (i) Client’s or its affiliates’ negligence, willful misconduct or breach of this Agreement including but not limited to, Client’s breach of its representations and warranties under this Agreement; (ii) any product liability or other Claim based upon the use or efficacy of any Product; (iii) the manufacture, sale, or distribution of the Product, (iv) content of Promotional Material that has been provided by Client or approved by Client in advance of publication; and (v) any use of Promotional Material by Client outside the scope of any third party license of which Cardinal Health has notified Client in accordance with Section 9(b). Client’s obligations under this section include all time charges and expenses (including reasonable attorneys’ fees) incurred in connection with any subpoena, discovery demand or other directive having the force of law or any governmental inquiry served upon Cardinal Health that relates to Client or its business. The provisions of this paragraph will not apply to a Claim to the extent such Claim arises as a result of the negligence or willful misconduct of Cardinal Health or any member of the Cardinal Health Group or any Cardinal Health Group member’s breach of this Agreement.
 
(c)                                   Each party’s agreement to indemnify, defend and hold the other party harmless is conditioned on the indemnified party (i) providing prompt written notice to the indemnifying party of any Claim subject to indemnification under this Section 11; (ii) permitting the indemnifying party to assume full responsibility to investigate, prepare for and defend against any such Claim, (iii) assisting the indemnifying party, at the indemnifying party’s reasonable expense, in the investigation of, preparation for and defense of any Claim, and (iv) not compromising or settling such Claim without the indemnifying party’s written consent.
 
9

 
§12.                         Confidential Information .  Neither party will, during the Term and for a period of five (5) years thereafter, without the other party’s prior written consent, disclose to any third party any of the other party’s Confidential Information, except that either party may disclose the other party’s Confidential Information to its affiliates, inChord and inChord affiliates solely as necessary for their performance of the Services, provided that the party conveying the other party’s Confidential Information will inform each recipient of the confidential nature of such information and will use all reasonable efforts to cause each recipient to receive and hold such information in accordance with the terms of this Agreement.  Each party will, during the Term and for a period of five (5) years thereafter, keep the other party’s Confidential Information secret and confidential, will use reasonable efforts to cause its affiliates, employees, representatives and agents to keep such Confidential Information secret and confidential, and will take reasonable precautions to prevent any use or disclosure of such Confidential Information except in the performance of the Services in accordance with the terms of this Agreement.
 
(a)                                   For purposes of this Agreement, “Confidential Information” means  information disclosed hereunder by, or on behalf of, Cardinal Health or Client to the other party, whether of a technical, business or other nature, including but not limited to non-public information which relates to Cardinal Health’s (including its affiliates) or Client’s trade secrets, product or service offerings, proprietary rights or business affairs.
 
(b)                                   Exceptions to Confidential Information.   Confidential Information does not include any information that, as evidenced by competent written proof: (i) was known to the receiving party prior to its disclosure by the disclosing party; (ii) is lawfully obtained by the receiving party from a third party, as a matter of right and without restriction on disclosure; (iii) is disclosed in public literature or becomes generally available to the public through no violation of this Agreement by the receiving party; or (iv) was independently developed or obtained by the receiving party without violation of this Agreement.
 
(c)                                   Permitted Disclosures. Notwithstanding the foregoing, a party may disclose Confidential Information of the other party to third parties to the extent such disclosure is required by order of a court, government agency or the like having competent jurisdiction; provided that, in the event such information is required to be disclosed pursuant to this Section 12(c), the party required to make such disclosure will promptly notify the other party prior to such disclosure, will disclose only what is reasonably necessary to comply with such order, and will use reasonable efforts to cooperate with such other party to allow assertion of whatever exclusions, exemptions or confidential treatment that may be available to it under applicable law or regulation.
 
(d)                                   It is understood and agreed that Cardinal Health may list Client as one of its RxPedite clients when furnishing proposals to other prospective clients or in client listings in trade publications and directories.
 
§13.                         Force Majeure .  Neither party will be liable to the other for failure to perform when and as specified in this Agreement (exclusive of payment obligations) if such failure to perform is caused by war, fire, flood, strike, labor dispute, public disaster, accident, serious illness, act of God, act of terrorism, act of governmental authority (including rule or regulation),
 
10

 
or other similar contingencies (a “Force Majeure”) beyond the reasonable control of the non-performing party and which materially interferes with such party’s ability to perform its obligations hereunder.  In the event of such a Force Majeure, the party so affected will be excused from performance hereunder for the period of time attributable to the Force Majeure; provided that such party uses and continues to use all reasonable efforts to overcome such Force Majeure.
 
§14.                         Termination .
 
(a)                                   The term of this Agreement will commence on the Effective Date and continue for a period equal to the longer of: (i) five (5) years thereafter, or (ii) twenty-four (24) months following the Program Launch, unless terminated earlier pursuant to the termination provisions below, or extended by written agreement of the parties.  The term “Program Launch” will mean the first Monday after completion of the Training Program (as defined in Section 3.1 of the Workplan for Detailing Services) by at least fifty (50) of the Representatives.  As used herein, “Term” will mean the term of this Agreement as specified above.
 
(b)                                   Either party will have the right to effect an early termination of this Agreement if the other party breaches any material obligation of this Agreement and fails to cure such breach as provided herein.  Following a material breach, the non-breaching party will provide the breaching party with written notice of the specific reason or reasons for the non-breaching party’s intention to terminate the Agreement early, and will provide the breaching party with (i) sixty (60) days to correct any non-performance or breach other than non-payment, or (ii) thirty (30) days to correct such breach in the case of non-payment.  If the breaching party fails to correct the specified non-performance or breach within the time period specified in the foregoing sentence (or, in the case of a breach other than non-payment, if such breach is not reasonably capable of cure within sixty (60) days, the breaching party fails to commence cure of the specified non-performance within sixty (60) days and diligently pursue completion of the cure thereafter), then the non-breaching party may immediately effect an early termination this Agreement upon written notice to the breaching party.
 
(c)                                   Either party may terminate this Agreement effective upon written notice to the other party, if the other party becomes insolvent or admits in writing its inability to pay its debts as they become due, files a petition for bankruptcy, makes an assignment for the benefit of its creditors or has a receiver, trustee or other court officer appointed for its properties or assets.
 
(d)                                   Either party may terminate this Agreement under the circumstances described in Section 1(b) upon sixty (60) days prior written notice to the other party.
 
(e)                                   Upon termination of this Agreement for any reason, Cardinal Health will cease work on all Projects and will give to Client a written report on the status of all Services. Each party will cooperate with the other and make reasonable efforts to facilitate a smooth and efficient transition of all pending Projects to Client or a successor agency designated by Client.  Client will pay Cardinal Health for all work performed and expenses incurred prior to the effective date of termination of this Agreement and for all non-cancelable commitments incurred by Cardinal Health prior to such time.  Any funds previously paid to Cardinal Health by Client
 
11

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
which are in excess of compensation and/or expenses to which Cardinal Health is entitled through the termination of this Agreement will be promptly returned to Client.
 
(f)                                     Upon termination of this Agreement pursuant to Section 14(d), Client will pay to Cardinal Health the following amounts:  (i) if such termination is effected by Client prior to Product launch or within six (6) months thereafter, then the sum of (1) the Aggregate Discount Amounts (as such term is defined in Exhibit A) actually given by Cardinal Health, and (2) a premium payment in the amount of [**] of the Aggregate Discount Amounts actually given by Cardinal Health and (ii) if such termination is effected by Client at any time more than six (6) months after the date of Product launch, then the sum of (1) the Aggregate Discount Amounts actually given by Cardinal Health and not already repaid in accordance with the Repayment Rate set forth in Exhibit B and (2) a premium payment in the amount of [***] of the Aggregate Discount Amounts actually given by Cardinal Health.  Client will pay the total amount due under this Section 14(f) in four (4) equal quarterly installments, the first of which is due on the first day of the calendar quarter immediately following the effective date of termination under Section 14(d).
 
§15.                         Records and Audit .  For a period of two (2) years following the termination of this Agreement, each party will maintain records, in commercially reasonable form, detail, and accuracy, relating to the Services, Product revenues, and other information reasonably relevant to the calculation of the Cardinal Health Fees and Discount Amounts.  During the Term and for a period of two (2) years thereafter, each party agrees that it will provide relevant information and access to relevant records to an independent third party accountant upon reasonable prior notice and during normal business hours for the purpose of inspection, examination and audit. All examinations of records will take place at the site at which the records are regularly kept and will be at the examining party’s sole expense.
 
§16.                         Limitation of Liability .  IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, INCIDENTAL, INDIRECT, CONSEQUENTIAL OR SIMILAR DAMAGES (INCLUDING BUT NOT LIMITED TO DAMAGES FOR INDIRECT LOSS OF PROFITS, LOSS OF BUSINESS REPUTATION OR THE LIKE) ARISING DIRECTLY OR INDIRECTLY OUT OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT.
 
§17.                         Insurance .
 
(a)                                   Cardinal Health .  Cardinal Health shall, at its own cost and expense, obtain and maintain in full force and effect the following insurance during the Term: (i) Commercial General Liability insurance with per-occurrence and general aggregate limits of not less than one million dollars ($1,000,000); (ii) Workers’ Compensation and Employer’s Liability Insurance with statutory limits for Workers’ Compensation and Employer’s Liability insurance limits of not less than one million dollars ($1,000,000); (iii) Professional Services Errors & Omissions Liability Insurance with per claim and aggregate limits of not less than ten million dollars ($10,000,000).  In the event that any of the required policies of insurance are written on a claims made basis, then such policies shall be maintained during the Term and for a period of not less than three (3) years following the termination or expiration of this Agreement.  Cardinal Health shall obtain a waiver from any insurance carrier with whom Cardinal Health carries
 
12

 
Workers’ Compensation insurance releasing its subrogation rights against Client.  Client shall be named as an additional insured under the Commercial General Liability insurance policies.  Cardinal Health shall furnish certificates of insurance for all of the above noted policies and required additional insured status to Client as soon as practicable after the Effective Date of the Agreement and upon renewal of any such policies.  Each insurance policy that is required under this Section shall be obtained from an insurance carrier with an A.M. Best rating of at least A- VII.
 
(b)                                   Client Insurance .  Client shall, at its own cost and expense, obtain and maintain in full force and effect the following insurance during the Term: (i) Products and Completed Operations Liability Insurance with per-occurrence and general aggregate limits of not less than ten million dollars ($10,000,000); and (ii) Workers’ Compensation and Employer’s Liability Insurance with statutory limits for Workers’ Compensation and Employer’s Liability insurance limits of not less than one million dollars ($1,000,000).  In the event that any of the required policies of insurance are written on a claims made basis, then such policies shall be maintained during the entire Term and for a period of not less than three (3) years following the termination or expiration of this Agreement.  Client shall obtain a waiver from any insurance carrier with whom Client carries Workers’ Compensation insurance releasing its subrogation rights against Cardinal Health.  Cardinal Health shall be named as additional insureds under the Products and Completed Operations Liability insurance policies.  Client shall furnish certificates of insurance for all of the above noted policies and required additional insured status to Cardinal Health as soon as practicable after the Effective Date of the Agreement and upon renewal of any such policies.  Each insurance policy that is required under this Section shall be obtained from an insurance carrier with an A.M. Best rating of at least A- VII.
 
§18.                         Representations and Warranties. 
 
(a)           Mutual Representations and Warranties.   Each party hereby represents and warrants that:
 
(i)                                     such party is duly organized and validly existing under the laws of the state of its organization and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
 
(ii)                                 such party is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder;
 
(iii)                             this Agreement is a legal and valid obligation binding upon such party and enforceable in accordance with its terms;
 
(iv)                                the execution, delivery and performance of this Agreement by such party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound; and
 
(v)                                    such party will perform the Services set forth herein in conformance with applicable federal, state and local laws and regulations including, but not limited to, the regulations and guidelines of the Food, Drug and Cosmetic Act.
 
13

 
(b)           Cardinal Health Representations and Warranties.    Cardinal Health hereby represents and warrants that:
 
(i)                                     all Work Product and Brand Features will be original works of Cardinal Health, its affiliates or its third party subcontractors;
 
(ii)                                 Cardinal Health and its affiliates will obtain all rights and licenses to any toolsets or other software embedded in Work Product, which rights shall extend to Client (subject to Section 9(b));
 
(iii)                             Cardinal Health and its affiliates will not create Work Product or Brand Features that Cardinal Health knows or reasonably should have known, infringes the intellectual property rights of a third party;
 
(iv)                                Cardinal Health and its affiliates will not grant, directly or indirectly, any rights or interest to third parties whatsoever in Work Product or Brand Features without the prior written approval of Client;
 
(v)                                    Cardinal Health and its affiliates (1) are not currently involved in any litigation, and is unaware of any pending litigation proceedings, relating to its role in the provision of medical education and sales force services for any third party with respect to a pharmaceutical product; and (2) have not received any warnings from the FDA (or any regulatory body in a country other than the United States) relating to medical education and sales force services it has provided to third parties with respect to a pharmaceutical product; and
 
(vi)                                Cardinal Health and its affiliates will not employ, contract with or retain any person in any capacity to perform Services under this Agreement if such a person is debarred by the FDA under 21 U.S.C. § 335(a) or disqualified as described in 21 C.F.R. §812.119.
 
§19.                         Notice .  All notices required or permitted to be given under this Agreement must be in writing and will be addressed to the appropriate party at the address specified below or  such other address as may be specified by a party in writing in accordance with this Section 19, and will be deemed to have been duly given (a) when received, if hand-delivered or sent by a reputable overnight courier service, (b) five (5) business days after mailing, if mailed by first-class certified or registered mail, postage prepaid, return receipt requested, or (c) when received as evidenced by confirmation of transmission, if sent by facsimile, provided that the sender calls and notifies the recipient prior to sending such facsimile.
 
Cardinal Health PTS, Inc.
Healthcare Marketing Services
1800 Valley Road
Wayne, New Jersey 07470
Attention:  Chief Financial Officer
Tel:  (973) 709-3003
Fax:  (973) 709-3203
 
14

 
Acorda Therapeutics, Inc.
15 Skyline Drive
Hawthorne, NY 10532
Attention: Director of Contracts and Grants
Tel:  (914) 347-4300
Fax (914) 347-4560
 
§20.                         Complete Agreement .  This Agreement, including the exhibits attached hereto and each Workplan, contain the entire agreement between the parties and supersede all prior or contemporaneous discussions, negotiations, representations, or agreements relating to the subject matter herein.  No changes to this Agreement will be made or be binding on any party unless made in writing and signed by an authorized representative of each party to this Agreement.
 
§21.                         Alternate Dispute Resolution .  If a dispute, controversy or disagreement (“Dispute”) arises between the parties in connection with this Agreement, then the Dispute shall be presented to the respective president or senior executive of Cardinal Health and Client for their consideration and resolution. If such executives cannot reach a resolution of the Dispute within forty-five (45) days of such referral, then such Dispute shall be resolved by binding Alternative Dispute Resolution in accordance with the then existing commercial arbitration rules of The CPR Institute for Dispute Resolution (“CPR”), 366 Madison Avenue, New York, NY 10017. Arbitration shall be conducted in New York, New York.
 
§22.                         Jurisdiction .  This Agreement will be governed by the laws of the State of New York without regard to conflicts of laws principles.
 
§23.                         No Benefit to Others .  The representations, warranties, covenants and agreements contained in this Agreement are for the sole benefit of the parties hereto and their affiliates, successors and assigns, and they shall not be construed as conferring any rights on any other persons.
 
§24.                         Severability .  Any provision of this Agreement which is invalid or unenforceable in any jurisdiction shall be ineffective to the extent of such invalidity or unenforceability without invalidating or rendering unenforceable the remaining provisions hereof, and any such invalidity or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction.  To the extent legally permissible, the parties shall use good faith efforts to agree to replace any invalid or unenforceable provision of this Agreement with a valid provision that shall implement as much as permitted the commercial intent of the invalid or unenforceable provision.
 
§25.                         Subcontractors .  Cardinal Health will be permitted to enter into subcontracts for the provision of portions of the Services to be supplied under this Agreement with the prior written approval by Client (subject to Section 28, and with such approval not to be unreasonably withheld), provided that such right to subcontract will not remove or limit Cardinal Health’s duties, rights, obligations, or liabilities to Client under this Agreement.  Any agreements entered into by Cardinal Health with third party subcontractors for the performance of Services under this Agreement shall, at a minimum, provide for ownership and allocation of intellectual property rights with respect to Work Product and Brand Features and for obligations of
 
15

 
confidentiality and non-use of Confidential Information that are consistent with the intent and terms of this Agreement.  Cardinal Health will ensure that each subcontractor who has contributed to Work Product or Brand Features will execute an assignment to Cardinal Health of all of such subcontractor’s right, title and interest in and to such Work Product or Brand Features to enable compliance by Cardinal Health with the assignment obligations of Section 8 with respect thereto.
 
§26.                         Successors and Assigns .  Neither party will be permitted to assign or transfer its rights, duties or obligations under this Agreement without the prior written consent of the other party, which consent will not be unreasonably withheld.  Notwithstanding the foregoing, upon the occurrence of a sale of the Product, merger, consolidation or other similar corporate transaction affecting either party (a “Special Event”), the benefits and obligations of this Agreement shall automatically pass to the successor entity without prior written consent of the other party; provided, however, that if, following a Special Event affecting Client (a) Cardinal Health’s continued performance of Services would result in an impermissible conflict as defined in section 2(d) with one or more of its other clients, Cardinal Health may effect an early termination of this Agreement without penalty upon delivery to Client of written notice specifying in detail such impermissible conflict, in which case, the provisions of Section 14(e) will apply, or (b) Client may terminate this Agreement in accordance with the provisions of Section 14(d) and 14(f).
 
§27.                         Publicity .  Except as provided in Section 12, neither party will make any press release or other public disclosure regarding this Agreement or the transactions contemplated hereby without the other party’s express prior written consent, except as required under applicable law or by any governmental agency, in which case the party required to make the press release or public disclosure shall use  commercially reasonable efforts to obtain the approval of the other party as to the form, nature and extent of the press release or public disclosure prior to issuing the press release or making the public disclosure.
 
§28.                         Performance by Affiliates .  Cardinal Health may have certain of its affiliates perform certain Services on its behalf, and Cardinal Health hereby covenants that its affiliates which will be providing certain of the Services under this Agreement are bound by this Agreement and guarantees the performance by such Cardinal Health affiliates of obligations assigned to Cardinal Health under this Agreement, and shall cause such Cardinal Health affiliates to comply with the terms and conditions of this Agreement in connection with such performance.  Any breach by such affiliates of any of Cardinal Health’s obligations under this Agreement shall be deemed a breach by Cardinal Health, and Client may proceed directly against Cardinal Health without any obligation to first proceed against such affiliates.
 
§29.                         No Implied Rights or Licenses.   The parties agree that neither party transfers to the other party by operation of this Agreement any patent right, copyright right, trademark right or other proprietary right (including any right with respect to the Product), except as specifically provided herein.
 
§30.                         Survival.   Sections 8, 11 (as to any Claims arising from the parties’ performance during the Term), 12, 14(e), 14(f), 15, 16, 21, 22, 26, 28 and 30 shall survive termination of this Agreement.
 
16

 
§31.                         Miscellaneous .
 
(a)                                   This Agreement may be executed in two (2) or more counterparts, each of which shall be binding as of the date first written above, and all of which shall constitute one and the same instrument.  Each such copy shall be deemed an original, and it shall not be necessary in making proof of this Agreement to produce or account for more than one such counterpart.
 
(b)                                   Cardinal Health is retained by Client only for the purposes and to the extent provided for under this Agreement, and Cardinal Health will for all purposes under this Agreement be deemed an independent contractor and not an employee, partner or joint venturer with Client or Cardinal Health.
 
(c)           No covenant or condition of this Agreement will be waived except by written consent of Client and Cardinal Health. The omission, or delay, by either party at any time to enforce any right or remedy reserved to it, or to require performance of any of the terms, covenants or provisions hereof, by the other party, shall not be a waiver of any such right or remedy to which the party is entitled.  Any waiver by a party of the breach by the other party of this Agreement shall not operate or be construed as a waiver of any subsequent breach by either party.
 
[ Remainder of page intentionally left blank. ]
 
17

 
IN WITNESS WHEREOF, the parties to this Agreement, each by a duly authorized representative, have executed this Agreement as of the Effective Date.

CARDINAL HEALTH:	CLIENT:	
Cardinal Health PTS, Inc.	Acorda Therapeutics, Inc.	

By:	 	 	By:	 	 	
 	 	
Print Name:	 	 	Print Name:	 	 	
 	 	
Title:	 	 	Title:	 	 	

18

 
Exhibit A
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
DISCOUNT MATRIX
 
(i)                                     In determining the Cardinal Health Fee for Services performed during “Period 1” of the Agreement beginning as of the Effective Date and continuing through the First Milestone, Client will be entitled to a Discount Amount of [**] of the total amount charged for such Services in accordance with the applicable Budget.  As used herein, the First Milestone will be the completion of the Product’s Phase III pivotal Trial 1 for spinal cord injuries (“SCI”).  As used in this Exhibit A, the term “completion” of a clinical trial means completion of conducting the trial, analyzing all data and results of such trial, and preparing the final and complete report of such analyzed data.  Period 1 is currently estimated to include the period from the Effective Date through [**].
 
(ii)                                 In determining the Cardinal Health Fee for Services performed during “Period 2” of the Agreement beginning as of the end of Period 1 and continuing through the Second Milestone, Client will be entitled to a Discount Amount within the range of [***] of the total amount charged for such Services in accordance with the applicable Budget, where the actual percentage within this range will be based on the study findings relative to those identified parameters of promotional success for the Product as described in the Target Product Profile (“TPP”) attached as Exhibit C. As used herein, the Second Milestone will be the completion of the Product’s Phase III pivotal Trial 2 for SCI.  Period 2 is currently estimated to include the period from [***].
 
(iii)                             In determining the Cardinal Health Fee for Services performed during “Period 3” of the Agreement beginning as of the end of Period 2 and continuing through the Third Milestone, Client will be entitled to a Discount Amount within the range of [***] of the total amount charged for such Services in accordance with the applicable Budget, where the actual percentage within this range will be based on the TPP study findings as described in Exhibit C. As used herein, the Third Milestone will be the NDA submission for SCI.  Period 3 is currently estimated to include the period from [***].
 
(iv)                                In determining the Cardinal Health Fee for Services performed during “Period 4” of the Agreement beginning as of the end of Period 3 and continuing through the Fourth Milestone, Client will be entitled to a Discount Amount within the range of [***] of the total amount charged for such Services in accordance with the applicable Budget, where the actual percentage within this range will be based on the TPP study findings as described in Exhibit C. As used herein, the Fourth Milestone will be FDA approval of the Product for the SCI indication.  Period 4 is currently estimated to include the period from [***].
 
(v)                                    In determining the Cardinal Health Fee for Services performed during “Period 5” of the Agreement beginning as of the end of Period 4 and continuing through the Fifth Milestone, Client will be entitled to a Discount Amount within the range of [***] of the total amount charged for such Services in accordance with the applicable Budget, where the actual percentage within this range will be based on the TPP study findings as described in
 
19

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Exhibit C. As used herein, the Fifth Milestone will be the six-month anniversary of the Product’s launch for SCI indication.  Period 5 is currently estimated to include the period from [***].
 
(vi)                                In determining the Cardinal Health Fee for Services performed during “Period 6” of the Agreement beginning as of the end of Period 5 and continuing through the end of the Term, Client will pay as Cardinal Health Fees the total amount charged for such Services in accordance with the applicable Budget and will not be entitled to any Discount Amount from such fees.  Period 6 is currently estimated to include the period from May 2006 through the end of the Term.
 
“Aggregate Discount Amount” means the total aggregate amount of all Discount Amounts actually allowed by Cardinal Health during Period 2 through Period 5.  The Aggregate Discount Amount will be “at risk.”  Such amount will be earned by and payable to Cardinal Health at the Repayment Rate described in the Discount Payment Matrix in Exhibit B, such rate will be based on the Product’s quarterly revenue performance during the twelve (12) month period following the Product’s launch.
 
20

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Exhibit B
 
DISCOUNT PAYMENT MATRIX
 
Contract Exhibit B
 
DISCOUNT PAYMENT DESCRIPTION
 
The “Actual Prescription Targets” means actual filled prescriptions of the Product, as measured by IMS, and the Repayment Rate will be based on comparing the actual filled prescriptions of the Product during the particular time period(s) with the Actual Prescription Target(s) during such period(s). The Actual Prescription Target for the period is [***] prescriptions.
 
Client agrees to make certain repayments to CHS, as percentages of the Aggregate Discount Amount, based on the actual filled prescriptions of the Product during the four quarterly periods immediately following the launch of the Product (such consecutive three month periods referred to as “Q1,” “Q2,” “Q3,” and “Q4.”), and the applicable Repayment Rate.  Such repayments by Client to CHS shall be made, using the applicable Repayment Rate determined as above, in four quarterly installments, with the first such payment occurring on the six month anniversary of the Product launch and with subsequent payments made on the ninth, twelfth, and fifteenth month anniversaries of the launch of the Product, in accordance with the following procedure:
 
(1)   The first such payment will be determined by applying the Q1 Repayment Rate (the “Q1 Rate”) – which is determined by comparing the actual filled prescriptions of the Product made during Q1, with Actual Prescriptions Target for Q1 – to one quarter of the Aggregate Discount Amount, according to the following formula. The Actual Prescription Target for Q1 is [***] prescriptions.
1 st Repayment = (1/4)(Aggregate Discount Amount)(Q1 Rate)
 
(2)   The second such payment will be determined by applying the Q2 Repayment Rate (the “Q2 Rate”) – which is determined by comparing the aggregate actual filled prescriptions of the Product made during Q1 and Q2, with sum of the Actual Prescriptions Targets for Q1 and Q2 – to one half of the Aggregate Discount Amount, less the 1 st Repayment, according to the following formula. The Actual Prescription Target for Q2 is [***] prescriptions.
2 nd Repayment = (1/2)(Aggregate Discount Amount)(Q2 Rate) – 1 st Repayment; In the event the 2nd Repayment is negative, then CHS will pay Client the amount of the 2nd Repayment.
 
(3)   The third such payment will be determined by applying the Q3 Repayment Rate (the “Q3 Rate”) – which is determined by comparing the aggregate actual filled prescriptions of the Product made during Q1, Q2, and Q3 with sum of the Actual Prescriptions Targets for Q1, Q2, and Q3 – to three quarters of the Aggregate Discount Amount, less the 1 st Repayment and the 2 nd Repayment, according to the following formula. The Actual Prescription Target for Q3 is [***] prescriptions.
3 rd Repayment = (3/4)(Aggregate Discount Amount)(Q3 Rate) – 1 st Repayment –2 nd Repayment; In the event the 3rd Repayment is negative, then CHS will pay Client the amount of the 3rd Repayment.
 
(4)   The fourth and final such payment will be based on applying the Q4 Repayment Rate (the “Q4 Rate”) – which is determined by comparing the aggregate actual filled prescriptions of the Product made during Q1, Q2, Q3, and Q4, with sum of the Actual Prescriptions Targets for Q1, Q2, Q3, and Q4 – to the total Aggregate Discount Amount, less the 1 st Repayment, 2 nd Repayment and 3 rd Repayment, according to the following formula. The Actual Prescription Target for Q4 is [***] prescriptions.
4 th Repayment = (Aggregate Discount Amount)(Q4 Rate) – 1 st Repayment –2 nd Repayment – 3 rd Repayment; In the event the 4th Repayment is negative, then CHS will pay Client the amount of the 4th Repayment.
 
21

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Contract Exhibit B

 	 	RANGE	 	Fees	 	DISCOUNTS	 	
Milestone	 	Low	 	High	 		 	Low	 	High	 	
1st Phase 3*	 	[********]	 	[********]	 	[********]	 	[********]	 	[********]	 	
2nd Phase 3	 	[********]	 	[********]	 	[********]	 	[********]	 	[********]	 	
NDA Filing	 	[********]	 	[********]	 	[********]	 	[********]	 	[********]	 	
NDA Approval	 	[********]	 	[********]	 	[********]	 	[********]	 	[********]	 	
Launch + 6	 	[********]	 	[********]	 	[********]	 	[********]	 	[********]	 	
TOTAL	 	 	 	 	 	 	 	[********]	 	[********]	 	

Low Discount	 	
 	 	Quarterly	 	Cumulative	 	% of Target	 	Repayment %	 	Repayment $	 	
Q1	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
Q2	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
Q3	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
Q4	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
TOTAL	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	

High Discount	 	 	
 	 	Quarterly	 	Cumulative	 	% of Target	 	Repayment %	 	Repayment $	 	
Q1	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
Q2	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
Q3	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
Q4	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
TOTAL	 	[****]	 	[****]	 	[****]	 	[****]	 	[****]	 	
 
22

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

Low	 	High	 	Payment	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
[***]	 	[***]	 	[***]	 	
 
23

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Exhibit C
 
TARGET PRODUCT PROFILE MATRIX
 
[****]
 
24

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
[****]
25

 
Exhibit 10.19
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
WORKPLAN FOR DETAILING SERVICES
 
This Workplan for Detailing Services (“Workplan”) is dated as of September 19, 2003 (“Effective Date”) by and between Cardinal Health PTS, Inc. (“Cardinal Health”) with a place of business at 7000 Cardinal Place, Dublin, Ohio, and Acorda Therapeutics, Inc. (“Acorda”), having a principal place of business at 15 Skyline Drive, Hawthorne, New York 10532.
 
Background Information
 
Cardinal Health and Acorda are parties to the RxPedite Acorda Marketing Services Agreement dated September 19, 2003 (“RxPedite Agreement”).  Cardinal Health provides a number of marketing related services to Acorda pursuant to the terms of the RxPedite Agreement as set forth in specific Workplans agreed to by the parties.  The parties desire to set forth the terms and conditions upon which Cardinal Health will provide Representatives to Detail certain products for Acorda as provided herein and in the RxPedite Agreement.  This Workplan is subject to the terms and conditions of the RxPedite Agreement and is incorporated by reference therein.  In the event of a conflict between the terms of the RxPedite Agreement and this Workplan, the RxPedite Agreement shall control.
 
ARTICLE I
DEFINITIONS
 
1.1.                               Definitions.   Initially capitalized terms used in this Workplan that are not otherwise defined in this Article 1 or elsewhere in this Workplan shall have the meanings as such terms are defined in the RxPedite Agreement.
 
(a)                                   “Act” means the Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder from time to time.
 
(b)                                  “Agency” means any governmental regulatory authority in the Territory responsible for granting approvals for the sale or maintaining regulatory oversight of the Products, including, without limitation, the FDA.
 
(c)                                   “Cardinal Health Employee” means individually, any Representative, Manager, National Account Manager, National Sales Director, or Medical Science Liaison, and “Cardinal Health Employees” means, collectively, all of the foregoing.
 
(d)                                  “FDA” means the United States Food and Drug Administration and any successor agency having substantially the same functions.
 
(e)                                   “Detail” means an interactive, face-to-face visit by a Representative with a Target Customer or his or her legally empowered designee in the Territory, during which the FDA-approved indicated uses, safety, effectiveness, contraindications, side effects, warnings and other relevant characteristics of one of the Products are described by the Representative in a fair and balanced manner consistent with the requirements of the Act, and using, as necessary or
 
1

 
desirable, the Product Labeling and the Product Promotional Materials.   When used as a verb, “Detail” or “Detailing” shall mean to engage in a Detail as defined in this Section 1.1(e).
 
(f)                                     “Manager” means an individual hired by and retained as an employee of Cardinal Health to supervise activities of Representatives under this Workplan, including district sales managers, regional sales directors, a National Sales Director, and a Project Manager.
 
(g)                                  “Medical Science Liaison” means an individual hired by Cardinal Health to educate target physicians on current trends relating to the Product, its approved indications, and other functions agreed to by the parties.
 
(h)                                  “MSL Commencement Date” means the date upon which Acorda delivers a written request to Cardinal Health for the recruitment and hiring of the Medical Science Liaisons as provided in Section 2.4.
 
(i)                                      “NAM Commencement Date” means the date upon which Acorda delivers a written request to Cardinal Health for the recruitment and hiring of the National Account Managers as provided in Section 2.3.
 
(j)                                      “National Account Manager” means an individual hired by Cardinal Health to manage national sales accounts for Products, including without limitation, accounts with wholesalers, managed care institutions, etc.
 
(k)                                   “National Sales Director” means an individual hired by Cardinal Health to supervise activities of Representatives, National Account Managers and Medical Science Liaisons under this Workplan and other functions agreed to by the parties.
 
(l)                                      “PDMA” means the Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder from time to time.
 
(m)                                “Product Labeling” means all labels and other written, printed, or graphic matter provided by the Acorda relating directly to Product labeling, including (i) any container or wrapper utilized with a Product, or (ii) any written material accompanying a Product, including, without limitation, Product package inserts.
 
(n)                                  “Product Promotional Materials” means all written, printed or graphic material provided by Acorda to Cardinal Health, including Product Labeling, intended for use by Representatives during a Detail, including visual aids, file cards, premium items, clinical studies, reprints, drug information updates and any other promotional support items that Acorda deems necessary or appropriate to conduct the Program.  Product Promotional Materials shall include FDA approved material provided by Acorda relating to indicated uses, safety, effectiveness, contraindications, side effects, warnings and other relevant characteristics of each of the Products.
 
(o)                                  “Products” means the pharmaceutical products to be detailed by Representatives and marketed by Acorda as set forth on attached Schedule 1.1(o), as such
 
2

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
schedule may be amended to include other Acorda products by mutual agreement between the parties.
 
(p)                                  “Program” means the program of Detailing the Products in the Territory  to be conducted by the Representatives pursuant to this Workplan and the RxPedite Agreement during the Term of this Workplan, as defined in  Section 10.1.
 
(q)                                  “Program Launch” means the first Monday following the completion of the Training Program (as defined in Section 3.1) by at least [***] of the Representatives.
 
(r)                                     “Representative” means an individual hired by and retained as an employee of Cardinal Health to conduct Detailing of Products in connection with the Program.  As sometimes used in this Workplan, “Representatives” shall also include “Managers.”
 
(s)                                   “Representative Commencement Date” shall mean the date upon which Acorda delivers a written request to Cardinal Health for the recruitment and hiring of the Representatives as provided in Section 2.1.
 
(t)                                     “Target” or “Target Customer” means a physician or other specialist identified by Acorda.
 
(u)                                  “Territory” means the geographical area specified in the attached Schedule  1.1(t).

ARTICLE II
GENERAL SCOPE OF ACTIVITIES
 
2.1                                  Furnishing Representatives.   Upon receipt of a written request from Acorda, Cardinal Health shall commence the recruitment and hiring of at least [***] Representatives within a timeframe to be mutually agreed upon by the parties.  Cardinal Health shall assign Representatives for such Target Customers, in such numbers, and in such Territories as shall be designated by Acorda during the Term of this Workplan.  Each Representative shall Detail his or her assigned Target Customers based on the general direction given by Acorda’s designated management team and as mutually agreed to by Cardinal Health, such agreement not to be unreasonably withheld.  Except as otherwise provided in Section 2.5, the duties of such Representatives shall be exclusively to Detail the Products and perform other related activities deemed necessary for the establishment and maintenance of new and existing customers of the Products in the Territory.
 
2.2                                  Furnishing Managers and National Sales Director .  Upon receipt of a written request from Acorda authorizing the recruitment of the Representatives, Cardinal Health shall commence the recruitment and hiring of [***] Managers and [***] National Sales Director to supervise the activities of Representatives, National Account Managers and Medical Science Liaisons and to perform this Workplan.
 
3

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
2.3                                  Furnishing National Account Managers .  Upon receipt of a written request from Acorda, Cardinal Health shall commence the recruitment and hiring of [***] National Account Managers within a timeframe to be mutually agreed upon by the parties and to perform the functions described on Schedule 2.3.
 
2.4                                  Furnishing Medical Science Liaisons .  Upon receipt of a written request from Acorda, Cardinal Health shall commence the recruitment and hiring of [***] Medical Science Liaisons within a timeframe to be mutually agreed upon by the parties and to perform the functions described on Schedule 2.4.
 
2.5.                               Sales Force Syndication .  During the Term, the primary activity of the Cardinal Health Employees will be the marketing and promotion of the Product in the Territory, provided, however, that Cardinal Health will have the right to propose to Acorda syndication of any additional capacity of the Representatives to other products from third party healthcare companies.  Upon Acorda’s acceptance of such proposal, the parties will negotiate in good faith a decrease in the Service Fees to reflect such syndication by Cardinal Health.  Cardinal Health may not syndicate such additional sales force capacity absent written approval of the proposal by Acorda, including approval of the negotiated adjustment in the Service Fees.  Acorda will consider any such proposed syndication in good faith, taking into account the type of product, target audience and level of sales effort for such product.
 
2.6                                  Scope of Activities.   The parties shall perform the following activities as applicable to each in connection with the Program:
 
(a)                                   Cardinal Health will recruit, interview and hire as its employees the Cardinal Health Employees.  Cardinal Health will use its best efforts to ensure that Cardinal Health Employees have prior experience and training in the pharmaceutical industry or other health care-related fields or such other experience deemed mutually acceptable by Acorda and Cardinal Health.  Cardinal Health shall use its best efforts to ensure that the Cardinal Health Employees have satisfactory references from prior employers. Cardinal Health shall have the sole authority to reject any applicant for employment as a Cardinal Health Employee. Acorda may, at its sole cost and expense, participate with Cardinal Health in the interviewing of Cardinal Health Employees.  If Cardinal Health rejects an applicant and thereafter hires such applicant at the request of Acorda, Acorda shall indemnify and hold Cardinal Health harmless from any Claim (as defined in the RxPedite Agreement) arising as a result of such Cardinal Health Employee’s wrongful or negligent acts or omissions.
 
(b)                                  Cardinal Health shall have sole and exclusive authority to discipline or terminate the employment of the Cardinal Health Employees.  Acorda may reasonably request that a Cardinal Health Employee be terminated or reassigned if such Cardinal Health Employee’s activities or conduct are not adequately (i) achieving the performance goals of the Product, or (ii) complying with Acorda requirements for Detailing the Product.  Cardinal Health shall use its best efforts to comply with such request; provided that such action complies with applicable laws and is in accordance with Cardinal Health’s policies and procedures, as determined by Cardinal Health’s human resources manager.  In the event Cardinal Health determines that its policies and procedures or applicable laws prohibit the termination or reassignment of any Cardinal Health
 
4

 
Employee so requested by Acorda, it shall notify Acorda of such determination and submit a corrective action plan for Acorda’s approval.  In any event, if a Cardinal Health Employee fails to comply with all applicable laws and regulations, or breaches Cardinal Health’s obligations under the RxPedite Agreement or this Workplan, then the parties shall take the actions set forth in Section 2.8..
 
(c)                                   Cardinal Health shall cause each Cardinal Health Employee to attend and successfully complete the Training Program (as defined in Section 3.1) conducted by Acorda for each of the Products prior to participating in the Program.  Any Cardinal Health Employee who does not successfully complete all requirements of the Training Program shall be removed and replaced by another Cardinal Health Employee who shall comply with such requirements.
 
(d)                                  Cardinal Health’s Managers shall periodically accompany Representatives on Details, conduct field evaluations of the Representatives and the Program, including time supervision, territory management, and reporting, and be available to review such evaluations with the Acorda’s coordinator of the Program.  At Acorda’s request, Cardinal Health shall permit Acorda or its designated representative to review Cardinal Health’s evaluations relating to the foregoing and to accompany the Representatives on such Details.
 
(e)                                   Acorda shall provide Cardinal Health without cost with sufficient quantities of the Product Promotional Materials and Product Labeling for the performance and supervision of Detailing.  Acorda shall be solely responsible for the preparation, content, and method of distribution of the Product Promotional Materials and the Product Labeling.  In connection with the Detailing of the Products, the Cardinal Health Employees shall use only the Product Labeling and the Product Promotional Materials provided by Acorda; and under no circumstances shall Cardinal Health or the Cardinal Health Employees develop, create, or use any other promotional material or literature for the Detailing of the Products.  Representatives and National Account Managers shall limit their verbal statements and claims regarding the Products, including efficacy and safety, to those that are consistent with the Product Labeling and the Product Promotional Materials, and Cardinal Health shall require that Representatives and National Account Managers so limit their statements and claims.  Acorda shall advise Cardinal Health immediately of any inaccuracy or incompleteness of the Product Promotional Materials or the Product Labeling, and upon such notice Cardinal Health and the Cardinal Health Employees shall immediately cease the use of any portion or all of the Product Promotional Materials or Product Labeling so identified by Acorda.
 
(f)                                     The Representatives and National Account Managers shall not add, delete, or modify claims of efficacy or safety in the Detailing of the Products, nor make any changes (including underlining or otherwise highlighting any language or adding any notes thereto) in the Product Promotional Materials.
 
(g)                                  The Cardinal Health Employees shall not make any disparaging, untrue, or misleading statements about any of Acorda or its Affiliates, employees, competitors, or competing products.
 
5

 
(h)                                  Representatives and National Account Managers shall Detail the Products in strict adherence to all applicable laws, regulations, and professional requirements, including, but not limited to, the Act, the Medicare and Medicaid Anti-Kickback Statute, and the American Medical Association Gifts to Physicians from Industry Guidelines.
 
(i)                                      The Cardinal Health Employees shall remain under the direct authority and control of Cardinal Health, but shall cooperate with the members of Acorda and shall receive advice and direction related to Detail activities on the Products from Acorda and Cardinal Health mutually.  Acorda shall make all decisions with respect to the overall strategy in connection with the Detailing of the Products in accordance with applicable laws and Cardinal Health Employees shall comply with such decisions.   Any Acorda personnel interacting with Cardinal Health Employees shall not discipline the Cardinal Health Employees or implement terms or conditions of employment or personnel policies and/or practices with respect to the Cardinal Health Employees or otherwise control the daily activities of the Cardinal Health Employees.  Acorda shall provide Cardinal Health with copies of all reports, memoranda, audits and other data it develops pertaining to (i) the Cardinal Health Employees, Detailing, and the Program within fifteen (15) days of the preparation of such documents, and (ii) any negligent or wrongful acts or omissions of the Cardinal Health Employees as promptly as practicable.
 
(j)                                      Cardinal Health shall supply Representatives, National Account Managers and Medical Science Liaisons with fleet vehicles for their use in performing and supervising the Detailing.  Acorda shall reimburse Cardinal Health for all reasonable out-of-pocket costs and expenses ( i.e. , airline tickets and other travel expenses, hotel, rent-a-car, fuel, business meals, travel meals, etc.) of the Cardinal Health Employees to the extent directly incurred in connection with performing services pursuant to this Workplan and subject to compliance with a budget to be mutually agreed upon by Acorda and Cardinal Health for the costs and expenses referenced in this subparagraph for each Territory.  Cardinal Health shall obtain prior approval for any such costs or expenses that exceed the budget.
 
(k)                                   Acorda shall provide Cardinal Health with a list of Target Customers in the Territory and with data on prescriptions and sales in the Territory for Cardinal Health’s use in performing this Workplan.  Acorda shall also provide Cardinal Health with such other sales and marketing information concerning the Products that is obtained or prepared during the Term of this Workplan.
 
2.7.                               Orders for Products .  Acorda shall be solely responsible for establishing the terms and conditions of the sale of the Products, including without limitation, the price at which the Products will be sold, whether sales of the Products will be subject to any discounts, the method of distribution of the Products, and whether any credit will be granted or refused in connection with the sale or return of any Product.  Acorda shall be exclusively responsible for accepting and filling all purchase orders for the Products, billing and returns for the Products, and all other activities in connection with the sale and delivery of the Products, other than Detailing.  If any Cardinal Health Employee receives an order for the Products, he/she shall immediately transmit such order to Acorda for further handling and communications with the submitter of the order, including acceptance or rejection, which shall be in Acorda’s sole discretion.
 
6

 
2.8                                  Wrongful Acts and Omissions .  Each party shall notify the other  in writing as promptly as practicable of any such material alleged negligent or wrongful acts or omissions on the part of any Cardinal Health Employee of which it becomes aware along with a plan to remedy such acts or omissions, and Acorda shall provide Cardinal Health with a reasonable opportunity to remedy such acts or omissions, and if indicated, to replace the involved Cardinal Health Employee(s).  Cardinal Health shall be responsible for all such acts or omissions except that Acorda shall be responsible for any such acts undertaken by any Cardinal Health Employee pursuant to the express direction, and under the direct control or supervision, of Acorda or its employees.
 
2.9.                               Vacancies/Turnover .  In the event of a vacancy in any Cardinal Health Employee position due to resignation, reassignment or termination of a Representative, Cardinal Health shall use its best efforts to fill any such vacancy within a nine (9) week period.  Acorda shall be responsible for paying the Service Fee (as defined in Section 6.1 below) during such vacancy, unless such vacancy exceeds the nine (9) week period, in which event, the associated Service Fee for vacancy of such Representative, National Account Manager, or Medical Science Liaison shall be suspended after the nine (9) week period and shall resume once the vacancy is filled by Cardinal Health.  All recruiting and other related expenses for filling a vacancy shall be borne by Cardinal Health; provided, however, that Acorda shall be responsible for all recruiting and other related expenses for filling any vacancy occurring pursuant to Acorda’s request for reassignment or termination other than a request pursuant to Section 2.8, or resulting from a Cardinal Health Employee’s failure to comply with any one or more of the provisions of Section 2.6.  In addition, if Acorda desires to interview any candidates, Acorda shall bear its own cost of attending any final interview conducted by Cardinal Health or the costs of any separate interview arranged for by Acorda.
 
2.10.                         Management Reports .  Cardinal Health shall provide Acorda with monthly reports in the form set forth in Schedule 2.10 within fifteen (15) days after the end of each month.  At the request of Acorda, Cardinal Health shall furnish Acorda at reasonable times such documentation as Acorda reasonably requests for purposes of verifying the accuracy of any monthly report.
 
2.11.                         Project Manager .  Cardinal Health shall appoint a Project Manager to serve as a liaison between Cardinal Health, Representatives and Acorda regarding the performance by Cardinal Health and Acorda of their respective obligations under this Workplan.
 
ARTICLE III
TRAINING
 
3.1.                               Training Programs .
 
(a)                                   Acorda shall conduct a training program (of approximately five (5) days duration) for the Cardinal Health Employees prior to the  commencement of the Program, which shall include such medical and technical information about the Products and such sales training as Acorda, along with Cardinal Health, deems necessary and appropriate (the “Training
 
7

 
Program”).  The Training Program shall also include instruction on compliance with applicable laws.  Cardinal Health shall assist Acorda with the Training Program only to the extent requested by Acorda.
 
(b)                                  In order to qualify for assignment in a Territory, a Representative must demonstrate thorough knowledge of the Products by passing Acorda approved Product tests at a level of proficiency agreed upon by Acorda and Cardinal Health.
 
3.2.                               Training Materials .    With the advice and assistance of Acorda, Cardinal Health shall prepare written training materials for the Training Program and an up-to-date programmed learning unit for the Products, to be sent to each Cardinal Health Employee for “at home” study a minimum of five (5) days prior to the commencement of the Training Program.  Acorda shall provide Cardinal Health with clinical and other information about the Products in order to prepare such written training materials and programmed learning unit.
 
3.3.                               Acorda Assistance .   During the Term of this Workplan, Acorda shall make available to Cardinal Health, free of charge, a reasonable number of, and for a reasonable amount of time, Acorda’s sales training and marketing personnel to assist Cardinal Health with respect to the Training Program and additional orientation and ongoing training for the Cardinal Health Employees.
 
ARTICLE IV
SAMPLES
 
4.1.                               Provision of Samples.   Acorda shall provide samples of the Products to the Cardinal Health Employees at Acorda’s option and at its expense.  Acorda shall determine the quantity and types of samples to be provided to the Cardinal Health Employees and the method of distribution of the samples.   In the event Acorda elects to have Cardinal Health manage the storage and distribution of samples, Cardinal Health shall pass on to Acorda the actual invoice costs for storage, distribution and other related costs  and use prudent business sense in costs incurred.  All samples shall be stored and handled by Acorda and Cardinal Health in compliance with the PDMA and applicable law.
 
4.2                                  Sample Accountability .  Cardinal Health shall prepare and provide to Acorda for approval a sample accountability program applicable to the samples provided by Acorda.
 
4.3.                               Return of Samples.   Within thirty (30) days following the termination or expiration of this Workplan or within thirty (30) days from the termination or removal from the Program of a Cardinal Health Employee (unless such Cardinal Health Employee has been hired or retained by Acorda), Cardinal Health shall cause the Cardinal Health Employee to return to Acorda all unused Product samples provided to Cardinal Health or the Cardinal Health Employee by Acorda.  Acorda shall pay or reimburse Cardinal Health for all costs and expenses in connection with the storage and shipment of returned samples.
 
8

 
ARTICLE V
COMMUNICATIONS; MONITORING THE PROGRAM
 
5.1.                               Communications from Third Parties.   Cardinal Health and the Cardinal Health Employees shall use their best efforts to advise Acorda of all comments, statements, requests and inquiries of the medical profession or any other third parties relating to the Products that are not addressed by either Product Labeling or the Product Promotional Materials, of which Cardinal Health becomes aware.  All responses to such communications to the medical profession or such other third parties shall be handled solely by Acorda.  Cardinal Health shall provide reasonable assistance to Acorda to the extent requested by Acorda, and at Acorda’s cost and expense, to fully respond to such communications.
 
5.2.                               Government Agencies.   All communications with government agencies, including the FDA, concerning the Products shall be the sole right and responsibility of Acorda.  Cardinal Health shall assist Acorda with respect to such communications with government agencies to the extent requested by Acorda, and at Acorda’s cost and expense, and shall not independently communicate with government agencies except to the extent required by applicable laws.  Cardinal Health shall use its best efforts to provide Acorda with any documents or information reasonably requested by Acorda for purposes of responding to any communications with government agencies within seventy-two (72) hours of Acorda’s request.
 
5.3.                               Customer Communications.   In addition to Detailing, Cardinal Health shall assist Acorda with respect to customer communications (as reasonably requested by Acorda and at Acorda’s cost and expense) within the Territory and shall regularly advise Acorda of market, economic, regulatory and other developments of which Cardinal Health may become aware which may affect the sale of the Products in the Territory.
 
5.4.                               Appointment of Coordinators.   The parties shall each appoint an authorized coordinator of the Program (“Coordinators”) between whom all communications required or desired to be given will be sent and between whom Detailing activities will be coordinated.  Within thirty (30) days of signing this Workplan, each party will notify the other as to the name of its Coordinator.  Each party may replace its Coordinator at any time, upon notice to the other party.
 
5.5.                               Review of Results.   The parties shall meet periodically, but at least once per calendar quarter, to review and discuss the actual results compared to the marketing plans for Detailing of the Products.  Acorda shall regularly and promptly share with Cardinal Health all reports, audits and other data it develops relative to the Program.
 
ARTICLE VI
COMPENSATION
 
6.1.                               Amount and Time of Payment .  For services hereunder, Acorda shall pay to Cardinal Health Fees set forth in Schedule 6.1 of this Workplan and incorporated by reference (the “Services Fee”), which shall be payable as set forth in the payment schedule set forth therein.
 
9

 
6.2.                               Early Termination Fee .  In the event Cardinal Health terminates this Workplan pursuant to Section 14(b) or 14(c) of the RxPedite Agreement, or either party terminates this Workplan pursuant to Section 14(d) of the RxPedite Agreement, Acorda shall pay to Cardinal Health an early termination fee as set forth on Schedule 6.2 (the “Early Termination Fee”).  The Early Termination Fee has been agreed to as a reasonable estimation of reimbursement of Cardinal Health’s expenses in preparing to perform under this Workplan and its expectancy interest, and shall not be construed or deemed to be a penalty.
 
6.3.                               Acorda’s Termination, Removal, or Hiring of Representatives or Managers .
 
(a)                                   Acorda acknowledges that Cardinal Health has or will incur costs and expenses in connection with recruiting and hiring Cardinal Health Employees.  If during the Term of this Workplan, Acorda (i) hires or retains as its own employee or as an independent contractor or agent any one or more of the Cardinal Health Employees, such employment to begin after the first twelve (12) months of the Program Launch, but prior to the end of the Initial Term, or (ii) requests termination or removal from the Program of any Cardinal Health Employee, other than pursuant to Section 2.8, or due to a failure of any Cardinal Health Employee to comply with the obligations under Section 2.6, and such Cardinal Health Employee is in fact so terminated or removed by Cardinal Health, Acorda shall pay Cardinal Health a fee in connection with such Cardinal Health Employee in the amounts set forth in the attached Schedule 6.3, for each such Cardinal Health Employee so hired, retained, terminated, or removed. Cardinal Health shall fill any vacancy created by Acorda’s hiring of Cardinal Health Employee pursuant to this Section as provided in Section 2.9.  Acorda shall not have the right to hire or retain any Cardinal Health Employee until after the first twelve (12) months of the Initial Term.
 
(b)                                  Notwithstanding Section 6.3(a) above, during the six (6) month period immediately prior to the end of the later of the Initial Term (if no Renewal Term is exercised) or the last exercised Renewal Term, as applicable, Acorda shall have the right to identify those Representatives, National Account Managers, and/or Medical Science Liaisons Acorda desires to hire upon expiration of this Workplan (collectively, the “Targeted Employees”) and to negotiate with any Targeted Employee concerning the terms on which Acorda might hire that Targeted Employee. Acorda shall have a period of thirty (30) days (the “Employee Selection Period”) following the expiration of this Workplan to hire such Targeted Employees.  Cardinal Health agrees not to interfere with the Acorda’s solicitation and hiring of the Targeted Employees prior to or during the Employee Selection Period, and Cardinal Health will assist Acorda in the transition of Targeted Employees from Cardinal Health to Acorda.  For a period of twelve (12) months after the expiration of the Employee Selection Period: (a) the Acorda shall not hire or retain as an employee or as agent or independent contractor any Cardinal Health Employees that are not Targeted Employees or are not actually hired by Acorda during the Employee Selection Period, and (b) Cardinal Health agrees not to solicit for hire as an employee, agent or independent contractor any Targeted Employee hired by Acorda during the Employee Selection Period.
 
10

 
6.4.                               Reimbursement of Expenses .  In addition to any expenses set forth in Section 5 of the RxPedite Agreement, Acorda shall reimburse Cardinal Health for those expenses set forth in Schedule 6.1, including but not limited to travel expenses under Section 2.6(j).
 
6.5                                  Cardinal Health Record Keeping: Inspection by Acorda.   Cardinal Health shall keep accurate records in sufficient detail as to costs and expenses for which Acorda must reimburse Cardinal Health under this Workplan.  Upon Acorda’s reasonable request made during or within one (1) year after the Term of this Workplan, and at Acorda’s expense, Cardinal Health shall permit Acorda’s  designated employees or agents to have access during ordinary business hours to records of such costs and expenses in order to verify the accuracy of amounts reimbursed by Acorda to Cardinal Health.  Acorda and its designated employees or agents shall maintain in confidence all such cost and expense records of Cardinal Health.
 
ARTICLE VII
REPRESENTATIONS, WARRANTIES AND COVENANTS
 
7.1.                               By Cardinal Health.    Cardinal Health represents, warrants, and covenants to Acorda, as of execution of this Workplan and during the Term of this Workplan, as follows:
 
(a)                                   that Cardinal Health and the Cardinal Health Employees shall perform the Detailing in a professional and timely manner; and
 
(b)                                  that Cardinal Health and the Cardinal Health Employees shall comply with all laws, rules and regulations that apply to the performance of services under this Workplan, including but not limited to the PDMA, the Medicare and Medicaid Anti-Kickback Act (42 U.S.C. § 1320a-7b(a)), the Civil False Claims Act (31 U.S.C. § 3729(a)), Sections 1128A, 1128B, and 1877 of the Social Security Act (42 U.S.C. §§ 1320a-7a, -7b, and 1395nn), the Health Care Fraud Act (18 U.S.C. § 1347), and the Criminal False Claims Act (18 U.S.C. § 287), as amended from time to time, as well as similar applicable state laws.
 
7.2.                               By Acorda .   Acorda represents, warrants, and covenants to Cardinal Health, as of execution of this Workplan and during the Term of this Workplan,  as follows:
 
(a)                                   that Acorda is under no obligation to any third party that would prevent the execution of this Workplan or interfere with its performance under this Workplan;
 
(b)                                  that Acorda shall comply with all laws, rules and regulations that apply to the Products and their sale, the Program, and this Workplan, including but not limited to the Act, the PDMA, the Medicare and Medicaid Anti-Kickback Act (42 U.S.C. § 1320a-7b(a)), the Civil False Claims Act (31 U.S.C. § 3729(a)), Sections 1128A, 1128B, and 1877 of the Social Security Act (42 U.S.C. §§ 1320a-7a, -7b, and 1395nn), the Health Care Fraud Act (18 U.S.C. § 1347), and the Criminal False Claims Act (18 U.S.C. § 287), as amended from time to time, as well as similar applicable state laws, all to the extent that such laws, rules and regulations apply to Acorda;
 
11

 
(c)                                   that the Product Labeling and Product Promotional Materials are accurate, complete, and in compliance with the Act and all rules and regulations of the United States, including without limitation, any rules, regulations or guidelines issued by the FDA; and
 
(d)                                  that, as of the Effective Date and to Acorda’s knowledge, the manufacture, sale, and distribution of the products do not infringe any patent or other proprietary rights of third parties, and the Products have all necessary governmental approvals and may be lawfully Detailed and sold by Acorda and the Representatives in the Territory.
 
ARTICLE VIII
ADVERSE REACTION REPORTING AND REGULATORY MATTERS
 
8.1.                               Immediate Notification.   Each of Cardinal Health and Acorda agrees to notify the other party as soon as reasonably practicable of any information that each may obtain or learn concerning any Product or package complaint or any serious unexpected side effect, injury, toxicity, or sensitivity reaction or any unexpected incidence of severity thereof associated with the clinical uses, studies, investigations, tests and marketing of the Products, whether or not determined to be attributable to the Products (each, an “Event”).  “Serious” as used in this  Section 8.1 refers to an experience which results in death, permanent or substantial disability, in-patient hospitalization, prolongation of existing in-patient hospitalization, a congenital anomaly or cancer, or a result of an overdose or life threatening condition.  “Unexpected” as used in this  Section 8.1 refers to (a) conditions or developments not previously submitted to governmental Agencies or encountered during clinical studies of the Products and not reflected in the Product Promotional Materials or the Product Labeling, or (b) conditions or developments occurring with greater frequency, severity, or specificity than shown by information previously submitted to governmental Agencies or encountered during clinical studies of the Products and not reflected in the Product Promotional Materials or the Product Labeling.  Each party shall also notify the other in a timely manner of any other adverse experience, i.e., any unfavorable and unintended change in the structure (signs), function (symptoms) or chemistry (laboratory data) of the body temporally associated with the use of the Products, whether or not considered related thereto.  Acorda has sole and exclusive right and authority to report any such Event to government authorities.
 
8.2.                               Threatened Agency Action.   Cardinal Health and Acorda shall each immediately notify the other party of any information that each may obtain or learn regarding any threatened or pending action by an Agency which may affect the Products.  Cardinal Health shall, at the request of Acorda and at the cost and expense of Acorda, cooperate with Acorda in formulating a procedure for taking appropriate action in response to such information.  Unless compelled by law, Cardinal Health shall not respond to an Agency without the prior written consent of Acorda.
 
8.3.                               Training .                                                 Cardinal Health and Acorda shall develop appropriate instructions in the Training Program for the Cardinal Health Employees as to handling of information received or obtained in accordance with Sections 8.1 and 8.2.
 
12

 
ARTICLE IX
RETURN/RECALL
 
9.1.                               Returned Products .
 
(a)                                   Acorda shall be responsible for handling all returned Products, including shipment and compensation or credit for the returned Products.  Any Products inadvertently returned to Cardinal Health shall be shipped to Acorda or another destination at Acorda’s direction, in compliance with Acorda’s returned goods policy, and Cardinal Health shall advise the customer who made the return that the Products have been returned to Acorda.  Acorda shall reimburse Cardinal Health’s shipping and other costs in connection with the handling of such returned Products within thirty (30) days of delivery to Acorda of Cardinal Health’s statement for such costs.  Upon request Cardinal Health shall provide Acorda with documentation relating to such costs.
 
(b)                                  At Acorda’s request, Cardinal Health shall assist Acorda in obtaining and receiving any Products that have been recalled, and any costs incurred by Cardinal Health with respect to participating in any such recall shall be reimbursed by Acorda within thirty (30) days of delivery to Acorda of Cardinal Health’s statement for such costs.
 
ARTICLE X
TERM AND TERMINATION
 
10.1.                         Term .  This Workplan shall take effect on the date on which both parties execute this Workplan and shall continue for a period of twenty-four (24) months after the Program Launch (the “Initial Term”), unless terminated earlier as set forth herein.  Notwithstanding the foregoing, Acorda may, at its option upon written notice to Cardinal Health at least one hundred twenty (120) days prior to the expiration of the Initial Term, and with the written consent of Cardinal Health, extend the Initial Term for one additional year (the “Renewal Term”).  If Acorda desires to extend the Initial Term, the parties shall negotiate in good faith the provisions of Section 6.1 regarding Service Fees.  For purposes of this Workplan, “Term” shall include both the Initial Term and the Renewal Term, if applicable.
 
10.2                            Termination Due To Delay in Product Launch .  If the Product is not approved by the FDA by October 31, 2006, either party may terminate this Workplan upon sixty (60) days written notice to the other.
 
10.3                            Termination Due To Regulatory And Other Problems .  If the Product is not being marketed due to regulatory problems, court or administrative proceedings, product liability claims, recalls, raw materials shortages, or similar factors beyond the control of Acorda, then, either party may terminate this Workplan upon thirty (30) days written notice to the other.
 
13

 
ARTICLE XI
INDEMNIFICATION
 
11.1                            Additional Indemnification Obligations .  In addition to those indemnification obligations set forth in Section 11 of the RxPedite Agreement, the parties agree, that solely with respect to the services provided under this Workplan, the parties shall each have additional indemnification obligations as set forth in this Article XI.  For purposes of this Article 12, the terms “Claim”, “Client Group”, and “Cardinal Health Group” shall have the meanings set forth in the RxPedite Agreement.
 
11.2.                         Indemnification by Cardinal Health.   In addition to those Claims for which Cardinal Health is obligated to indemnify, defend and hold the Client Group harmless under the RxPedite Agreement, Cardinal Health shall also be obligated to indemnify, defend and hold the Client Group from Claims made, brought or threatened by third parties and based upon or resulting from (a) Cardinal Health’s or Cardinal Health Employee’s violation of or failure to comply with all applicable laws relating to the promotion, distribution and sale of the Products, including but not limited to the Act, the PDMA, the Medicare and Medicaid Anti-Kickback Act (42 U.S.C. § 1320a-7b(a)), the Civil False Claims Act (31 U.S.C. § 3729(a)), Sections 1128A, 1128B, and 1877 of the Social Security Act (42 U.S.C. §§ 1320a-7a, -7b, and 1395nn), the Health Care Fraud Act (18 U.S.C. § 1347), and the Criminal False Claims Act (18 U.S.C. § 287), as amended from time to time, as well as similar applicable state laws, and (b) a breach of this Workplan.
 
11.3.                         Indemnification by Acorda.   In addition to those Claims for which Acorda is obligated to indemnify, defend and hold the Cardinal Health Group harmless under the RxPedite Agreement, Acorda shall also be obligated to indemnify, defend and hold the Cardinal Health Group from Claims made, brought or threatened by third parties and based upon or resulting from (a) Acorda’s violation of or failure to comply with all applicable laws relating to the manufacture, sale, distribution, possession and use of the Product, the Program and this Workplan, including but not limited to the Act, the PDMA, the Medicare and Medicaid Anti-Kickback Act (42 U.S.C. § 1320a-7b(a)), the Civil False Claims Act (31 U.S.C. § 3729(a)), Sections 1128A, 1128B, and 1877 of the Social Security Act (42 U.S.C. §§ 1320a-7a, -7b, and 1395nn), the Health Care Fraud Act (18 U.S.C. § 1347), and the Criminal False Claims Act (18 U.S.C. § 287), as amended from time to time, as well as similar applicable state laws; (b) Detailing of the Products, except to the extent such Damages arise from a negligent or wrongful act or omission of Cardinal Health; (c) the accuracy or completeness of the Product Labels, Product Promotional Materials, or the Training Program; and (d) a breach of this Workplan.
 
11.4.                         Other Obligations .  All other obligations of the parties with respect to indemnification shall be as set forth in the RxPedite Agreement.
 
ARTICLE XII
MISCELLANEOUS
 
12.1.                         Independent Contractor.   Cardinal Health is being retained and shall perform hereunder strictly as an independent contractor. The Cardinal Health Employees shall not be, and
 
14

 
shall not be considered to be, employees of Acorda for any purpose, and shall at all times remain employees of Cardinal Health, subject to Section 6.3.  Neither party shall have any responsibility for the hiring, termination, compensation, benefits or other conditions of employment of the other party’s employees, except as otherwise provided in this Workplan.
 
12.2.                         Entire Workplan: Modification.   This Workplan, together with the RxPedite Agreement, contains the entire and exclusive agreement between the parties in respect of the subject matter hereof and supersedes and cancels all previous agreements, negotiations, commitments and writings between the parties hereto in respect of the subject matter hereof.  Except as provided herein, this Workplan may not be changed or modified in any manner or released, discharged, abandoned or otherwise terminated unless in writing and signed by the duly authorized officers or representatives of the parties.  If and to the extent there are inconsistencies between the RxPedite Agreement and this Workplan, the terms of the RxPedite Agreement shall govern.
 
12.3.                         Execution in Counterparts.   This Workplan may be executed in counterparts, each of which, when executed and delivered, shall be deemed to be an original and all of which together shall constitute one and the same document.
 
12.4.                         Maintenance of Records.   Cardinal Health and Acorda each agree that throughout the Term of this Workplan and for a period of six (6) years after the termination of this Workplan, each will maintain records and otherwise establish procedures to assure compliance with all regulatory, professional, and other applicable legal requirements which relate to the Detailing and marketing of the Products and if applicable, with the other services and activities to be performed hereunder.
 
IN WITNESS WHEREOF, the parties have caused this Workplan to be executed by their duly authorized officers.

CARDINAL HEALTH PTS, INC.	ACORDA THERAPEUTICS, INC.	
 	 	 	 	
By:	 	 	By:	 	 	
 	 	 	 	 	 	
Name:	 	 	Name:	 	 	
 	 	 	 	 	 	
Title:	 	 	Title:	 	 	
 	 	 	 	 	 	
Date:	 	 	Date:	 	 	
 
15

 
Schedule 1.1(o)
 
List of Products
 
Fampridine SR
 
16

 
Schedule 1.1(t)
 
Definition of Territory

The Territories shall be within the continental United States and shall be agreed to by the parties prior to the Representative Commencement Date.
 
17

 
Schedule 2.3
 
National Account Manager Responsibilities
 
•                   The National Account Managers will participate in development of managed care and government contracting and reimbursement strategies as well as value add programs for select managed care and government accounts. The National Account Managers will also work with the Representatives to create provider demand for Fampridine-SR and to coordinate provider pull-through activities with the sales force once the product is under contract or has achieved favorable reimbursement status with an account, as described in more detail below.
 
•                   Generally, the National Account Managers will:
 
•                   Identify key players in the category and develop an understanding their needs.
 
•                   Position the benefits of Fampridine-SR in a way that is relevant and appealing to those providers.
 
•                   Develop an understanding of the key reimbursement issues, such as Formulary, CMS or other.
 
•                   Develop an understanding of employer needs and the role of quality initiatives such as HEDIS.
 
•                   Develop an understanding of how to impact Formulary pull-through.
 
•                   Develop an understanding of the role of specialty carve-outs and carve-ins.
 
•                   Develop an understanding of the product information needs of providers.
 
•                   Seek out viable disease management initiative opportunities.
 
•                   Find maximum price points.
 
•                   Develop an understanding of trends that may affect the use and/or reimbursement on the product in the future.
 
•                   The National Account Managers will also work closely with the Acorda management team, Cardinal Health Managers and Representatives to:
 
•                   Identify accounts in each sales region
 
•                   Identify model types/membership bases
 
•                   Determine who provides health care for major employers in each sales region
 
18

 
•                   Once accounts are identified, the National Account Managers will work closely with Cardinal Health Managers and Representatives to:
 
1)               Contact appropriate decision-makers in order to determine:
 
(a)                 Formulary policies
(b)                Bids and contracts policies
(c)                 Rebate and charge-back policies
(d)                Representative policies (promotion and sampling policies)
 
•                   Provider lists
 
(e)                 P&T Committee members
 
•                   The National Account Managers will also work closely with the Acorda management team, Cardinal Health Managers and Representatives to ensure company approved marketing messages are communicated for Fampridine-SR  to key decision-makers within each account in an effort to gain formulary acceptance.
 
•                   The National Account Managers will also work closely with the Acorda management team, Cardinal Health Managers and Representatives to develop strategies and tactics to gain formulary approval within select accounts.
 
1)               Identify champion physicians
2)               Encourage champion physicians to write Director of Pharmacy requesting product addition to formulary
3)               With numerous requests, product may be reviewed by the P&T Committee
4)               P&T Committee meeting (product may be reviewed a few times before approval)
5)               Formulary approval
 
•                   The National Account Managers will coordinate the capture of information for each account and ensure effective communication throughout the organization.
 
1)               What type of formulary is in place with each account (none, open, closed, etc.)
2)               Who provides the pharmacy benefit (in-house, contracted pharmacies, or both)
3)               Is PBM involved? (information about their formulary, contracts)
4)               What type of pharmacy intervention is used, if any?
 
(a)                 Counter detailing
(b)                Differential co-pays (e.g. $5.00 = generic; $10.00 = brand)
(c)                 Utilization Review (e.g. cost vs. efficacy)
(d)                Financial incentives
(e)                 Online adjudication at the pharmacy level (non-payment for items that are not on the formulary)
 
•                   The National Account Managers will lead and coordinate the investigation of identified accounts to assess priority within the sales regions.  Typical investigation would include inquiry into the following:
 
19

 
1)               How many MDs are affiliated with the account?
 
(a)                 Is it a significant number?
(b)                Are there key groups or individuals involved?
(c)                 Are any of them high volume prescribers?
 
2)               Geography covered
 
(a)                 What sales territories are impacted the most?
(b)                Does it impact other sales regions?
 
3)               Who owns the plan?
 
(a)                 Acorda/Cardinal may have contracts with that organization
(b)                History of parent organizations’ ability to impact business
 
4)               Names of key contacts
 
(a)                 Pharmacy director
(b)                Clinical pharmacists
(c)                 Purchasing director
(d)                Medical director
 
5)               Is there a P&T Committee?
 
(a)                 Who are the members?
(b)                How do we support this group?
(c)                 Are these individuals accessible to call on?
 
6)               Is there a formulary?
 
(a)                 What type of formulary?
(b)                Goal: obtain formulary status for Fampridine-SR
 
7)               How do members fill their prescriptions?
 
(a)                 In-house pharmacies will have more control over prescriptions than retail pharmacies
(b)                Which PBM processes the claims? Different PBMs have varying levels of control over prescription benefits
 
8)               Resources available to help in this process include:
 
(a)                 Local media
(b)                Physician offices
(c)                 Scott Levin databases
(d)                Acorda Management
(e)                 Cardinal Management
 
20

 
•                   At the direction of the Acorda management team, the National Account Managers will work with each sales territory to develop specific action plans or pull-through programs for select accounts. (Utilizing all available information)
 
1)               The overall impact that managed care has in each sales territory will be assessed by compiling the following information:
 
(a)                 List all managed care plans which do business in the sales region
(b)                How many target physicians are affiliated with these plans?
(c)                 Determine which plans have restrictive formularies
 
2)               For target physicians that are not affiliated with any managed care plans; direct sales management and Representatives to:
 
(a)                 Follow regular promotional strategies
(b)                Monitor for changes
(c)                 Determine whether mail-service organizations or PBMs are impacting physician prescribing habits
 
•                   Ask nurse or receptionist if they receive any phone calls from pharmacists asking for permission to change prescriptions
•                   What types of changes? (Generic substitution or brand interchange?)
•                   Which products/companies are involved?
•                   Collaborate with managed care personnel to determine our relationship with them
 
(d)                For target physicians that are affiliated with accounts that do not have restrictive formularies:
 
•                   Follow regular promotional strategy
 
•                   Ensure that physicians are aware that prescriptions for Acorda’s Fampridine-SR will be reimbursed by the account plan with which they are affiliated
•                   Take advantage of any favorable formulary listing Acorda has by incorporating this into the promotional message
•                   Determine whether mail-service or PBMs are impacting prescribing (not likely)
 
•                   Monitor for change
 
•                   For target physicians that are affiliated with account plans that have restrictive formularies
 
•                   Be aware of how Fampridine-SR is impacted
•                   Promote product if available on formulary
 
21

 
Schedule 2.4
 
Medical Science Liaison Responsibilities
 
•                   Acorda and Cardinal Health will work on a program designed to achieve the following objectives:
 
•                   educate target physicians and their professional staffs on current trends in SCI and MS management
 
•                   increase the flow of SCI and MS patients to Fampridine-SR
 
•                   facilitate Phase IV and V clinical studies for Fampridine-SR
 
•                   support hospital, P&T committee, and managed care formulary activities for Fampridine-SR
 
•                   position Acorda and its neurology product portfolio with key opinion & thought leaders (OTLs)
 
•                   The Acorda MSL function may have other responsibilities within the organization, and interact with other functioning teams. However, the top priority of the Acorda MSL function shall be to actively engage in activities that support the strategic direction of Fampridine-SR.
 
•                   The Acorda MSL function will be focused on Centers of Influence (COI) within select sales regions. The MSL for this program shall be a therapeutic specialist with advanced scientific training and a degree in life sciences (doctorates, advanced professional healthcare degrees, or masters in science). The majority of MSLs currently in industry are Doctors of Pharmacy (Pharm.D.), with a smaller percentage holding Ph.D. or M.D. degrees. Excellent scientific aptitude is critical to productive interactions between MSLs and OTLs who are research pioneers and authorities in a therapeutic field.
 
•                   The rationale for creating the MSL function is as follows:
 
•                   Provides feedback from key OTLs on how the company could best position Fampridine-SR and future products by conducting Regional Advisory Panels to glean opinions on research direction and other healthcare issues
 
•                   Produces and performs product presentations for OTLs
 
•                   Serves as the primary company contact with current and future OTLs by establishing peer relationships based on high levels of education and understanding of the clinical issues facing practitioners
 
•                   Provides clinical trial and off-label information to early adopters
 
•                   Collaborates on clinical research protocols for Phase IIIb and IV trials
 
•                   Manages budgets for clinical grants and medical education activities
 
22

 
•                   Serves as the “face” of the company’s pipeline
 
•                   Assists Medical Education department in setting up guest lectures, symposia and workshops
 
23

 
Schedule 2.10
 
Form of Management Report

Report Name	 	Description	 	Frequency	
Territory Assignment Report	 	Lists the individuals covering each region and territory.  If a territory is vacant, the report will indicate the date when the territory became vacant and what alternate coverage is being applied (i.e. District Manager, Adjacent Rep, etc.)
In addition, the report will indicate the current turnover rate.	 	Monthly	
 	 	 	 	 	
Territory Coverage Report	 	For each territory, the report provides the call statistics:
•      Percentage of call to target audience
•                        Percentage of samples delivered to target audience
•      Average number of calls/day (calculated on a six month moving average).
The report is summarized at the Regional and National levels.	 	Monthly
Quarterly	
 	 	 	 	 	
Sales Statistics Report	 	For each territory, based on NDC Health Information Services data, the report will show:
•      New Rx
•      Total Rx
•      Percent Change for New Rx
•      Percent Change for Total Rx
•      New Market Share Percent Change
•                        Total Market Change Percent Change
The report is summarized at the Regional and National levels.	 	Monthly
Quarterly	
 	 	 	 	 	
Inventory Report	 	For each Territory, the report will document all the sample distribution activities.  The report will reflect the following:
For each SKU:
•      Period beginning balance
•      Total shipments received
•      Total samples dropped
•      Total samples returned to distributor
•      Total adjustments
•      Period ending balance
•      Total variance (units / percent)
The report is summarized at the Regional and National levels.	 	Monthly	
 	 	 	 	 	
Inventory Exception Report	 	The report will provide details on variances and adjustments related to the distribution of samples if any has occurred.	 	Monthly	
 
24

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Schedule 6.1
 
Service Fees and Payment Schedule
 
REPRESENTATIVES:

Number of Representatives	 	[***]	
Annual Representative Fee	 	[***] per Representative, plus expenses	
Total Fees	 	[***] per year,   plus expenses	
 
•                   The Annual Representative Fee identified above includes sales force recruitment, salaries, payroll taxes and benefits, sales force training, administrative and operational support, electronic territory management systems and sample accountability processes, procedures and systems, fleet cars, & performance bonuses.
 
•                   The Annual Representative Fee identified above does not include expenses of regular territory business travel and promotional budgets.
 
NATIONAL ACCOUNT MANAGERS:

Number of Representatives	 	[***]	
Annual Manager Fee	 	[***] per Manager	
Total Fees	 	[***] per year	
 
•                   The Annual Manager Fee identified above includes Manager salaries, benefits, bonuses, & taxes, fleet cars, project manager salary, benefits, bonuses, & taxes, recruitment costs (including travel and turnover), supplies, printing, postage, and miscellaneous items, and laptops, software and printers
 
•                   The Annual Manager Fee identified above does not include actual business and promotional expenses as defined and approved by Acorda, and actual travel and lodging expenses for all training programs and POA meetings.
 
25

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
MEDICAL SCIENCE LIAISONS (“MSL”):

Number of MSLs	 	[***]	
Annual MSL Fee	 	[***] per MSL	
Total Fees	 	[***] per year	
 
•                   The Annual MSL Fee identified above includes MSL compensation during 2 week training period; MSL salary, payroll taxes, benefits, fleet car, and bonus during program; a project management team that includes a dedicated account executive and the following shared services: project manager, HR coordinator, finance coordinator, IT coordinator, and help desk; recruitment costs, including any turnover and travel during project; training and development services; territory management and CRM system; support services (operations and administration); and management fees.
 
•                   The Annual MSL Fee identified above does not include MSL actual in territory business expenses; and MSL actual travel expenses for all required participation at corporate training programs and POA meetings.
 
PRICE CHANGES
 
In the event of a change in salaries and benefits required to recruit and hire the Cardinal Health Employees between the Effective Date of this Workplan and the applicable MSL Commencement Date, NAM Commencement Date or Representative Commencement Date, the parties shall negotiate in good faith a change to the Service Fees to account for such change in salaries and benefits.
 
PAYMENT SCHEDULE
 
•                   Acorda shall pay [***] of the total amount of the first year’s fees for the Medical Science Liaisons on the MSL Commencement Date.
•                   Acorda shall pay [***] of the total amount of the first year’s fees for the National Account Managers on the NAM Commencement Date.
•                   Acorda shall pay [***] of the total amount of the first year’s fees for the Representatives on the Representative Commencement Date.
•                   The remainder of the fees for the first year shall be invoiced in equal pro-rated payments on the 1st day of each month beginning with the commencement of promotional activity.
 
26

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Schedule 6.2
 
Early Termination Fee
 
The Early Termination Fee under Section 6.2 shall be calculated as follows:
 
(i)                                      If termination occurs prior to Program Launch, Acorda shall pay to Cardinal Health an amount equal to [***] of the annual base salaries of all Cardinal Health Employees hired as of such date of termination.
 
(ii)                                   If termination occurs during the first six (6) months after Program Launch, Acorda shall pay to Cardinal Health an amount equal to [***] of the annual base salaries of all of the Cardinal Health Employees.
 
(iii)                                If termination occurs during the months seven (7) through eighteen (18) after Program Launch, Acorda shall pay to Cardinal Health an amount equal to [***] of the annual base salaries of all of the Cardinal Health Employees.
 
(iv)                               If termination occurs after completion of the eighteenth (18) month after Program Launch, but prior to the end of the Initial Term, Acorda shall pay to Cardinal Health an amount equal to [***] of the annual base salaries of all of the Cardinal Health Employees.
 
In the event of any such termination and upon the request of Acorda, Cardinal Health shall provide reasonable documentation evidencing the base salaries of each of the Cardinal Health Employees.
 
For purposes of this Schedule 6.2, “annual base salaries of all of the Cardinal Health Employees” means the actual, annualized base salaries, on an aggregate basis, of Cardinal Health Employees employed by Cardinal Health at the time that Cardinal Health receives notice of an early termination.
 
For example, if the Early Termination Fee in Section 6.2 is triggered in month nine (9) of the Initial Term, and at such time Cardinal Health employs twenty (20) Cardinal Health Employees of which there are eighteen (18) Representatives, one (1) National Account Manager and one (1) Medical Science Liaison, and the actual annual base salaries for each is $ [**] , $[**] and $[***], respectively, then the Early Termination Fee shall be calculated as follows:
 
Early Termination Fee = [**] % x [(18 x [***]) + (1 x [**]) + (1 x [**])] = $[**]
 
27

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Schedule 6.3
 
Acorda’s Hiring of Cardinal Health Employees
 
(a)                                   As to each Cardinal Health Employee hired or retained by Acorda pursuant to Section 6.3 or terminated or removed pursuant to Acorda’s request in accordance with Section 6.3 (either, a “Cardinal Termination Event”), the amount to be paid by Acorda shall be as follows:
 
(i)                                      If a Cardinal Health Employee is hired or retained by Acorda pursuant to Section 6.3 during months thirteen (13) through eighteen (18) after Program Launch or if Acorda requests termination or removal of a Cardinal Health Employee pursuant to Section 6.3 during any of the first eighteen (18) months of the Initial Term, Acorda shall pay to Cardinal Health [***] of such Cardinal Health Employee’s scheduled aggregate annual base salary.
 
(ii)                                   If a Cardinal Termination Event occurs with respect to a Cardinal Health Employee during months nineteen (19) through twenty-four (24) after Program Launch, Acorda shall pay Cardinal Health [***] of such Cardinal Health Employee’s scheduled aggregate annual base salary.
 
(iii)                                If a Cardinal Health Employee is hired or retained by Acorda upon completion of the Initial Term, Acorda shall have no further obligation to pay any fee under this Schedule 6.3 or any other Service Fees with respect to such Cardinal Health Employee so retained or hired by Acorda.
 
(b)                                  All such amounts shall be due and payable within thirty (30) days after the effective date of the applicable Cardinal Termination Event, and Acorda’s receipt of Cardinal Health’s invoice for amounts due and appropriate supporting documentation.
 
(c)                                   For purposes of this Schedule 6.3, “scheduled aggregate annual base salary” means the actual, annualized base salary, on an aggregate basis, of the Cardinal Health Employee who is the subject of a Cardinal Termination Event at the time of such event.  For example, if Acorda hires a Cardinal Health Employee in month fifteen (15) of the Initial Term and such employee’s actual annual base salary is [***] at such time, then Acorda shall pay to Cardinal Health the amount of [***], which represents [***] of such employee’s actual annual base salary.
 
28

 
Exhibit 10.20
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
LICENSE AGREEMENT
 
BETWEEN
 
ACORDA THERAPEUTICS, INC.
 
AND
 
THE MAYO FOUNDATION FOR
EDUCATION AND RESEARCH
 
Dated:  September 8, 2000

 
TABLE OF CONTENTS

1.	DEFINITIONS.	
 	1.1	“Affiliate”	
 	1.2	“FDA”	
 	1.3	“Field”	
 	1.4	“First Commercial Sale”	
 	1.5	“Key Claims”	
 	1.6	“Know-How”	
 	1.7	“Invention”	
 	1.8	“Licensed Patents”	
 	1.9	“Licensed Product”	
 	1.10	“Licensed Technology”	
 	1.11	“Marketing Exclusivity Rights”	
 	1.12	“Material Breach”	
 	1.13	“Net Sales”	
 	1.14	“Patent Term Extensions”	
 	1.15	“Patent Term Extensions Information”	
 	1.16	“Party”	
 	1.17	“PLA”	
 	1.18	“Regulatory Review Period”	
 	1.19	“Royalty Term”	
 	1.20	“Sublicensee”	
 	1.21	“Termination”	
 	1.22	“Territory”	
 	1.23	“Valid Claim”	
 	 	 	
2.	GRANT OF LICENSE.	
 	2.1	License Grant	
 	2.2	Reserved Rights	
 	2.3	Representations and Warranties.	
 	2.4	Right of First Offer	
 	2.5	Opportunity to Conduct Clinical Studies	
 	 	 	
3.	PAYMENTS; ROYALTIES.	
 	3.1	Upfront Consideration Royalty.	
 	3.2	Milestone Royalties for Licensed Products	
 	3.3	Running Royalties for Sales of Licensed Products.	
 	3.4	Third Party Royalties	
 	3.5	Certain Affiliate and Sublicensee Royalties	
 	3.6	Obligation to Pay Royalties	
 	3.7	Royalties on Combined Products	
 
i

 

4.	PAYMENTS AND RECORDS.	
 	4.1	Payment	
 	4.2	Mode of Payment	
 	4.3	Taxes	
 	4.4	Records Retention	
 	4.5	Audit Request	
 	 	 	
5.	DUE DILIGENCE.	
 	5.1	Diligence	
 	5.2	Reports	
 	5.3	Short-Form Arbitration	
 	 	 	
6.	“OWNERSHIP; PATENTS; MARKETING EXCLUSIVITY; PATENT TERM EXTENSIONS”	
 	6.1	Ownership.	
 	6.2	Patent Prosecution and Maintenance.	
 	6.3	Patent Enforcement.	
 	6.4	Infringement Action by Third Parties.	
 	6.5	Marketing Exclusivity/Patent Term Extensions	
 	 	 	
7.	PUBLICATION; CONFIDENTIALITY.	
 	7.1	Publication	
 	7.2	Confidentiality; Exceptions.	
 	7.3	Exceptions to Obligation	
 	7.4	Confidentiality regarding Patient Information	
 	 	 	
8.	INDEMNIFICATION.	
 	8.1	Products Liability	
 	8.2	MAYO Indemnification.	
 	8.4	Notice; Waiver of Subrogation.	
 	 	 	
9.	TERM AND TERMINATION.	
 	9.1	Term	
 	9.2	Breach	
 	9.3	Insolvency or Bankruptcy	
 	9.4	Termination by ACORDA	
 	9.5	Right to Sell Stock on Hand	
 	9.6	Effect of Termination.	
 	9.7	Accrued and Surviving Rights and Obligations	
 	 	 	
10.	MISCELLANEOUS PROVISIONS.	
 	10.1	Relationship of Parties	
 	10.2	Assignment	
 	10.3	Further Actions	
 
ii

 

 	10.4	Force Majeure	
 	10.5	No Trademark Rights	
 	10.6	Public Announcements	
 	10.7	Notices	
 	10.8	Amendment	
 	10.9	Waiver	
 	10.10	Severability	
 	10.11	Compliance with Law	
 	10.12	Governing Law and Jurisdiction	
 	10.13	Entire Agreement of the Parties	
 	10.14	Descriptive Headings	
 	10.15	Nondisclosure	
 	10.16	Counterparts	
 
iii

 
LIST OF EXHIBITS

 	EXHIBIT A	
 	 	
 	EXHIBIT B	
 	 	
 	EXHIBIT C	
 	 	
 	EXHIBIT D	
 	 	
 	EXHIBIT E	
 
iv

 
LICENSE AGREEMENT
 
THIS LICENSE AGREEMENT (this “Agreement”) is entered into as of September 8, 2000 (the “Effective Date”), by and between Acorda Therapeutics, Inc., a Delaware corporation, having offices at 15 Skyline Drive, Hawthorne, New York 10532, (“ACORDA”) and The Mayo Foundation for Medical Education and Research, a Minnesota charitable corporation located at 200 First Street SW, Rochester, Minnesota 55905 (“MAYO”).
 
PRELIMINARY STATEMENTS
 
A.                                    ACORDA has sponsored two research programs under the direction of Dr.  Moses Rodriguez and Dr.  Larry Pease, entitled (1) Preclinical Studies of a Monoclonal Antibody Designed to Promote Central Nervous Repair, and (2) Molecular Characterization of Antibody-Induced Remyelination and Isolation of Human Counterparts, (each a “Program” and collectively, the “Programs”), pursuant to two Sponsored Research Agreements between MAYO and ACORDA, dated as of October 1, 1995 and March 15, 1998, respectively, (the “Sponsored Research Agreements”) which are attached hereto as Exhibit A .  These Programs have related to, among other things, the therapeutic use of humanized and non-humanized antibodies for treatment of central nervous system conditions and disorders, including myelination or remyelination in conditions such as spinal cord injuries and multiple sclerosis.
 
B.                                      MAYO is the owner of certain right, title and interest to technology made or otherwise developed in performance of the Programs including certain inventions, discoveries and patents described in the Sponsored Research Agreements.
 
C.                                      MAYO has the right to grant licenses to this technology so that such technology may be utilized in the public interest, and is willing to grant a license thereunder to ACORDA.
 
D.                                     ACORDA has options, pursuant to ACORDA\MAYO Option Agreements dated as of October 1, 1995 and March 15, 1998 (the “Option Agreements”), which are attached hereto as Exhibit B, to acquire an exclusive, worldwide license to such technology and is desirous of obtaining certain rights and licenses from MAYO relating to the aforementioned technology.
 
E.                                       ACORDA wishes to exercise the options under both Option Agreements and ACORDA and MAYO now desire to provide for the license of all technology in all fields contemplated by the exercise of the options granted under both of the Option Agreements under one unified set of terms conditions, and for revised consideration, as provided under this Agreement, which shall be deemed to amend and supercede the provisions of the Option Agreements.
 
NOW THEREFORE, in consideration of the foregoing and of the mutual covenants contained in this Agreement, the Parties hereto agree to the provisions of the Preliminary Statements and as follows:

 
1.                                       DEFINITIONS.
 
As used in this Agreement, the following terms will have the meanings set forth in this Section 1 unless the context dictates otherwise.
 
1.1                                  “ Affiliate ” shall mean, with respect to either person, any corporation or other business entity which controls, is controlled by or is under common control with such person.  For this purpose, control means the possession of the power to direct or cause the direction of the management and the policies of an entity whether through ownership directly or indirectly of fifty percent (50%) or more of the stock entitled to vote, and for non-stock organizations, the right to receive over fifty percent (50%) of the profits by contract or otherwise, or if not meeting the preceding requirement, any company owned or controlled by or owning or controlling such person at the maximum control or ownership right permitted in the country where such entity exists.
 
1.2                                  “ FDA ” shall mean the U.S.  Food and Drug Administration, or the successor thereto.
 
1.3                                  “ Field ” shall mean the prevention, mitigation or treatment of nervous system disorders, diseases or injuries including, without limitation, pain, and any and all other diagnostic, therapeutic, pharmaceutical, cosmetic, medical or health care related applications.
 
1.4                                  “ First Commercial Sale ” shall mean, with respect to any Licensed Product, the first sale for use or consumption by the general public of such Licensed Product in any country in the Territory after all required marketing approvals have been granted, or, if such sale is otherwise permitted, by the governing health regulatory authority of such country.
 
1.5                                  “ Key Claims ” shall have the meaning assigned to such term in Section 3.2(a).
 
1.6                                  “ Know-How ” shall mean any and all technical data, information, inventions, biological materials, trade secrets, and other intellectual property, whether patentable or unpatentable, conceived or otherwise developed in the course of and in connection with the Programs, and all subsequent modifications, enhancements and improvements hereto, excluding the patent applications and patents within the Licensed Patents.
 
1.7                                  “ Invention ” shall mean any new and useful invention, discovery„ process, improvement or other intellectual property conceived of, first reduced to practice, made or otherwise developed by MAYO, its employees or agents including Dr.  Moses Rodriguez and Dr.  Larry Pease, in connection with and during the term of either of the Programs and this Agreement, and during the two year period thereafter.
 
1.8                                  “ Licensed Patents ” shall mean, collectively:
 
(a)                                   United States Patent No.  5,591,629, (formerly Application S.N.  08/236,520, filed April 29, 1994), entitled “Monoclonal Antibodies Which Promote Central Nervous System Remyelination,” the inventions described and claimed therein, and any substitutions, extensions, renewals, divisions, patents-of-addition, continuations, continuations-in-part to the extent the claims are directed to subject matter specifically described in such patent
 
2

 
(including, but not limited to, all of those continuations-in-part specifically listed on Exhibit C), patents issuing thereon or reissues, extensions or supplementary protection certificates thereof, and any and all patents and patent applications throughout the Territory corresponding thereto; and
 
(b)                                  All patents and patent applications, and any substitutions, extensions, renewals, divisions, patents-of-addition, continuations, continuations-in-part to the extent the claims are directed to subject matter specifically described in such patent or patent application, patents issuing thereon or reissues, re-examinations, extensions or supplementary protection certificates thereof, and any and all foreign counterparts thereto concerning any invention, technology or other intellectual property owned in whole or in part by MAYO and made, first reduced to practice or otherwise developed in connection with the Programs, whether before or after the date of this Agreement, or derivatives or analogs thereof, including any and all technology which may be subject to either of the Option Agreements.
 
1.9                                  “ Licensed Product ” shall mean any product or part thereof which is covered, in whole or in part, by a Valid Claim of a Licensed Patent in the country in which such product is made, used or sold, or which incorporates or utilizes Know-How.
 
1.10                            “ Licensed Technology ” shall mean the Licensed Patents and the Know-How, collectively.
 
1.11                            “ Marketing Exclusivity Rights ” shall mean any rights to which a Licensed Product may be eligible in addition to or in lieu of rights under the Licensed Patents including rights to exclusivity provided in 21 USC §505, 21 USC §360aa-ee, the Orphan Drug Act, the marketing exclusivity provisions of Article 8(a) of Directive 65/65/EEC Relating to Medicinal Products and any other legislation on regulations as amended from time to time in the Territory applicable to this Agreement providing for non-patent marketing exclusivity for any Licensed Product whether such legislation or regulation is operative on the Effective Date of this Agreement or becomes operative thereafter;
 
1.12                            “ Material Breach ” shall mean a breach of this Agreement which is specified in this Agreement as being a material breach, and in addition, any breach of this Agreement which is so injurious to the relationship between the Parties that this Agreement should reasonably be subject to immediate Termination by the non-breaching Party.
 
1.13                            “ Net Sales ” shall mean, with respect to any Licensed Product, the gross amount invoiced for such Product by ACORDA, its Affiliates and Sublicensees, to third parties, less deductions for: (i) trade, quantity and/or cash discounts, allowances and rebates (including, without limitation, promotional allowances or discounts or similar allowances) actually allowed or given; (ii) freight, postage, shipping, insurance and transportation expenses and similar charges (in each instance, if separately identified in such invoice); (iii) credits or refunds actually allowed for rejections, defects or recalls of such Licensed Product, outdated or returned Licensed Product, or because of rebates or retroactive price reductions; and (iv) sales, value-added and excise taxes, tariffs and duties, and other taxes directly related to the sale, to the extent that such items are included in the gross invoice price (but not including taxes assessed against the income derived from such sale).  Such amounts shall be determined from the books and records of
 
3

 
ACORDA, its Affiliates or its Sublicensees, maintained in accordance with the reasonable accounting principles used by such entity, consistently applied.
 
1.14                            “ Patent Term Extensions ” shall mean the interim or permanent extension ofthe term of any Licensed Patents or claims covered by any Licensed Patents for any Licensed Product for which MAYO may be eligible under 35 U.S.C.  § 156 or any otherU.S.  or non-U.S.  statute providing for extensions of patent terms;
 
1.15                            “ Patent Term Extensions Information ” shall mean information within a non-filing Party’s possession or control which may be requested by the Party responsible for filing and prosecuting an application or petition for a Patent Term Extension, such information as may be requested by the Patent and Trademark Office and execution of all necessary documentation in connection therewith for the filing Party to make a timely and complete filing and prosecution of an application for a Patent Term Extension;
 
1.16                            “ Party ” shall mean ACORDA or MAYO and, when used in the plural, shall mean ACORDA and MAYO.
 
1.17                            “ PLA ” shall mean a product license application, or with respect to any product license application already filed as of the Effective Date a supplemental product license application thereto, filed with the United States FDA, or the equivalent regulatory filing required to be filed with the regulatory authorities in any other jurisdiction outside the United States.
 
1.18                            “ Regulatory Review Period ” shall mean the period of time defined in 35 U.S.C.  § 156(g) and applicable to any Licensed Product;
 
1.19                            “ Royalty Term ” shall mean, with respect to each Product in each country in the Territory, the period commencing on the date of the First Commercial Sale of such Product and expiring on the earlier of: (a) the later of (i) the expiration of the last Key Claim covering such Product in such country, or (ii) the expiration of any exclusive approval period granted with respect to such Product under the Orphan Drug Act, 21 U.S.C.  § 360aa et.  seq., as amended from time to time, or (iii) ten years from the First Commercial Sale, or (iv) fifteen years from the Effective Date; or (b) the Termination of this Agreement.
 
1.20                            “ Sublicensee ” shall mean any non-Affiliate third party sublicensed by ACORDA to make, have made, import, use or sell any Licensed Product.
 
1.21                            “ Termination ” of this Agreement shall mean the ending, expiration, rescission, or any other discontinuation of this contract for any reason whatsoever.
 
1.22                            “ Territory ” shall mean the entire world.
 
1.23                            “ Valid Claim ” shall mean either: (i) a claim of an issued and unexpired patent included in the Licensed Patents, which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal, and which claim has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise, or (ii) a pending claim of a pending patent application that is classified under Section 1.7 as
 
4

 
Licensed Patents, which claim (a) was filed in good faith, (b) is reasonably likely to issue, (c) has not been abandoned or finally disallowed without the possibility of appeal or refining of said application, and (d) has not been pending for a period in excess of seven (7) years from the earliest date from which the patent application was filed or claims priority in such country.
 
2.                                       GRANT OF LICENSE.
 
2.1                                  License Grant .  Subject to the terms and conditions of this Agreement, MAYO hereby grants to ACORDA, subject to any rights of the U.  S.  Government under 35 U.S.C.  § 200 etseq.  and all regulations promulgated pursuant thereto, the exclusive (even as to MAYO), worldwide right and license under the Licensed Technology to develop, make, have made, use, import, export, lease, offer to sell, sell, have sold and otherwise exploit Licensed Products for use in the Field in the Territory, and to grant, offer for sale and authorize sublicenses with respect to the right and license granted under this Section 2.1 to other third parties.
 
2.2                                  Reserved Rights .  Notwithstanding the right and license granted in Section 2.1, MAYO reserves the right to use the Licensed Technology solely for purposes of education, internal research and verification of adherence to MAYO’s policies regarding the responsible conduct of research, and for MAYO’s • patient care, at the discretion of MAYO’s physicians, conducted within MAYO’s facilities located in Rochester, Minnesota, Scottsdale, Arizona and Jacksonville, Florida.  MAYO may also share aliquots of antibody related to Licensed Technology with other academic institutions solely for non-commercial research purposes as ACORDA may approve in advance, provided that no antibody shall be shared which is not already subject to an issued U.S.  Patent or pending U.S.  patent application, and provided further, that any such other academic institution must sign a material transfer agreement in form acceptable to ACORDA, whereby such institution confirms (a) that the antibody provided is the subject of an issued or pending Patent, (b) the proprietary rights of ACORDA under this Agreement, and (c) that all rights to all commercial applications resulting from such institution’s research making use of such transferred material shall belong exclusively to MAYO and be considered part of the license granted to ACORDA under this Agreement.  The Parties agree that the form of material transfer agreement attached to this Agreement as Exhibit E may be used for such purpose, provided that MAYO must still obtain ACORDA’s prior approval for any specific agreement and transfer in each instance.  Nothing in this Section 2.2 shall permit MAYO to use the Licensed Technology to develop any product for commercial use, or give any third party such right.
 
2.3                                  Representations and Warranties .
 
(a)                                   MAYO hereby represents and warrants that:
 
(i)                                      It has the right to grant the right and license granted to ACORDA under this Section 2 and that (except as may be provided in that certain agreement dated January 9, 1997 between MAYO and TEVA Pharmaceutical Industries, Ltd.  (the “TEVA Agreement”) which purports to grant certain rights to TEVA with respect to certain research results which may or may not be considered part of the Licensed Technology licensed hereunder and is the subject of the special indemnification provided under Section 8.2 (b) of this Agreement) MAYO
 
5

 
has not entered into any agreement with any third party which is in conflict with the rights granted to ACORDA pursuant to this Agreement; and
 
(ii)                                   It has fully disclosed to ACORDA all information in MAYO’s possession or control relating to the Licensed Technology, including, without limitation, any communications with any third parties relating to any of the foregoing.
 
(b)                                  NO OTHER WARRANTIES.
 
(i)                                      Except as expressly provided in this Agreement, nothing in this Agreement shall be construed as a warranty or representation by MAYO as to: the validity or scope of any patents contained in the Licensed Technology; an obligation to bring or to prosecute actions against third parties for infringement of patent; or conferring by implication, estoppel, or otherwise any patents of MAYO.
 
(ii)                                   MAYO HAS NOT MADE AND PRESENTLY MAKES NO PROMISES, GUARANTEES, REPRESENTATIONS OR WARRANTIES OF ANY NATURE, DIRECTLY OR INDIRECTLY, EXPRESS OR IMPLIED, REGARDING THE MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, SUITABILITY, DURABILITY, CONDITION, QUALITY, OR ANY OTHER CHARACTERISTIC OF THE LICENSED TECHNOLOGY.  THE COMPANY TAKES THE LICENSED TECHNOLOGY “AS IS,” “WITH ALL FAULTS,” AND “WITH ALL DEFECTS,” AND EXPRESSLY WAIVES ALL RIGHTS TO MAKE ANY CLAIM WHATSOEVER AGAINST MAYO FOR MISREPRESENTATION OR FOR BREACH OF PROMISE, GUARANTEE, OR WARRANTY OF ANY KIND RELATING TO THE LICENSED TECHNOLOGY.
 
2.4                                  Right of First Offer .  The Parties recognize that MAYO may continue to conduct internal research using the Licensed Technology, as it determines in its discretion.  In the event that MAYO develops any other application related to the Licensed Technology but outside the scope of the license granted under this Agreement (a “New Product”), MAYO hereby grants to ACORDA a right of first offer with respect to rights for any such New Product in the Field, as follows:
 
(a)                                   In the event that, at any time during the term of this Agreement, MAYO intends to offer to a third party any rights to any New Product or receives an offer from a third party to acquire any rights to any New Product, MAYO shall first offer such rights to ACORDA, in writing, on terms no less favorable to ACORDA than those to be offered to, or offered by, such third party
 
(b)                                  Within 30 days after receipt of any such offer, ACORDA shall notify MAYO in writing as to whether it wishes to obtain such rights on such terms.  If ACORDA provides timely notice that ACORDA wishes to obtain such rights, then the Parties shall conduct exclusive negotiations in good faith and conclude an agreement incorporating such terms within 120 days thereafter.
 
(c)                                   In the event that (i) ACORDA gives MAYO notice that ACORDA does not wish to obtain such rights, or (ii) ACORDA does not respond to MAYO’s notice within 30 days after receipt thereof, then MAYO shall have the unrestricted right to enter into an agreement with a third party for such rights.
 
6

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
(d)                                  In the event that the parties enter into negotiations pursuant to Section 2.4(b), but are unable to agree upon the terms of such rights, despite the use of good faith efforts, during the 120-day period set forth in Section 2.4(b), then MAYO shall have the right, for a period of six months thereafter, to enter into an agreement with a third party for such rights on terms no more favorable to such third party than those last offered to ACORDA pursuant to this Section 2.4.  In the event that MAYO wishes to enter into such an agreement on terms more favorable to such third party, MAYO shall reoffer such terms to ACORDA in accordance with this Section 2.4.  MAYO’s obligation to reoffer to ACORDA any particular New Product it has not licensed to a third party during the six month period contemplated in the first sentence of this Section 2.4(d) shall continue for the term of this Agreement, and if MAYO continues its internal research related to such New Product, it will disclose to ACORDA any material new information, technology, or data developed by MAYO related to the New Product to permit ACORDA to evaluate MAYO’s reoffer.
 
2.5                                  Opportunity to Conduct Clinical Studies .  In the event that ACORDA determines that it is desirable to conduct clinical studies in connection with development of Licensed Products using the Licensed Technology, ACORDA shall provide MAYO with the opportunity to be included as a study site for such clinical studies, provided that MAYO has the necessary expertise, and can perform such clinical study in a timely and cost efficient manner when compared to the use of a third party.  MAYO acknowledges that MAYO may not serve as a major clinical trial site, when MAYO has a conflict of interest, whether actual or perceived, such as in a registrational study.
 
3.                                       PAYMENTS; ROYALTIES.
 
3.1                                  Upfront Consideration Royalty .
 
(a)                                   In partial consideration of the right and license granted to ACORDA hereunder, ACORDA shall pay MAYO a fee of [**], due within thirty (30) days after the Effective Date.  Such fee shall be non-refundable, and non-creditable against any other royalty or fee payable under this Agreement.
 
(b)                                  In further consideration of the right and license granted to ACORDA hereunder, ACORDA acknowledges that this Agreement permits MAYO to exercise the warrants previously granted to MAYO in connection with the Option Agreement to purchase 60,000 shares of ACORDA common stock at the price of founders stock.  In the event MAYO elects to exercise such warrants, ACORDA shall reimburse to MAYO the price paid by MAYO in order to exercise such warrants.
 
3.2                                  Milestone Royalties for Licensed Product s .  In further consideration of the right and license granted to ACORDA hereunder, ACORDA shall pay to MAYO the following milestone payments upon the first occurrence of each event set forth below:
 
(a)                                   In as much as United States Patent No.  5,591,629, as described in Section 1.8(a) has issued and contains one or more of the key claims as contemplated by a prior Option Agreement among the Parties (“Key Claims”), [**], within 30 days following the Effective Date.
 
7

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
(b)                                  [**] within thirty days following the issuance of the first U.S.  composition of matter Licensed Patent for a human antibody.
 
(c)                                   [**] within 30 days after the initiation of the first U.S.  Phase II clinical trial for the first Licensed Product chosen for development (“First Licensed Product”) by ACORDA or its Affiliates or Sublicensees.
 
(d)                                  [**] upon the approval to market for therapeutic use given by the FDA to ACORDA or its Affiliates or Sublicensees (“FDA Approval”) of the First Licensed Product, which amount shall be paid in four equal installments, the first of which shall be paid within 30 days following the date of such FDA Approval and the balance of which shall be paid within 30 days after the end of the three-, six- and nine-month periods following such date.
 
(e)                                   [**] within 30 days after the earlier of (1) initiation of the second U.S.  Phase III clinical trial for the second Licensed Product chosen for development, if any, (“Second Licensed Product”) by ACORDA or its Affiliates or Sublicensees or (2) submission of a New Drug Application (“NDA”) by ACORDA or its Affiliates or Sublicensees to the FDA for such Second Licensed Product.
 
(f)                                     [**] upon FDA Approval of the Second Licensed Product, which amount shall be paid in four equal installments, the first of which shall be paid within 30 days following the date of such FDA Approval and the balance of which shall be paid within 30 days after the end of the three-, six- and nine-month periods following such date.
 
(g)                                  [**] within 30 days after the earlier of (1) initiation of the second U.S.  Phase III clinical trial for the third Licensed Product chosen for development, if any, (“Third Licensed Product”) by ACORDA or its Affiliates or Sublicensees or (2) submission of an NDA by ACORDA or its Affiliates or Sublicensees to the FDA for such Third Licensed Product.
 
(h)                                  [**] upon FDA Approval of the Third Licensed Product, which amount shall be paid in four equal installments, the first of which shall be paid within 30 days following the date of such FDA Approval and the balance of which shall be paid within 30 days after the end of the three-, six- and nine-month periods following such date.
 
3.3                                  Running Royalties for Sales of Licensed Products .
 
(a)                                   In further consideration of the right and license granted to ACORDA hereunder, ACORDA shall pay to MAYO, in connection with the sale of Licensed Products by ACORDA or its Affiliates or Sublicensees, in accordance with the following schedule and rates:
 
(i)                                      With respect to the First Licensed Product, provided that such First Licensed Product is covered by a Valid Claim which contains a valid composition of matter claim in the country where it is sold the applicable royalty rates shall be
 
[**] of the first [**] of annual Net Sales; and
 
[**] of all annual Net Sales in excess of [**].
 
8

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
(ii)                                   With respect to the Second Licensed Product, the Third Licensed Product, and each subsequent Licensed Product, provided that each such Licensed Product is covered by a Valid Claim which contains a valid composition of matter claim in the country where it is sold, and taking each Licensed Product into account separately and not aggregating Net Sales of separate Licensed Products, the applicable royalty rates shall be:
 
[**] of the first [**] of annual Net Sales;
 
[**] of annual Net Sales between [**] and [**];
 
[**] of annual Net Sales between [**] and [**]; and
 
[**] of annual Net Sales in excess of [**].
 
(iii)                                With respect to any Licensed Product which is not covered by a Valid Claim which contains a composition of matter claim in the country where it is sold, but is covered by a pending patent within the Licensed Patents containing a valid composition of matter claim in the country where such Licensed Product is sold, the applicable royalty rate shall be, in lieu of the foregoing rates, [**] on all annual Net Sales
 
(b)                                  In the event that any of the issued patents contemplated in Section 3.3(a) contain only awarded valid utility claims, the Parties shall negotiate in good faith lesser royalty rates for the sale of Licensed Products.  Such royalty rates shall reflect customary royalties for intellectual property of the type, degree of proprietary protection and value mutually agreed to by MAYO and ACORDA.
 
(c)                                   Beginning on the first anniversary of the first commercial sale of the First Licensed Product, ACORDA shall pay MAYO the following minimum annual royalties equal to the difference between the actual annual amounts paid to MAYO pursuant to Section 3.3(a) and (b) and the following:
 
(i)                                      [**] on the first anniversary;
 
(ii)                                   [**] on the second anniversary;
 
(iii)                                [**] on the third anniversary; and
 
(iv)                               [**] on the fourth anniversary and on each anniversary thereafter.
 
3.4                                  Third Party Royalties .  In the event that ACORDA, its Affiliates or Sublicensees, as the case may be, pays royalties or other amounts to any third party to make, use or sell a Licensed Product or to avoid or settle a claim of infringement of the intellectual property rights of such third party, ACORDA may offset such amounts paid against up to [**] of the amount of royalties due from ACORDA to MAYO, provided however, that in no event shall MAYO receive less that [**] of the Net Sales of the Licensed Product sold by ACORDA, its Affiliates or Sublicensees, as the case may be.
 
9

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
3.5                                  Certain Affiliate and Sublicensee Royalt ies .  In the event that ACORDA receives any royalties from Affiliates or Sublicensees with respect to the sale of Licensed Products for use in applications that ACORDA has decided, in its business judgment, not to commercialize, ACORDA shall pay MAYO [**] of such amounts received, provided however, that MAYO shall not be entitled to any share of amounts received by ACORDA from its Affiliates or Sublicensees for:
 
(a)                                   equity;
 
(b)                                  debt;
 
(c)                                   research and development;
 
(d)                                  any payments attributable to performance based milestones;
 
(e)                                   the license or sublicense of,
 
(i)                                      any intellectual property other than the Licensed Patents,
 
(ii)                                   any products other than the Licensed Products; or
 
(f)                                     reimbursement for patent or other expenses.
 
3.6                                  Obligation to Pay Royalties .  In no event shall more than one.  royalty be due hereunder with respect to any unit of Licensed Product even if covered by more than one patent or Valid Claim of any patent included in the Licensed Patents.  Except as provided in Section 3.5, there shall be no obligation to pay royalties to MAYO under this Section 3 on sales of Licensed Products between ACORDA and its Affiliates and Sublicensees, but in such instances the obligation to pay royalties shall arise upon the sale by ACORDA or its Affiliates or Sublicensees.  Failure to make such royalty payments shall be deemed a Material Breach of this Agreement.  Payments due under this Section 3 shall be deemed to accrue when payment is received by ACORDA for Licensed Products.
 
3.7                                  Royalties on Combined Products .  Where a Licensed Product is sold in combination with one or more other products that are not Licensed Products (the “Combined Product”), ACORDA shall pay royalties to MAYO based upon the value of the Combined Product attributable to the Licensed Patents.  The Parties agree to negotiate in good faith to reach a mutual agreement concerning the value of Combined Product attributable to such Licensed Patents, provided however, that ACORDA shall pay MAYO no less than [**] of the Net Sales of such Combined Product.
 
4.                                       PAYMENTS AND RECORDS.
 
4.1                                  Payment .  Except as otherwise provided herein, all royalties and other.payments due hereunder shall be paid quarterly within 45 days after the end of each calendar quarter in which such payments or royalties accrue.  Each such payment shall be accompanied by a statement identifying the payments made, including a Licensed Product-by-Licensed Product and
 
10

 
country-by-country statement of the amount of Net Sales during such quarter, the amount of royalties due on such Net Sales and the amount of any credits being applied to such royalties.  Failure to make such payments on time shall be deemed a Material Breach of this Agreement.
 
4.2                                  Mode of Payment .  ACORDA shall make all payments required under this Agreement in U.S.  Dollars.  The payments due shall be translated at the rate of exchange at which United States Dollars for the currency of the country in which the payment accrued, as listed in The Wall Street Journal on the last business day of the calendar quarter in which such sales, if any, were made.
 
4.3                                  Taxes .  Royalties shall be paid to MAYO free and clear of all foreign taxes, including withholding and turnover taxes, except such taxes which ACORDA may be required to withhold by a foreign country.  Any tax required to be withheld by ACORDA or its Affiliates or Sublicensees under the laws of any foreign country for the account of MAYO shall be promptly paid by ACORDA or its Affiliate or Sublicensee for and on behalf of MAYO, with proof of payment of such tax together with official or other appropriate evidence issued by the appropriate governmental authority sufficient to enable MAYO to support a claim for income tax credit in’ respect to any sum so withheld.  Any such tax required to be withheld shall be an expense of and borne solely by MAYO.
 
4.4                                  Records Retention .  ACORDA shall keep complete and accurate records pertaining to the manufacture, use and sale of Licensed Products and in sufficient detail to permit MAYO to confirm the accuracy of royalty calculations under this Agreement.
 
4.5                                  Audit Request .  At the request and expense of MAYO, ACORDA shall permit an independent, certified public accountant appointed by MAYO and acceptable to ACORDA, at reasonable times and upon reasonable notice, to examine those records as may be necessary to: (i) determine, with respect to any calendar year ending not more than three years prior to MAYO’s request, the correctness of any report or payment made under this Agreement; or (ii) obtain information as to the royalty payable for any calendar year in the case of ACORDA’S failure to report or pay pursuant to this Agreement.  Results of any such examination shall be made available to both Parties.  MAYO shall bear the full cost of the performance of any such audit; provided however, that in the event such audit reveals an underpayment by ACORDA in excess of five percent of the total amount of payment due by ACORDA to MAYO for any calendar year subject to such audit, ACORDA shall reimburse MAYO for the cost of such audit.
 
5.                                       DUE DILIGENCE.
 
5.1                                  Diligence .  ACORDA, directly or through its Affiliates or Sublicensees, shall use reasonable commercial efforts, consistent with its business judgment, to develop and commercialize Licensed Products during the term of this Agreement and obtain and maintain such approvals as may be necessary for the sale of Licensed Products in the United States and in such other worldwide markets as ACORDA selects to commercialize such Licensed Products.
 
5.2                                  Reports .  During the term of this Agreement and until the First Commercial Sale of the first Licensed Product, ACORDA shall deliver to MAYO semi-annual reports, due within
 
11

 
45 days after the end of each June and December, summarizing the efforts of ACORDA, its Affiliates and its Sublicensees to develop and commercialize Licensed Products.
 
(a)                                   If MAYO reasonably believes that ACORDA is not satisfying ACORDA’s diligence obligations set forth in Section 5.1 (or does not have sufficient information to make such determination), it may request ACORDA to inform MAYO of such efforts as ACORDA, its Affiliates or Sublicensees are undertaking to comply with its obligations thereunder.  Within 60 days from receipt of such request, ACORDA shall then report its efforts to develop and commercialize Licensed Products and, if either Party requests, the Parties shall meet to discuss the situation.
 
(b)                                  At any time during such 60-day period, either Party may request the use of a mediator to assist in the resolution of such dispute.  In such event, both Parties shall try in good faith to resolve such dispute by mediation administered by the American Arbitration Association under its Commercial Mediation Rules by a single mediator, who shall have experience and be knowledgeable in the pharmaceutical industry, appointed in accordance with such rules.  The Parties agree to submit to one day of mediation to take place within 30 days after the selection of such mediator, unless the Parties otherwise agree.  The costs of any such mediation, including administrative fees and fees of the mediator, shall be shared equally by the Parties, and each Party shall bear its own expenses in such mediation.
 
(c)                                   If, at the end of the later of the 60 day period referred to in Section 5.3(a) or the unsuccessful conclusion of the mediation, if any, commenced pursuant to Section 5.3(b), MAYO still believes that ACORDA is not exercising sufficient efforts to satisfy the diligence obligations set forth in Section 5.1, MAYO shall initiate a Short-Form Arbitration proceeding pursuant to Section 5.4 within 30 days thereafter.  The sole question before the arbitrator shall be whether ACORDA is exercising sufficient efforts to satisfy the diligence obligations set forth in Section 5.1.  If MAYO fails to initiate such arbitration within such 30 day period, MAYO shall have no further right to dispute ACORDA’s efforts to satisfy its diligence obligations with respect to the period in question.
 
(d)                                  The foregoing is intended to provide MAYO the means to reasonably exercise its rights hereunder, and shall not be used to place unreasonable reporting burdens on ACORDA.  MAYO may not commence a request for the foregoing information from ACORDA for at least one year after MAYO last commenced a request therefor.
 
5.3                                  Short-Form Arbitration .  Any dispute subject to short-form arbitration as provided in Section 5.3 shall be finally settled by binding arbitration in New York City, New York (at a specific location to be agreed upon by the Parties) under the Licensing Rules of the American Arbitration Association by a panel of one or more arbitrators, who shall have experience and be knowledgeable in the pharmaceutical industry, appointed in accordance with such rules.(Such arbitrators shall make their determination on the basis of “baseball arbitration” principles.  THE FOREGOING REMEDY SHALL BE EACH PARTY’S SOLE AND EXCLUSIVE REMEDY WITH RESPECT TO ANY SUCH DISPUTE.  Except as specifically otherwise set forth in Section 5.3 and this Section 5.4 such arbitration shall be conducted in accordance with the provisions of Exhibit D.
 
12

 
6.                                       “OWNERSHIP; PATENTS; MARKETING EXCLUSIVI TY; PATENT TERM EXTENSIONS”
 
6.1                                  Ownership .
 
(a)                                   Except as otherwise provided in Section 6.1(b) through (e), MAYO shall retain all right, title and interest in and to the Licensed Technology, regardless of which Party prepares and prosecutes the patent applications associated therewith, or maintains the patents or other intellectual property rights related, subject to the right and license granted to ACORDA pursuant to Section 2.
 
(b)                                  Rights to Inventions for which employees or agents of MAYO are the sole inventor(s) as determined in accordance with U.S.  patent laws shall belong to MAYO.
 
(c)                                   Rights to Inventions for which employees or agents of ACORDA are the sole inventor(s) as determined in accordance with U.S.  patent laws shall belong to ACORDA.
 
(d)                                  Rights to Inventions made jointly by employees and agents of MAYO and by employees and agents of ACORDA as determined in accordance with U.S.  patent laws shall belong jointly to MAYO and to ACORDA.
 
(e)                                   Rights held by MAYO in any Inventions, including without limitation, rights in and to patent applications and patents which may be obtained thereon, shall be within the terms Licensed Patents and shall be subject to the license granted to ACORDA herein.
 
(f)                                     In the event as to any Invention either Party determines that it may be advisable to consider special ownership or license arrangements among them in order to maximize the commercial protection or utility afforded under any applicable patent law, the Parties shall discuss and consider in good faith the implementation of such special arrangements as a means of maximizing the value of such Invention for their mutual benefit.
 
6.2                                  Patent Prosecution and Maintenance .
 
(a)                                   ACORDA, at its sole cost and expense (including, without limitation, legal fees, filing and maintenance fees or other governmental charges), shall (i) commencing on the Effective Date, have full responsibility for and shall control the preparation and prosecution of all patent applications, and the maintenance of all patents, related to the Licensed Technology, and (ii) reimburse the reasonable expenses in connection with such activities prior to the Effective Date.  actually incurred by MAYO, in connection with the filing, prosecution and maintenance of the Patent Rights, as shown by MAYO’s books and records.
 
(b)                                  ACORDA shall select qualified patent counsel to file and prosecute all such patent applications.  ACORDA shall provide copies to MAYO of any proposed filings to made to any patent office relating to the Patent Rights in advance, shall consult with MAYO, and shall in good faith consider and give due respect to MAYO’s position with respect thereto.  In addition, ACORDA shall provide copies to MAYO of any written communications received from any patent office relating to the Patent Rights.
 
13

 
(c)                                   MAYO shall provide ACORDA with a credit against earned royalties due MAYO in the amount of fifty percent (50%) of all expenses, costs and fees (including attorney’s fee’s) paid by ACORDA in pursuant to this Section 6.2.  At MAYO’s request, ACORDA shall provide MAYO with reasonable documentation of such costs.
 
(d)                                  Each Party agrees to cooperate with the other Party to execute all lawful papers and instruments, to make all rightful oaths and declarations and to provide consultation and assistance as may be necessary in the preparation, prosecution, maintenance, and enforcement of all Patent Rights.
 
6.3                                  Patent Enforcement .
 
(a)                                   If either Party learns of an infringement or other use, rights or ownership claim or threatened infringement or other such claim by a third party with respect to any Licensed Technology within the Territory, such Party shall promptly notify the other Party and shall provide such other Party with available evidence of such infringement, whereupon the parties shall consult to determine if they will jointly bring action to terminate such infringement or misappropriation.  The costs and expenses of any such action (including fees of attorneys and other professionals) shall be borne by the Parties in such proportions as they may agree in writing.  Any recovery obtained by the Parties in such action shall be used to reimburse the cost of such action to the Parties in proportion to their respective contributions to the costs and expenses incurred in such action, and the remainder shall be divided equally between the Parties.
 
(b)                                  In the event that the Parties fail to initiate an action to terminate such infringement or misappropriation within ninety (90) days after the last party receives notice of such infringement or misappropriation, MAYO shall have the first right, but not the duty, to institute at its sole cost and expense, actions against third parties based on any Licensed Technology under this Agreement.  Any recovery obtained by MAYO in such action shall be used to reimburse the cost of such action and the remainder shall be retained by MAYO.
 
(c)                                   In the event that the Parties fail to initiate an action to terminate such infringement or misappropriation within ninety (90) days after the last party receives notice of such infringement or misappropriation, and in the event MAYO does not institute an infringement proceeding against an offending third party within 180 days after the last party receives such notice, ACORDA shall have the right, but not the duty, to institute at its sole cost and expense, such an action with respect to any infringement or misappropriation by a third party.  Any recovery obtained by ACORDA shall be used to reimburse the cost of such action and the remainder shall be retained by ACORDA, provided however, that such amount shall be deemed to constitute Net Sales for purposes of this Agreement.
 
(d)                                  Unless the Parties otherwise agree in writing, each Party shall execute all necessary and proper documents and provide reasonable, but not financial, cooperation as shall be appropriate, to allow the other Party to institute and prosecute such infringement actions.
 
6.4                                  Infringement Action by Third Parties .
 
(a)                                   In the event of the institution of any suit by a third party against ACORDA for patent infringement involving the manufacture, sale, offer for sale, distribution or marketing
 
14

 
of any Product in the Territory, ACORDA shall have the right to defend such suit at its own expense, and MAYO hereby agrees to assist and cooperate with ACORDA, at ACORDA’s expense, to the extent necessary in the defense of such suit.  During the pendency of any such action, ACORDA shall continue to make all payments due under this Agreement, provided however, that ACORDA shall be entitled to a credit against such payments of an amount equal to one-half of the reasonable costs actually incurred in such action.
 
(b)                                  If ACORDA finally prevails and receives an award from such third party as a result of such action (whether by way of judgment, award, decree, settlement or otherwise), such award shall be allocated, first, to ACORDA and MAYO to reimburse each Party for its pro rata share of costs and expenses incurred in such action, and the remaining amount shall be retained by ACORDA, provided however, that such amount shall be deemed to constitute Net Sales for purposes of this Agreement.
 
(c)                                   If ACORDA finally loses, whether by judgment, award, decree or settlement, and is required to pay a royalty or damages to such third party, ACORDA shall continue to pay the royalties for such Licensed Product in the country(ies) which is the subject of such action, but shall be entitled to a credit against such payments in an amount-equal to the royalty or damages paid to such third party, but in no event shall such credit be more than 50% of the royalties due hereunder for such Licensed Product in such country(ies).
 
(d)                                  If ACORDA is required to pay a royalty or damages to a third party pursuant to Section 6.4(c) and the amount of such royalty or damages exceeds 50% of the royalties due hereunder for such Licensed Product in such country(ies), ACORDA shall have the right to terminate this Agreement solely with respect to such Licensed Product in such country(ies).  The effect of any such termination shall be the same as any termination by ACORDA pursuant to Section 9.4.
 
6.5                                  Marketing Exclusivity/Patent Term Extens ions
 
(a)                                   ACORDA shall be responsible for taking all necessary steps to prosecute, perfect and maintain such applicable Marketing Exclusivity Rights as it deems appropriate.
 
(b)                                  ACORDA grants to MAYO the exclusive right to rely on any Regulatory Review Period for any Licensed Product and agrees to be MAYO’s agent for such purposes.  In the event of any request from the Patent and Trademark Office for assurances that MAYO has the right to rely on the Regulatory Review Period, including assurances that ACORDA is MAYO’s agent for such purposes, this Section 6.5 shall be conclusive evidence ofACORDA’s agreement that MAYO has such right.  Except as may otherwise be contemplated under this Agreement with respect to the transfer of rights or obligations to Affiliates, Sublicensees and permitted assignees, ACORDA may not transfer, assign, license, mortgage or hypothecate in whole or in part to any person, whether voluntarily or involuntarily, its right to a Regulatory Review Period for any Licensed Product without the prior written consent of MAYO, which consent shall not be unreasonably withheld or delayed.
 
(c)                                   Subject to the provisions of Section 6.5 (e), MAYO reserves the right to determine that ACORDA should file and prosecute any application for a Patent Term Extension;
 
15

 
(d)                                  ACORDA agrees to take all reasonable actions which MAYO determines to be necessary to ensure the complete and timely filing and prosecution of any application for a Patent Term Extension, including but not limited to providing MAYO with relevant Patent Term Extension Information.
 
(e)                                   In the event that more than one Licensed Patent could be the subject of an application for a Patent Term Extension, ACORDA shall have the right, after consultation with MAYO, to select the Licensed Patent.
 
7.                                       PUBLICATION; CONFIDENTIALITY.
 
7.1                                  Publication .  ACORDA acknowledges that MAYO is dedicated to free scholarly exchange and to public dissemination of the results of its scholarly activities.  In the event MAYO, or any employee, student or other agent of MAYO who is performing any work with respect to the Program, wishes to make any publication or otherwise disseminate information concerning or obtained through the Program, MAYO will deliver to ACORDA copies of such scientific articles, papers and abstracts for review and comment at least 60 days prior to the date of submission for publication or presentation.  ACORDA’s permission to publish shall not be unduly withheld, and ACORDA’s permission or withholding of such permission will be submitted to MAYO in writing not later than 30 days following’ ACORDA’s receipt of the material for review.  If ACORDA determines that such proposed publication or presentation contains patentable subject matter that requires protection, ACORDA may require the delay of publication or presentation for a period not to exceed 90 days for the purpose of allowing the filing of patent applications.  If ACORDA identifies any of ACORDA’s Confidential Information (as defined herein) in such proposed publication or presentation, MAYO will delete such information from same, or modify the disclosure of such information from same in a manner reasonably acceptable to ACORDA.
 
7.2                                  Confidentiality; Exceptions .
 
(a)                                   “Confidential Information of a party shall mean all reports, data and information disclosed by such party to another party, which is (i) in writing and marked “CONFIDENTIAL” or “PROPRIETARY or marked with words of similar import, or (ii) disclosed through oral, visual, or other non-written means, identified as confidential or proprietary at the time of initial disclosure, and summarized and confirmed as confidential or proprietary in writing to the receiving party within thirty (30) days of such disclosure.  Any markings, stamps, or legends identifying confidential information shall not impose any obligations on either party inconsistent with this agreement.  Any copies of the information made by the receiving party shall reproduce the confidential markings and any other legends contained on such information.
 
(b)                                  Except to the extent expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that, during the term of this Agreement and for five years thereafter, the receiving Party, its Affiliates, its licensees and its Sublicensees shall keep, and shall ensure that their respective employees, officers, directors and trustees shall keep, completely confidential and shall not publish or otherwise disclose and shall not use any
 
16

 
Confidential Information for any purpose other than carrying out the obligations of the receiving Party under this Agreement except to the extent that it can be established by the receiving Party by competent proof in the form of written records maintained by the receiving Party that such information: (i) was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the disclosing Party; (ii) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party; (iii) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; or (iv) was disclosed to the receiving Party, other than under an obligation of confidentiality, by a third party who had no obligation to the disclosing Party not to disclose such information to others.
 
7.3                                  Exceptions to Obligation .  The restrictions contained in Section 7.2 shall not apply to Confidential Information that: (i) is submitted by the recipient to governmental authorities to facilitate the issuance of marketing approvals for Licensed Products, provided that reasonable measures shall be taken to assure confidential treatment of such information; (ii) is provided by the receiving Party to third parties under appropriate terms and conditions, including confidentiality provisions substantially equivalent to those in this Agreement, for consulting, manufacturing development, manufacturing, external testing and marketing trials; or (iii) is otherwise required to be disclosed in compliance with applicable laws or regulations or order by a court or other regulatory body having competent jurisdiction, provided that if a Party is required to make any such disclosure of the other Party’s Confidential Information it will, except where impracticable for necessary disclosures, for example to physicians conducting studies or to health authorities, give reasonable advance notice to the other Party of such disclosure requirement and, except to the extent inappropriate in the case of patent applications, will use its best efforts to secure confidential treatment of the Confidential Information required to be disclosed, and shall cooperate with efforts of the disclosing Party to limit disclosure, as appropriate.
 
7.4                                  Confidentiality regarding Patient Inform ation .  Notwithstanding anything in this Section 7 to the contrary, identifiable patient information obtained in the performance of the Program shall be deemed Confidential Information and shall be kept confidential by both Parties permanently except: (i) when that information is required to be disclosed by regulatory authorities; or (ii) with the patient’s consent.
 
8.                                       INDEMNIFICATION.
 
8.1                                  Products Liability .  ACORDA shall defend, indemnify and hold MAYO and MAYO’s Affilitates, and their respective trustees, officers and employees, harmless from and against any and all claims, suits or demands for liability, damages, losses, costs and expenses (including the costs and expenses of attorneys and other professionals) (collectively, a “Claim”) arising out of or resulting from third party claims or suits resulting from: (i) the use by ACORDA or its Affiliates or Sublicensees of any of the Licensed Technology, (ii) the use by ACORDA or its Affiliates or Sublicensees of information concerning or obtained through the Program, or (iii) the manufacture, use, sale or offer for sale of a Licensed Product by ACORDA or its Affiliates or Sublicensees pursuant to this Agreement; provided that such Claim does not arise out of or result from a breach of any of MAYO’s representations or warranties made under
 
17

 
this Agreement, and provided further that such Claim is not covered by MAYO’s indemnification provided in Section 8.2.
 
ACORDA shall, during the term of this Agreement, carry occurrence-based liability insurance with policy limits of at least THREE MILLION DOLLARS ($3,000,000).  In addition, such policy shall name MAYO as an additional-named insured.
 
8.2                                  MAYO Indemnification .
 
(a)                                   MAYO shall defend, indemnify and hold ACORDA and its Affiliates and Sublicensees and their respective directors, officers and employees, harmless from and against any and all Claims arising out of or resulting from third party claims or suits resulting from (a) any negligence, recklessness or wrongful intentional acts or omissions of MAYO and its trustees, officers, employees and agents, including Dr.  Moses Rodriguez and Dr.  Larry Pease in connection with (i) the work performed by MAYO, Dr.  Moses Rodriguez or Dr.  Larry Pease under the Program, and (ii) any other development and/or commercialization work relating to any Licensed Products or Licensed Technology before the Effective Date, or thereafter in connection with MAYO’s, Dr.  Rodriguez’ or Dr.  Pease’s development of Licensed Products or Licensed Technology; excepting in any case to the extent any such Claims result from the negligence, recklessness or wrongful intentional acts or omissions of ACORDA or its Affiliates or Sublicensees, or their respective directors, officers, employees or agents.
 
(b)                                  Notwithstanding any other provision of this Agreement, including those which may impose any obligation or cost on ACORDA in ‘connection with patent prosecution, enforcement and infringement actions from third parties under Section .6, MAYO shall defend, indemnify and hold ACORDA and its Affiliates and Sublicensees and their respective directors, officers and employees, harmless from and against any and all Claims arising out of or resulting from third party claims or suits resulting from or in any way related to the TEVA Agreement and MAYO shall, at its sole expense, take all reasonable actions and adopt all reasonable positions with third parties in order to permit ACORDA full enjoyment of the exclusive license granted under this Agreement and to avoid or mitigate any conflicts between with the license hereunder and any rights which MAYO may have granted under the TEVA Agreement in ACORDA’s favor.
 
8.4                                  Notice; Waiver of Subrogation .
 
(a)                                   In the event that any person entitled to indemnification (an “Indemnitee”) seeks indemnification under this Section 8, the Indemnitee agrees to: (i) promptly inform the indemnifying Party (the “Indemnitor”) of any claim, suit or demand threatened or filed, (ii) permit the Indemnitor to assume direction and control of the defense or Claims resulting therefrom (provided that Indemnitor may not settle any Claim against an Indemnitee without the consent of the Indemnitee, which consent shall not be unreasonably withheld), and (iii) cooperate as requested (at the expense of the Indemnitor) in the defense of the Claim.
 
(b)                                  Except as otherwise expressly provide in this Agreement, each Indemnitor waives any right of subrogation that it may have against an Indemnitee resulting from any Claim for which an Indemnitor has agreed to indemnify an Indemnitee under Section 8 of this
 
18

 
Agreement.  Such waiver shall not, however, be deemed a waiver of any subrogation rights an Indemnitor may have against third parties.
 
9.                                       TERM AND TERMINATION.
 
9.1                                  Term .  This Agreement shall commence as of the Effective Date and, unless sooner terminated as provided hereunder, shall expire as follows:
 
(a)                                   As to each Licensed Product and as to each country in the Territory, on a country-by-country and Licensed Product-by-Licensed Product basis upon the expiration of the last to expire Licensed Patent in such Licensed Product or in such country, as the case may be.
 
(b)                                  This Agreement shall terminate in its entirety upon its termination as to all Licensed Patents in all countries.
 
9.2                                  Breach .  A Material Breach by either Party of any of the obligations contained in this Agreement shall entitle the other Party to give to the Party in default notice specifying the nature of the Material Breach and requiring it to cure such Material Breach.  If such Material Breach is not cured within 90 days after the receipt of such notice (or, if such Material Breach reasonably cannot be cured within such 90-day period, if the Party in default does not commence and diligently continue actions to cure such default during such 90-day period), the notifying Party shall be entitled, without prejudice to any of the other rights conferred on it by this Agreement, and in addition to any other remedies available to it at law or in equity, to terminate this Agreement by giving written notice to take effect on the date of such notice.  The right of either Party to terminate this Agreement, as provided in this Section 9.2, shall not be affected in any way by its waiver or failure to take action with respect to any previous Material Breach.
 
9.3                                  Insolvency or Bankruptcy .  In the event that either Party shall become insolvent, shall make an assignment to the benefit of creditors, or shall have a petition in bankruptcy filed for or against it (which, in the case of an involuntary petition, is not dismissed or stayed within sixty (60) days after such petition is.filed) (a “Bankrupt Party”), the other Party shall have the right to terminate this Agreement in its entirety immediately upon written notice of such Termination.  All rights and licenses granted by the Bankrupt Party under this Agreement are, and shall otherwise be deemed to be; for purposes of Section 365(n) of Title 11, US Code (the “Bankruptcy Code”), licenses of rights to “intellectual property” as defined under Section 101(60) of the Bankruptcy Code.  Unless the other Party elects to terminate this Agreement under this Section, the Parties agree that the other Party, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code, subject to the continued fulfillment of its obligations under this Agreement.
 
9.4                                  Termination by ACORDA .  ACORDA shall have the right to terminate the right and license granted herein, in whole or as to any Licensed Product in any country in the Territory, at any time, and from time to time, by giving written notice to MAYO.  Such termination shall be effective 90 days from the date such notice is given, and all of ACORDA’s rights associated with such Licensed Product(s) and such country(ies) shall cease as of that date, subject to Sections 9.5 through 9.7.
 
19

 
9.5                                  Right to Sell Stock on Hand .  Upon the termination of any right and license granted herein, in whole or as to any Licensed Product, for any reason other than ACORDA’s failure to cure a Material Breach of this Agreement, ACORDA shall have the right for one year or such longer period as the Parties may reasonably agree in writing to dispose of all Licensed Products or substantially completed Licensed Products then on hand to which such termination applies, and royalties shall be paid to MAYO with respect to such Licensed Products as though this Agreement had not terminated.
 
9.6                                  Effect of Termination .
 
(a)                                   Following the expiration of any right and license granted under this Agreement in whole or in part as to any Licensed Product in any country in the Territory pursuant to Section 9.1, ACORDA shall have the royalty-free, non-exclusive right to continue to use the Licensed Technology for the manufacture, use and sale of Licensed Products as theretofore licensed under this Agreement.
 
(b)                                  Upon Termination of this Agreement by ACORDA pursuant to Section 9.2 or 9.3: (i) MAYO shall promptly transfer to ACORDA copies of all data, reports, records and materials in MAYO’s possession or control that relate to the Licensed Products and return to ACORDA all relevant records and materials in MAYO’s possession or control containing Confidential Information ofACORDA, including all information concerning or obtained through the Program; (ii) ownership of all INDs, PLAs and other regulatory filings made or filed for any Product shall be transferred solely to ACORDA, and (iii) at ACORDA’s election, any sublicenses granted by ACORDA under the Licensed Technology shall be deemed terminated or automatically assigned to MAYO.
 
(c)                                   Upon Termination of this Agreement by MAYO pursuant to Section 9.2 or 9.3: (i) ACORDA shall promptly transfer to MAYO copies of all data, reports, records and materials in ACORDA’s possession or control that relate to the Licensed Products and return to MAYO all relevant records and materials in ACORDA’s possession or control containing Confidential Information of MAYO; (ii) all licenses granted for Licensed Technology by MAYO to ACORDA under Section 2 shall terminate; (iii) all sublicenses granted by ACORDA under the Licensed Technology shall be deemed automatically assigned to MAYO.  Thereafter, MAYO shall have the right to develop, make, have made, use, sell or have sold any Licensed Product.
 
(d)                                  Upon Termination of this Agreement by ACORDA pursuant to Section 9.4: (i) each Party shall promptly transfer to the other Party copies of all data, reports, records and materials of the other Party in the possession or control of such Party that relate to the Licensed Products; (ii) each Party shall promptly return to the other Party all relevant records and materials in such Party’s possession or control containing Confidential Information of the other Party; and (ii) all licenses granted by either Party to the other Party under Section 2 shall terminate.  Thereafter, each Party shall have the right to develop, make, have made, use, sell or have sold any Licensed Product, to the extent legally permissible.
 
9.7                                  Accrued and Surviving Rights and Obligat ions .  Termination, relinquishment or expiration of this Agreement for any reason shall be without prejudice to any rights, obligations or liabilities which shall have accrued to the benefit of either Party prior to such Termination, relinquishment or expiration (including, without limitation, ACORDA’s obligation to pay all
 
20

 
royalties which shall have accrued hereunder as of the effective date of such Termination).  The Parties’ rights and obligations under Sections 4, 6, 7, 8, 9.5, 9.6, 9.7, 10.5, and 10.12 shall survive Termination.
 
10.                                MISCELLANEOUS PROVISIONS.
 
10.1                            Relationship of Parties .  Nothing in this Agreement is intended or shall be deemed to constitute • a partnership, agency, employer-employee or joint venture relationship between the Parties.  No Party shall incur any debts or make any commitments for the other, except to the extent, if at all, specifically provided herein.
 
10.2                            Assignment .  Except as otherwise provided herein, neither this Agreement nor any interest hereunder shall be assignable by any Party without the prior written consent of the other, which consent shall not be unreasonably withheld; provided, however, that either Party may assign this Agreement to any wholly-owned subsidiary or to any successor by merger or sale of substantially all of those of its assets to which this Agreement relates in a manner such that the assignor shall remain liable and responsible for the performance and observance of all its duties and obligations hereunder.  This Agreement shall be binding upon the successors and permitted assigns of the Parties, and the name of a Party appearing herein shall be deemed to include the names of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Agreement.  Any assignment not in accordance with this Section 10.2 shall be void.
 
10.3                            Further Actions .  Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement..
 
10.4                            Force Majeure .  Neither Party shall be liable to the other for loss or damages or shall have any right to terminate this Agreement for any default or delay attributable to any act of God, flood, fire, explosion, strike, lockout, labor dispute, shortage of raw materials, casualty or accident, war, revolution, civil commotion, act of public enemies, blockage or embargo, injunction, law, order, proclamation, regulation, ordinance, demand or requirement of any government or subdivision, authority or representative of any such government, or any other.  cause beyond the reasonable control of such Party, if the Party affected shall give prompt notice of any such cause to the other Party.  The Party giving such notice shall thereupon be excused from such of its obligations hereunder as it is thereby disabled from performing for so long as it is so disabled and for 30 days thereafter.
 
10.5                            No Trademark Rights .  Except as otherwise provided herein, neither Party shall have any right, express or implied, to use in any manner, in connection with the performance of this Agreement, the name or other designation of the other Party or any other logo, name, tradename, service mark or trademark of the other Party, or the name of any employee or agent of the other Party, without that Party’s prior, written, express consent.  Either Party may withhold such consent in either Party’s absolute discretion.  For MAYO or its Affiliates, such names and marks include, but are not limited to, the terms “Mayo®,” “Mayo Clinic®,” or any simulation, abbreviation, or adaptation of the same.  Violation of this Section 10.5 by either
 
21

 
Party shall be deemed a Material Breach of this Agreement, entitling the other Party to appropriate equitable or legal relief.
 
10.6                            Public Announcements .  Except as required by law, including but not limited to, disclosures to prospective investors as required under applicable state and federal securities laws or as.  required for documents or other communications to be filed or distributed pursuant to requirements of the Securities and Exchange Commission, any stock exchange or NASDAQ, (“Permitted Public Announcement”) neither party shall make any public announcement concerning this Agreement or the subject matter hereof without the prior written consent of the other to the text of such public announcement.  In the event of a Permitted Public Announcement, the Party making such announcement shall provide the other with a copy of the proposed text prior to such announcement.  In the event that a party has obtained consent to the text of such other public announcement, such party shall be entitled to use and reuse, without limitation and in any form, such text in one or more public announcements.
 
10.7                            Notices .  All notices and other communications required or permitted to be given under or in connection with this Agreement shall be in writing, and shall be deemed given if delivered personally or by facsimile transmission (receipt verified), express courier service (signature required), or mailed by registered or certified mail (return receipt requested), postage prepaid, to the Parties at the following addresses (or at such other address for a Party as shall be specified by like notice; provided, that notices of a change or address shall be effective only upon receipt thereof):

(a)	If to ACORDA, to:	
 	 	
 	ACORDA THERAPEUTICS, INC.	
 	15 Skyline Drive	
 	Hawthorne, New York 10532	
 	Attention: President	
 	Facsimile No.: (914)347-4560	
 	 	
(b)	If to MAYO, to:	
 	 	
 	MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH	
 	200 First Street, SW	
 	Rochester, Minnesota 55905	
 	Attention: Office of Technology Commercialization, Mayo Medical Ventures	
 	Facsimile No.: 507-284-5410	
 
If delivered personally or by facsimile transmission, the date of delivery shall be deemed to be the date on which such notice or request was given.  If sent by overnight express courier service, the date of delivery shall be deemed to be the next business day after such notice or request was deposited with such service.  If sent by registered or certified mail, the date of delivery shall be deemed to be the third business day after such notice or request was deposited with the U.S.  Postal Service.
 
10.8                            Amendment .  No amendment, modification or supplement of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party, and specifically referencing this Agreement.
 
22

 
10.9                            Waiver .  No provision of this Agreement shall be waived by any act, omission or knowledge of a Party or its agents or employees except by an instrument in writing expressly waiving such provision and signed by the waiving Party.
 
10.10                      Severability .  Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement.
 
10.11                      Compliance with Law .  Nothing in this Agreement shall be deemed to permit a Party to export, reexport or otherwise transfer any Know-How transferred hereunder or Licensed Products manufactured therefrom without compliance with applicable laws.
 
10.12                      Governing Law and Jurisdiction .  This Agreement shall be governed by Minnesota law, but specifically not including Article 2 of the Uniform Commercial Code as enacted in Minnesota.  This is not a contract for the sale of goods.  In addition, no Minnesota conflicts-of-law or choice-of-laws provisions apply to this Agreement.  To the extent the substantive and procedural law of the United States would apply to this Agreement, it supersedes the application of Minnesota law.  The parties agree that all disputes between them concerning this contract, other than as provided for in Section 5.4 hereto, whether arising before or after Termination, will be settled only according to the arbitration process described in Exhibit D, attached to and incorporated into this Agreement, and not through any action at law or in equity, except as otherwise permitted under Exhibit D.
 
10.13                      Entire Agreement of the Parties .  This Agreement, including the exhibits attached, constitutes and contains the entire understanding and agreement of the Parties and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether oral or written, between the Parties respecting the subject matter hereof.
 
10.14                      Descriptive Headings .  The descriptive headings of this Agreement are for convenience only, and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement.
 
10.15                      Nondisclosure .  Neither Party shall disclose any of the terms of this Agreement without the express, prior, written consent of the other Party, or unless required by law.
 
10.16                      Counterparts .  This Agreement maybe executed in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same agreement.
 
* * *
 
23

 
IN WITNESS WHEREOF, each of the Parties has caused this License Agreement to be signed by its duly authorized representative as of the date first written above.

 	ACORDA THERAPEUTICS	

 	By:	/s/ Ron Cohen	 	
 	 	
 	Name: Ron Cohen	
 	 	
 	Title: President and CEO	

 	MAYO FOUNDATION FOR MEDICAL
EDUCATION AND RESEARCH	

 	By:	/s/ Rick F. Colvin	 	
 	 	
 	Name: Rick F.  Colvin	
 	 	
 	Title:  Assistant Treasurer	

24

 
Exhibit 10.21

AERES BIOMEDICAL LIMITED	 	ACORDA THERAPEUTICS	
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
RESEARCH COLLABORATION AND COMMERCIALISATION
AGREEMENT
 
This Agreement is made the           day of February, 2002, (the “Effective Date”) between
 
(1)                AERES Biomedical Limited, whose principal place of business is situated at 1-3 Burtonhole Lane, Mill Hill, London NW7 1AD, England (hereinafter also called “AERES”)
 
and:
 
(2)                Acorda Therapeutics, Inc., whose principal place of business is situated at 15 Skyline Drive, Hawthorne, NY 10532 (hereinafter also called “ACORDA”); and:
 
Recitals
 
WHEREAS , ACORDA has research expertise, know-how and proprietary rights relating to discovery research leading toward new therapeutic products based on ACORDA monoclonal antibodies; and
 
WHEREAS , ACORDA has identified and developed know-how and proprietary rights to certain monoclonal antibodies, including the antibodies designated by ACORDA as Lym22 and Lym46, which may be capable of promoting the re-myelination of nerve sheaths in certain degenerative disease conditions; and
 
WHEREAS , AERES has developed processes and vectors to create stable cell lines expressing antibody genes and producing antibodies for research which are likely to be suitable for further development and optimisation for large scale manufacture; and
 
WHEREAS , AERES has genetic engineering expertise to modify antibodies expressed as IgM so that they are expressed as IgG, which modification is sometimes, in one aspect, commonly referred to as “class switching”; and
 
WHEREAS , ACORDA wishes AERES create stable cell lines involving inter-alia the modification of antibodies Lym22 and Lym46 in accordance with the research plan set out in Annex A hereto and referred to herein as the “Research Plan”; and
 
WHEREAS , AERES has the necessary expertise and facilities and is willing to perform such services for ACORDA.
 
1

 
NOW, THEREFORE , in consideration of the foregoing promises and of the mutual covenants and obligations hereinafter set forth, the parties agree as follows:
 
ARTICLE I - Definitions
 
As used in this Agreement, the following terms when used with initial capital letters shall have the following meanings and, where the context so permits, the singular shall include the plural and vice versa:
 
1.1               “Affiliate” shall mean any entity that directly or indirectly controls, is controlled by, or is under common control with a party, and for such purposes “control” shall mean ownership of more than fifty percent (50%) of the voting interest, or such lower maximum amount allowed by the law governing the ownership of said organization. For the purposes of this Agreement, any reference to “ACORDA” shall where the context so permits mean same reference to “ACORDA (and/or) its Affiliates” , and any reference to “AERES shall, where the context so permits, mean same reference to “AERES (and/or) its Affiliates.
 
1.2               “Commercial Introduction” in a given country shall mean the date upon which ACORDA or one or more Licensees (as defined hereunder) have first achieved Net Sales in such country following the final issuance of all required licences and approvals by the United States Food and Drug Administration (“FDA”) (or equivalent licences and approvals in countries other than the United States) allowing for the manufacture and sale of a Product for human use.
 
1.3               “Field” shall mean the development and production of antibodies potentially capable of promoting the re-myelination of human nerve fibres in certain degenerative disease conditions.
 
1.4               “Invention” shall mean an invention by either party arising from work conducted pursuant to the Research Plan.
 
1.5               “Know-how” shall mean all information and know-how in the Field which is owned with the right to disclose or otherwise controlled during the term of this Agreement, including, without limitation, processes, techniques, methods, products, transformed cells, other biological materials and compositions which are related to the Field.
 
1.6               “Licence” shall mean any licence granted by Acorda to make or have made, use, distribute and/or sell Products.
 
2

 
1.7               “Licensee” shall mean any organisation licensed by ACORDA to make or have made, use, distribute and/or sell Products.
 
1.8               “Net Sales” shall mean actual billings by ACORDA and/or its Licensees to independent third parties for Products less the following amounts:
 
(i) discounts or rebates actually allowed or granted; (ii) credits or allowances actually granted on rejections or returns, including for recalls or damaged goods (not exceeding the original billing); (iii) outbound freight, postage, shipping and insurance charges prepaid or allowed; (iv) bad debts relating to sales of Products that are actually written off by ACORDA in accordance with generally accepted accounting principles, consistently applied, during the applicable royalty calculation period; and (iv) sales, tariff duties and/or use taxes or other similar governmental charges included in the invoiced amount.  No allowance or deduction shall be made for commissions or collections, by whatever name known.
 
1.9               “Product” shall mean any product incorporating or derived from an antibody that is produced by a Stable Cell Line.
 
1.10         “Stable Cell Line” shall mean any cell line made by AERES and contracted by ACORDA hereunder together with any such cell line subsequently developed and optimised for the manufacture of antibodies.
 
1.11        “Third Party” shall mean any entity other than AERES or ACORDA and their respective Affiliates.
 
Article II - Research Collaboration
 
2.1                                  Upon the execution of this Agreement and the receipt from ACORDA of the necessary materials and information as specified in Article 2.2 below, AERES will undertake the class switching of ACORDA antibodies Lym22 and/or Lym46 together with the creation of a Stable Cell Line expressing each antibody in accordance with the Research Plan set forth in Annex A hereto.
 
3

 
2.2                                  ACORDA shall, at its expense and without charge to AERES, deliver to AERES ACORDA antibodies Lym22 and Lym46 and plasmids incorporating genes expressing said ACORDA antibodies and such Know-how including related technical information as sufficient (in the reasonable judgement of both parties) to enable AERES to carry out the Research Plan.  AERES shall disclose to ACORDA all Know-how created or used in carrying out the Research Plan and shall make such disclosure only to ACORDA except as provided in Article VII.
 
2.3                                  AERES shall permit duly authorized employees of ACORDA to have access to AERES’s laboratories from time to time at mutually agreeable times and upon reasonable notice.
 
2.4                                  ACORDA shall obtain and retain all rights, title and interest in DNA and RNA sequences expressing ACORDA antibodies Lym22 and Lym46 and any and all cell lines (including Stable Cell Lines) expressing the same.  AERES hereby assigns and agrees to assign all rights, title and interest in DNA and RNA sequences expressing ACORDA antibodies Lym22 and Lym46 and any and all cell lines (including Stable Cell Lines) expressing the same, and in all Inventions of AERES relating to any of the foregoing.  Antibodies Lym22 and Lym46 and cell lines for their production will be maintained within the sole possession and control of AERES (other than transfer to ACORDA as contemplated herein), and will not be distributed, transferred or sold by AERES to any third party for any purpose whatsoever without the prior written consent of ACORDA.
 
2.5                                  AERES shall retain all rights, title and interest in antibody engineering techniques, gene expression vectors, materials and Know-how used or developed in the course of the Research Plan at Annex A, including the use of such vectors for the expression of any gene or gene construct other than DNA and RNA sequences encoding genes and gene constructs developed for ACORDA hereunder.  In particular, information relating to antibody engineering techniques and gene expression vectors comprising Know-how used or developed by AERES in the course of the Research Plan at Annex A shall be (or remain) the confidential property of AERES, and information (“Information”) concerning DNA and RNA sequences expressing ACORDA antibodies Lym22 and Lym46, including protein, DNA, RNA, cell lines, and anything derived therefrom generated by AERES in the course of carrying out the Research Plan (“Materials”) shall be (or remain) the confidential property of ACORDA.
 
4

 
2.6                                  AERES agrees that, at ACORDA’s request, it will return to ACORDA any and all Information provided by ACORDA in documentary form and any and all unused Materials and will return or destroy the same and any copies thereof made by AERES, its directors, officers or employees, except that, in the event that ACORDA shall have failed on a timely basis to pay AERES in full the payments required under Article III of this Agreement, AERES shall have the right to provide written notice describing such failure and if ACORDA does not cure the failure to pay within thirty (30) days of receipt of such notice, then AERES will have the right to withhold and destroy any materials created during any stage of the Research Plan in respect of which payment has not been made in full unless an alternative payment has been agreed by the parties and paid in full pursuant to the provisions for early termination of the Research Plan set out in Article 8.4 below.  AERES may, subject to the continuing obligations of non-disclosure and non-use expressed herein, retain one copy of the Information in its legal files and a sample of the Materials in a secure depository, solely in order to be able to evidence the work performed hereunder if so required for any future legal or regulatory purpose but for no other use.
 
2.7                                  Except for the limited rights expressly granted in this Article II, nothing herein shall be deemed to grant to either party any other rights or licences under any patent applications or patents or under any know-how, technology or inventions of the other party.
 
2.8                                  AERES covenants that it shall not provide to any Third Party any services in the Field similar to those contemplated in this Agreement for a period of one year from the Effective Date.
 
Article III - Payments for Research Plan
 
3.1                                  ACORDA will pay AERES, for its research efforts carried out in accordance with Annex A, the payments set forth in the cost schedules attached at Annex B which shall be invoiced by AERES on signature of this Agreement and on completion of each of the research Milestones specified in Annex A.  ACORDA shall make payment in settlement of said invoices by wire transfer in Pounds Sterling (UK£) within 30 (thirty) days of the receipt of invoice to the account of AERES Biomedical Ltd. at “The Royal Bank of Scotland, London Cavendish Square Branch” (Bank Sort Code 16-00-30, Account No. 10114879), or such other account as shall be nominated by AERES  from time to time, and the transaction identified as “Agreement dated [as hereinabove] with ACORDA Therapeutics.
 
5

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
3.2                                  In the event that ACORDA does not agree that any one of the above Milestones has been met, ACORDA shall notify AERES within 10 (ten) working days from the date of delivery of the materials and written report relating to said Milestone.  On receipt of said notification, AERES will hold invoicing in respect of said Milestone for up to 30 (thirty) days, and ACORDA and AERES will each use best efforts to reach agreement on the clarification and redefinition of the Milestone(s) and (if applicable) the corresponding cost schedule.  In the event of an unresolved dispute arising under this Article 3.2, AERES can cease all ongoing work hereunder until such dispute is resolved, and the Parties will seek in good faith a mediation to assist in resolving the dispute as soon as practicable.
 
3.3                                  All payments hereunder shall be made free and clear of and without deduction or deferment in respect of any demand, set-off, counterclaim or other dispute. ACORDA and AERES shall use their best endeavours to do all such lawful acts and to sign all such lawful documents as will enable ACORDA to take advantage of any applicable legal provision or any double taxation treaty with the object of paying the sums due AERES without imposing or withholding any tax.
 
Article IV - Royalty Payments
 
4.1                                  ACORDA shall pay to AERES, in consideration for the use of its proprietary gene expression vectors, materials and Know-how used in the construction by AERES of a Stable Cell Line, an earned royalty of [*] of the Net Sales of ACORDA and its Licensees as defined herein.  Unless prohibited by law, ACORDA’s obligation to pay such earned royalties shall subsist and shall continue for a period of twelve (12) years after Commercial Introduction in any country.  Thereafter, ACORDA shall have a fully paid-up licence to make or have made, use and/or sell Products in said country.
 
4.2                                  Sales between ACORDA, its Affiliates and Licensees shall not be subject to a royalty, but in such cases the royalty specified in Article 4.1 shall be calculated upon such Affiliates’ and Licensees’ Net Sales to independent third parties.
 
4.3                                  ACORDA agrees that any Licence granted by it shall provide that the obligations owed by ACORDA to AERES under Articles IV, V, VII and X of this Agreement shall be reflected in the wording of the said Licence by a consistent and equivalent obligation on the part of the Licensee to ACORDA, which ACORDA shall use its best endeavours to enforce to the benefit of AERES, in the event of any breach thereof.  In particular, ACORDA shall use reasonable efforts to place AERES in a position where AERES can adequately monitor and enforce payment of all royalties due to it in consequence of this Agreement.
 
6

 
4.4                                  ACORDA agrees to provide to AERES written notification of any fully executed Licence entered into by ACORDA.  Such notification shall include confirmation that the Licence conforms to the provisions of Article 4.3 and shall provide all relevant information pursuant to Article 4.3 including the scope of the Licence in terms of manufacturing and/or distribution, marketing and/or sales and the territories covered.
 
Article V - Reports and Records
 
5.1                                  ACORDA shall keep full, true and accurate books of account containing all particulars that may be necessary for the purpose of showing the amounts payable to AERES and the accuracy of the reports made to AERES hereunder.  Such records shall be retained by ACORDA for three (3) years following the end of the calendar year to which they pertain. If so requested by AERES, abstracts thereof shall be made by an independent, certified public accountant appointed by AERES, all at the expense of AERES, except in the event that the results of the audit reveal a discrepancy to be corrected in AERES’s favour of five percent (5%) or more, then the audit fees shall be paid by ACORDA.  Any such discrepancies will be promptly corrected by a payment or refund as appropriate.
 
5.2                               ACORDA, within ninety (90) days after March 31, June 30, September 30 and December 31, of each year after Commercial Introduction, shall deliver to AERES true and accurate reports, giving such particulars of the business conducted by ACORDA, its Affiliates and Licensees during the preceding quarter as shall be pertinent to a royalty accounting hereunder.  These shall include at least the following:
 
(a)                                   number of Products sold;
 
(b)                                  total billings for Products sold on a country-by-country basis;
 
(c)                                   deductions applicable as provided in Article 1.8;
 
(d)                                  total royalties due;
 
(e)                                   names and addresses of all Affiliates and Licensees of ACORDA under this Agreement.
 
5.3                                  With each such report submitted, ACORDA shall pay to AERES the royalties due and payable under this Agreement.  If no royalties shall be due, ACORDA shall so report.
 
5.4                                  The royalties due shall be paid by ACORDA to AERES in Pounds Sterling (UK£) and shall be remitted to a bank designated in writing by AERES.
 
7

 
5.5                                  If a sum payable under this Agreement shall be overdue for thirty (30) days, ACORDA shall pay AERES interest on the sum outstanding at the rate of six percent (6%) per annum above the base rate of the Royal Bank of Scotland plc applying and calculated on a daily basis from the date that payment became due in respect of said sum; provided however, that if such interest rate shall be in excess of that allowed by applicable law, then the highest rate permitted by law shall apply.  The payment of such interest shall not foreclose AERES from exercising any other rights it may have a consequence of the lateness of any payment.
 
Article VI - Warranties and Representations
 
6.1                                  AERES warrants and represents that, to the best of its knowledge and belief, there are no known outstanding claims or encumbrances which would prevent ACORDA from making, using or selling Products. AERES warrants and represents that the use of AERES’ gene expression vectors as currently designed, the expression of recombinant proteins (including antibodies) in eukaryotic cell lines (including CHO cells) and/or the selection strategies used by AERES to identify and amplify the eukaryotic cell clones expressing recombinant proteins and ACORDA’s use, development and commercialization of Products will not infringe United States Patent No. 5,225,539.  ACORDA however acknowledges the existence, inter alia , of the third party patents listed in Exhibit C whose claims may cover the use of AERES’ gene expression vectors as currently designed, the expression of recombinant proteins (including antibodies) in eukaryotic cell lines (including CHO cells) and/or the selection strategies used by AERES to identify and amplify the eukaryotic cell clones expressing recombinant proteins . For the avoidance of doubt, ACORDA hereby accepts and agrees that it has the sole responsibility to pursue and enter into any third party licences that may be necessary for this purpose.
 
6.2                                  Except as otherwise expressly set forth in this Agreement, AERES makes no representations and extends no warranties of any kind, either express or implied, in respect of antibodies Lym22 and Lym46 or any vector or cell line expressing the same or any information or materials provided to ACORDA hereunder including but not limited to warranties of merchantability, fitness for any particular purpose, or the validity of any patent rights, issued or pending.
 
6.3                                  Each of AERES and ACORDA warrant and represent to the other that it has the full right and authority to enter into this Agreement, and that it is not aware of any impediment which would compromise or limit its ability to comply fully with the terms and conditions of this Agreement.
 
8

 
Article VII - Secrecy
 
7.1                                  Any information of a confidential nature conveyed by one party to the other under this Agreement and marked as “confidential” shall be the “Confidential Information” of such party (except as otherwise provided below in this Article VII), and may include, but not restricted to, Know-how created or used in the development of Stable Cell Lines or the production of antibodies.  All Confidential Information of a party shall be treated as strictly confidential by the other party during the term of this Agreement and for five (5) years thereafter, as if it were its own proprietary and confidential information, and such party shall take all reasonable steps to insure that the other’s Confidential information will not be disclosed or communicated to third parties or used for purposes other than for carrying out its obligations or exercising its express rights granted under this Agreement.
 
7.2                                  A party shall be relieved of the obligations of Section 7.1 solely with respect to particular Confidential Information of the other party to the extent that such party can demonstrate by proper evidence that such Confidential Information:
 
1)                                       was known by such party prior to disclosure of such Confidential Information to it by the other party; or
 
2)                                       is or becomes publicly known through no fault or omission attributable to such party; or
 
3)                                       is lawfully obtained by such party from a third party that has the right to disclose such information without a duty of confidentiality and is in lawful possession thereof.
 
For clarity, any Confidential Information of ACORDA that was originally developed by AERES hereunder and assigned to ACORDA as provided in Article II, shall not be subject to the exception to confidentiality in subclause 1) above.
 
7.3                                  AERES hereby confirms that information concerning the remyelinating antibody program, together with the vectors and cell lines expressing the same, gene constructs containing including, without limitation, protein, DNA, RNA, plasmids and organisms, and anything derived therefrom (the “Materials”) together with any confidential or proprietary information obtained from ACORDA or developed for ACORDA under the Confidential Disclosure Agreement of               or generated by AERES in the course of performing Services under this Agreement, are and shall be the Confidential Information of ACORDA, and shall be subject to all the obligations of AERES under Section 7.1.
 
9

 
7.4                                  Notwithstanding the limitations in this Article VII, each party shall have the right to disclose such Confidential Information solely to the extent required under any law, ruling or regulation of a governmental agency or a court of competent jurisdiction, and for the purpose of satisfying national, state or local requirements in order to conduct studies with the Product or to obtain regulatory approval for the commercial sale of a Product, provided, however, that such disclosing party will first give reasonable advance notice to the other party of such required disclosure and will use its best efforts to limit such disclosure to that which is required and to secure confidential treatment, or to assist the other party in securing a protective order or confidential treatment, of such information prior to its disclosure (whether through protective orders or otherwise).
 
7.5                                  The obligations imposed upon the parties under this Article VII shall survive termination of this Agreement for any reason whatsoever and continue for five years thereafter.
 
Article VIII - Term and Termination
 
8.1                                  The term of this Agreement shall commence on the effective date and shall continue on a country by country basis until no further payments in a given country are due from ACORDA to AERES under this Agreement unless terminated in accordance with the sections set forth below.
 
8.2                                  Either party may terminate this Agreement forthwith upon notice to the other party in the event of such other party going into insolvent liquidation or having a winding up order made against it unless such order is rescinded within 30 days.
 
8.3                                  Upon any material breach or default of this Agreement by either party, other than as set out in Article 8.2 above, which shall always take precedence in that order over any material breach or default referred to in this Article 8.3, the non-breaching party shall have the right to terminate this Agreement and the rights, privileges and license granted hereunder by ninety (90) days’ notice to the breaching party.  Such termination shall become effective unless the breaching party shall have cured any such material breach or default prior to the expiration of the ninety (90) day period, or has contested the existence of, or failure to cure, a material breach and has obtained an injunction from a court of competent jurisdiction granting a stay of termination, or the parties have agreed to proceed with the resolution of the dispute as provided in Article 10.1.
 
10

 
                Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [  ] and an asterisk*, have been separately filed with the Commission.
 
8.4                                  ACORDA may terminate the Agreement at any time prior to completion of the work under the Research Plan at Annex A on one (1) month’s prior written notice to AERES, except that ACORDA shall not be permitted to terminate the Research Plan prior to the completion of research Milestone 1 (at Annex A), and provided that if ACORDA for any reason terminates this Agreement during any subsequent stage of the Research Plan (as defined by the corresponding research Milestone) then ACORDA shall pay AERES for that stage an amount invoiced by AERES which shall be in the same proportion to the total amount payable in respect of the corresponding research Milestone (specified in Annex A) as the proportion of the total amount of work carried out by AERES when such notice of termination by ACORDA pursuant to this Article 8.4 takes effect.  AERES shall use its reasonable endeavours to mitigate and reduce its costs incurred in respect of any incomplete stage. Unless ACORDA has terminated this Agreement as provided hereunder, ACORDA shall be deemed to have approved the commencement of the next stage of the Research Plan specified in Annex A, thirty-five (35) days after completion of Milestone 1.
 
8.5                                  Upon termination of this Agreement for any reason, nothing herein shall be construed to release either party from any obligation that matured prior to the effective date of such termination.  In particular, the termination of this Agreement for any reason shall be without prejudice to:
 
a)                                       any party’s right to receive all payments to which such party is entitled under this Agreement and obtain performance of any obligations provided for in this Agreement which survive termination by their terms or by fair interpretation of this Agreement; and
 
b)                                      any other remedies which any party may then or thereafter have hereunder.
 
8.6                                  The right of either party to terminate this Agreement shall not be affected in any way by its waiver of or failure to take action with respect to any previous default.
 
Article IX - Patents
 
9.1                                  Any and all patents and patent applications arising out of the Research Plan specified in Annex A which include claims or statement of inventions [**] shall be owned by ACORDA which shall have the sole right to file such applications and will meet all costs in relation thereto.  AERES will assign any and all rights as necessary to vest such ownership in ACORDA.
 
11

                Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [  ] and an asterisk*, have been separately filed with the Commission.
 
9.2                                  In the event that ACORDA wishes to include in any patent application referred to in Article 9.1 any statement of invention (claim) to a patentable invention [**] then ACORDA shall advise AERES of the same and shall consult with AERES as to the programme of patent protection to be initiated and such patent application shall be filed in the appropriate names in accordance with the law of the country of filing.  AERES shall have the right to file a separate programme of patent protection solely in the name of AERES claiming priority rights from said application for [**]  and ACORDA shall have the right to file a programme of patent protection solely in the name of ACORDA claiming priority rights from said application for the protection of the production of antibodies within the Field.  Notwithstanding the foregoing, ACORDA shall prior to filing any such patent application disclose the same to AERES which shall have the right to comment on the wording of the said patent application and its statements of invention (claims) relating to processes of obtaining antibodies, such comments shall be reasonably considered by ACORDA. Where such patent application has been filed by ACORDA, each party shall provide to the other the necessary documentation to allow such party to proceed with a programme of patent protection in its own name as provided above.
 
9.3                                  The parties shall consult and co-operate fully on patent filings as provided in Article 9.1 and 9.2 but this shall not delay timely filing of patent applications by either party.  Each party shall supply the other in a timely manner with copies of relevant patent applications and drafts or amendments thereof as provided in Article 9.2.  Each party shall reasonably assist the other in filing, prosecution and maintenance of patent applications and patents arising from the collaboration.
 
9.4                                  When ACORDA undertakes filing, prosecution and maintenance of patent applications using its patent attorneys and if ACORDA does so after having both consulted and afforded AERES the opportunity to comment on said patent applications and/or file separately pursuant to Article 9.2 then neither ACORDA nor its patent attorneys shall be liable to AERES in respect of any act, omission, default or neglect on the part of the patent attorneys.
 
12

                Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [  ] and an asterisk*, have been separately filed with the Commission.
 
9.5                                  For the avoidance of doubt it is hereby stated that ACORDA will not exert any of its claims to intellectual property arising out of the collaboration pursuant to this Agreement against AERES in a manner which would inhibit AERES’s freedom to work in the general area of [**] AERES shall not, except in the event of an uncured material breach by ACORDA of this Agreement, exert any of its claims to intellectual property arising out of the said collaboration, against ACORDA in a manner which would inhibit ACORDA from commercialising any Product.
 
9.6                                  This Article 9 shall survive termination of this Agreement.
 
Article X - Arbitration
 
10.1                            If there is any dispute between the parties relating to the interpretation, implementation or application of this Agreement, or any other matter in connection with it, they will attempt in good faith to negotiate a settlement.  If the matter is not resolved by negotiation, the parties will refer the dispute to mediation in accordance with CEDR (Centre for Dispute Resolution, London) procedures (“ADR”).  If the parties fail to agree on a settlement within 28 days of the initiation of the ADR procedure, either party may refer the matter to binding arbitration by a sole arbitrator.  Unless otherwise agreed by the parties, the place of the arbitration shall be London, England.  The arbitrator shall be agreed by the parties, but if they fail to agree within 14 days of one party giving the other written notice requiring arbitration, either can apply to the President for the time being of the Law Society of England and Wales, who shall then nominate an appropriate independent arbitrator who shall, insofar as practicable, have experience in disputes of the nature which has arisen.  The decision of the arbitrator will be binding on both parties and the issues decided by the arbitrator shall not be raised in legal proceedings by either party.  Reference to mediation or arbitration shall be without prejudice to the rights of the parties to seek an injunction or other emergency interim relief before any court of competent jurisdiction.
 
Article XI - Miscellaneous
 
11.1                            Any notice required to be given hereunder shall be considered properly given if in writing, delivered personally or by facsimile (and promptly confirmed by personal delivery or courier), courier, telex or other electronic media or by first-class mail with postage properly prepaid addressed to the other party at the respective address as shown below.  Either party may change its address by written notice:
 
13

 

If to ACORDA:	
 	
Acorda Therapeutics, Inc.,	
15 Skyline Drive,	
Hawthorne,	
NY 10532	
U.S.A.	 	
Attention:	President	
 	
If to AERES:	
 	
AERES Biomedical Ltd.	
1-3 Burtonhole Lane	
Mill Hill	
London, NW7 1AD	
U.K.	 	
Attention:	Chief Operating Officer	

11.2                            Each of the parties shall contribute, to the extent reasonable, facilities, supplies, personnel and other resources without charge or expense to the other as may be necessary for proper performance of the respective obligations under this Agreement and that are consistent with Annex A.  To the extent reasonable and except as may otherwise be expressly provided, each party shall bear its own out-of-pocket costs and disbursements incurred in the performance of this Agreement.
 
11.3                            Nothing contained in this Agreement, or otherwise, shall constitute the parties as partners with one another or render either liable for the debts or obligations of the other.  Furthermore, nothing in this Agreement shall be construed to constitute, create, give affect to or otherwise imply a joint venture or formal business organization of any kind.
 
11.4                            Except as required by law, neither party shall use any of the names of the other party, nor of any Affiliate, shareholder, director, employee or associate of the other party, in connection with any publicity, including but not limited to any brochure, press release or statement to the press without the prior approval of the other party confirmed in writing, which shall not be unreasonably withheld.
 
14

 
11.5                            ACORDA agrees to indemnify and hold harmless AERES and its Affiliates, and their respective officers, employees and agents from and against any and all claims, damages and liabilities asserted by third parties, both government and private, arising from the manufacture, use or sale of Products by ACORDA or by its Affiliates or Licensees, or by any other party so authorised by ACORDA or by its Affiliates or Licensees, or the use thereof by others, against said claims, damages and liabilities including ultimate consumers except to the extent that such claims, damages and liabilities arise from the gross negligence or wilful misconduct of AERES.
 
11.6                            AERES agrees to indemnify and hold harmless ACORDA from and against any and all loss or damage suffered by ACORDA if it is unable to obtain final issuance of all required licences and approvals by the FDA (or the equivalent licences and approvals in countries other than the United States) allowing for the manufacture and sale of a Product for human use and such failure results from the negligence or willful misconduct of AERES in relation to information or materials provided by AERES, provided always:  (a) that ACORDA shall use all due diligence to identify and bring to the attention of AERES any potential deficiencies in the information or materials provided by it, so as to afford AERES a reasonable opportunity of rectifying the same; and  (b) that ACORDA shall itself act with all due diligence in avoiding unnecessary or premature costs or losses; and  (c) that (for the avoidance of doubt) this indemnity shall not extend to any indirect or consequential loss nor any claim, damage or liability arising in respect of Affiliates, Licensees, distributors or ultimate consumers of Products.
 
11.7                            This Agreement and the rights and licence granted herein shall be binding upon and shall inure to the benefit of successors of the parties hereto, or to an assignee of all or substantially all of the goodwill and entire business and assets of a party hereto, but shall not otherwise be assignable without the prior written consent of the other party, which consent will not be unreasonably withheld but shall be conditional, inter alia , upon the formal acceptance by the assignee of the payment obligations and terms and conditions of this Agreement.
 
11.8                            The parties hereto acknowledge that this Agreement sets forth the entire Agreement and understanding of the parties hereto as to the subject matter hereof, and shall not be subject to any change or modification except by the execution of a written instrument subscribed to by the parties hereto.
 
11.9                            The failure of any party to exercise or enforce any right granted in this Agreement shall not be deemed to be a waiver of such right or operate to bar the exercise of enforcement thereof at any time or times thereafter.
 
15

 
11.10                      Except where required by law, neither party shall use the name of any other party or make specific reference to the terms of this Agreement in any press release, advertisement or other public statement without the prior written consent and approval of the other party.
 
11.11                      The provisions of this Agreement are severable, and in the event that any provision of this Agreement shall be determined to be invalid or unenforceable under any controlling body of the law, such invalidity or unenforceability shall not in any way affect the validity or enforceability of the remaining provisions hereof.
 
11.12                      This Agreement shall be construed, governed, interpreted and applied in accordance with the laws of England, except that questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent was granted.
 
11.13       All captions herein are for convenience only, and shall not be interpreted as having any substantive effect.
 
IN WITNESS THEREOF , the parties hereto have caused this Agreement to be duly executed in duplicate by their authorized officers effective as of the date first written above.

AERES BIOMEDICAL LTD.	

By:	 	 	
 	
 	Dr Tarran Jones	
 	Chief Executive Officer	

Date:	
 	
Acorda Therapeutics, Inc.	

 	
By:	 	 	By:	 	 	

Date:	Date:	
 
16

 

AERES BIOMEDICAL	ANNEX A	COMMERCIAL IN CONFIDENCE	
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [               ] and an asterisk*, have been separately filed with the Commission.
 
ANNEX A
 
Stable Expression of a Recombinant Antibody in CHO Cells
and Subsequent CHO Cell Line Development
 
[*]
 
1

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
[*]
 
2

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
[*]
 
3

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Research Milestones
 
Milestone 1.
 
[*]
 
Milestone 2.
 
[*]
 
4

 

AERES BIOMEDICAL	ANNEX B	COMMERCIAL IN CONFIDENCE	
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
ANNEX B
 
Payments
 
The following payments will be invoiced to CUSTOMER and will be paid to AERES Biomedical Limited on signature and subsequently upon completion of each of the Milestones specified in Annex A. [*] of the total contract price will be invoiced to Acorda Therapeutics and will become due to AERES Biomedical immediately upon signature of the Agreement.  The advance payment in respect of each Stable Cell Line contracted for is non-refundable.

For the first Stable Cell Line (Lym22 or Lym46)	
 	
 	•	Advance Payment:	 	[*]	
 	 	 	 	 	
 	•	Completion of Milestone 1:	 	[*]	
 	 	 	 	 	
 	•	Completion of Milestone 2:	 	[*]	
 	
For the second Stable Cell Line (Lym46 or Lym22)	
 	 	 	 	 	
 	•	Advance Payment:	 	[*]	
 	 	 	 	 	
 	•	Completion of Milestone 1:	 	[*]	
 	 	 	 	 	
 	•	Completion of Milestone 2:	 	[*]	

A milestone shall be considered completed for the purpose of payment when Acorda Therapeutics has received all documentation and materials required to be transferred as described under the applicable milestone description in Annex A above.
 
Payment terms are 30 days from date of invoice
 
5

 

AERES BIOMEDICAL	 	 	
 
ANNEX C
 
Third Party Patents of which AERES is aware as of January 2002
 
HCMV PATENTS
 
US5168062 : Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter-regulatory DNA sequence
 
INVENTORS: Stinski; Mark F.
ASSIGNEES: University of Iowa Research Foundation
ISSUED: Dec. 1 , 1992
FILED: Sep. 10, 1990
SERIAL NUMBER: US1990000582130
 
ABSTRACT:
 
The cloning of a eucaryotic promoter-regulatory region that functions preferentially in human cells is disclosed. The invention is exemplified by the cloning of a section of the human cytomegalovirus genome comprising a DNA sequence with regulatory and promoter signals and an initiation site for RNA synthesis. The fragment, termed the human cytomegalovirus (HCMV) promoter-regulatory sequence, was obtained from purified HCMV DNA.
 
US5385839 : Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter regulatory DNA sequence
 
INVENTORS: Stinski; Mark F.
ASSIGNEES: University of Iowa Research Foundation
ISSUED: Jan. 31, 1995
FILED: June 17, 1992
SERIAL NUMBER: US1992000900056
 
ABSTRACT:
 
The cloning of a eucaryotic promoter-regulatory region that functions preferentially in human cells is disclosed. The invention is exemplified by the cloning of a section of the human cytomegalovirus genome comprising a DNA sequence with regulatory and promoter signals and an initiation site for RNA synthesis. The fragment, termed the human cytomegalovirus (HCMV) promoter-regulatory sequence, was obtained from purified HCMV DNA.
 
6

 
DHFR SELECTION PATENTS
 
US4399216: Processes for inserting DNA into eucaryotic cells and for producing proteinaceous materials
 
INVENTORS: Axel R., Wigler M.H., Silverstein S.J..
ASSIGNEES: The Trustees of Columbia University , New York, NY
ISSUED: Aug. 16, 1983
FILED: Feb. 25, 1980
SERIAL NUMBER: US1980000124513
 
ABSTRACT:
 
The present invention relates to processes for inserting DNA into eucaryotic cells, particularly DNA which includes a gene or genes coding for desired proteinaceous materials for which no selective criteria exist. The insertion of such DNA molecules is accomplished by cotransforming eucaryotic cells with such DNA together with a second DNA which corresponds to a gene coding for a selectable marker. The invention further relates to processes for inserting into eucaryotic cells a multiplicity of DNA molecules including genes coding for desired proteinaceous materials by cotransformation with the desired genes and with amplifiable genes for a dominant selectable marker in the presence of successively higher amounts of an inhibitor. Alternatively, the insertion of multiple copies of desired genes is accomplished by transformation using DNA molecules formed by ligating a DNA molecule including the desired gene to a DNA molecule which includes an amplifiable gene coding for a dominant selectable phenotype such as a gene associated with resistance to a drug in the presence of successively higher amounts of an agent such as a drug against which the gene confers resistance so that only those eucaryotic cells into which multiple copies of the amplifiable gene have been inserted survive.
 
7

 
And at least the following patent family members:
 
US4634665: Processes for inserting DNA into eucaryotic cells and for producing proteinaceous materials
 
INVENTORS: Axel R., Wigler M.H., Silverstein S.J..
ASSIGNEES: The Trustees of Columbia University , New York, NY
ISSUED: Jan. 6, 1987
FILED: Aug. 11, 1983
SERIAL NUMBER: US1983000522408
 
US4634665: Processes for inserting DNA into eucaryotic cells and for producing proteinaceous materials
 
INVENTORS: Axel R., Wigler M.H., Silverstein S.J..
ASSIGNEES: The Trustees of Columbia University , New York, NY
ISSUED: Jan. 12, 1993
FILED: June 18, 1991
SERIAL NUMBER: US1991000716915
 
TOGETHER WITH BOSS AND CABILLY II (SEE OVER)
 
8

 
BOSS PATENT

Inventors:	 	Boss, Michael Alan; Kenten,John Henry; Emtage, John Spencer; Wood, Clive Ross	
 	 	 	
Patentee:	 	Celltech Limited	
 	 	 	
Title:	 	Multichain Polypeptides or Proteins and processes for their production.	

Priority Application	 	Priority Date	
 	 	 	
UK PA 8308235	 	25.03.83	 	

Patent Co-operation Treaty (PCT) International Publication Number WO 84/03712 designating:	
 	
 	 	Application Number	 	Date of Filing	
 	 	(Publication Number)	 	(Date of Publication)	
Territory	 	Patent Number	 	Date of Grant	
 	 	 	 	 	
United Kingdom	 	8407571	 	23.03.84	
 	 	(GB 2137631A)	 	(10.10.84)	
 	 	GB 2137631B	 	12.11.86	
 	 	 	 	 	
International	 	PCT/GB 84/00094	 	23.03.84	
(USA, Europe, Japan)	 	(WO 84/03712)	 	(27.09.84)	
 	 	 	 	 	
USA	 	672265	 	23.03.84	
 	 	(as PCT)	 	(27.09.84)	
 	 	4816397	 	28.03.89	
 	 	 	 	 	
USA (Divisional)	 	233430	 	18.08.88	
 	 	 	 	 	
Europe	 	 	 	 	
(Austria, West Germany	 	84301996.9	 	23.03.84	
France, Luxembourg,	 	(EP 0120694)	 	(03.10.84)	
Netherlands, Sweden,	 	 	 	 	
Switzerland)	 	 	 	 	
 	 	 	 	 	
Japan	 	501609/84	 	23.03.84	
 	 	(as PCT)	 	(27.09.84)	
 
9

 
CABILLY II PATENT
 
US6331415: Methods of producing immunoglobulins, vectors and transformed host cells for use therein
 
INVENTORS:  Cabilly; Shmuel , Heyneker; Herbert L, Holmes; William E. ,
Riggs; Arthur D. , Wetzel; Ronald B.
ASSIGNEES:  Genentech, Inc.
ISSUED:  Dec. 18, 2001
FILED:  June 10, 1988
 
ABSTRACT
 
The invention relates to processes for producing an immunoglobulin or an immunologically functional immunoglobulin fragment containing at least the variable domains of the immunoglobulin heavy and light chains. The processes can use one or more vectors which produce both the heavy and light chains or fragments thereof in a single cell. The invention also relates to the vectors used to produce the immunoglobulin or fragment, and to cells transformed with the vectors.
 
CROSS-REFERENCE TO RELATED APPLICATIONS
 
This application is a continuation of U.S. patent application Ser. No. 06/483,457, filed Apr. 8, 1983, now U.S. Pat. No. 4,816,567 , issued Mar. 28, 1989.
 
10

 
Exhibit 10.22
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
EXECUTION COPY

COLLABORATION AGREEMENT

by and between

TEVA PHARMACEUTICAL INDUSTRIES LTD.

and

ACORDA THERAPEUTICS, INC.

 
COLLABORATION AGREEMENT
 
THIS COLLABORATION AGREEMENT (this “ Agreement ”) is made as of September 23, 2003, by and between TEVA PHARMACEUTICAL INDUSTRIES LTD. , a limited liability company organized under the laws of Israel, with its principal place of business located at 5 Basel Street, Petah Tiqva 49131, Israel (“ Teva ”), and ACORDA THERAPEUTICS, INC. , a corporation organized under the laws of Delaware, with its principal place of business located at 15 Skyline Drive, Hawthorne, New York 10532 U.S.A. (“ Acorda ”).
 
WHEREAS , Teva possesses certain rights to develop the chemical compound known under its project name TV-1901, and more commonly referred to as Valrocemide and further described in Annex A to this Agreement (the “ Compound ”), and to manufacture, market, promote, distribute, sell and otherwise commercially exploit pharmaceutical products that contain the Compound;
 
7(%2%!3 , Teva and Acorda desire to enter into a collaborative arrangement to Develop one or more finished pharmaceutical products that contain the Compound (with the initial intention that such products contain the Compound as the sole active ingredient), for the treatment of any appropriate indication, except Multiple Sclerosis unless as otherwise provided herein, all in accordance with the terms and conditions of this Agreement; and
 
7(%2%!3 , Teva and Acorda further desire that (i) Teva exclusively manufacture and supply all Collaboration Products for sale in the Territory, (ii) Teva and Acorda copromote all Collaboration Products in the Territory, and (iii) Teva exclusively Commercializes all Collaboration Products in the Territory, all in accordance with the terms and conditions of this Agreement.
 
./7  4(%2%&/2% , in consideration of the foregoing premises, and the mutual representations, warranties and covenants contained in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
 
ARTICLE 1
 
DEFINED TERMS
 
For purposes of this Agreement, the following initially capitalized terms, whether used in the singular or plural form, have the following respective meanings:
 
Section 1.1             “ Act ” means the United States Federal Food, Drug and Cosmetic Act of 1938, as amended from time to time, and all rules, regulations and guidance promulgated thereunder.
 
Section 1.2             “ Account Manager ” means a person engaged by a Party (or a Party’s subcontractor) to Promote Collaboration Products with Managed Care Organizations and Target Prescribers in accordance with the Marketing Plan for such Collaboration Products.

 
Section 1.3             “Acorda Background Technology” means the tangible or intangible know-how, trade secrets, inventions (whether patentable or unpatentable), discoveries, technical and other information (including preclinical data and clinical results), formulas, processes, data, patent rights and other intellectual property, if any, that (i) is owned or controlled by or licensed to (with the right to assign or sublicense by) Acorda in the Territory immediately prior to the Effective Date, and (ii) relates to the Compound or any Collaboration Product (including, without limitation, related to any interactions, contra-indications or use thereof, improvements or new combination therapies or new delivery systems suited thereto).
 
Section 1.4             “ Additional Compound ” has the meaning ascribed to it in Section 8.3 of this Agreement.
 
Section 1.5             “ Additional Indication Review Period ” has the meaning ascribed to it in Section 3.5(b) of this Agreement.
 
Section 1.6             “ Affiliate ” means any person, corporation, company, partnership or other entity (each, a “ Person ”) that directly or indirectly Controls, is Controlled by or is under common Control with Acorda or Teva, as the case may be, but only for so long as said Control continues.  As used in this Agreement, the term “Control” means possession of the power to direct or cause the direction of the management and policies of a Person whether by ownership of voting securities, contract or otherwise.  For the avoidance of doubt, neither Acorda, on the one hand, nor Teva, on the other hand, is considered an Affiliate of the other.
 
Section 1.7             “ Agreement ” means this Agreement, together with all annexes, exhibits and schedules attached hereto, all of which are hereby incorporated into this Agreement.
 
Section 1.8             “ AMA Guidelines ” means the American Medical Association Gifts to Physicians from Industry Guidelines, as revised from time to time.
 
Section 1.9             “ Arbitration ” has the meaning ascribed to it in Annex B of this Agreement.
 
Section 1.10          “ Arbitration Request ” has the meaning ascribed to it in Annex B of this Agreement.
 
Section 1.11          “ Arbitration Tribunal ” has the meaning ascribed to it in Section 14.12(a) of this Agreement.
 
Section 1.12          “ Arbitrator ” has the meaning ascribed to it in Annex B of this Agreement.
 
Section 1.13          “ Approvable Letter ” means a letter issued by the FDA as described in 21 C.F.R. Section 314.110, as amended from time to time.
 
Section 1.14          “ Bankruptcy Code ” has the meaning ascribed to it in Section 12.2(c) of this Agreement.
 
Section 1.15          “ Bankruptcy Party ” has the meaning ascribed to it in Section 12.2(c) of this Agreement.
 
2

 
Section 1.16          “ Business Day ” means any calendar day, except that if an activity to be performed or an event to occur falls on a Friday, Saturday, Sunday or a nationally recognized holiday in the United States or Israel, then the activity may be performed or the event may occur on the next day that is not a Friday, Saturday, Sunday or nationally recognized holiday.
 
Section 1.17          “ Certificate of Analysis ” means a written document describing the analyses and the results performed with respect to a Collaboration Product, in the form attached hereto as Annex C , as such form may be modified from time to time.
 
Section 1.18          “ Certificate of Release ” means a written document with respect to a particular batch of Collaboration Product indicating that such Collaboration Product has met the applicable specifications. Such certificate shall be in the form attached hereto as Annex C and may be modified from time to time.
 
Section 1.19          “ Change of Control ” means (i) the sale, lease, or other disposition of all or substantially all of the business or assets of a Party (whether by way of merger, sale of stock, sale of assets or otherwise); or (ii) an acquisition of a Party by a Third Party by consolidation, merger, or other reorganization in which the holders of the outstanding voting stock of the Party immediately prior to such transaction own, immediately after such transaction, securities representing less than fifty percent (50%) of the corporation or other entity surviving such transaction.  The Third Party acquiring the Party or its assets shall be referred to as the “ Acquiring Party” for purposes of this Agreement.  For clarity, neither the consummation of a public offering of newly issued securities by a Party pursuant to an effective registration statement under the United States Securities Act of 1933, as amended, nor an equity financing by a Party involving the sale and issuance of newly issued securities of the Party to purchasers in such equity financing, shall be deemed a “Change of Control,” even if such offering or financing results in such purchasers owning more than fifty percent (50%) of the total issued and outstanding securities of such Party; provided that no one purchaser (or group of affiliated purchasers) owns or controls more than thirty (30%) of the corporation or other entity as a result of such offering or financing.
 
Section 1.20          “ Claims ” has the meaning ascribed to it in Section 11.1(a) of this Agreement.
 
Section 1.21          “ Collaboration Product ” means a product intended for human pharmaceutical use containing the Compound as an active ingredient, in any formulation and dosage form and for any indication (except (i) Multiple Sclerosis, unless included in joint Development under this Agreement in accordance with Section 3.4, and (ii) an Independent Use).
 
Section 1.22          “ Commercialization” or “Commercialize ” means the activities carried out by Teva and/or its Affiliates and/or duly appointed Third Parties in distributing Collaboration Products within the Territory (including importing, transporting, customs clearance, warehousing, packing, handling and delivering the Collaboration Products to customers) and all sales related activities, including taking orders for and booking and fulfilling sales of Collaboration Products within the Territory.
 
3

 
Section 1.23          “ Common Cost Per Account Manager ,” “ Common Cost Per Professional Education Manager,” “Common Cost Per Sales Representative,” and “Common Cost Per Scientific Manager” have the respective meanings ascribed to them in Section 4.4(a) of this Agreement.
 
Section 1.24          “ Competitive Product ” means a finished human pharmaceutical product containing as an active ingredient a valproic acid-based compound that is intended for use, or that reasonably could be used, in the Territory for treating, preventing or curing a disease or condition that is the same or substantially the same as a labeled indication of a Collaboration Product in the Territory.
 
Section 1.25          “ Complaining Party ” has the meaning ascribed to it in Annex B of this Agreement.
 
Section 1.26          “ Compliance Committee ” has the meaning ascribed to it in Section 2.1(b)(iii) of this Agreement.
 
Section 1.27          “ Compound ” has the meaning ascribed to it in the first Whereas clause of this Agreement.
 
Section 1.28          “ Confidential Information ” has the meaning ascribed to it in Section 10.1 of this Agreement.
 
Section 1.29          “ Confidentiality Agreement ” means the Confidentiality Agreement by and between Teva and Acorda dated as of August 6, 2002.
 
Section 1.30          “ Copromotion Expenses ” means all costs and expenses expended by the Parties in Promoting Collaboration Products in the Territory pursuant to and in accordance with the applicable Marketing Plan and the budget therein, calculated in accordance with GAAP and pursuant to Annex D attached hereto.
 
Section 1.31          “ Copromotion Profit ” means, with respect to sales of a Collaboration Product in the Territory for the applicable period, an amount equal to the Net Sales for such Collaboration Product during such period, minus the (i) Production Costs, (ii) Distribution Costs, and (iii) Copromotion Expenses (subject to Section 4.5(e)) with respect thereto.
 
Section 1.32          “ CSC ” means the Central Steering Committee formed by the Parties in accordance with Section 2.1(a) of this Agreement.
 
Section 1.33          “ Detail ” means a face-to-face interactive meeting, in an individual or group practice setting, between a member of the Target Prescribers and a Sales Representative, during which Collaboration Product information is communicated to such Target Prescriber.  When used as a verb, “Detail” shall mean to engage in a Detail.
 
Section 1.34          “ Develop or Development ” means all activities undertaken by or on behalf of a Party under this Agreement (whether inside or outside the Territory) to develop a Collaboration Product (including, without limitation, line extensions) in order to achieve Regulatory Approval or enhancements to product labeling of such Collaboration Product for the
 
4

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Territory, as approved by the CSC and in accordance with the applicable Development Program, including such clinical studies and other activities conducted by the Parties with the intent of, and as are necessary to, generate data for submission to regulatory authorities in support of an application for Regulatory Approval necessary to permit the Commercialization of the Collaboration Product (including, without limitation,  line extensions) for the Territory.  For clarity, Teva shall have the right to use any data generated from the Development of a Collaboration Product to support Regulatory Approval or enhancements to product labeling of such Collaboration Product outside of the Territory.  When used as a verb, “Develop” means to engage in Development.  For clarity, the term “Development” may include research on new formulations (such as extended-release formulations) and new indications, to the extent such work is included in a Development Program.
 
Section 1.35          “ Development Committee ” has the meaning ascribed to it in Section 2.1(b)(i) of this Agreement.
 
Section 1.36          “ Development Costs ” means all costs incurred by each of the Parties in the Development of a Collaboration Product in accordance with its Development Program, including such costs (i) for clinical supplies at an amount equal [***] of the Market Price thereof in the Territory, or [***] of the anticipated Market Price thereof in the Territory if the actual market price is not available; (ii) associated with conducting the clinical studies for seeking Regulatory Approval in the Territory; and (iii) for labor (at the actual cost for such labor); but excluding, however, any costs incurred by Teva related directly to (A) achieving Regulatory Approval for a Collaboration Product outside the Territory, and (B) supplying the Collaboration Product to Acorda for the Next Trial, which, as discussed in Section 3.2(b), Teva is responsible for supplying at no cost to Acorda.  For clarity, the term “Development Costs” shall not include any costs relating to (1) any clinical trials or other Development work on a Collaboration Product where the results of such trials or other work are not materially used in seeking Regulatory Approval or enhancements to product labeling of such Collaboration Product for the Territory, (2) any manufacturing scale-up or related manufacturing development work for an immediate release tablet (or similar form) of Collaboration Product, or (3) any efforts by Teva in relation to preparation of the Chemistry, Manufacturing and Controls Section for any Collaboration Product for submission to the FDA, unless otherwise agreed to by the Parties.
 
Section 1.37          “ Development Program ” has the meaning ascribed to it in Section 2.1(b)(i) of this Agreement.
 
Section 1.38          “ Dispute ” has the meaning ascribed to it in Section 14.12(a) of this Agreement.
 
Section 1.39          “ Distribution Costs ” means, with respect to a Collaboration Product in a particular period, the lesser of:  (a) the actual costs and expenses (including labor) incurred by Teva and its Affiliates in performing the Commercialization activities in the Territory for such Collaboration Product in such period, including, without limitation, expenses associated with fulfilling orders for the Collaboration Product placed by Third Parties, handling, warehousing, refrigeration, insurance, transportation, and wholesaler’s fees (for avoidance of doubt, Distribution Costs also include any costs or expenses (including labor) incurred by Teva or its
 
5

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Affiliates to perform quality control and quality assurance necessary to release the Collaboration Product for distribution in the Territory, whether performed during or prior to the time the Collaboration Product is in Teva’s warehouse in the Territory) to the extent allocable to such activities relating directly to the Collaboration Product; or (b) [***] of Gross Sales for such Collaboration Product in such period.  For clarity, the term “Distribution Costs” shall not include any costs, expenses or amounts that are deducted from Gross Sales in calculating Net Sales under Section 1.70.
 
Section 1.40          “ Drug Interaction Study ” has the meaning ascribed to it in Section 3.2(b) of this Agreement.
 
Section 1.41          “ Effective Date ” means the date first set forth above in the introductory paragraph of this Agreement.
 
Section 1.42          “ FDA ” means the Food and Drug Administration of the United States of America, or any successor entity.
 
Section 1.43          “ Forecast ” has the meaning ascribed to it in Section 6.2(c) of this Agreement.
 
Section 1.44          “ Free Products ” means those quantities of Collaboration Products given free of charge to patients, including through an indigent patient program, such as the National Organization for Rare Diseases, or similar not-for-profit organizations, as included in a Marketing Plan and approved by the CSC.  The cost associated with such Collaboration Products shall, for the purposes of calculating Copromotion Expenses, be an amount equal to [***] of the Market Price thereof, or, if the actual Market Price is not available at the time the products are given, [***] of the anticipated Market Price.
 
Section 1.45          “ GAAP ” means United States generally accepted accounting principles, as then in effect, consistently applied.
 
Section 1.46          “ Good Manufacturing Practices ” means the then-current good manufacturing practices required by the FDA, as set forth in the Act and the regulations, promulgated thereunder, for the manufacture and testing of pharmaceutical materials, and comparable laws or regulations applicable to the manufacture and testing of pharmaceutical materials in jurisdictions outside the United States.
 
Section 1.47          “ Gross Sales ” means the total gross amount invoiced for a Collaboration Product sold in a particular period to Third Parties in the Territory in bona fide arms length transactions.
 
Section 1.48          “ GSC ” has the meaning ascribed to it in Section 2.2(a) of this Agreement.
 
Section 1.49          “ GSC Party ” has the meaning ascribed to it in Section 2.2(b) of this Agreement.
 
Section 1.50          “ Hearing ” has the meaning ascribed to it in Annex B of this Agreement.
 
6

 
Section 1.51          “ IND ” means, with respect to the Territory, an investigational new drug application, as defined in the Act.
 
Section 1.52          “ Indemnity Claim ” has the meaning ascribed to it in Section 11.1(d) of this Agreement.
 
Section 1.53          “ Indemnified Party ” and “ Indemnifying Party ” have the respective meanings ascribed thereto in Section 11.1(a) of this Agreement.
 
Section 1.54          “ Independent Development ” means all activities undertaken by or on behalf of an Independent Party pursuant to, and as permitted in, Section 3.5(b) of this Agreement to develop a Collaboration Product for a Proposed Use that has not been selected under such Section for Development jointly by the Parties, in order to achieve Regulatory Approval or enhancements to product labeling of such Collaboration Product in the Territory, including such clinical trials and other activities conducted with the intent to, and as are necessary to, generate data for submission to regulatory authorities in support of an application for Regulatory Approval necessary to permit the commercialization of the Collaboration Product for such Proposed Use in the Territory.
 
Section 1.55          “ Independent Development Costs ” means the actual costs and expenses incurred by the Independent Party in conducting Independent Development of a Collaboration Product for a particular Proposed Use.
 
Section 1.56          “ Independent Party ” means the Party that is conducting Independent Development of a Collaboration Product for a Proposed Use that has not been selected for Development jointly by the Parties, as provided in Section 3.5(b).
 
Section 1.57          “Independent Use” means a use in treating a particular indication that was the subject of Independent Development as a Proposed Use and for which the Re-Engagement Option expired unexercised as discussed in Section 3.5.
 
Section 1.58          “ Indication Termination ” has the meaning ascribed to it in Section 12.2(b) of this Agreement.
 
Section 1.59          “ Infringement Claim ” has the meaning ascribed to it in Section 9.2(a) of this Agreement.
 
Section 1.60          “ Know-How ” means all tangible or intangible know-how, trade secrets, inventions (whether patentable or unpatentable), discoveries, technical and other information (including preclinical data and clinical results), formulas, processes, data and other intellectual property owned, controlled or licensed by, or to, (with the right to assign or sublicense by) Teva or any Affiliate of Teva to the extent that any of the foregoing incorporates, uses or otherwise relates to, directly or indirectly, the Compound or any Collaboration Product (including, without limitation, related to any interactions, contra-indications or use thereof, improvements or new combination therapies or new delivery systems suited thereto) existing as of the Effective Date or that comes into existence during the Term of this Agreement, but excluding Patent Rights.
 
7

 
Section 1.61          “ Launch Date ” means the date that a Collaboration Product is first commercially launched by or on behalf of Teva for Promotion and Commercialization in the Territory after having obtained the applicable Regulatory Approval.
 
Section 1.62          “ Lead Indication ” has the meaning ascribed to it in Section 3.2(a) of this Agreement.
 
Section 1.63          “ Managed Care Organizations ” has the meaning ascribed to it in Section 2.1(b)(ii) of this Agreement.
 
Section 1.64          “ Marketing Committee ” has the meaning ascribed to it in Section 2.1(b)(ii) of this Agreement.
 
Section 1.65          “ Marketing Materials ” means all written, printed, electronic or graphic materials developed by Teva and/or Acorda, their respective Affiliates, and/or with, or on their behalf by, any Third Party, in connection with the Promotion of Collaboration Products pursuant to a Marketing Plan, which may include scientific education materials, professional education materials, patient lists, physician references, Detailing reports, Detailing pieces (such as visual aids and file cards), premium articles, reprints, market surveys, training materials and other reports and related data or programs.
 
Section 1.66          “ Market Price ” means the quotient obtained by dividing the Gross Sales of a Collaboration Product in a certain period as determined by the CSC, in the Territory, by the unit quantities of such Collaboration Product sold to Third Parties in the Territory in such period.
 
Section 1.67          “ Marketing Plan ” has the meaning ascribed to it in Section 2.1(b)(ii) of this Agreement.
 
Section 1.68          “ Monthly Report ” has the meaning ascribed to it in Section 4.3(a)(i) of this Agreement.
 
Section 1.69          “ NDA ” means, with respect to the Territory, a new drug application filed with the FDA in conformance with applicable laws and regulations.
 
Section 1.70          “ Net Sales ” means the total Gross Sales for a Collaboration Product, less the following deductions to the extent actually allowed or incurred with respect to such sales:  (i) quantity and/or cash discounts, but provided that such discounts are not given to a particular customer, within a reasonable sales cycle, disproportionately between the Collaboration Product and other Teva products reasonably similarly situated; (ii) customs, duties, sales and similar taxes, if any; (iii) amounts allowed or credited by reason of rejections, return of goods (including as a result of recalls), and retroactive price reductions or allowances specifically identifiable as relating to the Collaboration Product; (iv) amounts incurred resulting from government (or any agency thereof) mandated rebate programs in the Territory; (v) chargebacks or similar price concessions related to the sale of the Collaboration Product; (vi) bad debts, when and as such debts are recognized for accounting purposes as not collectible; (vii) freight, packing, shipping and similar charges separately stated on the invoices, and (viii) as agreed by the Parties, any other specifically identifiable amounts included in a Collaboration Product’s Gross Sales that were or ultimately will be credited and that are substantially similar to those listed above.  All of
 
8

 
the foregoing shall be calculated by Teva in accordance with GAAP, and no amount in clauses (i) through (viii) above shall be included in Distribution Costs, Production Costs, or Copromotion Expenses.  For the purposes of this provision, the transfer of a Collaboration Product by Teva or one of its Affiliates to another Affiliate of Teva is not a sale; in such cases, Net Sales will be determined based on the sale of the Collaboration Product by the Affiliate to independent, Third-Party customers in bona fide arms length transactions.
 
Section 1.71          “ Next Trial ” means, after the Effective Date, the first adequate well controlled, clinical trial, in accordance with the standards promulgated by the FDA for a Pivotal Trial, of a Collaboration Product for the Lead Indication, which trial shall be pre-approved by the CSC (such approval not to be unreasonably withheld).
 
Section 1.72          “ Non-Participating Party ” has the meaning ascribed to it in Section 3.5(c) of this Agreement.
 
Section 1.73          “ Option Study ” has the meaning ascribed to it in Section 3.6 of this Agreement.
 
Section 1.74          “ Parties ” or “ Party ” means, collectively or individually, as the case may be, Teva and/or Acorda.
 
Section 1.75          “ Patent Rights ” means all present and future patent applications and issued patents, owned, controlled or licensed by, or to, Teva or any Affiliate of Teva to the extent necessary or useful for the manufacture, use or sale of the Compound or any Collaboration Product, including any provisionals, divisionals, continuations, continuations-in-part, reissues, reexaminations or extensions derived therefrom, as well as all foreign patent applications, granted patents and all counterparts thereof including substitutions, confirmations, registrations, revalidations, supplemental protection certificates, administrative protection certificates or other governmental actions that provide exclusive rights to the patent holders in the patented subject matter that incorporates, uses or otherwise relates to, directly or indirectly, the Compound or any Collaboration Product.
 
Section 1.76          “ PDMA ” means the Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder.
 
Section 1.77          “ PhRMA Code ” means the PhRMA Code on Interactions with Healthcare Professionals promulgated and adopted by the Pharmaceutical Research and Manufacturers of America, which became effective July 1, 2002, as amended from time to time.
 
Section 1.78          “ Phase I Trials ” means the human clinical trials conducted on normal volunteers or patients designed to evaluate the safety, tolerability and/or pharmacokinetic profile of the relevant Collaboration Product, and in accordance with the relevant Development Program.
 
Section 1.79          “ Phase II Trials ” means the human clinical trials conducted on patients and designed to indicate a statistically significant level of efficacy, safety or tolerability for the relevant Collaboration Product in the desired indication, as well as to obtain some indication of dosage regimen required, and in accordance with the relevant Development Program.
 
9

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Section 1.80          “ Phase III Trials ” means the human clinical trials conducted on patients and designed to establish a Collaboration Product’s safety and efficacy, and which are required to obtain Regulatory Approval of the Collaboration Product with the FDA and other relevant regulatory authorities, and in accordance with the relevant Development Program.
 
Section 1.81          “ Pivotal Trial ” means a human clinical trial(s) designed to provide registration quality data that the FDA has agreed (in a pre-IND, IND or other setting) will be sufficient, if successful, to complete the efficacy data package for submission of an NDA.  For the purposes of clarity, the reference in the preceding sentence to “if successful” is not intended to imply that the results of the subject trial must, in fact, be successful in order to be considered a Pivotal Trial under this Agreement.
 
Section 1.82          “ Primary Detail ” means a Detail that has a Collaboration Product as the first product discussion a Sales Representative has with a Target Prescriber.
 
Section 1.83          “ Production Costs ” means [***] of Net Sales of the relevant Collaboration Product sold for use in the Territory; provided that the Production Costs (per 1000 tablets (or similar form) of an immediate release formulation of Collaboration Product) shall never be less than [***], adjusted on an annual basis to reflect the increase, if any, during such annual period in the consumer price index (with 2002 as the base year), as published by the U.S. Department of Labor on any successor entity.
 
Section 1.84          “ Product Samples ” means those quantities of Collaboration Products given to Target Prescribers by Teva or Acorda (as the case may be) for marketing purposes as determined by the Marketing Committee and approved by the CSC, which is to be provided by such Target Prescribers to patients without charge and the cost of which, for the purposes of calculating Copromotion Expenses, is [***] of the Market Price, or, if the actual Market Price is not available at the time the products are given, [***] of the anticipated Market Price.
 
Section 1.85          “ Professional Education Manager ” means a person engaged by a Party (or a Party’s subcontractors) to provide professional education to healthcare professionals in accordance with the applicable Marketing Plan for Collaboration Products.
 
Section 1.86          “ Program Intellectual Property ” means any invention, discovery, know-how, trade secrets or information (whether or not patentable) resulting from the Independent Development or joint Development of Collaboration Products under this Agreement, together with all intellectual property rights relating thereto, but excluding Patent Rights and Know-How, in each case.
 
Section 1.87          “ Promotion ” means those activities conducted by a Party or its Affiliates to promote and market a Collaboration Product in the Territory in accordance with the applicable Marketing Plan.  When used as a verb, “Promote” means to engage in Promotion.
 
Section 1.88          “ Proof of Concept Trial ” has the meaning ascribed to it in Section 3.3(a) of this Agreement.
 
10

 
Section 1.89          “ Proposed Use ” has the meaning ascribed to it in Section 3.5(a) of this Agreement.
 
Section 1.90          “ Quarterly Copromotion Expenses ” has the meaning ascribed to it in Section 4.3(a)(iv) of this Agreement
 
Section 1.91          “ Quarterly Participation Costs ” has the meaning ascribed to it in Section 4.3(b)(ii) of this Agreement.
 
Section 1.92          “ Quarterly Reconciliation Date ” has the meaning ascribed to it in Section 4.3(a)(iv) of this Agreement.
 
Section 1.93          “ Quarterly Report ” has the meaning ascribed to it in Section 4.3(a)(ii) of this Agreement.
 
Section 1.94          “ Re-Engagement Fee ” has the meaning ascribed to it in Section 3.5(c)(i) of this Agreement.
 
Section 1.95          “ Re-Engagement Option ” has the meaning ascribed to it in Section 3.5(c) of this Agreement.
 
Section 1.96          “ Regulatory Approval ” means all necessary governmental approvals, including FDA approval of an NDA and any applicable price and reimbursement approvals, and any other necessary governmental licenses, registrations, authorizations and permits for the manufacture, use, storage, import, transport, promotion, marketing and sale of a Collaboration Product in a regulatory jurisdiction.
 
Section 1.97          “ Residual Payments ” has the meaning ascribed to it in Section 12.4 of this Agreement.
 
Section 1.98          “ Sales Representative ” means a person engaged by a Party (or a Party’s subcontractor) to Detail Collaboration Products in accordance with the applicable Marketing Plan under this Agreement.
 
Section 1.99          “ Scientific Manager ” means a person engaged by a Party (or a Party’s subcontractor) to provide professional scientific educational support to healthcare professionals in accordance with the applicable Marketing Plan for Collaboration Products.
 
Section 1.100        “ Secondary Detail ” means a Detail during which a Collaboration Product is the second product discussed by the Sales Representative with the Target Prescriber.
 
Section 1.101        “ Secondary Indications ” has the meaning ascribed to it in Section 3.3(a) of this Agreement.
 
Section 1.102        “ Supply Disruption ” has the meaning ascribed to it in Section 6.2(d) of this Agreement.
 
11

 
Section 1.103        “ Target Labeling ” means the Collaboration Product labeling(s) desired to be achieved under this Agreement, as determined by the CSC.
 
Section 1.104        “ Target Prescribers ” means selected groups of healthcare professionals, who are authorized by applicable law to prescribe a Collaboration Product in the Territory, that are to be Detailed on the Collaboration Products by Sales Representatives as designated in the applicable Marketing Plan.
 
Section 1.105        “ Term ” has the meaning ascribed to it in Section 12.1 of this Agreement.
 
Section 1.106        “ Territory ” means the United States of America and its territories and possessions.
 
Section 1.107        “ Third Party ” means any Person who is not a Party or an Affiliate of any Party.
 
Section 1.108        “ Third Party Agreements ” means the agreements with Third Parties listed on Annex E attached hereto.
 
Section 1.109        “ Third Party Infringement ” has the meaning ascribed to it in Section 9.3(b) of this Agreement.
 
Section 1.110        “ Trademark ” has the meaning ascribed to it in Section 9.5 of this Agreement.
 
Section 1.111        “ USD ” or “ $ ” means the lawful currency of the United States of America, (i.e., the U.S. Dollar).
 
Section 1.112        “ Weighted Average Details ” means, with respect to a Collaboration Product, the sum of (i) the product of the total number of Primary Details (as determined by the respective Party’s call reporting system, which shall comply with reporting standards established by the CSC) performed by a Party’s Sales Representatives on Detailing such Collaboration Product for the applicable reporting or reconciliation period, times the percentage weight assigned to Primary Details (taking into account whether such Sales Representatives are detailing two (2) Collaboration Products or more, if applicable) in the Marketing Plan approved by the CSC for such period, and (ii) the product of the total number of Secondary Details (as determined by the respective Party’s call reporting system, which shall comply with reporting standards established by the CSC) performed by a Party’s Sales Representatives on Detailing such Collaboration Product for the applicable reporting or reconciliation period, times the percentage weight assigned to Secondary Details (taking into account whether such Sales Representatives are detailing two (2) Collaboration Products or more, if applicable) in the Marketing Plan approved by the CSC for such period.
 
12

 
ARTICLE 2
 
GOVERNANCE OF DEVELOPMENT AND COMMERCIALIZATION OF
COLLABORATION PRODUCTS
 
Section 2.1             Central Steering Committee.
 
(a)            Formation.   The Parties shall promptly form a central steering committee (the “ CSC ”) to oversee the Development, Promotion and Commercialization of Collaboration Products for the Territory.  The CSC shall have an equal number of representatives from each Party, not to exceed three (3) from each, including one (1) co-chairperson appointed by each Party.  Either Party may replace any of its representatives at any time, and from time to time, by giving written notice to the other Party.  Each Party must promptly fill any vacancy on the CSC caused by the death, resignation or other physical or mental incapacity of any of its representatives.  Each Party shall be responsible for its own expenses of participating on the CSC.  Each Party shall, within thirty (30) Business Days following the Effective Date, appoint the initial members of the CSC and provide to the other Party written notice setting forth the names of the representatives so appointed.
 
(b)            Subcommittees.   The CSC shall organize subcommittees to oversee activities of the Parties in the areas of Development and Promotion of Collaboration Products in accordance with this Section 2.1(b).  Each subcommittee shall have an equal number of representatives from each Party, not to exceed three (3) from each, including one (1) co-chairperson appointed by each Party.  Either Party may replace any of its representatives at any time, and from time to time, by giving written notice to the other Party.  Each Party must promptly fill any vacancy on a subcommittee caused by the death, resignation or other physical or mental incapacity of any of its representatives.  Each Party shall be responsible for its own expenses of participating in any subcommittee.  The CSC shall prescribe rules of procedure for the subcommittees, including but not limited to frequency of meetings and responsibility for meeting agendas.  All decisions of a subcommittee are subject to approval by the CSC.  In the event that any subcommittee fails to reach agreement on an issue within its respective area of oversight, the matter shall be referred to the CSC.  The CSC shall organize the following subcommittees:
 
(i)             The “ Development Committee ,” which shall be responsible for planning, overseeing and implementing the Development of Collaboration Products for the Territory.  The Development Committee shall establish a program and plan (a “ Development Program ”) for each Collaboration Product, or for each different indication for which a Collaboration Product is being developed, as applicable, that shall, among other things, (A) set forth a plan for achieving the Target Labeling as approved by the CSC, (B) set forth detailed budgets for the Development Costs to be incurred, for approval by the CSC, (C) in consultation with the Marketing Committee, as appropriate, prescribe the non-clinical and clinical activities, studies and trials to be conducted by the Parties, (D) specify the timing, finalization and reporting of each such activity, study and trial, and (E) otherwise specify all other Development activities to be conducted by the Parties required to obtain Regulatory Approval for the Territory.   The Development Committee shall coordinate and manage the Development activities as set forth in the Development Program for each Collaboration Product and if necessary, shall propose amendments to such Development Program for consideration and approval by the CSC.
 
(ii)            The “ Marketing Committee ,” which shall be responsible for planning, overseeing and implementing the Promotion of Collaboration Products in the Territory, and for overseeing the Commercialization of Collaboration Products in the Territory.  The
 
13

 
Marketing Committee shall create an annual plan for approval by the CSC, which shall contain the elements set forth in Annex F attached hereto, a budget for Promotion activities and an allocation of responsibility between Teva and Acorda for the Promotion of each Collaboration Product in the Territory, taking into account the relative strength and capabilities of each Party in the target market (the “ Marketing Plan ”).  In particular, the Marketing Committee shall address issues arising in the context of, and create a plan with a detailed budget for each expense category and an allocation of responsibility between Teva and Acorda for, the Promotion of Collaboration Products to: (A) managed care organizations, pharmacy benefit managers, group purchasing organizations, specialty pharmaceutical organizations, institutional buyers, long-term care facilities, consulting pharmacy entities, governmental entities and other managed care organizations in the Territory (collectively, the “ Managed Care Organizations ”); and (B) Target Prescribers.  The Marketing Committee shall also set the recommended list pricing for Collaboration Products in the Territory and shall establish guidelines for any discount, rebate, price reduction or chargeback programs or policies applicable to Commercialization of Collaboration Products in the Territory.
 
(iii)          The “ Compliance Committee ,” which shall be responsible for (A) ensuring that all Marketing Materials and Promotion of Collaboration Products comply with applicable laws and regulations of all regulatory authorities, (B) formulating policies regarding Promotional guidelines and grants to Target Prescribers in respect of Collaboration Products in the Territory, and (C) such other related compliance matters as are assigned by the CSC.
 
(iv)           Such other subcommittee(s) within the areas of Development and Promotion as the CSC deems necessary.
 
(c)            Rules of Procedure, Delegation, and Binding Power of CSC.
 
(i)             In addition to the subcommittees to be appointed pursuant to Section 2.1(b), the CSC may prescribe such rules of procedure and may delegate such of its oversight and responsibilities to one or more subcommittees (in each case to be equally represented by the Parties).
 
(ii)            The CSC shall (A) select treatment uses of a Collaboration Product for Development by the Parties under this Agreement, as applicable;  (B) approve or disapprove all budget(s) for a Development Program and the Development Costs associated therewith; (C) supervise and coordinate all Development activities of the Development Committee, including, without limitation, re-scheduling non-clinical studies and clinical trials; establishing milestones for the completion of Development Program objectives, including those relating to anticipated filing dates of NDAs, INDs, regulatory filings required to initiate clinical trials, and/or similar regulatory submissions; (D) evaluate the progress of Development Programs; (E) recommend to end the Development of any Collaboration Product; and (F) generally supervise the efforts of each Party to ensure that it exercises commercially reasonable efforts to undertake and complete those portions of a Development Program for which it is responsible.
 
(iii)          All decisions of the CSC within its scope of oversight and made in accordance with this Agreement, shall be binding on the Parties.
 
14

 
(d)            Deadlock.   In the event that the CSC cannot agree on an issue within its area of oversight or an issue properly referred to it by any subcommittee within twenty (20) Business Days of the initial referral to it (or such longer period as the CSC may agree), the matter shall be deemed a Dispute that the CSC cannot resolve and it shall be resolved in accordance with the Dispute resolution procedure set forth in Section 14.12.  Notwithstanding anything contained in this Agreement to the contrary, with regard to any Dispute as to those matters set forth on Annex G attached hereto, the Parties understand and agree that such Disputes shall not be referred to binding arbitration after the above process, but rather, Teva shall have the ultimate decision making authority in respect of each such Dispute, which decision shall be made in good faith taking into account the interests of Acorda under this Agreement.
 
(e)            Further Responsibilities of the CSC.
 
(i)             The CSC shall convene at least four (4) times annually or more frequently as it deems necessary.  The location of the meetings shall alternate between each Party’s facilities, or at such locations as the Parties may otherwise agree.  Meetings may be held by audio or video teleconference, with the consent of each Party; provided that at least one (1) meeting per calendar year shall be held in person.  Special meetings of the CSC may be called on at least fifteen (15) Business Days prior written notice by either of the co-chairpersons. Each Party shall be responsible for all of its own expenses of participating in the CSC.
 
(ii)            Each Party will have one (1) vote on CSC matters, which will be delivered by its co-chairperson.  The CSC shall at all times make decisions by unanimous vote of the two (2) co-chairpersons and may act by unanimous written consent in lieu of a meeting.  The CSC shall keep a written record of all its proceedings, which record shall be confirmed in writing by the two (2) co-chairpersons.
 
(iii)          The CSC shall manage and oversee (A) all activities of the Development Committee, the Marketing Committee, the Compliance Committee and any other subcommittees formed by the CSC, and (B) the implementation of the Marketing Plans, Development Programs and other plans created by any other subcommittees formed by the CSC.
 
(iv)           During the period of Development of a Collaboration Product, the CSC shall keep the Parties informed of the activities required under the Development Program(s) and each Party shall ensure that the activities of the Development Program(s) assigned to such Party are diligently carried out in due time.  The CSC shall establish, periodically review, and modify (as may be necessary and advisable), all draft protocols and draft reports (non-clinical and clinical), draft expert reports, draft summaries and final versions of the same, and the commercial objectives and activities set forth as part of the Development Program(s).  In connection therewith, the CSC shall review and evaluate the Development Program for each Collaboration Product, including any proposed amendments thereto submitted by the Development Committee, on a calendar quarter basis.  Any changes to a Development Program must be in writing and approved by the CSC pursuant to the provisions hereof.
 
(v)             The CSC shall oversee the planning and Promotion efforts of the Marketing Committee, as well as market support initiatives, overall marketing and brand strategy for each Collaboration Product, and other related Promotion activities in the Territory in
 
15

 
accordance with the relevant annual Marketing Plan, such as conferences, training materials and branding; provided that the CSC may amend in writing the relevant annual Marketing Plan to deviate from the marketing strategy set forth therein from time-to-time if and to the extent it reasonably believes that such deviation will maximize the Parties’ profits from the Promotion activities of the Collaboration Product in the Territory.
 
(vi)           The CSC shall use its best efforts to timely agree on and approve all Marketing Plans, with the expectation that such approval shall occur no later than sixty (60) Business Days prior to the commencement of each calendar year during the Term of this Agreement.  The CSC shall also have final approval, exercisable through its approval of the relevant Marketing Plan, over the allocation of Promotional responsibilities between Teva and Acorda in the Territory with the goal of splitting such responsibilities on a 50/50 basis.  The CSC shall be responsible for reviewing and approving the payments to either Party pursuant to Sections 4.2 and 4.3 with respect to Promotion activities.
 
Section 2.2             Global Strategic Committee.
 
(a)            Without in any manner expanding the rights provided hereunder to Acorda beyond the Territory, the Parties shall, at Teva’s request, promptly form a global strategic committee (the “ GSC ”) to oversee coordination of the global development and global strategic promotion of Collaboration Products; provided, however, that the GSC will not have oversight over the Development and Promotion of Collaboration Products in the Territory, which shall be within the sole purview of the CSC.
 
(b)            The GSC shall be comprised of an equal number of representatives, not to exceed three (3) representatives, from each of the following parties:  Teva, one or more Third Parties authorized by Teva, and Acorda (each, a “ GSC Party ”), including one (1) co-chairperson appointed by each GSC Party.  Each GSC Party may replace any of its representatives at any time, and from time to time, by giving written notice to the other GSC Parties.  Each GSC Party must promptly fill any vacancy to the GSC caused by the death, resignation or other incapacity of any of its representatives.  Each GSC Party shall be responsible for its own expenses of participating on the GSC.
 
(c)            At its initial meeting, the GSC will, in good faith, promulgate a reasonable meeting schedule and rules of procedure.
 
Section 2.3             Nature of Obligations Between Parties.   Unless otherwise expressly stated, nothing contained in this Agreement may be deemed to make any Party, or member of the CSC or GSC, or any subcommittee formed thereunder, a partner, agent or legal representative of the other Party.  No Party, or any member of the CSC or GSC, or any subcommittee formed thereunder, shall have any authority to act for, or to assume any obligation or responsibility on behalf of any other member of such committee, or the other Party.
 
16

 
ARTICLE 3
 
DEVELOPMENT OF PRODUCTS
 
Section 3.1             General
 
(a)            The Parties agree (i) unless otherwise set forth to the contrary in this Agreement or as may otherwise be decided by the CSC, to conduct and perform jointly (on a 50/50 basis) the Development Programs for the purpose of furthering the Development of each Collaboration Product, as those programs are promulgated by the Development Committee and approved by the CSC, and (ii) regardless of which Party is responsible for the performance of any specific Development activity, to take into account, in good faith, the comments, if any, made by the other Party in respect of such activity.
 
(b)            The Party that is responsible for the performance of a specific activity under a Development Program shall use commercially reasonable efforts to complete such activity within the time frame set forth in the Development Program and to ensure that the actual costs of such activity do not exceed the budgeted costs therein as approved by the CSC.  If the responsible Party believes that the actual costs in relation to a particular activity will exceed the budgeted costs, that Party shall promptly notify the CSC and must obtain the CSC’s approval in order to incur such excess costs, which approval shall not be unreasonably withheld, conditioned or delayed.  The Parties agree that all costs incurred and reported in the Development, manufacture, Commercialization and Promotion of Collaboration Products for the Territory shall reflect each Party’s actual costs of performing such activities and shall not include any additional cost mark-up by, or overhead of, such Party.
 
(c)            The Parties agree to Develop the Collaboration Products as selected by the CSC diligently and collaboratively, using good pharmaceutical practices with the goal of maximization of profits from the sale of Collaboration Products in the Territory.  Each Party shall use reasonable and diligent efforts consistent with good pharmaceutical practices to perform the tasks assigned to it under the Development Program.  Subject to confidentiality, non-disclosure and similar undertakings, each Party shall provide the CSC, or any duly authorized representatives of the CSC, with reasonable access during regular business hours to all of its records and documents that are specific to the Development of any Collaboration Product that the CSC may reasonably require in order to perform its obligations hereunder.  In addition, each Party shall report to the CSC in writing, in a format and on a schedule established by the CSC, summarizing the results of such Party’s Development work and efforts and identifying any significant matters, developments or issues.
 
(d)            Upon successful completion of a Development Program, or earlier as reasonably determined by Teva, Teva, in consultation with Acorda, shall use commercially reasonable efforts to seek Regulatory Approval for the relevant Collaboration Product in the Territory.  As between Teva and Acorda, Teva shall be the sole owner of all Regulatory Approvals (as well as applications, including without limitation, INDs and NDAs) (all of which shall be applied for in the name of Teva or one of its Affiliates) received with respect to all Collaboration Products.  Teva shall also be responsible for and perform all activities relating to the maintenance of such Regulatory Approvals in the Territory during the Term of this Agreement.  With respect to Teva seeking and maintaining Regulatory Approval for a Collaboration Product in the Territory, Teva shall provide copies to Acorda of any proposed filings and material correspondence related thereto in sufficient time for Acorda to provide its comments, if any, prior to submission.  Teva shall consider Acorda’s comments in good faith and shall, to the extent practicable, otherwise consult with Acorda in such activities.  If there are any
 
17

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
meetings with the FDA concerning such Regulatory Approvals, Teva shall, to the extent practicable, provide sufficient notice to Acorda to enable Acorda to attend such meetings.
 
(e)            The Parties understand and agree to conduct all pre-clinical and clinical research and studies involving Collaboration Products in accordance with then-current good laboratory practices and good clinical practices, as specified by the applicable laws and regulations in the country where such research and studies are performed.
 
Section 3.2             Development of the Lead Indication.
 
(a)            Acorda shall perform all activities related to the Development of a Collaboration Product as an adjunct therapy for the treatment of epilepsy (the “ Lead Indication ”) as required to obtain and maintain (for and in the name of Teva) the necessary Regulatory Approvals in the Territory, all in accordance with the Development Program for the Lead Indication and the provisions of this Section 3.2.  Teva will have the right to participate and be involved actively in all such Development activities undertaken by Acorda.
 
(b)            Without limiting any of Acorda’s other obligations hereunder, and notwithstanding any other provision of this Agreement to the contrary, Acorda shall bear [***] of the Development Costs, as incurred, for the Next Trial and the carcinogenicity study to be conducted for a Collaboration Product for the Lead Indication, each as more particularly described in Annex H attached hereto, and any pre-clinical studies, drug interaction studies or other testing that the FDA requires or the CSC desires to conduct for a Collaboration Product for the Lead Indication.  Teva shall supply Collaboration Product [***] for conducting the Next Trial.  Acorda shall use commercially reasonable efforts to complete the Next Trial by the first quarter of 2006, subject to any unexpected delays caused by matters outside of Acorda’s control (such as FDA-required additional studies or delays).  [***] of the Development Costs (as approved by the Development Committee or the CSC) expended by Acorda for the carcinogenicity study, or the aforementioned pre-clinical studies, drug interaction or other testing (excluding the Next Trial) for the Collaboration Product for the Lead Indication will be credited against and deducted from the payment due Teva pursuant to Section 4.1(c).
 
(c)            After completion of the Next Trial, if the FDA requires further clinical trials or other studies (in addition to those referred to in Section 3.2(b) hereof) to obtain Regulatory Approval of the Collaboration Product for the Lead Indication in the Territory, then the Parties shall perform such trials and studies only if the CSC desires to perform same.  In the event the CSC so desires to perform such additional trials or studies, then the Parties shall share the Development Costs thereof on a 50/50 basis in accordance with the applicable Development Program.  If on the other hand the CSC does not desire to perform same, such lack of desire shall be considered a decision by the CSC and, accordingly, not subject to the provisions of Section 2.1(d) hereof.
 
Section 3.3             Development of Secondary Indications.
 
(a)            The CSC shall, promptly after the Effective Date, decide whether it is commercially desirable to develop a Collaboration Product for use in the treatment of bipolar
 
18

 
disorder or neuropathic pain (such indications, the “ Secondary Indications ”), in addition to the Lead Indication.  Following the CSC’s decision, the Development Committee (with the approval of the CSC) shall establish a human clinical trial to be implemented by the Parties for the chosen indication (the “ Proof of Concept Trial ”), which the Parties agree shall be tailored in scope and size to provide only the necessary information to determine whether such Collaboration Product achieves the proof of concept criteria established by the Development Committee and approved by the CSC for such indication.  Such clinical trial shall be conducted by the Parties contemporaneously, or as close in time as is commercially practical, with the Next Trial for the Lead Indication (as discussed in Section 3.2(b) above).  The Parties shall use commercially reasonable efforts to complete such Proof of Concept Trial by the first quarter of 2006, subject to any unexpected delays caused by matters outside of Acorda’s control (such as FDA-required additional studies or delays).  The costs of such Proof of Concept Trial shall be deemed Development Costs, which the Parties shall share on a 50/50 basis.
 
(b)            The Secondary Indication not chosen by the CSC to be the subject of the Proof of Concept Trial under Section 3.3(a), will be subject to further Development by the Parties, if at all, only as permitted in, and in accordance with, the provisions of Section 3.5.
 
(c)            Within sixty (60) Business Days of the code opening of the Proof of Concept Trial, the CSC shall decide whether it is commercially desirable to further pursue the Development of the Collaboration Product for the applicable indication.  If the CSC timely decides to pursue such further Development, then the Collaboration Product will be Developed for such indication pursuant to the terms and conditions of this Agreement under a Development Program to obtain and maintain the necessary Regulatory Approvals in the Territory, and such Development shall be funded by the Parties on a 50/50 basis and overseen by the CSC.
 
(d)            Notwithstanding anything contained herein to the contrary, if the CSC does not choose within sixty (60) Business Days of the code opening of the Proof of Concept Trial to further pursue the Development of the Collaboration Product for either or both of the Secondary Indications, then either Party may conduct the further development of the Collaboration Product for such indication as an Independent Party only as permitted in, and in accordance with, the provisions of Section 3.5 applicable to Independent Development.
 
Section 3.4             Development of a Multiple Sclerosis Indication.
 
(a)            Except as expressly provided in this Section 3.4, and for the avoidance of doubt, the Development, Commercialization, Promotion and sale of a Collaboration Product for the treatment of Multiple Sclerosis is excluded from the scope of this Agreement.  Teva and/or its Affiliates may develop, promote, market, sell and commercialize a product containing the Compound specifically to treat Multiple Sclerosis (the “MS Product”).  In the event that Teva and/or any of its Affiliates elects to undertake such activities with respect to the MS Product in the Territory, alone rather than in collaboration with a Third Party, it shall provide Acorda with written notice thereof [ prior to commencing Phase III trials on the MS Product ] .  Following such notice, the Parties shall meet (at a time and place mutually convenient) to discuss the impact, if any, that any potential off-label sales of the MS Product in the Territory or of Collaboration Products in the Territory may have on the sales of the other and the resulting impact on Copromotion Profits yielded therefrom or Teva sales of the MS Product in the Territory,
 
19

 
respectively.  The Parties shall then negotiate in good faith and agree on an amendment to this Agreement to provide for an annual adjustment and reconciliation, based on a reasonable and mutually agreed procedure, for addressing in a fair manner any such impact on Copromotion Profits, and/or on Teva’s sales of MS Products, based on any such off-label sales, with the understanding that the Parties will employ, in such procedure, the best available resources for determining actual sales of Collaboration Products and MS Products, respectively, for uses for treatment of Multiple Sclerosis, as distinct from sales for all other uses developed hereunder, and with the further understanding that such adjustment or reconciliation for the first year of sales of the MS Product, after regulatory approval in the Territory of such product, would necessarily involve an agreed approximation of expected sales, with a reconciliation after the end of such year, based on actual results from such year (as determined using such available resources).  If the Parties are unable to reach agreement on such amendment within sixty (60) Business Days, of Acorda’s receipt of Teva’s notice, the matter shall be resolved pursuant to Section 14.12.
 
(b)            Further, notwithstanding the foregoing, if Teva desires to license a Third Party to develop and commercialize an MS Product (alone or in collaboration with Teva) in the Territory, then prior to entering into any bona fide negotiations with such a Third Party, Teva shall provide written notice thereof to Acorda.  If within sixty (60) Business Days of Acorda’s receipt of Teva’s notice under this subsection (b), Acorda provides written notification to Teva of its desire to Develop a Collaboration Product for the treatment of Multiple Sclerosis under this Agreement with Teva, then the Collaboration Product will be Developed for Multiple Sclerosis pursuant to the terms and conditions of this Agreement under a Development Program to obtain and maintain the necessary Regulatory Approvals in the Territory, and such Development shall be funded by the Parties on a 50/50 basis and overseen by the CSC in accordance with the applicable provisions of this Agreement.  If Acorda declines to pursue such Development, or does not respond to such Teva notice, by the end of such sixty (60) Business Day period, Teva shall no longer have any obligation under this Agreement or otherwise to further negotiate or proceed with Acorda with respect to the Development of a Collaboration Product for the treatment of Multiple Sclerosis and shall thereafter be free to develop, commercialize, promote and sell the Compound for the treatment of Multiple Sclerosis in the Territory outside the scope of this Agreement, itself or with any Third Party.
 
(c)            For the avoidance of doubt, Acorda has no rights whatsoever under this Agreement or otherwise with respect to the Compound for the treatment of Multiple Sclerosis outside the Territory (including, without limitation, the right to receive royalties in respect thereof, unless a Collaboration Product is Developed under this Agreement for treatment of Multiple Sclerosis in the Territory, and Section 4.2(a)(iii) applies to Teva’s (or its Affiliate’s or licensee’s) use of the results of such Development work outside the Territory).  Neither Party has any obligation whatsoever to collaborate with the other to develop the Compound for a Multiple Sclerosis indication outside the Territory and Teva is free to collaborate at any time with a Third Party to develop, or to develop on its own, the Compound for the treatment of Multiple Sclerosis outside the Territory.  For clarity, as used in this section, “Collaboration Product (or Compound) for the treatment of Multiple Sclerosis” means a Collaboration Product (or Compound) or an MS Product with Multiple Sclerosis as a labeled treatment indication, and any use of a Collaboration Product (or Compound) to treat any secondary condition associated with Multiple Sclerosis (e.g., neuropathic pain or muscle weakness) that is not already being Developed pursuant to Section
 
20

 
3.3, will be deemed a Proposed Use, subject to the provisions of Section 3.5 and not the provisions of this Section 3.4.
 
Section 3.5             Development of Other Indications and/or Dosage Forms.
 
(a)            At any time after the Effective Date, either Party may make a written proposal to the CSC regarding the Development of a Collaboration Product for any indication, and/or dosage form, and/or other formulation (such as an extended-release formulation), that is not then being Developed or Commercialized, for Commercialization within the Territory under this Agreement (a “ Proposed Use ”), including any Secondary Indication not selected or pursued under Section 3.3, but excluding a Multiple Sclerosis indication, which may only be proposed by Teva to Acorda in accordance with Section 3.4 above.  Such proposal shall include (i) any data and other information in its possession that may be relevant to the use of a Collaboration Product for such Proposed Use, (ii) a reasonably detailed outline for the major Development activities required to obtain Regulatory Approval for such Proposed Use in the Territory, including a timeline for performing such activities, (iii) an estimated budget for the expected Development Costs, Copromotion Expenses, Production Costs and Distribution Costs for the Development and Copromotion of a Collaboration Product for such Proposed Use, (iv) an appropriate market analysis of such Proposed Use, including, without limitation, expected market size and competitive analysis, and (v) preliminary sales forecasts for the Collaboration Product for such Proposed Use.  Thereafter, the CSC shall meet in order to review such proposal.
 
(b)            The CSC will have ninety (90) Business Days, or such longer period as the Parties may mutually agree, from receipt of such proposal (the “ Additional Indication Review Period ”) to decide whether the Development of a Collaboration Product for such Proposed Use is commercially desirable to both Parties.  If such proposal is accepted by the CSC, then the Parties will jointly Develop the appropriate Collaboration Product for such Proposed Use pursuant to the terms and conditions of this Agreement, including establishing a Development Program for such Proposed Use by the CSC and funding by the Parties on a 50/50 basis.  If the CSC rejects a proposal for a Proposed Use, or does not make a decision within the applicable Additional Indication Review Period, a Collaboration Product for such Proposed Use may be developed independently by either Party (an “ Independent Party ”), at the Independent Party’s sole cost and expense, but otherwise subject to the applicable terms and conditions of this Agreement (such independent development for such Proposed Use, “ Independent Development ”), by providing written notice thereof to the other Party.  Notwithstanding the foregoing, if Acorda decides to pursue such Independent Development and provides written notice thereof to Teva, Acorda shall not be permitted to engage in any such Independent Development without Teva’s prior written consent, which shall not be unreasonably withheld or delayed.  Teva shall include in any such written consent a determination as to whether it has the intention and commitment to manufacture and supply the Collaboration Product for such Proposed Use to Acorda, in the event that Teva does not exercise the Re-Engagement Option for such Proposed Use in accordance with Section 3.5(c).  If Teva determines that it shall not manufacture and supply to Acorda the Collaboration Product for such Proposed Use hereunder, Acorda shall be prohibited from undertaking Independent Development for such Proposed Use.  Upon receipt of Teva’s written consent, Acorda may commence such Independent Development and shall provide Teva with written notice of the commencement thereof.  Notwithstanding the foregoing, if, at any time during Independent Development of a Collaboration Product for a
 
21

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Proposed Use, Teva determines, in its reasonable business and/or scientific judgment, that the continuation of such Independent Development activities could reasonably be anticipated to have a material detrimental impact upon Teva, the Compound, any Collaboration Product or any of Teva’s other rights or obligations, than such Independent Development activities shall cease.  If Teva makes such a determination, it shall reimburse Acorda for the actual direct out-of-pocket costs incurred by Acorda as a result of such Independent Development activities, but such reimbursement shall not include the payment of any interest thereon.
 
(c)            If a Party undertakes the Independent Development of a Collaboration Product for a Proposed Use pursuant to Section 3.5(b), then such Independent Party, with respect to such Proposed Use, shall:  (i) provide the CSC with a summary of its development plans and accommodate any reasonable comments of the CSC, to ensure that such development efforts are coordinated with and not contrary to the joint Development efforts of the Parties on Collaboration Products; (ii) provide the other Party (the “ Non-Participating Party ” as to such development) with quarterly written summaries of the data and results of such development efforts as to such Proposed Use; and (iii) provide written notices to the Non-Participating Party promptly after completion of each stage, including the proof of concept clinical trial, the first Pivotal Trial and the second Pivotal Trial, for the relevant Proposed Use of a Collaboration Product.  Such Non-Participating Party shall have the exclusive option to re-engage after the completion of each stage in the joint Development and Promotion of the Collaboration Product for such Proposed Use (a “ Re-Engagement Option ”), which shall be exercisable by the Non-Participating Party, by notifying the Independent Party in writing of its election, promptly after the completion of each stage for such Proposed Use and before the Independent Party’s receipt of an Approvable Letter for such Proposed Use, or, absent such Approvable Letter, before the Independent Party’s receipt of Regulatory Approval in the Territory for such Proposed Use of a Collaboration Product.  Exercise of a Re-Engagement Option shall be subject to the following terms and conditions:
 
(i)             Within fifteen (15) Business Days of exercise of the Re-Engagement Option as to a particular Proposed Use, the Non-Participating Party shall pay to the Independent Party an amount (the “ Re-Engagement Fee ”) equal to the sum of:  (A) [***] of all Independent Development Costs incurred by the Independent Party through the date of payment (the “ Development Share ”), plus (B) the following additional amount, as applicable: (1) if the Non-Participating Party exercises the Re-Engagement Option after the completion of the proof of concept clinical trial but before the completion of the first Pivotal Trial for the relevant Proposed Use, a risk factor mark-up of an additional [***] of such Development Share;  (2) if the Non-Participating Party exercises the Re-Engagement Option after completion of the first Pivotal Trial but before the completion of the second Pivotal Trial for the relevant Proposed Use, a risk factor mark-up of an additional [***] of such Development Share; or (3) if the Non-Participating Party exercises the Re-Engagement Option after the completion of the second Pivotal Trial but before the Independent Party’s receipt of an Approvable Letter for such Proposed Use, or, absent such Approvable Letter, before the Independent Party’s receipt of Regulatory Approval in the Territory for such Proposed Use, a risk factor mark-up of [***] of such Development Share; provided that , the Non-Participating Party may, at its discretion, satisfy any such payment due under subsection 3.5(c)(i)(B)(3) in two equal quarterly installments, each of which shall be due on the last day of the following two (2) calendar quarters, respectively, after exercise of the Re-Engagement
 
22

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Option.  As used in this Section, the phrase “completion of” a particular Clinical Trial means completion of conducting the trial, analyzing all data and results of the trial, preparing the final and complete report of such analyzed data, and delivering all such data, analysis and report to the Non-Participating Party.
 
(ii)            Effective upon the exercise of the Re-Engagement Option and satisfaction by the Non-Participating Party of the payment conditions set forth under, and in accordance with, Section 3.5(c)(i) above, the relevant Proposed Use for the appropriate Collaboration Product will be Developed and Promoted by the Parties jointly pursuant to the terms and conditions of this Agreement, which shall include establishing a Development Program for such Proposed Use by the CSC for such Collaboration Product and funding of any Development and Promotion activities by the Parties for such Proposed Use on a 50/50 basis, and the Independent Development of such Proposed Use shall terminate.  The Independent Party that had been conducting Independent Development of such Proposed Use shall disclose to the Non-Participating Party all data and results of such development.
 
(iii)          The Parties will share, on a 50/50 basis, any Development Costs that are incurred by either Party following the date of exercise of the Re-Engagement Option, in accordance with a Development Program approved by the CSC, for the Proposed Use of such Collaboration Product (which shall include any such costs of the Independent Party that were committed but not yet incurred under its development of such Proposed Use).
 
(iv)           If the Non-Participating Party does not exercise the Re-Engagement Option prior to the Independent Party’s receipt of an Approvable Letter in respect of the relevant Proposed Use of the appropriate Collaboration Product, or, absent such Approvable Letter, before the Independent Party’s receipt of Regulatory Approval in the Territory for such Proposed Use, then the Non-Participating Party shall be barred from re-engaging in the joint Development and Promotion of the Collaboration Product for such Proposed Use, and the Independent Party shall thereafter be entitled to commercialize, promote and sell such Collaboration Product (in the Territory only, in the case in which Acorda is the Independent Party), independently at its own cost and expense, subject to the following:
 
(1)            Promptly after receipt of such Approvable Letter or Regulatory Approval (as applicable) in the Territory for the Independent Use, Teva and Acorda shall meet and discuss in good faith and agree on an amendment to the Agreement to provide for an annual adjustment, based on a reasonable and mutually agreed procedure, to the sharing of the Copromotion Profits such that the Independent Party (as to such Independent Use) shall receive [***] of the Copromotion Profits resulting from its commercialization and promotion activities with respect to sales of the applicable Collaboration Product in the Territory for the Independent Use, with the understanding that the Parties will employ, in such procedure, the best available resources for determining actual sales of Collaboration Product for such Independent Use, as distinct from sales for uses that are Developed jointly by the Parties hereunder, and with the further understanding that such adjustment for the first year of sales of the Collaboration Product for the Independent Use after Regulatory Approval would necessarily involve an agreed approximation of expected sales, with a reconciliation after the end of such year, based on actual results from such year (as determined using such available resources).
 
23

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
(2)            In addition, if the Non-Participating Party is Teva, then Teva or its designee will have the right to be the exclusive manufacturer and supplier of the subject Collaboration Product for the Independent Use, and the Parties shall enter into a detailed manufacturing, supply and license agreement, to be negotiated in good faith, which agreement shall incorporate the applicable terms and conditions of this Agreement, and where the supply of the Collaboration Product for such Independent Use shall be on commercially reasonable terms typical for similar Third Party manufacturing and supply agreements.
 
Section 3.6             Option Studies.   The Parties may, from time to time, consider whether to undertake any particular Option Study proposed by either Party with respect to a Collaboration Product for the Lead Indication.  For the purposes of this provision, an “Option Study” shall mean a Phase IV human clinical trial initiated after receipt of initial Regulatory Approval in the Territory.  If, within ninety (90) days of any such Option Study proposal by a Party, (i) the Parties consider such proposed Option Study to be commercially viable, then such Option Study shall be performed under this Agreement, and it shall be funded by the Parties on a 50/50 basis, or (ii) either Party does not approve of, or wish to undertake such proposal, then the other Party may, upon written notice to the other Party, undertake such Option Study at its sole cost and expense; provided that , notwithstanding the foregoing, if the Option Study is successful, then the Party that undertook the Option Study will be reimbursed for an amount equal to the sum of [***] of all costs and expenses incurred or committed by such Party in connection with conducting such Option Study, plus a risk factor mark-up of an additional [***] of the [***] share.  For the purposes of this provision an Option Study shall be considered to be successful if the study end points or if the study goals are substantially achieved.
 
ARTICLE 4
FINANCIAL PROVISIONS
 
Section 4.1             Milestone and Other Payments.   Acorda shall make each of the following payments to Teva upon achievement of the respective milestones indicated below:
 
(a)            [***] upon Acorda's execution of this Agreement; plus
 
(b)            [***] upon the code break of the last Pivotal Trial approved by the CSC for the first Collaboration Product in the Territory; plus
 
(c)            [***] upon the first filings of an NDA for the first Collaboration Product in the Territory; plus
 
(d)            [***] upon the approval by the FDA of the NDA for the first Collaboration Product in the Territory.
 
24

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Section 4.2             Co-Promotion Profit Sharing.
 
(a)            Payments.
 
(i)             If, within any calendar quarter during the Term of this Agreement, the Copromotion Profit is a positive number, Teva shall, pursuant to the provisions of Section 4.2(b), pay to Acorda a fee in an amount equal to [***] of the Copromotion Profit.
 
(ii)            If, within any calendar quarter during the Term of this Agreement, the Copromotion Profit is a negative number, Acorda shall, pursuant to the provisions of Section 4.2(b), pay to Teva a fee in an amount equal to [***] of the absolute value of the Copromotion Profit.
 
(iii)          During the Term of this Agreement, Teva shall pay to Acorda, on a country-by-country basis, a fee based on sales by Teva or Teva’s Affiliates of Collaboration Product(s) outside the Territory, if any, in an amount equal to [***] of Net Sales in each country outside of the Territory, where, in each such instance, clinical data developed jointly by the Parties or independently by Acorda under this Agreement is used to obtain Regulatory Approval in such country and provided that such clinical data constitutes a material part of the clinical data used for such approvals.  For the purposes of this Section 4.2(a)(iii), the term “Net Sales,” as defined in Section 1.70, will be deemed to mean the total gross amount invoiced for sales of the aforementioned Collaboration Products in such countries outside of the Territory less the deductions as described in Section 1.70, to the extent actually allowed or incurred with respect to such sales, as applicable.  For clarity, the above royalty obligation shall not apply to any Net Sales of Collaboration Product(s) for indications or uses that are not jointly developed by the Parties under this Agreement, or after an Indication Termination as to an indication or use under this Agreement in accordance with Section 12.2(b).
 
(b)            Payment Date.   Each Party shall, within seven (7) Business Days after each Quarterly Reconciliation Date, pay to the other Party any amounts owed under this Section 4.2 and Section 4.3, as applicable; provided that the Party required to make the payment shall have received an invoice covering such amount at least ten (10) Business days prior to the Quarterly Reconciliation Date.
 
Section 4.3             Reporting; Reconciliation of Accounts and Reimbursement.
 
(a)            Teva and Acorda shall conduct an accounting of Net Sales and Gross Sales, and a reconciliation of Copromotion Expenses, all on a Collaboration Product-by-Collaboration Product basis, as follows:
 
(i)             Within ten (10) Business Days after the end of each month, each Party shall submit to the other Party and the CSC (or its authorized subcommittee) a monthly itemized report (the “ Monthly Report ”), in reasonable detail, of all Copromotion Expenses incurred by it during the preceding month, together with such information as further described in Section 4.3(b)(i) with respect to Development Costs.  Teva’s Monthly Report shall also include all Gross Sales and calculation of Net Sales, including details on the basis for any deductions, during the preceding month.
 
(ii)            Within thirty (30) Business Days after the end of each calendar quarter, each Party shall submit to the other Party and the CSC (or its authorized subcommittee) a quarterly itemized report (a “ Quarterly Report ”) in reasonable detail of all Copromotion
 
25

 
Expenses incurred by it during the preceding calendar quarter, together with such information as is required by the CSC to reconcile such Copromotion Expenses and such information as further described in Section 4.3(b)(ii) with respect to Development Costs.
 
(iii)          In addition to the information required under Section 4.3(a)(ii), Teva’s Quarterly Report shall specify:  (A) the total Gross Sales and calculation of Net Sales of such Collaboration Product, including details on the basis for any deductions, during the preceding calendar quarter in the Territory, including all information required for calculation of such quarterly period Net Sales and Gross Sales, respectively, as required by the CSC, and (B) the total Distribution Costs in the Territory during such calendar quarter, including all information required for calculation of such quarterly Distribution Costs, as agreed upon by the CSC.
 
(iv)           Prior to the date that is sixty (60) Business Days after the end of each calendar quarter (the “ Quarterly Reconciliation Date ”), the CSC shall (A) reconcile for such calendar quarter, the Parties’ respective Copromotion Expenses (the “ Quarterly Copromotion Expenses ”) and (B) determine the aggregate Gross Sales for such calendar quarter with regard to applicable Collaboration Product.  Issues arising in the context of any such reconciliation shall be resolved by the CSC, which shall be required to sign off on any reconciliation as promptly as possible, but, in any event, by no later than the applicable Quarterly Reconciliation Date.
 
(v)             Teva shall, pursuant to Section 4.2(b), reimburse Acorda for the Quarterly Copromotion Expenses, if any, incurred by Acorda.
 
(b)            Teva and Acorda shall conduct a reconciliation of the Development Costs, on a Collaboration Product-by-Collaboration Product basis, as follows:
 
(i)             The Parties’ Monthly Report shall also include an itemized report in reasonable detail of the total Development Costs incurred by each Party during the preceding month, as well as that portion of such Development Costs as to which this Agreement provides for the sharing on a 50/50 basis by the Parties.
 
(ii)            The Parties’ Quarterly Report shall also include an itemized report in reasonable detail of the total Development Costs incurred by each Party during the preceding calendar quarter, as well as that portion of such Development Costs as to which this Agreement provides for the sharing on a 50/50 basis by the Parties (such portion, the “ Quarterly Participation Costs ”), together with such information as is required by the CSC to reconcile such Quarterly Participation Costs.
 
(iii)          Prior to the Quarterly Reconciliation Date, the CSC shall reconcile for such calendar quarter the Quarterly Participation Costs.  Issues arising in the context of any such reconciliation shall be resolved by the CSC, which shall be required to sign off on any such reconciliation as promptly as possible, but, in any event, by no later than the applicable Quarterly Reconciliation Date.
 
(iv)           If the Quarterly Participation Costs of one Party are higher than the Quarterly Participation Costs of the other Party, then the Party with lower Quarterly Participation
 
26

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Costs shall, pursuant to Section 4.2(b), pay to the other Party the reimbursement amount calculated pursuant to the following formula:

 	 	[***]	 	
 	 	 	 	
 	Where	 	 	
 	 	 	 	
 	 	RA = reimbursement amount	
 	 	 	 	
 	 	[***]	 	
 	 	 	 	
 	 	[***]	 	
 
Section 4.4             Mechanics of Reconciliation.   The following applies to reconciliation of Copromotion Expenses:
 
(a)            The CSC shall agree on a common cost per Sales Representative, Professional Education Manager, Scientific Manager and Account Manager (each, the “ Common Cost Per Sales Representative ,” “ Common Cost Per Professional Education Manager ,” “ Common Cost Per Scientific Manager ,” and “ Common Cost Per Account Manager ,” respectively), which cost shall be based upon actual commercially reasonable costs for each such function, and shall be used by the Parties for purposes of preparing the joint profit and loss statements required hereunder and for billing Copromotion Expenses, on a Collaboration Product-by-Collaboration Product basis, and updated annually.  For purposes of calculating costs under this Section 4.4(a), each Party shall only allocate those costs that are directly attributable to such functions for Collaboration Products and shall not include costs relating to each respective Party’s other products ( i.e., other than Collaboration Products) in such calculation of Copromotion Expenses.  To the extent that a cost is attributable to both Collaboration Products and other products of a Party, only that portion of the cost attributable to Collaboration Products shall be included in the calculation.  The aforementioned common costs shall, in every year in which determined by the CSC, take into account the factors set forth on Annex D attached hereto.
 
(i)             The Parties’ sales force costs for Promoting Collaboration Products in the applicable period shall be determined by multiplying the Common Cost Per Sales Representative by (A) the number of Sales Representatives that are Detailing one or more Collaboration Products, in accordance with an approved Marketing Plan and their field-based management, on a full-time basis, and (B) a fraction, the numerator of which is the Weighted Average Details and the denominator of which is the total number of Details (as determined by the respective Party’s call reporting system, which shall comply with reporting standards established by the CSC) delivered by the Sales Representatives included in the Weighted Average Details for all Collaboration Products Detailed by such Sales Representatives.
 
(ii)            The Parties’ Professional Education Manager costs for Promoting Collaboration Products in the applicable period, shall be determined by multiplying the Common Cost Per Professional Education Manager by an amount equal to the sum of: (A) the number of Professional Education Managers working with one or more Collaboration Products, in accordance with an approved Marketing Plan and their field-based management, on a full-time
 
27

 
basis, plus (B) that number equal to (1) the number of Professional Education Managers working with one or more Collaboration Products, in accordance with an approved Marketing Plan and their field-based management, on a part-time basis, multiplied by (2) a fraction that is agreed upon annually by the CSC, to reasonably reflect the average percentage of time that such part-time managers dedicate to working with Collaboration Products.
 
(iii)          The Parties’ Scientific Manager costs for Promoting Collaboration Products in the applicable period, shall be determined by multiplying the Common Cost Per Scientific Manager by an amount equal to the sum of:  (A) the number of Scientific Managers working with one or more Collaboration Products in accordance with an approved Marketing Plan and their field-based management, on a full-time basis, plus (B) that number equal to (1) the number of Scientific Managers working with one or more Collaboration Products in accordance with an approved Marketing Plan and their field-based management, on a part-time basis, multiplied by (2) a fraction that is agreed upon annually by the CSC, to reasonably reflect the average percentage of time that such part-time managers dedicate to working with Collaboration Products.
 
(iv)           The Parties’ Account Manager costs for Promoting Collaboration Products in the applicable period shall be determined by multiplying the Common Cost Per Account Manager by an amount equal to the sum of:  (A) the number of Account Managers working with one or more Collaboration Products in accordance with an approved Marketing Plan and their field-based management, on a full-time basis, plus (B) that number equal to (1) the number of Account Managers working with one or more Collaboration Products in accordance with an approved Marketing Plan and their field-based management, on a part-time basis, multiplied by (2) a fraction that is agreed upon annually by the CSC, to reasonably reflect the average percentage of time that such part-time managers dedicate to working with Collaboration Products.
 
Section 4.5             General.
 
(a)            All applicable costs and expenses incurred by the Parties under this Agreement shall be charged at cost (without markup or any other allocation of overhead) for the purpose of calculating Copromotion Expenses and Development Costs, all in accordance with GAAP.
 
(b)            Each Party shall maintain accurate accounts and records reflecting such Party’s actual Copromotion Expenses and Development Costs, on a Collaboration Product-by-Collaboration Product basis, in sufficient detail to facilitate any reconciliation required hereunder, and with regard to Teva, accounts and records relating to Production Costs, Distribution Costs, Gross Sales and Net Sales on a Collaboration Product-by-Collaboration Product basis.  All accounts and records evidencing revenues, deductions, fees, expenses, costs and reconciliations relating to Collaboration Products shall be subject to audit by an independent auditor of recognized national standing selected by the Party requesting such audit, reasonably acceptable to the other Party and subject to the execution of a confidentiality/non-disclosure agreement reasonably acceptable to the other Party; provided, however that:  (i) no Party may require more than one such audit in any calendar year; (ii) audits may not be conducted in a manner or at any time that would conflict with the fiscal year end of the Party being audited or
 
28

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
that would fall within any “blackout” periods agreed by the Parties; (iii) twenty (20) Business Days prior notice will be given by the Party requiring the audit to the other Party; (iv) all audits will be completed within a period not to exceed thirty (30) Business Days; (iv) the auditor’s fees and expenses will be for the account of the Party requesting the audit, provided, however, that if it is determined that such Party was underpaid or overpaid by more than five (5%) percent of the amount properly due, then the other Party shall reimburse such Party the fees and expenses of such audit, together with the sum of such underpayment or overpayment plus interest at the rate of twelve (12%) percent per annum or the maximum rate allowed by applicable law, whichever is lower; and (v) the audits shall be conducted in a manner that minimizes any disruption to the audited Party’s business.  The Party invoking the audit hereunder shall ensure that any independent auditor performing the audit shall be subject to a confidentiality agreement sufficient to comply with such the confidentiality obligations set forth in Article 10 hereof.  The internal expenses of any Party subject to audit will be for such Party’s account and any overage or underpayment will be promptly refunded or paid, as the case may be.
 
(c)            Copromotion Expenses shall include the costs of non-field based personnel as described in Annex D attached hereto if and only to the extent included in the budget in the applicable Marketing Plan, but not include the cost to the Parties of senior management personnel or other overhead costs, except as otherwise expressly provided to the contrary herein or agreed to by the CSC.
 
(d)            The CSC (or its authorized subcommittee) will be required to approve any reconciliation of Copromotion Expenses and Quarterly Participation Costs amounts due by the Parties prior to the payment of any reimbursement amounts due.
 
(e)            Sales force costs and all other Promotion costs and expenses, to be reimbursable as Copromotion Expenses in any year after the relevant Collaboration Product Launch Date, shall not exceed [***] of amounts budgeted for such costs in the relevant Marketing Plan, without the approval of the CSC not to be unreasonably withheld.
 
(f)             Teva shall prepare and file all sales, income (excluding Acorda income tax filings) and use tax returns and related filings relating to the Promotion and Commercialization of Collaboration Products in the Territory, and will pay all taxes payable for such purposes, which payments shall be considered Quarterly Copromotion Expenses incurred by Teva for the relevant period except to the extent that any such tax payments have already been deducted from Gross Sales in calculating Net Sales.
 
(g)            Any disagreement regarding payment amounts owed to Teva or Acorda shall be submitted to the CSC promptly for resolution.
 
(h)            Each Party shall maintain its financial records relating to this Agreement for the period as follows:  (i) a minimum period of five (5) years for all tax return records and (ii) three (3) years for all other financial records, in each case, from the date that such records were created.
 
29

 
(i)             All amounts due to Teva and/or Acorda under this Agreement shall be paid by wire transfer to such bank as Teva and/or Acorda, as the case may be, may direct from time to time.  All bank expenses incurred by the remitting Party in making such wire transfers will be for its account.
 
(j)             All payments of any amounts pursuant to this Agreement shall be made in USD.  To the extent amounts are incurred in a currency other than USD, the applicable amount will be converted into USD on a quarterly basis using as a rate of exchange the arithmetic average of the applicable actual foreign currency exchange rate for the quarter in which the income is received or expense is incurred, as quoted at the closing of each Business Day by the Reuters News Service for the applicable quarter.
 
(k)            All payments of any amounts pursuant to this Agreement must be in compliance with applicable tax withholding obligations.  Each Party shall be entitled to withhold any amounts required to be withheld by any applicable law from the amounts payable to the other Party.  The Party withholding any such amounts will provide the other Party with all relevant information and documentation with respect to the amounts so withheld.
 
ARTICLE 5
 
COPROMOTION; PROMOTIONAL EFFORTS; PRODUCT SAMPLING
 
Section 5.1             Copromotion.   During the Term of this Agreement, Teva hereby grants to Acorda, and Acorda hereby accepts from Teva, the co-exclusive right to Promote the Collaboration Products in the Territory, together with Teva and its Affiliates and their respective approved agents or representatives, in accordance with the terms and conditions of this Agreement, including, without limitation, the Marketing Plans.  It is agreed that either Party may use Third Party service providers approved by the CSC in connection with such Promotion, provided that unless expressly agreed to in a separate writing no Party may utilize a Third Party service provider that develops, manufactures, promotes, or sells a Competitive Product or is otherwise a competitor of such other Party.  Each Party shall participate in the planning of Promotion activities for Collaboration Products through its membership in the Marketing Committee and shall perform the Promotion activities allocated to it by the Marketing Committee as set forth in the Marketing Plans.
 
Section 5.2             Promotional Efforts.
 
(a)            Throughout the Term of this Agreement, each Party shall devote appropriate resources and use commercially reasonable efforts to perform the functions allocated to it under the Marketing Plans as necessary to Promote Collaboration Products throughout the Territory consistent with the Marketing Plans, and in a manner that it would use efforts to market and promote products of comparable commercial and medical significance in the Territory that are developed and/or controlled by such Party.  Each Party shall employ its expertise, best professional judgment and good working relationships with Target Prescribers, as applicable, to generate maximum profits of Collaboration Products under this Agreement.  The Parties intend that, to the extent it is commercially feasible and not a detriment to the successful sales of Collaboration Products, the Marketing Plans will allocate Promotion efforts such that each Party
 
30

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
will expend about [*   *] of the total efforts and apply [*   *] of the total resources required to Promote the Collaboration Products in the Territory.
 
(b)            Each Party shall assign a total number of Sales Representatives annually as are reasonably necessary to achieve the agreed number of Details for such Party as determined by the Marketing Committee, and to implement its responsibilities under the Marketing Plans for all Collaboration Products applicable with respect to each such year, in accordance with such Marketing Plans.
 
(c)            Each Party shall ensure that it and its respective Affiliates’ statements and claims regarding Collaboration Products, including those as to efficacy and safety, are consistent with the applicable product labeling and Marketing Materials.  The Parties and their respective Affiliates may not add, delete or modify claims of efficacy or safety stated in the Marketing Materials of Collaboration Products nor make any other changes in the Marketing Materials without the approval of the Compliance Committee.  Each Party and its respective Affiliates shall Promote Collaboration Products in strict adherence with regulatory and professional requirements and all applicable federal, state and local laws, guidances, rules and regulations, including the Act, the AMA Guidelines, the PDMA and the PhRMA Code, and keep the other Party fully informed of all compliance matters related to the Promotion of Collaboration Products.
 
(d)            Each Party may utilize only those Marketing Materials that have been approved by the Compliance Committee and the Marketing Committee to Promote Collaboration Products under this Agreement.  All Marketing Materials used or intended to be used in the Promotion of the Collaboration Products in the Territory shall be owned exclusively by Teva and Teva has the sole and exclusive right to use the Marketing Materials outside the Territory.  The Parties shall Promote Collaboration Products in the Territory only under the Trademarks approved for Collaboration Products in accordance with this Agreement.
 
(e)            The use of either Party’s name and/or logo on all Marketing Materials shall be determined by the Marketing Committee and in accordance this Agreement.  Unless prohibited by applicable laws and regulations (as determined by the Compliance Committee), Teva’s and Acorda’s name and logo shall appear on all product packaging, package inserts and product labeling for Collaboration Products.  The Marketing Committee shall have the final determination as to the use of all other names and/or logos on such product packaging, package inserts and product labeling.
 
Section 5.3             Product Sampling.
 
(a)            Teva shall ship the Product Samples and either Teva and/or Acorda, as applicable, shall ship Marketing Materials as directed by the Marketing Committee.  Each Party shall include an allowance for Product Samples in the forecasts that it provides to the other Party.  Acorda and Teva shall be responsible for distributing the Product Samples to their respective sales forces in a timely manner.  Each Party shall also be responsible for securing the return and reconciliation of existing Product Sample and Marketing Materials inventories from its discontinued field Sales Representatives.  All Product Samples provided to Acorda shall be accompanied by an appropriate Certificate of Analysis and Certification of Release in
 
31

 
compliance with the relevant Collaboration Product’s specifications and an indication of expiration dating.
 
(b)            Product Samples supplied by Teva to Acorda shall be used by Acorda solely in connection with the Promotion of the relevant Collaboration Product in the Territory in accordance with the relevant Marketing Plan.  Each Party shall be responsible for following its own policies with respect to compliance with the PDMA, and other applicable federal, state and local laws and regulations relating to the distribution and use of Product Samples.  Each Party shall be responsible for adherence by its sales force to such laws and regulations, and the Parties shall establish, maintain and adhere to written procedures to assure that each Party and its representatives comply with all requirements of the PDMA.  Such written procedures will include a requirement that Acorda notify Teva immediately upon learning that any Product Samples shipped to it have been lost or have not been received as scheduled.  Acorda and Teva shall maintain records as required by the PDMA and all other applicable laws.  Each Party shall promptly provide the other Party with copies of all its correspondence to and from the FDA and any other regulatory authorities relating to losses and thefts of Product Samples and significant or consistent variances in Product Sample inventory.  Each Party will have the right to itself audit the records and/or reports for the Product Samples, as required to be kept by the other Party under the PDMA, during normal business hours, at convenient times and upon no less than five (5) Business Days’ notice.
 
ARTICLE 6
 
MANUFACTURE AND COMMERCIALIZATION OF COLLABORATION PRODUCTS
 
Section 6.1             Manufacture .  Teva and its Affiliates shall have the sole right, authority and responsibility to manufacture all Collaboration Products in connection with the development, promotion and commercialization of Collaboration Products in the Territory.  Teva shall supply (as provided under this Agreement) all of the Parties’ requirements for such development, and shall supply finished Collaboration Products to meet all orders for sale of such Collaboration Products.  Teva shall manufacture and keep in inventory appropriate amounts of finished Collaboration Products dedicated for sale in the Territory, at a level as established as reasonable by the CSC.  Teva covenants that, in the event of any inability to satisfy all open orders for Collaboration Products anywhere in the world, Teva shall not allocate the supply of Compound or finished products to countries outside the Territory in disproportion to orders for the Collaboration Products in the Territory.
 
Section 6.2             Commercialization.
 
(a)            Teva and its Affiliates shall be solely responsible for and shall possess the sole and exclusive right and authority to Commercialize all Collaboration Products in the Territory, in accordance with the Marketing Plans, but except as otherwise provided in Section 3.5(c)(iv).  Teva and its Affiliates shall use commercially reasonable efforts to Commercialize all Collaboration Products in the Territory, including taking, processing and fulfilling all orders for Collaboration Products in the Territory on a timely basis and in accordance with applicable industry standards.  Teva shall also be solely responsible for, and shall assess and address, all Collaboration Product quality control issues.  If Acorda receives any Collaboration Product
 
32

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
orders, it shall use reasonable efforts to forward such orders to Teva within one (1) Business Day after Acorda’s receipt thereof.  Teva shall provide to the CSC written reports, in a format and on a schedule established by the CSC, summarizing the Commercialization activities undertaken by Teva (or its Affiliate) and the results thereof and any significant developments or results of such Commercialization.  Teva shall consult with Acorda regarding its Commercialization efforts and methods and shall answer and seek to accommodate all reasonable questions and comments of Acorda.
 
(b)            All sales of Collaboration Products shall be recorded, invoiced and collected by Teva.  All terms regarding Collaboration Product sales, including, without limitation, terms respecting credit, pricing, cash discounts, rebates, chargebacks, bad debt write-offs, and other fees, charges, returns and allowances shall be set by Teva in accordance with applicable guidelines established by the Marketing Committee.
 
(c)            Teva and its Affiliates shall use commercially reasonable efforts, consistent with good pharmaceutical industry practices, to ensure that clinical trial supplies and Collaboration Products are manufactured in accordance with the then-current Good Manufacturing Practices, as specified by the applicable laws and regulations in the Territory, and the relevant specifications as determined in writing by the Parties.  Teva and its Affiliates shall use commercially reasonable efforts, consistent with good pharmaceutical industry practices, to conduct all manufacturing of Collaboration Products so that Teva can supply Collaboration Products in sufficient quantities to meet all accepted firm purchase orders for Collaboration Products in the Territory in accordance with the then-current Marketing Plans, as determined by the Marketing Committee, and which purchase orders do not exceed [***]  of the quantity of Collaboration Product that is in the relevant Forecast (as defined below).  Not less than six (6) months prior to any Launch Date, and thereafter on or before the first day of September of each year, the Marketing Committee shall provide to Teva a three (3) year forecast, with an annual breakdown, of the anticipated Collaboration Product requirements (by quantity, NDC number and SKU) for the next succeeding three (3) calendar years.  Furthermore, within ten (10) Business Days of the beginning of each calendar quarter, the Marketing Committee shall provide to Teva a forecast of the anticipated Collaboration Product requirements (by quantity, NDC number and SKU) for the next four (4) calendar quarters on a quarterly basis, which quarterly forecasts will be the basis for firm orders to Teva.  (Each three (3) year forecast and quarterly forecast, including allowances for Product Samples and Free Products, a “ Forecast .”)  The Parties shall use their diligent efforts to adjust to changes in any Forecast.  Each Forecast shall also specify Collaboration Product quantities required for use as Product Samples.
 
(d)            If Teva and its Affiliates (i) fail to manufacture and supply Collaboration Products in accordance with the provisions of Section 6.2(c), or (ii) are otherwise unwilling or unable to manufacture Collaboration Products or experiencing difficulties with manufacturing Collaboration Products such that it may be unable to meet Collaboration Product requirements as provided under Section 6.2(c) (in either case, a “ Supply Disruption ”), Teva shall provide prompt written notice of such situation to Acorda.  Teva shall, in any event, use its reasonable commercial efforts to resolve any Supply Disruption and avoid any inability to supply the market demands for the Collaboration Products in the Territory, and shall keep Acorda fully informed of all such efforts.
 
33

 
ARTICLE 7
 
REGULATORY COMPLIANCE; MEDICAL COMPLAINTS; MANAGED CARE AND
GOVERNMENT CONTRACTING
 
Section 7.1             Regulatory Affairs and Compliance.   Teva shall have the sole authority and responsibility for (a) filing, maintaining and updating any INDs and NDAs for Collaboration Products, (b) reporting Adverse Drug Experience Reports and Serious Adverse Drug Experience Reports to the FDA and/or other governmental or regulatory authorities, (c) submitting or filing Marketing Materials with the FDA and (d) handling medical and technical complaints and disputes with the FDA, patients and physicians in respect of any Collaboration Product.  Notwithstanding the foregoing, Teva shall consult with Acorda in all planning for seeking Regulatory Approval and in preparing NDAs for the Collaboration Products in the Territory.  Acorda shall provide Teva with such assistance as is reasonably requested by Teva from time to time to perform its responsibilities under this Section 7.1, provided that the costs associated with such assistance shall be considered Development Costs.  Such assistance and actions shall include, among other things, keeping Teva informed, commencing within two (2) Business Days of notification of any action by, or notification or other information that Acorda receives (directly or indirectly) from the FDA or any other governmental or regulatory authority that (i) raises any material concerns regarding the safety or efficacy of any Collaboration Product, (ii) indicates or suggests a potential material liability for either Party to Third Parties arising in connection with any Collaboration Product or (iii) is reasonably likely to lead to a recall or market withdrawal of any Collaboration Product.  Teva shall consult with Acorda with regard to, and prior to implementation of any changes in Collaboration Product labeling.  With respect to reports and communications described in this Article 7, the Parties shall establish a protocol for timely handling of such items in accordance with FDA and relevant global regulatory requirements and appoint a primary liaison with whom the other Party is to principally communicate.
 
Section 7.2             Adverse Drug Experience Reports.
 
(a)            Teva shall maintain a global safety database recording information on any adverse drug experience during clinical trials and post-marketing.  Subject to the Act and ICH Guidelines on safety reporting (ICH-E2A and ICH-E2C), Teva shall be responsible for submitting to the FDA any Serious Adverse Drug Experience Reports and Adverse Drug Experience Reports relating to Collaboration Products for both INDs and NDAs as required.  Acorda shall, in respect of a Collaboration Product:  (i) notify Teva of all Serious Adverse Drug Experience Reports as soon as practicable, but in no event later than two (2) calendar days, after any Serious Adverse Drug Experience Report becomes known to it; and (ii) notify Teva of all Adverse Drug Experience Reports as soon as practicable, but in no event later than four (4) Business Days, after any Adverse Drug Experience Report becomes known to it.  Each Party shall keep the other Party informed of all significant safety issues to its knowledge regarding any Collaboration Product.  Teva will provide to Acorda copies of all Serious Adverse Drug Experience Reports, Adverse Drug Experience Reports and periodic safety update reports submitted to the FDA or any other regulatory authority related to a Collaboration Product.
 
34

 
(b)            With regard to a Collaboration Product, (i) Teva has the right to determine whether any complaint, Adverse Drug Experience Report or Serious Adverse Drug Experience Report must be reported to the FDA or any other governmental or regulatory authority and (ii) Acorda may not disclose any information concerning Adverse Drug Experience Reports or Serious Adverse Drug Experience Reports to a Person or any governmental or regulatory authority without Teva’s prior written consent, except (A) as may be otherwise required by law, in which case Acorda shall provide prompt written notice thereof in sufficient detail to Teva and the Parties shall in good faith decide upon and effect an appropriate response thereto, or (B) in connection with Acorda’s conduct of clinical trials and other activities in accordance with the applicable Development Program, provided, however, that such disclosure is limited to sites participating in the study.
 
(c)            Teva shall provide Acorda with periodic summary reports (as outlined in the regulatory protocol) of all fifteen (15) day “Alert Reports” relating to the relevant Collaboration Product and submitted to the FDA in accordance with 21 C.F.R. 314.80(c)(1).  Within ten (10) Business Days after submission, Teva shall provide Acorda with copies of all FDA periodic and annual Adverse Drug Experience Reports relating to the relevant Collaboration Product and submitted in accordance with 21 C.F.R. 314.80(c)(2).  Acorda agrees to (i) provide Teva with all reasonable assistance, including assisting Teva in meeting its reporting and other obligations as required by applicable law and (ii) take all actions required by law or regulation under the Act to the extent that such law or regulation is applicable to Acorda with respect to any Collaboration Product.
 
(d)            Within five (5) Business Days after submission or receipt, as applicable, Teva shall provide Acorda with copies of all correspondence submitted to or received from any governmental or regulatory authority in the Territory related to Collaboration Product safety.
 
Section 7.3             Medical Inquiries.   Each Party shall comply with the directions and policies formulated by the Compliance Committee concerning responses to be made to medical questions or inquiries from members of the medical and paramedical professions and consumers regarding a Collaboration Product.  Each Party shall keep records as necessary to document inquiries of health care professionals in compliance with applicable regulatory requirements and the Parties shall make those records available to each other promptly upon request, except that each Party shall provide the other Party with copies of all documentation and information pertaining to medical emergencies promptly, without need for request by the other Party.  The Parties shall cooperate to develop form response letters containing responses to the most frequently asked medical and any routine questions received regarding each Collaboration Product, which materials shall be used by both Parties in responding to medical inquiries directed to their respective personnel.  The Parties shall bear their respective costs for maintaining personnel and facilities to receive, review, forward and/or (as applicable) respond to Collaboration Product medical inquiries, which costs shall be Promotion Costs to the extent directly allocable to efforts related to Collaboration Products in the Territory.  The Parties shall develop mutually acceptable guidelines for receipt, recordation and communication (as between the Parties) of medical inquiry information, and the maintenance and the appropriate period reconciliation of records pertaining thereto.
 
35

 
Section 7.4             Complaints.   Acorda shall refer any complaint that it receives concerning any Collaboration Product, including, without limitation, complaints regarding physical or pharmacologic properties of a Collaboration Product, unexpected increase or decrease in the expected dose-effectiveness of an agent, and changes or alterations of expected appearance, count color or consistency, to Teva as soon as practicable, but in no event later than four (4) Business Days after its receipt of the same; provided, that Acorda must notify Teva of all complaints concerning suspected or actual Collaboration Product tampering, damage, contamination or mix-up (e.g., wrong ingredients or incorrect labeling) as soon as practicable, but in no event later than one (1) Business Day after its receipt of the same.  Teva shall provide to Acorda on a monthly basis a summary report of all known complaints in respect of any Collaboration Product.
 
Section 7.5             Recalls.   Each Party shall notify the other promptly of any material facts or circumstances that it becomes aware of and believes may necessitate or be the basis for a recall, removal, market withdrawal or any other corrective action regarding Collaboration Products in the Territory.  Teva shall promptly notify Acorda of any material actions to be taken by Teva with respect to any recall, removal, market withdrawal or any other corrective action regarding Collaboration Products prior to such action so as to permit Acorda a reasonable opportunity to consult with Teva with respect thereto.  Teva shall consider Acorda’s consultation and recommendations in good faith; provided, however, that nothing in this Section 7.5 is intended to limit Teva’s ability to recall, remove, withdraw or take any other corrective action relating to any Collaboration Products to the extent reasonably necessary to comply with applicable laws.  Upon Teva’s request, Acorda shall assist Teva in conducting any such recall, removal, market withdrawal or other corrective action.  Any documented out-of-pocket costs incurred by a Party with respect to participating in any such recall, removal, withdrawal or other corrective action shall be shared by the Parties on a 50/50 basis as Copromotion Expenses; except that a Party shall be responsible for all such costs if such recall, market withdrawal or other corrective action results from the negligence or willful misconduct of such Party or a Third Party engaged by such Party.
 
Section 7.6             Managed Care and Government Contracting.   Teva and Acorda agree that the Marketing Committee (under the supervision of the CSC) shall be responsible for Promotion of Collaboration Products to Managed Care Organizations in accordance with the then-current Marketing Plans.  Teva shall, in accordance with the applicable Marketing Plan, be responsible for entering into contracts with the Managed Care Organizations for the distribution and sale of Collaboration Products and the payment of applicable rebates and other similar discounts and payments.  Such contracts shall be on commercially reasonable terms and require prior approval by the Marketing Committee.  The Marketing Committee shall designate a primary contact, as between Acorda and Teva, for each, and/or a group of, Managed Care Organizations taking into consideration factors such as each Party’s expertise and existing working relationships with Target Prescribers to maximize the successful sales of Collaboration Products.  The Party not designated as the primary contact for a given Managed Care Organization may continue to participate in Promotion efforts to such Managed Care Organization in collaboration with the designated primary contact.
 
36

 
ARTICLE 8
 
GRANT OF RIGHTS AND NONCOMPETITION
 
Section 8.1             License Grants.
 
(a)            Teva hereby grants to Acorda, subject to, and in accordance with, the terms and conditions of this Agreement, a co-exclusive license (together with Teva and its Affiliates) under the Patent Rights and Know-How to, and only to, Develop and Promote Collaboration Products under this Agreement solely for the Territory during the Term of this Agreement.
 
(b)            Acorda hereby grants Teva, subject to, and in accordance with, the terms and conditions of this Agreement, a co-exclusive, worldwide license (together with Acorda and its Affiliates) under Acorda Background Technology solely to develop, manufacture, commercialize and promote Collaboration Products during the Term of this Agreement.
 
(c)            Teva hereby grants to Acorda a non-exclusive, worldwide, royalty-free, fully paid-up, perpetual, irrevocable license, with full rights to sublicense, under that portion of the Program Intellectual Property either developed solely by Acorda or jointly by Teva and Acorda to develop, make, have made, use, offer for sale, sell and import, one or more products, excluding, however, any products or service that are directly or indirectly competitive with any of Teva’s, or any of its Affiliates’, products or services (excluding the provisions of this Agreement).
 
(d)            Except as expressly provided in this Agreement (including without limitation Section 9.1), no right, title or interest is provided, licensed, granted or otherwise conveyed by one Party to the other Party with respect to such Party’s know-how, patent rights, trade secrets or any other intellectual property right, owned, controlled, licensed or developed by such Party.
 
Section 8.2             Exchange of Information .  From time to time during the Term of this Agreement, upon the request of Acorda, Teva shall, subject to all legal requirements and contractual obligations, promptly disclose to Acorda any and all of its Know-How and Patent Rights as necessary or reasonably useful for Acorda to perform its obligations and exercise its rights under this Agreement.  From time to time during the Term of this Agreement, upon the request of Teva, Acorda shall, subject to all legal requirements and contractual obligations, promptly disclose to Teva any and all of the Acorda Background Technology as necessary or reasonably useful for Teva to perform its obligations and exercise its rights under this Agreement.  Further, from time to time during the Term of this Agreement, as provided herein and at any time upon the request of the other Party, each Party shall disclose to the other Party the results, data and information resulting from such Party’s Development and Promotion efforts.
 
Section 8.3             Right of First Negotiation for Additional Compounds .  Subject to the terms and conditions of this Agreement, during the Term of this Agreement, each Party hereby grants to the other Party the following right of first negotiation to obtain from such Party the co-exclusive right, together with the Party and its Affiliates, to develop and promote in the Territory
 
37

 
any analogues, derivatives or metabolites based upon the Compound, or any other valproic acid related compound similar to the Compound that such Party has or may hereafter acquire (each, an “ Additional Compound ”).  If a Party has or obtains rights to any Additional Compound and intends to develop or license such compound in the Territory, then such Party shall promptly issue to the other Party a written notice to this effect and provide to such other Party all material information in its possession relating to the development or commercialization of such compound.  If the other Party notifies such Party within thirty (30) Business Days after receiving the notice and all such information that it desires to negotiate an agreement to jointly develop and promote such Additional Compound, then Teva and Acorda shall in good faith proceed to negotiate such an agreement over the period up to sixty (60) Business Days from the date of such other Party’s timely notice.  If the Parties are not able to agree upon the terms of a development and promotion agreement (including terms respecting adequate financial resources and security) within the aforementioned sixty (60) Business Day negotiation period (or such longer period as may be agreed by the Parties), or if such other Party does not provide notice to the Party of its interest in such Additional Compound within the aforementioned thirty (30) Business Day notice period, then such right of first negotiation as to such compound shall expire and be of no further force or effect.  Notwithstanding anything to the contrary set forth in this Section 8.3, neither Party shall have a right of first negotiation for, nor shall either Party otherwise be entitled to receive any rights from the other Party to develop and/or promote, any Additional Compound for the Multiple Sclerosis indication or any generic version of any Collaboration Product.
 
ARTICLE 9
 
INTELLECTUAL PROPERTY
 
Section 9.1             Ownership Rights.   Regardless of whether developed solely by Teva or Acorda, or jointly by Teva and Acorda, or on the behalf of either of them, Teva, or its designee, shall own all right, title and interest in and to all Program Intellectual Property.  Any and all patents issued or issuable in respect of such Program Intellectual Property shall be issued in the name of Teva or its designee.  Acorda hereby assigns and transfers to Teva all of its right, title and interest in and to all Program Intellectual Property and agrees, as may reasonably be requested by Teva, to perform those acts necessary to confer upon and to perfect Teva’s full and complete ownership rights in and to the Program Intellectual Property as contemplated under this Section 9.1, including, without limitation, freely sharing with Teva any and all information related to Acorda’s development of any Collaboration Product.  In furtherance of the foregoing, at any time during or after the Term of this Agreement, Acorda shall (a) preserve the confidentiality of all Program Intellectual Property that may form the basis of a patent application and (b) at Teva’s sole cost, fully support Teva’s efforts to obtain patent protection on such potentially patentable subject matter, including participating in the preparation, execution and filing of appropriate formal documents in national and international patent offices and obtaining the cooperation of the inventors in supporting said patent application.  Acorda shall retain the exclusive right, title and interest in and to all Acorda Background Technology, subject only to the license rights granted under this Agreement.
 
38

 
Section 9.2             Intellectual Property Litigation.
 
(a)            Notice of Infringement Claim.   If the developing, making, using, selling or importing of Collaboration Products or any other activity performed by the Parties in the Territory under this Agreement results in a claim against a Party for patent infringement or Trademark infringement or for inducing or contributing to patent infringement or trademark infringement of a Third Party’s rights, as applicable (an “ Infringement Claim ”), the Party first having notice of an Infringement Claim shall, within fifteen (15) days of such notice, provide written notice to the other Party thereof.  Such notice to the other Party shall set forth the facts of the Infringement Claim in reasonable detail.
 
(b)            Responsibilities.   With respect to any Infringement Claim, the Parties shall attempt to negotiate in good faith a resolution with respect thereto.  If the Parties cannot reach an agreeable resolution with the Third Party bringing such Infringement Claim, then (i) Teva will have the sole right and obligation to control the defense of any such Infringement Claim that relates to the Patent Rights, the Know-How, the Trademarks, or the Program Intellectual Property, including any practice or use thereof; and (ii) Acorda will have the sole right and obligation to control the defense of any such Infringement Claim that relates to the Acorda Background Technology, all pursuant to and consistent with the terms of this Agreement.  The Parties shall share all costs and expenses incurred in connection with any such Infringement Claims on a 50/50 basis.  The controlling Party will have the right, after consultation with the other Party, to choose legal counsel to represent the Parties in such Infringement Claim and each of Teva and Acorda will waive any conflict of interest that may arise from one (1) attorney or firm representing both Parties with respect to such Infringement Claim.  The Party not controlling the defense will have the right, at its sole cost and expense (without any right of reimbursement) to retain its own counsel to monitor any such proceeding.  Each Party shall keep the other Party continually informed of all significant matters relating to all Infringement Claims.
 
Section 9.3             Infringement Claims Against Third Parties.
 
(a)            Protection Against Infringement.   Each Party agrees to take reasonable actions to protect the Trademarks, Patent Rights, Know-How, Acorda Background Technology, Program Intellectual Property and any related technology from infringement and from unauthorized possession or use by Third Parties, as provided in this Section 9.3.
 
(b)            Notice of Infringement By Third Party.   If any Trademark, Know-How, Patent Right, Acorda Background Technology or Program Intellectual Property under this Agreement is infringed or misappropriated or if such infringement or misappropriation is threatened, as the case may be, by a Third Party in the Territory during the Term of this Agreement (each, a “ Third Party Infringement ”), the Party to this Agreement first having knowledge of such Third Party Infringement, shall promptly notify the other Party in writing.  The notice shall set forth, in reasonable detail, the facts of such Third Party Infringement.  Teva shall have the primary right, but not the obligation, to institute, prosecute, and control any action or proceeding, with counsel of its choice, with respect to Third Party Infringement of Trademarks or Program Intellectual Property, and Acorda shall have the right to fully participate in any such action.  If Teva chooses not to institute an action, Acorda shall then have the right, but not the obligation, to commence, prosecute, and control the action, with counsel of its choice, subject to the right of reasonable participation of Teva.  Any Third Party Infringement of any Know-How or Patent Right will be solely instituted, prosecuted and controlled, if at all, by Teva,
 
39

 
subject to the right of reasonable participation of Acorda.  Third Party Infringement of any Acorda Background Technology or Acorda trademark or logo will be solely instituted, prosecuted and controlled, if at all, by Acorda, subject to the reasonable participation of Teva.  The parties shall bear all costs and expenses, and retain any amounts received or payable, as a result of any of the foregoing actions or proceedings on a 50/50 basis.  The Parties will use their good faith reasonable efforts to consult each other on the costs associated therewith.  For clarity, if a Party’s intellectual property rights are infringed by an activity that does not involved making, using, importing, offering for sale or selling a product containing the Compound, such Party shall have the sole right to enforce its intellectual property against such infringement, at such Party’s sole expense, and it shall retain any and all recovery from such enforcement
 
(c)            Party’s Failure to Institute, Prosecute and Control.   If either party fails to institute, prosecute and control such action or prosecution of Third Party Infringement of Trademarks or Program Intellectual Property within a period of one hundred twenty (120) Business Days after receiving notice of such Third Party Infringement, then the other Party shall have the right to do so at its own expense; provided however, that such party shall first obtain the other’s consent, not to be unreasonably withheld or delayed, to institute actions to terminate or otherwise prevent continuation of such infringement.  If a Party so consents, it agrees to be joined as a party plaintiff in such action, and such Party has the right, at its own expense, to be represented in any such action by counsel of its own choice.  Except as otherwise agreed to by the Parties as part of a cost-sharing arrangement, any amounts received as a result of such litigation instituted by a Party under this Section 9.3(c), after reimbursement of one hundred (100%) of any litigation expenses of each of Party (including the costs and expenses incurred by a Party in providing reasonable assistance to the other), will be retained solely by the Party instituting the action.
 
(d)            Invalidity Claims Against Intellectual Property.   Each Party shall promptly notify the other of any events relating to any challenges or threatened challenges to the validity or enforceability of the Trademarks, Know-How, Patent Rights, Acorda Background Technology or Program Intellectual Property.
 
Section 9.4             Prosecution and Maintenance of Patents.   Teva shall, at its sole cost and expense, have the exclusive right and responsibility to prepare, file, prosecute and maintain all Patent Rights, and any patents and related applications with respect to Program Intellectual Property that, in Teva’s opinion, are materially useful to the Development, Promotion and/or Commercialization of Collaboration Products in the Territory.  Acorda shall, upon Teva’s request, execute such documents and take such other actions as Teva deems necessary for Teva to apply for, secure, and maintain such patents.  Teva shall reimburse Acorda for any costs and expenses incurred by Acorda in taking any such actions under this Section 9.4.
 
Section 9.5             Use of Trademarks.   All Collaboration Products shall be Promoted by the Parties in the Territory only under the trademarks, trade names and logos that are selected by the Marketing Committee and approved by the CSC (each, a “ Trademark ”).  Teva shall file and prosecute trademark applications in the Territory for each Trademark (except for the Acorda name and logo); provided that the costs with respect thereto shall be shared by the Parties on a 50/50 basis.
 
40

 
Section 9.6             Marking.   Teva shall mark each Collaboration Product used or sold by it in accordance with the requirements of the country of manufacture and sale relating to the marking of patented articles.  If a Collaboration Product incorporates processes, products or other materials or methods covered by a pending patent application for Patent Rights or Program Intellectual Property, Teva shall mark the Collaboration Product with a “patent pending” or similarly appropriate legend.
 
Section 9.7             Rights to Trademarks.
 
(a)            Except as otherwise provided in this Agreement, all Trademarks are Teva’s sole and exclusive property (except the Acorda name, logo and other Acorda trademarks).  Teva hereby grants to Acorda a non-exclusive license to use the Trademarks in the Territory solely in connection with the purposes of this Agreement.  The foregoing non-exclusive license shall terminate upon the termination of this Agreement for any reason (whether by expiration of the Term or otherwise) unless otherwise agreed by the Parties.
 
(b)            Acorda hereby grants to Teva a non-exclusive license to use any Acorda name, logo and other Acorda trademarks that are selected and approved as Trademarks in accordance with Section 9.5 solely in connection with the Promotion of Collaboration Products.  The foregoing non-exclusive license shall terminate upon the termination of this Agreement for any reason (whether by expiration of the Term or otherwise) unless otherwise agreed by the Parties.
 
(c)            After termination or expiration of this Agreement for any reason, except as otherwise expressly provided in this Agreement, Teva remains the sole and exclusive owner of any Trademarks (which excludes, for clarity, the Acorda name, logo and other Acorda trademarks), and all of same shall be promptly transferred to Teva.
 
Section 9.8             Settlements.   Any Party prosecuting a Third Party Infringement or defending an Infringement Claim has the right to settle any such Third Party Infringement or Infringement Claim without the consent of the other Party; provided, however, that neither Party shall have any right, without the other Party’s express written consent, to settle any such Third Party Infringement or Infringement Claim if such settlement could reasonably be expected to have a material adverse impact upon the other Party’s rights under this Agreement, or in respect of the Compound or any Collaboration Product.
 
ARTICLE 10
 
CONFIDENTIALITY
 
Section 10.1          Confidentiality.   Each Party agrees to maintain the confidentiality and secrecy of any information provided to it by, or on behalf of, the other Party under this Agreement, including, without limitation, pursuant to Article 8 hereof (collectively, the “ Confidential Information ” of the disclosing Party), which may include proprietary, financial, trade secret, technical, know-how, business, marketing, data or other confidential information, such as information relating to the Compound or any Collaboration Product, pricing, facilities, methods, formulae, processes, strategies, corporate initiatives, production efforts or
 
41

 
requirements, operations, income, projections, contractual and business arrangements, personnel data, whether in verbal, written or other tangible form, and expressly includes Patent Rights, Know How, and Program Intellectual Property.  Each Party agrees to maintain the confidentiality and secrecy of, and not disclose to any Third Party, the other Party’s Confidential Information using at least the same degree of care that it uses to maintain its own confidential and secret information, but, in any event, never less than a reasonable degree of care.  Neither Party shall use the other Party’s Confidential Information for any purpose other than to exercise its rights, and/or fulfill its duties and obligations, under this Agreement.  Each Party may, however, disclose the other Party’s Confidential Information to its Affiliates, officers, directors, employees and agents who have need to know or who have access to that Confidential Information in order to exercise its rights under and/or fulfill its duties and obligations under this Agreement or to its existing investors and professional advisors and, with the other party’s written consent, to any bona fide potential investor, acquirer, merger partner or other potential financial partner, in all such cases, subject to the terms and conditions of this Section 10.1; provided that in each case, the Party conveying the other Party’s Confidential Information shall inform each recipient of the confidential nature of such information and shall cause each recipient to receive and hold such information in accordance with the terms of this Agreement.  Each Party will also keep in confidence and not disclose to any Third Parties the terms and conditions of this Agreement, except to its existing investors and professional advisors, and, with the written consent of the other party, such consent not to be unreasonably withheld, to any bona fide potential investor, acquirer, merger partner or other potential financial partner; provided further that the Party disclosing such terms and conditions shall inform each recipient of the confidential nature of such information and shall cause each recipient to receive and hold such information as confidential in accordance with the terms of this Agreement.  Each Party shall be responsible for any breach of this Section 10.1 by its Affiliates, officers, directors, employees, agents and other persons to whom the other Party’s Confidential Information is disclosed.  The above obligations of confidentiality and non-use do not apply to any information received by Teva from Acorda hereunder that Teva owns pursuant to the terms of this Agreement and to information that the receiving Party can demonstrate by competent written evidence:
 
(a)            Is or becomes known to the public through no fault or omission on the part of the receiving Party;
 
(b)            As evidenced by the receiving Party’s written records, was independently developed by or for the receiving Party without any reference to, or reliance upon, the disclosing Party’s Confidential Information;
 
(c)            Is made available to the receiving Party from another source rightfully in possession of the disclosing Party’s Confidential Information and not under an obligation of confidentiality with respect thereto; or
 
(d)            Is disclosed with the prior written approval of the disclosing Party.
 
Section 10.2          Permitted Disclosure.   Notwithstanding anything to the contrary set forth in Section 10.1, the Parties understand and agree that Teva has existing obligations under the Third Party Agreements and Teva shall be permitted to disclose certain Confidential Information to such Persons as, and solely to the extent, required under such Third Party Agreements;
 
42

 
provided that such Persons are bound by obligations of confidentiality that are substantially similar to those set forth in Section 10.1.  Further, the recipient Party may disclose certain of the other Party’s Confidential Information, to the extent that such disclosure is required in order to comply with applicable law or pursuant to an order of the government or a court of competent jurisdiction, provided that the recipient Party (a) provides such other Party with adequate prior notice of the required disclosure, (b) cooperates with such other Party’s efforts to protect its Confidential Information with respect to such disclosure and (c) takes all reasonable measures requested by such other Party to challenge or to limit the scope of such required disclosure.
 
Section 10.3          Confidential Information Upon Termination or Expiration.   Each Party agrees that upon the expiration or termination of this Agreement, upon the other Party’s request, such Party shall promptly deliver to the other Party or otherwise dispose of in accordance with the other Party’s directions, the other Party’s Confidential Information.  Upon an Indication Termination for a Collaboration Product under Section 12.2(b), each Party shall continue to maintain the other Party’s Confidential Information that relates to the indication, dosage form or use that is the subject of such Indication Termination, if any, in accordance with Section 10.1.
 
Section 10.4          Privacy.   Notwithstanding anything to the contrary, the Parties agree to treat all individually-identifiable health information as confidential in accordance with all applicable federal, state and local laws and regulations governing the privacy of individually-identifiable health information, including the Health Insurance Portability and Accountability Act of 1996, as amended from time to time, and any regulations and guidance promulgated under that Act.  The Parties will execute those amendments to this Agreement as are necessary to ensure that the Parties remain in compliance with such laws and regulations.
 
Section 10.5          Confidentiality Agreement.   The confidentiality provisions set out in this Agreement are in addition to, and do not derogate from, the terms of the Confidentiality Agreement; provided, however, to the extent that any discrepancy exists between the Confidentiality Agreement and this Agreement, the confidentiality provisions of this Agreement shall govern.
 
ARTICLE 11
 
INDEMNIFICATION; LIMITATION OF LIABILITY; WARRANTY DISCLAIMER
 
Section 11.1          Indemnification .
 
(a)            A Party (the “ Indemnifying Party ”) shall defend, indemnify and hold harmless the other Party and its Affiliates and each of their respective officers, directors, employees, representatives, successors and assigns (collectively, the “ Indemnified Party ”), from and against all losses, liabilities, damage, costs and expenses (including reasonable attorneys’ fees) resulting from any charges, complaints, actions, suits, proceedings, hearings, investigations, claims and demands of Third Parties (collectively, “ Claims ”), to the extent that the Claim results from:  (i) the Indemnifying Party’s negligence or willful misconduct in performing any of its obligations under this Agreement, (ii) a breach by the Indemnifying Party of any of its representations, warranties, covenants or agreements under this Agreement, or (iii)
 
43

 
as to Teva as the Indemnifying Party, any Claim, to the extent directly based upon, and resulting from, Teva’s decision to act under the Agreement in a manner contrary to Acorda’s desires (to the extent Acorda’s desires were reasonable and in good faith) as to a matter for which Teva has, under the terms of the Agreement, the ultimate authority to decide.
 
(b)            In the event the negligence or willful misconduct of Acorda or Teva, as applicable, and/or their respective Affiliates, contribute to any Claims, then Teva or Acorda, respectively, shall be responsible for that portion of such Claim to which its negligence or willful misconduct have contributed.
 
(c)            With respect to Claims that arise, in whole or in part, from the use of any Collaboration Product in the Territory (including Claims that arise with respect to the Development Programs and/or Commercialization of any Collaboration Product) and which Claims do not arise or occur from the events and/or activities described in Sections 11.1(a) or 11.1(b) above, the Parties shall share such Claims on a 50/50 basis as provided in Section 11.2.
 
(d)            The Indemnified Party shall give the Indemnifying Party notice of any Claim upon which the Indemnified Party intends to base an indemnification claim (an “ Indemnity Claim ”).  The Indemnifying Party has the right to control the defense, settlement or disposition of any Indemnity Claim using counsel of its choice and on terms that the Indemnifying Party deems are appropriate, except that the Indemnified Party may, at its own expense, participate in that defense, settlement or disposition using counsel of its own choice.  With respect to the defense, settlement or disposition of an Indemnity Claim, the Indemnified Party shall provide the Indemnifying Party with reasonable assistance and cooperation as reasonably requested by the Indemnifying Party.  Without limiting the generality of the foregoing, the Indemnifying Party may not cease to defend, settle or otherwise dispose of any Indemnity Claim without the Indemnified Party’s prior written consent, which consent may be unreasonably withheld, if, as a result thereof, the Indemnified Party would become subject to injunctive or other equitable relief or such disposition would otherwise have a material adverse effect on the Indemnified Party.
 
Section 11.2          Non-Indemnification Eligible Claims.   If any Third Party makes any Claim against a Party based on or resulting from the use of a Collaboration Product in the Territory, and such Claim does not arise from any event or activity requiring one Party to indemnify the other under Section 11.1, then the Parties shall promptly meet and determine the best way to defend against, and resolve, such Claim.  Unless the Parties agree otherwise, the Parties shall jointly defend the claim, using mutually acceptable counsel, and shall share the costs equally of such defense and of any settlement or amount of damages paid based on such Claim.
 
Section 11.3          Limitation of Liability.  IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT,
 
44

 
OR OTHERWISE, ARISING OUT OF THIS AGREEMENT.  THE FOREGOING SENTENCE SHALL NOT LIMIT THE RIGHTS OR OBLIGATIONS OF EITHER PARTY WITH RESPECT TO INDEMNIFICATION FOR THIRD PARTY CLAIMS UNDER SECTIONS 11.1 AND 11.2 OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 10.
 
Section 11.4          Disclaimer of Warranty.   Except as expressly set forth in this Agreement, nothing in this Agreement may be construed as a warranty or representation by either Party (a) regarding the effectiveness, value, safety or non-toxicity of the Compound or any Collaboration Product, or any information or results provided by either Party pursuant to this Agreement or (b) that any Collaboration Product will obtain Regulatory Approval.  Each Party explicitly accepts all of the same as experimental and for development purposes, and without any express or implied warranty from the other Party.  EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, EACH PARTY EXPRESSLY DISCLAIMS, WAIVES, RELEASES, AND RENOUNCES ANY WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
 
ARTICLE 12
 
TERM AND TERMINATION
 
Section 12.1          Term.   The Term of this Agreement shall commence on the Effective Date and shall continue with respect to all Collaboration Products, unless earlier terminated in accordance with the terms and conditions of this Agreement, until the earlier of (i) the sixth (6th) anniversary of the Effective Date, if the Parties have not achieved a statistically significant primary endpoint (as set forth in the relevant Development Program, established by the Development Committee and approved by the CSC) as accepted by the FDA for the first Pivotal Trial in respect of any Collaboration Product; (ii) six (6) months after the first generic version of any Collaboration Product is launched in the Territory; or (iii) nine (9) years from the Effective Date, if the Parties have not commenced the Promotion and/or Commercialization of any Collaboration Product.
 
Section 12.2          Termination.
 
(a)            Termination for General Breach.   Except as otherwise provided in subsection (b) below, a Party may terminate this Agreement in its entirety if the other Party breaches any material provision of this Agreement and does not fully cure that breach within thirty (30) Business Days after it receives notice thereof from the other party, or, where that breach is not susceptible to cure during the aforementioned thirty (30) Business Day period, such breaching Party does not begin bona fide efforts to cure that breach during such period and thereafter diligently cure that breach to the non-breaching party’s reasonable satisfaction within ninety (90) Business Days after it receives notice of that breach.
 
(b)            Termination of Indications for Breach of Development.   Notwithstanding anything to the contrary in this Agreement, if Acorda materially breaches any of its obligations relating to the Development of a Collaboration Product for a particular
 
45

 
indication, use or dosage form, other than the Lead Indication or with regard to the Proof of Concept Trial for the Secondary Indication selected by the Parties for joint Development under this Agreement (which material breach with respect to either or both thereto is subject to the termination provisions of this Agreement), then Teva shall not have the right to terminate this Agreement in its entirety, but rather Teva may give Acorda written notice of such breach under this subsection (b).  If Acorda does not fully cure that breach within thirty (30) Business Days after it receives notice thereof or, where that breach is not susceptible to cure during the aforementioned thirty (30) Business Day period, begin bona fide efforts to cure that breach during such period and thereafter diligently cure that breach to Teva’s reasonable satisfaction within ninety (90) Business Days after it receives notice of that breach, then Teva may by written notice terminate Acorda’s rights under the Agreement as to further Development and Promotion and profit participation with respect to the Collaboration Products for the indication, use or dosage form that was the subject of such uncured material breach (the “ Indication Termination ”).  In the event of such Indication Termination by Teva, Acorda will not thereafter be entitled to Develop, Commercialize, Promote or sell any Collaboration Products for any indications, uses or dosage forms that were not then being Developed, Commercialized, Promoted or sold under this Agreement at the time of such Indication Termination, without providing assurances to Teva, acceptable to Teva, that Acorda will be able meet its funding and other obligations under this Agreement with respect to any such future indications, uses or dosage forms.  Absent such assurances, this Agreement shall also be deemed terminated as to such indications, uses or dosage forms for Collaboration Products.
 
(c)            Termination for Bankruptcy.  Either Party may terminate this Agreement in its entirety, upon written notice, if the other Party ceases to function as a going concern, makes an assignment for the benefit of creditors, files a voluntary petition in bankruptcy, has an involuntary petition in bankruptcy filed against it that is not dismissed within sixty (60) Business Days, admits in writing its inability to pay its debts as they become due or if an encumbrances takes possession, custody or control or a receiver is appointed over substantially all of the property or assets of such other Party.  All rights and licenses granted under or pursuant to this Agreement by one Party to the other Party are, for all purposes of Section 365(n) of Title 11, U.S. Code (the “ Bankruptcy Code ”), licenses of rights to “intellectual property” as defined in the Bankruptcy Code.  As a licensee of such rights under this Agreement, a Party shall retain, and may fully exercise, all of its rights and elections under the Bankruptcy Code.  If a Bankruptcy Code case is commenced by or against a Party (the “ Bankruptcy Party ”), and this Agreement is rejected as provided in the Bankruptcy Code, and the Bankruptcy Party elects to retain its rights hereunder as provided in the Bankruptcy Code, then the Bankruptcy Party (in any capacity, including debtor-in-possession) and its successors and assigns (including, without limitation, a Bankruptcy Code trustee) shall take such steps as are necessary to permit the other Party to exercise its rights under this Agreement.  All rights, powers and remedies of the non-Bankruptcy Party provided under this provision are in addition to, and not in substitution for, any and all other rights, powers and remedies now or hereafter existing at law or in equity (including, without limitation, the Bankruptcy Code) in the event of any such commencement of a bankruptcy proceeding by or against a Bankruptcy Party.
 
(d)            Unacceptable Change of Control.   If there occurs a Change of Control of Acorda, then Acorda shall provide Teva with prompt written notice of same, but, in any event, no later than fifteen (15) days after the effective date of such Change of Control.  Teva shall
 
46

 
thereafter have the right, upon written notice provided within sixty (60) Business Days of its receipt of Acorda’s notice of such Change of Control, to terminate this Agreement in its entirety.
 
Section 12.3          Effect of Expiration or Termination.
 
(a)            Termination or Expiration of this Agreement .  Upon the expiration or termination of this Agreement, the following shall apply:
 
(i)             All rights, licenses and privileges granted under this Agreement by Teva to Acorda shall automatically terminate and immediately revert to Teva, subject only to the survival provisions of Section 12.5;
 
(ii)            Acorda shall promptly transfer to Teva originals and all copies of all Know-How, Patent Rights, as well as all Marketing Materials, Product Samples, and other materials in its possession or control that relate to the Compound or any Collaboration Product, and ownership in and to all INDs and all Regulatory Approvals (including NDAs) for all Collaboration Products;
 
(iii)          Without waiving any rights or remedies that it has or that are granted to it by operation of law, each Party shall pay to the other Party all undisputed sums accrued that are due and owing under this Agreement;
 
(iv)           The Parties shall comply with the provisions of Section 10.4 of this Agreement;
 
(v)             Except as otherwise expressly provided in this Agreement, including Section 12.4, and subject to any rights or obligations that have accrued prior to expiration or termination, neither Party shall have any further obligation to the other Party under this Agreement, nor shall any Party be entitled to receive any fees or other payments on account of such termination or expiration; and
 
(vi)           Acorda will cooperate and provide reasonable assistance to Teva, at Teva’s expense, to transition the Detailing of the relevant Collaboration Product(s) currently being Detailed jointly by the Parties to a Detailing effort to be borne solely by Teva.
 
(b)            Indication Termination .  Upon an Indication Termination, the following shall apply:
 
(i)             All rights, licenses and privileges granted under this Agreement by Teva to the Acorda in respect of Collaboration Product with respect to the indication, use or dosage form that was the subject of the Indication Termination shall automatically terminate and immediately revert to Teva;
 
(ii)            Acorda shall promptly transfer to Teva originals and all copies of all Know-How, Patent Rights, as well as all Marketing Materials, Product Samples, and other materials in its possession or control that relate to such indication, use or dosage form, to the extent practicable and only if such materials can be entirely separated from, and are not being utilized with respect to, then-existing Collaboration Products;
 
47

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
(iii)          The Parties shall comply with the provisions of Section 10.4 of this Agreement.
 
(iv)           Except as otherwise expressly provided in this Agreement, including Section 12.4, and subject to any rights or obligations that have accrued prior to expiration or termination, neither Party shall have any further obligation to the other Party under this Agreement nor shall any Party be entitled to receive any fees or other payments on account of such termination or expiration in respect of such indication, use or dosage form for Collaboration Products; and
 
(v)             The Parties shall promptly meet and agree on a procedure to adjust the sharing of Copromotion Profits, as per the process set forth in Section 3.5(c)(iv)(1), as if such indication, use or dosage form of the Collaboration Product were a Proposed Use for which Acorda was the Non-Participating Party.
 
Section 12.4          Residual Payments after Certain Terminations.
 
(a)            If Acorda terminates this Agreement early pursuant to Section 12.2(c), or if Teva terminates this Agreement early pursuant to Section 12.2(d), then, and in any such event, the terminated Party shall not be entitled to any compensation or consideration for such termination unless the effective date of such termination of Acorda occurs after the date Acorda completes the Next Trial and the carcinogenicity study for a Collaboration Product for the Lead Indication as contemplated in Section 3.2(b), in which event as Acorda’s sole compensation and consideration arising out of such termination, Teva shall thereafter pay to Acorda residual payments (the “ Residual Payments ”) in the following applicable amounts:
 
(i)             If such termination occurs prior to FDA approval of an NDA for a Collaboration Product for the Lead Indication, the Residual Payments shall equal [***] of Net Sales, if any, of any Collaboration Products in the Territory, until the date on which the Term of this Agreement would have expired pursuant to Section 12.1 (if it had not been earlier terminated pursuant to Sections 12.2(c) or 12.2(d)); provided, however, that notwithstanding the foregoing, in no event shall Residual Payments to Acorda pursuant to this Section 12.4(a)(i) exceed an amount equal, in the aggregate, to the sum of: [****] of Acorda's share of the Development Costs in respect of Collaboration Products through such date of termination and [***] of the milestone payments paid to Teva by Acorda pursuant to Section 4.1 through the date of Termination.
 
(ii)            If such termination occurs after receipt of FDA approval of an NDA for a Collaboration Product for the Lead Indication and the acquiring party in the Change of Control that gave rise to the termination is an entity (or an affiliate thereof) that is selling, commercializing, manufacturing or developing a product that competes (or, if approved, will compete) directly with a Collaboration Product, the Residual Payments shall be an amount equal to the aggregate share of Copromotion Profits that Acorda would have received from Teva under this Agreement during the two (2) year period commencing with the date of termination, as if the Agreement had not been earlier terminated by Teva pursuant to Subsection 12.2(d).
 
48

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
(iii)          If such termination occurs after receipt of FDA approval of an NDA for a Collaboration Product for the Lead Indication and the termination is effected by Teva pursuant to Subsection 12.2(d) for any reason other than that set forth in paragraph (ii) above, the Residual Payments shall be an amount equal to [***] of Net Sales, if any, of Collaboration Products in the Territory for the period commencing on the date that is the second (2 nd ) anniversary of the Launch Date and ending on the date on which the Term of this Agreement would have expired pursuant to Section 12.1, as if the Agreement had not been earlier terminated by Teva pursuant to Subsection 12.2(d).
 
(b)            Residual Payments shall accrue upon the receipt of the amounts covered under applicable invoices for the sale of any such Collaboration Product by Teva, its Affiliates or licensees.  Residual Payments that accrue in a particular calendar quarter shall be paid by Teva to Acorda within thirty (30) Business Days after the end of such quarter.  With each such Residual Payment, Teva shall provide Acorda with a written report setting forth for each such Collaboration Product during the relevant calendar quarter, the Gross Sales, Net Sales, the basis for all deductions used in calculating Net Sales of each such Collaboration Product and the calculation of Residual Payments owed on such sales.
 
(c)            Acorda shall retain the right under Section 4.5(b) to have a third party auditor reasonably acceptable to Teva and subject to such appropriate confidentiality agreement to audit Teva’s records to confirm the accuracy of the Residual Payments owed and paid under this Section 12.4.
 
Section 12.5          Survival.  Sections 4.5(b), 4.5(h), 8.1(c), 11.1, 11.2, 11.3, 12.3, 12.4 and 12.5, and Articles 9, 10 and 14 shall survive any expiration or termination of this Agreement.
 
ARTICLE 13
 
REPRESENTATIONS AND WARRANTIES; COVENANTS
 
Section 13.1          Mutual Representations and Warranties .  Acorda and Teva each hereby represent and warrant to the other that, as of the Effective Date:
 
(a)            It has the full right, power and authority to enter into and perform this Agreement and to grant the rights granted in this Agreement.
 
(b)            The execution, delivery and performance of this Agreement does not conflict with, violate, or breach any other agreement to which it is a party, or its articles of incorporation or by-laws, or any judgment, order or decree to which it is subject.
 
(c)            This Agreement has been duly executed and delivered by it and is a legal, valid and binding obligation enforceable against it in accordance with its terms, subject to and limited by:  (i) applicable bankruptcy, insolvency, reorganization, moratorium, and other laws generally applicable to creditors’ rights and (ii) judicial discretion in the availability of equitable relief that enforceability is limited by applicable federal and state bankruptcy laws.
 
(d)            In the case of Teva, that it owns all right, title and interest in and to, or has licensed the right to use for the purposes of this Agreement, its Patent Rights.
 
49

 
(e)            In the case of Teva, that it owns, or has licensed the right to use for the purposes of this Agreement, its Know-How.
 
(f)             In the case of Teva, to the best of its knowledge, its Patent Rights are valid and enforceable.
 
(g)            In the case of Acorda, to the best of its knowledge, that it owns all right, title and interest in and to, or has received an assignable license to use for the purposes of this Agreement, the Acorda Background Technology, if any, and that its rights thereto are valid and enforceable.
 
Section 13.2          Mutual Covenants .  Each Party, as applicable, hereby covenants and agrees to the other:
 
(a)            To carry out its obligations and activities under this Agreement in accordance with all applicable laws and regulations.
 
(b)            That except as otherwise permitted pursuant to the terms of this Agreement, during the Term of this Agreement that it will not enter into any agreement with a Third Party that would have a material adverse effect on its ability to perform the obligations undertaken by it in the Agreement.
 
(c)            It will maintain, throughout the Term of this Agreement, adequate liability insurance (including product liability coverage) in order to satisfy its obligations under this Agreement of no less than two million dollars ($2,000,000) per occurrence and five million dollars ($5,000,000) in the aggregate.  Each Party shall ensure that the other Party is named as an additional insured under those liability insurance policies, and will furnish the other with certificates evidencing that insurance coverage no later than thirty (30) Business Days after the Effective Date and thereafter, on each anniversary of the Effective Date upon the written request of the other Party.
 
Section 13.3          Further Representations, Warranties and Covenants of Acorda.
 
(a)            Acorda represents and warrants that it has furnished to Teva a consolidated balance sheet of Acorda as at December 31, 2002, and consolidated statements of income and cash flows of Acorda for the fiscal year then ended, audited by KPMG and consolidated balance sheets of the Acorda as of March 31, 2003, and statements of income of Acorda for the period then ended.  Except as otherwise specifically identified to Teva in writing by Acorda, the foregoing financial statements have been prepared in accordance with GAAP and fairly present in all material respects the consolidated financial condition of Acorda as at the close of business on the date thereof and the results of operations for the periods then ended (subject, in the case of unaudited statements, to year-end and audit adjustments and the absence of footnotes).  There are no contingent liabilities of Acorda or any of its subsidiaries as of such dates involving material amounts known to the officers of Acorda that were not disclosed in such balance sheets and the notes related thereto.
 
(b)            Acorda represents and warrants to Teva that (i) as of the Effective Date, it is not in default under any loan or credit agreement, note, bond, indenture, mortgage or other
 
50

 
evidence of indebtedness or instrument securing indebtedness to which it is a party or by which its assets are bound, and it reasonably expects not to be in default under any of the foregoing during the Term of this Agreement, and (ii) it has immediately available funds sufficient to carry out the transactions contemplated by this Agreement and to perform all of its obligations under or arising out of this Agreement.
 
(c)            Acorda represents and warrants to Teva that, as of the Effective Date, other than any plans or negotiations relating to a public offering of its securities pursuant to Sections 12 or 15 of the Securities Act of 1933, it is not involved in any negotiations nor does it have any plans for negotiations, nor does it anticipate the receipt, in the period of six (6) months after the Effective Date, of any offers to negotiate, to be acquired by any Third Party or to sell all or substantially all of its assets or business to any Third Party.
 
ARTICLE 14
 
MISCELLANEOUS
 
Section 14.1          Assignment.   This Agreement is personal to each Party and neither Party may assign, mortgage, dispose of, transfer or delegate any of its rights, duties or obligations under this Agreement or any interest in this Agreement without the other Party’s prior written consent, which consent may not be unreasonably withheld, except that (a) Teva may assign or delegate any or all of its rights and obligations under this Agreement to its Affiliates without Acorda’s prior written consent; provided that Teva remains primarily liable for the performance and non-performance of its Affiliate’s duties and obligations under this Agreement, and (b) either Party may assign this Agreement without such consent to its successor in interest in connection with a merger, acquisition or sale of all or substantially all of such Party’s assets, provided that such successor in interest agrees in writing to be bound by all of such Party’s obligations as assignee.  This Agreement is binding upon, enforceable against, and inures to the benefit of the Parties hereto and their respective successors and permitted assigns (but, in the case of Acorda, subject to the provisions of Section 12.2(d)).  Any attempt by either Party to assign or delegate any of the duties, responsibilities or other obligations of this Agreement that is not in compliance with this Section 14.1 shall be deemed to be null and void from the beginning.
 
Section 14.2          Notices.   Unless otherwise specified in this Agreement, all notices, requests, demands and other communications required under this Agreement must be in writing at the Parties’ respective addresses as set forth below, unless notification of change of address is given.  Notice may be given by express mail using a nationally-recognized courier, by certified mail, return receipt requested, and by facsimile (with proof of receipt), and is deemed to have been given at the time it is received:

If to Acorda:	Acorda Therapeutics, Inc.	
 	15 Skyline Drive	
 	Hawthorne, New York 10532 U.S.A.	
 	Attention:	
 	Telephone:	
 	Facsimile:	
 
51

 

With a copy to:	Acorda’s General Counsel at the above address	
 	 	
If to Teva:	Teva Pharmaceutical Industries Ltd.	
 	5 Basel Street, P.O. Box 3190	
 	Petah Tiqva 49131	
 	Israel	
 	Attention:	Chief Executive Officer	
 	Telephone:	972-3-926-7208	
 	Facsimile:	972-2-924-6026	
 	 	
With a copy to:	Teva’s General Counsel, Uzi Karniel, at the above address and	
 	 	
 	Richard S. Egosi, Esq.	
 	Vice President and General Counsel	
 	Teva North America	
 	1090 Horhsam Road	
 	North Wales, PA 19454-1090	
 	Telephone:	(215) 591-8627	
 	Facsimile:	(215) 591-8813	
 
Section 14.3          Entire Agreement.   This Agreement, the Exhibits and Annexes attached hereto, all of which are hereby incorporated into this Agreement, and except as preempted by Section 10, the Confidentiality Agreement, contain the entire agreement between the Parties with respect to the subject matter of this Agreement and supersede all previous agreements and understandings between the Parties, whether written or oral, with respect thereto.  Any amendment or modification of this Agreement must be in writing executed by duly authorized representatives of the Parties in the same manner as this Agreement.
 
Section 14.4          No Endorsements.   Except as contemplated and permitted in Section 9.7, neither Party may use the other Party’s corporate name or logo or the name or logo of that other Party’s Affiliates in a manner that could reasonably be construed to imply an endorsement by that other Party or for publicity or advertising purposes or as a reference to current or prospective customers without that other Party’s prior written consent, which may be granted or withheld by that other Party in its sole discretion.
 
Section 14.5          No Waiver.   No consent by either Party to, or a waiver of, a breach by either Party, whether express or implied, constitutes consent to, waiver of, or excuse of, any other, different or subsequent breach by either Party.
 
Section 14.6          Affiliates.   Each Party shall cause their respective Affiliates to cooperate, in good faith, with the other Party and its Affiliates, in the execution of any responsibilities assigned or delegated to them with respect to the Development, Promotion and/or the Commercialization of Collaboration Products, in such a manner as to maximize sales and profitability with respect to Collaboration Products and to otherwise comply with all applicable provisions of this Agreement.  Each Party undertakes to ensure, to the extent applicable, that any
 
52

 
or all of their respective Affiliates will take those actions as may be necessary in order to ensure the foregoing.
 
Section 14.7          Force Majeure.
 
(a)            Neither Party shall be liable to the other for any failure or delay in the fulfillment of its obligations under this Agreement (other than the payment of monies due and owing to a Party under this Agreement), when any such failure or delay is caused by fire; flood; earthquakes; accidents; explosions; sabotage; strikes, or other labor disturbances (regardless of the reasonableness of the demands of labor); civil commotions; riots; invasions; wars; acts, restraints, requisitions, regulations, or directions of government authorities; acts of God; or any other cause (similar to the foregoing) beyond the reasonable control of the performing Party (collectively, “ Force Majeure Events ”).
 
(b)            In the event that either Party is unable to discharge its obligations under this Agreement on account of a Force Majeure Event (i) the performing Party will notify the other Party forthwith, and will nevertheless make every endeavor, in the utmost good faith, to discharge its obligations, even if in a partial or compromised manner and (ii) the other Party has the right to terminate this Agreement, if the performing Party’s inability to discharge such obligations continues for a period of more than one hundred eighty (180) days.
 
Section 14.8          Relationship of the Parties.
 
(a)            This Agreement does not in any way create the relationship of principal and agent or partners or joint venturers or agents or any similar relationship between Acorda and Teva.  Neither Party has the right, power or authority to bind the other to the fulfillment of any condition not contained in this Agreement or to any other contract or obligation or liability nor make any representation on behalf, or in the name, of the other Party, whether express or implied.
 
(b)            Neither Party is responsible for the hiring, firing or compensation of the other Party’s employees or for any employee benefits.  No employee or representative of a Party has any authority to bind or obligate the other Party for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on the other Party without that Party’s authorization.
 
Section 14.9          Public Announcements.   Neither Party shall issue any press release or make any public statement pertaining to this Agreement, the Development activities or any other transaction under this Agreement without obtaining the prior written approval of the other Party.  Each Party may, however, issue any such release or statement, upon the advice of its counsel, that such issuance is required in order to comply with applicable law or securities rules or regulations.  With respect to any such required disclosure, each Party shall share such proposed disclosure in advance with the other Party and shall take into account in good faith the comments, if any, made by such Party; provided that such comments are made in a timely manner, and provided further, that the disclosing Party shall retain the final decision regarding the content and timing of such disclosure.  Further, the Party making any such required disclosure shall, to the extent available, seek confidential treatment of the same.
 
53

 
Section 14.10        Severability.   The provisions of this Agreement are severable, and if any one or more provisions is determined to be illegal or otherwise unenforceable, either in whole or in part, the remaining provisions or portions hereof nevertheless continue to be valid and binding on, and enforceable by and between, the Parties.
 
Section 14.11        Fees and Expenses.   Except as otherwise provided in this Agreement, each of the Parties hereto shall pay its own respective fees and expenses (including, without limitation, the fees of any attorneys, accountants, investment bankers or other representatives) incurred in connection with this Agreement and the transactions contemplated hereunder, whether or not such transactions are consummated.
 
Section 14.12        Dispute Resolution, Arbitration and Governing Law.
 
(a)            Subject to Annex G, in the event of any dispute, controversy or claim between the Parties relating to or arising out of this Agreement (a “ Dispute ”), each Party will use its best efforts to expeditiously settle the Dispute in an amicable manner within a time reasonable under the circumstances.  In the absence of a settlement, the Dispute will be initially referred to the CSC.  If the CSC is unable to resolve the Dispute within twenty (20) Business Days of referral (or such longer period as the Parties or the CSC may agree), the Dispute will be referred by either of the CSC co-chairpersons in writing to the Chief Executive Officers of, or such other senior executive officers designated by, Teva and Acorda for resolution.  In the event that those senior executive officers fail to reach agreement within twenty (20) Business Days of referral of the Dispute, or such other period as the Parties may agree, then such Dispute will be decided by arbitration in accordance with the International Rules of the American Arbitration Association for Commercial Arbitration (the “ Arbitration Tribunal ”) in effect at the time the Dispute arises, unless the Parties mutually agree otherwise.  Any such arbitration under this Section 14.12(a) shall be conducted in accordance with the provisions of Annex B attached hereto.
 
(b)            Neither Party has the right to independently seek recourse from a court of law or other authorities in lieu of arbitration, but each Party has the right, before or during the arbitration, to seek and obtain, from a court of competent jurisdiction, provisional equitable remedies to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration.
 
(c)            This Agreement is governed by, and construed in accordance with, the laws of the State of New York, U.S.A., without reference to its conflict of laws principles, or the conflict of laws principles of any other jurisdiction.
 
Section 14.13        Performance of Affiliates.   Each Party acknowledges that certain obligations under this Agreement may be performed by its Affiliates.  Each of Acorda and Teva guarantees performance of this Agreement by any of its Affiliates and shall be responsible curing or otherwise remedying any breach of this Agreement by its Affiliates.
 
Section 14.14        Third Party Agreements.   The Parties acknowledge and agree that all of the rights granted, and obligations owed, by Teva as set forth in this Agreement are subject to the Third Party Agreements.  Teva agrees, to the extent that the Development, Promotion or
 
54

 
Commercialization of any Collaboration Product for the Territory is negatively impacted by the Third Party Agreements, upon the written request of Acorda, to disclose such portions of the applicable Third Party Agreements for Acorda’s review, subject to any confidentiality obligations that Teva may have to Third Parties, and provided that Teva shall use commercially reasonable good faith efforts to obtain a waiver of such confidentiality obligations that would prevent Teva from disclosing to Acorda such portions of such Third Party Agreements.
 
Section 14.15        Maintenance of Records .  Each Party shall keep and maintain all records required by law or regulation with respect to Collaboration Products and, to the extent appropriate hereunder, will make copies of such records available to the other Party upon request.
 
Section 14.16        No Strict Construction.   This Agreement has been prepared jointly by the Parties and may not be strictly construed against either Party.  Ambiguities, if any, in this Agreement may not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.
 
Section 14.17        Translations.   This Agreement is in the English language only, which controls in all respects, and any versions of this Agreement in any other language are for accommodation only and is not binding upon the Parties.  All communications and notices to be made or given pursuant to this Agreement, and any dispute proceeding related to, or arising under, this Agreement, must be in the English language.
 
Section 14.18        Interpretation and Definitions.   The preamble to this Agreement is hereby integrated into this Agreement.  All Exhibits and Annexes to this Agreement, attached at the time of signature of this Agreement, are hereby integrated into this Agreement.
 
Section 14.19        Headings; Section References.   The Section and other headings contained in this Agreement are for reference purposes only and do not affect the meaning or interpretation of this Agreement.  As used in this Agreement, the word “including” and phrase “such as” are illustrative and not limitative, and incorporate, in all instances, the idea of “without limitation”.  All references in this Agreement to Sections, Exhibits and Annexes are to Sections of, and Exhibits and Annexes to, this Agreement, except as may be expressly specified otherwise.
 
Section 14.20        Counterparts.   This Agreement may be executed in any number of counterparts, each of which is deemed to be an original of the same instrument, but all of which together constitute but one and the same instrument.
 
Section 14.21        Further Instruments and Acts.   The Parties agree to execute, acknowledge and deliver such further instruments and do all other acts as may be necessary or appropriate to effect the purpose and intent of this Agreement.
 
[The remainder of this page has been intentionally left blank.]
 
55

 
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed by its duly authorized representative as of the date first set forth above.

 	TEVA PHARMACEUTICAL INDUSTRIES LTD.	

 	By:	 	 	
 	 	Name:	Eli Shohet	
 	 	Title:	Vice-President - Business Development	

 	ACORDA THERAPEUTICS, INC.	

 	By:	 	 	
 	 	Name:	Ron Cohen	
 	 	Title:	Chief Executive Officer	

56

 
ANNEX A
 
Description of TV-1901
 
TV-1901 is referred to by its chemical name, N-(2-amino-2-oxoethyl)-2-propylpentanamide, or its International Non-proprietary Name, Valrocemide.  TV-1901 is the active ingredient in TV-1901 tablets.

 
ANNEX B
 
Arbitration
 
1.              Initiation of Arbitration .  A Party (“ Complaining Party ”) that intends to begin an arbitration to resolve a Dispute as contemplated by Section 14.12 of the Agreement (“ Arbitration ”) shall initiate the Arbitration by providing written notice (“ Arbitration Request ”) of such intent by certified or registered mail or properly documented overnight delivery to the other Party (“ Responding Party ”).  The Arbitration Request shall include a copy of the description of Dispute, set forth a proposed solution to the Dispute, and include a suggested time frame within which the Parties must act to affect such solution.  Contemporaneously with sending the Arbitration Request, the Complaining Party shall submit a copy of the Arbitration Request to the Arbitration Tribunal in the City of New York, New York.
 
2.              Selection of Arbitration .  Any and all Disputes to be resolved pursuant to Arbitration shall be submitted to a neutral arbitrator  (“ Arbitrator ”).  The Parties shall select the Arbitrator by mutual agreement but if the Parties are unable to agree, then the Arbitrator shall be selected in accordance with the procedures of the Arbitration Tribunal.  The Arbitrator shall be a former judge of a state or federal court who shall not be a current or former employee, director or shareholder of, or otherwise have any current or previous relationship with, either Party or its respective Affiliates.
 
3.              American Arbitration Association Rules .  The Arbitration shall be conducted in accordance with the rules of the American Tribunal then in effect, subject to the time periods and other provisions of this Annex or as otherwise set forth in the Agreement.
 
4.              Hearing .  Consistent with the time schedule established pursuant to this Section 4 and Section 5 below, the Arbitrator shall hold a hearing (“ Hearing ”) to resolve each of the issues identified in the description of Dispute.  To the extent practicable, taking into account the nature of the Dispute and the availability of the Arbitrator, the Hearing shall be conducted over a period not to exceed ten (10) consecutive Business Days, with each Party entitled to approximately half of the allotted time, unless otherwise ordered by the Arbitrator.  The Hearing shall be conducted

 
in a location in the City of New York to be mutually agreed by the Parties.
 
5.              Discovery .  Within ten (10) Business Days of receipt by the Responding Party of the Arbitration Request, the Parties shall negotiate in good faith the scope and schedule of discovery, including depositions, document production and other discovery devices, taking into account the nature of the Dispute submitted for resolution.  If the Parties are unable to reach agreement as to the scope and schedule of discovery, the Arbitrator may order such discovery, as he or she deems necessary.  In either case, such discovery shall be completed within thirty (30) Business Days from the date of the selection of the Arbitrator.  At the Hearing, which shall commence within twenty (20) Business Days after the completion of discovery, unless the Arbitrator otherwise orders, the Parties may present testimony (either live witness or deposition), subject to cross-examination, and documentary evidence.
 
6.              Hearing Submission .  At least twenty (20) Business Days prior to the date set for the Hearing, each Party shall submit to each other and the Arbitrator a list of all documents on which such Party intends to rely in any oral or written presentation at the Hearing, a list of all witnesses, if any, such Party intends to call at the Hearing and a brief summary of each witness’s testimony.  At least five (5) Business Days prior to the Hearing, each Party must submit to the Arbitrator and serve on each other Party proposed findings of fact and conclusions of law on each issue to be resolved.  Within five (5) days following the close of the Hearing, each Party shall submit post-Hearing briefs to the Arbitrator addressing the evidence and issues to be resolved as may be required or permitted by the Arbitrator.
 
7.              Arbitrator’s Duties and Authority .  The Arbitrator shall preside over and resolve any Disputes between the Parties in connection with the Arbitration.  The Arbitrator shall have sole discretion with regard to the admissibility of any evidence and all other matters relating to the conduct of the Hearing.  The Arbitrator shall, in rendering its decision, apply the substantive law of the State of New York, excluding its conflict of laws provisions.  The decision of the Arbitrator shall be final and not appealable, except in the case of fraud or bad faith on the part of the Arbitrator in connection with the conduct of such proceedings.
 
B - 2

 
8.              Decision and Award .  The Arbitrator shall render a decision and award as expeditiously as possible, but in no event more than thirty (30) Business Days after the close of the Hearing.  In making the award, the Arbitrator shall rule on each disputed issue.  Nothing contained herein shall be construed to permit the Arbitrator or any court or any other forum to award punitive, exemplary or any similar damages.  Subject to Section 11.3 of the Agreement, the Parties expressly waive any claim for punitive, exemplary or any similar damages and the only damages recoverable under this Agreement are compensatory damages.
 
9.              Costs and Expenses .  Each Party shall pay its own costs (including, without limitation, reasonable attorneys’ fees) and expenses in connection with the Arbitration; provided, however, that if the Arbitrator determines that the action of any Party was arbitrary, frivolous or in bad faith, the Arbitrator may award such costs and expenses to the prevailing Party.
 
10.            Confidentiality .  The Arbitration shall be confidential and, except as required by law, neither Party shall make (or instruct the Arbitrator to make) any public announcement with respect to the proceedings or decision of the Arbitrator without the prior written consent of the other Party.  The existence of any Dispute, and the award of the Arbitrator, shall be kept in confidence by the Parties and the Arbitrator, except as required in connection with the enforcement of such award or as otherwise required by applicable law.
 
11.            Jurisdiction to Enforce Award .  For the purposes of these arbitration provisions, the decision may be entered in any court of competent jurisdiction.
 
12.            Exclusive Procedures .  The procedures specified herein shall be the sole and exclusive procedures for the resolution of Disputes between the Parties that are expressly identified for resolution in accordance with these arbitration provisions.
 
B - 3

 
 
TABLE OF CONTENTS

ARTICLE 1	DEFINED TERMS	
￠	￠	
ARTICLE 2	GOVERNANCE OF DEVELOPMENT AND COMMERCIALIZATION OF COLLABORATION PRODUCTS	
￠	￠	
ARTICLE 3	DEVELOPMENT OF PRODUCTS	
￠	￠	
ARTICLE 4	FINANCIAL PROVISIONS	
￠	￠	
ARTICLE 5	COPROMOTION; PROMOTIONAL EFFORTS; PRODUCT SAMPLING	
￠	￠	
ARTICLE 6	MANUFACTURE AND COMMERCIALIZATION OF COLLABORATION PRODUCTS	
￠	￠	
ARTICLE 7	REGULATORY COMPLIANCE; MEDICAL COMPLAINTS; MANAGED CARE AND GOVERNMENT CONTRACTING	
￠	￠	
ARTICLE 8	GRANT OF RIGHTS AND NONCOMPETITION	
￠	￠	
ARTICLE 9	INTELLECTUAL PROPERTY	
￠	￠	
ARTICLE 10	CONFIDENTIALITY	
￠	￠	
ARTICLE 11	INDEMNIFICATION; LIMITATION OF LIABILITY; WARRANTY DISCLAIMER	
￠	￠	
ARTICLE 12	TERM AND TERMINATION	
￠	￠	
ARTICLE 13	REPRESENTATIONS AND WARRANTIES; COVENANTS	
￠	￠	
ARTICLE 14	MISCELLANEOUS	

Annex A	-	Description of TV-1901	
Annex B	-	Arbitration	
Annex C	-	Form of Certificate of Analysis and Form of Certificate of Release	
Annex D	-	Copromotion Expenses	
Annex E	-	Third Party Agreements	
Annex F	-	Elements of a Marketing Plan	
Annex G	-	Matters Within Teva’s Sole Decision Making Authority	
Annex H	-	Next Trial and Carcinogenicity Study for the Lead Indication	
 
i

 

 
 
September 23, 2003

Eli Shohet
Vice President of Business Development
Teva Pharmaceutical Industries, Ltd.
P.O. Box 3190
Petah Tiqva  49131
Israel
 
Re: Fampridine Right of First Negotiation Grant
 
Dear Mr. Shohet:
 
This letter shall confirm our agreement regarding a possible collaboration agreement to develop, co-promote and commercialize in the United States (including its possessions and territories), Canada and Mexico (collectively, the “Territory”) all finished pharmaceutical products that contain Acorda’s chemical compound referred to as fampridine (the “Fampridine Agreement”).
 
Commencing on the date hereof Acorda hereby grants to Teva the exclusive right of first negotiation pursuant to which it shall enter into good faith negotiations exclusively with Teva regarding terms of a possible mutually acceptable Fampridine Agreement.   It is understood that neither party is obligated to enter into such a Fampridine Agreement except on terms acceptable to it in its discretion, and that Acorda may determine that the terms proposed by Teva are not as attractive as proceeding on its own (or, as permitted below, with a third party).  If the parties are unable to agree upon mutually acceptable terms for the Fampridine Agreement, and Teva has not already provided Acorda with its written notice to terminate such good faith negotiations, then Acorda may terminate the right of first negotiation hereunder upon written notice given to Teva at any time from and after the date sixty (60) days from the last date (the “Trial Completion Date”) on which Acorda has delivered to Teva summary results (in the format described in Appendix A to this Letter Agreement) of the completed SCI-F301, SCI-F302 and  MS-F202 clinical trials for Fampridine SR currently being conducted by Acorda (collectively, the “Clinical Trials”).  The period commencing on the date hereof and ending on the earlier of sixty (60) days after the Trial Completion Date, or the date Teva terminates such good faith negotiations is referred to herein as the “Negotiation Period”.  Upon the end of the Negotiation Period, Acorda may thereafter negotiate the terms of, and enter into, an agreement regarding rights to fampridine in any of the countries of the Territory with one or more third parties on any terms.  However, Acorda may, if it so elects and Teva is willing, continue negotiations with Teva regarding reaching terms for the Fampridine Agreement.  Throughout the Negotiation Period, Acorda shall not, directly or indirectly, negotiate any terms of a potential Fampridine Agreement with any party other than Teva; provided, however, that the foregoing would not prevent Acorda from (a) entering into strategic alliances with service vendors at any time before, during or after the end of the Negotiation Period, or (b) providing to possible licensees due diligence disclosures solely of technical data and intellectual property rights respecting fampridine (but in no event shall Acorda, directly or indirectly, discuss with or accept during the Negotiation Period from any licensees (or other third parties), business terms, or the economic structure of a potential agreement respecting fampridine for any country in the Territory, whether in connection with such due diligence disclosures or otherwise).

15 SKYLINE DRIVE	PHONE: (914) 347-4300	E-MAIL: ACORDA@ACORDA.COM	
HAWTHORNE, NY 10532	FAX: (914) 347-4560	WWW.ACORDA.COM	

 
 
Notwithstanding the provisions of the immediately preceding paragraph of this Letter Agreement, if prior to the end of the Trial Completion Date, Acorda desires to enter into negotiations with a third party regarding terms of an agreement respecting fampridine for any country in the Territory, then Acorda shall first issue written notice to Teva requesting Teva’s best and final offer for its terms of the Fampridine Agreement (the “B&F Notice”).   Teva shall then have fifteen (15) business days after its receipt of the B&F Notice to provide Acorda with its written best and final offer.  If Acorda does not accept such proposed Teva best and final offer (as set forth in a written notice to Teva) or Teva fails to timely provide such a best and final offer, then Acorda shall have the right to negotiate the terms and thereafter enter into an agreement regarding rights to fampridine with a third party, provided that the terms of such third party agreement respecting fampridine are more favorable to Acorda (on a financial or such other basis as reasonably determined by Acorda) than the terms set forth in Teva’s written best and final offer (if any), and such agreement is duly executed by such third party and Acorda prior to the Trial Completion Date.
 
If prior to the Trial Completion Date Acorda does not enter into an agreement regarding fampridine with a third party as provided in the immediately preceding paragraph, then Teva shall have the right to provide to Acorda a written best and final offer for its terms of the Fampridine Agreement within sixty (60) days after the Trial Completion Date.   If Teva issues such best and final offer and Acorda does not accept same (as set forth in a written notice to Teva), then Acorda shall have the right to thereafter proceed on its own in connection with the development, promotion and commercialization of fampridine in the Territory or enter into an agreement respecting fampridine for any country in the Territory on any terms
 
For clarity, it is understood that this Letter Agreement grants Teva no rights of negotiation (or any other rights) regarding fampridine in any country or territory outside the Territory, and that Acorda retains all such rights exclusively. Throughout the Negotiation Period, and following review by Teva of the summary results of the Clinical Trials in Appendix A hereof, the parties acknowledge that additional due diligence may be necessary, including on-site review and discussion at Acorda regarding protocols, protocol amendments, analytical plans, and final data.  Notwithstanding the foregoing, such additional due diligence shall not be interpreted to extend the Negotiation Period beyond the term as defined above.
 
Please indicate your agreement with the foregoing by signing and returning a copy of this letter to the undersigned, whereupon this shall constitute a legal and binding agreement between us.
 
Very truly yours,

Acorda Therapeutics, Inc.	 	Teva Pharmaceutical Industries, Ltd.	

 	 	Eli Shohet	
 	 	Vice President of Business Development	

 
!PPENDIX !
 
As defined in the Letter Agreement to which this Appendix A is attached, the Trial Completion Date will be the last date upon which Acorda provides the following summary results of the Clinical Trials to Teva.
 
One summary will be provided for the each of the two Phase 3 clinical trials (SCI-F301 and SCI-F302) evaluating the safety and efficacy of Fampridine-SR in the treatment of spasticity and the Phase 2 clinical trial (MS-F202) evaluating safety and efficacy of Fampridine-SR for the treatment of lower extremity motor dysfunction
 
The parties agree that the following summary results may not include summary results of secondary or sub-group analyses or the extension studies, if such analyses or studies are completed after completion and delivery of the following summary results.  Acorda would provide such summaries of such additional analyses or extension studies to Teva, when available, but such additional summary information shall not extend the Negotiation Period.
 
SCI-F301/SCI-F301 Data Table

Baseline Demographics	 	Placebo	 	Fampridine-
SR 25mg	 	Delta	 	p-value	
Age	 	 	 	 	 	 	 	 	
Sex	 	 	 	 	 	 	 	 	
ASIA classification (B/C/D)	 	 	 	 	 	 	 	 	
Duration of injury	 	 	 	 	 	 	 	 	
Ashworth Score	 	 	 	 	 	 	 	 	
Spasm Frequency Score	 	 	 	 	 	 	 	 	
Spasm Severity Score	 	 	 	 	 	 	 	 	
Subject Global Impression (SGI)	 	 	 	 	 	 	 	 	
Clinical Global Impression (CGI)	 	 	 	 	 	 	 	 	
International Index of Erectile Function (IIEF)	 	 	 	 	 	 	 	 	
Female Sexual Function Index (FSFI)	 	 	 	 	 	 	 	 	
Bowel function questionnaire	 	 	 	 	 	 	 	 	
Bladder function questionnaire	 	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	 	
Efficacy Variables	 	 	 	 	 	 	 	 	
Primary endpoints	 	 	 	 	 	 	 	 	
Ashworth Score	 	 	 	 	 	 	 	 	
Subject Global Impression (SGI)	 	 	 	 	 	 	 	 	
Secondary endpoints	 	 	 	 	 	 	 	 	
Spasm Frequency Score	 	 	 	 	 	 	 	 	
Spasm Severity Score	 	 	 	 	 	 	 	 	
Clinical Global Impression (CGI)	 	 	 	 	 	 	 	 	
International Index of Erectile Function (IIEF)	 	 	 	 	 	 	 	 	
Female Sexual Function Index (FSFI)	 	 	 	 	 	 	 	 	
Bowel function questionnaire	 	 	 	 	 	 	 	 	
Bladder function questionnaire	 	 	 	 	 	 	 	 	

Treatment-Emergent Adverse Events	 	Placebo	 	Fampridine-SR 25mg	p-value	 	
This table is representative.  The actual treatment-emergent adverse events will be listed in as many rows as are required.	 	 	 	 	 	 	

 
MS-F202 Data Table

Baseline Demographics	 	Placebo	 	Fampridine-SR (bid dose)	 	p-values (vs. placebo)	
 	 	 	 	10 mg	 	15 mg	 	20 mg	 	10 mg	 	15 mg	 	20 mg	
Age	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Sex	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
MS classification	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Ashworth Score	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
LEMMT	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Timed 25 foot walk	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
9 hole peg test	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
PASAT 3”	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Efficacy Variables	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Primary endpoint	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Timed 25 foot walk	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Secondary endpoints	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
LEMMT	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Ashworth score	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
9-hole peg test	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
PASAT	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Subject Global Impression (SGI)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Clinical Global Impression (CGI)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	

Treatment-Emergent
Adverse Events	 	Placebo	 	Fampridine-SR (bid dose)	 	p-values (vs. placebo)	
 	 	 	 	10 mg	 	15 mg	 	20 mg	 	10 mg	 	15 mg	 	20 mg	
This table is representative.  The actual treatment-emergent adverse events will be listed in as many rows as are required.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	

 
Exhibit 10.23
 
THIS NOTE HAS BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH THE SALE OR DISTRIBUTION THEREOF. NEITHER THIS CONVERTIBLE PROMISSORY NOTE NOR ANY OF THE SECURITIES ISSUABLE HEREUNDER HAVE BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR THE APPLICABLE SECURITIES LAWS OF ANY STATE, AND MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, OTHER THAN TO AFFILIATES, IN THE ABSENCE OF A REGISTRATION STATEMENT IN EFFECT WITH RESPECT TO SUCH CONVERTIBLE PROMISSORY NOTE OR SECURITIES, OR DELIVERY OF AN OPINION OF COUNSEL WHO SHALL BE AND WHOSE OPINION SHALL BE REASONABLY SATISFACTORY TO THE CORPORATION STATING THAT SUCH OFFER, SALE OR TRANSFER IS EXEMPT FROM THE REGISTRATION AND PROSPECTUS DELIVERY REQUIREMENTS OF SAID ACT AND APPLICABLE STATE SECURITIES LAWS.
 
ACORDA THERAPEUTICS, INC.
 
LIMITED RECOURSE CONVERTIBLE PROMISSORY NOTE

$5,000,000.00	New York, New York	
 	January 22, 1997	
 
FOR VALUE RECEIVED, Acorda Therapeutics, Inc., a Delaware corporation (the “Company”), hereby promises to pay to Elan International Services, Ltd., a Bermuda corporation (the “Holder”), the principal sum of Five Million Dollars ($5,000,000.00), plus interest compounded annually on the unpaid balance commencing to accrue from and after the first anniversary of the date hereof ‘at a rate of three percent (3%) per annum payable upon the earlier of the prepayment in accordance with Section 2 hereof or on the Maturity Date (as defined below).
 
This Promissory Note is issued in connection with that certain Series B and Series C Preferred Stock, Convertible Note and Warrant Purchase Agreement, dated as of January 22, 1997 (the “Purchase Agreement”) between the Company and the Holder, and that certain License and Supply Agreement, dated as of January 22, 1997 (the “License Agreement”), between the Company and Elan Corporation, plc.
 
Section 1.                       Payment . If the Holder has not converted the outstanding principal hereunder into Preferred. Stock in accordance with Section 3 hereof by the date which is the first anniversary after the first Regulatory Approval (as defined below)(the “Maturity Date”), the Company shall be obligated to pay the outstanding principal sum remaining on this Promissory Note, together with all accrued and unpaid interest thereon, to Holder in seven (7) equal installments, the first of which shall be paid on the Maturity Date, and the balance of which shall be paid on the six (6) successive anniversaries of the Maturity Date; provided, however, that if the Committee (as defined in the License Agreement) reasonably determines that such Regulatory Approval is unlikely to be obtained or shall not be obtained in a timely manner and

 
provides written notice (the “Notice”) thereof to the Company and the Holder (a “Committee Termination”), then on the tenth day following receipt of the Notice, the outstanding principal sum remaining on this Promissory Note, together with all accrued and unpaid interest thereon, shall be canceled and not repayable and shall result in the termination of this Promissory Note; provided, further, that if the Company otherwise determines to terminate the License Agreement as a result of its reasonable and good faith belief that the market for the Products (as defined in the License Agreement) is not economically significant and there is not at such time a material default by the Company thereunder, which termination complies with the provisions of the License Agreement (a “Company Termination”), then, subject to earlier conversion, the Company shall be obligated to pay the outstanding principal sum remaining on this Promissory Note to Holder, together with all accrued and unpaid interest thereon, in fifteen (15) equal installments, the first of which shall be paid on the first anniversary after the date of the Notice, and the balance of which shall be paid on the fourteen (14) successive anniversaries of the date of the Notice. “Regulatory Approval” shall mean (x) approval for the sale and marketing of one or more of the Products by the United States Food and Drug Administration or (y) approval for the sale and marketing of one or more of the Products by the CPMP in the European Union and/or not more than one of the applicable regulatory authorities in the United Kingdom, France or Germany denying such approval.
 
All payments of principal and accrued interest made in accordance with this Promissory Note are to be made at the address of the Holder as indicated on the signature page hereto, or at such other address as the Holder may designate from time to time by written notice to the Company. Such payments may be made (i) by check or wire transfer in next day United States funds, (ii) by delivery of certificates evidencing shares of the Company’s Common Stock, if the Company is then a reporting issuer registered under Section 12 of the Securities Exchange Act of ‘1934, as amended, or (iii) any combination thereof. Where payment is made in shares of the Company’s Common Stock, such stock will be valued for purposes hereof at 100% of its Market Value if such shares have been registered under the Securities Act of 1933, as amended (the “1933 Act”), and freely tradeable by the Holder without restriction under applicable federal or state securities laws, and will be valued for purposes hereof at 80% of its Market Value if such shares are “restricted securities” within the meaning of Rule 144 under the 1933 Act. “Market Value” shall mean the average of the closing sales prices of the Company’s Common Stock as reported by Nasdaq (or other principal securities exchange on which the Company’s Common Stock may then be traded) for the fifteen (15) trading days ending on the third day preceding the date of payment.
 
The Holder expressly acknowledges that all payments of principal and accrued interest under this Promissory Note shall be derived from the sales of the Products as described below in this paragraph. In the event that in any fiscal year of the Company, the Company’s Gross Margin (as defined below) is less than $5 million, then, in such event, notwithstanding the other provisions of this Promissory Note, the Company shall be obligated to pay to the Holder in respect of payment of principal and accrued interest next due and payable following the end of such fiscal year an amount equal to the lesser of (x) the amount of principal and accrued interest otherwise payable hereunder for each year or (y) an amount equal to 50% of such Gross Margin; provided, that in the event that clause (y) above is applicable, the difference between the amount described in clause (x) above and the amount described in clause (y) above in respect of such fiscal year shall be deferred and carried forward until such succeeding fiscal year or fiscal years
 
2

 
of the Company in respect of which there is any excess of the amount of the Gross Margin over the amount otherwise payable under this Promissory Note (i.e., without regard to this paragraph), in which case, such excess amount described in this proviso shall be applied to pay such deferred and carried forward amount; provided, further, that the maximum number of fiscal years during which any amount of principal and interest may be deferred hereunder shall not exceed two, after which period the Company’s obligation to pay such deferred principal and interest shall resume. “Gross Margin” for each fiscal year of the Company shall be determined by an audit in accordance with generally accepted accounting principles consistently applied and shall mean the difference between the net revenues derived from the Products and the cost of sales in respect thereof (including, without limitation, all direct costs such as materials, insurance, freight, discounts and similar costs) and an appropriate allocation of corporate overhead (but excluding research and development expenses) as reasonably determined by the Company.
 
If action is instituted to collect on this Promissory Note, the Company promises to pay all costs and expenses, including reasonable attorneys’ fees, incurred in connection with such action. The Company also agrees to pay on demand all costs and expenses of the Holder, including reasonable attorneys’ fees, in connection with the enforcement or attempted enforcement of, and preservation of any rights under, this Promissory Note.
 
Interest payable under this Promissory Note shall be calculated on the basis of actual number of days elapsed over a year of 365 days. All payments received by the Holder hereunder will be applied first to costs of collection and other costs and expenses owing hereunder or in connection herewith, if any, then to interest and the balance to principal.
 
No delay or omission on the part of the Holder in exercising any right hereunder shall operate as a waiver of such right or any other right of the Holder, nor shall any delay, omission or waiver of any one occasion be deemed a bar to or waiver of the same or any other right or any other occasion. The Company and every endorser and guarantor of this Promissory Note regardless of the time, order or place of signing hereby waives presentment, demand, protest and notice of every kind, and assents to any extension or postponement of the time for payment or any other indulgence, to any substitution, exchange or release of collateral, and to the addition or release of any other party or person or entity primarily or secondarily liable.
 
Section 2.                       Prepayment . The Company, at its option, may at any time on or after the date hereof prepay in whole or in part, without penalty, the principal balance of this Promissory Note, together with accrued interest to the date of payment, by giving written notice to the Holder at least thirty (30) days prior to the date of such prepayment; provided, however, that during such thirty (30) day period, the Holder shall be entitled to convert the principal balance of this Promissory Note in accordance with the provisions of Section 3 hereof.
 
Section 3.                       Conversion .
 
3.1                                  Voluntary Conversion into Series D Preferred Stock . The Holder has the right and option, upon written notice and prior to the payment in full of the principal balance of this Promissory Note, to convert the then unpaid principal amount of this Promissory Note (but not accrued and unpaid interest), in accordance with the provisions of Section 3.2 hereof, in whole or in part, into fully paid and nonassessable shares of the Series D Preferred Stock of the
 
3

 
Company (the “Series D Preferred”) at a rate which shall be equal to the quotient obtained by dividing:
 
(x)                                    the principal amount of this Promissory Note to be converted, by
 
(y)                                  $12.50.
 
The right and option of the Holder to convert the unpaid principal amount of this Promissory Note into Series D Preferred shall terminate upon the first to occur of: (i) the termination of this Promissory Note as a result of a Committee Termination; or (ii) the payment (or prepayment) by the Company of all amounts owing under this Promissory Note (subject to the notice requirements of Section 2 hereof). For purposes of this Note, “Series D Preferred” shall be deemed to include the Common Stock of the Company upon the automatic conversion of all of the outstanding Preferred of the Company in accordance with the provision of the Company’s Certificate of Incorporation.
 
3.2                                  Mechanics and Effect of Conversion . No fractional shares of Preferred will be issued upon any conversion of this Promissory Note. In lieu of any fractional share to which the Holder would otherwise be entitled, the Company will pay to the Holder that amount of the unconverted principal balance of this Promissory Note in cash. Upon any conversion of this Promissory Note pursuant to this Section 3, the Holder shall surrender this Promissory Note, duly endorsed, together with a written notice of election to convert, at the principal offices of the Company or any transfer agent for the Company. At its expense, the Company will, as soon as practicable thereafter, issue and deliver to the Holder, a certificate or certificates for the number of shares of Series D Preferred to which the Holder is entitled upon such conversion, together with a check for immediately available funds payable to the Holder for any cash amounts payable to Holder. Upon any conversion of the entire principal amount of this Promissory Note, the Company will be forever released from all of its obligations and liabilities under this Promissory Note with regard to the entire principal amount, including, without limitation, the obligation to pay such principal amount.
 
4

 
Section 4.                       Senior Indebtedness . The Company agrees that it shall not, after the date hereof, incur any Senior Indebtedness to this Promissory Note and the indebtedness evidenced hereby. “Senior Indebtedness” shall mean the principal of and unpaid interest on any secured or other indebtedness of the Company which purports to provide for a preference or priority in payment to this Promissory Note and the indebtedness evidenced hereby; provided, however, that this term shall exclude (i) the principal of and unpaid interest on any amounts borrowed or to be borrowed from, or owing to, a bank, trust company, insurance company or other financial institution regularly engaged in the business of lending money, whether secured or unsecured; (ii) amounts owed or to be owed to equipment lessors pursuant to equipment lease lines (so long as recourse is limited to the specific item of equipment); and (iii) amounts owed or to be owed to trade creditors in the ordinary course of business, in accordance with reasonable and customary business practices.
 
Section 5.                       Miscellaneous .
 
5.1                                  Titles and Subtitles . The titles and subtitles used herein are for convenience only and are not to be considered in construing or interpreting this Promissory Note.
 
5.2                                  Notices . Unless otherwise provided, any notice required or permitted under this Promissory Note shall be given in writing and shall be deemed effectively given upon personal delivery to the party to be notified, upon delivery by facsimile transmission, or upon the fifth business day after deposit with the United States Post Office, postage prepaid and addressed to the party to be notified at the address indicated for such party on the signature page hereof, or at such other address as such party may designate by ten (10) days advance written notice to the other party.
 
5.3                                  Highest Lawful Rate . Anything in this Promissory Note to the contrary notwithstanding, the Company shall never be required to pay interest on this Promissory Note at a rate in excess of the Highest Lawful Rate (as hereinafter defined), and if the effective rate of interest which would otherwise be payable under this Promissory Note would exceed the Highest Lawful Rate, or if the maturity of this Promissory Note is accelerated for any reason before the Maturity Date, or in the event of voluntary prepayment by the Company hereof, or if the Holder shall otherwise receive any unearned interest or shall receive monies that are deemed to constitute interest which would increase the effective rate of interest payable under this Promissory Note to a rate in excess of the Highest Lawful Rate, then (a) the amount of interest which would otherwise be payable under this Promissory Note shall be reduced to the amount allowed under applicable law, and (b) any interest paid by the Company or any interest paid by the Company in excess of the Highest Lawful Rate shall be credited to the principal of this Promissory Note. It is further agreed that, without limitation of the foregoing, all calculations of the rate of interest contracted for, charged or received by the Holder under this Promissory Note that are made for the purpose of determining whether such rate exceeds the Highest Lawful Rate shall be made, to the extent permitted by applicable usury laws (now or hereafter enacted), by amortizing, prorating and spreading in equal parts during the period of the full stated term of this Promissory Note all interest at any time contracted for, charged or received by the Holder in connection herewith. “Highest Lawful Rate” shall mean the maximum rate of interest which the Holder is permitted by applicable law to contract for, charge or receive and as to which the Company could not successfully assert a claim or defense of usury.
 
5

 
5.4                                  Amendments and Waivers . Any term of this Promissory Note may be amended and the observance of any term of this Promissory Note may be waived (either generally or in a particular instance and either retroactively or prospectively), only with the written consent of the Company and the Holder.
 
5.5                                  Severability . If one or more provisions of this Promissory Note are held to be unenforceable under applicable law, such provision shall be excluded from this Promissory Note, and the remaining provisions of this Promissory Note shall be interpreted as if such provision were so excluded and shall be enforceable in accordance with their terms, with the effect of the excluded provision being taken into consideration and the remaining terms construed in accordance with the intent of this Promissory Note.
 
5.6                                  Governing Law . This Promissory Note shall be governed by and construed and enforced in accordance with the internal laws of the State of Delaware, without giving effect to principles governing conflicts of laws.
 
5.7                                  Non-Transferability ,. This Promissory Note may not be transferred or assigned by the Holder without the prior written consent of the Company; provided, however, that no consent of the Company shall be required for any transfer or assignment of this Promissory Note to an affiliate (within the meaning of the Securities Act of 1933, as amended) of the Holder.
 
[Remainder of Page Intentionally Left Blank]
 
6

 
IN WITNESS WHEREOF , this Limited Recourse Convertible Promissory Note has been duly executed and delivered as of the date first above written.

ACORDA THERAPEUTICS, INC.
a Delaware corporation	 	
 	 	
By:	 	 	 	
 	Ron Cohen, M.D.	 	
 	President and Chief Executive Officer	 	
 	 	
Address:	145 West 58th Street	 	
 	New York, New York 10019	 	

7

 
Exhibit 10.24
 
THIS NOTE HAS BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH THE SALE OR DISTRIBUTION THEREOF. NEITHER THIS CONVERTIBLE PROMISSORY NOTE NOR ANY OF THE SECURITIES ISSUABLE HEREUNDER HAVE BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR THE APPLICABLE SECURITIES LAWS OF ANY STATE, AND MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, OTHER THAN TO AFFILIATES, IN THE ABSENCE OF A REGISTRATION STATEMENT IN EFFECT WITH RESPECT TO SUCH CONVERTIBLE PROMISSORY NOTE OR SECURITIES, OR DELIVERY OF AN OPINION OF COUNSEL WHO SHALL BE AND WHOSE OPINION SHALL BE REASONABLY SATISFACTORY TO THE CORPORATION STATING THAT SUCH OFFER, SALE OR TRANSFER IS EXEMPT FROM THE REGISTRATION AND PROSPECTUS DELIVERY REQUIREMENTS OF SAID ACT AND APPLICABLE STATE SECURITIES LAWS.
 
ACORDA THERAPEUTICS, INC.
 
FULL RECOURSE CONVERTIBLE PROMISSORY NOTE

$ 2,500,000.00	 	New York, New York	
 	 	January 22, 1997	
 
FOR VALUE RECEIVED, Acorda Therapeutics, Inc., a Delaware corporation (the “Company”), hereby promises to pay to Elan International Services, Ltd., a Bermuda corporation (the “Holder”) the principal sum of Two Million Five Hundred Thousand Dollars ($2,500,000.00), without interest, until paid or converted in accordance with the terms hereof, payable on the Maturity Date (as defined below).
 
This Promissory Note is issued in connection with that certain Series B and Series C Preferred Stock, Convertible Note and Warrant Purchase Agreement, dated as of January 22, 1997 (the “Purchase Agreement”) between the Company and the Holder, and that certain License and Supply Agreement, dated as of January 22, 1997 (the “License Agreement”), between the Company and Elan Corporation, plc.
 
Section 1.                                           Payment . If the Holder has not converted the outstanding principal hereunder into Preferred Stock in accordance with Section 3 hereof by the date which is the first anniversary after the first Regulatory Approval (as defined below)(the “Maturity Date”), the Company shall be obligated to pay the outstanding principal sum remaining on this Promissory Note to Holder in seven (7) equal installments, the first of which shall be paid on the Maturity Date, and the balance of which shall be paid on the six (6) successive anniversaries of the Maturity Date; provided, however, that if (i) the Committee (as defined in the License Agreement) reasonably determines that such Regulatory Approval is unlikely to be obtained or shall not be obtained in a timely manner and provides written notice (the “Notice”) thereof to the Company and the Holder (a “Committee Termination”), or (ii) the Company otherwise determines to terminate the License Agreement as a result of its reasonable and good faith belief

 
that the market for the Products (as defined in the License Agreement) is not economically significant and there is not at such time a material default by the Company thereunder, which termination complies with the provisions of the License Agreement (a “Company Termination”), then, subject to earlier termination, the Company shall be obligated to pay the outstanding principal sum remaining on this Promissory Note to Holder in fifteen (15) equal installments, the first of which shall be paid on the first anniversary after the date of the Notice, and the balance of which shall be paid on the fourteen (14) successive anniversaries of the date of the Notice. “Regulatory Approval” shall mean (x) approval for the sale and marketing of one or more of the Products by the United States Food and Drug Administration or (y) approval for the sale and marketing of one or more of the Products by the CPMP in the European Union and/or not more than one of the applicable regulatory authorities in the United Kingdom, France or Germany denying such approval.
 
All payments of principal made in accordance with this Promissory Note are to be made at the address of the Holder as indicated on the signature page hereto, or at such other address as the Holder may designate from time to time by written notice to the Company. Such payments may be made (i) by check or wire transfer in next day United States funds, (ii) by delivery. of certificates evidencing shares of the Company’s Common Stock, if the Company is then a reporting issuer registered under Section 12 of the Securities Exchange Act of 1934, as amended, or (iii) any combination thereof. Where payment is made in shares of the Company’s Common Stock, such stock will be valued for purposes hereof at 100% of its Market Value if such shares have been registered under the Securities Act of 1933, as amended (the “1933 Act”), and freely tradeable by the Holder without restriction under applicable federal or state securities laws, and will be valued for purposes hereof at 80% of its Market Value if such shares are “restricted securities” within the meaning of Rule 144 under the 1933 Act. “Market Value” shall mean the average of the closing sales prices of the Company’s Common Stock as reported by Nasdaq (or other principal securities exchange on which the Company’s Common Stock may then be traded) for the fifteen (15) trading days ending on the third day preceding the date of payment.
 
If action is instituted to collect on this Promissory Note, the Company promises to pay all costs and expenses, including reasonable attorneys’ fees, incurred in connection with such action. The Company also agrees to pay on demand all costs and expenses of the Holder, including reasonable attorneys’ fees, in connection with the enforcement or attempted enforcement of, and preservation of any rights under, this Promissory Note.
 
No delay or omission on the part of the Holder in exercising any right hereunder shall operate as a waiver of such right or any other right of the Holder, nor shall any delay, omission or waiver of any one occasion be deemed a bar to or waiver of the same or any other right or any other occasion. The Company and every endorser and guarantor of this Promissory Note regardless of the time, order or place of signing hereby waives presentment, demand, protest and notice of every kind, and assents to any extension or postponement of the time for payment or any other indulgence, to any substitution, exchange or release of collateral, and to the addition or release of any other party or person or entity primarily or secondarily liable.
 
Section 2.                                           Prepayment . Subject to Section 3.1, the Company, at its option, may at any time on or after the date hereof prepay in whole or in part, without penalty, the principal
 
2

 
balance of this Promissory Note by giving written notice to the Holder at least thirty (30) days prior to the date of such prepayment; provided, however, that during such thirty (30) day period, the Holder shall be entitled to convert the principal balance of this Promissory Note in accordance with the provisions of Section 3 hereof.
 
Section 3.                                           Conversion .
 
3.1                                Voluntary Conversion into Preferred Stock . The Holder has the right and option, upon written notice and at any time subsequent to January 22, 1999 and prior to the payment in full of the principal balance of this Promissory Note, to convert the then unpaid principal amount of this Promissory Note, in accordance with the provisions of Section 3.2 hereof, in whole or in part, into fully paid and nonassessable shares of Preferred Stock of the Company (the “Preferred”) at a rate which shall be equal to the quotient obtained by dividing:
 
(x)                                    the principal amount of this Promissory Note to be converted, by
 
(y)                                  the greater of:
 
(a)      $2.00, and
 
(b)     80% of the closing sales price of the Institutional Financing (as defined below) most recently completed by the Company prior to the written notice of conversion.
 
Provided, however, that the Company shall be obligated to provide prompt notice to the Holder of its intent to negotiate terms with respect to any Institutional Financing, and thereafter, the Holder’s right of conversion (and the Company’s right to prepay under Section 2) may not be exercised during the thirty (30) day period that precedes the closing date of any Institutional Financing.
 
In the event that the denominator of the above formula shall be determined by reference to (y)(a), then “Preferred” shall mean the Series B Preferred Stock of the Company. In the event that the denominator of the above formula shall be determined by reference to (y)(b), then “Preferred” shall mean shares of a series of Preferred Stock of the Company which shall be convertible initially into one fully paid and nonassessable share of the Common Stock of the Company, in accordance with the same terms and conditions and having the rights, preferences and privileges substantially on parity with those of the Company’s Series B Preferred Stock as set forth in the Company’s Amended and Restated Certificate of Incorporation (the “Certificate”).
 
For the purposes of this Section 3.1, an “Institutional Financing” shall mean a bona fide equity financing of the Company occurring after the date hereof which is completed with any institutional and/or venture capital or similar financing sources.
 
The right and option of the Holder to convert the unpaid principal amount of this Promissory Note into Preferred shall terminate upon the payment (or prepayment) by the Company of all amounts owing under this Promissory Note (subject to the notice requirements of Section 2 hereof). For purposes of this Section 3.1, “Preferred” shall be deemed to include the
 
3

 
Common Stock of the Company upon the automatic conversion of all of the outstanding Preferred of the Company in accordance with the provisions of the Certificate.
 
3.2                                Mechanics and Effect of Conversion . No fractional shares of Preferred will be issued upon any conversion of this Promissory Note. In lieu of any fractional share to which the Holder would otherwise be entitled, the Company will pay to the Holder that amount of the unconverted principal balance of this Promissory Note in cash. Upon any conversion of this Promissory Note pursuant to this Section 3, the Holder shall surrender this Promissory Note, duly endorsed, together with a written notice of election to convert, at the principal offices of the Company or any transfer agent for the Company. At its expense, the Company will, as soon as practicable thereafter, issue and deliver to the Holder, a certificate or certificates for the number of shares of Preferred to which the Holder is entitled upon such conversion, together with a check for immediately available funds payable to the Holder for any cash amounts payable to Holder. Upon any conversion of the entire principal amount of this Promissory Note, the Company will be forever released from all of its obligations and liabilities under this Promissory Note with regard to the entire principal amount, including, without limitation, the obligation to pay such principal amount.
 
Section 4.                                           Senior Indebtedness . The Company agrees that it shall not, after the date hereof, incur any Senior Indebtedness to this Promissory Note and the indebtedness evidenced hereby. “Senior Indebtedness” shall mean the principal of and unpaid interest on any secured or other indebtedness of the Company which purports to provide for a preference or priority in payment to this Promissory Note and the indebtedness evidenced hereby; provided, however, that this term shall exclude (i) the principal off and unpaid interest on any amounts borrowed or to be borrowed from, or owing to, a bank, trust company, insurance company or other financial institution regularly engaged in the business of lending money, whether secured or unsecured, (ii) amounts owed or to be owed to equipment lessors pursuant to equipment lease lines (so long as recourse is limited to the specific item of equipment); and (iii) amounts owed or to be owed to trade creditors in the ordinary course of business, in accordance with reasonable and customary business practices.
 
Section 5.                                           Miscellaneous .
 
5.1                                Titles and Subtitles . The titles and subtitles used herein are for convenience only and are not to be considered in construing or interpreting this Promissory Note.
 
5.2                                Notices . Unless otherwise provided, any notice required or permitted under this Promissory Note shall be given in writing and shall be deemed effectively given upon personal delivery to the party to be notified, upon delivery by facsimile transmission, or upon the fifth business day after deposit with the United States Post Office, postage prepaid and addressed to the party to be notified at the address indicated for such party on the signature page hereof, or at such other address as such party may designate by ten (10) days advance written notice to the other party.
 
5.3                                Amendments and Waivers . Any term of this Promissory Note may be amended and the observance of any term of this Promissory Note may be waived (either generally or in a particular instance and either retroactively or prospectively), only with the
 
4

 
written consent of the Company and the Holder. Any amendment or waiver effected in accordance with this subsection 5.3 shall be binding upon the Holder of this Promissory Note, each future holder of all such securities and the Company.
 
5.4                                Severability . If one or more provisions of this Promissory Note are held to be unenforceable under applicable law, such provision shall be excluded from this Promissory Note, and the remaining provisions of this Promissory Note shall be interpreted as if such provision were so excluded and shall be enforceable in accordance with their terms, with the effect of the excluded provision being taken into consideration and the remaining terms construed in accordance with the intent of this Promissory Note.
 
5.5                                Governing Law . This Promissory Note shall be governed by and construed and enforced in accordance with the internal laws of the State of Delaware, without giving effect to principles governing conflicts of laws.
 
5.6                                Non-Transferability . This Promissory Note may not be transferred or assigned by the Holder without the prior written consent of the Company; provided, however, that no consent of the Company shall be required for any transfer or assignment of this Promissory Note to an affiliate (within the meaning of the Securities Act of 1933, as amended) of the Holder.
 
[Remainder of Page Intentionally Left Blank]
 
5

 
IN WITNESS WHEREOF , this Full Recourse Convertible Promissory Note has been duly executed and delivered as of the date first above written.

ACORDA THERAPEUTICS, INC.	
a Delaware corporation	
 	
By:	 	 	
 	Ron Cohen, M.D.	
 	President and Chief Executive Officer	
 	
Address:	145 West 58th Street	
 	New York, New York 10019	

6

 
Exhibit 10.25

SECURITIES AMENDMENT AGREEMENT

AMONG

ELAN CORPORATION, PLC,

ELAN INTERNATIONAL SERVICES, LTD.
 
AND

!#/2$! 4(%2!0%54)#3  )NC

 
THIS SECURITIES AMENDMENT AGREEMENT made this 26th day of September, 2003 (this “ Agreement ”)
 
AMONG:-
 
(1)                                  ELAN CORPORATION, PLC , a public limited company incorporated under the laws of Ireland and having its registered office at Lincoln House, Lincoln Place, Dublin 2, Ireland (“ Elan Corp ”);
 
(2)                                  ELAN INTERNATIONAL SERVICES, LTD., an exempted limited liability company incorporated under the laws of Bermuda, and having its registered office at Clarendon House, 2 Church St., Hamilton, Bermuda, a wholly-owned subsidiary of Elan Corp ( “EIS” ); and
 
(3)                                  !#/2$! 4(%2!0%54)#3  )NC , a Delaware corporation having its principal place of business at 15 Skyline Drive, Hawthorne, NY 10532, United States of America (“ Acorda ”).
 
RECITALS
 
A.                                    Acorda and EIS have entered into agreements whereby Acorda sold and EIS purchased certain securities of Acorda and such parties agreed to certain matters related to the ownership of such securities.  Specifically:
 
(i)                                      EIS and Acorda entered into a Preferred Stock, Convertible Note and Warrant Purchase Agreement dated as of January 22, 1997 (the “ 1997 Securities Purchase Agreement ”);
 
(ii)                                   EIS and Acorda entered into a Securities Purchase Agreement dated April 21, 1998 (the “ 1998 Securities Purchase Agreement ”);
 
(iii)                                EIS and Acorda entered into a Subscription Agreement dated as of August 6, 1999 (the “ 1999 Securities Purchase Agreement ”);
 
(iv)                               Acorda and certain stockholders of Acorda including EIS entered into an Amended and Restated Registration Rights Agreement with respect to the capital stock of Acorda dated January 22, 1997, as amended and restated July 7, 1998, August 6, 1999, December 20, 2000 and May 8, 2003, as a result of which, inter alia , additional purchasers were added as parties to such agreement (as amended and restated, the “ Acorda Registration Rights Agreement ”); and
 
(v)                                  Elan Corp, Acorda and certain other stockholders entered into an Amended and Restated Stockholders Agreement dated December 20,

 
2000, as amended and restated as of May 8, 2003 (the “Stockholders Agreement” ).
 
B.                                      The Parties have entered into a Termination Agreement of even date herewith (the “ Termination Agreement ”).
 
C.                                      Simultaneously with the execution of the Termination Agreement, Elan Corp and Acorda are entering into a Amended and Restated License and Supply Agreement, pursuant to which, among other things, certain of the parties thereto are amending and restating that certain License Agreement (the “ Restated Elan License Agreement ”) by and among Acorda, Elan Corp and MS Research and Development Corporation (“ MS R&D ”).
 
D.                                     The Parties desire to enter into this Agreement to set forth their agreements relating to certain matters relating to: (i) the securities of Acorda held by Elan, (ii) amendments to the 1997 Securities Purchase Agreement, the Limited Recourse Note (as defined below), the Full Recourse Note (as defined below), the Acorda Registration Rights Agreement, the Second Closing Warrant and the SSDA (collectively, the “ Amended Finance Documents ”); and (iii) Board observation rights in favor of EIS.
 
IN CONSIDERATION OF THE MUTUAL COVENANTS CONTAINED HEREIN, AND OTHER GOOD AND VALUABLE CONSIDERATION, THE RECEIPT AND ADEQUACY OF WHICH ARE HEREBY ACKNOWLEDGED, IT IS HEREBY AGREED AS FOLLOWS:
 
1.                                     DEFINITIONS
 
Capitalized terms used in this Agreement shall have the same meanings assigned to them in the Termination Agreement , unless such terms are expressly defined to the contrary in this Agreement.
 
“ Affiliate ” shall mean any corporation or entity controlling, controlled or under the common control of any other corporation or entity.  For the purpose of this definition, (i) “control” shall mean direct or indirect ownership of fifty  (50%) percent or more of the stock or shares entitled to vote for the election of directors and (ii) MS R&D shall not be an Affiliate of Elan Corp, EPIL II or EIS.
 
“ Effective Date ” shall mean the date of this Agreement.
 
“ Elan ” shall mean Elan Corp and its Affiliates.
 
“ EPIL II ” shall mean Elan Pharmaceuticals Investment II, Ltd. an exempted limited liability company incorporated under the laws of Bermuda.
 
2

 
“ Force Majeure ” shall mean causes beyond a Party’s reasonable control, including, without limitation, acts of God, fires, strikes, acts or war or terrorism, or intervention of a governmental authority.
 
“ Full Recourse Note ” shall mean the Full Recourse Convertible Promissory Note dated January 22, 1997 in the principal amount of $2,500,000 issued by Acorda to EIS.
 
“ Limited Recourse Note ” shall mean the Limited Recourse Convertible Promissory Note dated January 22, 1997 in the principal amount of $5,000,000 issued by Acorda to EIS.
 
“ Party ” shall mean Elan Corp, EIS, Acorda or MS R&D, as the case may be, and “ Parties ” shall mean all such parties together.
 
 “ Second Closing Warrant ” shall mean the Second Closing Warrant to up to 100,000 Shares of the Series B Preferred Stock of Acorda dated February 4, 2007 having an exercise price of $2.00 per share issued to EIS.
 
2.                                        Milestone Purchases .  The Parties hereto acknowledge and agree that none of Elan Corp, EIS, EPIL II or their respective affiliates, subsidiaries, successors or assigns are obligated to purchase additional securities of or from Acorda, or their respective affiliates or subsidiaries, successors or assigns.
 
3.                                        Transfer Restrictions .  The Parties hereby agreed to amend the Amended Finance Agreements as set forth hereinbelow:
 
3.1                                  1997 Securities Purchase Agreement
 
(a)                                   Section 8.1 of the 1997 Securities Purchase Agreement is hereby amended by changing all references to “50,000 of the Shares” to “2,200,000 of the Shares.”  The references to 2,200,000 shares shall be subject to adjustment for stock splits, combinations, reclassifications, and other similar events.
 
(b)                                  Section 8.2 of the 1997 Securities Purchase Agreement is hereby deleted and replaced with the following:
 
“ Assignment of Rights to Financial Information .  The rights granted pursuant to Section 8.1 may not be assigned or conveyed by the Purchaser or by any subsequent transferee of such rights without the prior written consent of the Company; provided , however , that the Purchaser and any transferee, after giving notice to the Company, may assign such rights to any transferee that acquires no fewer than 2,200,000 shares of Common Stock (subject to adjustment for stock splits, combinations, reclassifications, and other similar events) (including for purposes of determining the number of shares of Common Stock, any shares of
 
3

 
Common Stock issued or issuable upon conversion or exercise of other securities), other than a transferee that is a Competitor. For purposes of this Agreement, “Competitor” shall mean any party engaged, directly or indirectly, in drug development for therapies for spinal cord injuries or multiple sclerosis.”
 
(c)                                   Section 10 of the 1997 Securities Purchase Agreement is hereby deleted in its entirety and replaced with the following:
 
“The Purchaser shall not sell, assign or otherwise transfer any of the Securities to a Competitor without the prior written consent of the Company.  In addition and in any event, the Purchaser shall be obligated to comply with all applicable restrictions on transfer under applicable federal and state securities laws.”
 
3.2                                  Limited Recourse Note
 
(a)                                   The first proviso of Section 1 of the Limited Recourse Note shall be amended and restated in its entirety to read as follows:
 
“; provided, however, that if the Board of Directors of the Company reasonably determines that such Regulatory Approval is unlikely to be obtained or shall not be obtained in a timely manner and provides written notice (the “Notice”) thereof to the Holder (a “Board Termination”), then, on the thirtieth day following receipt of the Notice by the Holder (the “Board Termination Date”), the outstanding principal sum remaining on this Promissory Note, together with all accrued and unpaid interest thereon, shall be automatically converted into shares of the Series D Preferred Stock of the Company (the “Series D Preferred”) in accordance with Section 3.2 below effective as of the Board Termination Date, unless the Holder shall have delivered a written notice to the Company prior to the Board Termination Date of its desire to have such amount canceled (the “Cancellation Right”), in which event, such amount shall be canceled as of the Board Termination Date;”
 
(b)                                  Section 3.1 of the Limited Recourse Note shall be amended to:
 
(i)                                      replace the reference to “the Series D Preferred Stock of the Company (the “Series D Preferred”)” with “Series D Preferred”;
(ii)                                   insert the following parenthetical after reference to $12.50: “(subject to adjustment for stock splits, combinations, reclassifications, and other similar events)”; and
(iii)                                amend and restate the first line of the second paragraph of Section 3.1 of the Limited Recourse Note to read in its entirety as follows: “The right and option of the Holder to convert the unpaid principal amount of this Promissory Note into Series D Preferred shall terminate upon the first to occur of: (i) the automatic conversion thereof on the Board Termination Date; and (ii) the payment (or repayment) by the Company of all amounts owing under this
 
4

 
Promissory Note (subject to the notice requirements of Section 2 hereof).”
 
(c)                                   Section 3.2 shall be renumbered Section 3.3, and all references in the Limited Recourse Note to Section 3.2 (other than as set forth in this Agreement) shall become references to Section 3.3.
 
(d)                                  A new Section 3.2 shall be inserted into the Limited Recourse Note to read in its entirety as follows:
 
“ Automatic Conversion into Series D Preferred Sock .  Subject to the Holder exercising the Cancellation Right in accordance with Section 1 above, immediately prior to the Board Termination Date, the full unpaid principal balance and accrued interest outstanding under this Promissory Note at such time shall be automatically converted into fully paid and nonassessable shares of Series D Preferred at a rate which shall be equal to the quotient obtained by dividing:
 
(x) the principal amount of this Promissory Note plus all accrued and unpaid interest thereon, by
 
(y) $12.50 (subject to adjustment for stock splits, combinations, reclassifications, and other similar events).”
 
(e)                                   Section 5.7 of the Limited Recourse Note is hereby deleted and replaced in its entirety to read as follows:
 
“ Transfer Restrictions . The Holder shall not sell, assign or otherwise transfer all or any portion of this Promissory Note to a Competitor (as defined below) without the prior written consent of the Company.  In addition and in any event, the Holder shall be obligated to comply with all applicable restrictions on transfer under applicable federal and state securities laws. For purposes of this Note, “Competitor” shall mean any party engaged, directly or indirectly, in drug development for therapies for spinal cord injuries or multiple sclerosis.
 
(f)                                     All references to “Committee Termination” and “Committee Termination Date” shall become references to “Board Termination” and “Board Termination Date.”
 
3.3                                  Full Recourse Note
 
(a)                                   The first clause of Section 1 of the Full Recourse Note shall be amended and restated in its entirety to read as follows:
 
“If the Holder has not converted the outstanding principal hereunder into Preferred Stock in accordance with Section 3 hereof by the date which is the earlier of (i) the first anniversary after the first Regulatory Approval (as defined below) and (ii) September 30, 2008 (the “Maturity Date”),”
 
5

 
(b)                                  The first proviso of Section 1 of the Full Recourse Note shall be amended to replace the reference to “the Committee (as defined in the License Agreement)” with “the Board of Directors of the Company”.
 
(c)                                   The following proviso shall be inserted at the end of the first sentence of Section 1 of the Full Promissory Note, immediately prior to the definition of “Regulatory Approval”:
 
“; provided further, however, if no Regulatory Approval has been received on or prior to the Maturity Date, the Company shall have the right to extend the Maturity Date by six month periods (each, an “Extension Period”) by delivery of a written notice to the Holder certifying that it is the reasonable, good faith belief, after due diligence and inquiry by the Company’s Board of Directors, of the Company that such Regulatory Approval is likely to be obtained in a timely manner (each, an “Extension Notice”), at least 30 days prior to the Maturity Date or the then current Extension Period, as the case may be.”
 
(d)                                  Section 5.6 of the Full Recourse Note is hereby deleted and replaced in its entirety to read as follows:
 
“ Transfer Restrictions . The Holder shall not sell, assign or otherwise transfer all or any portion of this Promissory Note to a Competitor (as defined below) without the prior written consent of the Company.  In addition and in any event, the Holder shall be obligated to comply with all applicable restrictions on transfer under applicable federal and state securities laws. For purposes of this Note, “Competitor” shall mean any party engaged, directly or indirectly, in drug development for therapies for spinal cord injuries or multiple sclerosis.”
 
(e)                                   All references to “Committee Termination” shall become references to “Board Termination” and all references to “Committee” shall become references to the “Board of Directors of the Company”).
 
3.4                                  Acorda Registration Rights Agreement
 
(a)                                   Acorda hereby agrees that the amendments to the Acorda Registration Rights Agreement set forth in this Clause 3.4 constitute a superseding agreement between Acorda and Elan that does not require the consent of the other parties to the Acorda Registration Rights Agreement.
 
(b)                                  Acorda agrees that the legend set forth in Section 2(b) of the Acorda Registration Rights Agreement shall be amended and restated to read in its entirety as follows:
 
“THESE SECURITIES ARE SUBJECT TO CERTAIN RESTRICTIONS ON TRANSFER AS SET FORTH IN AN AGREEMENT BETWEEN THE
 
6

 
COMPANY AND THE STOCKHOLDER, A COPY OF WHICH IS ON FILE WITH THE SECRETARY OF THE COMPANY.”
 
(c)                                   Acorda agrees that the restrictions set forth in Section 3 of the Acorda Registration Rights Agreement shall not apply to Elan or its transferees of any Restricted Securities (as defined in the Acorda Registration Rights Agreement); provided, however, Elan agrees to provide written notice to Acorda of any transfer of Restricted Securities to a third party which notice shall set forth the name of the relevant transferee, the date of such transfer and the Restricted Securities transferred and which such notice shall also be accompanied by, if requested by Acorda, at Elan’s expense, an unqualified written opinion of legal counsel who shall and whose legal opinion shall be satisfactory to Acorda, which opinion shall be addressed to Acorda to the effect that the proposed transfer of the Restricted Securities may be effected without registration under the Securities Act of 1933, as amended.
 
(d)                                  Acorda agrees that the reference to 100,000 shares in Section 13 of the Acorda Registration Rights Agreement shall be subject to adjustment for stock splits, combinations, reclassifications and other similar events.
 
3.5                                  Second Closing Warrant .  The first two sentences of Section 10 (Transfers) of the Second Closing Warrant are hereby deleted and replaced in their entirety with the following:
 
“This Warrant may be transferred or assigned by the Warrantholder, in whole or in part, subject to compliance by the Warrantholder with all applicable federal and state securities laws, without the prior written consent of the Company; provided, however, any assignee or transferee of this Warrant (“permitted assignee”) shall be required to accept this Warrant subject to all rights and obligations of the Warrantholder as set forth herein.”
 
4.                                        Board Observation Right .  Subject to earlier termination as provided herein, as long as Elan holds not less than 2,200,000 shares of Acorda’s outstanding common stock on a fully-diluted basis (subject to stock splits, combinations, reclassifications and other similar events), Elan shall have the right to have an observer (the “Elan Observer”) present at two meetings each year of Acorda’s board of directors, the determination of which meetings to be at Acorda’s sole discretion. The Elan Observer may be excused from any meeting or discussion by the Board of Directors to the extent that the Board may deem it to be inappropriate, in the judgment of the Board, for the Elan Observer to be present during any such meeting or discussion.  The out-of-pocket expenses of the Elan Observer with respect to attending such meetings will be reimbursed by Acorda to the same extent that Acorda reimburses such expenses of its Directors. Elan may transfer its right to the Elan Observer to any third party to which it sells, transfers or assigns not less than 2,200,000 shares of Acorda’s outstanding common stock on a fully-diluted basis (subject to stock splits, combinations, reclassifications and other similar events). The observer right provided for herein shall terminate upon the earlier to occur of (i) the closing of an initial public offering of Acorda’s securities or (ii) the date upon which Elan
 
7

 
or its transferee ceases to own five percent (5%) or more of Acorda’s outstanding common stock on a fully-diluted basis.
 
5.                                        General
 
5.1                                  Governing law and jurisdiction :
 
(a)                                   This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to conflicts of law principles under the laws of the State of New York.
 
(b)                                  For the purposes of this Agreement, the Parties submit to the nonexclusive jurisdiction of the State and Federal Courts of New York.
 
5.2                                  Assignment :
 
(a)                                   Subject to Clause 5.2(b), this Agreement shall not be assigned by any Party without the prior written consent of the others, save that any Party:
 
(i)              may assign this Agreement in whole or in part and delegate its duties hereunder to its Affiliate or Affiliates without such consent; and
(ii)           may assign its rights and obligations to a successor (whether by merger, consolidation, reorganization or other similar event) or purchaser of all or substantially all of its assets relating to such Party’s technology related to this Agreement, provided that such successor or purchaser has agreed in writing to assume all of such Party’s rights and obligations hereunder and a copy of such assumption is provided to the other Parties.
 
(b)                                  For the avoidance of doubt, nothing in this Clause 5.2 shall affect the provisions governing assignment of securities set forth elsewhere in this Agreement.
 
5.3                                  Notices :
 
(a)                                   Any notice to be given under this Agreement shall be sent in writing in English by registered airmail, internationally recognized courier or telefaxed to the following addresses:

If to Acorda at:	
 	
Acorda Therapeutics, Inc.	
15 Skyline Drive	
Hawthorne, NY  10532	
 
8

 

Facsimile:	
Attention:	President	
 	
If to MS R&D or Acorda,
with a copy to:	
 	
Wilson, Sonsini, Goodrich & Rosati	
650 Page Mill Road	
Palo Alto, CA  94304	
Facsimile: 650-493-6811	
Attention:	Douglas Collom	
 	
If to Elan and/or EIS at:	
 	
Elan Corporation, plc	
Elan International Services, Ltd.	
C/o Elan International Services, Ltd.	
102 St. James Court	
Flatts,	
Smiths FL04	
Bermuda	
Attention:	Secretary	
Telephone:	441 292 9169	
Fax:	441 292 2224	
 
or to such other address(es) and telefax numbers as may from time to time be notified by any Party to the others hereunder.
 
(c)                                   Any notice sent by mail shall be deemed to have been delivered within seven (7) working days after dispatch or delivery to the relevant courier and notice sent by fax shall be deemed to have been delivered upon confirmation receipt.  Notice of change of address shall be effective upon receipt.
 
5.4                                  Waiver .  No waiver of any right under this Agreement shall be deemed effective unless contained in a written document signed by the Party charged with such waiver, and no waiver of any breach or failure to perform shall be deemed to be a waiver of any future breach or failure to perform or of any other right arising under this Agreement.
 
5.5                                  Severability .  If any provision in this Agreement is agreed by the Parties to be, or is deemed to be, or becomes invalid, illegal, void or unenforceable under any law that is applicable hereto:
 
(a)                                   such provision will be deemed amended to conform to applicable laws so as to be valid and enforceable; or
 
9

 
(b)                                  if it cannot be so amended without materially altering the intention of the Parties, it will be deleted, with effect from the date of this Agreement or such earlier date as the Parties may agree, and the validity, legality and enforceability of the remaining provisions of this Agreement shall not be impaired or affected in any way.
 
5.6                                  Further Assurances .   At the request of any of the Parties, the other Party or Parties shall (and shall use reasonable efforts to procure that any other necessary parties shall) execute and perform all such documents, acts and things as may reasonably be required subsequent to the signing of this Agreement for assuring to or vesting in the requesting Party the full benefit of the terms hereof.
 
5.7                                  Successors .   This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns.
 
5.8                                  Amendments .   No amendment, modification or addition hereto shall be effective or binding on any Party unless set forth in writing and executed by a duly authorized representative of each Party.
 
5.8                                  Counterparts . This Agreement may be executed in any number of counterparts, each of which when so executed shall be deemed to be an original and all of which when taken together shall constitute this Agreement.
 
5.9                                  Costs .   Each Party shall bear its own costs and expenses in connection with the transactions contemplated by this Agreement.
 
5.10                            Force Majeure .   No Party to this Agreement shall be liable for failure or delay in the performance of any of its obligations hereunder if such failure or delay results from Force Majeure, but any such failure or delay shall be remedied by such Party as soon as practicable.
 
5.11                            Relationship of the Parties .       The Parties are independent contractors under this Agreement.  Nothing herein contained shall be deemed to create or establish an employment, agency, joint venture, or partnership relationship between the Parties or any of their agents or employees, or any other legal arrangement that would impose liability upon one Party for the act or failure to act of another Party.  No Party shall have any express or implied power to enter into any contracts, commitments or negotiations or to incur any liabilities in the name of, or on behalf of, another Party, or to bind another Party in any respect whatsoever.
 
5.11                            Entire Agreement .
 
(a)                                   T his Agreement, the Amended Finance Documents, the 1998 Securities Purchase Agreement, the Termination Agreement and the Restated Elan License set forth all of the agreements and understandings between the
 
10

 
Parties with respect to the subject matter hereof.  There are no agreements or understandings with respect to the subject matter hereof, either oral or written, between the Parties other than as set forth in such agreements and documents.
 
(b)                                  No provision of this Agreement shall be construed so as to negate, modify or affect in any way the provisions of any other agreement between the Parties unless specifically provided herein and only to the extent so specified.
 
(c)                                   Other than as expressly set forth herein, the Amended Finance Documents remain in full force and effect and all future references to them shall be deemed to give effect to the amendments set forth herein.
 
THE REMAINDER OF THIS PAGE
HAS BEEN INTENTIONALLY LEFT BLANK.
 
11

 
IN WITNESS WHEREOF the Parties have executed this Agreement.

SIGNED	

Elan Corporation, plc	

BY:	 	 	
 	Name:	
 	Title:	

SIGNED	
 	
Elan International Services, Ltd	

BY:	 	 	
 	Name:	
 	Title:	

SIGNED	
 	
Acorda Therapeutics, Inc.	

BY:	 	 	
 	Name:	
 	Title:	
 
12

 
Exhibit 10.26
 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Fampridine Tablets (10mg, 15mg, 20mg, 25mg)
Technical Transfer Program Proposal for
Commercial Registration

For
 
Acorda Therapeutics

Proposal No. ELN-FQ-0001-1002-R4
 
Dated:  February 26, 2003

Confidential

 
TABLE OF CONTENTS

1.0	Project Scope	
 	 	
2.0	Environmental, Health and Safety	
 	 	
3.0	Analytical Development	
 	 	
 	3.1	Cleaning Residuals Assay (Method Development and Validation)	
 	 	 	
 	3.2	Drug Substance Potency and Related Substance Assay (Method Transfer)	
 	 	 	
 	3.3	Drug Substance – Particle Size (Method Transfer)	
 	 	 	
 	3.4	Drug Substance – Residual Solvent Assay (Method Verification)	
 	 	 	
 	3.5	Drug Substance – Moisture by KF (Verification)	
 	 	 	
 	3.6	Drug Product Potency & Related Substance Assay, Two Methods (Method Transfer)	
 	 	 	
 	3.7	Dissolution Assay (Method Validation)	
 	 	 	
 	3.8	Drug Product – Moisture by KF (Verification)	
 	 	 	
 	3.9	Release Testing of the Drug Substance, per Lot	
 	 	 	
4.0	Feasibility Manufacturing	
 	 	
5.0	Registration Manufacturing	
 	 	
6.0	Stability - Registration	
 	 	
7.0	Project Management	
 	 	
8.0	Assumptions, Terms and Conditions	
 	 	
Appendix A: Budget Summary	
 	
Appendix B: High Level Timeline	
 
2

 
Patheon Proposal # ELN-FQ-0001-1002-R4
29-Feb-03
 
1.0          Project Scope
 
Patheon Inc. (“Patheon”) will perform manufacturing and analytical services in order to manufacture Fampridine Tablets (10mg, 15mg, 20mg, 25mg) for Acorda Therapeutics (“Client”).  Analytical methods will be assessed to support the manufacturing program.
 
The Budget Summary for this proposal is presented in Appendix A.
 
Patheon will commence the activities described in this proposal following the execution of the Contract by both parties.
 
Reference standards for Fampridine and impurities and tablet samples will be provided by the Client.  Source technical documents (e.g., current Elan methods, validation reports, and master batch records, etc) and an HPLC column for initiation of method familiarization activities will be provided by the Client.  Patheon will be responsible for the generation of documentation and protocols required to support methods familiarization, methods transfer, manufacturing studies, and process transfer activities to be performed as part of this proposal.  The Client will review and approve all protocols generated by Patheon prior to execution of studies with the exception of the Clean Residuals Assay method.  Patheon will provide final reports at key stages in the project, as indicated in this proposal.  The Client will review and approve final reports.
 
2.0          Environmental , Health and Safety
 
Prior to the commencement of analytical method development, formulation development and manufacturing activities, a thorough review by Patheon of the Environmental, Health and Safety (EH&S) requirements for Fampridine will be completed.  The fee assumes the EH&S review will determine that Fampridine can be safely handled at Patheon.  A summary report for this evaluation will be provided to the Client.
 
3.0          Analytical Development
 
Patheon will perform the required method familiarization, method transfer, method development and/or method validation work required to support the manufacture of Fampridine Tablets.  Patheon is responsible for preparing all protocols.  The Client will review and approve all protocols prior to execution of the work. Upon completion of individual studies, Patheon will prepare final reports to document results of all studies with the exception of the Clean Residuals Assay method.  The Client will review and approve all reports before moving forward with activities that rely on results of the activities that are the subject of a report.
 
3

 
3.1          Cleaning Residuals Assay (Method Development and Validation)
 
Patheon will develop and validate the test methods required for testing cleaning residuals and swab samples in order to support the manufacturing program.  Analytical protocols and report will be prepared by Patheon.  The development and validation will challenge the following parameters:
 
•                   System Suitability
•                   Linearity
•                   LOD
•                   LOQ
•                   Recovery / Accuracy
•                   Repeatability
•                   Intermediate Precision
•                   Robustness
•                   Specificity
•                   Stability
 
3.2          Drug Substance Potency and Related Substance Assay (Method Transfer)
 
Patheon will transfer the test method required for drug substance testing in order to support the manufacturing program. The Client will supply Patheon in advance with the relevant Validation data to allow Patheon to set acceptance criteria for the protocol. Method Transfer protocols will be prepared by Patheon and submitted to the Client for approval prior to execution.  A final report documenting the methods transfer results will be prepared by Patheon and submitted to the Client for approval prior to use of the method for release testing. The method transfer will challenge the following parameters:
 
•                   System Suitability
•                   LOD and LOQ
•                   Specificity
•                   Repeatability
•                   Reproducibility
•                   Robustness
 
3.3          Drug Substance – Particle Size (Method Transfer)
 
Patheon will transfer the test method required for drug substance particle size testing in order to support the manufacturing program. The Client will supply Patheon in advance with the relevant Validation data to allow Patheon to set acceptance criteria for the protocol. Method Transfer protocols will be prepared by Patheon and submitted to the Client for approval prior to execution.   A final report documenting the methods transfer results will be prepared by Patheon and submitted to the Client for approval prior to use of the method for release testing. The method transfer will challenge the following parameters:
 
•                   Reproducibility
•                   Robustness
•                   Repeatability
 
4

 
3.4          Drug Substance – Residual Solvent Assay (Method Verification)
 
Patheon will verify the test method required for drug substance residual solvent testing in order to support the manufacturing program. Analytical protocols will be prepared by Patheon and submitted to the Client for approval prior to execution.  A final report documenting the method verification results will be prepared by Patheon and submitted to the Client for approval prior to use of the method for release testing. The method verification will evaluate the following parameters:
 
•                  System Suitability
•                  LOD and LOQ
•                  Specificity
•                  Repeatability
•                  Reproducibility
 
3.5          Drug Substance – Moisture by KF (Verification)
 
Patheon will verify the test method (up to 6 samples) required for drug substance moisture testing to ensure the method is precise and accurate in order to support the manufacturing program. Analytical protocols will be prepared by Patheon and submitted to the Client for approval prior to execution. A final report documenting the method verification results will be prepared by Patheon and submitted to the Client for approval prior to use of the method for release testing.
 
3.6                                Drug Product Potency & Related Substance Assay, Two Methods (Method Transfer)
 
Patheon will perform method familiarization for the methods in advance of methods transfer.  A report documenting the method familiarization results will be prepared by Patheon and submitted to the Client for approval prior to commencement of method transfer studies.  The client will supply Patheon with the relevant validation data to allow Patheon to set acceptance criteria for the protocol
 
Patheon will transfer the test methods required for drug product potency and related substances testing in order to support the manufacturing program.  It is noted that in addition to testing the coated finished product using Methods 1 and Method 2, a separate HPLC method will be used for the following:
 
•                   content uniformity testing,
•                   assay of the uncoated tablets
•                   blend homogeneity testing.
•                   Unit dose testing
 
Method Transfer protocols will be prepared by Patheon and submitted to the Client for approval prior to execution. Final reports documenting the method transfer results will be prepared by
 
5

 
Patheon and submitted to the Client for approval prior to use of the methods for testing.  The transfer will challenge the following parameters:
 
•                   System Suitability
•                   LOD and LOQ
•                   Specificity
•                   Repeatability
•                   Reproducibility
•                   Robustness
 
3.7          Dissolution Assay (Method Validation)
 
Patheon will perform full validation of the method required for testing dissolution of the drug product in order to support the manufacturing program.  Analytical protocols will be prepared by Patheon and submitted to the Client for approval prior to execution.  A final report documenting the method validation results will be prepared by Patheon and submitted to the Client for approval prior to use of the method for release testing. The validation will be performed according to ICH guideline requirements typically:
 
•                   System Suitability
•                   Linearity & Range
•                   Accuracy
•                   Precision (Reproducibility)
•                   Robustness of dissolution parameters & HPLC Methodology
•                   Specificity
•                   Solution Stability
 
3.8          Drug Product – Moisture by KF (Verification)
 
Patheon will verify the test method (up to 6 samples) required for drug product moisture testing to ensure that the method is   precise and accurate in order to support the manufacturing program. Analytical protocols will be prepared by Patheon and submitted to the Client for approval prior to execution. A final report documenting the method verification results will be prepared by Patheon and submitted to the Client for approval prior to use of the method for release testing.
 
3.9          Release Testing of the Drug Substance , per Lot
 
Patheon will test drug substance for receiving and releasing for manufacture as per Client’s CoA or as specified by Client instruction.
 
Note :
Release testing of the excipients and drug product has been included as “Analytical Support” under each section of the manufacturing.
 
6

 
4.0          Feasibility Manufacturing
 
Patheon will manufacture up to three feasibility batches of Fampridine Tablets at the 10mg strength.  These batches will be approximately 50 kilograms each and will not be manufactured back-to-back.  A protocol to evaluate blend times, tablet press parameters and coating parameters will be prepared by Patheon and submitted to the Client for approval prior to execution of the feasibility study.  The protocol will specify a detailed sampling plan and acceptance criteria.
 
All excipients will undergo complete analytical release testing in compliance with USP/NF (if the Client requires additional testing on the excipients, this will be addressed and costed separately as an amendment to this proposal).  Patheon will prepare a master batch record(s), which will be provided to the Client for approval prior to manufacturing and specifies manufacturing procedures and acceptance criteria.
 
The feasibility batches will not be GMP batches and will not undergo a full QA review; the batches will be bulk packaged. A report documenting the results of the feasibility studies will be prepared by Patheon and submitted to the Client for approval prior to proceeding to the registration batch production phase of this proposal.
 
Feasibility Manufacturing Process Train (50 kilograms):
 
•                   325L Gallay
•                   Beta Press
•                   Vector Lab Coater
•                   Comil
 
The following in-process and finished product testing is based upon the described tests. 
 
Blend Analysis
 
•                   Blend Homogeneity / uniformity of dosage (total of 10 samples)
•                   Composite sample Assay
•                   Flow Properties
•                   Bulk and Tap Densities (Including one sieve analysis)
 
Coated Tablet Analysis:
 
•                   Appearance
•                   Weight Variation
•                   Potency & Related Substances
•                   Identification
•                   Dissolution Profile
•                   Physical Parameters (hardness and friability)
•                   Moisture (KF)
 
7

 
Uncoated Tablet Analysis:
 
•                   Content Uniformity (As per USP)
•                   Physical Parameters (Note Weight thickness and hardness will be evaluated as part of in-process monitoring these are performed as part of the process) – hardness and friability
•                   Appearance
•                   Moisture (KF)
 
5.0                                Registration Manufacturing
 
Patheon will manufacture twelve registration batches of Fampridine Tablets (three of each tablet strength) that are colored and debossed tablets.  These batches will be approximately 50 kilograms each and may be manufactured back-to-back. Processing parameters will be based on recommendations from the feasibility study.  All excipients will undergo complete analytical release testing in compliance with USP/NF (if the Client requires addition testing on the excipients, this will be addressed and costed separately as an amendment to this proposal).  Patheon will prepare a protocol and provide the protocol to the Client for approval prior to execution of the registration batch production work.  The protocol will specify a detailed sampling plan and acceptance criteria. Patheon will prepare master batch records, which will be provided to the Client for approval prior to manufacturing; the batch records will specify manufacturing procedures and acceptance criteria.
 
The registration batches will be manufactured in accordance with cGMPs and will undergo a full QA review by Patheon.  The batches will be packaged as follows by Patheon (packaging configuration split to be determined by Client):

10mg Tablets	 	HDPE Bottles of 14’s and 60’s	
15mg Tablets	 	HDPE Bottles of 14’s and 60’s	
20mg Tablets	 	HDPE Bottles of 14’s, 60’s and 180’s	
25mg Tablets	 	HDPE Bottles of 14’s, 60’s and 180’s	
 
(all packaging configurations will include desiccant, filler and induction seal)
 
Registration Manufacturing Process Train (50 kilograms):
 
•                   325L Gallay
•                   Beta Press
•                   Vector Lab Coater
•                   Comil
 
8

 
The following in-process and finished product testing will be conducted.
 
Blend Analysis:
 
•                   Blend Homogeneity/uniformity of dosage (total of 10 samples)
•                   Composite sample assay, appearance, and ID
•                   Flow Properties
•                   Bulk and Tap Densities (Including one sieve analysis)
 
Coated Tablet Analysis:
 
•                   Appearance
•                   Potency & Related Substances
•                   Identification
•                   Dissolution Profile
•                   Physical Parameters (hardness and friability)
•                   Moisture (KF)
•                   Uniformity of dosage
 
Uncoated Tablet Analysis:
 
•                   Weight Variation
•                   Physical Parameters (hardness,  and friability)
•                   Appearance ID
•                   Moisture (KF)
•                   Assay
 
Patheon will provide copies of executed batch records to the Client with the associated completed sampling protocol and summary of results.  The Client will review the batch records prior to initiation of registration stability studies by Patheon.
 
6.0          Stability - Registration
 
For quoting purposes a non-matrix approach has been suggested to monitor the 30 lots (12 Registration batches, two packaging formats for the 10 and 15mg strengths, and three packaging formats for 20 and 25mg strengths of Fampridine Tablets) as per ICH guidelines.
 
Additional samples will be stored as contingency samples if required to generate data for long-term stability of the product.
 
The following storage conditions and test-points are suggested for testing:
 
•                                           1, 2, 3 and 6 months for 40 ° C ± 2 ° C / 75% ± 5% RH
•                                           1, 2, 3, 6, 9, and 12 months for 30 ° C ± 2 ° C / 60% ± 5% RH*
•                                           3, 6, 9, 12, 18, 24 and 36 months for 25 ° C ± 2 ° C / 60% ± 5% RH
•                                           Contingency samples at 5 ° C, Ambient RH*

(* Tested only if required due to significant changes in the next level condition)
 
9

 
The analytical data used for the release of each lot manufactured at Patheon will be considered as initial (T=0) data if samples are placed on stability within 30 days of batch release.
 
Cost efficiencies for analytical testing have been built into the stability program based upon the number of samples pulled in a given month.  The fee for this stability program assumes that all lots will be placed on stability at the same time.  If these lots are not placed on stability at the same time, the fee will be adjusted accordingly through an Amendment to Proposal. The number of Pulls and costing is based on the assumption that no testing is required at 30 ° C/60%RH.

Pullpoint Month	 	1	 	2	 	3	 	6	 	9	 	12	 	18	 	24	 	36	
Number of Samples Pulled	 	30	 	30	 	60	 	60	 	30	 	30	 	30	 	30	 	30	
 
Therefore, the stability sample breakdown is:
 
•                   0 Single Sample Pullpoints (0 Samples)
•                   0 Double Sample Pullpoints (0 Samples)
•                   0 More Than Two Sample Pullpoints (0 Samples)
•                   0 More Than Five Sample Pullpoints (330 Samples)
•                   9 More Than Ten Sample Pullpoints (330 Samples)
 
The following standard tests are usually performed as part of the Stability Program:
 
•                   Potency &Related Substances
•                   Dissolution Profile
•                   Physical Appearance
•                   Moisture
•                   Hardness
•                   Friability
 
This estimate is based on a full ICH program.  Patheon will prepare the ICH stability protocol.  The protocol will be approved by the Client prior to initiation of the stability studies.  Patheon will provide results to the Client for each test interval that has been reviewed by Patheon quality assurance.  Patheon will prepare a report at the 3 and 6 month test stations and will prepare reports at every subsequent 6 month test station thereafter (or at each 12 month test interval, as appropriate, based upon the protocol).
 
There is the possibility to reduce the fees for this work based on the mutual agreement between Patheon and the Client to matrix the testing design.  The final cost is to be determined.
 
7.0          Project Management
 
Patheon will provide project management support to monitor the progress of the project against established timelines and will update the Client of changes in events. The project manager will coordinate regular biweekly teleconference meetings and quarterly face-to-face meetings.  The fee for project management is incorporated in the breakdown of each activity.
 
10

 
8.0          Assumptions , Terms and Conditions
 
1.             Development Activities :  Patheon shall undertake and perform the product development work described in this Proposal (the “Development Activities”) which when accepted by CLIENT shall become a contract binding on Patheon and CLIENT (the “Contract”).  Notwithstanding the foregoing, CLIENT and Patheon acknowledge that certain changes are contemplated in the scope of the Development Activities the details and costs of which will be negotiated at a later date. No changes, deletions or additions to the Development Activities will be considered valid without prior written agreement between CLIENT and Patheon.  Patheon shall notify Client, in advance of incurring any costs, when additional development activities by Patheon, beyond the Development Activities set forth in this Proposal, become necessary due to unforeseen events.  Patheon shall not perform any additional development activities without CLIENT approval of such related costs.
 
It is assumed that, based on the information available to Patheon at this time, Patheon can safely perform the Development Activities at its Toronto Region Operations facility.  If it is determined by Patheon’s Environmental Health and Safety personnel that any of the active ingredients are a Category III or Category IV compound, an occupational exposure level, then an air sampling method will be required at CLIENT’s expense prior to commercialization.  Patheon reserves the right, in its sole and absolute discretion, to conduct an air sampling method on Category I and II compounds, at such price and upon such terms as may be mutually agreed to between the parties prior to commercialization.
 
1.1           “Intellectual Property”: includes, without limitation, rights in patents, patent applications, trade-marks, trade-mark applications, trade-names, confidential information, trade secrets, inventions, copyrights, industrial designs.
 
1.2           Grant of Non-Exclusive License to Patheon :  The CLIENT hereby grants to Patheon, for the term of the Contract, a royalty-free, non-exclusive license to use Client’s Intellectual Property for the performance of the Development Activities.  The nonexclusive license granted herein shall be limited to Intellectual Property of the CLIENT that is necessary for the performance of the Development Activities and Patheon shall not use such Intellectual Property for any other purpose than performance of the Development Activities.  The non-exclusive license shall not include any right not expressly stated hereunder.  CLIENT represents and warrants that as of the date of the Contract to the best of its knowledge, without conducting any inquiry, that the Development Activities performed by Patheon will not, to the best of CLIENT’s belief, infringe any Intellectual Property held by any third party.
 
2.             Supply of Products :
 
(a)           CLIENT shall supply Patheon with sufficient bulk quantities of the active ingredients and certain excipients for Patheon’s use in conducting the Development Activities under this Proposal.  Such ingredients and excipients shall by supplied by CLIENT at its expense.
 
11

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
(b)           Patheon shall purchase all other materials required to conduct the Development Activities.  CLIENT shall pay Patheon’s direct cost thereof plus an additional [**] as a handling charge upon receipt of an invoice detailing such costs.  Prior to making any such purchases in excess of [**], Patheon shall obtain CLIENT approval.  In addition, Patheon shall obtain prior client approval for each and every purchase of other materials once the total amount invoiced to CLIENT during performance of the Development Activities exceeds [**].
 
3.             Payment for Service :
 
(a)           CLIENT shall pay Patheon for the services to be provided during the term of this Proposal in such amounts and in such manner as set forth in this Proposal.  All amounts quoted are in USD funds and are valid for sixty (60) days from the date of this Proposal.  All amounts quoted are subject to review by Patheon of all product specifications, development reports and, Environmental, Health and Safety assessment.  One review with changes is included in the fee for final reports.  Any additional changes shall be invoiced separately at the then prevailing hourly rates.
 
(b)           Project specific items, which include but are not limited to special equipment, change parts, excipients, laboratory columns and reagents, tooling etc., obtained by Patheon from third party suppliers as well as services to be provided by any third party suppliers are subject to prior CLIENT approval, and will be billed back to CLIENT upon Patheon’s receipt of invoice from any supplier of Patheon.  The purchase of project specific items and services are subject to the same prior approval requirements in Section 2 (b) of the Contract.
 
(c)           Each Patheon invoice shall be due and payable within thirty (30) days of the date of such invoice.
 
4.             Deposit :  Prior to the commencement of any Development Activities by Patheon pursuant to this Proposal, Patheon shall have received from CLIENT a deposit in the amount set out in the Project Summary.  This deposit amount will be held by Patheon as a deposit until the Development Activities, as modified from time to time, are fully completed or until this Contract expires or is terminated for whatever reason.  The deposit amount shall be credited towards the final invoice for the Project.  Patheon may apply this deposit amount against any accounts overdue in excess of 60 days of the date of the invoice.  In addition, Patheon may, at its option, suspend all Development Activities until such time the outstanding amounts have been paid in full and the original deposit amount has been replenished.
 
5.             Term and Termination :  This Contract will take effect on the date of execution and shall continue until completion by Patheon of the Development Activities.  Either party may terminate this Contract if the other party is in material breach of any provisions thereof and the breaching party fails to remedy any such breach within thirty (30) days of the notice of such breach by the non-breaching party. Additionally, CLIENT shall have the right to terminate this Contract immediately for any business reason.
 
In either such case, Patheon shall cease performance of the Development Activities upon termination and CLIENT shall pay to Patheon:  (i) any fees and expenses due to Patheon for the
 
12

 
services rendered up to the date of termination; (ii) all actual costs incurred by Patheon to complete activities associated with the termination and close of the Project; and (iii) any additional costs incurred by Patheon in connection with the Project that are required to fulfill applicable regulatory and contractual requirements.  Any re-scheduling of the Development Activities requested by CLIENT beyond one hundred twenty (120) days, notwithstanding a request made pursuant to Section 8.8, shall be deemed to be a termination.
 
All materials and supplies shall be picked up within five (5) business days of termination otherwise, a $20.00 per square foot per month surcharge will be assessed for storage.
 
6.             Confidential Information :  All proprietary or confidential information of either party that is disclosed or otherwise made known to the other party as a result of the Development Activities performed under this Contract shall be considered confidential property of the disclosing party (the “Confidential Information”).  The Confidential Information shall be used by the receiving party, its employees and external advisors only for the purpose of performing the receiving party’s obligations hereunder.  For purposes of this paragraph, Confidential Information shall not be deemed to include any information that is (i) known to the receiving party at the time of the disclosure, as evidenced by its written records prior to disclosure by the disclosing party; (ii) is or becomes available publicly other than as a result of a breach of this Contract by the receiving party, (iii) obtained from a third party lawfully in possession of such information and under no obligation to maintain such information confidential or (iv) independently developed by the receiving party without use of the Confidential Information.
 
Each party agrees that it will not reveal, publish or otherwise disclose the Confidential Information of the other party to any third party without prior written consent of the disclosing party.  However, disclosure of Confidential Information may be made if required by law or by any regulatory or governmental authority to which the receiving party or any of its respective affiliates may be subject, in each case, on prior written notice to the disclosing party, so that the disclosing party may determine whether to seek a protective order or other appropriate remedy.  This obligation of confidentiality and non-disclosure shall remain in effect for a period of ten (10) years after the effective date of termination of this Contract.
 
7.             Inventions, Etc. :  All data, information and Intellectual Property generated or derived by Patheon as a result of Development Activities performed by Patheon under this Contract, to the extent it is specific to the development, manufacture, use and sale of the CLIENT’s product the subject of the Development Activities (“CLIENT’s Product”) shall be and remain the exclusive property of CLIENT.  In addition, any data, information and Intellectual Property generated or derived by Patheon through the use of CLIENT’s Intellectual Property that is not a result of the Development Activities performed by Patheon shall be the exclusive property of CLIENT.  On the other hand, all data information and Intellectual Property generated or derived by Patheon as a result of Development Activities performed by Patheon under this Contract, which is not specific to the development the development, manufacture, use and sale of the CLIENT’S product and has application beyond the CLIENT’s Product shall be and remain the exclusive property of Patheon.  Notwithstanding the foregoing, CLIENT acknowledges that Patheon possesses certain inventions, processes, know-how, trade secrets, other intellectual properties and other assets, including but not limited to, analytical methods, computer technical expertise and
 
13

 
software which have been independently developed by Patheon (collectively “Patheon Property”).  CLIENT and Patheon agree that any Patheon Property or improvement thereto which are used, improved, modified or developed by Patheon under or during the term of this Contract, is the product of Patheon’s technical expertise possessed and developed by Patheon prior to or during performance of this Contract and are the sole and exclusive property of Patheon.
 
8.              Errors and Omissions :  In the event of a material error by Patheon in the performance of the Development Activities, CLIENT shall have the option to request Patheon to (1) repeat the service at Patheon’s own costs provided that CLIENT provides the active ingredient, or (2) reimburse CLIENT for the price for that particular service, excluding the cost of the active ingredient.  In any event, Patheon shall not reimburse the amount of the active ingredient.
 
9.              Indemnification :
 
(a)           CLIENT shall defend, indemnify and hold harmless Patheon and its affiliates and their respective directors, officers, employees and agents (together with Patheon, the “Patheon Indemnitees”) from and against any and all claims, actions, causes of action, damages, liabilities, expenses including reasonable attorneys’ fees and expenses (collectively, “Losses”) to and in favour of third parties (other than affiliates) resulting from, relating to, or arising from: (i) any breach by CLIENT of any of its obligations under this Contract; and (ii) the Intellectual Property rights of third parties except to the extent such Losses are: (I) determined to have resulted from the negligence or willful misconduct of Patheon; or (2) for which Patheon is obligated to indemnify the CLIENT Indemnitees pursuant to Section 9(b).
 
(b)           Patheon shall defend, indemnify and hold harmless CLIENT and its affiliates and their respective directors, officers, employees and agents (together with CLIENT, the “CLIENT Indemnitees”) from and against any and all Losses resulting from, relating to, or arising from any breach by Patheon of any of its obligations under this Contract except to the extent such Losses are: (i) determined to have resulted from negligence or willful misconduct of CLIENT; or (ii) for which CLIENT is obligated to indemnify the Patheon Indemnitees pursuant to Section 9(a).
 
(c)           Under no circumstances whatsoever shall either party be liable to the other in contract, tort, negligence, or breach of statutory duty for any otherwise for any indirect or consequential damages.
 
10.           Indemnification Procedures :   In the event that either party seeks indemnification, it shall inform the other party of the claim as soon as reasonably practicable after it receives notice thereof and, shall permit the other party, at that party’s cost, to assume direction and control of the defense of the claim, and shall cooperate as reasonably requested (at the expense of the other party), in defense of the claim.  Neither party shall settle or otherwise compromise any claim or suit in any manner that adversely affects that other party hereunder or imposes obligations on the other party in addition to those set forth in this Contract, without prior written consent of the other party, which consent shall not be unreasonably withheld or delayed.
 
14

 
11.          Miscellaneous :   This Contract contains the entire understanding of the parties with respect to the subject matter herein and supersedes all previous agreements (oral and written), negotiations and discussions.  The parties may modify or amend the provisions hereof only by an instrument in writing duly executed by both of the parties.  Neither this Contract, nor any of either party’s rights hereunder, may be assigned or otherwise transferred by either party without the prior written consent of the other party.  Any attempt to assign the rights or obligations under this Contract shall be void. This Contract shall be deemed to be made in the State of New York and shall be interpreted and enforced in accordance with the laws of the State of New York, without regard to conflict of law principles.  The parties hereby submit to the jurisdiction of the state and federal courts located within the State of New York.  The obligation of the parties contained in Sections 6, 7, 8, 9 and 10 shall survive the expiration or earlier termination of this Contract.
 
Patheon and CLIENT have executed this Contract in duplicate by the duly authorized officers of each party.

Acorda Therapeutics	 	Patheon Inc.	

By:	 	 	 	By:	 	 	
 	 	 	 	 	 	 	
Name:	Mitchell Katz, PhD	 	 	Name:	 	 	
 	 	 	 	 	 	 	
Title:	Vice President, Clinical Programs	 	 	Title:	 	 	
 	 	 	 	 	 	 	
Date:	 	 	 	Date:	 	 	
 
15

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.
 
Appendix A: Budget Summary
 
THE FOLLOWING COSTS ARE ALL QUOTED IN:                               USD

2.0 ENVIRONMENTAL HEALTH AND SAFETY	 	 	 	 	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	 	 	 	 	
 	ACTIVITY	 	 	 	 	 	 	 	 	 	PRICE	 	
 	 	 	 	 	 	 	 	 	 	 	 	
EH&S Assessment ($3,000 per active)	 	 	 	 	 	 	 	 	 	[**]	 	
 	 	 	 	 	 	 	 	 	 	 	 	
3.0 ANALYTICAL DEVELOPMENT	 	 	 	 	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	 	 	 	 	
 	ACTIVITY SHIFTS	 	HOURS	 	PRICE	 	 	 	HOURS	 	PRICE	 	
 	 	 	 	 	 	 	 	 	 	 	 	
3.1   Cleaning Residuals Assay (Method Development and Validation)	 	 	 	 	 	 	 	 	 	 	 	
Protocol/benchwork	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
Final Report	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	[**]	 	 	[**]	 	
3.2   Drug Substance Potency & Related Substances (Method Transfer)	 	 	 	 	 	 	 	 	 	 	 	
Protocol/benchwork	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
Final Report	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	[**]	 	 	[**]	 	
 	 	 	 	 	 	 	 	 	 	 	 	
3.3   Drug Substance - Particle Size (Method Transfer)	 	 	 	 	 	 	 	 	 	 	 	
Protocol/benchwork	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
Final Report	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	[**]	 	 	[**]	 	
 	 	 	 	 	 	 	 	 	 	 	 	
3.4   Drug Substance - Residual Solvents Assay (Method Verification)	 	 	 	 	 	 	 	 	 	 	 	
Protocol/benchwork	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
Final Report	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	[**]	 	 	[**]	 	
 	 	 	 	 	 	 	 	 	 	 	 	
3.5   Drug Substance - Moisture by KF (MethodVerification)	 	 	 	 	 	 	 	 	 	 	 	
Protocol/benchwork	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
Final Report	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	[**]	 	 	[**]	 	
 	 	 	 	 	 	 	 	 	 	 	 	
3.6   Drug Product Potency & Related Substances Assay (Method Transfer)	 	 	 	 	 	 	 	 	 	 	 	
Protocol/benchwork	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
Final Report	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	[**]	 	 	[**]	 	
 	 	 	 	 	 	 	 	 	 	 	 	
3.7   Dissolution (Validation)	 	 	 	 	 	 	 	 	 	 	 	
Protocol/benchwork	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
Final Report	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	[**]	 	 	[**]	 	
 	 	 	 	 	 	 	 	 	 	 	 	
3.8   Drug Product - Moisture by KF (Method Verification)	 	 	 	 	 	 	 	 	 	 	 	
Protocol/benchwork	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
Final Report	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	[**]	 	 	[**]	 	
 	 	 	 	 	 	 	 	 	 	 	 	
3.9   Full Release testing of the Drug Substance (per Lot)	 	 	 	 	 	 	 	 	 	 	 	
Protocol/benchwork	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
Final Report	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	[**]	 	 	[**]	 	
 	 	 	 	 	 	 	 	 	 	 	 	
TOTAL (Analytical Development)	 	 	 	 	 	 	 	[**]	 	 	[**]	 	
 	 	 	 	 	 	 	 	 	 	 	 	
4.0 FEASIBILITY MANUFACTURING - OPTIMIZATION BATCHES	 	 	 	 	 	
 	 	 	 	 	 	 	 	 	 	 	 	
 	ACTIVITY	 	SHIFTS	 	HOURS	 	PRICE	 	SHIFTS	 	HOURS	 	PRICE	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission.	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Per Batch:	Manufacturing	 	[**]	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	Bulk Packaging	 	[**]	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	Analytical Support	 	 	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	Project Support	 	 	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	[**]	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	TOTAL (Three Feasibility Batches)	 	 	 	 	 	 	 	[**]	 	[**]	 	 	[**]	 	
 
16

 
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

5.0 REGISTRATION MANUFACTURING	 	 	 	 	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	ACTIVITY	 	SHIFTS	 	HOURS	 	PRICE	 	SHIFTS	 	HOURS	 	PRICE	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Per Batch:	 	Manufacturing	 	[**]	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	Packaging	 	[**]	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	Analytical Support	 	 	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	Project Support	 	 	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	First Batch	 	 	 	 	 	 	 	[**]	 	[**]	 	 	[**]	 	
 	 	 	11	Additional Batches Manufactured Back-to-Back from First Batch	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	 	 	Cost Savings Per Additional Batch:	 	3.5	 	Shifts/	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	 	Cost Per Additional Batch:	 	 	 	 	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	 	 	[**]	 	[**]	 	[**]	 	
 	 	OPTIONAL: For 4 Registration Batches Manufacture Back-to-Back the Cost will be $249,820	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Bulk Hold Time Study (per Strength - one Timepoint)	 	 	 	 	 	 	 	 	 	[**]	 	 	[**]	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	TOTAL (Registration Manufacturing)	 	 	 	 	 	 	 	[**]	 	[**]	 	 	[**]	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
6.0 STABILITY - REGISTRATION	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	ACTIVITY	 	 	 	 	 	 	 	 	 	HOURS	 	PRICE	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Number of Lots	24	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Total Samples	264	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	 	 	Cost per Sample	 	# of Samples	 	Subtotal	 	 	 	 	 	 	 	
 	 	Analytical Support (1 sample per pullpoint)	 	$	[**]	 	0	 	$	0	 	 	 	 	 	 	 	
 	 	Analytical Support (2 samples per pullpoint)	 	$	[**]	 	0	 	$	0	 	 	 	 	 	 	 	
 	 	Analytical Support (2+ samples per pullpoint)	 	$	[**]	 	0	 	$	0	 	 	 	 	 	 	 	
 	 	Analytical Support (5+ samples per pullpoint)	 	$	[**]	 	0	 	$	0	 	 	 	 	 	 	 	
 	 	Analytical Support (10+ samples per pullpoint)	 	$	[**]	 	[**]	 	 	[**]	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	TOTAL (Stability - Validation)	 	 	 	 	 	 	 	 	 	[**]	 	 	[**]	 	
BUDGET TOTAL *	 	 	 	 	 	 	 	 	 	USD	 	 	[**]	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Deposit	 	 	 	 	 	 	 	 	 	 	 	 	 	$	[**]	 	

* The manufacturing cost given in this proposal is based upon the assumption that the drug substance is classified as a high potency material in accordance with Patheon’s Categorization System.  If it is determined through Patheon’s Environmental Health and Safety Review that the drug substance is not categorized as a high potency material, the manufacturing cost will be revised through a Change of Scope to reflect handling charges for a low potency product.
 
17

 
Appendix B: High Level Timeline
(2 pages)
 
The attached High Level Timeline is presented at this stage as a projected estimate of the duration and achievable milestones, based upon Patheon’s experience and history.  The High Level Timeline should not be taken as part of an agreed legal deliverable of this proposal.
 
Once the project has been awarded to Patheon and the relevant legal documentation is in place, a revised Timeline detailing set milestones and duration of deliverables will be agreed upon between Patheon and the Client.  The revised Timeline would likely have a similar duration and would be based upon resources and the availability of manufacturing time at the initiation of the project.
 
18

 
Exhibit 10.27
 
Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission
 
AGREEMENT

between

LONZA BIOLOGICS PLC

and

ACORDA THERAPEUTICS

 
THIS AGREEMENT is made the 29 th day of April 2003
 
BETWEEN
 
1.                                        LONZA BIOLOGICS PLC, the registered office of which is at 228 Bath Road, Slough, Berkshire SL1 4DY, England (“LB”); and
 
2.                                        ACORDA THERAPEUTICS, 15 Skyline Drive, Hawthorne, New York 10532, United States (“Customer”).
 
WHEREAS
 
A.                                    Customer is the proprietor of the recombinant human glial growth factor (rhGGF2), and
 
B.                                      LB has the expertise in the evaluation and production of recombinant proteins for therapeutic use using such Cell Lines, and
 
C.                                      Customer wishes to contract LB for Services relating to the Cell Line as described in the Agreement, and
 
D.                                     LB is prepared to perform such Services for Customer on the terms and conditions set out herein.
 
NOW THEREFORE it is agreed as follows:
 
1.                                        In this Agreement, its recitals and the Schedules hereto, the words and phrases defined in Schedule 4 hereto and in the Standard Terms for Contract Services set out in Schedule 5 hereto shall have the meanings set out therein.
 
2.                                        Subject to the Standard Terms for Contract Services set out in Schedule 5 and any Special Terms, LB agrees to perform the Services and the Customer agrees to pay the Price together with any additional costs and expenses that fall due hereunder.
 
3                                           3.1                                  Any notice or other communication to be given under this Agreement shall be delivered personally or sent by facsimile transmission, or if facsimile transmission is not available, by first class pre-paid post addressed as follows:

3.1.1	If to LB to:	Lonza Biologics plc	 	 	
 	 	228 Bath Road	 	 	
 	 	Slough	 	 	
 	 	Berkshire SL1 4DY	 	 	
 	 	England	 	 	
 	 	Facsimile: 01753 777001	 	 	
 	For the attention of:	The Head of Legal Services	 	 	
 
2

 

3.1.2	If to the Customer to:	Acorda Therapeutics	 	 	
 	 	15 Skyline Drive	 	 	
 	 	Hawthorne	 	 	
 	 	New York 10532	 	 	
 	 	United States	 	 	
 	 	Facsimile: +01 914 347 4560	 	 	
 	For the attention of:	Eric W. T. Chojnicki	 	 	
 	 	
 	or to such other destination as either party hereto may hereafter notify to the other in accordance with the provisions of this Clause 3.	
 
3.2                                  All such notices or other communications shall be deemed to have been served as follows:
 
3.2.1                         if delivered personally, at the time of such delivery;
 
3.2.2                         if sent by facsimile, upon receipt of the transmission confirmation slip showing completion of the transmission;
 
3.2.3                         if sent by first class pre-paid post, ten (10) business days (Saturdays, Sundays and Bank or other public holidays excluded) after being placed in the post.
 
AS WITNESS the hands of the duly authorised representatives of the parties hereto the day and year first above written.

Signed for and on behalf of	 	 	
LONZA BIOLOGICS PLC	 	 	
 	 	 	
 	 	TITLE	
 	 	 	
Signed for and on behalf of	 	 	
ACORDA THERAPEUTICS	 	 	
 	 	 	
 	 	TITLE	
 
3

 
SCHEDULE 1
 
“Cell Line” shall mean the CHO Cell Line provided by the Customer expressing Product.
 
“Product” shall mean the recombinant human glial growth factor (rhGGF2)
 
A.                                     SPECIFICATION FOR BULK PURIFIED PRODUCT
 
Below is a list of tests typically carried out as GMP Specification testing for a recombinant protein product by LB.  During the course of the Services LB and Customer will agree the testing appropriate to a GMP Specification for Product.

Test
No.	 	Criterion	 	Method
(Lonza Biologics SOP
number)	 	Draft Specification	
 	 	 	 	 	 	 	
1.	 	Characteristics	 	 	 	 	
1.1	 	Appearance (visual)	 	60516C	 	Clear, colourless liquid	
1.2	 	Protein concentration
(A 280 ) E 0.1% = TBC
             1cm	 	60284C	 	To be advised by Customer	
1.3	 	pH at 24 ± 1 ° C	 	60328C	 	pH 6.5 ± 0.5	

	
TBC: To be confirmed by Customer	 	 	
 	 	 	 	 	 	 	
2.	 	Identity	 	 	 	 	
1.4	 	Isoelectric focusing	 	Protocol to be decided	 	For information only. Comparable to reference.

Report number of visible bands and pI range	
 	 	 	 	 	 	 	
3.	 	Activity	 	 	 	 	
1.5	 	Sialic acid content	 	Protocol to be decided	 	Comparable to reference	
1.6	 	Oligosaccharide profiling	 	60837C	 	Comparable to reference	
1.7	 	Peptide mapping	 	Protocol to be decided	 	Comparable to reference	
 
4

 

Test
No.	 	Criterion	 	Method
(Lonza Biologics
SOP number)	 	Draft Specification	
 	 	 	 	 	 	 	
4.	 	Purity	 	 	 	 	
1.8	 	Novex SDS-electrophoresis (4-20% gel)

Coomassie blue	 	60805C	 	Report result. Target specification:

Report result as % purity and comparison to reference	
1.9	 	Gel permeation HPLC	 	To be decided	 	Report result, target specification:
Area % of monomer, %aggregates and % fragments.	
1.10	 	RP – HPLC	 	To be decided	 	Report result. Target specification:
% purity	
 	 	 	 	 	 	 	
5.	 	Impurities	 	 	 	 	
Test
No.	 	Criterion	 	Method (Lonza
Biologics SOP
number)	 	Specification	
 	 	 	 	 	 	 	
1.11	 	Hamster DNA	 	60841C	 	Report result. Target specification:
Target: Less than or equal to 10.0 pg per mg (by A 280 ) protein	
1.12	 	CHO Host cell protein	 	60845C	 	Report result. Target specification: 
Report the number and molecular weight of bands detected, and percentage of Host Cell Protein to Total Protein concentration w/w.	
 
5

 

Test
No.	 	Criterion	 	Method (Lonza
Biologics SOP
number)	 	Specification	
 	 	 	 	 	 	 	
6.	 	Safety	 	 	 	 	
1.13	 	Extended bioburden by direct inoculation	 	TM-25043	 	No growth detected after 14 days	
1.14	 	Endotoxins (LAL)	 	60186C	 	For information only.
Less than or equal to 1.0 Eu per mg (by A 280 ) protein	
 	 	 	 	 	 	 	
7.	 	Sample from production fermenter on day of harvest	
1.15	 	Mycoplasmas	 	BioReliance
102003A FDA points to consider	 	Hoeschst stain negative

Cell Line – no growth detected	
1.16	 	In Vitro test (4 cell lines:  MRC5, VERO,
CHO-K1, )

Or Q=-PCR for mvm	 	Q One Protocol
38163

Q One Protocol
37149	 	Negative

Report result	
1.17	 	Number of virus-like particles per ml of bulk harvest (EM)	 	Q One Protocol
38131	 	Report Result	

8.	 	Final Bulk Product Disposition	 	 	
Final Formulation Buffer	 	To be confirmed by Customer	
Bottling of Bulk Product:	 	 	
Containers	 	Nalgene high density polyethylene	
Denominations	 	Bulk x 1 litre (residual x 125mL).	
Product storage conditions	 	2 – 8 ° C	
Shipment temperature	 	2 – 8 ° C	
 
Note:
 
Bulk Product will be dispensed into 1L nalgenes, filling to a tolerance of ± 10% of the nominal volume of the container.
 
Any remaining Product will be in 125 mL nalgenes, filling to a tolerance of ± 10% of the nominal volume of the container.
 
Any 125 mL containers not filled with a tolerance of ± 10% will be labelled as Customer samples and not be released for clinical use.
 
6

 
B.                                     SPECIFICATION FOR A MASTER OR WORKING CELL BANK
 
Starting Material Definition
 
A Master Cell Bank (MCB) or Working Cell Bank (WCB) of a cryopreserved CHO cell line will be imported from the Customer and stored in individual ampoules in liquid nitrogen refrigerators.
 
General Master Cell Bank Specification
 
1.                                        In order for the Cell Line to be accepted into LB’s cGMP facility, the following testing is required and the appropriate specifications achieved.

Test
No.	 	Test	 	Method	 	Result	
1.1	 	Mycoplasma
(DNA Stain)	 	Compliant with FDA Points to Consider or European pharmacopeia	 	Negative	
1.2	 	Mycoplasma
(Direct Isolation)	 	Compliant with FDA Points to Consider or European pharmacopeia	 	No growth detected	
1.4	 	Sterility	 	Lonza SOP 60159C or testing laboratory protocol	 	No growth detected after 14 days	
1.5	 	Species Identity
(Isoenzyme analysis)*	 	Testing Laboratory Protocol	 	Hamster	
1.6	 	In vitro virus test
(with 3 cell lines: MRC5, VERO, CHO)*	 	Testing Laboratory Protocol	 	Negative	
1.7	 	Hamster Antibody Production*	 	Testing Laboratory Protocol	 	Negative	

*these tests may be performed on a linearly related cell stock.
 
7

 
SCHEDULE 2
 
CONTENTS

Supply of Customer Materials and Customer Know How	
 	 	
1	Stage 1 - Cell Line Importation, Cell Culture Process Transfer and Evaluation of Growth and Productivity of a CHO Cell Line	
 	 	
2	Stage 2 - Establish Assays for Product Concentration	
 	 	
3.	Stage 3 - Purification Process Evaluation	
 
8

 
Supply of Customer Materials and Customer Know How
 
Prior to commencement of the Services at LB or, if appropriate, prior to the commencement of the relevant Stage of the Services, Customer shall supply LB with the following:
 
(i)                                      Sufficient information on the Product to allow a risk assessment as required by the “Genetically Modified Organisms (Contained Use) (Amendment)” Regulations 1996 and a safety assessment by LB’s Biological Safety Committee.
 
(ii)                                   If available, a reference standard sample (approximately 60mg) of the Product suitable for the purposes intended.
 
(iii)                                At least 2 identical ampoules of viable frozen cells from the Master cell bank (MCB) for the purposes of performing development work, and sufficient Working cell bank (WCB) ampoules of the Cell Line, to perform any subsequent GMP manufacture, each containing approximately 1x107 cells per ampoule and which express Product. The Cell Line is understood to be clonal, stable and suitable for the purpose intended.
 
(iv)                               These ampoules shall be sent to LB’s cGMP facility in the UK to allow the Services contained herein to commence.
 
(v)                                  Copies of the Customer’s test reports for all mycoplasma, sterility and virus testing carried out on the MCB and WCB of the Cell Line.  This information needs to be reviewed by LB’s QA department to confirm acceptability for release of the Cell Line into the cGMP facility at LB if required.
 
(vi)                               List of materials, supplier and catalogue numbers that Customer proposes LB use.
 
(vii)                            Details of the formulation buffer for the bulk Product, including excipient concentrations, pH and protein concentration.
 
(viii)                         Details of the purification process, as developed by the Customer, including buffer formulations, operating conditions for the column chromatography steps, example chromatograms, expected yields, etc
 
(ix)                                 Copy of USDA permit for shipping, cells, samples and Product from UK into USA.
 
(x)                                    Copies of reports and procedures describing the analytical, cell culture and purification procedures developed by Customer (if available):
 
•                   Cell Line history and characterization
•                   Master cell bank creation
•                   Working cell bank creation
•                   Viability and homogeneity on cell revival
•                   Cell Line stability study (including method of generation number calculation)
•                   Purification process development reports
•                   Assay development and assay validation reports for all assays to be transferred to LB.
 
For the avoidance of doubt LB shall source materials from those suppliers nominated by Customer in accordance with Schedule 4 Clause 1.
 
9

 
Stage 1 - Cell Line Importation , Cell Culture Process Transfer and Evaluation of Growth and Productivity of a CHO Cell Line
 
1.1                                Objectives
 
1.1.1                         To import Customer’s Cell Line (MCB or WCB) and Process in to LB’s Development and GMP manufacturing facility
 
1.1.2                         To ensure that sufficient test information is available for rapid transfer of the selected Cell Line to LB’s GMP manufacturing facility.  Testing for potential adventitious agents is required so that all cell lines and products are protected for customers.
 
1.1.3                         To determine fermentation production kinetics and evaluate the fermentation procedures proposed by the Customer for production of Product from the Cell Line.
 
1.1.4                         To evaluate the growth and productivity of a CHO Cell Line supplied by the Customer in batch and fed-batch fermentation.
 
Before the commencement of this Stage, the project has to undergo a Risk Assessment by LB’s Biological Safety Committee.  This activity takes approximately 4 weeks.
 
Stage 1 is designed to ensure that all the testing and relevant history with regard to the creation of the Cell Line, including productivity data at various scales (if available) is transferred to LB.  If additional testing is required to comply with LB’s requirements for use of the Cell Line in the GMP facility, this will be performed or out-sourced as needed.  Additional testing will incur extra cost.  Mycoplasma and sterility testing have to be performed by LB prior to acceptance of the Cell Line into the GMP facility, unless satisfactory reports are provided.
 
1.2                                Activities
 
1.2.1                         Carry out and complete the risk Assessment by Lonza’s Biological Safety Committee.
 
1.2.2                         Receive the incoming Cell Line into quarantine in LB’s cGMP facility in the UK.
 
1.2.3                         Review the testing carried out on either the MCB or WCB of the Cell Line supplied by the Customer.  Determine the acceptability of the Cell Line for entry into LB’s cGMP facility by approval of the following reports:

(a) Virus Testing:-	 	(i) In vitro test assay  (3 cell lines:-
MRC-5, VERO and CH0-K1)	
 	 	 	
 	 	(ii) Hamster Antibody Production (HAP)	
 	 	 	
(b) Isoenzyme Analysis	 	(Cell Line identity)	
 	 	 	
(c) Sterility	 	 	
 	 	 	
(d) Mycoplasma	 	 	
 
1.2.4                         Following review, inform the Customer of the acceptability of the Cell Line for entry into LB’s cGMP facility.  If approved, establish standard maintenance, storage and release procedures for the Cell Line at LB.
 
10

 
 
Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission
 
1.2.5                         Receive process information and define any process modifications required for operation at LB.
 
1.2.6                         Visit the Customer and observe process performed by Customer, if required, as part of the technology transfer.
 
1.2.7                         Source any required raw materials that are not currently used within LB facility in accordance with Clause 1 of Schedule 4, based upon the list of materials provided by the Customer for the cell culture Process developed by the Customer.  At LB’s request, Customer will provide to LB specific raw materials that Customer proposes LB use in the Process.
 
1.2.8                         Evaluate revival and inoculum expansion of the Cell Line in shake flask culture in CD-CHO using the Customer’s Process.  Adapt this inoculum expansion process as appropriate to fit LB’s cGMP facility.
 
1.2.9                         Carry out a time course of cell growth in a series of shake flasks to evaluate for example; cell culture medium, feeds and other nutrient additions on Product accumulation, nutrient utilization and Product quality.  The final experimental plan will be agreed with the Customer prior to initiation of this Section 1.2.9.  LB will evaluate Product accumulation using the assays established in Stage 2 of the services.  Samples will be sent to the Customer for analysis of Product characteristics.  Results from these trials will determine the experimental plan for the laboratory scale evaluation in Section 1.2.10.
 
1.2.10                   Carry out a time course of cell growth and Product accumulation in two laboratory scale fermenters (up to 2 x 10 litres scale) using parameters defined in Section 1.2.9.
 
1.2.11                   Evaluate product accumulation using assays established in Stage 2 and provide samples to customer for Product quality analysis.
 
1.2.12                   Prepare a summary report.
 
Evaluation Point
Review and agree with Customer whether to proceed with the selected media and process.  Identify and agree with the Customer any further process optimisation that may be required.  These activities will be outlined in a subsequent stage and performed at additional cost.
 
Timescale
Stage 1 can commence once the Customer Materials are available and LB’s Biological Safety Committee has approved the programme.  Stage 1 is expected to take [*] months and will be complete upon issue of a summary report.
 
11

 
 
Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission
 
Stage 2 – Establish Assays for Product Concentration
 
2.1                                Objectives
 
To import ELISA and RP-HPLC assay methods from the Customer to determine product concentration.
 
2.2                                Activities
 
2.2.1                         Receive ELISA and RP-HPLC assay methods, assay reagents and product reference from Customer.
 
2.2.2                         Establish the assays for routine use with LB.  If further development of the assays is required for satisfactory operation within LB’s laboratories then additional activities will be required.  The scope and subsequent price of these activities (if required) will be agreed with the Customer.
 
Timescale
 
It is estimated that Stage 2 will take [*] months to complete
 
12

 
Stage 3 – Purification Process Transfer and Evaluation
 
3.1                                Objectives
 
3.1.1                         To evaluate purification of the Product by the process provided by the Customer and make recommendations on modifications to the process.
 
3.1.2                         To establish a purification Process suitable for purification of Product for use in clinical studies manufactured at 200L fermentation scale.
 
3.1.3                         To provide a sample of Product purified using the selected Process to the Customer for evaluation.
 
3.2                                Activities
 
3.2.1                         Receive complete details of the purification process developed by the Customer, including buffer formulations, process operating parameters with tolerances, information on performance of the purification process at the Customer’s facility, etc. Source and qualify new raw materials as required.
 
3.2.2                         Observe the purification process at the Customer’s laboratories.
 
Note: If at this point difficulties in supply or adaptation to LB’s equipment and procedures are identified, these will be discussed with the Customer. Extra costs may be incurred if specialist equipment or resins have to be sourced.
 
3.2.3                         Import Customer’s purification process. Design a purification process based on the Customer’s process that will fit with LB’s equipment and procedures.
 
3.2.4                         Receive cell culture supernatant produced under Stage 1.
 
3.2.5                         Run through the Customer’s purification process at laboratory scale. Take in-process and purified product samples and ship to the Customer for analysis. (No analysis of the purified product is planned at LB).
 
3.2.6                         Evaluate operating conditions for any Ultrafiltration steps and for a DV20 virus filter to be inserted into the purification process at an appropriate point (operational parameters for purification of Product will be evaluated in this Stage, not virus removal).  At least one further viral reduction/inactivation step will be required.  A list of options for consideration will be provided to the Customer.  The scope and timing of a specific programme which may require further development activities will be agreed between LB and the Customer. This will be in a subsequent stage at additional cost with activities to be defined.
 
3.2.7                         If sufficient Product is produced at laboratory scale deliver a sample (5mg or less) of Product to Customer for evaluation.
 
Evaluation Point:
 
3.2.8                         Review the performance of the purification process with the Customer.  Review requirements (if any) for Process modifications that may be needed following this study.  Any such Process modifications are subject to agreement with Customer.  Additional work will be performed in a subsequent stage at additional cost.
 
13

 
3.2.9                         Issue report of activities to Customer.  This shall include:
 
•                                           a summary of the key experimental data generated in this Stage;
•                                           an outline of the recommended manufacturing Process including an estimate of the expected yield of Product from the Cell Line at 200L production scale.
 
3.3                                Timescale
 
Stage 3 shall commence any time after Product is available from Stage 1.
Stage 3 shall be complete upon issue of the report of activities. It is estimated that this will be 3 months from provision of product from laboratory scale fermenters carried out under Stage 1.
 
14

 
Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission
 
SCHEDULE 3
 
Price and Terms of Payment
 
1.                                        Price
 
In consideration for LB carrying out the Services as detailed in Schedule 2 the Customer shall pay LB as follows:

Stage	 	 	 	Price (UK £
Sterling)	 	
 	 	 	 	 	 	
Stage 1	 	Cell Line Importation, Cell Culture Process Transfer and Evaluation of Growth and Productivity of a CHO Cell Line	 	 	[**]	 	
 	 	 	 	 	 	
Stage 2	 	Establish Assays for Product Concentration.	 	 	[**]	 	
 	 	 	 	 	 	
Stage 3	 	Purification Process Transfer and Evaluation	 	 	[**]	 	
 
15

 
Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission
 
2.                                        Payment

Payment by the Customer of the Price for each Stage shall be made against LB’s invoices as follows:	
 	
2.1	 	For Stage 1	
 	 	[**] upon commencement of Stage 1.	
 	 	[**] upon completion of Stage 1.	
 	 	 	
2.2	 	For Stage 2	
 	 	[**] upon commencement of Stage 2.	
 	 	[**] upon completion of Stage 2.	
 	 	 	
2.3	 	For Stage 3	
 	 	[**] upon commencement of Stage 3.	
 	 	[**] upon completion of Stage 3.	
 
16

 
SCHEDULE 4
 
SPECIAL TERMS
 
1.                                        LB shall use all reasonable endeavours to source required raw materials that are not currently used within LB’s facility, based upon the list of materials provided by the Customer in accordance with Schedule 2 for the cell culture purification and analytical procedures developed by the Customer.  At LB’s request, Customer will provide to LB specific raw materials that Customer proposes LB use in the Process.  To the extent that LB is unable at any time, despite using all reasonable endeavours, to obtain any materials necessary or desirable for the carrying out of the Services from the suppliers identified by Customer then Customer shall forthwith following request by LB supply the same and notwithstanding any other provision in this Agreement LB shall not be responsible for any delay in carrying out the Services caused by a delay in the supply of such materials.
 
2.                                        At LB’s request Customer will provide to LB appropriate GMP approval for specific raw materials that Customer proposes LB’s use.  LB and Customer agree that LB’s QA will make the final decision to allow entry of a raw material into the GMP facility based upon its assessment of audit findings, test protocols and results.
 
3.                                        The Customer will supply the testing laboratory protocols for review and approval by LB’s Quality department, prior to use of the Cell Line in the GMP facility. LB and Customer agree that LB’s QA will make the final decision to allow entry of a Cell Line into the GMP facility based upon its assessment of the testing protocols and results.
 
17

 
SCHEDULE 5
 
STANDARD TERMS FOR CONTRACT SERVICES (NON GS)

1.	 	Interpretation	
 	 	 	
1.1	 	In these Standard Terms, unless the context requires otherwise :	
1.1.1	 	“Affiliate” means any Company, partnership or other entity which directly or indirectly controls, is controlled by or is under common control with the relevant party to this Agreement. “control” means the ownership of more than fifty per cent (50%) of the issued share capital or the legal power to direct or cause the direction of the general management and policies of the party in question.	
1.1.2	 	“Agreement” means this agreement incorporating Schedules 1 (Product Specification), 2 (Services) 3 (Price and Terms of Payment) and 4 (Special Terms) as amended or varied from time to time by written agreement of the parties.	
1.1.3	 	“Batch” means the total Product obtained from one fermentation and associated purification using the Process and carried out in accordance with cGMP.	
1.1.4	 	“Cell Line” means the cell line, particulars of which are set out in Schedule 1.	
1.1.5	 	“cGMP” means Good Manufacturing Practices and General Biologics Products Standards as promulgated under the US Federal Food Drug and Cosmetic Act at 21CFR (Chapters 210, 211, 600 and 610) and the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC.  For the avoidance of doubt, LB’s operational quality standards are defined in internal GMP policy documents.	
1.1.6	 	“cGMP Product” means Product which is required under Schedule 2 to be manufactured in accordance with cGMP.	
1.1.7	 	“Competing Contract Manufacturer” shall mean any party who undertakes or performs more than twenty five percent (25%) of their business as a third party manufacturer of monoclonal antibodies and/or therapeutic proteins or any product of a similar nature to that to which this Agreement relates.	
1.1.8	 	“Customer” means Acorda Therapeutics, Inc. and its successors in title and lawful assigns.	
1.1.9	 	“Customer Information” means all technical and other information not known to LB or in the public domain relating to the Cell Line, the Process (including for the avoidance of doubt improvements or modifications thereto from time to time) and the Product, from time to time supplied by the Customer to LB.	
1.1.10	 	“Customer Materials” means the Materials supplied by Customer to LB (if any) and identified as such by Schedule 1 hereto.	
1.1.11	 	“Deliver”, “Delivered” or “Delivery” has the meaning ascribed to it by Clause 5.1	
1.1.12	 	“LB Know-How” means all technical and other information relating directly or indirectly to the Process known to LB from time to time other than confidential Customer Information and information in the public domain.	
1.1.13	 	“LB Patent Rights” means all patents and patent applications of any kind throughout the world relating to the Process which from time to time LB is the owner of or is entitled to use.	
1.1.14	 	“Price” means the price specified in Schedule 3 for the Services.	
1.1.15	 	“Process” means the process for the production of the Product from the Cell Line, including any improvements or modifications thereto from time to time.	
1.1.16	 	“Product” means all or any part of the product manufactured using the Process (including any sample thereof), particulars of which are set out in Schedule 1 and includes all derivatives therof.	
1.1.17	 	“Customer Patent Rights” means all patents and patent applications of any kind throughout the world that are necessary or useful in performance of the Services excluding the LB Patent Rights.	
1.1.18	 	“Services” means all or any part of the services the subject of the Agreement (including, without limitation, cell culture evaluation, purification evaluation, master, working and extended cell bank creation, and sample and bulk production), particulars of which are set out in Schedule 2.	
1.1.19	 	“Specification” means the specification for Product, particulars of which are set out in Schedule 1.	
1.1.20	 	“Terms of Payment” means the terms of payment specified in Schedule 3.	
1.1.21	 	“Testing Laboratories” means any third party instructed by LB to carry out tests on the Cell Line or the Product.	
 
18

 

1.2	 	Unless the context requires otherwise, words and phrases defined in any other part of the Agreement shall bear the same meanings in these Standard Terms, references to the singular number include the plural and vice versa, references to Schedules are references to schedules to the Agreement, and references to Clauses are references to clauses of these Standard Terms.	
1.3	 	In the event of a conflict between a term in Schedule 4 or any supplemental or additional term agreed in writing from time to time between the parties and these Standard Terms, the former shall prevail.	
 	 	 	
2.	 	Applicability of Standard Terms	
 	 	Unless otherwise specified, this Agreement shall not be effective until it (or a counterpart of it) has been signed on behalf of both parties.  No variation of or addition to this Agreement or any part thereof shall be effective unless in writing and signed on behalf of both parties.  Notwithstanding the above the parties hereby confirm that amendments to the Specification shall be effective if reduced to writing and signed by the quality and/or regulatory representative of both parties, which quality and/or regulatory representative shall be nominated from time to time by each party.	
 	 	 	
3.	 	Supply by Customer, Safekeeping and Customer Warranties and Indemnity	
 	 	 	
3.1	 	Immediately following the date of the Agreement the Customer shall supply to LB the Customer Information, together with full details of any hazards relating to the Cell Line and/or the Customer Materials, their storage and use.  On review of this Customer Information, the Cell Line and/or the Customer Materials shall be provided to LB at LB’s request.  Property in the Cell Line and/or the Customer Materials and/or the Customer Information supplied to LB shall remain vested in the Customer.	
3.2	 	The Customer hereby grants LB the non-exclusive right to use the Cell Line, the Customer Materials and the Customer Information for the purpose of the Agreement.  LB hereby undertakes not to use the Cell Line, the Customer Materials or the Customer Information (or any part thereof) for any other purpose.	
3.3	 	LB shall:	
3.3.1	 	at all times use all reasonable endeavours to keep the Cell Line and/or the Customer Materials secure and safe from loss and damage in such manner as LB stores its own material of similar nature;	
3.3.2	 	not part with possession of the Cell Line and/or the Customer Materials or the Product, save for the purpose of tests at the Testing Laboratories; and	
3.3.3	 	procure that all Testing Laboratories are subject to obligations of confidence substantially in the form of those obligations of confidence imposed on LB under these Standard Terms.	
 	 	 	
3.4	 	The Customer warrants to LB that:	
3.4.1	 	Customer has the right to enter into this Agreement;	
3.4.2	 	Customer has and shall at all times throughout the term of this Agreement have the right to supply the Cell Line, the other Customer Materials and the Customer Information to LB and the necessary rights to license or permit LB to use the same for the purpose of the Services;	
3.4.3	 	Any of the Cell Line, the other Customer Materials, Customer Information and Customer Patent Rights not owned by Customer are licensed to Customer under a licence which will permit their use by LB to perform the Services;	
3.4.4	 	To the best of Customer’s knowledge and belief, the use by LB of the Cell Line, other Customer Materials, Customer Information and Customer Patent Rights for the Services (including without limitation the manufacture of the Product) will not infringe any intellectual property rights of any third party (provided, however, that LB shall waive any breach of this warranty which arises if a court of competent jurisdiction determines that the use by LB of the Cell Line, other Customer Materials, Customer Information or Customer Patent Rights for the Services infringes the intellectual property rights of a third party, provided that and for so long as Customer actually indemnifies LB pursuant to Clause 3.5); and	
3.4.5	 	Customer will promptly notify LB in writing if it receives or is notified of a claim from a third party that the Cell Line, other Customer Materials, Customer Information or the Customer Patent Rights or that the use by LB thereof for the provision of the Services infringes any intellectual property rights of such third party.	
 	 	 	
3.5	 	The Customer undertakes to indemnify and to maintain LB promptly indemnified against any loss, damage, costs and expenses of any nature (including court costs and legal fees on a full indemnity basis), whether direct or consequential, and whether or not foreseeable or in the contemplation of LB or the Customer, that	
 
19

 

 	 	LB may suffer arising out of or incidental to any breach of the warranties given by the Customer under Clause 3.4 above or any claims alleging LB’s use of the Cell Line, the Customer Materials or the Customer Information infringes any rights (including, without limitation, any intellectual or industrial property rights) vested in any third party (whether or not the Customer knows or ought to have known about the same)  provided that there shall be excluded from this indemnity all LB actual or potential profits other than those which are an integral part of any Price or fees which the Customer is obliged to pay to LB under this Agreement.	
 	 	 	
3.6	 	The obligations of the Customer under this Clause 3 shall survive the termination for whatever reason of the Agreement.	
 	 	 	
4.	 	Provision of the Services	
 	 	 	
4.1	 	LB shall diligently carry out the Services as provided in Schedule 2 and shall use all reasonable efforts to achieve the estimated timescales therefor	
4.2	 	LB shall manufacture cGMP Product to meet the Specification provided that there shall be no such obligation to meet the Specification in respect of the first three Batches of cGMP Product manufactured or in respect of the first cGMP Batch manufactured following any change in the Process agreed to or requested by Customer.	
4.3	 	Due to the unpredictable nature of the biological processes involved in the Services, the timescales set down for the performance of the Services (including without limitation the dates for production and Delivery of Product) and the quantities of Product for delivery set out in Schedule 2 are estimated only.	
4.4	 	Subject to Clause 4.2. the Customer shall not be entitled to cancel any unfulfilled part of the Services or to refuse to accept the Services on grounds of late performance, late delivery or failure to produce the estimated quantities of Product for delivery.  LB shall not be liable for any loss, damage, costs or expenses of any nature, whether direct or consequential, occasioned by:	
4.4.1	 	any delay in performance or delivery howsoever caused; or	
4.4.2	 	any failure to produce the estimated quantities of Product for delivery, provided that if a significant failure to produce the agreed estimated quantities (if any) of Product for delivery arises due to negligence by LB the parties shall agree a commercially reasonable mechanism by which to compensate Customer.	
4.5	 	LB shall comply with the International Committee for Harmonisation regulatory requirements from time to time applicable to the Services as set out in Schedule 2 hereto.	
 	 	 	
5.	 	Delivery, Transportation of Product and Customer Tests	
 	 	 	
5.1	 	Product shall be delivered EXW (ex-works) LB premises (as defined by Incoterms 2000) which means (a) when LB places Product at the disposal of Customer at LB’s premises not cleared for export and not loaded onto any collecting vehicle and (b) risk and title to Product pass to Customer upon delivery (“Deliver,” “Delivery,” or “Delivered,” as appropriate). Subject to Clause 5.2, LB shall deliver to Customer the Certificate of Analysis not later than the date of Delivery.  Transportation of Product, whether or not under any arrangements made by LB on behalf of Customer, shall be made at the sole risk and expense of the Customer.	
 	 	 	
5.2	 	At Customer’s request, LB will Deliver Product in quarantine prior to delivery of the Certificate of Analysis.  Such request shall be accompanied by Customer’s written acknowledgement that the Product has been Delivered without the transmittal to Customer of a Certificate of Analysis, that accordingly the Product cannot be administered to humans until transmittal of the Certificate of Analysis, and that Customer nevertheless accepts full risk of loss, title and ownership of the Product.  The Delivery of Product in quarantine shall be subject to such testing requirements as LB may reasonably require, and the forty-five (45) day period referred to in Clause 5.8 shall run from Delivery in quarantine by Customer of the Product.	
 	 	 	
5.3	 	Unless otherwise agreed, LB shall package and label Product for Delivery in accordance with its standard operating procedures.  It shall be the responsibility of the Customer to inform LB in writing in advance of any special packaging and labeling requirements for Product.  All additional costs and expenses of whatever nature incurred by LB in complying with such special requirements shall be charged to the Customer in addition to the Price.	
 
20

 

5.4	 	If requested in writing by the Customer, LB will (acting as agent for Customer) arrange for insurance of Product whilst held by LB after Delivery (awaiting transportation) for a maximum of fourteen (14) days on terms equivalent to those under which LB insures product prior to Delivery. All additional costs and expenses of whatever nature incurred by LB in arranging such insurance shall be charged to the Customer in addition to the Price.	
5.5	 	If requested in writing by the Customer, LB will (acting as agent of the Customer for such purpose) arrange the transportation of Product from LB’s premises to the destination indicated by the Customer together with insurance cover for Product in transit at its invoiced value.  All additional costs and expenses of whatever nature incurred by LB in arranging such transportation and insurance shall be charged to the Customer in addition to the Price.	
5.6	 	Where LB has made arrangements for the transportation of Product, the Customer shall diligently examine the Product as soon as practicable after receipt.  Notice of all claims (time being of the essence) arising out of:	
5.6.1	 	visible damage to or total or partial loss of Product in transit shall be given in writing to LB and the carrier within three (3) working days of receipt by Customer; or	
5.6.2	 	non-delivery shall be given in writing to LB within ten (10) days after the date of LB’s despatch notice.	
5.7	 	The Customer shall make damaged Product and associated packaging materials available for inspection and shall comply with the requirements of any insurance policy covering the Product notified by LB to the Customer.  LB shall offer the Customer all reasonable assistance (at the cost and expense of the Customer) in pursuing any claims arising out of the transportation of Product.	
5.8	 	Promptly following receipt of Product or any sample thereof, the Customer may carry out any of the tests outlined or referred to in the Specification set out in Schedule 1 Subject to Clause 4.2, if such tests show that the Product fails to meet Specification, the Customer shall give LB written notice thereof within forty-five (45) days from the date of Delivery and shall return such Product to LB’s premises for further testing.  In the absence of such written notice Product shall be deemed to have been accepted by the Customer as meeting Specification.  Subject to Clause 4.2, if Customer has reasonably demonstrated to LB that Product returned to LB fails to meet Specification and that such failure is not due (in whole or in part) to acts or omissions of the Customer or any third party after Delivery, LB shall at Customer’s discretion refund that part of the Price that relates to the production of such Product or replace such Product at its own cost and expense.  In the event Customer requires LB to replace such Product, LB shall use all reasonable endeavours to do so with the minimum delay having regard to its commitments to third parties in the timing of such replacement.	
5.9	 	Subject to Clause 4.2, if there is any dispute concerning whether Product returned to LB fails to meet Specification or whether such failure is due (in whole or in part) to acts or omissions of the Customer or any third party after Delivery, such dispute shall be referred for decision to an independent expert (acting as an expert and not as an arbitrator) to be appointed by agreement between LB and the Customer or, in the absence of agreement by the President for the time being of the Association of the British Pharmaceutical Industry.  The costs of such independent expert shall be borne equally between LB and the Customer.  The decision of such independent expert shall be in writing and, save for manifest error on the face of the decision, shall be binding on both LB and the Customer.	
5.10	 	The provisions of Clauses 5.8 and 5.9 shall be the sole remedy available to the Customer in respect of Product that fails to meet Specification.	
 	 	 	
6.	 	Price and Terms of Payment	
6.1	 	The Customer shall pay the Price in accordance with the Terms of Payment.	
6.2	 	Unless otherwise indicated in writing by LB, all prices and charges are exclusive of Value Added Tax or of any other applicable taxes, levies, imposts, duties and fees of whatever nature imposed by or under the authority of any government or public authority, which shall be paid by the Customer (other than taxes on LB’s income).  All invoices are strictly net and payment must be made within thirty (30) days of date of invoice.  Payment shall be made without deduction, deferment, set-off, lien or counterclaim of any nature.	
6.3	 	In default of payment on due date:	
6.3.1	 	interest shall accrue on any amount overdue at the rate of four per cent (4%) above the base lending rate from time to time of National Westminster Bank plc, interest to accrue on a day to day basis both before and after judgement; and	
 
21

 
Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission

6.3.2	 	LB shall, at its sole discretion, and without prejudice to any other of its accrued rights, be entitled to suspend the provision of the Services or to treat the Agreement as repudiated on not less than ten (10) days’ prior notice in writing to Customer given at any time thereafter.	
 	 	 	
7.	 	LB Warranty and Limitation of Liability	
 	 	 	
7.1	 	LB warrants that :	
7.1.1	 	the Services shall be performed in accordance with Clause 4.1 and 4.2;	
7.1.2	 	unencumbered title (save for any IP rights which may exist) to Product will be conveyed to Customer upon Delivery;	
7.1.3	 	as of the date of this Agreement the LB Information and the LB know how are owned by LB or LB is otherwise entitled to use them for the purposes of providing Services under this Agreement and during the term of this Agreement LB shall not do or cause anything to be done which would adversely affect their ownership or entitlement to use the same for those purposes;	
7.1.4	 	LB has the necessary corporate authorisations to enter into this Agreement;	
7.1.5	 	as of the date of this Agreement, to the best of LB’s knowledge and belief, the use by LB of the process (excluding any modifications or steps made or developed by Customer, the Customer Materials, Customer Information and Customer Patent Rights) and LB Patent Rights and LB Information for the performance of the Services as provided herein will not infringe any rights (including without limitation any intellectual or industrial property rights) vested in any third party;	
7.1.6	 	LB will notify Customer in writing immediately if it receives or is notified of a claim from a third party that the use by LB of the Process and/or the LB Information or the LB Patents Rights for Services infringes any intellectual property rights vested in such third party;	
7.2	 	Clause 7.1 is in lieu of all conditions, warranties and statements in respect of the Services and/or the Product whether expressed or implied by statute, custom of the trade or otherwise (including but without limitation any such condition, warranty or statement relating to the description or quality of the Product, its fitness or suitability for a particular purpose or use under any conditions whether or not known to LB) and any such condition, warranty or statement is hereby excluded.	
7.3	 	Without prejudice to the terms of Clauses 5.10, 5.6, 7.2, 7.4 and 7.6, the liability of LB for any loss or damage suffered by the Customer as a result of any breach of the Agreement or of any other liability of LB (including misrepresentation and negligence) in respect of the Services (including without limitation the production and/or supply of the Product) shall be limited to the payment by LB of damages which shall not exceed pounds sterling [**].	
7.4	 	Subject to Clause 7.6, LB shall not be liable for the following loss or damage howsoever caused (even if foreseeable or in the contemplation of LB or the Customer):	
7.4.1	 	loss of profits, business or revenue whether suffered by the Customer or any other person; or	
7.4.2	 	special, indirect or consequential loss, whether suffered by the Customer or any other person; and	
7.4.3	 	any loss arising from any claim made against the Customer by any other person.	
7.5	 	The Customer shall indemnify and maintain LB promptly indemnified against all claims, actions, costs, expenses (including court costs and legal fees on a full indemnity basis) or other liabilities whatsoever in respect of :	
7.5.1	 	any product liability (in respect of Product, unless such liability is caused by the negligent act or omission of LB in the production and/or supply of Product or occasioned by breach of LB warranty relating to IP infringement or title;	
7.5.2	 	any negligent or wilful act or omission of the Customer in relation to the use, processing, storage or sale of the Product.	
7.6	 	Nothing contained in these Standard Terms shall purport to exclude or restrict any liability for death or personal injury resulting directly from negligence by LB in carrying out the Services or any liability for breach of the implied undertakings of LB as to title.	
7.7	 	The obligations of the Customer under this Clause 7 shall survive the termination for whatever reason of the Agreement.	
 	 	 	
8.	 	Customer Information, LB Know-How and LB Patent Rights	
 	 	 	
8.1	 	The Customer acknowledges that LB Know-How and LB Information and LB acknowledges that Customer Information with which it is supplied by the other pursuant to the Agreement is supplied, subject to Clause	
 
22

 

 	 	8.5, in circumstances imparting an obligation of confidence and each agrees to keep such LB Know-How and LB Information or such Customer Information secret and confidential and to respect the other’s proprietary rights therein and not at any time for any reason whatsoever to disclose or permit such LB Know-How or LB Information or such Customer Information to be disclosed to any third party save as expressly provided herein.	
8.2	 	The Customer and LB shall each procure that all their respective employees, consultants, contractors and persons for whom it is responsible having access to confidential LB Know-How or LB Information or confidential Customer Information shall be subject to the same obligations of confidence as the principals pursuant to Clauses 8.1 and 8.3 and shall be bound by secrecy agreements in support of such obligations. LB and the Customer each undertake not to disclose or permit to be disclosed to any third party (including any contractors or consultants not previously approved in writing by the non-disclosing party, provided that such approval shall not be unreasonably withheld or delayed), or otherwise make use of or permit to be made use of (a) any trade secrets or confidential information relating to the technology, business affairs or finances of the other, any subsidiary, holding company or subsidiary or any such holding company of the other, or of any suppliers, agents, distributors, licensees or other customers of the other which comes into its possession under this Agreement. or (b) the commercial terms of this Agreement except to the extent that the same is required to be disclosed pursuant to subpoena, court order, judicial process or otherwise by law, provided the Receiving Party provides prompt notice to the Disclosing Party of such requirement in order to give the Disclosing Party an opportunity to timely seek a protective order or other appropriate judicial relief. In the event the Disclosing Party is unable to obtain a protective order or other appropriate judicial relief, the Receiving Party shall disclose only that portion of the Disclosing Party’s Confidential Information which is legally required to be disclosed, and ensure that all such Confidential Information of the Disclosing Party shall be redacted to the fullest extent permitted by law prior to such disclosure and that the Disclosing Party shall be given an opportunity to review the Confidential Information prior to its disclosure.	
8.3	 	The obligations of confidence referred to in this Clause 8 shall not extend to any information which:	
8.3.1	 	is or becomes generally available to the public otherwise than by reason of a breach by the recipient party of the provisions of this Clause 8;	
8.3.2	 	is known to the recipient party and is at its free disposal prior to its receipt from the disclosing party;	
8.3.3	 	is subsequently disclosed to the recipient party without being made subject to an obligation of confidence by a third party;	
8.3.4	 	LB or the Customer may be required to disclose under any statutory, regulatory or similar legislative requirement, subject to the imposition of obligations of secrecy wherever possible in that relation; or	
8.3.5	 	is developed by any servant or agent of the recipient party without access to or use or knowledge of the information by the disclosing party.	
8.4	 	The Customer acknowledges that:	
8.5	 	without prejudice to any other rights and remedies that the parties may have, the parties agree that the Confidential Information is valuable and that damages may not be an adequate remedy for any breach of the provisions of Clauses 8.1, 8.2, 8.3.  The parties agree that the relevant party will be entitled without proof of special damage to the remedies of an injunction and other equitable relief for any actual or threatened breach by the other party.	
8.6	 	the Customer shall not at any time have any right, title, licence or interest in or to LB Know-How, LB Information the LB Patent Rights or any other intellectual property rights relating to the Process which are vested in LB or to which LB is otherwise entitled.	
8.7	 	LB acknowledges that save as provided herein LB shall not at any time have any right, title, licence or interest in or to the Customer Information, Customer Patent Rights or any other intellectual property rights vested in Customer or to which the Customer is entitled.	
8.8	 	The obligations of LB and the Customer under this Clause 8 shall survive the termination for whatever reason of the Agreement.	
 	 	 	
9.	 	Termination	
 	 	 	
9.1	 	If it becomes apparent to either LB or the Customer at any stage in the provision of the Services that it will not be possible to complete the Services for scientific or technical reasons, a sixty (60) day period shall be allowed for good faith discussion and attempts to resolve such problems.  If such problems are not resolved within such period, LB and the Customer shall each have the right to terminate the Agreement forthwith by	
 
23

 
Certain  portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [     ] and an asterisk*, have been separately filed with the
Commission

 	 	notice in writing.  In the event of such termination, the Customer shall pay to LB a termination sum calculated by reference to all the Services performed by LB prior to such termination (including a pro rata proportion of the Price for any stage of the Services which is in process at the date of termination) and all expenses reasonably incurred by LB in giving effect to such termination, including the costs of terminating any commitments entered into under the Agreement, such termination sum not to exceed the Price.	
9.2	 	Customer may in its sole discretion terminate the Services at any time for any reason by giving not less than (thirty) 30 days’’ notice in writing to LB.  In the event of termination pursuant to this Clause 9.2 and subject to Clauses 9.3 and 9.4 the Customer shall pay LB a termination sum calculated in accordance with the principles of Clause 9.1 above plus	
9.2.1	 	in the event notice to terminate Services pursuant to this Clause 9.2 is issued to LB six (6) months or less before LB’s then estimated start date for any stage of those Services which include cGMP fermentation activities, Customer shall pay LB a sum equal to the [**] that stage or those stages in question, which payment shall fall due to LB on or before the date of termination of such Services; or	
9.2.2	 	in the event notice to terminate Services pursuant to this Clause 9.2 is issued to LB more than six (6) but not more than twelve (12) months before LB’s then estimated start date for any stage of those Services which include cGMP fermentation activities, Customer shall pay LB a sum equal to [**] of the full price of that stage or those stages in question; which payment shall fall due to LB on or before the date of termination of such Services; or	
9.2.3	 	The obligation to make payment under Clause 9.2 shall be reduced (retrospectively, and hence LB shall make an appropriate refund to Customer) to the extent that LB mitigates its loss in this regard (and LB shall promptly notify the Customer of any such mitigation).  This provision shall not entitle the Customer to be refunded an amount greater than that paid by customer to LB pursuant to this Clause 9 and LB shall be entitled to deduct from the amount due to be refunded to Customer its reasonable personnel and associated costs in attempting to mitigate its loss.  For the avoidance of doubt LB shall be under no obligation to take any active steps to mitigate such loss.	
9.3	 	For the avoidance of doubt activities relating to cGMP fermentation shall be deemed to commence with the date of removal of the vial of cells for the performance of the fermentation from frozen storage.	
9.4	 	LB and the Customer may each terminate the Agreement forthwith by notice in writing to the other upon the occurrence of any of the following events:	
9.4.1	 	if the other commits a material breach of the Agreement (which shall include a breach of the warranties set out in Clauses 3 and 7 respectively) which in the case of a breach capable of remedy is not remedied within thirty (30) days of the receipt by the other of notice identifying the breach and requiring its remedy; or	
9.4.2	 	if the other ceases for any reason to carry on business or compounds with or convenes a meeting of its creditors or has a receiver or manager appointed in respect of all or any part of its assets or is the subject of an application for an administration order or of any proposal for a voluntary arrangement or enters into liquidation (whether compulsorily or voluntarily) or undergoes any analogous act or proceedings under foreign law.	
9.5	 	Upon the termination of the Agreement for whatever reason:	
9.5.1	 	LB shall promptly return to the Customer all Customer Information and shall dispose of or return to the Customer the Customer Materials (and where supplied by Customer the Cell Line) and any materials therefrom, as directed by the Customer;	
9.5.2	 	the Customer shall promptly return to LB all LB Know-How and LB Information it has received from LB;	
9.5.3	 	the Customer shall not thereafter use or exploit the LB Patent Rights, the LB Know-How, or the L B Information in any way whatsoever;	
9.5.4	 	LB and the Customer shall do all such acts and things and shall sign and execute all such deeds and documents as the other may reasonably require to evidence compliance with this Clause 9.5.	
9.6	 	Termination of the Agreement for whatever reason shall not affect the accrued rights of either LB or the Customer arising under or out of this Agreement and all provisions which are expressed to survive the Agreement shall remain in full force and effect.	
 	 	 	
10.	 	Force Majeure	
 	 	 	
10.1	 	If LB is prevented or delayed in the performance of any of its obligations under the Agreement by Force Majeure and shall give written notice thereof to the Customer specifying the matters constituting Force Majeure together with such evidence as LB reasonably can give and specifying the period for which it is estimated that such prevention or delay will continue, LB shall be excused from the performance or the	
 
24

 

 	 	punctual performance of such obligations as the case may be from the date of such notice for so long as such cause of prevention or delay shall continue.	
10.2	 	The expression “Force Majeure” shall be deemed to include any cause affecting the performance by LB of the Agreement arising from or attributable to acts, events, acts of God, omissions or accidents beyond the reasonable control of LB.	
 	 	 	
11.	 	Governing Law, Jurisdiction and Enforceability	
 	 	 	
11.1	 	The construction, validity and performance of the Agreement shall be governed by the laws of England, and LB and the Customer submit to the non-exclusive jurisdiction of the Courts of England and Wales.	
11.2	 	No failure or delay on the part of either LB or the Customer to exercise or enforce any rights conferred on it by the Agreement shall be construed or operate as a waiver thereof nor shall any single or partial exercise of any right, power or privilege or further exercise thereof operate so as to bar the exercise or enforcement thereof at any time or times thereafter.	
11.3	 	The illegality or invalidity of any provision (or any part thereof) of the Agreement or these Standard Terms shall not affect the legality, validity or enforceability of the remainder of its provisions or the other parts of such provision as the case may be.	
 	 	 	
12.	 	Miscellaneous	
 	 	 	
12.1	 	Neither party shall be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement without the prior written consent of the other which consent shall not be unreasonably withheld or delayed, save that both parties shall be entitled without prior written consent to assign, transfer, charge, sub-contract, deal with or in any other manner make over the benefit and/or burden of this Agreement to any company with which that party may merge, or transfer its assets and undertakings to any company, save that Customer shall not be permitted to make any assignment to a Competing Contract Manufacturer (as herein defined).	
12.2	 	The text of any press release or other communication to be published by or in the media concerning the subject matter of the Agreement shall require the prior written approval of LB and the Customer.	
12.3	 	The Agreement embodies the entire understanding of LB and the Customer and there are no promises, terms, conditions or obligations, oral or written, expressed on implied, other than those contained in the Agreement.  The terms of the Agreement shall supersede all previous agreements (if any) which may exist or have existed between LB and the Customer relating to the Services.	
12.4	 	The parties to this Agreement do not intend that any term hereof should be enforceable by virtue of the Contracts (Rights of Third Parties) Act 1999 by any person who is not a party to this Agreement.	
 
25

 
Exhibit 10.28
 
CONFIDENTIAL
 
LABORATORY SERVICES AGREEMENT
 
This Laboratory Services Agreement (“ Agreement ”) effective as of April 1, 2003 (the “ Effective Date ”) is between Acorda Therapeutics, Inc. with an address at 15 Skyline Drive, Hawthorne, New York 10532, USA (“ Acorda ”) and Cardinal Health PTS, Inc. with an address of 160 Magellan Labs Ct., Morrisville, North Carolina, USA (“ Cardinal Health ”).
 
Acorda and Cardinal Health agree to the following terms and conditions:
 
1.                                        Services .
 
1.1                                  Cardinal Health agrees to provide to Acorda the laboratory services described in Quotes identified in Exhibit A to this Agreement, relating to Acorda’s Stability Study on the compound, Fampridine, and as set out in the Protocols agreed to by the parties or previously approved by Elan (the “Protocols”) and on any additional exhibit as may be mutually agreed by the parties in writing and attached hereto from time to time (the “ Services ”). Each such exhibit shall be incorporated by reference into this Agreement and shall be subject to the terms and conditions contained herein.  Cardinal Health shall use reasonable commercial efforts to perform the Services in an efficient and timely manner and in accordance with the timeframes set out in the Quotes identified in Exhibit A.  Cardinal Health agrees that there shall be no deviations from the provisions of the quotes identified in Exhibit A or from the Protocols or from any instructions provided to Cardinal Health in writing by Acorda without Acorda’s prior written consent. Cardinal Health further agrees that all reports generated hereunder will meet the requirements set forth in the documents identified in Exhibit A, the Protocols and this Agreement.  In the event of a conflict between the terms of this Agreement and the terms set forth in any quote identified in Exhibit A, or any quote later agreed to by the parties which is subject to this Agreement, the terms of this Agreement shall control.
 
1.2                                  Unless otherwise agreed to by the parties in writing, Acorda is solely responsible to (i) provide complete and accurate scientific data regarding Acorda’s requirements for the Services, (ii) provide Cardinal Health with complete and accurate information necessary to develop the scope of work, and estimated or fixed costs for the Services, (iii) review and approve all Service instructions, the Protocols and any subsequent protocol or exhibit, (iv) if applicable, prepare all submissions to regulatory authorities.
 
2.                                        Payment of Fees and Expenses .
 
2.1                                  Acorda will pay Cardinal Health for the Services actually rendered by Cardinal Health at the rates specified in the Quotes identified in Exhibit A and this Agreement.  Cardinal
 
1

 
Health may amend such rates once annually upon written notice to Acorda.  Cardinal Health will invoice Acorda post completion of each Stability Test interval or as separately agreed for services provided under this Agreement.  Acorda shall pay all amounts due within thirty (30) days of receipt of Cardinal Health’s itemized invoices for work completed.  Acorda will pay any sales, use, gross receipts, compensating or other taxes (excluding income and franchise taxes) required to be paid by Cardinal Health as a result of the Services and any other action necessary to fulfill the terms of this Agreement.  Cardinal Health will charge a late payment fee of 1.5% per month, or the maximum amount permitted by law if less than 1.5% per month, for any undisputed payment not received within thirty (30) days from receipt of invoice by Acorda.  All payments shall be made in United States Dollars unless otherwise agreed. Without limiting Cardinal Health’s rights under law or in equity, Cardinal Health and its affiliates, parent or related entities, collectively or individually, may exercise a right of set-off against any and all amounts due to Cardinal Health from Acorda.  For purposes of this Section 2.1, Cardinal Health, its affiliates, parent or related entities shall be deemed to be a single creditor.
 
2.2                                  Cardinal Health will be responsible for discharging all payments to its staff who will be providing the Services hereunder.  Unless otherwise agreed to by the parties, and except as otherwise provided in this Agreement, Cardinal Health will be responsible for procuring and paying for all equipment necessary to carry out the Services. Cardinal Health shall maintain complete and accurate records verifying time and materials expended by Cardinal Health during the provision of the Services.  These records shall be available for inspection, review and audit at reasonable times by Acorda and Cardinal Health, or its duly authorized representative, during and for one year following the termination of this Agreement.  In no event shall Acorda be entitled to review Cardinal Health’s financial, accounting or cost records at any time.
 
2.3                                  Each stability study has a stability management fee and stability storage fee as set forth in the quotes identified in Exhibit A and agreed to by the parties.  There is a minimum billable amount of $2,500 per study phase (i.e., individual stability timepoint pulls, method transfers, etc.).  Rush order services may be available for certain services as agreed to by the parties.  Surcharges for such rush orders typically range from 10% to 300% of the cost for the rushed service, are agreed in advance by the parties and will be quoted separately as requested by Acorda.  The cost of all reference standards, specialty chemicals and supplies, and HPLC or GC columns ordered by Cardinal Health for the Services will be billed to Acorda.
 
2.4                                  All required investigational studies or additional Acorda requests not outlined in this Agreement, the Protocols or an exhibit to this Agreement will be invoiced for the cost of performance at the standard hourly rate, plus associated fees.  Cardinal Health reserves the right to expend up to 16 hours per occurrence to complete all required investigational work (such as OOS investigations, troubleshooting chromatographic methods, etc.) without approval from Acorda.  If the additional work requires more than 16 hours, Cardinal Health will contact Acorda prior to continuation.  Additional work will be performed based on verbal agreement from Acorda and will be documented on a Cardinal Health Telephone Conversation Record (TCR).
 
2

 
3.                                    Term .
 
This Agreement shall commence on the Effective Date and shall continue for a period of three (3) years (the “ Term ”), unless mutually extended by the parties or terminated according to the terms of this Agreement.
 
4.                                    Confidentiality .
 
The parties Agree that the Services performed hereunder and all communications in relation to such Services shall be governed by the terms of the Confidential Disclosure Agreement between Elan Corporation, Cardinal Health and Acorda, attached hereto as Exhibit B .
 
5.                                        Ownership
 
5.1                                  All specimens, biological materials, data and information necessary for Cardinal Health to conduct the Services, under this Agreement, will be provided by Acorda to Cardinal Health, and shall remain the sole and exclusive property of Acorda.  At all times, Acorda shall have the full and free right to use any and all information generated by Cardinal Health in the conduct of the Services (“Data”) in any way deemed by Acorda to be necessary or advisable, either directly or through agents or otherwise, without payment of any compensation to Cardinal Health for same, except as herein specifically provided.
 
5.2                                  All intellectual property rights subsisting in or relating to any calculations, Data, specifications, papers, documents, any other items, material or information generated by Cardinal Health in the performance of the Services or any study are vested in Acorda, save only that Cardinal Health shall have the rights to any general material such as Standard Operating Procedures, software, and any innovative laboratory methodology or process developed in the course of the Services.  Cardinal Health agrees that Acorda shall be entitled to own and control all proprietary technology and all financial, operating, training ideas, data, processes, procedures and materials, including works of expression, all copyrights, all patent rights, and all trade secret rights in such works that are developed, written, or conceived by Cardinal Health under this Agreement, to the extent that they relate to the Services or performance of the requirements of this Agreement.  Cardinal Health shall promptly disclose to Acorda any such Intellectual Property, and shall make, execute and deliver any and all instruments and documents and perform any and all acts, necessary to obtain, maintain and enforce patents, trademarks and copyrights for such Intellectual Property, and shall make, execute and deliver any and all instruments and documents and perform any and all acts, necessary to obtain, maintain and enforce patents, trademarks and copyrights for such Intellectual Property as Acorda may desire in any and all countries.  All costs and expenses of application and prosecution of such patents, trademarks and copyrights shall be paid by Acorda.
 
3

 
6.                                        Work Quality; Regulatory Compliance; Inspection; Other Representations and Warranties .
 
6.1                                  Cardinal Health agrees to carry out the Services and maintain records and the Data during and after the Term of this Agreement in compliance with all applicable Federal, State and local legal and regulatory requirements, including, without limitation, Guidelines issued by the International Conference on Harmonisation (“ ICH/GCP ”), and any requirements of the United States Food and Drug Administration (“ FDA ”) and the United States Drug Enforcement Administration (together, “ Laws ”).  Acorda’s remedies for Cardinal Health’s failure to meet the warranties set forth in this section shall be as set forth in Section 15.3.
 
6.2                                  Neither Cardinal Health nor any of Cardinal Health’s employees rendering the Services pursuant to this Agreement is under investigation by the FDA for debarment action or is presently debarred pursuant to the Generic Drug Enforcement Act of 1992.  Cardinal Health shall notify Acorda immediately upon any inquiry concerning or the commencement of any such proceeding concerning Cardinal Health or any such employee.
 
6.3                                  If, with respect to any study or Services provided under this Agreement any governmental or regulatory authority conducts or gives notice to Cardinal Health of its intent to conduct an inspection at Cardinal Health’s facilities which are used in the performance of the Services or take any other regulatory action with respect to such facilities, Cardinal Health will promptly give Acorda notice thereof, including all information pertinent thereto.
 
6.4                                  Cardinal Health hereby represents and warrants to Acorda that performance of the Services as contemplated by this Agreement will not result in the breach or violation of any contract, arrangement or understanding which Cardinal Health may have with any third party.
 
6.5                                  Cardinal Health shall use reasonable commercial efforts and shall take all reasonable endeavours and shall take all reasonable precautions to ensure that all Data provided for the purposes of and/or resulting from the provision of the Services shall be protected against all risk of loss thereof.  In addition, Cardinal Health shall warrant that all electronic Data provided hereunder is backed up onto backup media tape on a daily basis and stored in a secure off-site location.
 
6.6                                  At a minimum, all Data shall be retained by Cardinal Health for a period of ten (10) years following completion of the applicable study or such longer period as may be required by applicable Laws.  Cardinal Health will notify Acorda in writing not less than thirty (30) days prior to destruction or disposal of such records, and will forward such records to Acorda or another site designated by Acorda upon Acorda’s request and at Acorda’s expense.
 
4

 
7.                                        Review of Work and Facilities Inspection .
 
During the Term of this Agreement, Cardinal Health will permit Acorda’s representative(s) to examine the work performed and all documentation related to such work and to inspect Cardinal Health’s facilities as agreed to by the parties upon reasonable advance notice and during regular business hours.  Acorda and its authorized representatives shall also have the right to copy any applicable items referred to in this Section.
 
8.                                        Publication .
 
Publication of Data, information or test results arising in connection with the Services provided by Cardinal Health and owned by Acorda shall be within the sole and absolute discretion of Acorda and shall not be published or referred to, in whole or in part, without the prior written consent of Acorda.
 
9.                                        Termination .
 
9.1                                  This Agreement, the Protocols and/or any study conducted hereunder, may be terminated (a) with or without cause by Acorda at any time during the Term of this Agreement upon the provision of thirty (30) days prior written notice to Cardinal Health; (b) by either party, upon thirty (30) days’ prior written notice of a breach of this Agreement which is not cured within such thirty (30) day period; and (c) by either party, if the other party files for protection under any bankruptcy law, enters into liquidation or becomes insolvent.  In the event this Agreement is terminated by Acorda, Cardinal Health shall complete all Services commenced for Acorda under this Agreement (including completion of all Services required in support of a particular clinical trial), to the extent requested by Acorda.  In the event of  termination pursuant to this Section, Acorda shall pay Cardinal Health any fees for the Services actually rendered by Cardinal Health under this Agreement together with all actual costs incurred by Cardinal Health as may be reasonably required to wind-down such activities and provided Cardinal Health uses all reasonable efforts to mitigate such costs, save that all payments to Cardinal Health will immediately cease in the event of termination of this Agreement due to a material breach by Cardinal Health.
 
9.2                                  Except to the extent otherwise required by law, upon termination of this Agreement and satisfaction of all obligations hereunder, Cardinal Health shall deliver to Acorda all Data and materials provided by Acorda to Cardinal Health for the conduct of the Services under this Agreement, whether provided before or after the date of this Agreement, plus all specimens or Data created by Cardinal Health under this Agreement.
 
9.3                                  Except as to payments required under this Agreement, if any default or delay occurs which prevents or materially impairs a party’s performance and is due to a cause beyond the party’s reasonable control, and provided that the default or delay is not caused by or the fault of such party, including but not limited to an act of God, flood, fire, explosion, earthquake, casualty, accident, war, revolution, civil commotion, blockade or embargo, injunction, law, proclamation, order, regulation or governmental demand, the affected party shall promptly notify the party in writing of such cause and shall exercise diligent
 
5

 
efforts to resume performance under this Agreement as soon as possible.  Neither party will be liable to the other party for any loss or damage due to such cause, and the Term will not be extended thereby.  Neither party may terminate this Agreement because of such default or delay except upon thirty (30) days prior written notice to the other party if the default or delay has existed for three (3) months and is continuing at the end of the thirty (30) day notice period.
 
10.                                  Independent Contractor .
 
Cardinal Health is an independent contractor of Acorda, and nothing contained in this Agreement shall be construed to place the parties in the relationship of partners, principal and agent, employer and employee, or joint venturers.
 
11.                                  Insurance
 
11.1                            At all times while this Agreement is in effect, each party shall procure and maintain at their own expense and for their own benefit, from an insurance carrier(s) having a minimum AM Best rating of A-VII, at least the following minimum levels of insurance coverage.

11.1.1	 	Worker’s Compensation	 	Statutory	
 	 	 	 	 	
11.1.2	 	General Liability*	 	USD$10,000,000 bodily injury, death and property damage combined single limit per occurrence and in the aggregate	

*(including Products Liability)
 
In addition, Cardinal Health shall procure and maintain Errors and Omissions Liability insurance, in the amount of USD$10,000,000 per occurrence and in the aggregate, at its own expense and for its own benefit, from an insurance carrier(s) having a minimum AM Best rating of A-VII.
 
11.2                            In lieu of insurance, either party may self-insure any or a portion of the above required insurance.  In the event that any of the required policies of insurance are written on a claim made basis, then such policies shall be maintained during the entire Term of this Agreement and for a period of not less than three (3) years following the termination or expiration of this Agreement.
 
11.3                            Upon request, no more often than on an annual basis, either party shall furnish the other a certificate(s) from the insurance carrier(s) (having a minimum AM Best rating of A-VII) showing the coverages set forth above.  The insurance may be cancelled or altered only after thirty (30) days written notice is given to the other party.
 
6

 
12.                                Representations and Warranties
 
12.1                            Cardinal Health represents, warrants and covenants that:
 
12.1.1                   it will carry out the Services in accordance with the Protocols all applicable Laws including without limitation applicable current Good Laboratory Practices and current Good Manufacturing Practices;
 
12.1.2                    there is no pending or threatened litigation, arbitration, mediation or governmental, administrative or regulatory audit, investigation or proceeding involving Cardinal Health which arises out of or relates to compliance with applicable Laws or the conduct of the Services;
 
12.1.3                    it is and shall continue to be trained and experienced in accordance with cGLP and ICH/GCP and the Laws and shall it provide the Services in a diligent and workmanlike manner;
 
12.1.4                    the Services shall be performed with requisite care, skill and diligence, in accordance with industry standards by individuals who are appropriately trained, experienced and qualified; and
 
12.1.5                    it is responsible for the professional quality and technical accuracy of the Services to be performed hereunder.
 
12.2                            Acorda represents, warrants and covenants that:
 
12.2.1                   it will perform all of its obligations under this Agreement and will use the results of all Services and the Data in accordance with all applicable Laws;
 
12.2.2                   there are no specific safe handling instructions that are applicable to any materials provided by Acorda, except as disclosed to Cardinal Health in writing by Acorda in sufficient time for review and training by Cardinal Health prior to such delivery.
 
12.3                            Each party represents, warrants and covenants to the other that:
 
12.3.1                   it (i) is duly organized, validly existing and in good standing under the laws of the state in which it is organized, (ii) has the power and authority and the legal right to own and operate its property and assets, and to carry on its business as it is now being conducted, and (iii) is in compliance with all requirements of applicable law, except to the extent that any noncompliance would not materially adversely affect such party’s ability to perform its obligations under the Agreement;
 
12.3.2                   it (i) has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder and thereunder and (ii) has taken all necessary action on its part to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder.  The Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal,
 
7

 
valid, binding obligation, enforceable against such party in accordance with its terms;
 
12.3.3                   all necessary consents, approvals and authorizations of all agencies and other persons required to be obtained by such party in connection with the Agreement have been obtained;
 
12.3.4                   the execution and delivery of this Agreement and the performance of such party’s obligations hereunder (i) do not conflict with or violate any requirement of applicable laws or regulations or any material contractual obligation of such party and (ii) do not materially conflict with, or constitute a material default or require any consent under, any material contractual obligation of such party.
 
12.4                            THE LIMITED WARRANTIES SET FORTH IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCUDING ANY WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
 
13.                                Indemnity
 
13.1                            Cardinal Health shall be liable for and shall indemnify and hold Acorda, its affiliates, officers, directors, employees, and agents (each, an “Acorda Indemnitee”) against any loss, claim, proceedings or prosecution (whether such arises under Statute or Common Law) and including reasonable attorneys fees and other reasonable costs of defense) (collectively, “Losses”) in connection with any and all actions, suits, claims or demands that may be brought or instituted against any Acorda Indemnitee by any third party to the extent based on or arising out of or resulting from any (a) breach by Cardinal Health of its representations, warranties and covenants hereunder, or (b) any negligent act or omission or willful misconduct of Cardinal Health.
 
13.2                            Acorda shall indemnify, defend and hold harmless Cardinal Health, its affiliates, officers, directors, employees and agents (each a “Cardinal Health Indemnitee”) from and against any and all Losses in connection with any and all actions, suits, claims or demands that may be brought or instituted against any Cardinal Health Indemnitee by any third party to the extent based on or arising out of or resulting from (a) any breach by Acorda of its representations, warranties and covenants hereunder, (b) any negligent act or omission or willful misconduct of Acorda, or (c) the manufacture, sale, promotion, distribution or use of any Product which is the subject of the Services.
 
14.                                  Limitations of Liability.
 
14.1                            NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF PERFORMANCE UNDER THIS AGREEMENT.
 
8

 
14.2                            IN NO EVENT SHALL MAGELLAN’S LIABILITY FOR ANY LOST, DAMAGED OR DESTROYED PRODUCT PROVIDED BY ACORDA TO MAGELLAN UNDER THIS AGREEMENT EXCEED $15,000.
 
14.3                            IN THE EVENT OF A MATERIAL ERROR BY MAGELLAN IN PERORMING ANY SERVICES UNDER THIS AGREEMENT WHICH RENDERS SUCH SERVICES OR THE RESULTS OF SUCH SERVICES UNACCEPTABLE EITHER TO ACORDA OR ANY REGULATORY AGENCY, ACORDA’S SOLE REMEDY SHALL BE TO EITHER (A) REQUEST MAGELLAN TO REPEAT THE SERVICES AT MAGELLAN’S COST, OR (B) TERMINATE THIS AGREEMENT IN ACCORDANCE WITH SECTION 9.1 AND/OR OBTAIN A REFUND OF ALL AMOUNTS PAID TO MAGELLAN FOR THE DEFECTIVE SERVICES.
 
15.                                Miscellaneous
 
15.1                            Survival .  The obligations of the parties contained in Sections 2.1, 4, 5, 6, 8, 10, 11 12, 13, 14 and 15, shall survive the termination of this Agreement.
 
15.2.                         Entire Agreement; Amendments .  This Agreement, together with the Exhibits, contains the entire understanding of the parties with respect to the subject matter herein, and supersedes all previous agreements (oral and written), negotiations and discussions, other than any currently effective confidentiality or non-disclosure agreement between the parties or their affiliates regarding the subject matter herein. The parties may modify or amend the provisions hereof only by an instrument in writing duly executed by the parties.
 
15.3                            Remedies .  Cardinal Health acknowledges that Acorda will have no adequate remedy at law if Cardinal Health violates the terms of Section 4 hereof.  Accordingly, in such event, Acorda shall have the right, in addition to any other rights it may have at law or equity, to obtain in any tribunal of competent jurisdiction injunctive relief to restrain any breach or threatened breach of this Agreement.  If, due to reasons within Cardinal Health’s reasonable control, Cardinal Health’s Services fail to meet the warranty set forth in Section 12.1, Acorda shall have the right to: (a) terminate this Agreement in accordance with Section 9; or (b) require that defective Services be replaced, as the case may be, without charge to Acorda; or (c) request a refund for the Services in accordance with the terms of this Agreement.
 
15.4                            Binding Agreements and Assignment.   This Agreement shall be binding upon and inure to the benefit of Acorda and Cardinal Health and their respective successors and permitted assigns. Cardinal Health may not delegate its obligation to perform the Services under this Agreement, assign or otherwise transfer this Agreement without the prior written consent of Acorda.  Acorda may assign this Agreement to its Affiliates.  Cardinal Health may not appoint any sub-contractors to provide the Services under this Agreement unless it has the prior written consent of Acorda.
 
15.5                            Publicity.  Neither party will make any press release or other public disclosure regarding
 
9

 
this Agreement or the transactions contemplated hereby without the other party’s express prior written consent, except as required under applicable law or by any governmental agency, in which case the party required to make the press release or public disclosure shall use commercially reasonable efforts to obtain the approval of the other party as to the form, nature and extent of the press release or public disclosure prior to issuing the press release or making the public disclosure.
 
15.6                            Waiver .  No waiver by either party of any breach of any provision of this Agreement shall constitute a waiver of any other or subsequent breach.
 
15.7                            Governing Law.   This Agreement shall be governed by and construed in accordance with the laws of New York.
 
IN WITNESS WHEREOF , this Agreement has been executed by the parties hereto through their duly authorized officers effective as of the date first set forth above.

Acorda Therapeutics, Inc.	Cardinal Health PTS, Inc.	

By:	 	 	By:	 	
 	 	
Name:	 	 	Name:	 	
 	 	
Title:	 	 	Title:	 	
 	 	
Date:	 	 	Date:	 	
 
10

 
EXHIBIT A
 
QUOTES SUBJECT TO THIS AGREEMENT

Quote ID	 	Title	
 	 	 	
QTE-ELR-0009	 	IRF / NDA and Phase III
Clinical Program
(Fampridine)	
 	 	 	
QTE-ELR-0012	 	Method Familiarization	
 	 	 	
QTE-ELR-0013	 	Method Transfer	
 	 	 	
QTE-ELR-0014	 	Robustness Study	
 	 	 	
QTE-ELR-0015	 	Hours for Additional Data
in Reports	
 	 	 	
QTE-ELR-0016	 	Fampridine Coloured
Stability Programme for
API Supplier I	
 	 	 	
QTE-ELR-0017	 	Fampridine Coloured
Stability Programme for
API Supplier II	
 	 	 	
QTE-ELR-0018	 	Induction Seal Investigation	
 
The parties recognize that the Quotes identified in this Exhibit were previously approved and executed by Cardinal Health and Elan Corporation, plc.  The parties agree that all of the quotes listed above and all services provided pursuant to such quotes are subject to the terms and conditions of this Agreement.
 
11

 
Exhibit B
 
CONFIDENTIALITY AGREEMENT

1.4                                  This Agreement shall become effective upon the date of the last party to sign (the “ Effective Date ”) and shall expire two (2) years from such date.  Notwithstanding expiration or termination of the Agreement the parties shall maintain in confidence Information obtained from the other under this Agreement for five (5) years after the Effective Date.
 
2.                                        Each party agrees to treat Information disclosed to it by the other with the same degree of care as it does in protecting its own confidential information, and Information shall be disclosed within the recipient company only on a need-to-know basis.  For this purpose, Affiliates, employees, agents and consultants of the recipient company bound by obligations of secrecy no less strict than those set out herein shall not be regarded as third parties.  Furthermore, each party agrees not to undertake any analysis of samples or materials embodying such Information or permit any third party analysis thereof without the prior written consent of the other party.
 
3.1.                               The restrictions and obligations of non-disclosure and non-use shall not apply to Information which:
 
3.1.1.                      is in the public domain at the time of disclosure by the disclosing party hereunder or which later enters the public domain through no fault of the receiving party; or
 
3.1.2.                      is in the possession of the receiving party at the time of disclosure; or
 
3.1.3.                      becomes available to the receiving party from a third party who is under no obligation to the disclosing party; or
 
3.1.4.                      is proven by documentary evidence to have been independently discovered by the receiving party without the aid, application or use of Information; or
 
3.1.5.                      is required by law to be disclosed.  In such event, the receiving party shall notify the disclosing party of the required disclosure in advance to enable the disclosing party to have an opportunity to object to such governmental entity or court of law regarding the required disclosure.  The receiving party shall use all reasonable efforts to obtain confidential treatment of such Information required to be disclosed.
 
3.2.                               Information shall not be deemed to be in the public domain merely because it may be derived from one or more items publicly known.
 
12

 
4.                                        The receiving party undertakes that any further confidential information which may come to the knowledge of the receiving party as a result of any visits, inclusive of the form, materials and design of the various elements of any relevant plant and equipment which may be seen at such establishments as well as the plant as a whole, the methods of operation thereof and the various applications thereof, shall be kept strictly confidential, and shall be deemed to be Information which is protected by the terms of this Agreement.
 
5.                                        The disclosing party may provide the receiving party with samples of products, technologies or formulations (hereinafter referred to as “ Samples ”) for the purpose of this Agreement.  The receiving party undertakes that it shall not:
 
5.1                                  use the Samples other than for the purpose of performing the Evaluation;
 
5.2                                  make any Samples available to any third party;
 
5.3                                  allow access to the Samples by any of its employees except those who are directly involved in the discussions;
 
5.4                                  make any commercial use of the Samples or any composition made using the Samples; and
 
5.5                                  analyse or otherwise attempt to determine the composition, construction or formulation of the Samples.
 
Upon request, the receiving party shall return all Samples to the disclosing party.
 
6.                                        All written, printed, or other tangible documents, materials and Information submitted by one party to the other hereunder, and all copies thereof, shall be returned to the disclosing party upon request except that the receiving party may retain one (1) copy of Information (with the exception of any samples) solely for ensuring compliance with the terms contained therein.
 
7.                                        None of the parties makes any representation or warranty as to the accuracy or completeness of Information or as to any sample, material, item, or document embodying Information.
 
8.                                        This Agreement constitutes the entire agreement and understanding between the parties hereto relating to the subject matter hereof.  No modification, amendment, or waiver of any provision of this Agreement shall be valid unless in writing and signed by a duly authorised officer or representative of each of the parties hereto.
 
3
 
13

 
9.                                        Each party shall be an independent contractor in its performance of this Agreement and shall not be deemed, expressly or by implication, to be an agent, employee, representative, or servant of the other party for any purpose whatsoever.  Neither party shall have the power to control the manner in which the other party performs its obligations under this Agreement but shall look to it only for the results achieved.
 
10.                                  Nothing in this Agreement shall be understood as granting, expressly or by implication, any rights to either party under the patents, technical information, proprietary information or know-how of the other except to the extent expressly set forth herein, or as giving rise to any obligation on the part of the parties hereto to supply or purchase any materials, compositions, or products.  Termination of this Agreement for any reason shall not relieve either party of the obligations set forth in this Agreement.
 
11.                                  None of the parties shall disclose the existence of this Agreement, the subject matter hereof, or the fact that discussions are taking place, nor originate any publicity, news release or other public announcement, written or oral, in relation thereto, without the prior written consent of the other party.
 
12.                                  This Agreement shall be governed by the laws of New York and both parties submit to the exclusive jurisdiction of the New York courts.
 
AGREED TO AND ACCEPTED:

ELAN CORPORATION, PLC	CARDINAL HEALTH PTS, INC.	
 	 	
BY:	/s/ LIAM DANIEL	 	BY:	/s/ Bruce W. Boucher	
 	 	
NAME:	LIAM DANIEL	 	NAME:	Bruce W. Boucher	
 	 	
TITLE:	COMPANY SECRETARY	 	TITLE:	Sr. Vice President & Chief Financial Officer	
 	 	
DATE:	November 22, 2002.	 	DATE:	 	

ACORDA THERAPEUTICS, INC	 	
 	 	
BY:	/s/ Mitchell Katz	 	 	
 	 	
NAME:	Mitchell Katz	 	 	
 	 	
TITLE:	Vice President	 	 	
 	 	
DATE:	11\26\02	 	 	

 
4
 
14

 
Exhibit 21.1
 
MS Research and Development Corp.

 
 
Exhibit 23.1

 
 
Independent Auditors’ Consent
When the transaction referred to in note 13 (i) of the notes to the consolidated financial statements has been consummated, we will be in a position to render the following consent.
 
                                                                                                                KPMG LLP
 
The Board of Directors
Acorda Theratutics, Inc:
We consent to the use of our report included herein and to the references to our firm under the headings “Experts” and “Selected Consolidated Financial and Operating Data” in the prospectus.

 
Short Hills, New Jersery