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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
 	 	 	
þ	 	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934	
For the quarterly period ended September 30, 2010
OR
 	 	 	
o	 	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934	
For the transition period from     to     
Commission file number: 001-34263
Impax Laboratories, Inc.
 
(Exact name of registrant as specified in its charter)

Delaware	 	65-0403311	
 	 	 	
(State or other jurisdiction of	 	(I.R.S. Employer Identification No.)	
incorporation or organization)	 	 	
 	 	 	
30831 Huntwood Avenue, Hayward, CA	 	94544	
 	 	 	
(Address of principal executive offices)	 	(Zip Code)	
(510) 476-2000
 
( Registrant’s telephone number, including area code )
Not Applicable
 
( Former name, former address and former fiscal year, if changed since last report )
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  þ  No  o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes  o  No  o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer  o	Accelerated filer  þ  	Non-accelerated filer  o
(Do not check if a smaller reporting company)	Smaller reporting company  o	
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes  o  No  þ
As of November 1, 2010, there were 64,242,134 shares of the registrant’s common stock outstanding.

 

 

Impax Laboratories, Inc.
INDEX

PART I: FINANCIAL INFORMATION	
 	 	 	 	 	
Item 1: Financial Statements	 	 	 	 	
 	 	 	 	 	
- Consolidated Balance Sheets as of September 30, 2010 (unaudited) and December 31, 2009	 	 	3	 	
 	 	 	 	 	
- Consolidated Statements of Operations for each of the three and nine months ended September 30, 2010 and 2009 (unaudited)	 	 	4	 	
 	 	 	 	 	
- Consolidated Statements of Cash Flows for each of the nine months ended September 30, 2010 and 2009 (unaudited)	 	 	5	 	
 	 	 	 	 	
- Notes to Consolidated Financial Statements (unaudited)	 	 	7	 	
 	 	 	 	 	
Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations	 	 	44	 	
 	 	 	 	 	
Item 3: Quantitative and Qualitative Disclosures About Market Risk	 	 	74	 	
 	 	 	 	 	
Item 4: Controls and Procedures	 	 	74	 	
 	 	 	 	 	
PART II: OTHER INFORMATION	
 	 	 	 	 	
Item 1: Legal Proceedings	 	 	75	 	
 	 	 	 	 	
Item 1A: Risk Factors	 	 	78	 	
 	 	 	 	 	
Item 2: Unregistered Sales of Equity Securities and Use of Proceeds	 	 	79	 	
 	 	 	 	 	
Item 3: Defaults Upon Senior Securities	 	 	80	 	
 	 	 	 	 	
Item 4: (Removed and Reserved)	 	 	80	 	
 	 	 	 	 	
Item 5: Other Information	 	 	80	 	
 	 	 	 	 	
Item 6: Exhibits	 	 	81	 	
 	 	 	 	 	
SIGNATURES	 	 	82	 	
 	 	 	 	 	
EXHIBIT INDEX	 	 	83	 	
 	 	 	 	 	
  Exhibit 10.2	
  Exhibit 31.1	
  Exhibit 31.2	
  Exhibit 32.1	
  Exhibit 32.2	
 
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PART I: FINANCIAL INFORMATION
ITEM 1: FINANCIAL STATEMENTS
Impax Laboratories, Inc.
 CONSOLIDATED BALANCE SHEETS
 (in thousands, except share and per share data)
 	 	 	 	 	 	 	 	 	
 	 	September 30,	 	 	December 31,	 	
 	 	2010	 	 	2009	 	
 	 	(unaudited)	 	 	 	 	
ASSETS	 	 	 	 	 	 	 	 	
Current assets:	 	 	 	 	 	 	 	 	
Cash and cash equivalents	 	$	165,772	 	 	$	31,770	 	
Short-term investments	 	 	192,579	 	 	 	58,599	 	
Accounts receivable, net	 	 	95,567	 	 	 	185,854	 	
Inventory, net	 	 	42,036	 	 	 	49,130	 	
Current portion of deferred product manufacturing costs-alliance agreements	 	 	3,006	 	 	 	11,624	 	
Current portion of deferred income taxes	 	 	37,114	 	 	 	32,286	 	
Prepaid expenses and other current assets	 	 	2,958	 	 	 	4,748	 	
 	 	 	 	 	 	 	
Total current assets	 	 	539,032	 	 	 	374,011	 	

Property, plant and equipment, net	 	 	103,066	 	 	 	101,650	 	
Deferred product manufacturing costs-alliance agreements	 	 	8,231	 	 	 	96,619	 	
Deferred income taxes, net	 	 	1,396	 	 	 	48,544	 	
Other assets	 	 	25,587	 	 	 	12,358	 	
Goodwill	 	 	27,574	 	 	 	27,574	 	
 	 	 	 	 	 	 	
Total assets	 	$	704,886	 	 	$	660,756	 	

LIABILITIES AND STOCKHOLDERS’ EQUITY	 	 	 	 	 	 	 	 	
Current liabilities	 	 	 	 	 	 	 	 	
Accounts payable	 	$	19,156	 	 	$	23,295	 	
Accrued expenses	 	 	82,083	 	 	 	62,055	 	
Accrued income taxes payable	 	 	32,942	 	 	 	31,627	 	
Accrued profit sharing and royalty expenses	 	 	15,235	 	 	 	53,695	 	
Current portion of deferred revenue-alliance agreements	 	 	19,438	 	 	 	33,196	 	
 	 	 	 	 	 	 	
Total current liabilities	 	 	168,854	 	 	 	203,868	 	

Deferred revenue-alliance agreements	 	 	36,773	 	 	 	224,522	 	
Other liabilities	 	 	13,645	 	 	 	10,139	 	
 	 	 	 	 	 	 	
Total liabilities	 	$	219,272	 	 	$	438,529	 	

Commitments and contingencies (Note 8)	 	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	 	
Stockholders’ equity:	 	 	 	 	 	 	 	 	
Preferred Stock, $0.01 par value, 2,000,000 shares authorized, 0 shares outstanding at September 30, 2010 and December 31, 2009	 	$	—	 	 	$	—	 	
Common stock, $0.01 par value, 90,000,000 shares authorized and 63,800,776 and 62,210,089 shares issued at September 30, 2010 and December 31, 2009, respectively	 	 	638	 	 	 	622	 	
Additional paid-in capital	 	 	247,764	 	 	 	223,239	 	
Treasury stock — 243,729 shares	 	 	(2,157	)	 	 	(2,157	)	
Accumulated other comprehensive income (loss)	 	 	366	 	 	 	(524	)	
Retained earnings	 	 	238,824	 	 	 	828	 	
 	 	 	 	 	 	 	
 	 	 	485,435	 	 	 	222,008	 	
Noncontrolling interest	 	 	179	 	 	 	219	 	
 	 	 	 	 	 	 	
Total stockholders’ equity	 	 	485,614	 	 	 	222,227	 	
 	 	 	 	 	 	 	
Total liabilities and stockholders’ equity	 	$	704,886	 	 	$	660,756	 	
 	 	 	 	 	 	 	
The accompanying notes are an integral part of these interim consolidated financial statements.
 
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Impax Laboratories, Inc.
 CONSOLIDATED STATEMENTS OF OPERATIONS
 (dollars in thousands, except share and per share data)
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Three Months Ended	 	 	Nine Months Ended	 	
 	 	September 30,	 	 	September 30,	 	 	September 30,	 	 	September 30,	 	
 	 	2010	 	 	2009	 	 	2010	 	 	2009	 	
 	 	(unaudited)	 	 	(unaudited)	 	 	(unaudited)	 	 	(unaudited)	 	
Revenues:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Global Product sales, net	 	$	91,051	 	 	$	46,636	 	 	$	537,794	 	 	$	123,144	 	
Private Label Product sales	 	 	528	 	 	 	1,752	 	 	 	1,539	 	 	 	5,269	 	
Rx Partner	 	 	202,800	 	 	 	8,328	 	 	 	213,504	 	 	 	30,183	 	
OTC Partner	 	 	2,365	 	 	 	1,769	 	 	 	6,439	 	 	 	5,255	 	
Research Partner	 	 	3,714	 	 	 	2,962	 	 	 	10,593	 	 	 	8,406	 	
Promotional Partner	 	 	3,535	 	 	 	3,499	 	 	 	10,538	 	 	 	10,077	 	
Other	 	 	—	 	 	 	—	 	 	 	—	 	 	 	11	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Total revenues	 	 	303,993	 	 	 	64,946	 	 	 	780,407	 	 	 	182,275	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Cost of revenues	 	 	143,122	 	 	 	28,055	 	 	 	291,589	 	 	 	81,589	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Gross profit	 	 	160,871	 	 	 	36,891	 	 	 	488,818	 	 	 	100,686	 	

Operating expenses:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Research and development	 	 	23,846	 	 	 	15,243	 	 	 	63,264	 	 	 	46,744	 	
Patent litigation	 	 	1,033	 	 	 	1,647	 	 	 	4,786	 	 	 	4,058	 	
Litigation settlement	 	 	—	 	 	 	818	 	 	 	—	 	 	 	1,674	 	
Selling, general and administrative	 	 	12,632	 	 	 	9,020	 	 	 	37,136	 	 	 	29,926	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Total operating expenses	 	 	37,511	 	 	 	26,728	 	 	 	105,186	 	 	 	82,402	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Income from operations	 	 	123,360	 	 	 	10,163	 	 	 	383,632	 	 	 	18,284	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Other (expense) income, net	 	 	(91	)	 	 	(6	)	 	 	(134	)	 	 	52	 	
Interest income	 	 	405	 	 	 	180	 	 	 	680	 	 	 	636	 	
Interest expense	 	 	(38	)	 	 	(185	)	 	 	(108	)	 	 	(735	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Income before income taxes	 	 	123,636	 	 	 	10,152	 	 	 	384,070	 	 	 	18,237	 	
Provision for income taxes	 	 	48,501	 	 	 	3,495	 	 	 	146,114	 	 	 	6,373	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Net income before noncontrolling interest	 	 	75,135	 	 	 	6,657	 	 	 	237,956	 	 	 	11,864	 	
Add back loss attributable to noncontrolling interest	 	 	28	 	 	 	28	 	 	 	40	 	 	 	53	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Net income	 	$	75,163	 	 	$	6,685	 	 	$	237,996	 	 	$	11,917	 	

Net Income per share:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Basic	 	$	1.20	 	 	$	0.11	 	 	$	3.85	 	 	$	0.20	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Diluted	 	$	1.15	 	 	$	0.11	 	 	$	3.65	 	 	$	0.20	 	

Weighted average common shares outstanding:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Basic	 	 	62,435,116	 	 	 	60,559,064	 	 	 	61,778,465	 	 	 	60,130,608	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Diluted	 	 	65,470,341	 	 	 	61,247,700	 	 	 	65,171,055	 	 	 	60,667,227	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
The accompanying notes are an integral part of these unaudited interim consolidated financial statements.
 
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Impax Laboratories, Inc.
 CONSOLIDATED STATEMENTS OF CASH FLOWS
 (dollars in thousands)
 	 	 	 	 	 	 	 	 	
 	 	Nine Months Ended	 	
 	 	September 30,	 	 	September 30,	 	
 	 	2010	 	 	2009	 	
 	 	(unaudited)	 	 	(unaudited)	 	
 	 	 	 	 	 	 	 	 	
Cash flows from operating activities:	 	 	 	 	 	 	 	 	
Net income	 	$	237,996	 	 	$	11,917	 	
Adjustments to reconcile net income to net cash provided by (used in) operating activities:	 	 	 	 	 	 	 	 	
Depreciation	 	 	9,066	 	 	 	7,806	 	
Amortization of 3.5% Debentures discount and deferred financing costs	 	 	—	 	 	 	301	 	
Amortization of Credit Agreement deferred financing costs	 	 	25	 	 	 	50	 	
Accretion of interest income on short-term investments	 	 	(374	)	 	 	(424	)	
Deferred income taxes (benefit)	 	 	46,657	 	 	 	(9,430	)	
Provision for uncertain tax positions	 	 	35	 	 	 	695	 	
Tax benefit related to the exercise of employee stock options	 	 	(4,337	)	 	 	—	 	
Deferred revenue-Alliance Agreements	 	 	22,947	 	 	 	36,388	 	
Deferred product manufacturing costs-Alliance Agreements	 	 	(9,739	)	 	 	(20,853	)	
Recognition of deferred revenue-Alliance Agreements	 	 	(224,454	)	 	 	(43,844	)	
Amortization of deferred product manufacturing costs-Alliance Agreements	 	 	106,746	 	 	 	29,750	 	
Accrued profit sharing and royalty expense	 	 	86,985	 	 	 	523	 	
Payments of profit sharing and royalty expense	 	 	(125,445	)	 	 	(455	)	
Payments of exclusivity period fees	 	 	—	 	 	 	(6,000	)	
Payments of accrued litigation settlements	 	 	(5,865	)	 	 	(8,037	)	
Share-based compensation expense	 	 	7,706	 	 	 	5,179	 	
Bad debt expense	 	 	215	 	 	 	131	 	
Changes in certain assets and liabilities:	 	 	 	 	 	 	 	 	
Accounts receivable	 	 	90,072	 	 	 	(18,368	)	
Inventory	 	 	7,094	 	 	 	(6,606	)	
Prepaid expenses and other assets	 	 	(11,225	)	 	 	1,346	 	
Accounts payable, accrued expenses and income taxes payable	 	 	22,349	 	 	 	14,824	 	
Other liabilities	 	 	3,431	 	 	 	2,740	 	
 	 	 	 	 	 	 	
Net cash provided by (used in) operating activities	 	$	259,885	 	 	$	(2,367	)	

Cash flows from investing activities:	 	 	 	 	 	 	 	 	
Purchase of short-term investments	 	 	(306,784	)	 	 	(49,563	)	
Maturities of short-term investments	 	 	173,178	 	 	 	47,748	 	
Purchases of property, plant and equipment	 	 	(10,541	)	 	 	(8,405	)	
 	 	 	 	 	 	 	
Net cash (used in) investing activities	 	$	(144,147	)	 	$	(10,220	)	

Cash flows from financing activities:	 	 	 	 	 	 	 	 	
Repayment of long-term debt	 	 	—	 	 	 	(12,887	)	
Tax benefit related to the exercise of employee stock options	 	 	4,337	 	 	 	—	 	
Proceeds from exercise of stock options and ESPP	 	 	13,927	 	 	 	3,776	 	
 	 	 	 	 	 	 	
Net cash provided by (used in) financing activities	 	$	18,264	 	 	$	(9,111	)	

Net increase (decrease) in cash and cash equivalents	 	$	134,002	 	 	$	(21,698	)	
Cash and cash equivalents, beginning of period	 	$	31,770	 	 	$	69,275	 	
 	 	 	 	 	 	 	
Cash and cash equivalents, end of period	 	$	165,772	 	 	$	47,577	 	

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Supplemental disclosure of non-cash investing and financing activities:
 	 	 	 	 	 	 	 	 	
 	 	Nine Months Ended	 	
 	 	September 30,	 	 	September 30,	 	
 	 	2010	 	 	2009	 	
(in $000s)	 	 	 	 	 	 	 	 	
Cash paid for interest	 	$	108	 	 	$	597	 	
 	 	 	 	 	 	 	
Cash paid for income taxes	 	$	98,201	 	 	$	187	 	
 	 	 	 	 	 	 	
Accrued vendor invoices of approximately $4,022,000 and $1,391,000 at September 30, 2010 and September 30, 2009, respectively, are excluded from the purchase of property, plant, and equipment and the change in accounts payable and accrued expenses.
The accompanying notes are an integral part of these unaudited interim consolidated financial statements.
 
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NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
1. BASIS OF PRESENTATION
The accompanying unaudited interim consolidated financial statements of Impax Laboratories, Inc. (“Impax” or the “Company”), have been prepared based upon United States Securities and Exchange Commission (“SEC”) rules permitting reduced disclosure for interim periods, and include all adjustments necessary for a fair presentation of statements of operations, statements of cash flows, and financial condition for the interim periods shown, including normal recurring accruals and other items. While certain information and disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) have been condensed or omitted pursuant to SEC rules and regulations, the Company believes the disclosures are adequate to make the information presented not misleading.
The unaudited interim consolidated financial statements of the Company include the accounts of the operating parent company, Impax Laboratories, Inc., its wholly-owned subsidiary, Impax Laboratories (Taiwan) Inc., and an equity investment in Prohealth Biotech, Inc. (“Prohealth”), in which the Company held a 58.11% majority ownership interest at September 30, 2010. All significant intercompany accounts and transactions have been eliminated.
The unaudited results of operations and cash flows for the interim period are not necessarily indicative of the results of the Company’s operations for any other interim period or for the full year ending December 31, 2010.
The unaudited interim consolidated financial statements and footnotes should be read in conjunction with the consolidated financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2009 as filed with the SEC, wherein a more complete discussion of significant accounting policies and certain other information can be found.
The preparation of financial statements in conformity with GAAP requires the use of estimates and assumptions, based on complex judgments considered reasonable, and affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The most significant judgments are employed in estimates used in determining values of tangible and intangible assets, legal contingencies, tax assets and tax liabilities, fair value of share-based compensation of equity incentive awards issued to employees and directors, and estimates used in applying the Company’s revenue recognition policy including those related to accrued chargebacks, rebates, product returns, Medicare, Medicaid, and other government rebate programs, shelf-stock adjustments, and the timing and amount of deferred and recognized revenue and deferred and amortized manufacturing costs under the Company’s several alliance and collaboration agreements. Actual results may differ from estimated results. Certain prior year amounts have been reclassified to conform to the current year presentation.
In the normal course of business, the Company is subject to loss contingencies, such as legal proceedings and claims arising out of its business, covering a wide range of matters, including, among others, patent litigation, and product and clinical trial liability. In accordance with Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) Topic 450, “Contingencies”, the Company records accrued loss contingencies when it is probable a liability has been incurred and the amount of loss can be reasonably estimated. The Company, in accordance with FASB ASC Topic 450, does not recognize gain contingencies until realized.
 
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2. REVENUE RECOGNITION
The Company recognizes revenue when the earnings process is complete, which under SEC Staff Accounting Bulletin No. 104, Topic No. 13, “Revenue Recognition” (“SAB 104”), is when revenue is realized or realizable and earned, and, additionally: there is persuasive evidence a revenue arrangement exists; delivery of goods or services has occurred; the sales price is fixed or determinable, and collectibility is reasonably assured.
The Company accounts for revenue arrangements with multiple deliverables in accordance with FASB ASC Topic 605, revenue recognition for arrangements with multiple elements, which addresses the determination of whether an arrangement involving multiple deliverables contains more than one unit of accounting. A delivered item within an arrangement is considered a separate unit of accounting only if both of the following criteria are met, including: the delivered item has value to the customer on a stand alone basis; and, if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially in the control of the vendor. Under FASB ASC Topic 605, if the fair value of any undelivered element cannot be objectively or reliably determined, then separate accounting for the individual deliverables is not appropriate. Revenue recognition for arrangements with multiple deliverables constituting a single unit of accounting is recognizable generally over the greater of the term of the arrangement or the expected period of performance, either on a straight-line basis or on a proportional performance method.
Global Product sales, net :
The “Global Product sales, net” line item of the statement of operations, includes revenue recognized related to shipments of pharmaceutical products to the Company’s customers, primarily drug wholesalers and retail chains. Gross sales revenue is recognized at the time title and risk of loss passes to the customer — generally when product is received by the customer. Included in Global Product revenue are deductions from the gross sales price, including deductions related to estimates for chargebacks, rebates, returns, shelf-stock, and other pricing adjustments. The Company records an estimate for these deductions in the same period when revenue is recognized. A summary of each of these deductions is as follows:
Chargebacks — The Company’s chargeback is the difference between the Company’s invoice price to a wholesaler and the final price paid by the wholesaler. The final price paid by the wholesaler can be lower than the Company’s invoice price based upon the customer to whom the wholesaler sells the Company’s products. The chargeback generally takes the form of a credit against the invoiced gross sales amount charged to the wholesaler. A provision for chargeback deductions is estimated and recorded in the same period the revenue is recognized based upon the terms of the various chargeback arrangements in effect at the time of product shipment. The Company monitors actual chargebacks granted and compares them to the estimated provision for chargebacks to assess the reasonableness of the chargebacks reserve at each balance sheet date on a quarterly basis.
Rebates — The Company maintains various rebate programs with its Global products customers. The rebate programs are integral to the Company’s effort to maintain a competitive position in its marketplace, as well as to promote greater product sales along with customer loyalty. The rebates generally take the form of a credit against the invoiced gross sales amount charged to a customer for products shipped. A provision for rebate deductions is estimated and recorded in the same period when revenue is recognized based upon the terms of the various rebate programs in effect at the time of product shipment. The Company monitors actual rebates granted and compares them to the estimated provision for rebates to assess the reasonableness of the rebates reserve at each balance sheet date on a quarterly basis.
 
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2. REVENUE RECOGNITION (continued)
Returns — The Company allows its customers to return product (i) if approved by authorized personnel in writing or by telephone with the lot number and expiration date accompanying any request and (ii) if such products are returned within six months prior to or until twelve months following, the products’ expiration date. The Company estimates a provision for product returns as a percentage of gross sales based upon historical experience of Global product sales. The sales return reserve is estimated using a historical lag period — which is the time between when the product is sold and when it is ultimately returned, as determined from the Company’s system generated lag period report — and return rates, adjusted by estimates of the future return rates based on various assumptions, which may include changes to internal policies and procedures, changes in business practices, and commercial terms with customers, competitive position of each product, amount of inventory in the wholesaler supply chain, the introduction of new products, and changes in market sales information. The Company considers other factors when estimating its current period returns provision, including significant market changes which may impact future expected returns, and actual product returns. The Company monitors actual returns on a quarterly basis and may record specific provisions for returns it believes are not covered by historical percentages.
Medicaid Rebate — As required by law, the Company provides a rebate on drugs dispensed under the Medicaid program. The Company determines its estimated Medicaid rebate accrual primarily based on historical experience of claims submitted by the various states and any new information regarding changes in the Medicaid program which may impact the Company’s estimate of Medicaid rebates. In determining the appropriate accrual amount, the Company considers historical payment rates and processing lag for outstanding claims and payments. The Medicaid rebate accrual for the nine months ended September 30, 2010 includes the effect of the increase in the Medicaid rebate rates, which were effective on a retroactive basis to January 1, 2010, resulting from the March 2010 enactment into law of the Patient Protection and Affordable Care Act and the Health Care and Education Affordability Reconciliation Act (the “Acts”). The change in the Medicaid rebate rates resulting from the Acts did not have a material impact on the Company’s results of operations. The Company records estimates for Medicaid rebates as a deduction from gross sales, with corresponding adjustments to accrued liabilities.
Shelf-Stock Adjustment — The Company will occasionally reduce the selling price of certain products. The Company may issue a credit against the sales amount to customers based upon their remaining inventory of the product in question, provided the customer continues to make future purchases of product from the Company. This type of customer credit is referred to as a shelf-stock adjustment, which is the difference between the sales price and the revised lower sales price, multiplied by an estimate of the number of product units on hand at a given date. Decreases in selling prices are discretionary decisions made by the Company in response to market conditions, including estimated launch dates of competing products and estimated declines in market price.
Cash Discounts — The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for paying within invoice terms, which generally range from 30 to 90 days. An estimate of cash discounts is recorded in the same period when revenue is recognized.
 
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2. REVENUE RECOGNITION (continued)
Private Label Product sales:
The “Private Label Product sales” line item of the statement of operations includes revenue recognized related to shipments of generic pharmaceutical products to customers who sell the product to third parties under their own label (i.e. these products are not sold under the Company’s label). Sales revenue is recognized at the time title and risk of loss passes to the customer — generally when product is received by the customer. Revenue received from Private Label Product sales is not subject to deductions for chargebacks, rebates, product returns, and other pricing adjustments. Additionally, Private Label Product sales do not have upfront, milestone, or lump-sum payments and do not contain multiple deliverables under FASB ASC Topic 605.
Rx Partner and OTC Partner:
The “Rx Partner” and “OTC Partner” line items of the statement of operations include revenue recognized under alliance agreements between the Company and other unrelated third-party pharmaceutical companies. The Company has entered into these alliance agreements to develop marketing and /or distribution relationships with its partners to fully leverage its technology platform.
The Rx Partners and OTC Partners alliance agreements obligate the Company to deliver multiple goods and/or services over extended periods. Such deliverables include manufactured pharmaceutical products, exclusive and semi-exclusive marketing rights, distribution licenses, and research and development services, among others. In exchange for these deliverables, the Company receives payments from its alliance agreement partners for product shipments, and may also receive royalty, profit sharing, and/or upfront or periodic milestone payments. Revenue received from the alliance agreement partners for product shipments under these agreements is not subject to deductions for chargebacks, rebates, product returns, and other pricing adjustments. Royalty and profit sharing amounts the Company receives under these agreements are calculated by the respective alliance agreement partner, with such royalty and profit share amounts generally based upon estimates of net product sales or gross profit which include estimates of deductions for chargebacks, rebates, product returns, and other adjustments the alliance agreement partners may negotiate with their customers. The Company records the alliance agreement partner’s adjustments to such estimated amounts in the period the alliance agreement partner reports the amounts to the Company.
The Company applied the updated guidance of ASC 605-25 “Multiple Element Arrangements” to the Strategic Alliance Agreement with Teva (“Teva Agreement”) during the three months ended September 30, 2010 — see Note 11 Alliance and Collaboration Agreements for a detailed discussion of the application of the updated guidance to the Teva Agreement. Rx Partner revenue is related to the Teva Agreement. All consideration received under the Teva Agreement is contingent, and therefore can not be allocated to the deliverables. The Company looks to the underlying delivery of goods and /or services which give rise to the payment of consideration under the Teva Agreement to determine the appropriate revenue recognition. Consideration received as a result of research and development-related activities performed under the Teva Agreement are initially deferred and recorded as a liability captioned “Deferred revenue-alliance agreements”. The Company recognizes the deferred revenue on a straight-line basis over the Company’s expected period of performance of such services. Consideration received as a result of the manufacture and delivery of products under the Teva Agreement is recognized at the time title and risk of loss passes to the customer — generally when product is received by Teva. The Company recognizes profit share as current period revenue when earned.
 
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OTC Partner revenue is related to the Company’s alliance agreements with Merck (formerly Shering-Plough) and Pfizer (formerly Wyeth) with respect to supply of over-the-counter pharmaceutical products and related research and development services. The Company initially defers all revenue earned under its OTC Partners alliance agreements. The deferred revenue is recorded as a liability captioned “Deferred revenue — alliance agreements.” The Company also defers its direct product manufacturing costs to the extent such costs are reimbursable by the OTC Partners. These deferred product manufacturing costs are recorded as an asset captioned “Deferred product manufacturing costs — alliance agreements.” The product manufacturing costs in excess of amounts reimbursable by the OTC Partners are recognized as current period cost of revenue. The Company recognizes revenue as OTC Partner revenue and amortizes deferred product manufacturing costs as cost of revenues — as the Company fulfills its contractual obligations. Revenue is recognized and associated costs are amortized over the respective alliance agreements’ term of the arrangement or the Company’s expected period of performance, using a modified proportional performance method. Under the modified proportional performance method of revenue recognition utilized by the Company, the amount recognized in the period of initial recognition is based upon the number of years elapsed under the respective alliance agreement relative to the estimated total length of the recognition period. Under this method, the amount of revenue recognized in the year of initial recognition is determined by multiplying the total amount realized by a fraction, the numerator of which is the then current year of the alliance agreement and the denominator of which is the total estimated life of the alliance agreement. The amount recognized during each remaining year is an equal pro rata amount. Finally, cumulative revenue recognized is limited to the extent of cash collected and /or the fair value received. The result of the Company’s modified proportional performance method is a greater portion of the revenue is recognized in the initial period with the remaining balance being recognized ratably over either the remaining life of the arrangement or the Company’s expected period of performance of each respective alliance agreement.
Research Partner :
The “Research Partner” line item of the statement of operations includes revenue recognized under development agreements with other unrelated third-party pharmaceutical companies. The development agreements generally obligate the Company to provide research and development services over multiple periods. In exchange for this service, the Company received upfront payments upon signing of each development agreement and is eligible to receive contingent milestone payments, based upon the achievement of contractually specified events. Additionally, the Company may also receive royalty payments from the sale, if any, of a successfully developed and commercialized product under one of these development agreements. Revenue received from the provision of research and development services, including the upfront payment and the contingent milestone payments, if any, will be deferred and recognized on a straight line basis over the expected period of performance of the research and development services. Royalty fee income, if any, will be recognized by the Company as current period revenue when earned. The Company determined these agreements do not include multiple deliverables under FASB ASC Topic 605.
Promotional Partner:
The “Promotional Partner” line item of the statement of operations includes revenue recognized under promotional services agreements with other unrelated third-party pharmaceutical companies. The promotional services agreements obligate the Company to provide physician detailing sales calls to promote its partners’ branded drug products over multiple periods. In exchange for this service, the Company has received fixed fees generally based on either the number of sales force representatives utilized in providing the services, or the number of sales calls made (up to contractual maximum amounts). The Company recognizes revenue from providing physician detailing services as those services are provided and as performance obligations are met and contingent payments, if any, at the time when they are earned. The Company determined these agreements do not include multiple deliverables under FASB ASC Topic 605.
Shipping and Handling Fees and Costs
Shipping and handling fees related to sales transactions are recorded as selling expense
 
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3. RECENT ACCOUNTING PRONOUNCEMENTS
In September 2009, the FASB approved an update to the accounting standard related to multiple-element revenue arrangements currently within the scope of FASB ASC Topic 605-25. The updated ASC 605-25 provides principles and guidance to be used to determine whether a revenue arrangement has multiple deliverables, and if so, how those deliverables should be separated. If multiple deliverables exist, the updated standard requires revenue received under the arrangement to be allocated using the estimated selling price of the deliverables if vendor-specific objective evidence or third-party evidence of selling price is not available. The updated accounting standard is effective for revenue arrangements entered into or materially modified in fiscal years beginning on, or after June 15, 2010, with early application permitted. The Company adopted the updated guidance of ASC 605-25 in the three months ended September 30, 2010. As required, the Company applied the updated guidance of ASC 605-25 retrospectively from the beginning of the Company’s fiscal year of adoption as of January 1, 2010. Accordingly, the updated guidance of ASC 605-25 will apply to all multiple-element revenue arrangements entered into or materially modified from January 1, 2010 forward. The application of the updated guidance did not have any impact on the Company’s revenue recognition during the three and six months ended June 30, 2010. The updated guidance of ASC 605-25 was applied to the Teva Agreement during the three months ended September 30, 2010. For a discussion of the impact of FASB ASC Topic 605-25 on the Teva Agreement, see “Part I: Financial Information — Item 1. Financial Statements — Footnote 11, Alliance and Collaboration Agreements — Strategic Alliance Agreement with Teva.”
In January 2010, the FASB issued Accounting Standards Update No. 2010-02, Consolidation (Topic 810): Accounting and Reporting for Decreases in Ownership of a Subsidiary — a Scope Clarification. This update provides amendments to Subtopic 810-10, and related guidance within US GAAP, to clarify the scope of the decrease in ownership provisions. For those entities that have already adopted Statement 160, the amendments are effective at the beginning of the first interim or annual reporting period ending on or after December 15, 2009. The amendments should be applied retrospectively to the first period that an entity adopted Statement 160. Upon becoming effective this update did not have an impact on the Company’s consolidated financial statements.
In March 2010, the FASB issued Accounting Standards Update No. 2010-17, Revenue Recognition-Milestone Method of Revenue Recognition (Topic 605), which addresses accounting for arrangements in which a vendor satisfies its performance obligations over time, with all or a portion of the consideration contingent on future events, referred to as “milestones.” The Milestone Method of Revenue Recognition is limited to arrangements which involve research or development activities. A milestone is defined as an event for which, at the date the arrangement is entered into, there is substantive uncertainty whether the event will be achieved, and the achievement of the event is based in whole or in part on either the vendor’s performance or a specific outcome resulting from the vendor’s performance. In addition, the achievement of the event would result in additional payments being due to the vendor. The Milestone Method of Revenue Recognition allows a vendor to adopt an accounting policy to recognize arrangement consideration that is contingent on the achievement of a substantive milestone in its entirety in the period the milestone is achieved. The Milestone Method of Revenue Recognition is effective on a prospective basis, with an option for retrospective application for milestones achieved in fiscal years and interim periods within those fiscal years beginning on or after June 15, 2010. Early adoption is permitted. If an entity elects early application in a period that is not the first reporting period of its fiscal year, then the guidance must be applied retrospectively from the beginning of that fiscal year. The Company will determine the impact of the new accounting standard as it achieves milestones, and earns payments under either new or existing revenue arrangements.
 
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4. INVESTMENTS
Investments consist of commercial paper, corporate bonds, and medium-term notes, government enterprise obligations, and /or certificates of deposit. The Company’s policy is to invest in only high quality “AAA-rated” or investment-grade securities. Investments in debt securities are accounted for as ‘held-to-maturity’ and are recorded at amortized cost, which approximates fair value, based upon observable market values. The Company has historically held all investments in debt securities until maturity, and has the ability and intent to continue to do so. All of the Company’s investments have remaining contractual maturities of less than 12 months and are classified as short-term. Upon maturity the Company uses a specific identification method.
A summary of short-term investments as of September 30, 2010 and December 31, 2009 follows:
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	 	 	 	 	Gross	 	 	Gross	 	 	 	 	
(in $000’s)	 	Amortized	 	 	Unrecognized	 	 	Unrecognized	 	 	Fair	 	
September 30, 2010	 	Cost	 	 	Gains	 	 	Losses	 	 	Value	 	
Commercial paper	 	$	106,656	 	 	$	47	 	 	$	(8	)	 	$	106,695	 	
Government sponsored enterprise obligations	 	 	75,994	 	 	 	75	 	 	 	—	 	 	 	76,069	 	
Corporate bonds	 	 	9,688	 	 	 	12	 	 	 	—	 	 	 	9,700	 	
Certificates of deposit	 	 	241	 	 	 	—	 	 	 	—	 	 	 	241	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Total short-term investments	 	$	192,579	 	 	$	134	 	 	$	(8	)	 	$	192,705	 	

 	 	 	 	 	 	Gross	 	 	Gross	 	 	 	 	
(in $000’s)	 	Amortized	 	 	Unrecognized	 	 	Unrecognized	 	 	Fair	 	
December 31, 2009	 	Cost	 	 	Gains	 	 	Losses	 	 	Value	 	
Commercial paper	 	$	13,387	 	 	$	4	 	 	$	(1	)	 	$	13,390	 	
Government sponsored enterprise obligations	 	 	41,953	 	 	 	32	 	 	 	(1	)	 	 	41,984	 	
Corporate bonds	 	 	3,021	 	 	 	1	 	 	 	(1	)	 	 	3,021	 	
Certificates of deposit	 	 	238	 	 	 	—	 	 	 	—	 	 	 	238	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Total short-term investments	 	$	58,599	 	 	$	37	 	 	$	(3	)	 	$	58,633	 	

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5. ACCOUNTS RECEIVABLE
The composition of accounts receivable, net is as follows:
 	 	 	 	 	 	 	 	 	
 	 	September 30,	 	 	December 31,	 	
(in $000’s)	 	2010	 	 	2009	 	
Gross accounts receivable	 	$	138,128	 	 	$	254,094	 	
Less: Chargeback reserve	 	 	(17,298	)	 	 	(21,448	)	
Less: Rebate reserve	 	 	(16,993	)	 	 	(37,781	)	
Less: Other deductions	 	 	(8,270	)	 	 	(9,011	)	
 	 	 	 	 	 	 	
Accounts receivable, net	 	$	95,567	 	 	$	185,854	 	
 	 	 	 	 	 	 	
A roll forward of the chargeback and rebate reserves activity for the nine months ended September 30, 2010 and the year ended December 31, 2009 is as follows:
 	 	 	 	 	 	 	 	 	
(in $000’s)	 	September 30,	 	 	December 31,	 	
Chargeback reserve	 	2010	 	 	2009	 	
 	 	 	 	 	 	 	 	 	
Beginning balance	 	$	21,448	 	 	$	4,056	 	
Provision recorded during the period	 	 	141,653	 	 	 	126,105	 	
Credits issued during the period	 	 	(145,803	)	 	 	(108,713	)	
 	 	 	 	 	 	 	
Ending balance	 	$	17,298	 	 	$	21,448	 	

(in $000’s)	 	September 30,	 	 	December 31,	 	
Rebate reserve	 	2010	 	 	2009	 	
 	 	 	 	 	 	 	 	 	
Beginning balance	 	$	37,781	 	 	$	4,800	 	
Provision recorded during the period	 	 	73,397	 	 	 	72,620	 	
Credits issued during the period	 	 	(94,185	)	 	 	(39,639	)	
 	 	 	 	 	 	 	
Ending balance	 	$	16,993	 	 	$	37,781	 	
 	 	 	 	 	 	 	
Other deductions include allowance for uncollectible amounts and cash discounts. The Company maintains an allowance for uncollectible amounts for estimated losses resulting from amounts deemed to be uncollectible from its customers, with such allowances for specific amounts on certain accounts. The Company recorded an allowance for uncollectible amounts of $566,000 and $372,000 at September 30, 2010 and December 31, 2009, respectively.
 
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6. INVENTORY
Inventory, net at September 30, 2010 and December 31, 2009 consisted of the following:
 	 	 	 	 	 	 	 	 	
 	 	September 30,	 	 	December 31,	 	
(in $000’s)	 	2010	 	 	2009	 	
Raw materials	 	$	30,789	 	 	$	30,758	 	
Work in process	 	 	3,064	 	 	 	2,768	 	
Finished goods	 	 	15,828	 	 	 	17,051	 	
 	 	 	 	 	 	 	
Total inventory, net	 	$	49,680	 	 	$	50,577	 	
 	 	 	 	 	 	 	 	 	
Less: Non-current inventory, net	 	 	(7,644	)	 	 	(1,447	)	
 	 	 	 	 	 	 	
Total inventory-current, net	 	$	42,036	 	 	$	49,130	 	
 	 	 	 	 	 	 	
The balance of inventory carrying value reserves were $5,274,000 and $4,646,000 at September 30, 2010 and December 31, 2009, respectively.
To the extent inventory is not scheduled to be utilized in the manufacturing process and/or sold within twelve months of the balance sheet date, it is included as a component of other non-current assets. Amounts classified as non-current inventory consist of raw materials, net of valuation reserves. Raw materials generally have a shelf life of approximately three to five years, while finished goods generally have a shelf life of approximately two years.
When the Company concludes United States Food and Drug Administration (“FDA”) approval is expected within approximately six months, the Company will generally begin to schedule manufacturing process validation studies as required by FDA to demonstrate the production process can be scaled up to manufacture commercial batches. Consistent with industry practice, the Company may build quantities of pre-launch inventories of certain products pending required final FDA approval and/or resolution of patent infringement litigation, when, in the Company’s assessment, such action is appropriate to increase the commercial opportunity, FDA approval is expected in the near term, and/or the litigation will be resolved in the Company’s favor.
The Company recognizes pre-launch inventories at the lower of its cost or the expected net selling price. Cost is determined using a standard cost method, which approximates actual cost, and assumes a FIFO flow of goods. Costs of unapproved products are the same as approved products and include materials, labor, quality control, and production overhead. The carrying value of unapproved inventory, less reserves, was approximately $1,958,000 and $8,702,000 at September 30, 2010 and December 31, 2009, respectively.
The capitalization of unapproved pre-launch inventory involves risks, including, among other items, FDA approval of product may not occur; approvals may require additional or different testing and/or specifications than used for unapproved inventory, and, in cases where the unapproved inventory is for a product subject to litigation, the litigation may not be resolved or settled in favor of the Company. If any of these risks were to materialize and the launch of the unapproved product delayed or prevented, then the net carrying value of unapproved inventory may be partially or fully reserved. Generally, the selling price of a generic pharmaceutical product is at discount from the corresponding brand product selling price. Typically, a generic drug is easily substituted for the corresponding brand product, and once a generic product is approved, the pre-launch inventory is typically sold within the next three months. If the market prices become lower than the product inventory carrying costs, then the pre-launch inventory value is reduced to such lower market value. If the inventory produced exceeds the estimated market acceptance of the generic product and becomes short-dated, a carrying value reserve will be recorded. In all cases, the carrying value of the Company’s pre-launch product inventory is lower than the respective estimated net selling prices.
 
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7. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment, net consisted of the following:
 	 	 	 	 	 	 	 	 	
 	 	September 30,	 	 	December 31,	 	
(in $000’s)	 	2010	 	 	2009	 	
Land	 	$	2,270	 	 	$	2,270	 	
Buildings and improvements	 	 	81,093	 	 	 	77,778	 	
Equipment	 	 	65,938	 	 	 	59,612	 	
Office furniture and equipment	 	 	8,118	 	 	 	7,425	 	
Construction-in-progress	 	 	4,867	 	 	 	4,880	 	
 	 	 	 	 	 	 	
Property, plant and equipment, gross	 	$	162,286	 	 	$	151,965	 	
 	 	 	 	 	 	 	 	 	
Less: Accumulated depreciation	 	 	(59,220	)	 	 	(50,315	)	
 	 	 	 	 	 	 	
Property, plant and equipment, net	 	$	103,066	 	 	$	101,650	 	
 	 	 	 	 	 	 	
Depreciation expense was $2,998,000 and $2,614,000 for the three months ended September 30, 2010 and 2009, respectively, and $9,066,000 and $7,806,000 for the nine months ended September 30, 2010 and 2009, respectively.
 
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8. ACCRUED EXPENSES
The following table sets forth the Company’s accrued expenses:
 	 	 	 	 	 	 	 	 	
 	 	September 30	 	 	December 31	 	
(in $000’s)	 	2010	 	 	2009	 	
Payroll-related expenses	 	$	15,235	 	 	$	15,274	 	
Product returns	 	 	39,478	 	 	 	22,114	 	
Shelf stock adjustments	 	 	614	 	 	 	225	 	
Medicaid rebates	 	 	14,913	 	 	 	9,759	 	
Physician detailing sales force fees	 	 	2,330	 	 	 	2,449	 	
Legal and professional fees	 	 	4,651	 	 	 	3,660	 	
Litigation settlements	 	 	—	 	 	 	5,865	 	
Other	 	 	4,862	 	 	 	2,709	 	
 	 	 	 	 	 	 	
Total accrued expenses	 	$	82,083	 	 	$	62,055	 	
 	 	 	 	 	 	 	
Accrued Litigation Settlement Expenses
In January 2010, the Company entered into an agreement to settle a suit related to the Company’s Lipram UL products. Under the terms of this agreement, the Company agreed to reimburse the plaintiff for litigation costs, which was paid by the Company in January 2010. The Company recorded an accrued expense for this payment in the year ended December 31, 2009, along with corresponding incurred legal and professional fees, as litigation settlement expense in the consolidated statement of operations.
On January 28, 2009, the Company entered into an agreement settling the securities class actions pending in the United States District Court for the Northern District of California. Under the terms of the settlement, plaintiffs agreed to dismiss the actions with prejudice, and defendants, including the Company, without admitting the allegations or any liability, agreed to pay the plaintiff class $9.0 million, of which the Company paid approximately $3.4 million in January 2009, with the balance paid by the Company’s directors and officers liability insurance carriers. The Company recorded an accrued expense for its portion of the settlement payment, in the year ended December 31, 2008.
Taiwan Facility Construction
The Company has constructed a facility in Jhunan Taiwan, R.O.C., currently utilized for manufacturing, research and development, warehouse, and administrative space. In conjunction with the construction of this facility, as of September 30, 2010, the Company entered into several contracts aggregating approximately $16,653,000, of which approximately $1,144,000 of remaining obligations are included in the other line in the table above. The Company cumulatively capitalized interest expense of $596,000 in conjunction with the construction of the Taiwan facility.
 
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8. ACCRUED EXPENSES (continued)
Product Returns
The Company maintains a product return policy to allow customers to return product within specified guidelines. At the time of sale, the Company estimates a provision for product returns based upon historical experience for sales made through its Global Products sales channel. Sales of product under the Private Label, the Rx Partner, and the OTC Partners alliance agreements generally are not subject to returns. A roll forward of the product return reserve for the nine months ended September 30, 2010 and the year ended December 31, 2009, is as follows:
 	 	 	 	 	 	 	 	 	
	 	September 30,	 	 	December 31,	 	
Product Return Reserve	 	2010	 	 	2009	 	
(in $000’s)	 		 	 		 	
Beginning balance	 	$	22,114	 	 	$	13,675	 	
Provision related to sales recorded in the period	 	 	20,340	 	 	 	11,847	 	
Credits issued during the period	 	 	(2,976	)	 	 	(3,408	)	
 	 	 	 	 	 	 	
Ending balance	 	$	39,478	 	 	$	22,114	 	
 	 	 	 	 	 	 	
Purchase Order Commitments
As of September 30, 2010, the Company had approximately $23,387,000 of open purchase order commitments, primarily for raw materials. The terms of these purchase order commitments are less than one year in duration.
 
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9. INCOME TAXES
The Company calculates its interim income tax provision in accordance with FASB ASC Topics 270 and 740. At the end of each interim period, the Company makes an estimate of the annual expected effective tax rate and applies the estimated effective rate to its ordinary year-to-date taxable earnings or loss. In addition, the effect of changes in enacted tax laws, rates, or tax status is recognized in the interim period in which such change occurs.
The computation of the annual estimated effective tax rate at each interim period requires certain estimates and assumptions including, but not limited to, the expected operating income for the year, projections of the proportion of income (or loss) earned and taxed in United States, and the various state and local tax jurisdictions, as well as tax jurisdictions outside the United States, along with permanent and temporary differences, and the likelihood of recovering deferred tax assets generated in the current year. The accounting estimates used to compute the provision for income taxes may change as new events occur, more experience is acquired or additional information is obtained. The computation of the annual estimated effective tax rate includes modifications, which were projected for the year, for share-based compensation, the domestic manufacturing deduction, and state research and development credits, among others.
During the nine months ended September 30, 2010, the Company recorded a tax provision of $146,114,000 for United States domestic income taxes and for foreign income taxes. The nine months ended September 30, 2010 tax provision also included an accrual for uncertain tax positions of $35,000. In the nine months ended September 30, 2009, the Company recorded a tax provision of $6,373,000 for United States domestic income taxes and for foreign income taxes. The nine months ended September 30, 2009 tax provision also included an accrual for uncertain tax positions of $676,000. The increase in the tax provision was driven by higher income before taxes in the nine months ended September 30, 2010. The tax provision for the nine months ended September 30, 2010 does not include the effect of the federal research and development tax credit which expired on December 31, 2009, and as of the September 30, 2010 balance sheet date, has not been reinstated. The tax provision for the nine months ended September 30, 2009 included the effect of the federal research and development tax credit.
 
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10. REVOLVING LINE OF CREDIT
The Company has a $35,000,000 revolving credit facility under a credit agreement with Wells Fargo Bank, N.A. (“Credit Agreement”), with a January 31, 2011 expiration date, effective with a sixth amendment to the Credit Agreement executed in September 2010. The revolving credit facility, intended for working capital and general corporate purposes, is collateralized by eligible accounts receivable, inventory, and machinery and equipment, subject to limitations and other terms. There were no amounts outstanding under the revolving credit facility as of September 30, 2010 and December 31, 2009, respectively.
The interest rate for the revolving credit facility is set at either the prime rate plus a margin ranging from 0.25% to 0.75% or LIBOR plus a margin ranging from 2.25% to 3.0% based upon certain terms and conditions. The Company is required to pay an unused line fee of 50 basis points per annum and a servicing fee of $1,500 during any month in which no revolver loans are outstanding. During the nine months ended September 30, 2010 and 2009, the Company paid unused line fees of $133,000 and $128,000, respectively.
The Credit Agreement contains various financial covenants, the most significant of which include a “fixed charge coverage ratio” and a capital expenditure limitation. The fixed charge coverage ratio, applicable only for periods during which the Company’s net cash position is less than $50.0 million, requires EBITDA less cash paid for taxes, dividends, and certain capital expenditures, to be not less than 1.25 to 1.00 as compared to scheduled principal payments coming due in the next 12 months plus cash interest paid during the applicable period. The Company is limited to capital expenditures of no more than $25.0 million for each calendar year. The Credit Agreement also provides for certain information reporting covenants, including a requirement to provide certain periodic financial information. At September 30, 2010, the Company was in compliance with the various financial and information reporting covenants contained in the Credit Agreement.
 
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11. ALLIANCE AND COLLABORATION AGREEMENTS
License and Distribution Agreement with Shire
In January 2006, the Company entered into a License and Distribution Agreement with an affiliate of Shire Laboratories, Inc. (“Shire License and Distribution Agreement”), under which the Company received a non-exclusive license to market and sell an authorized generic of Shire’s Adderall XR® product (“AG Product”) subject to certain conditions, but in any event by no later than January 1, 2010. The Company commenced sales of the AG Product in October 2009. Under the terms of the Shire License and Distribution Agreement, Shire is responsible for manufacturing the AG Product, and the Company is responsible for marketing and sales of the AG Product. The Company is required to pay a profit share to Shire on sales of the AG Product, of which the Company accrued a profit share payable to Shire of $86,755,000 and $0 on sales of the AG Product during the nine months ended September 30, 2010 and 2009, respectively, with a corresponding charge included in the cost of revenues line on the consolidated statement of operations.
 
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11. ALLIANCE AND COLLABORATION AGREEMENTS (continued)
Strategic Alliance Agreement with Teva
The Company entered into a Strategic Alliance Agreement with Teva in June 2001 (“Teva Agreement”). The Teva Agreement commits the Company to develop and manufacture, and Teva to distribute, ten (10) specified controlled release generic pharmaceutical products (“generic products”), each for a 10-year period. The Company identified the following deliverables under the Teva Agreement: (i) the manufacture and delivery of generic products; (ii) the provision of research and development activities (including regulatory services) related to each product; and (iii) market exclusivity associated with the products.
In July 2010, the Teva Agreement was amended to terminate the provisions of the Teva Agreement with respect to the Omeprazole 10mg, 20mg and 40mg products. Additionally, the Company agreed to pay to Teva a profit share on future sales of the fexofenadine HCI/psuedoephedrine product, if any, but in no event will such profit share payments exceed an aggregate amount of $3,000,000.
As the July 2010 amendment materially modified the Teva Agreement, the Company elected to apply the updated guidance of FASB ASC 605-25 Multiple Element Arrangements (“ASC 605-25”) to the amended Teva Agreement beginning in the three months ended September 30, 2010.
There are two criteria under the updated guidance of ASC 605-25 for determining if deliverables shall be considered separate units of accounting, including: (i) the deliverable has value to the customer on a standalone basis, and (ii) if the arrangement has a general right of return relative to delivered items, delivery or performance of the undelivered items is considered probable and substantially in the control of the vendor. The Company evaluated the deliverables of the amended Teva Agreement under ASC 605-25 and determined there are two units of accounting, including: a combined unit consisting of research and development activities plus market exclusivity, and the manufacture and delivery of 10 products (i.e. contract manufacturing). The market exclusivity deliverable does not meet the first criteria for separation as it does not have standalone value to Teva. As the products contemplated by the Teva Agreement were to be developed by the Company, the market exclusivity has no value to Teva without the research and development services needed to complete the products. The contract manufacturing deliverable has standalone value to Teva as it is able to resell the delivered items (i.e. finished product) to third-parties.
The consideration received by the Company from Teva under the Teva Agreement is contingent upon future performance, as such the Company was unable to allocate any of the consideration received to delivered items, and therefore the Company looked to the underlying services which gave rise to the payment of consideration by Teva to determine the appropriate recognition of revenue as follows:

 	•	 	Research and development related activities (the Combined Unit) — Consideration received as a result of research and development related activities performed under the Teva Agreement will be deferred and recognized on the straight-line method over the Company’s expected period of performance of the research and development related services, which is estimated to be from July 2001 (following the June 2001 commencement of the Teva Agreement) to October 2014 (with FDA approval of the ANDA for the final product under the Teva Agreement).	
 		
 	•	 	Manufacture and delivery of 10 products — Consideration received as a result of the manufacture and delivery of 10 products under the Teva Agreement will be recognized under the Company’s revenue recognition policy, as proscribed by SAB 104, as follows:	

 	•	 	Product shipments — The Company will account for the shipment of products under the Teva Agreement as current period revenue in accordance with its revenue recognition policy applicable to its Global products.	
 		
 	•	 	Profit share — The Company will recognize profit share, if any, as current period revenue when earned.	

 	•	 	Gain on the repurchase of Company stock — This represents additional profit share revenue resulting from the successful December 2006 commercial sale of a Tier 2 or Tier 3 product, and was recognized as revenue in the period earned.	
 
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The Company applied the updated guidance of ASC 605-25 to the Teva Agreement on a prospective basis beginning in the quarter ended September 30, 2010. In the three months and nine months ended September 30, 2010, the application of the updated guidance of ASC 605-25 had the effect of increasing Rx Partner revenue by $196,440,000, and increasing cost of revenues by $95,426,000, and correspondingly, basic earnings per share increased by approximately $0.98 and $1.01 for the three and nine months ended September 30, 2010, respectively. The increase in Rx Partner revenue as a result of applying the updated guidance of ASC 605-25 in the three months ended September 30, 2010, represents the recognition of previously deferred revenue which would otherwise have been recognized, under the previous accounting standards, over the remaining life of the Teva Agreement, using a modified proportional performance method. Under the previous accounting standards, in the three and nine months ended September 30, 2010, Rx Partner revenue would have been $5,922,000 and $16,627,000, respectively, cost of revenues would have been $47,998,000 and $196,466,000, respectively, and basic earnings per share would have been $0.21 and $2.85, respectively.
The Company previously determined, under the previous accounting standards, no single deliverable represented a separate unit of accounting as there was not sufficient objective and reliable evidence of the fair value of any single deliverable. As such, under the previous accounting standards, the Company was required to account for the entirety of the Teva Agreement as a single unit of accounting, resulting in the Company previously deferring revenue earned and product manufacturing costs incurred under the Teva Agreement and then recognizing such deferred revenue and amortizing such deferred manufacturing costs over the estimated life of the Teva Agreement utilizing a modified proportional performance method.
 
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The following tables show the additions to and deductions from the deferred revenue and deferred product manufacturing costs under the Teva Agreement:
 	 	 	 	 	 	 	 	 	
 	 	Nine Months	 	 	 	 	
 	 	Ended	 	 	Inception	 	
(in $000’s)	 	September 30,	 	 	Through	 	
Deferred revenue	 	2010	 	 	Dec 31, 2009	 	
Beginning balance	 	$	202,032	 	 	$	—	 	
Additions:	 	 	 	 	 	 	 	 	
Product-related and cost sharing	 	 	10,084	 	 	 	417,269	 	
Exclusivity charges	 	 	—	 	 	 	(50,600	)	
All other	 	 	—	 	 	 	12,527	 	
 	 	 	 	 	 	 	
Total additions	 	$	10,084	 	 	$	379,196	 	

Less:	 	 	 	 	 	 	 	 	
Amount recognized	 	 	(10,978	)	 	 	(177,164	)	
Accounting adjustment	 	 	(196,440	)	 	 	—	 	
 	 	 	 	 	 	 	
Total deferred revenue	 	$	4,698	 	 	$	202,032	 	

 	 	Nine Months	 	 	 	 	
(in $000’s)	 	Ended	 	 	Inception	 	
Deferred product	 	September 30,	 	 	Through	 	
manufacturing costs	 	2010	 	 	Dec 31, 2009	 	
Beginning balance	 	$	94,040	 	 	$	—	 	
Additions	 	 	7,416	 	 	 	175,565	 	
 	 	 	 	 	 	 	 	 	
Less:	 	 	 	 	 	 	 	 	
Amount recognized	 	 	(6,030	)	 	 	(81,525	)	
Accounting adjustment	 	 	(95,426	)	 	 	—	 	
 	 	 	 	 	 	 	
Total deferred product manufacturing costs	 	$	—	 	 	$	94,040	 	

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11. ALLIANCE AND COLLABORATION AGREEMENTS (continued)
OTC Partners Alliance Agreements
The following table shows the additions to and deductions from deferred revenue and deferred product manufacturing costs under the OTC Agreements:
 	 	 	 	 	 	 	 	 	
 	 	Nine Months	 	 	 	 	
 	 	Ended	 	 	Inception	 	
(in $000’s)	 	September 30	 	 	Through	 	
Deferred revenue	 	2010	 	 	Dec 31, 2009	 	
Beginning balance	 	$	16,162	 	 	$	—	 	
Additions:	 	 	 	 	 	 	 	 	
Upfront fees and milestone payments	 	 	—	 	 	 	8,436	 	
Cost-sharing and other	 	 	—	 	 	 	1,642	 	
Product-related deferrals	 	 	2,863	 	 	 	83,826	 	
 	 	 	 	 	 	 	
Total additions	 	$	2,863	 	 	$	93,904	 	

Less: amount recognized	 	 	(6,438	)	 	 	(77,742	)	
 	 	 	 	 	 	 	
Total deferred revenue	 	$	12,587	 	 	$	16,162	 	

 	 	Nine Months	 	 	 	 	
(in $000’s)	 	Ended	 	 	Inception	 	
Deferred product	 	September 30,	 	 	Through	 	
manufacturing costs	 	2010	 	 	Dec 31, 2009	 	
Beginning balance	 	$	14,203	 	 	$	—	 	
Additions	 	 	2,323	 	 	 	77,870	 	
Less: amount recognized	 	 	(5,289	)	 	 	(63,667	)	
 	 	 	 	 	 	 	
Total deferred product manufacturing costs	 	$	11,237	 	 	$	14,203	 	

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11. ALLIANCE AND COLLABORATION AGREEMENTS (continued)
Joint Development Agreement with Medicis Pharmaceutical Corporation
The Joint Development Agreement provides for the Company and Medicis to collaborate in the development of a total of five dermatology products, including four of the Company’s generic products and one branded advanced form of Medicis’s SOLODYN® product. Under the provisions of The Joint Development Agreement the Company received a $40,000,000 upfront payment, paid by Medicis in December 2008. The Company has also received an aggregate $12,000,000 in milestone payments composed of two $5,000,000 milestone payments, paid by Medicis in March 2009 and September 2009, and a $2,000,000 milestone payment received in December 2009. The Company has the potential to receive up to an additional $11,000,000 of contingent milestone payments upon achievement of certain contractually specified clinical and regulatory milestones, as well as the potential to receive royalty payments from sales, if any, by Medicis of its advanced form SOLODYN® brand product. Finally, to the extent the Company commercializes any of its four generic dermatology products covered by the Joint Development Agreement, the Company will pay to Medicis a 50% gross profit share on sales, if any, of such products.
The following table shows the additions to and deductions from deferred revenue and deferred product manufacturing costs under the Joint Development Agreement with Medicis:
 	 	 	 	 	 	 	 	 	
 	 	Nine Months	 	 	 	 	
 	 	Ended	 	 	Inception	 	
(in $000’s)	 	September 30,	 	 	Through	 	
Deferred revenue	 	2010	 	 	Dec 31, 2009	 	
Beginning balance	 	$	39,487	 	 	$	—	 	
Additions:	 	 	 	 	 	 	 	 	
Upfront fees and milestone payments	 	 	—	 	 	 	52,000	 	
Product-related deferrals	 	 	—	 	 	 	—	 	
 	 	 	 	 	 	 	
Total additions	 	$	—	 	 	$	52,000	 	

Less: amount recognized	 	 	(10,153	)	 	 	(12,513	)	
 	 	 	 	 	 	 	
Total deferred revenue	 	$	29,334	 	 	$	39,487	 	

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11. ALLIANCE AND COLLABORATION AGREEMENTS (continued)
Development and Co-Promotion Agreement with Endo Pharmaceuticals Inc.
In June 2010, the Company and Endo Pharmaceuticals, Inc. (“Endo”) entered into a Development and Co-Promotion Agreement (“Endo Agreement”) under which the Company and Endo have agreed to collaborate in the development and commercialization of a next-generation advanced form of the Company’s lead branded product candidate (“Endo Agreement Product”). Under the provisions of the Endo Agreement, in June 2010, Endo paid to the Company a $10,000,000 up-front payment. The Company has the potential to receive up to an additional $30,000,000 of contingent payments upon achievement of certain specified clinical and regulatory milestones. Upon commercialization of the Endo Agreement Product in the United States, Endo will have the right to co-promote such product to non-neurologists, which will require the Company to pay Endo a co-promotion service fee of up to 100% of the gross profits attributable to prescriptions for the Endo Agreement Product which are written by the non-neurologists.
The $10,000,000 up-front payment is being recognized as revenue on a straight-line basis over a period of 91 months, which is the Company’s estimated expected period of performance of the Endo Agreement Product research and development activities, commencing with the June 2010 effective date of the Endo Agreement and ending in December 2017, the estimated date of FDA approval of the Company’s NDA. The FDA approval of the Endo Agreement Product NDA represents the end of the Company’s expected period of performance, as the Company will have no further contractual obligation to perform research and development activities under the Endo Agreement, and therefore the earnings process will be completed. Deferred revenue is recorded as a liability captioned “Deferred revenue-alliance agreement.” Revenue recognized under the Endo Agreement is reported on the consolidated statement of operations, in the line item captioned Research Partner. The Company determined the straight-line method aligns revenue recognition with performance as the level of research and development activities performed under the Endo Agreement are expected to be performed on a ratable basis over the Company’s estimated expected period of performance.
Upon FDA approval of the Company’s Endo Agreement Product NDA, the Company will have the right (but not the obligation) to begin manufacture and sale of such product. The Company will sell its manufactured branded product to customers in the ordinary course of business through its Impax Pharmaceuticals Division. The Company will account for the sale of the product covered by the Endo Agreement as current period revenue. The co-promotion service fee paid to Endo, as described above, if any, will be accounted for as a current period selling expense as incurred.
 
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11. ALLIANCE AND COLLABORATION AGREEMENTS (continued)
Co-Promotion Agreement with Pfizer
In March 2010, the Company and Pfizer, Inc. (“Pfizer”) entered into the First Amendment to the Co-Promotion Agreement (originally entered into with Wyeth, now a wholly owned subsidiary of Pfizer) (“Pfizer Co-Promotion Agreement”). Under the terms of the Pfizer Co-Promotion Agreement, effective April 1, 2010, the Company provides physician detailing sales call services for Pfizer’s Lyrica® product to neurologists. The Company receives a fixed fee, effective January 1, 2010, subject to annual cost adjustment, for providing such physician detailing sales calls within a contractually defined range of an aggregate number of physician detailing sales calls rendered, determined on a quarterly basis. There is no opportunity for the Company to earn incentive fees under the terms of the Pfizer Co-Promotion Agreement. Pfizer is responsible for providing sales training to the Company’s physician detailing sales force personnel. Pfizer owns the product and is responsible for all pricing and marketing literature as well as product manufacture and fulfillment. The Company recognizes the physician detailing sales force fee revenue as the related services are performed and the performance obligations are met. The Company recognized $3,535,000 and $3,499,000 in the three months ended September 30, 2010 and 2009, respectively, and $10,538,000 and $3,499,000 in the nine months ended September 30, 2010 and 2009, respectively, under the Pfizer Co-Promotion Agreement, with such amounts presented in the captioned line item “Promotional Partner” revenue on the consolidated statement of operations.
As noted above, the Company previously entered into a three year Co-Promotion Agreement with Wyeth, an unrelated third-party pharmaceutical company, prior to Wyeth becoming a wholly-owned subsidiary of Pfizer, under which the Company performed physician detailing sales calls for the Wyeth Pristiq® product to neurologists, with such services commencing on July 1, 2009, and ending in connection with the Pfizer Co-Promotion Agreement described above. Wyeth paid the Company a service fee, subject to an annual cost adjustment, for each physician detailing sales call. During the term of the (former Wyeth) Co-Promotion Agreement, the Company was required to complete a minimum and maximum number of physician detailing sales calls. Wyeth was responsible for providing sales training to the Company’s sales force. Wyeth owned the product and was responsible for all pricing and marketing literature as well as product manufacture and fulfillment. The Company recognized service fee revenue as the related physician detailing sales call services were performed and the performance obligations were met. The Company did not earn any incentive fee revenue under the terms of the (former Wyeth) Co-Promotion Agreement.
Promotional Services Agreement with Shire
In January 2006, the Company entered into a three year Promotional Services Agreement with an affiliate of Shire Laboratories, Inc. (“Shire Co-Promotion Agreement”), under which the Company was engaged to perform physician detailing sales calls services in support of Shire’s Carbatrol® product, from July 1, 2006 to June 30, 2009. The Company recognized $0 in sales force fee revenue in each of the three months ended September 30, 2010 and 2009, and $0 and $6,508,000 in sales force fee revenue for the nine months ended September 30, 2010 and 2009, respectively, under the (expired) Shire Co-Promotion Agreement, with such amounts presented in the captioned line item “Promotional Partner” under revenues on the consolidated statement of operations.
 
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12. SHARE-BASED COMPENSATION
The Company recognizes the fair value of each stock option and restricted share over its vesting period. Stock options and restricted stock awards are granted under the Company’s Amended and Restated 2002 Equity Incentive Plan (“2002 Plan”) and generally vest over a three or four year period and have a term of ten years.
Total share-based compensation expense recognized in the consolidated statement of operations was as follows:
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Three Months Ended:	 	 	Nine Months Ended:	 	
 	 	September 30,	 	 	September 30,	 	 	September 30,	 	 	September 30,	 	
(in $000’s)	 	2010	 	 	2009	 	 	2010	 	 	2009	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Manufacturing expenses	 	$	482	 	 	$	409	 	 	$	1,841	 	 	$	1,145	 	
Research and development	 	 	797	 	 	 	655	 	 	 	2,535	 	 	 	1,906	 	
Selling, general & administrative	 	 	1,194	 	 	 	922	 	 	 	3,330	 	 	 	2,128	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Total	 	$	2,473	 	 	$	1,986	 	 	$	7,706	 	 	$	5,179	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
The following table summarizes stock option activity:
 	 	 	 	 	 	 	 	 	
 	 	 	 	 	 	Weighted Average	 	
 	 	Number of Shares	 	 	Exercise Price	 	
 	 	Under Option	 	 	per Share	 	
Outstanding at December 31, 2009	 	 	8,229,818	 	 	$	9.87	 	
 	 	 	 	 	 	 	 	
Options granted	 	 	349,000	 	 	$	20.06	 	
Options exercised	 	 	(1,481,766	)	 	$	8.75	 	
Options forfeited	 	 	(122,342	)	 	$	9.55	 	
 	 	 	 	 	 	 	 	
Outstanding at September 30, 2010	 	 	6,974,710	 	 	$	10.63	 	
 	 	 	 	 	 	 	 	
Vested and expected to vest at September 30, 2010	 	 	6,918,474	 	 	$	10.64	 	
 	 	 	 	 	 	 	 	
Options exercisable at September 30, 2010	 	 	3,923,311	 	 	$	11.55	 	
 	 	 	 	 	 	 	 	
The Company estimated the fair value of each stock option award on the grant date using the Black-Scholes Merton option-pricing model, wherein: expected volatility is based solely on historical volatility of the Company’s common stock over the period commensurate with the expected term of the stock options. The expected term calculation is based on the “simplified” method described in SAB No. 107, Share-Based Payment and SAB No. 110, Share-Based Payment, as the Company has limited historical experience of option exercise activity. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for an instrument with a maturity that is commensurate with the expected term of the stock options. The dividend yield of zero is based on the fact that the Company has never paid cash dividends on its common stock, and has no present intention to pay cash dividends.
A summary of the Company’s non-vested restricted stock awards is presented below:
 	 	 	 	 	 	 	 	 	
 	 	 	 	 	 	Weighted Average	 	
Restricted	 	Number of Restricted	 	 	Grant-Date	 	
Stock Awards	 	Stock Awards	 	 	Fair Value	 	
Non-vested at December 31, 2009	 	 	1,152,923	 	 	$	7.72	 	
Granted	 	 	167,800	 	 	$	18.65	 	
Vested	 	 	(234,219	)	 	$	7.67	 	
Forfeited	 	 	(45,161	)	 	$	8.95	 	
 	 	 	 	 	 	 	 	
Non-vested at September 30, 2010	 	 	1,041,343	 	 	$	9.44	 	
 	 	 	 	 	 	 	 	
The Company grants restricted stock awards to certain eligible employees and directors as a component of its long-term incentive compensation program. The restricted stock award grants are made in accordance with the Company’s 2002 Plan, and typically specify the restricted stock awards underlying shares of common stock are not issued until they vest. The restricted stock awards generally vest ratably over a three or four year period from the date of grant.
 
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12. SHARE-BASED COMPENSATION (continued)
As of September 30, 2010, the Company had total unrecognized share-based compensation expense, net of estimated forfeitures, of $21,079,000 related to all of its share-based awards, which will be recognized over a weighted average period of 2.06 years. The intrinsic value of stock options exercised during the nine months ended September 30, 2010 and 2009 was $14,172,000 and $2,970,000, respectively. The total fair value of restricted stock awards which vested during the nine months ended September 30, 2010 and 2009 was $1,796,000 and $389,000, respectively. In May 2010, the Company’s stockholders approved an increase of 2,000,000 in the number of shares available for issuance of equity incentive awards including stock options, restricted stock awards and stock appreciation rights under the Company’s 2002 Plan. As of September 30, 2010, the Company had 3,114,817 shares of common stock available for issuance of stock options, restricted stock awards or stock appreciation rights.
 
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13. STOCKHOLDERS’ EQUITY
Preferred Stock
Pursuant to its certificate of incorporation, the Company is authorized to issue 2,000,000 shares, $0.01 par value per share, “blank check” preferred stock, which enables the Board of Directors, from time to time, to create one or more new series of preferred stock. Each series of preferred stock issued can have the rights, preferences, privileges and restrictions designated by the Board of Directors. The issuance of any new series of preferred stock could affect, among other things, the dividend, voting, and liquidation rights of the Company’s common stock. During the nine months ended September 30, 2010 and 2009, the Company did not issue any preferred stock.
Common Stock
The Company’s Certificate of Incorporation, as amended, authorizes the Company to issue 90,000,000 shares of common stock with $0.01 par value.
Shareholders Rights Plan
On January 20, 2009, the Board of Directors approved the adoption of a shareholder rights plan and declared a dividend of one preferred share purchase right for each outstanding share of common stock of the Company. Under certain circumstances, if a person or group acquires, or announces its intention to acquire, beneficial ownership of 20% or more of the Company’s outstanding common stock, each holder of such right (other than the third party triggering such exercise), would be able to purchase, upon exercise of the right at a $15 exercise price, subject to adjustment, the number of shares of the Company’s common stock having a market value of two times the exercise price of the right. Subject to certain exceptions, if the Company is consolidated with, or merged into, another entity and the Company is not the surviving entity in such transaction or shares of the Company’s outstanding common stock are exchanged for securities of any other person, cash or any other property, or more than 50% of the Company’s assets or earning power is sold or transferred, then each holder of the rights would be able to purchase, upon the exercise of the right at a $15 exercise price, subject to adjustment, the number of shares of common stock of the third party acquirer having a market value of two times the exercise price of the right. The rights expire on January 20, 2012, unless extended by the Board of Directors. In connection with the shareholder rights plan, the Board of Directors designated 100,000 shares of series A junior participating preferred stock.
 
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14. EARNINGS PER SHARE
The company’s earnings per share (EPS) includes basic net income per share, computed by dividing net income (as presented on the consolidated statement of operations), by the weighted-average number of common shares outstanding for the period, along with diluted earnings per share, computed by dividing net income by the weighted-average number of common shares adjusted for the dilutive effect of common stock equivalents outstanding during the period. A reconciliation of basic and diluted net income per common share for the three and nine months ended September 30, 2010 and 2009 was as follows:
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Three Months Ended:	 	 	Nine Months Ended:	 	
 	 	September 30,	 	 	September 30,	 	 	September 30,	 	 	September 30,	 	
(in $000’s except per share amounts)	 	2010	 	 	2009	 	 	2010	 	 	2009	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Numerator:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Net income	 	$	75,163	 	 	$	6,685	 	 	$	237,996	 	 	$	11,917	 	

Denominator:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Weighted average common shares outstanding	 	 	62,435,116	 	 	 	60,559,064	 	 	 	61,778,465	 	 	 	60,130,608	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Effect of dilutive options and common stock purchase warrants	 	 	3,035,225	 	 	 	688,636	 	 	 	3,392,590	 	 	 	536,619	 	

Diluted weighted average common shares outstanding	 	 	65,470,341	 	 	 	61,247,700	 	 	 	65,171,055	 	 	 	60,667,227	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Basic net income per share	 	$	1.20	 	 	$	0.11	 	 	$	3.85	 	 	$	0.20	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Diluted net income per share	 	$	1.15	 	 	$	0.11	 	 	$	3.65	 	 	$	0.20	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
For the three months ended September 30, 2010 and 2009, the Company excluded 1,123,516 and 5,859,308, respectively and for the nine months ended September 30, 2010 and 2009, the Company excluded 1,121,991 and 7,133,607, respectively, of stock options from the computation of diluted net income per common share as the effect of these options would have been anti-dilutive.
15. COMPREHENSIVE INCOME
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Three Months Ended:	 	 	Nine Months Ended:	 	
 	 	September 30,	 	 	September 30,	 	 	September 30,	 	 	September 30,	 	
(in $000’s)	 	2010	 	 	2009	 	 	2010	 	 	2009	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Net income	 	$	75,163	 	 	$	6,685	 	 	$	237,996	 	 	$	11,917	 	
Currency translation adjustments	 	 	(127	)	 	 	351	 	 	 	890	 	 	 	380	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Comprehensive income	 	 	75,036	 	 	 	7,036	 	 	 	238,886	 	 	 	12,297	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Comprehensive income attributable to the noncontrolling interest	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 	

Comprehensive income attributable to Impax Laboratories, Inc.	 	$	75,036	 	 	$	7,036	 	 	$	238,886	 	 	$	12,297	 	

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16. SEGMENT INFORMATION
The Company has two reportable segments, the “Global Pharmaceuticals Division” (“Global Division”) and the “Impax Pharmaceuticals Division” (“Impax Division”). The Company currently markets and sells its Global Division products within the continental United States of America and the Commonwealth of Puerto Rico.
The Global Division develops, manufactures, sells, and distributes generic pharmaceutical products, primarily through the following sales channels: the Global Products sales channel, for sales of generic prescription products, directly to wholesalers, large retail drug chains, and others; the Private Label Product sales channel, for generic pharmaceutical over-the-counter and prescription products sold to unrelated third-party customers, who in-turn sell the products to third-parties under their own label; the Rx Partner sales channel, for generic prescription products sold through unrelated third-party pharmaceutical entities under their own label pursuant to alliance agreements; and the OTC Partner sales channel, for over-the-counter products sold through unrelated third-party pharmaceutical entities under their own label pursuant to alliance agreements. The Company also generates revenue in its Global Division from research and development services provided under a joint development agreement with another unrelated third-party pharmaceutical company, and reports such revenue under the caption “Research Partner” revenue on the consolidated statement of operations.
The Impax Division is engaged in the development of proprietary branded pharmaceutical products through improvements to already-approved pharmaceutical products to address central nervous system (CNS) disorders. The Impax Division is also engaged in product co-promotion through a direct sales force focused on promoting to physicians, primarily in the CNS community, pharmaceutical products developed by other unrelated third-party pharmaceutical entities. The Company also generates revenue in its Impax Division from research and development services provided under a development and license agreement with another unrelated third-party pharmaceutical company, and reports such revenue under the caption “Research Partner” revenue on the consolidated statement of operations.
The Company’s chief operating decision maker evaluates the financial performance of the Company’s segments based upon segment income (loss) before income taxes. Items below income (loss) from operations are not reported by segment, except litigation settlements, since they are excluded from the measure of segment profitability reviewed by the Company’s chief operating decision maker. Additionally, general and administrative expenses, certain selling expenses, certain litigation settlements, and non-operating income and expenses are included in “Corporate and Other.” The Company does not report balance sheet information by segment since it is not reviewed by the Company’s chief operating decision maker. The accounting policies for the Company’s segments are the same as those described above in the discussion of “Revenue Recognition” and in the “Summary of Significant Accounting Policies” in the Company’s Form 10-K for the year ended December 31, 2009. The Company has no inter-segment revenue.
 
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16. SEGMENT INFORMATION (continued)
The tables below present segment information reconciled to total Company consolidated financial results, with segment operating income or loss including gross profit less direct research and development expenses, and direct selling expenses as well as any litigation settlements, to the extent specifically identified by segment:
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
(in $000’s)	 	Global	 	 	Impax	 	 	Corporate	 	 	Total	 	
Three Months Ended September 30, 2010	 	Division	 	 	Division	 	 	and Other	 	 	Company	 	
Revenue, net	 	$	300,128	 	 	$	3,865	 	 	$	—	 	 	$	303,993	 	
Cost of revenue	 	 	140,279	 	 	 	2,843	 	 	 	—	 	 	 	143,122	 	
Research and development	 	 	12,819	 	 	 	11,027	 	 	 	—	 	 	 	23,846	 	
Patent Litigation	 	 	1,033	 	 	 	—	 	 	 	—	 	 	 	1,033	 	
Income (loss) before provision for income taxes	 	$	141,870	 	 	$	(10,935	)	 	$	(7,299	)	 	$	123,636	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
(in $000’s)	 	Global	 	 	Impax	 	 	Corporate	 	 	Total	 	
Three Months Ended September 30, 2009	 	Division	 	 	Division	 	 	and Other	 	 	Company	 	
Revenue, net	 	$	61,447	 	 	$	3,499	 	 	$	—	 	 	$	64,946	 	
Cost of revenue	 	 	25,098	 	 	 	2,957	 	 	 	—	 	 	 	28,055	 	
Research and development	 	 	8,909	 	 	 	6,337	 	 	 	—	 	 	 	15,243	 	
Patent Litigation	 	 	1,647	 	 	 	—	 	 	 	—	 	 	 	1,647	 	
Income (loss) before provision for income taxes	 	$	23,232	 	 	$	(6,553	)	 	$	(6,527	)	 	$	10,152	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
(in $000’s)	 	Global	 	 	Impax	 	 	Corporate	 	 	Total	 	
Nine Months Ended September 30, 2010	 	Division	 	 	Division	 	 	and Other	 	 	Company	 	
Revenue, net	 	$	769,429	 	 	$	10,978	 	 	$	—	 	 	$	780,407	 	
Cost of revenue	 	 	282,309	 	 	 	9,280	 	 	 	—	 	 	 	291,589	 	
Research and development	 	 	32,608	 	 	 	30,656	 	 	 	—	 	 	 	63,264	 	
Patent Litigation	 	 	4,786	 	 	 	—	 	 	 	—	 	 	 	4,786	 	
Income (loss) before provision for income taxes	 	$	438,577	 	 	$	(31,436	)	 	$	(23,071	)	 	$	384,070	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
(in $000’s)	 	Global	 	 	Impax	 	 	Corporate	 	 	Total	 	
Nine Months Ended September 30, 2009	 	Division	 	 	Division	 	 	and Other	 	 	Company	 	
Revenue, net	 	$	172,268	 	 	$	10,007	 	 	$	—	 	 	$	182,275	 	
Cost of revenue	 	 	72,339	 	 	 	9,250	 	 	 	—	 	 	 	81,589	 	
Research and development	 	 	28,761	 	 	 	17,983	 	 	 	—	 	 	 	46,744	 	
Patent Litigation	 	 	4,058	 	 	 	—	 	 	 	—	 	 	 	4,058	 	
Income (loss) before provision for income taxes	 	$	59,482	 	 	$	(19,754	)	 	$	(21,493	)	 	$	18,237	 	
 
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17. LEGAL AND REGULATORY MATTERS
Patent Litigation
There is substantial litigation in the pharmaceutical, biological, and biotechnology industries with respect to the manufacture, use, and sale of new products which are the subject of conflicting patent and intellectual property claims. One or more patents typically cover most of the brand name products for which the Company is developing generic versions.
Under federal law, when a drug developer files an ANDA for a generic drug, seeking approval before expiration of a patent, which has been listed with the FDA as covering the brand name product, the developer must certify its product will not infringe the listed patent(s) and/or the listed patent is invalid or unenforceable (commonly referred to as a “Paragraph IV” certification). Notices of such certification must be provided to the patent holder, who may file a suit for patent infringement within 45 days of the patent holder’s receipt of such notice. If the patent holder files suit within the 45 day period, the FDA can review and tentatively approve the ANDA, but is prevented from granting final marketing approval of the product until a final judgment in the action has been rendered in favor of the generic, or 30 months from the date the notice was received, whichever is sooner. Lawsuits have been filed against the Company in connection the Company’s Paragraph IV certifications.
Should a patent holder commence a lawsuit with respect to an alleged patent infringement by the Company, the uncertainties inherent in patent litigation make the outcome of such litigation difficult to predict. The delay in obtaining FDA approval to market the Company’s product candidates as a result of litigation, as well as the expense of such litigation, whether or not the Company is ultimately successful, could have a material adverse effect on the Company’s results of operations and financial position. In addition, there can be no assurance any patent litigation will be resolved prior to the end of the 30-month period. As a result, even if the FDA were to approve a product upon expiration of the 30-month period, the Company may elect to not commence marketing the product if patent litigation is still pending.
Further, under the Teva Agreement, the Company and Teva have agreed to share in fees and costs related to patent infringement litigation associated with the generic pharmaceutical products covered by the Teva Agreement. With respect to the six products with ANDAs already filed with the FDA at the time the Teva Agreement was signed, Teva is required to pay 50% of the fees and costs in excess of $7,000,000; with respect to two of the products with ANDAs filed since the Teva Agreement was signed, Teva is required to pay 45% of the fees and costs; and with respect to the remaining two products, Teva is required to pay 50% of the fees and costs. The Company is responsible for the remaining fees and costs relating to the generic pharmaceutical products covered by the Teva Agreement.
The Company is responsible for all of the patent litigation fees and costs associated with current and future products not covered by the Teva Agreement. The Company records as expense the costs of patent litigation as incurred.
Although the outcome and costs of the asserted and unasserted claims is difficult to predict, the Company does not expect the ultimate liability, if any, for such matters to have a material adverse effect on its financial condition, results of operations, or cash flows.
 
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17. LEGAL AND REGULATORY MATTERS (continued)
Patent Infringement Litigation
AstraZeneca AD et al. v. Impax Laboratories, Inc. (Omeprazole)
In litigation commenced against the Company in the U.S. District Court for the District of Delaware in May 2000, AstraZeneca AB alleged the Company’s submission of an ANDA seeking FDA permission to market Omeprazole Delayed Release Capsules, 10mg, 20mg and 40mg, constituted infringement of AstraZeneca’s U.S. patents relating to its Prilosec® product and sought an order enjoining the Company from marketing its product until expiration of the patents. The case, along with several similar suits against other manufacturers of generic versions of Prilosec®, was subsequently transferred to the U.S. District Court for the Southern District of New York. In September 2004, following expiration of the 30-month stay, the FDA approved the Company’s ANDA, and the Company and its alliance agreement partner, Teva, commenced commercial sales of the Company’s product. In January 2005, AstraZeneca added claims of willful infringement, for damages, and for enhanced damages on the basis of this commercial launch. Claims for damages were subsequently dropped from the suit against the Company, but were included in a separate suit filed against Teva. In May 2007, the court found the product infringed two of AstraZeneca’s patents and these patents were not invalid. The court ordered FDA approval of the Company’s ANDA be converted to a tentative approval, with a final approval date not before October 20, 2007, the expiration date of the relevant pediatric exclusivity period. In August 2008, the U.S. Court of Appeals for the Federal Circuit affirmed the lower court’s decision of infringement and validity. In January, 2010, AstraZeneca, Teva and the Company entered into a settlement agreement and the suits against both Teva and the Company were dismissed.
Aventis Pharmaceuticals Inc., et al. v. Impax Laboratories, Inc. (Fexofenadine/Pseudoephedrine)
The Company is a defendant in an action brought in March 2002 by Aventis Pharmaceuticals Inc. and others in the U.S. District Court for the District of New Jersey alleging the Company’s proposed Fexofenadine and Pseudoephedrine Hydrochloride tablets, generic to Allegra-D®, infringe seven Aventis patents and seeking an injunction preventing the Company from marketing the products until expiration of the patents. The case has since been consolidated with similar actions brought by Aventis against five other manufacturers (including generics to both Allegra® and Allegra-D®). In March 2004, Aventis and AMR Technology, Inc. filed a complaint and first amended complaint against the Company and one of the other defendants alleging infringement of two additional patents, owned by AMR and licensed to Aventis, relating to a synthetic process for making the active pharmaceutical ingredient, Fexofenadine Hydrochloride and intermediates in the synthetic process. The Company believes it has defenses to the claims based on non-infringement and invalidity.
In June 2004, the court granted the Company’s motion for summary judgment of non-infringement with respect to two of the patents. The Company will have the opportunity to file additional summary judgment motions in the future and to assert both non-infringement and invalidity of the remaining patents (if necessary) at trial. No trial date has yet been set. In September 2005, Teva launched its Fexofenadine tablet products (generic to Allegra®), and Aventis and AMR moved for a preliminary injunction to bar Teva’s sales based on four of the patents in suit, which patents are common to the Allegra® and Allegra-D® litigations. The district court denied Aventis’s motion in January 2006, finding Aventis did not establish a likelihood of success on the merits, which decision was affirmed on appeal. Discovery is proceeding. No trial date has been set.
 
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17. LEGAL AND REGULATORY MATTERS (continued)
Endo Pharmaceuticals, Inc., et al. v. Impax Laboratories, Inc. (Oxymorphone)
In November 2007, Endo Pharmaceuticals, Inc. and Penwest Pharmaceuticals Co. (together, “Endo”) filed suit against the Company in the U.S. District Court for the District of Delaware, requesting a declaration of the Company’s Paragraph IV Notices with respect to the Company’s ANDA for Oxymorphone Hydrochloride Extended Release Tablets 5 mg, 10 mg, 20 mg and 40 mg, generic to Opana® ER, are null and void and, in the alternative, alleging patent infringement in connection with the filing of such ANDA. Endo subsequently dismissed its request for declaratory relief and in December 2007 filed another patent infringement suit relating to the same ANDA. In July 2008, Endo asserted additional infringement claims with respect to the Company’s amended ANDA, which added 7.5mg, 15mg and 30mg strengths of the product. The cases were subsequently transferred to the U.S. District Court for the District of New Jersey. The Company filed an answer and counterclaims. Discovery was completed. The court issued its Markman decision and final pretrial orders in March 2010. The Company and Endo entered into a Settlement and License Agreement, and this matter was dismissed, on June 15, 2010.
Pfizer Inc., et aI. v. Impax Laboratories, Inc. (Tolterodine)
In March 2008, Pfizer Inc., Pharmacia & Upjohn Company LLC, and Pfizer Health AB (collectively, “Pfizer”) filed a complaint against the Company in the U.S. District Court for the Southern District of New York, alleging the Company’s filing of an ANDA relating to Tolterodine Tartrate Extended Release Capsules, 4 mg, generic to Detrol® LA, infringes three Pfizer patents. The Company filed an answer and counterclaims seeking declaratory judgment of non-infringement, invalidity, or unenforceability with respect to the patents in suit. In April 2008, the case was transferred to the U.S. District Court for the District of New Jersey. On September 3, 2008, an amended complaint was filed alleging infringement based on the Company’s ANDA amendment adding a 2mg strength. For one of the patents-in-suit, U.S. Patent No. 5,382,600, expiring on September 25, 2012 with pediatric exclusivity, the Company agreed by stipulation to be bound by the decision in Pfizer Inc. et al. v. Teva Pharmaceuticals USA, Inc. , Case No. 04-1418 (D. N.J.). After the Pfizer court conducted a bench trial, it found the ‘600 patent not invalid on January 20, 2010, and that decision is on appeal to the U.S. Court of Appeals for the Federal Circuit. Discovery is proceeding in the Company’s case, and no trial date has been set.
Boehringer Ingelheim Pharmaceuticals, et al. v. Impax Laboratories, Inc. (Tamsulosin)
In July 2008, Boehringer Ingelheim Pharmaceuticals Inc. and Astellas Pharma Inc. (together, “Astellas”) filed a complaint against the Company in the U.S. District Court for the Northern District of California, alleging patent infringement in connection with the filing of the Company ANDA relating to Tamsulosin Hydrochloride Capsules, 0.4 mg, generic to Flomax®. After filing its answer and counterclaim, the Company filed a motion for summary judgment of patent invalidity. The District Court conducted hearings on claim construction in May 2009, and summary judgment in June 2009. In October 2009, the parties announced they had entered a settlement agreement allowing the Company to launch its product no later than March 2, 2010. A stipulated consent judgment was entered by the Court and the case was dismissed.
 
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17. LEGAL AND REGULATORY MATTERS (continued)
Purdue Pharma Products L.P., et al. v. Impax Laboratories, Inc. (Tramadol)
In August 2008, Purdue Pharma Products L.P., Napp Pharmaceutical Group LTD., Biovail Laboratories International, SRL, and Ortho-McNeil-Janssen Pharmaceuticals, Inc. (collectively, “Purdue”) filed suit against the Company in the U.S. District Court for the District of Delaware, alleging patent infringement for the filing of the Company’s ANDA relating to Tramadol Hydrochloride Extended Release Tablets, 100 mg, generic to 100mg Ultram® ER. In November 2008, Purdue asserted additional infringement claims with respect to the Company’s amended ANDA, which added 200 mg and 300 mg strengths of the product. The Company filed answers and counterclaims to those complaints. In August 2009, one of the patents-in-suit, U.S. Patent No. 6,254,887, was found invalid in another ANDA case relating to Ultram® ER, Purdue Pharma Products L.P. et al, v. Par Pharmaceutical, Inc. et al. , Case No. 07-255 (D. Del.) (“Par action”) The Par action is now on appeal to the U. S. Court of Appeals for the Federal Circuit. On November 16, 2009, the Company and Purdue agreed by stipulation to stay the case until the earlier of the following two events: (a) the Federal Circuit issues a mandate in the Par action or that action is otherwise disposed of, or (b) an undisclosed event. The Federal Circuit affirmed the decision of invalidity in the Par action on June 3, 2010 . On September 2, 2010, this matter was dismissed with prejudice.
Eli Lilly and Company v. Impax Laboratories, Inc. (Duloxetine)
In November 2008, Eli Lilly and Company filed suit against the Company in the U.S. District Court for the Southern District of Indiana, alleging patent infringement for the filing of the Company’s ANDA relating to Duloxetine Hydrochloride Delayed Release Capsules, 20 mg, 30 mg, and 60 mg, generic to Cymbalta®. In February 2009, the parties agreed to be bound by the final judgment concerning infringement, validity and enforceability of the patent at issue in cases brought by Eli Lilly and Company against other generic drug manufacturers that have filed ANDAs relating to this product and proceedings in this case were stayed.
Warner Chilcott, Ltd. et.al. v. Impax Laboratories, Inc. (Doxycycline Hyclate)
In December 2008, Warner Chilcott Limited and Mayne Pharma International Pty. Ltd. (together, “Warner Chilcott”) filed suit against the Company in the U.S. District Court for the District of New Jersey, alleging patent infringement for the filing of the Company’s ANDA relating to Doxycycline Hyclate Delayed Release Tablets, 75 mg and 100 mg, generic to Doryx®. The Company filed an answer and counterclaim. Thereafter, in March 2009, Warner Chilcott filed another lawsuit in the same jurisdiction, alleging patent infringement for the filing of the Company’s ANDA for the 150 mg strength. Discovery is proceeding, fact discovery closes on December 17, 2010, and no trial date has been set.
Eurand, Inc., et al. v. Impax Laboratories, Inc. (Cyclobenzaprine)
In January 2009, Eurand, Inc., Cephalon, Inc., and Anesta AG (collectively, “Cephalon”) filed suit against the Company in the U.S. District Court for the District of Delaware, alleging patent infringement for the filing of the Company’s ANDA relating to Cyclobenzaprine Hydrochloride Extended Release Capsules, 15 mg and 30 mg, generic to Amrix®. The Company has filed an answer and counterclaim. This matter was settled and dismissed on October 11, 2010.
Genzyme Corp. v. Impax Laboratories, Inc. (Sevelamer Hydrochloride)
In March 2009, Genzyme Corporation filed suit against the Company in the U.S. District Court for the District of Maryland, alleging patent infringement for the filing of the Company’s ANDA relating to Sevelamer Hydrochloride Tablets, 400 mg and 800 mg, generic to Renagel®. The Company has filed an answer and counterclaim. Fact discovery closes on December 3, 2010, the Markman hearing is set for January 21, 2011, and trial is scheduled for September 27, 2012.
 
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17. LEGAL AND REGULATORY MATTERS (continued)
Genzyme Corp. v. Impax Laboratories, Inc. (Sevelamer Carbonate)
In April 2009, Genzyme Corporation filed suit against the Company in the U.S. District Court for the District of Maryland, alleging patent infringement for the filing of the Company’s ANDA relating to Sevelamer Carbonate Tablets, 800 mg, generic to Renvela®. The Company has filed an answer and counterclaim. Fact discovery closes on December 3, 2010, the Markman hearing is set for January 21, 2011, and trial is scheduled for September 27, 2012.
The Research Foundation of State University of New York et al. v. Impax Laboratories, Inc. (Doxycycline Monohydrate)
In September 2009, The Research Foundation of State University of New York; New York University; Galderma Laboratories Inc.; and Galderma Laboratories, L.P. (collectively, “Galderma”) filed suit against the Company in the U.S. District Court for the District of Delaware alleging patent infringement for the filing of the Company’s ANDA relating to Doxycycline Monohydrate Delayed-Release Capsules, 40 mg, generic to Oracea®. The Company filed an answer and counterclaim. In October 2009, the parties agreed to be bound by the final judgment concerning infringement, validity and enforceability of the patent at issue in cases brought by Galderma against another generic drug manufacturer that has filed an ANDA relating to this product and proceedings in this case were stayed. In June 2010, Galderma moved for a preliminary injunction to bar sales by the other generic manufacturer based on two of the patents in suit, which motion was granted by the magistrate judge in a decision finding Galderma had shown a likelihood of success on the merits. In July, 2010 the generic manufacturer filed a motion for reargument of Galderma’s motion for preliminary injunction and temporary restraining order. The motion is pending.
Elan Pharma International Ltd. and Fournier Laboratories Ireland Ltd. v. Impax Laboratories, Inc. Abbott Laboratories and Laboratoires Fournier S.A. v. Impax Laboratories, Inc. (Fenofibrate)
In October 2009, Elan Pharma International Ltd. with Fournier Laboratories Ireland Ltd. and Abbott Laboratories with Laboratories Fournier S.A. filed separate suits against the Company in the U.S. District Court for the District of New Jersey alleging patent infringement for the filing of the Company’s ANDA relating to Fenofibrate Tablets, 48 mg and 145 mg, generic to Tricor®. The Company has filed an answer and counterclaim. In September 2010, the Court vacated the schedule and ordered a stay in the two matters related to the Company.
Daiichi Sankyo, Inc. et al. v. Impax Laboratories, Inc. (Colesevelam)
In January 2010, Daiichi Sankyo, Inc. and Genzyme Corporation (together, “Genzyme”) filed suit against the Company in the U.S. District Court for the District of Delaware alleging patent infringement for the filing of the Company’s ANDA relating to Colesevelam Hydrochloride Tablets, 625 mg, generic to Welchol®. The Company has filed an answer and counterclaim. Fact discovery closes June 30, 2011, and no trial date has been scheduled.
Abbott Laboratories, et al. v. Impax Laboratories, Inc. (Choline Fenofibrate)
In March 2010, Abbott Laboratories and Fournier Laboratories Ireland Ltd. (together, “Abbott”) filed suit against the Company in the U.S District Court for the District of New Jersey alleging patent infringement for the filing of the Company’s ANDA related to Choline Fenofibrate Delayed Release Capsules, 45 mg and 135 mg, generic of Trilipix®. The Company has filed an answer. Discovery is proceeding, fact discovery closes February 4, 2011, and no trial date has been scheduled.
Shionogi Pharma, Inc. and LifeCycle Pharma A/S v. Impax Laboratories, Inc. (Fenofibrate)
In April 2010, Shionogi Pharma, Inc. and LifeCycle Pharma A/S filed suit against the Company in the U.S. District Court for the District of Delaware alleging patent infringement for the filing of the Company’s ANDA relating to Fenofibrate Tablets, 40 and 120 mg, generic to Fenoglide®. The Company has filed its answer.
 
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17. LEGAL AND REGULATORY MATTERS (continued)
Genzyme Corp. v. Impax Laboratories, Inc. (Sevelamer Carbonate Powder)
In July 2010, Genzyme Corporation filed suit against the Company in the U.S. District Court for the District of Maryland, alleging patent infringement for the filing of the Company’s ANDA relating to Sevelamer Carbonate Powder, 2.4 g and 0.8 g packets, generic to Renvela® powder. The Company has filed an answer and counterclaim. Fact discovery closes on December 3, 2010, the Markman hearing is set for January 21, 2011, and trial is scheduled for September 27, 2012.
Schering Corporation, et al. v. Impax Laboratories, Inc. (Ezetimibe/Simvastatin)
In August 2010, Schering Corporation and MSP Singapore Company LLC filed suit against the Company in the U.S. District Court for the District of New Jersey alleging patent infringement for the filing of the Company’s ANDA relating to Ezetimibe/Simvastatin Tablets, 10 mg/80 mg, generic to Vytorin ®. The Company has filed an answer and counterclaim.
 
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Other Litigation Related to Our Business
Axcan Scandipharm Inc. v. Ethex Corp, et al. (Lipram UL)
In May 2007, Axcan Scandipharm Inc., a manufacturer of the Ultrase® line of pancreatic enzyme products, brought suit against the Company in the U.S. District Court for the District of Minnesota, alleging the Company engaged in false advertising, unfair competition, and unfair trade practices under federal and Minnesota law in connection with the marketing and sale of the Company’s now-discontinued Lipram UL products. The suit seeks actual and consequential damages, including lost profits, treble damages, attorneys’ fees, injunctive relief and declaratory judgments to prohibit the substitution of Lipram UL for prescriptions of Ultrase®. The District Court granted in part and denied in part the Company’s motion to dismiss the complaint, as well as the motion of co-defendants Ethex Corp. and KV Pharmaceutical Co., holding any claim of false advertising pre-dating June 1, 2001, is barred by the statute of limitations. On January 5, 2010, the parties settled the case and the case was subsequently dismissed with prejudice.
Budeprion XL Litigation
In June 2009, the Company was named a co-defendant in class action lawsuits filed in California state court in an action titled Kelly v. Teva Pharmaceuticals Indus. Ltd, et al. , No. BC414812 (Calif. Superior Crt. L.A. County). Subsequently, additional class action lawsuits were filed in Louisiana ( Morgan v. Teva Pharmaceuticals Indus. Ltd, et al ., No. 673880 (24th Dist Crt., Jefferson Parish, LA.)), North Carolina ( Weber v. Teva Pharmaceuticals Indus., Ltd., et al. , No. 07 CV5002556, (N.C. Superior Crt., Hanover County)), Pennsylvania ( Rosenfeld v. Teva Pharmaceuticals USA, Inc.. et al. , No. 2:09-CV-2811 (E.D. Pa.)), Florida ( Henchenski and Vogel v. Teva Pharmaceuticals Industries Ltd., et al. , No. 2:09-CV-470-FLM-29SPC (M.D. Fla.)), Texas ( Anderson v. Teva Pharmaceuticals Indus., Ltd., et al. , No. 3-09CV1200-M (N.D. Tex.)), Oklahoma ( Brown et al. v. Teva Pharmaceuticals Inds., Ltd., et al. , No. 09-cv-649-TCK-PJC (N.D. OK)), Ohio ( Latvala et al. v. Teva Pharmaceuticals Inds., Ltd., et al. , No. 2:09-cv-795 (S.D. OH)), Alabama ( Jordan v. Teva Pharmaceuticals Indus. Ltd et al. , No. CV09-709 (Ala. Cir. Crt. Baldwin County)), and Washington ( Leighty v. Teva Pharmaceuticals Indus. Ltd et al. , No. CV09-01640 (W. D. Wa.)). All of the complaints involve Budeprion XL, a generic version of Wellbutrin XL® that is manufactured by the Company and marketed by Teva, and allege that, contrary to representations of Teva, Budeprion XL is less effective in treating depression, and more likely to cause dangerous side effects, than Wellbutrin XL. The actions are brought on behalf of purchasers of Budeprion XL and assert claims such as unfair competition, unfair trade practices and negligent misrepresentation under state law. Each lawsuit seeks damages in an unspecified amount consisting of the cost of Budeprion XL paid by class members, as well as any applicable penalties imposed by state law, and disclaims damages for personal injury. The state court cases have been removed to federal court, and a petition for multidistrict litigation to consolidate the cases in federal court has been granted. These cases and any subsequently filed cases will be heard under the consolidated action entitled In re: Budeprion XL Marketing Sales Practices, and Products Liability Litigation, MDL No. 2107, in the United States District Court for the Eastern District of Pennsylvania. The Company filed a motion to dismiss and a motion to certify that order for interlocutory appeal, both of which were denied. Discovery is proceeding, and no trial date has been scheduled.
Impax Laboratories, Inc. v. Shire LLC and Shire Laboratories, Inc. (generic Adderall XR)
On November 1, 2010, the Company filed suit against Shire LLC and Shire Laboratories, Inc. (collectively “Shire”) in the Supreme Court of the State of New York, alleging breach of contract and other related claims due to Shire’s failure to fill the Company’s orders for the generic Adderall XR product as required by the parties’ Settlement Agreement and License and Distribution Agreement, signed in January 2006. In addition, the Company has filed a motion for a preliminary injunction and a temporary restraining order seeking to require Shire to fill product orders placed by the Company.
 
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18. SUPPLEMENTARY FINANCIAL INFORMATION (unaudited)
Selected (unaudited) financial information for the quarterly period noted is as follows:
 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	2010 Quarters Ended:	 	
(in $000’s except per share amounts)	 	March 31	 	 	June 30	 	 	September 30	 	
Revenue:	 	 	 	 	 	 	 	 	 	 	 	 	
Global Product sales, gross	 	$	425,986	 	 	$	224,318	 	 	$	167,759	 	
Less:	 	 	 	 	 	 	 	 	 	 	 	 	
Chargebacks	 	 	56,168	 	 	 	49,420	 	 	 	36,065	 	
Rebates	 	 	29,425	 	 	 	16,739	 	 	 	21,630	 	
Product Returns	 	 	7,400	 	 	 	4,596	 	 	 	8,344	 	
Other credits	 	 	23,888	 	 	 	15,925	 	 	 	10,669	 	
 	 	 	 	 	 	 	 	 	 	
Global Product sales, net	 	 	309,105	 	 	 	137,638	 	 	 	91,051	 	

Private Label Product sales	 	 	672	 	 	 	339	 	 	 	528	 	
Rx Partner	 	 	4,903	 	 	 	5,802	 	 	 	202,799	 	
OTC Partner	 	 	1,765	 	 	 	2,309	 	 	 	2,365	 	
Research Partner	 	 	3,385	 	 	 	3,494	 	 	 	3,714	 	
Promotional Partner	 	 	3,503	 	 	 	3,500	 	 	 	3,535	 	
Other	 	 	—	 	 	 	—	 	 	 	—	 	
 	 	 	 	 	 	 	 	 	 	
Total revenues	 	 	323,333	 	 	 	153,082	 	 	 	303,992	 	

Gross profit	 	 	243,757	 	 	 	84,190	 	 	 	160,871	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Net income	 	$	131,485	 	 	$	31,348	 	 	$	75,163	 	

Net income per share (basic)	 	$	2.16	 	 	$	0.51	 	 	$	1.20	 	
 	 	 	 	 	 	 	 	 	 	
Net income per share (diluted)	 	$	2.06	 	 	$	0.48	 	 	$	1.15	 	

Weighted Average:	 	 	 	 	 	 	 	 	 	 	 	 	
common shares outstanding:	 	 	 	 	 	 	 	 	 	 	 	 	
Basic	 	 	61,008,015	 	 	 	61,876,599	 	 	 	62,435,116	 	
 	 	 	 	 	 	 	 	 	 	
Diluted	 	 	63,865,678	 	 	 	65,538,805	 	 	 	65,470,341	 	
 	 	 	 	 	 	 	 	 	 	
Quarterly computations of (unaudited) net income per share amounts are made independently for each quarterly reporting period, and the sum of the per share amounts for the quarterly reporting periods may not equal the per share amounts for the year-to-date reporting period.
 
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18. SUPPLEMENTARY FINANCIAL INFORMATION (unaudited) (continued)
Selected (unaudited) financial information for the quarterly period noted is as follows:
 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	2009 Quarters Ended:	 	
(in $000’s except per share amounts)	 	March 31	 	 	June 30	 	 	September 30	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Revenues:	 	 	 	 	 	 	 	 	 	 	 	 	
Global Product sales, gross	 	$	78,696	 	 	$	81,764	 	 	$	82,514	 	
Less:	 	 	 	 	 	 	 	 	 	 	 	 	
Chargebacks	 	 	22,638	 	 	 	24,844	 	 	 	21,265	 	
Rebates	 	 	10,819	 	 	 	13,425	 	 	 	9,411	 	
Product Returns	 	 	3,256	 	 	 	3,100	 	 	 	2,030	 	
Other credits	 	 	2,862	 	 	 	3,008	 	 	 	3,172	 	
 	 	 	 	 	 	 	 	 	 	
Global Product sales, net	 	 	39,121	 	 	 	37,387	 	 	 	46,636	 	

Private Label Product sales	 	 	1,297	 	 	 	2,220	 	 	 	1,752	 	
Rx Partner	 	 	10,736	 	 	 	11,119	 	 	 	8,328	 	
OTC Partner	 	 	1,858	 	 	 	1,628	 	 	 	1,769	 	
Research Partner	 	 	2,611	 	 	 	2,833	 	 	 	2,962	 	
Promotional Partner	 	 	3,284	 	 	 	3,224	 	 	 	3,499	 	
Other	 	 	6	 	 	 	5	 	 	 	—	 	
 	 	 	 	 	 	 	 	 	 	
Total revenues	 	 	58,913	 	 	 	58,416	 	 	 	64,946	 	

Gross profit	 	 	32,663	 	 	 	31,132	 	 	 	36,891	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
Net income	 	$	2,219	 	 	$	3,013	 	 	$	6,685	 	

Net income per share (basic)	 	$	0.04	 	 	$	0.05	 	 	$	0.11	 	
 	 	 	 	 	 	 	 	 	 	
Net income per share (diluted)	 	$	0.04	 	 	$	0.05	 	 	$	0.11	 	
 	 	 	 	 	 	 	 	 	 	
Weighted average	 	 	 	 	 	 	 	 	 	 	 	 	
common shares outstanding:	 	 	 	 	 	 	 	 	 	 	 	 	
Basic	 	 	59,711,133	 	 	 	60,112,308	 	 	 	60,559,064	 	
 	 	 	 	 	 	 	 	 	 	
Diluted	 	 	60,222,215	 	 	 	60,552,344	 	 	 	61,247,700	 	
 	 	 	 	 	 	 	 	 	 	
Quarterly computations of (unaudited) net income per share amounts are made independently for each quarterly reporting period, and the sum of the per share amounts for the quarterly reporting periods may not equal the per share amounts for the year-to-date reporting period.
 
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ITEM 2.	 	MANAGEMENT’S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION	
The following discussion and analysis, as well as other sections in this Quarterly Report on Form 10-Q, should be read in conjunction with the unaudited interim consolidated financial statements and related notes to the unaudited interim consolidated financial statements included elsewhere herein.
Statements included in this Quarterly Report on Form 10-Q not related to present or historical conditions are “forward-looking statements.” Additional oral or written forward-looking statements may be made by us from time to time. Such forward-looking statements involve risks and uncertainties which could cause results or outcomes to differ materially from those expressed in the forward-looking statements. Forward-looking statements may include statements relating to our plans, strategies, objectives, expectations and intentions. Words such as “believes,” “forecasts,” “intends,” “possible,” “estimates,” “anticipates,” and “plans” and similar expressions are intended to identify forward-looking statements. Our ability to predict results or the effect of events on our operating results is inherently uncertain. Forward-looking statements involve a number of risks, uncertainties and other factors that could cause actual results to differ materially from those discussed in this Quarterly Report on Form 10-Q. Such risks and uncertainties include the effect of current economic conditions on our industry, business, financial position, results of operations and market value of our common stock, our ability to maintain an effective system of internal control over financial reporting, fluctuations in our revenues and operating income, reductions or loss of business with any significant customer, the impact of competitive pricing and products and regulatory actions on our products, our ability to sustain profitability and positive cash flows, our ability to maintain sufficient capital to fund our operations, any delays or unanticipated expenses in connection with the operation of our Taiwan facility, our ability to successfully develop and commercialize pharmaceutical products, the uncertainty of patent litigation, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration (“FDA”) filings and approvals, our inexperience in conducting clinical trials and submitting new drug applications, our reliance on key alliance, collaboration, license and distribution agreements, the availability of raw materials, our ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, exposure to product liability claims, and other risks described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in our Quarterly Report on Form 10-Q for the fiscal quarters ended March 31, 2010, and June 30, 2010. You should not place undue reliance on forward-looking statements. Such statements speak only as to the date on which they are made, and we undertake no obligation to update publicly or revise any forward-looking statement, regardless of future developments or availability of new information.
 
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Overview
We are a technology based, specialty pharmaceutical company applying formulation and development expertise, as well as our drug delivery technology, to the development, manufacture and marketing of controlled-release and niche generics, in addition to the development of branded products. As of November 1, 2010, we manufactured and marketed 93 generic pharmaceuticals, which represent dosage variations of 29 different pharmaceutical compounds through our own Global Pharmaceuticals division; another 16 of our generic pharmaceuticals representing dosage variations of 4 different pharmaceutical compounds are marketed by our alliance agreement partners. We have 38 applications pending at the FDA, including 4 tentatively approved by FDA, and 58 other products in various stages of development for which applications have not yet been filed.
In the generic pharmaceuticals market, we focus our efforts on controlled-release generic versions of selected brand-name pharmaceuticals covering a broad range of therapeutic areas and having technically challenging drug-delivery mechanisms or limited competition. We employ our technologies and formulation expertise to develop generic products that will reproduce the brand-name product’s physiological characteristics but not infringe any valid patents relating to the brand-name product. We generally focus on brand-name products as to which the patents covering the active pharmaceutical ingredient have expired or are near expiration, and we employ our proprietary formulation expertise to develop controlled-release technologies that do not infringe patents covering the brand-name products’ controlled-release technologies.
We are also developing specialty generic pharmaceuticals that we believe present one or more barriers to entry by competitors, such as difficulty in raw materials sourcing, complex formulation or development characteristics or special handling requirements. In the brand-name pharmaceuticals market, we are developing products for the treatment of central nervous system (“CNS”) disorders. Our brand-name product portfolio consists of development-stage projects to which we are applying our formulation and development expertise to develop differentiated, modified, or controlled-release versions of currently marketed (either in the U.S. or outside the U.S.) drug substances. We intend to expand our brand-name products portfolio primarily through internal development and also through licensing and acquisition.
 
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We operate in two segments, referred to as the “Global Pharmaceuticals Division” (“Global Division”) and the “Impax Pharmaceuticals Division” (“Impax Division”).
The Global Division develops, manufactures, sells, and distributes generic pharmaceutical products through four sales channels: the “Global Products” sales channel, for generic pharmaceutical prescription (“Rx”) products we sell directly to wholesalers, large retail drug chains, and others; the “Private Label Products” sales channel, for generic pharmaceutical and over-the-counter (“OTC”) prescription products we sell to unrelated third-party customers who in-turn sell the product to third parties under their own label, the “Rx Partner” sales channel, for generic prescription products sold through unrelated third-party pharmaceutical entities under their own label pursuant to alliance agreements; and the “OTC Partner” sales channel, for sales of generic pharmaceutical OTC products sold through unrelated third-party pharmaceutical entities under their own label pursuant to alliance agreements. We also generate revenue in the Global Division from research and development services provided under a joint development agreement with another unrelated third-party pharmaceutical company, and report such revenue under the caption “Research partner” revenue on the consolidated statement of operations.
The Impax Division is engaged in the development of proprietary brand pharmaceutical products through improvements to already approved pharmaceutical products to address central nervous system (CNS) disorders. The Impax Division is also engaged in the provision of co-promotion services (referred to as “physician detailing sales calls”) of products developed by unrelated third-party pharmaceutical entities through our direct sales force to physicians in the CNS community. We also generate revenue in the Impax Division from research and development services provided under a development and license agreement with another unrelated third-party pharmaceutical company, and report such revenue under the caption “Research Partner” revenue on the consolidated statement of operations.
Our total revenues for the three and nine months ended September 30, 2010 and 2009 were predominantly derived from our Global Division. See “Part I: Financial Information — Item 1: Financial Statements — Note 16” to the unaudited interim consolidated financial statements for financial information about our segments for the three and nine months ended September 30, 2010 and 2009. We sell our Global Division products within the continental United States of America and the Commonwealth of Puerto Rico. We have no sales in foreign countries.
We have entered into several alliance, collaboration or license and distribution agreements with respect to certain of our products and services and may enter into similar agreements in the future. These agreements may require us to relinquish rights to certain of our technologies or product candidates, or to grant licenses on terms which ultimately may prove to be unfavorable to us. Relationships with alliance partners may also include risks due to incomplete marketplace information, inventories, and commercial strategies of our partners, and our agreements may be the subject of contractual disputes. If we, or our partners, are not successful in commercializing the products covered by the agreements, such commercial failure could adversely affect our business. Under one of our license and distribution agreements we are dependent on another pharmaceutical company to supply us with product we market and sell, and we may enter into similar agreements in the future. Any delay or interruption in the supply of product under such agreements could curtail or delay our product shipments and adversely affect our revenues, as well as jeopardize our relationships with our customers.
Global product sales, net. We recognize revenue from direct sales in accordance with SEC Staff Accounting Bulletin No. 104, Topic 13, “Revenue Recognition” (“SAB 104”). Revenue from direct product sales is recognized at the time title and risk of loss pass to customers. Accrued provisions for estimated chargebacks, rebates, product returns, and other pricing adjustments are provided for in the period the related sales are recorded.
Private Label Sales. We recognize revenue from direct sales in accordance with SAB 104. Revenue from direct product sales is recognized at the time title and risk of loss pass to customers. Revenue received from Private Label product sales is not subject to deductions for chargebacks, rebates, product returns, and other pricing adjustments. Additionally, Private Label product sales do not have upfront, milestone, or lump-sum payments and do not contain multiple deliverables under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification TM (“ASC” or “the Codification”) Topic 605.
 
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Rx Partner and OTC Partner. Each of our alliance agreements involves multiple deliverables in the form of products, services and/or licenses over extended periods. FASB ASC Topic 605-25 supplemented SAB 104 for accounting for such multiple-element revenue arrangements. With respect to our multiple-element revenue arrangements, we determine whether any or all of the elements of the arrangement should be separated into individual units of accounting under FASB ASC Topic 605-25. If separation into individual units of accounting is appropriate, we recognize revenue for each deliverable when the revenue recognition criteria specified by SAB 104 are achieved for the deliverable. If separation is not appropriate, we recognize revenue (and related direct manufacturing costs) over the estimated life of the agreement or the Company’s estimated expected period of performance using either the straight-line method or a modified proportional performance method. Under the modified proportional performance method, the amount recognized in the period of initial recognition is based upon the number of years elapsed under the agreement relative to the estimated total recognition period of the particular agreement. The amount of revenue recognized in the year of initial recognition is thus determined by multiplying the total amount realized by a fraction, the numerator of which is the then current year of the agreement and the denominator of which is the total number of years estimated to be the recognition period. The remaining balance of the amount realized is then recognized in equal amounts in each of the succeeding years of the recognition period. Thus, for example, with respect to profit share or royalty payments reported by an alliance agreement partner during the third year of an agreement with an estimated recognition period of 15 years, 3 / 15 of the amount reported is recognized in the year reported and 1/15 of the amount is recognized during each of the remaining 12 years. A fuller description of our analysis under FASB ASC Topic 605 and the modified proportional performance method is set forth in “Part I: Financial Information — Item 1: Financial Statements — Note 2.”
As noted above, our alliance agreements obligate us to deliver multiple goods and /or services over extended periods. Such deliverables include manufactured pharmaceutical products, exclusive and semi-exclusive marketing rights, distribution licenses, and research and development services. In exchange for these deliverables, we receive payments from our alliance agreement partners for product shipments, and may also receive royalty, profit sharing, and /or upfront or periodic milestone payments. Revenue received from the alliance agreement partners for product shipments under these agreements is generally not subject to deductions for chargebacks, rebates, returns, shelf-stock adjustments, and other pricing adjustments. Royalty and profit sharing amounts we receive under these agreements are calculated by the respective alliance agreement partner, with such royalty and profit share amounts generally based upon estimates of net product sales or gross profit which include estimates of deductions for chargebacks, rebates, returns, shelf stock adjustments and other adjustments the alliance agreement partners may negotiate with their customers. We record the alliance agreement partner’s adjustments to such estimated amounts in the period the alliance agreement partner reports the amounts to us.
 
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Research Partner . We have entered into development agreements with other unrelated third-party pharmaceutical companies under which we are collaborating in the development of five dermatological products, including four generic products and one branded dermatological product, and one branded CNS product. Under each of the development agreements, we received an upfront fee with the potential to receive additional milestone payments upon completion of contractually specified clinical and regulatory milestones. Additionally, we may also receive royalty payments from the sale, if any, of a successfully developed and commercialized branded product under one of the development agreements. Revenue received from the provision of research and development services, including the upfront payment and the contingent milestone payments, if any, will be deferred and recognized on a straight line basis over the expected period of performance of the research and development services. Royalty fee income, if any, will be recognized by us as current period revenue when earned. We determined these agreements do not include multiple deliverables under FASB ASC Topic 605.
Promotional Partner . We have entered into promotional services agreements with other unrelated third-party pharmaceutical companies under which we provide physician detailing sales calls services to promote certain of those companies’ branded drug products. In exchange for our services we receive service fees. We recognize revenue from provision of physician detailing sales calls as such services are rendered and the performance obligations are met and from contingent payments, if any, at the time they are earned.
Impact of Economic Conditions
The global economy has been undergoing a period of significant volatility which has led, to among other impacts, diminished credit availability, declines in consumer confidence, and increases in unemployment rates. There remains a high degree of caution about the stability of the U. S. economy due to the ongoing domestic and global financial markets conditions, and there can be no assurances further deterioration in the financial markets will not occur. These economic conditions have resulted in, and could lead to further, reduced consumer spending related to healthcare in general and pharmaceutical products in particular. While generic drugs present a cost-effective alternative to higher-priced branded products, our sales and those of our alliance agreement and collaboration partners could be negatively affected if patients forego obtaining healthcare. In addition, reduced consumer spending may force our competitors and us to decrease prices.
In addition, we have exposure to many different industries and counterparties, including our partners under our alliance, research, and promotional services agreements, suppliers of raw chemical materials, drug wholesalers and other customers, who may be financially or operationally unstable or may become unstable in the current and /or future economic environment. Any such instability may affect these parties’ ability to fulfill their respective contractual obligations to us or cause them to limit or place burdensome conditions upon future transactions with us.
 
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Critical Accounting Estimates
The preparation of our consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (GAAP) and the rules and regulations of the United States Securities & Exchange Commission (SEC) require the use of estimates and assumptions, based on complex judgments considered reasonable, and affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The most significant judgments are employed in estimates used in determining values of tangible and intangible assets, legal contingencies, tax assets and tax liabilities, fair value of share-based compensation of equity incentive awards issued to employees and directors, and estimates used in applying the Company’s revenue recognition policy including those related to accrued chargebacks, rebates, product returns, Medicare, Medicaid, and other government rebate programs, shelf-stock adjustments, and the timing and amount of deferred and recognized revenue and deferred and amortized manufacturing costs under the Company’s several alliance and collaboration agreements. Actual results may differ from estimated results. Certain prior year amounts have been reclassified to conform to the current year presentation.
Although we believe our estimates and assumptions are reasonable when made, they are based upon information available to us at the time they are made. We periodically review the factors having an influence on our estimates and, if necessary, adjust such estimates. Although historically our estimates have generally been reasonably accurate, due to the risks and uncertainties involved in our business and evolving market conditions, and given the subjective element of the estimates made, actual results may differ from estimated results. This possibility may be greater than normal during times of pronounced economic volatility.
Consistent with industry practice, we record an accrued provision for estimated deductions for chargebacks, rebates, product returns, Medicare, Medicaid, and other government rebate programs, shelf-stock adjustments, and other pricing adjustments, in the same period when revenue is recognized. The objective of recording provisions for such deductions at the time of sale is to provide a reasonable estimate of the aggregate amount we expect to ultimately credit our customers. Since arrangements giving rise to the various sales credits are typically time driven (i.e. particular promotions entitling customers who make purchases of our products during a specific period of time, to certain levels of rebates or chargebacks), these deductions represent important reductions of the amounts those customers would otherwise owe us for their purchases of those products. Customers typically process their claims for deductions in a reasonably timely manner, usually within the established payment terms. We monitor actual credit memos issued to our customers and compare such actual amounts to the estimated provisions, in the aggregate, for each deduction category to assess the reasonableness of the various reserves at each quarterly balance sheet date. Differences between our estimated provisions and actual credits issued have not been significant, and are accounted for in the current period as a change in estimate in accordance with GAAP. We do not have the ability to specifically link any particular sales credit to an exact sales transaction and since there have been no material differences, we believe our systems and procedures are adequate for managing our business. An event such as the failure to report a particular promotion could result in a significant difference between the estimated amount accrued and the actual amount claimed by the customer, and, while there have been none to date, we would evaluate the particular events and factors giving rise to any such significant difference in determining the appropriate accounting.
 
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Chargebacks. We have agreements establishing contract prices for certain products with certain indirect customers, such as managed care organizations, hospitals, and government agencies who purchase our products from drug wholesalers. The contract prices are lower than the prices the customer would otherwise pay to the wholesaler, and the difference is referred to as a chargeback, which generally takes the form of a credit issued by us to reduce the gross sales amount we invoiced to our wholesaler customer. An accrued provision for chargeback deductions is estimated and recorded at the time we ship the products to our wholesaler customers. The primary factors we consider when estimating the accrued provision for chargebacks are the average historical chargeback credits given, the mix of products shipped, and the amount of inventory on hand at the three major drug wholesalers with whom we do business. We monitor aggregate actual chargebacks granted and compare them to the estimated accrued provision for chargebacks to assess the reasonableness of the chargeback reserve at each quarterly balance sheet date.
The following table is a roll-forward of the activity in the chargeback reserve for the nine months ended September 30, 2010 and the year ended December 31, 2009:
 	 	 	 	 	 	 	 	 	
(in $000’s)	 	September 30,	 	 	December 31,	 	
Chargeback reserve	 	2010	 	 	2009	 	
Beginning balance	 	$	21,448	 	 	$	4,056	 	
Provision recorded during the period	 	 	141,653	 	 	 	126,105	 	
Credits issued during the period	 	 	(145,803	)	 	 	(108,713	)	
 	 	 	 	 	 	 	
Ending balance	 	$	17,298	 	 	$	21,448	 	

Provision as a percent of gross Global Product sales	 	 	17	%	 	 	24	%	
 	 	 	 	 	 	 	
The decrease in the accrued provision for estimated chargebacks as a percent of gross Global Product sales, principally resulted from our tamsulosin product and our authorized generic Adderall XR products, both of which generally resulted in higher gross Global Product sales and carried a lower average chargeback credit amount, relative to our other products sold through our Global Division’s Global Products sales channel, resulting in a lower overall aggregate average chargebacks as a percentage of gross Global Product Sales during the nine months ended September 30, 2010. We commenced sales of our tamsulosin product on March 2, 2010 and had contractual market exclusivity for this generic product for the succeeding eight weeks, during which we were able to achieve high market-share penetration. Our tamsulosin product sales after the end of the contractual exclusivity period, have not remained at this level, as additional competing generic versions of the product entered the market in late April 2010, and have resulted in both price erosion and reduction of our market-share. (See Results of Operations below for additional discussion.)
 
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Rebates. In an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty, we maintain various rebate programs with our customers to whom we market our products through our Global Division Global Products sales channel. The rebates generally take the form of a credit memo to reduce the invoiced gross sales amount charged to a customer for products shipped. An accrued provision for rebate deductions is estimated and recorded at the time of product shipment. The accrued provision for rebates is based upon historical experience of aggregate credits issued compared with payments made, the historical relationship of rebates as a percentage of total Global Product sales, gross, and the contract terms and conditions of the various rebate programs in effect at the time of shipment. We monitor aggregate actual rebates granted and compare them to the estimated accrued provision for rebates to assess the reasonableness of the rebate reserve at each quarterly balance sheet date.
The following table is a roll-forward of the activity in the rebate reserve for the nine months ended September 30, 2010 and the year ended December 31, 2009:
 	 	 	 	 	 	 	 	 	
(in $000’s)	 	September 30,	 	 	December 31,	 	
Rebate reserve	 	2010	 	 	2009	 	
Beginning balance	 	$	37,781	 	 	$	4,800	 	
Provision recorded during the period	 	 	73,397	 	 	 	72,620	 	
Credits issued during the period	 	 	(94,185	)	 	 	(39,639	)	
 	 	 	 	 	 	 	
Ending balance	 	$	16,993	 	 	$	37,781	 	

Provision as a percent of gross Global Product sales	 	 	9	%	 	 	14	%	
 	 	 	 	 	 	 	
The decrease in the accrued provision for estimated rebates as a percent of gross Global Product sales, principally resulted from our tamsulosin product and our authorized generic Adderall XR products, both of which generally resulted in higher gross Global Product sales and carried a lower rebate credit amount, relative to our other products sold through our Global Division’s Global Products sales channel, resulting in a lower overall aggregate average rebate as a percentage of gross Global Product sales during the nine months ended September 30, 2010. We commenced sales of our tamsulosin product on March 2, 2010 and had contractual market exclusivity for this generic product for the succeeding eight weeks, during which we were able to achieve high market-share penetration. Our tamsulosin product sales after the end of the contractual exclusivity period, have not remained at this level, as additional competing generic versions of the product entered the market in late April 2010, and have resulted in both price erosion and reduction of our market-share. (See Results of Operations below for additional discussion.)
 
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Returns. We allow our customers to return product (i) if approved by authorized personnel in writing or by telephone with the lot number and expiration date accompanying any request and (ii) if such products are returned within six months prior to, or until 12 months following, the products’ expiration date. We estimate a provision for product returns as a percentage of gross sales based upon historical experience of Global Division Global Product sales. The product return reserve is estimated using a historical lag period (the time between the month of sale and the month of return) and return rates, adjusted by estimates of the future return rates based on various assumptions, which may include changes to internal policies and procedures, changes in business practices, and commercial terms with customers, competitive position of each product, amount of inventory in the wholesaler supply chain, and the introduction of new products. We also consider other factors, including significant market changes which may impact future expected returns, and actual product returns and may record additional provisions for specific product returns we believe are not covered by the historical rates. We monitor aggregate actual product returns on a quarterly basis and may record specific provisions for product returns we believe are not covered by historical percentages.
The following table is a roll-forward of the activity in the product returns reserve for nine months ended September 30, 2010 and the year ended December 31, 2009:
 	 	 	 	 	 	 	 	 	
(in $000’s)	 	September 30,	 	 	December 31,	 	
Product Returns Reserve	 	2010	 	 	2009	 	
Beginning balance	 	$	22,114	 	 	$	13,675	 	
Provision related to sales recorded in the period	 	 	20,340	 	 	 	11,847	 	
Credits issued during the period	 	 	(2,976	)	 	 	(3,408	)	
 	 	 	 	 	 	 	
Ending balance	 	$	39,478	 	 	$	22,114	 	

Provision as a percent of gross Global Product sales	 	 	2	%	 	 	2	%	
 	 	 	 	 	 	 	
The period over period change in the provision for returns, as a percent of gross Global Product sales was de minimis.
 
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Medicaid Rebate. As required by law, we provide a rebate payment on drugs dispensed under the Medicaid program. We determine our estimate of the accrued Medicaid rebate reserve primarily based on historical experience of claims submitted by the various states and any new information regarding changes in the Medicaid program which may impact our estimate of Medicaid rebates. In determining the appropriate accrual amount, we consider historical payment rates and processing lag for outstanding claims and payments. We record estimates for Medicaid payments as a deduction from gross sales, with corresponding adjustments to accrued liabilities. The accrual for Medicaid payments totaled $14.9 million and $9.8 million as of September 30, 2010 and December 31, 2009, respectively. The estimated accrued Medicaid rebate reserve increased significantly as a result of the launch of our mixed amphetamine salts products in October 2009, as well as the launch of our tamsulosin product in March 2010. As our mixed amphetamine salts products are authorized generics to the related brand product, Medicaid rebate payments are calculated under the regulations applicable to branded products. The Medicaid rebate accrual for the three and nine months ended September 30, 2010 includes the effect of the increase in the Medicaid Rebate rates, which were effective on a retroactive basis to January 1, 2010, resulting from the March 2010 enactment into law of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act (the “Acts”). The change in the Medicaid Rebate rates resulting from the Acts did not have a material impact on our results of operations. Historically, differences between our estimated and actual payments made have not been significant.
Shelf-Stock Adjustments. When, based on competitive market conditions, we may reduce the ultimate net selling price of a product by issuing a so-called shelf-stock adjustment credit to a customer, the amount of which is typically agreed upon by us and our customer by reference to an estimate of the amount of a specific product held by the customer, as an inducement for our customer to continue to purchase future additional quantities of our product. The primary factors we consider when estimating an accrued shelf-stock adjustment reserve include the per-unit credit amount and an estimate of the level of inventory held by the customer. The accrued shelf-stock adjustment totaled $0.6 million and $0.2 million as of September 30, 2010 and December 31, 2009, respectively. Differences between our estimated and actual credits issued for shelf stock adjustments have not been significant.
Allowance for Uncollectible Amounts . We maintain allowances for uncollectible amounts for estimated losses resulting from amounts we deem to be uncollectible from our customers. These allowances are for specific amounts on certain accounts. The allowance for uncollectible amounts totaled $0.6 million and $0.4 million at September 30, 2010 and December 31, 2009, respectively.
 
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Estimated Lives of Alliance Agreements. The revenue we receive under our alliance agreements is not subject to adjustment for estimated chargebacks, rebates, product returns and other pricing adjustments as such adjustments are included in the amounts we receive from our alliance partners. However, because we recognize revenue we receive under our alliance agreements, which is required to be deferred, over the estimated life of the related agreement or our expected performance utilizing either the straight-line method or a modified proportional performance method, we are required to estimate the recognition period under each such agreement in order to determine the amount of revenue to be recognized in the current period. Sometimes this estimate is based solely on the fixed term of the particular alliance agreement. In other cases the estimate may be based on more subjective factors as noted in the following paragraphs. While changes to the estimated recognition periods have been infrequent, such changes, should they occur, may have a significant impact on our financial statements.
As an illustration, with the application of the updated generally accepted accounting principles promulgated by FASB ASC 605-25, to the Teva Agreement beginning in the quarter ended September 30, 2010, our estimated expected period of performance to provide research and development services under the Teva Agreement is now estimated to be a 160 month period, starting in July 2001 (following the June 2001 effective date of the Teva Agreement) and ending in October 2014 (with the estimated date of FDA approval of the final product covered by the Teva Agreement). The FDA approval of the final product under the Teva Agreement represents the end of our expected period of performance as we will have no further contractual obligation to perform research and development services under the Teva Agreement and, therefore, the earnings process for consideration received from the provision of research and development services will be complete. In accordance with our accounting policy, the change in the recognition period for the Teva Agreement was applied prospectively, as an adjustment in the period of change in the quarter ended September 30, 2010. If we determine our estimated timing of FDA approval of the final product under the Teva Agreement requires further adjustment, then we would adjust the recognition period under the Teva Agreement on a prospective basis, resulting in a change to the periodic revenue recognized under the Teva Agreement. For additional information on the accounting afforded the Teva Agreement, see “Part I: Financial Information — Item 1. Financial Statements — 11. Alliance and Collaboration Agreements — Strategic Alliance Agreement with Teva.”
Additionally, for example, our expected period of performance to provide research and development services under the Joint Development Agreement with Medicis is estimated to be a 48 month period, starting in December 2008 (i.e. when the $40.0 million upfront payment was received) and ending in November 2012 (i.e. upon FDA approval of the fifth and final submission). The FDA approval of the final submission under the Joint Development Agreement represents the end of our estimated expected period of performance, as we will have no further contractual obligation to perform research and development services under the Joint Development Agreement, and therefore the earnings process will be complete. If the timing of FDA approval for the final submission under the Joint Development Agreement is different from our estimate, the revenue recognition period will change on a prospective basis at the time such event occurs. While no such change in the estimated life of the Medicis Joint Development Agreement has occurred to date, if we were to conclude significantly more time will be required to obtain FDA approval, then we would increase our estimate of the revenue recognition period under the Joint Development Agreement, resulting in reduced revenue recognition (and related amortized costs, if any) in current and future periods.
 
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Third-Party Research and Development Agreements. In addition to our own research and development resources, we may use unrelated third-party vendors, including universities and independent research companies, to assist in our research and development activities. These vendors provide a range of research and development services to us, including clinical and bio-equivalency studies. We generally sign agreements with these vendors which establish the terms of each study performed by them, including, among other things, the technical specifications of the study, the payment schedule, and timing of work to be performed. Payments are generally earned by third-party researchers either upon the achievement of a milestone, or on a pre-determined date, as specified in each study agreement. We account for third-party research and development expenses as they are incurred according to the terms and conditions of the respective agreement for each study performed, with an accrued expense at each balance sheet date for estimated fees and charges incurred by us, but not yet billed to us. We monitor aggregate actual payments and compare them to the estimated provisions to assess the reasonableness of the accrued expense balance at each quarterly balance sheet date. Differences between our estimated and actual payments made have been de minims.
Share-Based Compensation. We recognize the fair value of each stock option and restricted stock award over its respective vesting period. Stock options and restricted stock awards granted under the Amended and Restated 2002 Equity Incentive Plan (the “2002 Plan”) generally vest over a three or four year period and have a term of ten years. We estimate the fair value of each stock option on its grant date using the Black-Scholes Merton option-pricing model, wherein: expected volatility is based solely on historical volatility of our common stock over the period commensurate with the expected term of the stock options. The expected term calculation is based on the “simplified” method described in SAB No. 107, Share-Based Payment and SAB No. 110, Share-Based Payment. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for an instrument with a maturity commensurate with the expected term of the stock options. The dividend yield is zero as we have never paid cash dividends on our common stock, and have no present intention to pay cash dividends.
Income Taxes. We are subject to United States federal, state and local income taxes and Taiwan, R.O.C. income taxes. We create a deferred tax asset, or a deferred tax liability, when we have temporary differences between the results for GAAP financial reporting purposes and tax reporting purposes. The computation of the annual estimated effective tax rate at each interim period requires us to exercise judgment to make certain estimates and assumptions including, but not limited to, the expected operating income for the year, projections of the proportion of income (or loss) earned and taxed in foreign jurisdictions, permanent and temporary differences, and the likelihood of recovering deferred tax assets generated in the current year. The accounting estimates used to compute the provision for income taxes may change as new events occur, more experience is acquired or additional information is obtained. The computation of our annual estimated effective tax rate includes modifications, which were projected for the year, for share based compensation, the domestic manufacturing deduction, and state research and development credits, among others. The tax provision for the three and nine months ended September 30, 2010 does not include the effect of the federal research and development tax credit as such tax credit expired on December 31, 2009, and has not been reinstated for 2010. The tax provision for the three and nine months ended September 30, 2009 included the effect of the federal research and development tax credit.
Fair Value of Financial Instruments. Our cash and cash equivalents include a portfolio of high-quality credit securities, including U.S. Government sponsored entity securities, treasury bills, corporate bonds, short-term commercial paper, and /or high rated money market funds. Our entire portfolio matures in less than one year. The carrying value of the portfolio approximated the market value at September 30, 2010. Our deferred compensation liability is carried at fair value, based upon observable market values. We had no debt outstanding as of September 30, 2010. Our only remaining debt instrument at September 30, 2010 was the revolving credit facility with Wells Fargo Bank, N.A., which would be subject to variable interest rates and principal payments should we decide to borrow against it.
Contingencies. In the normal course of business, we are subject to loss contingencies, such as legal proceedings and claims arising out of our business, covering a wide range of matters, including, among others, patent litigation, shareholder lawsuits, and product and clinical trial liability. In accordance with FASB ASC Topic 450 — Contingencies, we record accrued loss contingencies when it is probable a liability will be incurred and the amount of loss can be reasonably estimated and we do not recognize gain contingencies until realized.
 
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Goodwill — In accordance with FASB ASC Topic 350, “Goodwill and Other Intangibles”, goodwill is subject to an annual assessment for impairment by applying a fair-value-based test, and not periodic amortization. Under FASB ASC Topic 350, if the fair value of the reporting unit exceeds the reporting unit’s carrying value, including goodwill, then goodwill is considered not impaired, making further analysis not required. We consider each of our Global Division and Impax Division operating segments to be a reporting unit, as this is the lowest level for each of which discrete financial information is available. We attribute the entire carrying amount of goodwill to the Global Division. We concluded the carrying value of goodwill was not impaired as of December 31, 2009, as the fair value of the Global Division exceeded its carrying value at such date. We perform our annual goodwill impairment test in the fourth quarter of each year. We estimate the fair value of the Global Division using a discounted cash flow model for both the reporting unit and the enterprise, as well as earnings and revenue multiples per common share outstanding for enterprise fair value. In addition, on a quarterly basis, we perform a review of our business operations to determine whether events or changes in circumstances have occurred which may have a material adverse effect on the estimated fair value of the reporting unit, and thus indicate a potential impairment of the goodwill carrying value. If such events or changes in circumstances were deemed to have occurred, we would perform an interim impairment analysis, which may include the preparation of a discounted cash flow model, or consultation with one or more valuation specialists, to analyze the impact, if any, on our assessment of the reporting unit’s fair value. We have not to date deemed there to be any significant adverse changes in the legal, regulatory, or business environment in which we conduct our operations.
 
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Results of Operations
Three Months Ended September 30, 2010 Compared to the Three Months Ended September 30, 2009
Overview:
The following table sets forth summarized, consolidated total Company results of operations for the three months ended September 30, 2010 and 2009:
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Three Months Ended	 	 	 	 	
 	 	September 30,	 	 	September 30,	 	 	Increase/	 	
 	 	2010	 	 	2009	 	 	(Decrease)	 	
(in $000’s)	 	(unaudited)	 	 	(unaudited)	 	 	$	 	 	%	 	
Total revenues	 	$	303,993	 	 	$	64,946	 	 	$	239,047	 	 	 	368	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Gross profit	 	 	160,871	 	 	 	36,891	 	 	 	123,980	 	 	 	336	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Income from operations	 	 	123,360	 	 	 	10,163	 	 	 	113,197	 	 	nm	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Income before income taxes	 	 	123,636	 	 	 	10,152	 	 	 	113,484	 	 	nm	 	
Provision for income taxes	 	 	48,501	 	 	 	3,495	 	 	 	45,006	 	 	nm	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	 	75,135	 	 	 	6,657	 	 	 	68,478	 	 	nm	 	
Non-controlling interest	 	 	28	 	 	 	28	 	 	 	—	 	 	 	0	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Net income	 	$	75,163	 	 	$	6,685	 	 	$	68,478	 	 	nm	 	

— nm — not meaningful	
Net Income
Net income for the three months ended September 30, 2010 was $75.2 million, an increase of $68.5 million as compared to $6.7 million for the three months ended September 30, 2009, primarily attributable to an adjustment to the accounting for the Teva Agreement. For additional information regarding the accounting afforded the Teva Agreement, see “Part I: Financial Information — Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition — Overview — Critical Accounting Estimates — Estimated Lives of Alliance Agreements.” The adjustment to the accounting for the Teva Agreement resulted in an increase of approximately $61.4 million to net income in the current quarter, (i.e. tax effected at the periodic effective tax rate for the three months ended September 30, 2010). Net income, in the current quarter, before the adjustment to the accounting for the Teva Agreement would have been approximately $13.8 million, an increase of $7.1 million, or 107% from the prior year period, resulting principally from increased Global Product sales, net, resulting in increased gross profit, partially offset by higher total operating expenses and an increase in the provision for income taxes. As discussed throughout this section, we earned significant revenues and gross profit from sales of our authorized generic Adderall XR, and fenofibrate products during the three months ended September 30, 2010. With respect to our authorized generic Adderall XR products, we are dependent on another unrelated third-party pharmaceutical company to supply us with such products we market and sell through our Global Division. Any delay or interruption in the supply of our authorized generic Adderall XR products from the unrelated third-party pharmaceutical company could curtail or delay our product shipments and adversely affect our revenues, as well as jeopardize our relationships with our customers. Any significant diminution of our authorized generic Adderall XR and fenofibrate product sales revenue and /or gross profit due to competition and /or product supply or any other reasons in future periods may materially and adversely affect our results of operations in such periods.
 
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Global Division
The following table sets forth results of operations for the Global Division for the three months ended September 30, 2010 and 2009:
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Three Months Ended	 	 	 	 	
 	 	September 30,	 	 	September 30,	 	 	Increase/	 	
 	 	2010	 	 	2009	 	 	(Decrease)	 	
(in $000’s)	 	(unaudited)	 	 	(unaudited)	 	 	$	 	 	%	 	
Revenues:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Global Product sales, net	 	$	91,051	 	 	$	46,636	 	 	$	44,415	 	 	 	95	%	
Private Label Product sales	 	 	528	 	 	 	1,752	 	 	 	(1,224	)	 	 	(70	)%	
Rx Partner	 	 	202,800	 	 	 	8,328	 	 	 	194,472	 	 	nm		
OTC Partner	 	 	2,365	 	 	 	1,769	 	 	 	596	 	 	 	34	%	
Research Partner	 	 	3,384	 	 	 	2,962	 	 	 	422	 	 	 	14	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Total revenues	 	 	300,128	 	 	 	61,447	 	 	 	238,681	 	 	 	388	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Cost of revenues	 	 	140,279	 	 	 	25,098	 	 	 	115,181	 	 	 	459	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Gross profit	 	 	159,849	 	 	 	36,349	 	 	 	123,500	 	 	 	340	%	

Operating expenses:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Research and development	 	 	12,819	 	 	 	8,909	 	 	 	3,910	 	 	 	44	%	
Patent litigation	 	 	1,033	 	 	 	1,647	 	 	 	(614	)	 	 	(37	)%	
Selling, general and administrative	 	 	4,127	 	 	 	2,561	 	 	 	1,566	 	 	 	61	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Total operating expenses	 	 	17,979	 	 	 	13,117	 	 	 	4,862	 	 	 	37	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Income from operations	 	$	141,870	 	 	$	23,232	 	 	$	118,638	 	 	 	511	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
— nm — not meaningful
Revenues
Total revenues for the Global Division for the three months ended September 30, 2010, were $300.1 million, an increase of 388% over the same period in 2009.
Global Product sales, net, were $91.1 million, an increase of 95% over the same period in 2009 primarily as a result of sales of our authorized generic Adderall XR, and fenofibrate products. We commenced sales of our authorized generic Adderall XR products, indicated for the treatment of attention deficit hyperactivity disorder, in October 2009, and thus had no sales of these products in the prior-year period. The increase in sales of our fenofibrate products, a cholesterol-lowering drug, resulted from a continued increase in demand for generic versions of cholesterol-lowering drugs in general.
Private Label Product sales were $0.5 million, a decrease of 70% primarily due to lower demand for our generic loratadine /pseudoephedrine products.
Rx Partner revenues were $202.8 million, an increase over the prior year period attributable to an adjustment to revenue recognition under the Teva Agreement. For additional information regarding revenue recognition applied to the Teva Agreement, see “Part I: Financial Information — Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition — Overview — Critical Accounting Estimates — Estimated Lives of Alliance Agreements.” The adjustment to revenue recognition for the Teva Agreement resulted in an increase in Rx Partner revenue of $196.4 million in the quarter ended September 30, 2010. Such adjustment represents the recognition of previously deferred revenue which otherwise would have been recognized, under the previous accounting standards, over the remaining life of the Teva Agreement, using the modified proportional performance method. The Rx Partner revenues before the adjustment to revenue recognition for the Teva Agreement were $6.4 million for the three months ended September 30, 2010, a decrease of $1.9 million, or 23% from the prior year period primarily attributable to reduced sales of our generic Wellbutrin® XL 300mg. The reduction of revenue for generic Wellbutrin® XL 300mg resulted from increased marketplace competition.
 
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OTC Partner revenues were $2.4 million, an increase of $0.6 million primarily attributable to royalty payments received from Merck (formerly Schering-Plough) on their sales of Claritin-D® 12-hour Extended Release Tablets. There were no such royalty payments received from Merck (formerly Schering-Plough) in the prior year period.
Research Partner revenues were $3.4 million, an increase of $0.4 million, primarily driven by revenue recognition related to three milestone payments aggregating $12.0 million, received at various times during 2009, including $5.0 million in May 2009, $5.0 million received in September 2009, and $2.0 million received in December 2009.
Cost of Revenues
Cost of revenues was $140.3 million for the three months ended September 30, 2010, an increase of $115.2 over the prior year period, of which $95.4 million was related to the adjustment to amortization of deferred manufacturing costs (corresponding to the adjustment to revenue recognition) under the Teva Agreement. Before the adjustment to the recognition of deferred manufacturing costs under the Teva Agreement, cost of revenues were $44.9 million, up 79% primarily related to the higher sales of our authorized generic Adderall XR, and fenofibrate products.
Gross Profit
Gross profit for the three months ended September 30, 2010 was $159.8 million, or approximately 53% of total revenues, as compared to $36.3 million or 59% of total revenue in the same period of the prior year. Gross profit in our Global Division, before the adjustment to the accounting for the Teva Agreement, was $58.8 million, up $22.5 million primarily due to higher sales of our authorized generic Adderall XR and fenofibrate products, as discussed above.
Research and Development Expenses
Total research and development expenses for the three months ended September 30, 2010 were $12.8 million, an increase of 44%, as compared to the same period of the prior year. Generic research and development expense increased $2.0 million due to higher spending on bio-equivalency study costs, $0.9 million on active pharmaceutical ingredient used for research purposes, and $0.5 million related to higher employee compensation costs.
Patent Litigation Expenses
Patent litigation expenses for the three months ended September 30, 2010 and 2009 were $1.0 million and $1.6 million, respectively, a decrease of $0.6 million principally resulting from the settlement of two matters in the first half of 2010 which were active during the three months ended September 30, 2009.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the three months ended September 30, 2010 were $4.1 million, a 61% increase, generally attributable to overall higher sales levels period over period, and including $0.3 million in increased product freight charges, $0.3 million in higher sales personnel incentive compensation, and $1.1 million of higher marketing expenses.
 
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Impax Division
The following table sets forth results of operations for the Impax Division for the three months ended September 30, 2010 and 2009:
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Three Months Ended,	 	 	 	 	
 	 	September 30,	 	 	September 30,	 	 	Increase/	 	
 	 	2010	 	 	2009	 	 	(Decrease)	 	
(in $000’s)	 	(unaudited)	 	 	(unaudited)	 	 	$	 	 	%	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Promotional Partner revenue	 	$	3,535	 	 	$	3,499	 	 	 	36	 	 	 	1	%	
Research Partner revenue	 	 	330	 	 	 	—	 	 	 	330	 	 	nm	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Total revenues	 	 	3,865	 	 	 	3,499	 	 	 	366	 	 	 	10	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Cost of revenues	 	 	2,843	 	 	 	2,957	 	 	 	(114	)	 	 	(4	)%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Gross profit	 	 	1,022	 	 	 	542	 	 	 	480	 	 	 	89	%	

Operating expenses:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Research and development	 	 	11,027	 	 	 	6,334	 	 	 	4,693	 	 	 	74	%	
Selling, general and administrative	 	 	930	 	 	 	761	 	 	 	169	 	 	 	22	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Total operating expenses	 	 	11,957	 	 	 	7,095	 	 	 	4,862	 	 	 	69	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Loss from operations	 	$	(10,935	)	 	$	(6,553	)	 	 	(4,382	)	 	 	(67	)%	

— nm — not meaningful		
Revenues
Total revenues were $3.9 million for the three months ended September 30, 2010, an increase of 10% compared to the same period in the prior year, principally related to $0.3 million of Research Partner revenue resulting from the Development and Co-Promotion Agreement with Endo Pharmaceuticals, Inc, which was entered into in June 2010, and accordingly, there were no similar revenues in the prior year period. In addition, physician detailing services under our Co-Promotion Agreement with Pfizer commenced on July 1, 2009 (these services were initially provided under the former Co-Promotion Agreement with Wyeth, which is now a wholly-owned subsidiary of Pfizer). The Promotional Partner revenue in the three months ended September 30, 2009, was earned under the terms of the previous Promotional Services Agreement with Shire, which expired on June 30, 2009.
Cost of Revenues
Cost of revenues was $2.8 million for the three months ended September 30, 2010, with nominal change from the same period in 2009.
Gross Profit
Gross profit for the three months ended September 30, 2010 was $1.0 million, an increase of $0.5 million attributed primarily to the higher Promotional Partner revenues (as described above).
Research and Development Expenses
Total research and development expenses for the three months ended September 30, 2010 were $11.0 million, an increase of 74%, as compared to $6.3 million in the prior year period, with the $4.7 million increase principally driven by research and development expenses related to our branded product initiatives, including increases of $4.1 million for clinical trial studies and $0.2 million for R&D active pharmaceutical ingredient.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $0.9 million in the current period, as compared to $0.8 million in the prior period, with the increase primarily related higher employee compensation expense.
 
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Corporate and other
The following table sets forth Corporate general and administrative expenses, as well as other items of income and expense presented below income from operations for the three months ended September 30, 2010 and 2009:
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Three Months Ended	 	 	 	 	
 	 	September 30,	 	 	September 30,	 	 	Increase/	 	
 	 	2010	 	 	2009	 	 	(Decrease)	 	
(in $000’s)	 	(unaudited)	 	 	(unaudited)	 	 	$	 	 	%	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Litigation settlement	 	$	—	 	 	$	818	 	 	 	(818	)	 	 	(100	)%	
General and administrative expenses	 	 	7,575	 	 	 	5,698	 	 	 	1,877	 	 	 	33	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Total operating expenses	 	 	7,575	 	 	 	6,516	 	 	 	1,059	 	 	 	16	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Loss from operations	 	 	(7,575	)	 	 	(6,516	)	 	 	(1,059	)	 	 	(16	)%	

Other income (expense), net	 	 	(91	)	 	 	(6	)	 	 	(85	)	 	nm	 	
Interest income	 	 	405	 	 	 	180	 	 	 	225	 	 	 	125	%	
Interest expense	 	 	(38	)	 	 	(185	)	 	 	147	 	 	 	79	%	
Provision for income taxes	 	$	48,501	 	 	$	3,495	 	 	 	45,006	 	 	nm	 	
—  nm — not meaningful
Litigation settlement
The $0.8 million of litigation settlement expense for the three months ended September 30, 2009 included legal and other professional fee expenses incurred by us in defense of a suit related to our (previously marketed) Lipram UL products which we settled in January 2010, and accordingly there were no similar amounts in the current year period.
General and Administrative Expenses
General and administrative expenses for the three months ended September 30, 2010 were $7.6 million, a $1.9 million increase over the prior period, principally driven by an increase in compensation-related expenses of $0.6 million, higher insurance costs related to increasing levels of business activity of $0.3 million and an increase in systems implementation and integration expenses of $0.3 million. In addition, the prior year period included a $0.7 million reduction in general and administrative expense related to the August 2009 repayment-in-full of a subordinated promissory note, which did not repeat in the current year period.
Other income (expense), net
Other income (expense), net was minimal for the three months ended September 30, 2010 and 2009, and contained no individually-significant items.
Interest Income
Interest income in the three months ended September 30, 2010 was $0.4 million, with the period over period increase of $0.2 million resulting from higher average balances of cash and cash equivalents and short-term investments, partially offset by lower overall interest income rates.
Interest Expense
Interest expense in the three months ended September 30, 2010 declined $0.1 million to $0.04 million, compared to the prior year period due to the absence of interest bearing debt.
 
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Income Taxes
During the three months ended September 30, 2010, we recorded a tax provision of $48.5 million for United States domestic, federal and state income taxes and for income taxes in jurisdictions outside the United States. Included in the tax provision for the three months ended September 30, 2010 is an accrual for uncertain tax positions of $0.01 million. In the three months ended September 30, 2009, we recorded a tax provision of $3.5 million for United States domestic federal and state income taxes and for income taxes in jurisdictions outside the United States. Included in the tax provision for the three months ended September 30, 2009 is an accrual for uncertain tax positions of $0.2 million. The tax provision for the three months ended September 30, 2010 does not include the effect of the federal research and development tax credit which expired on December 31, 2009, and as of the September 30, 2010 balance sheet date had not been reinstated for 2010. The tax provision for the three months ended September 30, 2009 included the effect of the federal research and development tax credit. The effective tax rate of 39% for the three months ended September 30, 2010 was higher than the effective tax rate of 34% for the three months ended September 30, 2009, resulting principally from the absence of the federal research and development tax credit in the current year period.
 
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Results of Operations
Nine Months Ended September 30, 2010 Compared to the Nine Months Ended September 30, 2009
Overview:
The following table sets forth summarized, consolidated total Company results of operations for the nine months ended September 30, 2010 and 2009:
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Nine Months Ended	 	 	 	 	
 	 	September 30,	 	 	September 30,	 	 	Increase/	 	
 	 	2010	 	 	2009	 	 	(Decrease)	 	
(in $000’s)	 	(unaudited)	 	 	(unaudited)	 	 	$	 	 	%	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Total revenues	 	$	780,407	 	 	$	182,275	 	 	$	598,132	 	 	 	328	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Gross profit	 	 	488,818	 	 	 	100,686	 	 	 	388,132	 	 	 	385	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Income from operations	 	 	383,632	 	 	 	18,284	 	 	 	365,348	 	 	nm	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Income before income taxes	 	 	384,070	 	 	 	18,237	 	 	 	365,833	 	 	nm	 	
Provision for income taxes	 	 	146,114	 	 	 	6,373	 	 	 	139,741	 	 	nm	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	 	237,956	 	 	 	11,864	 	 	 	226,092	 	 	nm	 	
Non-controlling interest	 	 	40	 	 	 	53	 	 	 	(13	)	 	 	(25	)%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Net income	 	$	237,996	 	 	$	11,917	 	 	$	226,079	 	 	nm	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
—  nm — not meaningful
Net Income
Net income for the nine months ended September 30, 2010 was $238.0 million, an increase of $226.1 million as compared to $11.9 million for the nine months ended September 30, 2009, primarily attributable to an adjustment to the accounting for the Teva Agreement. For additional information on the accounting afforded the Teva Agreement, see “Part I: Financial Information — Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition — Overview — Critical Accounting Estimates — Estimated Lives of Alliance Agreements.” The adjustment to the accounting for the Teva Agreement resulted in an increase of approximately $62.6 million to net income in the current year period (i.e. tax effected at the periodic effective tax rate for the nine months ended September 30, 2010). Net income, in the current year period, before the adjustment to the accounting for the Teva Agreement would have been approximately $175.4 million, an increase of $163.5 million from the prior year period, resulting principally from increased Global Product sales, net, resulting in increase in gross profit, partially offset by higher total operating expenses and an increase in the provision for income taxes. As discussed throughout this section, we earned significant revenues and gross profit from sales of our tamsulosin, authorized generic Adderall XR, and fenofibrate products during the nine months ended September 30, 2010. With respect to our authorized generic Adderall XR products, we are dependent on another unrelated third-party pharmaceutical company to supply us with such products we market and sell through our Global Division. Any delay or interruption in the supply of our authorized generic Adderall XR products from the unrelated third-party pharmaceutical company could curtail or delay our product shipments and adversely affect our revenues, as well as jeopardize our relationships with our customers. Any significant diminution of our authorized generic Adderrall XR and fenofibrate product sales revenue and /or gross profit due to competition and /or product supply or any other reasons in future periods may materially and adversely affect our results of operations in such periods.
 
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Global Division
The following table sets forth results of operations for the Global Division for the nine months ended September 30, 2010 and 2009:
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Nine Months Ended	 	 	 	 	
 	 	September 30,	 	 	September 30,	 	 	Increase/	 	
 	 	2010	 	 	2009	 	 	(Decrease)	 	
(in $000’s)	 	(unaudited)	 	 	(unaudited)	 	 	$	 	 	%	 	
Revenues:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Global Product sales, net	 	$	537,794	 	 	$	123,144	 	 	$	414,650	 	 	 	337	%	
Private Label Product sales	 	 	1,539	 	 	 	5,269	 	 	 	(3,730	)	 	 	(71	)%	
Rx Partner	 	 	213,504	 	 	 	30,183	 	 	 	183,321	 	 	 	607	%	
OTC Partner	 	 	6,439	 	 	 	5,255	 	 	 	1,184	 	 	 	23	%	
Research Partner	 	 	10,153	 	 	 	8,406	 	 	 	1,747	 	 	 	21	%	
Other	 	 	—	 	 	 	11	 	 	 	(11	)	 	 	(100	)%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Total revenues	 	 	769,429	 	 	 	172,268	 	 	 	597,161	 	 	 	347	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Cost of revenues	 	 	282,309	 	 	 	72,339	 	 	 	209,970	 	 	 	290	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Gross profit	 	 	487,120	 	 	 	99,929	 	 	 	387,191	 	 	 	387	%	

Operating expenses:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Research and development	 	 	32,608	 	 	 	28,761	 	 	 	3,847	 	 	 	13	%	
Patent litigation	 	 	4,786	 	 	 	4,058	 	 	 	728	 	 	 	18	%	
Selling, general and administrative	 	 	11,149	 	 	 	7,628	 	 	 	3,521	 	 	 	46	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Total operating expenses	 	 	48,543	 	 	 	40,447	 	 	 	8,096	 	 	 	20	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Income from operations	 	$	438,577	 	 	$	59,482	 	 	$	379,095	 	 	 	637	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Revenues
Total revenues for the Global Division for the nine months ended September 30, 2010, were $769.4 million, an increase of 347% over the same period in 2009.
Global Product sales, net, were $537.8 million, an increase of 337% over the same period in 2009 primarily as a result of sales of our tamsulosin, authorized generic Adderall XR, and fenofibrate products. Of the $414.7 million increase, $207.4 million resulted from sales of tamsulosin, our generic version of Flomax ® , a drug used to improve symptoms associated with an enlarged prostate. We commenced sales of our tamsulosin product on March 2, 2010 and had contractual market exclusivity for this generic product for the succeeding eight week period, during which we were able to achieve high market-share penetration. Our future tamsulosin product sales, however, have not remained at this level, as additional competing generic versions of the product entered the market in late April 2010, at the conclusion of our contractual exclusivity period, and have resulted in both price erosion and reduction of our market share. We commenced sales of our authorized generic Adderall XR products, indicated for the treatment of attention deficit hyperactivity disorder, in October 2009, and thus had no sales of these products in the prior-year period. The increase in sales of our fenofibrate products a cholesterol-lowering drug, resulted from a continued increase in demand for generic versions of cholesterol-lowering drugs in general.
Private Label Product sales were $1.5 million, a decrease of 71%, primarily due to lower demand for our generic loratadine /pseudoephedrine products.
 
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Rx Partner revenues were $213.5 million, an increase over the prior year period attributable to an adjustment to the revenue recognition under the Teva Agreement. For additional information on the accounting afforded the Teva Agreement, see “Part I: Financial Information — Item 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition — Overview — Critical Accounting Estimates — Estimated Lives of Alliance Agreements.” The adjustment to revenue recognition for the Teva Agreement resulted in an increase of $196.4 million in the nine months ended September 30, 2010. Such adjustment represents the recognition of previously deferred revenue which otherwise would have been recognized, under the previous accounting standards, over the remaining life of the Teva Agreement, using the modified proportional performance method. The Rx Partner revenues before the adjustment to the revenue recognition for the Teva Agreement were $17.1 million in the current year period, representing a decrease of $13.1 million, or 44% from the prior year period, primarily attributable to reduced sales of our generic Wellbutrin® XL 300mg. The reduction of revenue for generic Wellbutrin® XL 300mg resulted from increased marketplace competition.
OTC Partner revenues were $6.4 million, an increase of $1.2 million, primarily attributable to royalty payments received from Merck (formerly Schering-Plough) on their sales of Claritin-D ® 12-hour Extended Release Tablets; there were no such royalty payments received from Merck (formerly Schering-Plough) in the prior year period.
Research Partner revenues were $10.2 million, an increase of $1.7 million, primarily driven by revenue recognition related to three milestone payments aggregating $12.0 million, received at various times during 2009, including $5.0 million in May 2009, $5.0 million received in September 2009, and $2.0 million received in December 2009.
Cost of Revenues
Cost of revenues was $282.3 million for the nine months ended September 30, 2010, an increase of $210.0 million over the prior year period, of which $95.4 million was related to the adjustment to the amortization of deferred manufacturing costs (corresponding to the adjustment to revenue recognition) under the Teva Agreement. Before the adjustment to the recognition of deferred manufacturing costs under the Teva Agreement, cost of revenues were $186.9 million, up 158% primarily related to the higher sales of our tamsulosin, authorized generic Adderall XR, and fenofibrate products.
Gross Profit
Gross profit for the nine months ended September 30, 2010 was $487.1 million, or approximately 63% of total revenues, as compared to $99.9 million or 58% of total revenue in the same period of the prior year. Gross profit in our Global Division, before the adjustment to the accounting for the Teva Agreement, was $386.1 million, up $286.2 million primarily due to higher sales of our tamsulosin product, which accounted for $190.3 million of the period over period increase. Also contributing to the increase were higher sales of our authorized generic Adderall XR and fenofibrate products, as discussed above.
Research and Development Expenses
Total research and development expenses for the nine months ended September 30, 2010 were $32.6 million, an increase of 13% as compared to the same period of the prior year. Generic research and development expense increased $2.1 million due to higher spending on bio-equivalency study costs, $0.8 million on active pharmaceutical ingredient used in research related activities, and $0.5 million of higher outside development costs, partially offset by lower levels of other development-related expenses.
 
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Patent Litigation Expenses
Patent litigation expenses for the nine months ended September 30, 2010 and 2009 were $4.8 million and $4.1 million, respectively, an increase of $0.7 million principally resulting from higher overall expenses in the current year period as a result of increased activity related to two matters which were settled in the first six months of 2010.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the nine months ended September 30, 2010 were $11.1 million, a 46% increase generally attributable to overall higher sales levels period-over-period, and including $1.1 million in increased product freight expenses, $0.9 million of higher marketing expenses, and $0.6 million of post-approval product clinical study costs (of which such clinical study costs were not present in the prior year period).
 
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Impax Division
The following table sets forth results of operations for the Impax Division for the nine months ended September 30, 2010 and 2009:
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Nine Months Ended,	 	 	 	 	
 	 	September 30,	 	 	September 30,	 	 	Increase/	 	
 	 	2010	 	 	2009	 	 	(Decrease)	 	
(in $000’s)	 	(unaudited)	 	 	(unaudited)	 	 	$	 	 	%	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Promotional Partner revenue	 	$	10,538	 	 	$	10,007	 	 	 	531	 	 	 	5	%	
Research Partner revenue	 	 	440	 	 	 	—	 	 	 	440	 	 	nm	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Total revenues	 	 	10,978	 	 	 	10,007	 	 	 	971	 	 	 	10	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Cost of revenues	 	 	9,280	 	 	 	9,250	 	 	 	30	 	 	 	0.3	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Gross profit	 	 	1,698	 	 	 	757	 	 	 	941	 	 	 	124	%	

Operating expenses:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Research and development	 	 	30,656	 	 	 	17,983	 	 	 	12,673	 	 	 	70	%	
Selling, general and administrative	 	 	2,478	 	 	 	2,528	 	 	 	(50	)	 	 	(2	)%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Total operating expenses	 	 	33,134	 	 	 	20,511	 	 	 	12,623	 	 	 	62	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Loss from operations	 	$	(31,436	)	 	$	(19,754	)	 	 	(11,682	)	 	 	(59	)%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
—  nm — not meaningful
Revenues
Total revenues were $11.0 million for the nine months ended September 30, 2010, an increase of 10% compared to the same period in the prior year, principally related to the commencement of physician detailing services under our Co-Promotion Agreement with Pfizer which commenced on July 1, 2009 (these services were initially under the former Co-Promotion Agreement with Wyeth, which is now a wholly-owned subsidiary of Pfizer). The Promotional Partner revenue earned by us during the first six month of 2009 was earned under the terms of the previous Promotional Services Agreement with Shire, which expired on June 30, 2009. In addition, we recognized $0.4 million of Research Partner revenue related to a Development and Co-Promotion Agreement with Endo Pharmaceuticals, Inc. which was entered into in June 2010, and accordingly, there were no similar revenues in the prior year period.
Cost of Revenues
Cost of revenues was $9.3 million for the nine months ended September 30, 2010, with no individually significant changes from the same period in 2009.
Gross Profit
Gross profit for the nine months ended September 30, 2010 was $1.7 million, an increase of $0.9 million attributed primarily to the higher Promotional Partner revenues (as described above).
Research and Development Expenses
Total research and development expenses for the nine months ended September 30, 2010 were $30.7 million, an increase of 70%, as compared to $18.0 million in the prior year period, with the $12.7 million increase principally driven by research and development expenses related to our branded product initiatives, including increases of $10.6 million for clinical trial studies, $1.5 million on employee compensation, $0.4 million on active pharmaceutical ingredient used in research related activities, and $0.2 million on PK studies.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $2.5 million, with no individually significant changes from the same period in 2009.
 
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Corporate and other
The following table sets forth Corporate general and administrative expenses, as well as other items of income and expense presented below income from operations for the nine months ended September 30, 2010 and 2009:
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Nine Months Ended	 	 	 	 	
 	 	September 30,	 	 	September 30,	 	 	Increase/	 	
 	 	2010	 	 	2009	 	 	(Decrease)	 	
(in $000’s)	 	(unaudited)	 	 	(unaudited)	 	 	$	 	 	%	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Litigation settlement	 	$	—	 	 	$	1,674	 	 	 	(1,674	)	 	 	(100	)%	
General and administrative expenses	 	 	23,509	 	 	 	19,770	 	 	 	3,739	 	 	 	19	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Total operating expenses	 	 	23,509	 	 	 	21,444	 	 	 	2,065	 	 	 	10	%	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Loss from operations	 	 	(23,509	)	 	 	(21,444	)	 	 	(2,065	)	 	 	(10	)%	

Other income (expense), net	 	 	(134	)	 	 	52	 	 	 	(186	)	 	 	(358)	%	
Interest income	 	 	680	 	 	 	636	 	 	 	44	 	 	 	7	%	
Interest expense	 	 	(108	)	 	 	(735	)	 	 	627	 	 	 	85	%	
Provision for income taxes	 	$	146,114	 	 	$	6,373	 	 	 	139,741	 	 	nm	 	
—  nm — not meaningful
Litigation settlement
The $1.7 million of Litigation settlement expense for the nine months ended September 30, 2009 included legal and other professional fee expenses incurred by us in defense of a suit related to our (previously marketed) Lipram UL products which we settled in January 2010, and accordingly there were no similar amounts in the current year period.
General and Administrative Expenses
General and administrative expenses for the nine months ended September 30, 2010 were $23.5 million, a 19% increase attributable principally to an increase in compensation-related expenses of $1.9 million, higher insurance costs related to increasing levels of business activity of $0.7 million, and an increase in system implementation and integration expenses of $0.4 million. In addition, in the prior year period there was a $0.7 million reduction in general and administrative expenses related to the August 2009 repayment-in-full of a subordinated promissory note, which did not repeat in the current year period.
Other income (expense), net
Other income (expense), net was minimal for the nine months ended September 30, 2010 and 2009, and contained no individually-significant items.
Interest Income
Interest income in the nine months ended September 30, 2010 was $0.7 million, a 7% increase as compared to the prior year period due primarily to higher average balances of cash and cash equivalents and short-term investments partially offset by lower overall interest rates.
Interest Expense
Interest expense in the nine months ended September 30, 2010 declined $0.6 million to $0.1 million, compared to the prior year period due to the absence of interest bearing debt resulting from the repurchase, on the contractual June 15, 2009 prepayment option date, of the $12.75 million remaining outstanding balance of our 3.5% convertible senior subordinated debentures, otherwise due in June 2012.
 
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Income Taxes
During the nine months ended September 30, 2010, we recorded a tax provision of $146.1 million for United States domestic federal and state income taxes and for income taxes in jurisdictions outside the United States. Included in the tax provision for the nine months ended September 30, 2010 is an accrual for uncertain tax positions of $0.04 million. In the nine months ended September 30, 2009, we recorded a tax provision of $6.4 million for United States domestic federal and state income taxes and for income taxes in jurisdictions outside the United States. Included in the tax provision for the nine months ended September 30, 2009 is an accrual for uncertain tax positions of $0.7 million. The tax provision for the nine months ended September 30, 2010 does not include the effect of the federal research and development tax credit which expired on December 31, 2009, and to-date has not been reinstated for 2010. The tax provision for the nine months ended September 30, 2009 included the effect of the federal research and development tax credit. The tax provision for the nine months ended September 30, 2009 also included the effect of the reversal of a valuation allowance on the deferred tax asset related to net operating losses at our wholly-owned subsidiary Impax Laboratories (Taiwan), Inc. We reversed the valuation allowance related to these net operating losses as a result of retroactive changes in Taiwan tax law published in the second quarter of 2009. The effective tax rate of 38% for the nine months ended September 30, 2010 was higher than the effective tax rate of 35% for the nine months ended September 30, 2009, resulting principally from the absence of the federal research and development tax credit in the current year period and the reversal of the valuation allowance in the prior year period described above.
 
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Liquidity and Capital Resources
We have historically funded our operations with the proceeds from the sale of debt and equity securities, and more recently, with cash from operations. Currently, our principal source of liquidity is cash from operations, consisting of the proceeds from the sales of our products and provision of services.
We expect to incur significant operating expenses, including expanded research and development activities and patent litigation expenses, for the foreseeable future. We estimate research and development expenses will be approximately $85.0 million and patent litigation expenses will be approximately $8.0 million for the 12 months ending December 31, 2010. We also anticipate incurring capital expenditures of approximately $20.0 million during the 12 months ending December 31, 2010, principally for continued improvements and expansion of our research and development and manufacturing facilities in the State of California, our packaging and distribution facilities in the Commonwealth of Pennsylvania, and our facility in Jhunan Taiwan, R.O.C. In addition, we are generally required to make cash expenditures to manufacture and /or acquire finished product inventory in advance of selling the finished product to our customers and collecting payment for such product sales, which may result in a significant use of cash.
We believe our existing cash and cash equivalents and short-term investment balances, together with cash expected to be generated from operations, and our bank revolving line of credit, will be sufficient to meet our financing requirements through the next 12 months. We may, however, seek additional financing through alliance, collaboration, and /or licensing agreements, as well as from the equity and /or debt capital markets to fund the planned capital expenditures, our research and development plans, potential acquisitions, and potential revenue shortfalls due to delays in new product introductions.
Cash and Cash Equivalents
At September 30, 2010, we had $165.8 million in cash and cash equivalents, an increase of $134.0 million as compared to December 31, 2009. As more fully discussed below, the increase in cash and cash equivalents during the nine months ended September 30, 2010 was primarily driven by $259.9 million of cash provided by operations, which included a decrease in accounts receivable, as well as an increase in accounts payable and accrued expenses to be paid in subsequent periods. The increase in cash was also impacted by $13.9 million received from the exercise of stock options and employee stock purchase plan contributions, while being offset by net purchases of short term investments of $133.6 million and $10.5 million of purchases of property, plant and equipment, during the nine month period ended September 30, 2010.
Cash Flows
Nine Months Ended September 30, 2010 Compared to the Nine Months Ended September 30, 2009.
Net cash provided by operating activities for the nine months ended September 30, 2010 was $259.9 million, an increase of $262.3 million as compared to the prior year period $2.4 million net cash used in operating activities.
The period-over-period increase in net cash provided by operating activities resulted principally from a higher net income, a decrease in accounts receivable, and an increase in accounts payable and accrued expenses. The decrease in accounts receivable to $95.6 million at September 30, 2010, resulted in a $90.1 million source of cash, compared to the same period in the prior year when accounts receivable resulted in a $18.4 million use of cash flows. In addition, higher levels of accounts payable and accrued expenses resulted in a period-over-period increase of $7.5 million in cash flows. The decreased level of accounts receivable at September 30, 2010 was primarily the result of the collection of amounts owed by our customers related to product sales from the launch of our tamsulosin product in March 2010, and of our authorized generic Adderall XR products (launched in October 2009). We commenced sales of our tamsulosin product on March 2, 2010 and had contractual market exclusivity for this generic product for the succeeding eight week period, during which we were able to achieve high market-share penetration. Our future tamsulosin product sales, however, will not remain at this level, as additional competing generic versions of the product entered the market in late April 2010 at the conclusion of the contractual exclusivity period, and have resulted in both price erosion and reduction of our market-share. (See Results of Operations above for additional discussion.)
 
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Net cash used by investing activities for the nine months ended September 30, 2010, amounted to $144.1 million, an increase of $133.9 million as compared to the prior year period $10.2 million use of cash flows in investing activities, with the change due to a period-over-period $131.8 million net increase in the purchase of short-term investments, and $2.1 million in higher expenditures on property, plant and equipment. Net purchases of short-term investments during the nine months ended September 30, 2010 resulted in a $133.6 million use of cash flows, as compared to a $1.8 million use of cash flows from net purchases of short-term investments during the same period in the prior year. Purchases of property, plant and equipment for the nine months ended September 30, 2010 amounted to $10.5 million as compared to $8.4 million for the prior year period. We expect continued investment in facilities, equipment, and information technology projects supporting our quality initiatives to ensure we have appropriate levels of technology infrastructure to manage and grow our global business.
Net cash provided by financing activities for the nine months ended September 30, 2010 was approximately $18.3 million, representing an increase of $27.4 million as compared to the prior year period $9.1 million of net cash used in financing activities. The period-over-period increase in net cash provided by financing activities was primarily due to an increase in cash proceeds received from the exercise of stock options and contributions to the employee stock purchase plan (“ESPP”) of $13.9 million for the nine months ended September 30, 2010, as compared to $3.8 million received in the prior year period. In addition, on the contractual June 15, 2009 prepayment option date, at the request of the holders, we repurchased the remaining $12.75 million principal amount of the 3.5% Debentures at 100% of face value, plus accrued interest resulting in a net use of cash in financing activities in the prior year period.
 
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Outstanding Debt Obligations
Senior Lenders; Well Fargo Bank
We have a $35.0 million revolving credit facility under a credit agreement with Wells Fargo Bank, N.A. (“Credit Agreement”), with a January 31, 2011 expiration date. The revolving credit facility, intended for working capital and general corporate purposes, is collateralized by eligible accounts receivable, inventory, and machinery and equipment, subject to limitations and other terms. There were no amounts outstanding under the revolving credit facility as of September 30, 2010 and December 31, 2009, respectively.
The interest rate for the revolving credit facility is either the prime rate plus a margin ranging from 0.25% to 0.75% or LIBOR plus a margin ranging from 2.25% to 3.0% based upon certain terms and conditions. We are required to pay an unused line fee of 50 basis points per annum and a servicing fee of $1,500 during any month in which no revolver loans are outstanding. During the nine months ended September 30, 2010 and 2009, we paid unused line fees of $133,000 and $128,000, respectively.
The Credit Agreement contains various financial covenants, the most significant of which include a “fixed charge coverage ratio” and a capital expenditure limitation. The fixed charge coverage ratio, applicable only for periods during which our net cash position is less than $50.0 million, requires EBITDA less cash paid for taxes, dividends, and certain capital expenditures to be not less than 1.25 to 1.00 as compared to scheduled principal payments coming due in the next 12 months plus cash interest paid during the applicable period. We are limited to capital expenditures of no more than $25.0 million for each calendar year. The Credit Agreement also provides for certain information reporting covenants, including a requirement to provide certain periodic financial information. At September 30, 2010, we were in compliance with the various financial and information reporting covenants contained in the Credit Agreement.
 
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Recent Accounting Pronouncements
In September 2009, the FASB approved an update to the accounting standard related to multiple-deliverable revenue arrangements currently within the scope of FASB ASC Topic 605. The updated accounting standard provides principles and guidance to be used to determine whether a revenue arrangement has multiple deliverables, and if so, how those deliverables should be separated. If multiple deliverables exist, the updated standard requires revenue received under the arrangement to be allocated using the estimated selling price of the deliverables if vendor-specific objective evidence or third-party evidence of selling price is not available. The updated accounting standard is effective for revenue arrangements entered into or materially modified in fiscal years beginning on, or after June 15, 2010, with early application permitted. We adopted the updated guidance of ASC 605-25 in the three months ended September 30, 2010. As required, we applied the updated guidance of ASC 605-25 retrospectively from the beginning of our fiscal year of adoption, as of January 1, 2010. Accordingly, the updated guidance of ASC 605-25 will apply to all multiple-element revenue agreements entered into or materially modified by us from January 1, 2010 forward. The application of the updated guidance did not have any impact on our revenue recognition during the three and six months ended June 30, 2010. The updated guidance of ASC 605-25 was applied to the Teva Agreement during the three months ended September 30, 2010. For a discussion of the impact of FASB ASC Topic 605-25 on the Teva Agreement, see “Part I: Financial Information — Item 1. Financial Statements — 11. Alliance and Collaboration Agreements — Strategic Alliance Agreement with Teva.”
In January 2010, the FASB issued Accounting Standards Update No. 2010-02, Consolidation (Topic 810): Accounting and Reporting for Decreases in Ownership of a Subsidiary — a Scope Clarification. This update provides amendments to Subtopic 810-10, and related guidance within US GAAP, to clarify the scope of the decrease in ownership provisions. For those entities that have already adopted Statement 160, the amendments are effective at the beginning of the first interim or annual reporting period ending on or after December 15, 2009. The amendments should be applied retrospectively to the first period that an entity adopted Statement 160. Upon becoming effective this update did not have an impact on our consolidated financial statements.
In March 2010, the FASB approved the “Milestone Method of Revenue Recognition,” which addresses accounting for arrangements in which a vendor satisfies its performance obligations over time, with all or a portion of the consideration contingent on future events, referred to as “milestones.” The Milestone Method of Revenue Recognition is limited to arrangements which involve research or development activities. A milestone is defined as an event for which, at the date the arrangement is entered into, there is substantive uncertainty whether the event will be achieved, and the achievement of the event is based in whole or in part on either the vendor’s performance or a specific outcome resulting from the vendor’s performance. In addition, the achievement of the event would result in additional payments being due to the vendor. The Milestone Method of Revenue Recognition allows a vendor to adopt an accounting policy to recognize arrangement consideration that is contingent on the achievement of a substantive milestone in its entirety in the period the milestone is achieved. The Milestone Method of Revenue Recognition is effective on a prospective basis, with an option for retrospective application, for milestones achieved in fiscal years and interim periods within those fiscal years beginning on or after June 15, 2010. Early adoption is permitted. If an entity elects early application in a period that is not the first reporting period of its fiscal year, then the guidance must be applied retrospectively from the beginning of that fiscal year. We will determine the impact of the new accounting standard as we achieve milestones, and earn payments under either new or existing revenue arrangements.
 
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There were no material changes to the quantitative and qualitative disclosures about market risk set forth in our Annual Report on Form 10-K for the year ended December 31, 2009.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
The Company maintains disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) that are designed to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the Company’s management, including its principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.
The Company’s management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the Company’s disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based upon that evaluation, the Company’s Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures, as defined in Rule 13a-15(e) of the Exchange Act, were effective as of September 30, 2010.
Changes in Internal Control over Financial Reporting
During the quarter ended September 30, 2010, there were no changes in the Company’s internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
 
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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Patent Infringement Litigation
Purdue Pharma Products L.P., et al. v. Impax Laboratories, Inc. (Tramadol)
In August 2008, Purdue Pharma Products L.P., Napp Pharmaceutical Group LTD., Biovail Laboratories International, SRL, and Ortho-McNeil-Janssen Pharmaceuticals, Inc. (collectively, “Purdue”) filed suit against us in the U.S. District Court for the District of Delaware, alleging patent infringement for the filing of our ANDA relating to Tramadol Hydrochloride Extended Release Tablets, 100 mg, generic to 100mg Ultram® ER. In November 2008, Purdue asserted additional infringement claims with respect to our amended ANDA, which added 200 mg and 300 mg strengths of the product. We filed answers and counterclaims to those complaints. In August 2009, one of the patents-in-suit, U.S. Patent No. 6,254,887, was found invalid in another ANDA case relating to Ultram® ER, Purdue Pharma Products L.P. et al, v. Par Pharmaceutical, Inc. et al. , Case No. 07-255 (D. Del.) (“Par action”) The Par action is now on appeal to the U. S. Court of Appeals for the Federal Circuit. On November 16, 2009, we and Purdue agreed by stipulation to stay the case until the earlier of the following two events: (a) the Federal Circuit issues a mandate in the Par action or that action is otherwise disposed of, or (b) an undisclosed event. The Federal Circuit affirmed the decision of invalidity in the Par action on June 3, 2010 . On September 2, 2010, this matter was dismissed with prejudice.
Warner Chilcott, Ltd. et.al. v. Impax Laboratories, Inc. (Doxycycline Hyclate)
In December 2008, Warner Chilcott Limited and Mayne Pharma International Pty. Ltd. (together, “Warner Chilcott”) filed suit against us in the U.S. District Court for the District of New Jersey, alleging patent infringement for the filing of our ANDA relating to Doxycycline Hyclate Delayed Release Tablets, 75 mg and 100 mg, generic to Doryx®. We have filed an answer and counterclaim. Thereafter, in March 2009, Warner Chilcott filed another lawsuit in the same jurisdiction, alleging patent infringement for the filing of our ANDA for the 150 mg strength. Discovery is proceeding, fact discovery closes on December 17, 2010, and no trial date has been set.
Eurand, Inc., et al. v. Impax Laboratories, Inc. (Cyclobenzaprine)
In January 2009, Eurand, Inc., Cephalon, Inc., and Anesta AG (collectively, “Cephalon”) filed suit against us in the U.S. District Court for the District of Delaware, alleging patent infringement for the filing of our ANDA relating to Cyclobenzaprine Hydrochloride Extended Release Capsules, 15 mg and 30 mg, generic to Amrix®. We have filed an answer and counterclaim. This matter was settled and dismissed on October 11, 2010.
The Research Foundation of State University of New York et al. v. Impax Laboratories, Inc. (Doxycycline Monohydrate)
In September 2009, The Research Foundation of State University of New York; New York University; Galderma Laboratories Inc.; and Galderma Laboratories, L.P. (collectively, “Galderma”) filed suit against us in the U.S. District Court for the District of Delaware alleging patent infringement for the filing of our ANDA relating to Doxycycline Monohydrate Delayed-Release Capsules, 40 mg, generic to Oracea®. We filed an answer and counterclaim. In October 2009, the parties agreed to be bound by the final judgment concerning infringement, validity and enforceability of the patent at issue in cases brought by Galderma against another generic drug manufacturer that has filed an ANDA relating to this product and proceedings in this case were stayed. In June 2010, Galderma moved for a preliminary injunction to bar sales by the other generic manufacturer based on two of the patents in suit, which motion was granted by the magistrate judge in a decision finding Galderma had shown a likelihood of success on the merits. In July, 2010 the generic manufacturer filed a motion for reargument of Galderma’s motion for preliminary injunction and temporary restraining order. The motion is pending.
 
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Elan Pharma International Ltd. and Fournier Laboratories Ireland Ltd. v. Impax Laboratories, Inc. and Abbott Laboratories and Laboratories Fournier S.A. v. Impax Laboratories, Inc. (Fenofibrate)
In October 2009, Elan Pharma International Ltd. with Fournier Laboratories Ireland Ltd. and Abbott Laboratories with Laboratories Fournier S.A. filed separate suits against us in the U.S. District Court for the District of New Jersey alleging patent infringement for the filing of our ANDA relating to Fenofibrate Tablets, 48 mg and 145 mg, generic to Tricor®. We have filed an answer and counterclaim. In September 2010, the Court vacated the schedule and ordered a stay in each matter.
Abbott Laboratories, et al. v. Impax Laboratories, Inc. (Choline Fenofibrate)
In March 2010, Abbott Laboratories and Fournier Laboratories Ireland Ltd. (together, “Abbott”) filed suit against us in the U.S District Court for the District of New Jersey alleging patent infringement for the filing of our ANDA related to Choline Fenofibrate Delayed Release Capsules, 45 mg and 135 mg, generic of Trilipix®. We have filed an answer. Discovery is proceeding, fact discovery closes February 4, 2011, and no trial date has been scheduled.
Genzyme Corp. v. Impax Laboratories, Inc. (Sevelamer Carbonate Powder)
In July 2010, Genzyme Corporation filed suit against us in the U.S. District Court for the District of Maryland, alleging patent infringement for the filing of our ANDA relating to Sevelamer Carbonate Powder, 2.4 g and 0.8 g packets, generic to Renvela® powder. We have filed an answer and counterclaim. Fact discovery closes on December 3, 2010, the Markman hearing is set for January 21, 2011, and trial is scheduled for September 27, 2012.
Schering Corporation, et al. v. Impax Laboratories, Inc. (Ezetimibe/Simvastatin)
In August 2010, Schering Corporation and MSP Singapore Company LLC filed suit against us in the U.S. District Court for the District of New Jersey alleging patent infringement for the filing of our ANDA relating to Ezetimibe/Simvastatin Tablets, 10 mg/80 mg, generic to Vytorin ®. We have filed an answer and counterclaim.
 
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Other Litigation Related to Our Business
Impax Laboratories, Inc. v. Shire LLC and Shire Laboratories, Inc. (generic Adderall XR)
On November 1, 2010, we filed suit against Shire LLC and Shire Laboratories, Inc. (collectively “Shire”) in the Supreme Court of the State of New York, alleging breach of contract and other related claims due to Shire’s failure to fill our orders for the generic Adderall XR product as required by the parties’ Settlement Agreement and License and Distribution Agreement, signed in January 2006. In addition, we have filed a motion for a preliminary injunction and a temporary restraining order seeking to require Shire to fill product orders placed by us.
 
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ITEM 1A. RISK FACTORS
During the quarter ended September 30, 2010, there were no material changes to the risk factors included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2009, and in our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2010 and June 30, 2010. Please carefully consider the information set forth in this Quarterly Report on Form 10-Q and the risk factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2009, and in Part II, “Item 1A. Risk Factors” in our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2010 and June 30, 2010, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K, and in our Quarterly Reports on Form 10-Q, are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.
 
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ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
The following table provides information regarding the purchases of our equity securities by us during the quarter ended September 30, 2010.
 	 	 	 	 	 	 	 	 	 	 	
 	 	 	 	 	 	 	 	 	 	Maximum Number (or	
 	 	 	 	 	 	 	 	Total Number of	 	Approximate Dollar	
 	 	 	 	 	 	 	 	Shares (or Units)	 	Value) of Shares	
 	 	 	 	 	 	 	 	Purchased as Part	 	(or Units) that May	
 	 	Total Number of	 	 	 	 	 	of Publicly	 	Yet Be Purchased	
 	 	Shares (or Units)	 	Average Price Paid	 	 	Announced Plans or	 	Under the Plans or	
Period	 	Purchased(1)	 	Per Share (or Unit)	 	 	Programs	 	Programs	
July 1, 2010 to July 31, 2010	 	311 shares of common stock	 		$17.90	 	 	—	 	—	
 		
August 1, 2010 to August 31, 2010	 	—	 	 	—	 	 	—	 	—	
 		
September 1, 2010 to September 30, 2010	 	4,955 shares of common stock	 		$16.22	 	 	—	 	—	

(1)	 	Represents shares of our common stock we accepted during the indicated periods as a tax withholding from certain of our employees in connection with the vesting of shares of restricted stock pursuant to the terms of our 2002 Plan.	
 
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ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not Applicable.
ITEM 4. (REMOVED AND RESERVED)
ITEM 5. OTHER INFORMATION
Not Applicable.
 
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ITEM 6. EXHIBITS
 	 	 	
Exhibit No.	 	Description of Document	
10.1	 	Fifth Amendment to Amended and Restated Loan and Security Agreement, dated as of June 30, 2010, by and among the Company and Wells Fargo Bank, National Association, successor by merger to Wachovia Bank, National Association. (1)	
10.2	 	Sixth Amendment to Amended and Restated Loan and Security Agreement, dated as of September 30, 2010, by and among the Company and Wells Fargo Bank, National Association, successor by merger to Wachovia Bank, National Association.	
11.1	 	Statement re computation of per share earnings (incorporated by reference to Note 14 to the Notes to the unaudited interim Consolidated Financial Statements in this Quarterly Report on Form 10-Q).	
31.1	 	Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.	
31.2	 	Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.	
32.1	 	Certification of the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.	
32.2	 	Certification of the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.	

(1)	 	Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2010.	
 
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 	 	 	 	 	
Date: November 4, 2010	Impax Laboratories, Inc.
 	 	
 	By:  	/s/ Larry Hsu, Ph.D .  	 	
 	 	Name:   	Larry Hsu, Ph.D.  	 	
 	 	Title:   	President and Chief Executive Officer
(Principal Executive Officer)  	 	

 	By:  	/s/ Arthur A. Koch, Jr.  	 	
 	 	Name:   	Arthur A. Koch Jr.  	 	
 	 	Title:   	Senior Vice President, Finance and
Chief Financial Officer
(Principal Financial and Accounting Officer)  	 	
 
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EXHIBIT INDEX
 	 	 	
Exhibit No.	 	Description of Document	
10.1	 	Fifth Amendment to Amended and Restated Loan and Security Agreement, dated as of June 30, 2010, by and among the Company and Wells Fargo Bank, National Association, successor by merger to Wachovia Bank, National Association. (1)	
10.2	 	Sixth Amendment to Amended and Restated Loan and Security Agreement, dated as of September 30, 2010, by and among the Company and Wells Fargo Bank, National Association, successor by merger to Wachovia Bank, National Association.	
11.1	 	Statement re computation of per share earnings (incorporated by reference to Note 14 to the Notes to the unaudited interim Consolidated Financial Statements in this Quarterly Report on Form 10-Q).	
31.1	 	Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.	
31.2	 	Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.	
32.1	 	Certification of the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.	
32.2	 	Certification of the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.	

(1)	 	Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2010.	
 
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Exhibit 10.2
SIXTH AMENDMENT TO AMENDED AND RESTATED
LOAN AND SECURITY AGREEMENT
THIS SIXTH AMENDMENT TO AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT (the “Amendment”) is made effective as of the 30th day of September, 2010, by and among IMPAX LABORATORIES, INC., a Delaware corporation (“Borrower”), and WELLS FARGO BANK, NATIONAL ASSOCIATION successor by merger to WACHOVIA BANK, NATIONAL ASSOCIATION ( together with its successors and assigns , “Bank”).
BACKGROUND
A. Pursuant to that certain Amended and Restated Loan and Security Agreement dated December 15, 2005 by and between Borrower and Bank (as amended by that certain First Amendment to Amended and Restated Loan and Security Agreement dated October 14, 2008, that certain Second Amendment to Amended and Restated Loan and Security Agreement dated December 31, 2008, that certain Third Amendment to Amended and Restated Loan and Security Agreement dated March 31, 2009, that certain Fourth Amendment to Amended and Restated Loan and Security Agreement dated March 12, 2010, that certain Fifth Amendment to Amended and Restated Loan and Security Agreement dated June 30, 2010 and as the same may hereafter be further amended, modified, supplemented or restated from time to time, being referred to herein as the “Loan Agreement”), Bank agreed, inter alia, to amend and restate an existing revolving line of credit in the maximum principal amount of Thirty-Five Million Dollars ($35,000,000.00).
B. Borrower has requested and Bank has agreed to amend the Loan Agreement in accordance with the terms and conditions contained herein.
C. All capitalized terms contained herein and not otherwise defined herein shall have the meanings set forth in the Loan Agreement.
NOW, THEREFORE, intending to be legally bound hereby, the parties hereto agree as follows:
1.  Termination Date. The reference to “September 30, 2010” contained in the definition of “Termination Date” in Section 1.1 of the Loan Agreement is hereby deleted and replaced with “January 31, 2011”.
2.  Amendment/References. The Loan Agreement and the Loan Documents are hereby amended to be consistent with the terms of this Amendment. All references in the Loan Agreement and the Loan Documents to (a) the “ Loan Agreement ” shall mean the Loan Agreement as amended hereby; and (b) the “ Loan Documents ” shall include this Amendment and all other instruments or agreements executed pursuant to or in connection with the terms hereof.
3.  Release. Borrower acknowledges and agrees that it has no claims, suits or causes of action against Bank and hereby remises, releases and forever discharges Bank, their officers, directors, shareholders, employees, agents, successors and assigns, and any of them, from any claims, suits or causes of action whatsoever, in law or at equity, which Borrower has or may have arising from any act, omission or otherwise, at any time up to and including the date of this Amendment.

 

4.  Additional Documents; Further Assurances. Borrower covenants and agrees to execute and deliver to Bank, or to cause to be executed and delivered to Bank contemporaneously herewith, at the sole cost and expense of Borrower, the Amendment and any and all documents, agreements, statements, resolutions, searches, insurance policies, consents, certificates, legal opinions and information as Bank may require in connection with the execution and delivery of this Amendment or any documents in connection herewith, or to further evidence, effect, enforce or protect any of the terms hereof or the rights or remedies granted or intended to be granted to Bank herein or in any of the Loan Documents, or to enforce or to protect Bank’s interest in the Collateral. All such documents, agreements, statements, etc., shall be in form and content acceptable to Bank in its sole discretion. Borrower hereby authorizes Bank to file, at Borrower’s cost and expense, financing statements, amendments thereto and other items as Bank may require to evidence or perfect Bank’s continuing security interest and liens in and against the Collateral. Borrower agrees to join with Bank in notifying any third party with possession of any Collateral of Bank’s security interest therein and in obtaining an acknowledgment from the third party that it is holding the Collateral for the benefit of Bank. Borrower will cooperate with Bank in obtaining control with respect to Collateral consisting of deposit accounts, investment property, letter-of-credit rights and electronic chattel paper.
5.  Further Agreements and Representations . Borrower does hereby:
(a) ratify, confirm and acknowledge that the statements contained in the foregoing Background are true and complete and that, as amended hereby, the Loan Agreement and the other Loan Documents are in full force and effect and are valid, binding and enforceable against Borrower and its assets and properties, all in accordance with the terms thereof, as amended;
(b) covenant and agree to perform all of Borrower’s obligations under the Loan Agreement and the other Loan Documents, as amended;
(c) acknowledge and agree that as of the date hereof, Borrower has no defense, set-off, counterclaim or challenge against the payment of any of the Obligations or the enforcement of any of the terms of the Loan Agreement or of the other Loan Documents, as amended;
(d) acknowledge and agree that all representations and warranties of Borrower contained in the Loan Agreement and/or the other Loan Documents, as amended (including, without limitation as modified by the amendments set forth on Schedule A hereto), are true, accurate and correct on and as of the date hereof as if made on and as of the date hereof,
(e) represent and warrant that no Default or Event of Default exists;
(f) covenant and agree that Borrower’s failure to comply with any of the terms of this Amendment or any other instrument or agreement executed or delivered in connection herewith, shall constitute an Event of Default under the Loan Agreement and each of the other Loan Documents; and
 
 -2- 

 

(g) acknowledge and agree that nothing contained herein, and no actions taken pursuant to the terms hereof, are intended to constitute a novation of the Note, the Loan Agreement or of any of the other Loan Documents and does not constitute a release, termination or waiver of any existing Event of Default or of any of the liens, security interests, rights or remedies granted to the Bank in any of the Loan Documents, which liens, security interests, rights and remedies are hereby expressly ratified, confirmed, extended and continued as security for all of the Obligations.
Borrower acknowledges and agrees that Bank is relying on the foregoing agreements, confirmations, representations and warranties of Borrower and the other agreements, representations and warranties of Borrower contained herein in agreeing to the amendments contained in this Amendment.
6.  Fees, Cost, Expenses and Expenditures. Borrower will pay all of Bank’s reasonable, out-of-pocket expenses in connection with the review, preparation, negotiation, documentation and closing of this Amendment and the consummation of the transactions contemplated hereunder, including without limitation, fees, disbursements, expenses and disbursements of counsel retained by Bank and all fees related to filings, recording of documents, searches, environmental assessments and appraisal reports, whether or not the transactions contemplated hereunder are consummated.
7.  No Waiver. Nothing contained herein constitutes an agreement or obligation by Bank to grant any further amendments to the Loan Agreement or any of the other Loan Documents. Nothing contained herein constitutes a waiver or release by Bank of any Event of Default or of any rights or remedies available to Bank under the Loan Documents or at law or in equity.
8.  Inconsistencies. To the extent of any inconsistencies between the terms and conditions of this Amendment and the terms and conditions of the Loan Agreement or the other Loan Documents, the terms and conditions of this Amendment shall prevail. All terms and conditions of the Loan Agreement and other Loan Documents not inconsistent herewith shall remain in full force and effect and are hereby ratified and confirmed by Borrower.
9.  Binding Effect. This Amendment, upon due execution hereof, shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns.
10.  Governing Law. This Amendment shall be governed and construed in accordance with the laws of the Commonwealth of Pennsylvania without regard to conflict of law principles.
11.  Severability. The provisions of this Amendment and all other Loan Documents are deemed to be severable, and the invalidity or unenforceability of any provision shall not affect or impair the remaining provisions which shall continue in full force and effect.
 
 -3- 

 

12.  Modifications. No modification of this Amendment or any of the Loan Documents shall be binding or enforceable unless in writing and signed by or on behalf of the party against whom enforcement is sought.
13.  Headings. The headings of the Articles, Sections, paragraphs and clauses of this Amendment are inserted for convenience only and shall not be deemed to constitute a part of this Amendment.
14.  Counterparts. This Amendment may be executed in multiple counterparts, each of which shall constitute an original and all of which together shall constitute the same agreement.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
 
 -4- 

 

IN WITNESS WHEREOF, the parties hereto, intending to be legally bound hereby, have caused this Amendment to be executed the day and year first above written.
 	 	 	 	 	
 	IMPAX LABORATORIES, INC.
 	 	
 	By:  	/s/ Arthur A. Koch, Jr.  	 	
 	Name/Title: Arthur A. Koch, Jr. 		

 	WELLS FARGO BANK, NATIONAL
ASSOCIATION, Successor By Merger To
WACHOVIA BANK, NATIONAL ASSOCIATION
 	 	
 	By:  	/s/ Margaret A. Byrne  	 	
 	 	Margaret A. Byrne 	 	
 	 	Vice President 	 	
 
 -5- 

EXHIBIT 31.1
CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Larry Hsu, certify that:

1.	 	I have reviewed this Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2010 of Impax Laboratories, Inc.;	
 		
2.	 	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;	
 		
3.	 	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;	
 		
4.	 	The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:	

 	(a)	 	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;	
 		
 	(b)	 	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;	
 		
 	(c)	 	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and	
 		
 	(d)	 	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and	

5.	 	The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):	

 	(a)	 	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and	
 		
 	(b)	 	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.	

November 4, 2010 	By:  	/s/ Larry Hsu, Ph.D.  	 	
 	 	Larry Hsu, Ph.D. 	 	
 	 	President and Chief Executive Officer 	 	

EXHIBIT 31.2
CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Arthur A. Koch, Jr., certify that:

1.	 	I have reviewed this Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2010 of Impax Laboratories, Inc.;	
 		
2.	 	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;	
 		
3.	 	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;	
 		
4.	 	The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:	

 	(a)	 	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;	
 		
 	(b)	 	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles	
 		
 	(c)	 	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and	
 		
 	(d)	 	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and	

5.	 	The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):	

 	(a)	 	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and	
 		
 	(b)	 	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.	

November 4, 2010 	By:  	/s/ Arthur A. Koch, Jr.  	 	
 	 	Arthur A. Koch, Jr. 	 	
 	 	Senior Vice President, Finance, and
Chief Financial Officer 	 	

EXHIBIT 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Impax Laboratories, Inc. (the “Company”) for the fiscal quarter ended September 30, 2010 (the “Report”), Larry Hsu, President and Chief Executive Officer, hereby certifies, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Section 1350 of Chapter 63 of Title 18 of the United States Code), that:

(1)	 	the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and	
 		
(2)	 	the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.	

November 4, 2010 	By:  	/s/ Larry Hsu, Ph.D.  	 	
 	 	Larry Hsu, Ph.D. 	 	
 	 	President and Chief Executive Officer 	 	
 	
The foregoing certification is being furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Section 1350 of Chapter 63 of Title 18 of the United States Code) and is not being filed as part of the Report or as a separate disclosure document.

EXHIBIT 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Impax Laboratories, Inc. (the “Company”) for the fiscal quarter ended September 30, 2010 (the “Report”), Arthur A. Koch, Jr., Senior Vice President, Finance, and Chief Financial Officer, hereby certifies, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Section 1350 of Chapter 63 of Title 18 of the United States Code), that:

(1)	 	the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and	
 		
(2)	 	the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.	

November 4, 2010 	By:  	/s/ Arthur A. Koch, Jr.  	 	
 	 	Arthur A. Koch, Jr. 	 	
 	 	Senior Vice President, Finance, and
Chief Financial Officer 	 	
 	
The foregoing certification is being furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Section 1350 of Chapter 63 of Title 18 of the United States Code) and is not being filed as part of the Report or as a separate disclosure document.