-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, SAY7ikK4exDo9ZbnBWnQb4iMXrTSwPbXXxwEZPNGWpt2qX4/8YhL5b46WNAJwqxI pLHtWoUUrMzdJIjxy6ijgw== 0001144204-08-012727.txt : 20080229 0001144204-08-012727.hdr.sgml : 20080229 20080229170536 ACCESSION NUMBER: 0001144204-08-012727 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 17 CONFORMED PERIOD OF REPORT: 20071231 FILED AS OF DATE: 20080229 DATE AS OF CHANGE: 20080229 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PAR PHARMACEUTICAL COMPANIES, INC. CENTRAL INDEX KEY: 0000878088 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 223122182 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-10827 FILM NUMBER: 08656801 BUSINESS ADDRESS: STREET 1: 300 TICE BOULEVARD CITY: WOODCLIFF LAKE STATE: NJ ZIP: 07677 BUSINESS PHONE: 201-802-4000 MAIL ADDRESS: STREET 1: 300 TICE BOULEVARD CITY: WOODCLIFF LAKE STATE: NJ ZIP: 07677 FORMER COMPANY: FORMER CONFORMED NAME: PHARMACEUTICAL RESOURCES INC DATE OF NAME CHANGE: 19940526 10-K 1 v104574_10k.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549

FORM 10-K

Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the Fiscal Year Ended December 31, 2007
Commission File Number: 1-10827

PAR PHARMACEUTICAL COMPANIES, INC.
(Exact name of Registrant as specified in its charter)
Delaware
22-3122182
(State or other jurisdiction of
(I.R.S. Employer
incorporation or organization)
Identification No.)

300 Tice Boulevard, Woodcliff Lake, New Jersey
07677
(Address of principal executive offices)
(Zip Code)
 
Registrant‘s telephone number, including area code: (201) 802-4000

Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:

Title of Class:
 
Name of each exchange on which registered:
Common Stock, $0.01 par value
 
The New York Stock Exchange, Inc.
Preferred Share Purchase Rights
 
The New York Stock Exchange, Inc.

Securities registered pursuant to Section 12(g) of the Securities Exchange Act of 1934:

None

Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act: Yes o Nox

Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act:  Yes o No x

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 (the “Exchange Act”) 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 x  No o

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the Registrant’s knowledge, in a definitive proxy or information statement incorporated by reference in Part III of the Form 10-K or any amendment to the Form 10-K. o

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act:

Large accelerated filer x      Accelerated filer o      Non-accelerated filer 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 x

The aggregate market value of the common equity held by non-affiliates as of June 29, 2007 (the last business day of the Registrant’s completed second fiscal quarter in 2007) was approximately $978,559,000. For purposes of making this calculation only, the Registrant included all directors and executive officers as affiliates. The aggregate market value is based on the closing price of such stock on the New York Stock Exchange on June 29, 2007.

Number of shares of the Registrant’s common stock outstanding as of February 15, 2008: 34,554,814.


 
TABLE OF CONTENTS

   
PAGE
     
PART I
 
   
Forward-Looking Statements  
     
Item 1.
Business
3
     
Item 1A.
Risk Factors
14
     
Item 2.
Properties
27
     
Item 3.
Legal Proceedings
27
     
Item 4.
Submission of Matters to a Vote of Security Holders
35
     
PART II
 
     
Item 5
Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
35
     
Item 6.
Selected Financial Data
37
     
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
39
     
Item 7A
Quantitative and Qualitative Disclosures about Market Risk
53
     
Item 8.
Consolidated Financial Statements and Supplementary Data
54
     
Item 9
Changes In and Disagreements with Accountants on Accounting and Financial Disclosure
54
     
Item 9A.
Controls and Procedures
54
     
Item 9B.
Other Information
55
     
PART III
 
     
Item 10
Directors and Executive Officers of the Registrant
56
     
Item 11
Executive Compensation
56
     
Item 12
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
56
     
Item 13
Certain Relationships and Related Transactions
56
     
Item 14
Principal Accountant Fees and Services
56
     
PART IV
 
     
Item 15
Exhibits
56
     
SIGNATURES
63
 
2


PART I


Certain statements in this Report constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including those concerning management’s expectations with respect to future financial performance, trends and future events, particularly relating to sales of current products and the introduction of new manufactured and distributed products. Such statements involve known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. These statements are often, but not always, made using words such as “estimates,” “plans,” “projects,” “anticipates,” “continuing,” “ongoing,” “expects,” “intends,” “believes,” “forecasts” or similar words and phrases. Factors that might affect such forward-looking statements set forth in this Report include: (i) increased competition from new and existing competitors, and pricing practices from such competitors (particularly upon completion of exclusivity periods), (ii) pricing pressures resulting from the continued consolidation by the Company’s distribution channels, (iii) the amount of funds available for internal research and development and research and development joint ventures, (iv) research and development project delays and unanticipated costs in obtaining regulatory approvals, (v) continuation of distribution rights under significant agreements, (vi) the continued ability of distributed product suppliers to meet future demand, (vii) the costs, delays involved in and outcome of any threatened or pending litigations, including patent and infringement claims, (viii) unanticipated costs, delays and liabilities in integrating acquisitions, (ix) obtaining or losing 180-day marketing exclusivity periods on products, and (x) general industry and economic conditions. To the extent that any statements made in this Report contain information that is not historical, such statements are essentially forward-looking and are subject to certain risks and uncertainties, including the risks described above as well as the risks and uncertainties discussed under Item 1A Risk Factors and from time to time in other of the Company's filings with the SEC, including its Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements included in this Annual Report on Form 10-K are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

ITEM 1. Business

GENERAL and RECENT DEVELOPMENTS

Par Pharmaceutical Companies, Inc. is a Delaware holding company that, principally through its wholly owned subsidiary, Par Pharmaceutical, Inc. (collectively referred to herein as the “Company”), is in the business of developing, manufacturing and distributing generic and branded drugs in the United States. In January 2006, the Company announced its divestiture of one of its subsidiaries, FineTech Laboratories, Ltd. (“FineTech”), effective December 31, 2005 to a former officer and director of the Company. As a result of the divestiture, the business is being reported as a discontinued operation for all periods presented, as applicable. On June 10, 2004, the Company acquired Kali Laboratories, Inc. (“Kali”), a generic pharmaceutical research and development company located in Somerset, New Jersey, which has been integrated with the Company’s internal research and development program. The Company’s fiscal year ends on December 31 of each year presented. The Company’s fiscal quarters end on the Saturday closest to each calendar quarter end. The Company’s principal executive offices are located at 300 Tice Boulevard, Woodcliff Lake, NJ 07677, and its telephone number at such address is (201) 802-4000. Additional information concerning the Company can be found on the Company’s website at www.parpharm.com.

The Company makes its electronic filings with the SEC, including the Company’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and any amendments to these reports, available through its website, free of charge, as soon as reasonably practicable after the Company electronically files or furnishes them with the SEC. Information on the website is not, and should not be construed to be, part of this Annual Report on Form 10-K. The SEC maintains an internet site at www.sec.gov that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC. Also available on the Company’s website are the Company’s Corporate Governance Guidelines, charters for the Audit, Compensation and Management Development and Nominating and Corporate Governance Committees of the Company’s Board of Directors (the “Board”) and the Company’s Code of Ethics.

  Prescription pharmaceutical products are sold as either generic products or brand products. In the third quarter of 2005, the Company shipped its first brand product, MegaceÒ ES and is now in two reportable business segments: generic pharmaceuticals and brand pharmaceuticals. In 2007, the Company began operating the brand pharmaceutical segment under the name Strativa Pharmaceuticals. See Notes to Consolidated Financial Statements “Note 19 – Segment Information.”

3

 
Generic Segment
 
Generic drugs are the pharmaceutical and therapeutic equivalents of brand name drugs and are usually marketed under their generic (chemical) names rather than by brand names. Typically, a generic drug may not be marketed until the expiration of applicable patent(s) on the corresponding brand name drug. Generic drugs must meet the same governmental standards as brand name drugs, but they are sold generally at prices below those of the corresponding brand name drugs. Generic drugs provide a cost-effective alternative for consumers, while maintaining the safety and effectiveness of the brand name pharmaceutical product.

The Company’s product line comprises generic prescription drugs consisting of approximately 180 products representing various dosage strengths for approximately 80 separate drugs. The Company’s products are manufactured principally in the solid oral dosage form (tablet, caplet and two-piece hard shell capsule). In addition, the Company markets several oral suspension products and products in the semi-solid form of a cream. The Company develops and manufactures some of its own internally developed products and has strategic alliances and relationships with several pharmaceutical and chemical companies that provide the Company with products for sale through various distribution, manufacturing, development and licensing agreements. The Company is continuing its efforts in developing generic equivalents of existing brand drugs, exploring potential acquisitions of complementary products and businesses and seeking additional strategic alliances and relationships.

A growing practice within the generic industry is the use of authorized generics. Brand name companies do not face any regulatory barriers when attempting to introduce a generic version of their proprietary brand and they often license this right to a subsidiary or a generic distributor. Authorized generics may be sold during (and after) the exclusivity period granted to the developer of a generic equivalent to the brand product. The Company has marketed authorized generics, including metformin ER (Glucophage XRÒ) and glyburide & metformin HCl (GlucovanceÒ) licensed through Bristol-Myers Squibb Company (“BMS”), fluticasone (FlonaseÒ) and ranitidine HCl syrup (ZantacÒ) licensed through GlaxoSmithKline plc (“GSK”), and metoprolol succinate ER (Toprol XLÒ) licensed through AstraZeneca.

The Company markets its generic products primarily to wholesalers, drug store chains, supermarket chains, mass merchandisers, distributors, managed health care organizations, mail order accounts, and government, principally through its internal staff. The Company also promotes the sales efforts of wholesalers and drug distributors that sell the Company’s products to clinics, governmental agencies and other managed health care organizations.

Brand Segment
 
Brand products are marketed under trademarked brand names designed to create an association between the products and their intended uses. This builds awareness of the products with healthcare providers, as well as loyalty among consumers. Brand products usually benefit from patent protection, which greatly reduces competition and provides a significant amount of market exclusivity for the products. This exclusivity generally allows a brand product to remain profitable for a relatively long period of time as compared to generic products. In addition, due to the public awareness of the brand name and resulting consumer and physician loyalty, brand products may remain profitable even after the cessation of their patent related market exclusivity.

Our branded products are sold by our specialty field force, which communicates the therapeutic and health economic benefits of our products, versus our competitors, to healthcare providers and managed care organizations.

As part of the Company’s business plan to sustain future growth, the Company has created a proprietary products division focused on commercialization of Megace® ES and the licensing and commercialization of other proprietary, specialty products. Megace® ES, the Company’s first brand product, is indicated for the treatment of anorexia, cachexia or any unexplained significant weight loss in patients with a diagnosis of AIDS. To provide the branded products division with a unique and recognizable identity in the marketplace, the Company named the proprietary products division Strativa Pharmaceuticals in September 2007.

The Company believes that brand products generally have more limited competition, longer product life cycles and long-term higher profitability than generic products. The Company continues to pursue product or business acquisitions or licensing arrangements to expand its brand product line.
 
4

 
The Company submitted its first New Drug Application (“NDA”) in June 2004, pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the “FFDC Act”), for megestrol acetate oral suspension NanoCrystal® Dispersion (“NCD”). This NDA was approved by the Food and Drug Administration (the “FDA”) in July 2005 and the Company began marketing megestrol acetate oral suspension NCD, under the brand name Megace® ES, soon thereafter. In 2007, net sales of Megace® ES increased 74% to $75.3 million as compared to 2006. In September 2006, the Company entered into an extended-reach agreement with Solvay Pharmaceuticals, Inc. (“Solvay”) that provides for the Company’s branded sales force to co-promote Androgel®, as well as future versions of the product or other products that are mutually agreed upon, for a period of six years. As compensation for its marketing and sales efforts, the Company will receive up to $10 million annually, paid quarterly, for the six-year period. The Company has progressed on its business plan during 2007 by acquiring the rights to additional branded products currently in Phase III clinical trials. In July 2007, the Company also acquired an exclusive licensing agreement under which the Company will receive commercialization rights in the U.S. to BioAlliance Pharma S.A's (“BioAlliance”) Loramyc (miconazole Lauriad®), an antifungal therapy for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immunocompromised patients, including those with HIV and cancer. In August 2007, the Company also acquired the North American commercial rights to ZensanaTM (ondansetron HCl) Oral Spray from Hana Biosciences, Inc. (“Hana”). Ondansetron is used to prevent nausea and vomiting after chemotherapy, radiation and surgery, and following successful development and approval, ZensanaTM could be among the first in its class of 5-HT3 antagonist anti-emetic therapies to be available in an oral spray form. The Company also announced that it has entered into an agreement with NovaDel Pharma Inc. (“NovaDel”), to collaborate on the reformulation of ZensanaTM. Following completion of reformulation efforts already under way, the Company will reconfirm the product's pharmacokinetic profile and resubmit the NDA to the FDA. On January 14, 2008, the Company entered into an exclusive license agreement with Alfacell Corporation (“Alfacell”) under which the Company received the exclusive U.S. commercialization rights to Alfacell’s ONCONASE® (ranpirnase).  ONCONASE® is currently in Phase III clinical development for the treatment of inoperable malignant mesothelioma, a rare cancer affecting the lungs usually associated with exposure to asbestos. In June 2007, the Company had acquired the U.S. commercialization rights to Immtech Pharmaceuticals, Inc.’s (“Immtech”) lead oral drug candidate, pafuramidine maleate, for the treatment of pneumocystis pneumonia in AIDS patients, but Immtech terminated its development program for pafuramidine in February 2008 after Immtech had received reports of adverse events related to abnormal kidney function that resulted in hospitalization of several volunteers from a safety study. See below for details on the termination of the pafuramidine program.

It is anticipated that growth of the brand segment of the Company’s business will be based largely on the in-licensing of new compounds and approval of existing new compounds licensed, as well as increasing the number of prescriptions on the Company’s current brand products.

Other
 
The Company has adopted a Code of Ethics that applies to all of its directors, officers, employees and representatives. This code is publicly available on the Company’s website. Amendments to the code of ethics and any grant of a waiver from a provision of the code requiring disclosure under applicable SEC rules will be available on the Company’s website. The Company’s corporate governance principles and the charters of the Audit, Nominating and Corporate Governance and Compensation and Management Development Committees of its Board are also available on the Company’s website. Any of these materials may also be requested in print by writing to the Company, Attention: Thomas Haughey, Executive Vice President, General Counsel and Secretary, at 300 Tice Boulevard, Woodcliff Lake, NJ 07677.

As described in the “Forward-Looking Statements” section appearing above, certain statements made in this document may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including those concerning management’s expectations with respect to future financial performance, projected expenditures, trends and future events. Such statements involve various risks, uncertainties and contingencies, many of which are beyond the control of the Company and that could cause actual results and performance to differ materially from those stated herein. Any forward-looking statements included in this document are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.

The financial data and share amounts contained in Parts I and II are in thousands, except per share data, employee, drug and stockholder numbers.

PRODUCT INFORMATION

The Company distributes approximately 80 products, representing various dosage strengths for approximately 40 separate drugs that are manufactured by the Company and approximately 100 additional products representing various dosage strengths for approximately 40 separate drugs that are manufactured for it by other companies. The Company holds the Abbreviated New Drug Applications (“ANDAs”) and NDAs for the drugs that it manufactures. Set forth below is a list of the drugs manufactured and/or distributed by the Company, including the brand name product Megace® ES, for which the Company holds the NDA. The names of all of the drugs under the caption “Competitive Brand Name Drug” are trademarked. The holders of the trademarks are non-affiliated pharmaceutical manufacturers.

Name
 
Competitive Brand Name Drug
Generic:
   
     
Acebutolol
 
Sectral
Acyclovir
 
Zovirax
Allopurinol
 
Zyloprim
 
5

 
Name
 
Competitive Brand Name Drug
Amiloride Hydrochloride
 
Midamor
Amiodarone Hydrochloride
 
Cordarone
Amoxicillin Oral Suspension
 
Amoxil
Amoxicillin Tabs 
 
Amoxil
Amoxicillin/Clavalunate (Chew Tabs)
 
Amoxil
Amoxicillin/Clavalunate (Oral Susp.)
 
Amoxil
Amoxicillin/Clavalunate (Tabs)
 
Amoxil
Aspirin (zero order release)
 
Zorprin
Benztropine Mesylate
 
Cogentin
Buspirone
 
BuSpar
Cabergoline
 
Dostinex
Captopril
 
Capoten
Captopril HCTZ
 
Capozide
Carisoprodol and Aspirin
 
Soma Compound
Chlordiazepoxide and Amitripylene
 
Librium DS
Chlordiazepoxide HCl
 
Librium
Cholestyramine & Light (Generic)
 
Questran & Light
Cholestyramine (Brand)
 
Questran
Cholestyramine Light (Brand)
 
Questran Light
Citalopram
 
Celexa
Clomiphene
 
Clomid
Clonazepam ODT
 
Klonopin
Clozapine
 
Clozaril
Cyproheptadine Hydrochloride
 
Periactin
Diphenoxylate Hydrochloride and Antropine Sulfate
 
Lomotil
Doxepin Hydrochloride
 
Sinequan, Adapin
Doxycycline Monohydrate
 
Adoxa, Monodox
Enalapril
 
Vasotec
Enalapril Maleate HCTZ
 
Vaseretic
Estazolam
 
Prosom
Famotidine
 
Pepcid
Flecainide
 
Tambocor
Fluoxetine
 
Prozac
Fluoxetine Syrup
 
Prozac
Fluphenazine Hydrochloride
 
Prolixin
Flutamide
 
Eulexin
Fluticasone Nasal Spray
 
Flonase
Glycopyrrolate
 
Robinul
Glycopyrrolate Forte
 
Robinul Forte
Guanfacine
 
Tenex
Hydralazine Hydrochloride
 
Apresoline
Hydra-Zide
 
Apresazide
Hydroquinone HCL
 
Eldoquin
Hydroxurea
 
Hydrea
Ibuprofen
 
Advil, Nuprin, Motrin
Imipramine Hydrochloride
 
Tofranil
Isosorbide Dinitrate
 
Isordil
Leflunomide
 
Arava
Lovastatin
 
Mevacor
Meclizine Hydrochloride
 
Antivert
Megestrol Acetate
 
Megace
Megestrol Acetate Oral Suspension
 
Megace Oral Suspension
Mercaptopurine
 
Purinethol
Metaproterenol Sulfate
 
Alupent
Methimazole
 
Tapazole
Metoprolol Succinate
 
Toprol-XL
Metronidazole
 
Flagyl
 
6

 
Name
 
Competitive Brand Name Drug
Minocycline
 
Minocin
Minoxidil
 
Loniten 
Nabumetone
 
Relafen
Nizatidine
 
Axid
Nystatin Powder
 
Mycostatin
Ondansetron ODT
 
Zofran ODT
Paroxetine
 
Paxil
Pravastatin
 
Pravachol
Propoxyphene Hydrochloride
 
Darvon
Propranolol ER
 
Inderal LA
Quinapril
 
Accupril 
Ranitidine Syrup
 
Zantac
Ranitidine
 
Zantac
Silver Sulfadiazine (SSD)
 
Silvadene
Sotalol
 
Betapace
Ticlopidine Hydrochloride
 
Ticlid
Tizanidine
 
Zanaflex
Torsemide
 
Demadex
Tranylcypromine Sulfate
 
Parnate
 
Brand:
   
     
Megace® ES 
   

The Company seeks to introduce new products through its internal research and development program and through joint venture, distribution and other agreements, including licensing of authorized generics and branded products, with pharmaceutical companies located in various parts of the world. As such, the Company has pursued and continues to pursue arrangements and relationships that share development costs, generate profits from jointly-developed products and expand distribution channels for new and existing products. The Company’s distribution and supply agreements that it believes are material to its business are described in the Notes to Consolidated Financial Statements – Note 12 – “Distribution and Supply Agreements.” The Company entered into several recent agreements, which are described in the Notes to Consolidated Financial Statements – Note 11 – “Research and Development Agreements” and – Note 22 – “Subsequent Events.”
 
RESEARCH AND DEVELOPMENT

Generic Segment

The Company’s research and development activities for generic products consist principally of (i) identifying and conducting patent and market research on brand name drugs for which patent protection has expired or is expected to expire in the near future, (ii) identifying and conducting patent and market research on brand name drugs for which the Company believes the patents are invalid or the Company can develop a non-infringing formulation, (iii) researching and developing new product formulations based upon such drugs and (iv) introducing technology to improve production efficiency and enhance product quality. The scientific process of developing new products and obtaining FDA approval is complex, costly and time-consuming; there can be no assurance that any products will be developed regardless of the amount of time and money spent on research and development. The development of products may be curtailed in the early or later stages of development due to the introduction of competing generic products or other reasons.

The research and development of the Company’s pharmaceutical products, including pre-formulation research, process and formulation development, required studies and FDA review and approval, have historically taken approximately two to three years to complete. Accordingly, the Company typically selects products for development that it intends to market several years in the future. However, the length of time necessary to bring a product to market can vary significantly and depends on, among other things, the availability of funding, problems relating to formulation, safety or efficacy and patent issues associated with the product.

The Company contracts with outside laboratories to conduct biostudies, which, in the case of oral solids, generally are required in order to obtain FDA approval. These biostudies are used to demonstrate that the rate and extent of absorption of a generic drug are not significantly different from the corresponding brand name drug and can cost from approximately $0.2 million to $1.1 million for each biostudy. Biostudies are required to be conducted and documented in conformity with FDA standards (see “Government Regulation”). During 2007, the Company contracted with outside laboratories, expending approximately $9.7 million to conduct biostudies for 12 potential new products. The Company intends to continue to contract for additional biostudies in the future.
 
7

 
In addition to its own internal development program, the Company, from time to time, enters into product development and license agreements with various third parties with respect to the development or marketing of new products and technologies. The Company’s product development agreements that it believes are material to its business are described in Notes to Consolidated Financial Statements – Note 11 – “Research and Development Agreements” and Note 22 – “Subsequent Events.” Pursuant to these agreements, the Company has advanced funds to several unaffiliated companies for products in various stages of development. As a result of its product development program, the Company or its strategic partners currently have approximately 45 ANDAs pending with the FDA.

Brand Segment

The first step in obtaining FDA approval for a drug that has not been previously approved is pre-clinical testing. Pre-clinical tests are intended to provide a laboratory evaluation of the product to determine its chemistry, formulation and stability. Toxicology studies are also performed to assess the potential safety and efficacy of the product. The results of these studies are submitted to the FDA as part of an Investigational New Drug Application (“IND”).

An IND, in order to be approved, must demonstrate that the product adequately delivers the drug into the bloodstream or intended site of action to produce the desired therapeutic results before the product can proceed to human clinical trials. The toxicology studies are also analyzed to ensure that clinical trials can safely proceed. There is a 30-day period in which the FDA can raise concerns regarding the trials proposed in the IND. If the FDA raises any such concerns, the Company must address those concerns before the clinical trials can begin. The IND becomes effective 30 days after receipt by the FDA if the FDA does not raise any concerns. Prior to the start of any clinical study, an independent institutional review board must review and approve such study.
 
There are three main stages to each clinical trial. In Phase I of the clinical trial, the drug is tested for safety, absorption, tolerance and metabolism in a small number of subjects. In Phase II, the drug is tested for efficacy in a limited number of subjects. The drug is further tested for safety, absorption, tolerance and metabolism. In Phase III, after successful Phase II evaluations, the subject population is enlarged and further tests are done to determine safety and efficacy. The Company then submits a NDA containing the results from the pre-clinical and clinical trials. The NDA drug development and approval process could take from approximately three to more than ten years.

It is the Company’s intention to bypass the substantial investments associated with INDs and NDAs and support the continued sales growth of its existing brand product (Megace® ES), and to add to its portfolio of branded, single-source prescription drug products through in-licensing and the acquisition of late-stage development or currently marketed products.

In July 2005, the Company received FDA approval and began shipping Megace® ES, its first brand product. The Company has also made strategic investments related to the in-licensing of the products described below and the Company expects to spend significant amounts related to development and sales milestones and royalties related to these in-licensed products in the future.
 
In June 2007, the Company entered into an exclusive licensing agreement under which it received the U.S. commercialization rights to Immtech Pharmaceuticals’ lead oral drug candidate, pafuramidine maleate, for the treatment of pneumocystis pneumonia in AIDS patients. The Company made an initial payment of $3.0 million, with additional payments subject to pafuramidine advancing successfully through Phase III clinical trials and regulatory approval. In December 2007, Immtech announced that the pafuramidine program had been placed on clinical hold, due to preliminary findings of abnormal laboratory values found in several volunteers following treatment with pafuramidine in an ongoing safety study. In February 2008, Immtech announced that it had chosen to discontinue the development program for pafuramidine, due to additional reports of adverse events in several volunteers in the safety study. Due to Immtech’s termination of the development program, the Company has no further monetary obligations under the licensing agreement.
 
In July 2007, the Company entered into an exclusive licensing agreement under which the Company will receive commercialization rights in the U.S. to BioAlliance's Loramyc (miconazole Lauriad®), an antifungal therapy currently in Phase III development for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immunocompromised patients, including those with HIV and cancer. Under the terms of the agreement, the Company paid BioAlliance an initial payment of $15.0 million and will pay BioAlliance $20.0 million upon FDA approval. Additionally, the Company will pay BioAlliance royalties on sales, BioAlliance may receive milestone payments on future sales.

In August 2007, the Company announced that it acquired the North American commercial rights to ZensanaTM (ondansetron HCl) Oral Spray from Hana. Ondansetron is used to prevent nausea and vomiting after chemotherapy, radiation and surgery, and following successful development and approval, ZensanaTM could be among the first in its class of 5-HT3 antagonist anti-emetic therapies to be available in an oral spray form. Under terms of the agreement, the Company made a $5.0 million equity investment in Hana. In addition, Hana would receive milestone payments and royalties on future sales of ZensanaTM. The Company also announced that it has entered into an agreement with NovaDel, to collaborate in the reformulation of ZensanaTM. Following completion of reformulation efforts already under way, the Company will reconfirm the product's pharmacokinetic profile and resubmit the NDA to the FDA. In addition, as part of the Company’s strategy to continue to concentrate resources on supportive care in AIDS and oncology, the Company has returned to NovaDel the rights to NitroMistTM , NovaDel’s proprietary oral spray form of the drug used to treat angina pectoris.
 
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On January 14, 2008, the Company entered into an exclusive license agreement with Alfacell Corporation (“Alfacell”).  Under the agreement, the Company received the exclusive U.S. commercialization rights to Alfacell’s ONCONASE® (ranpirnase).  ONCONASE® is currently in Phase III clinical development for the treatment of inoperable malignant mesothelioma, a rare cancer affecting the lungs usually associated with exposure to asbestos.  In exchange for the U.S. commercialization rights, the Company made an initial payment to Alfacell of $5 million and will make a subsequent payment of up to $30 million upon (and subject to) Alfacell’s receipt of FDA approval for the product.  If ONCONASE® receives FDA approval, the Company will commercialize the product in the United States and pay Alfacell royalties on net sales of the product, and Alfacell will be eligible to receive additional milestone payments if net sales reach certain threshold amounts in any given calendar year.  In addition, Alfacell may be eligible to receive milestone payments upon the achievement of certain development and regulatory milestones with respect to future indications for ONCONASE®.  Under a separate supply agreement between Alfacell and the Company, Alfacell will supply commercial quantities of ONCONASE® to the Company.  

The Company’s product development agreements that it believes are material to its Strativa brand business are described in Notes to Consolidated Financial Statements – Note 11 – “Research and Development Agreements” and Note 22 – “Subsequent Events.”
 
No assurances can be given that the Company or any of its strategic partners will successfully complete the development of these products either under development or proposed for development, that they will obtain regulatory approvals for any such product, that any approved product will be produced in commercial quantities or that any approved product can be sold profitably.

MARKETING AND CUSTOMERS

The Company markets its products under the Par Pharmaceutical label principally to wholesalers, drug store chains, supermarket chains, mass merchandisers, distributors, managed health care organizations, mail order accounts, and government, principally through its internal staff. Some of the Company’s wholesalers and distributors purchase products and warehouse those products for certain retail drug store chains, independent pharmacies and managed health care organizations. Customers in the managed health care market include health maintenance organizations, nursing homes, hospitals, clinics, pharmacy benefit management companies and mail order customers.

The Company has approximately 86 customers, some of which are part of larger buying groups. In 2007, the Company’s four largest customers in terms of net sales dollars, McKesson Drug Co., AmerisourceBergen Corporation, Cardinal Health, Inc. and Walgreen Co., accounted for approximately 22%, 12%, 11% and 10%, respectively, of its total revenues. In 2006, the Company’s four largest customers in terms of net sales dollars, McKesson Drug Co., Cardinal Health, Inc., Walgreen Co., and AmerisourceBergen Corporation, accounted for approximately 14%, 12%, 10% and 7%, respectively, of its total revenues. The Company does not have written agreements that guarantee future business with any of these major customers and the loss of any one or more of these customers or the substantial reduction in orders from any of such customers could have a material adverse effect on the Company’s operating results, prospects and financial condition. See Notes to Consolidated Financial Statements – Note 19 – “Segment Information.”

ORDER BACKLOG

The approximate dollar amount of open orders (net sales basis), believed by management to be firm, at December 31, 2007, was approximately $24.6 million, as compared to approximately $18.1 million at December 31, 2006, and approximately $18.6 million at December 31, 2005. These orders represent unfilled orders as of December 31, 2007 along with orders that were scheduled to be shipped at December 31, 2007. Open orders are subject to cancellation without penalty.

COMPETITION

The pharmaceutical industry is highly competitive. At times, the Company may not be able to differentiate its products from its competitors, successfully develop or introduce new products that are less costly than those of its competitors or offer purchasers of its products payment and other commercial terms as favorable as those offered by its competitors. The Company believes that its principal generic competitors are the Actavis Group (“Actavis”), Mylan Laboratories, Inc. (“Mylan”), Teva Pharmaceutical Industries, Inc. (“Teva”), Watson Pharmaceuticals, Inc. (“Watson”), Barr Laboratories, Inc. (“Barr”), Apotex Pharmaceutical Healthcare, Inc. (“Apotex”), Sandoz Pharmaceuticals, Inc. (“Sandoz”), Roxane Laboratories, Inc. (“Roxane”) and Ranbaxy Laboratories, Ltd. (“Ranbaxy”). The Company’s principal strategy in addressing its competition is to offer customers a consistent supply of a broad line of generic drugs at competitive pricing. There can be no assurance, however, that this strategy will enable the Company to compete successfully in the industry or that it will be able to develop and implement any new or additional viable strategies.
 
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Competition in the generic drug industry has also increased due to the proliferation of authorized generics, which occur when manufacturers of brand name drugs and/or their affiliates introduce generic pharmaceutical products equivalent to their brand name drugs at relatively lower prices or partner with generic companies to introduce equivalent generic products. This is a significant source of competition for the Company because brand-name companies do not face any regulatory barriers when attempting to introduce a generic version of their proprietary brand and authorized generics may be sold during the Company’s exclusivity period significantly affecting the profits the Company could receive as an exclusive marketer of a product. Such actions have the effect of reducing the potential market share and profitability of generic products developed by the Company and may inhibit it from developing and introducing generic pharmaceutical products corresponding to certain brand name drugs. The Company has also marketed authorized generics during the exclusivity period of competitors.

In addition to the introduction of competing products, increased price competition has also resulted from consolidation among wholesalers and retailers and the formation of large buying groups which has caused reductions in sales prices and gross margin. This competitive environment has led to an increase in customer demand for downward price adjustments from the manufacturers of generic pharmaceutical products, including the Company, for certain products that have already been delivered. There can be no assurance that such price reductions for these products or others, will not continue, or even increase, with a consequent material adverse effect on the Company’s revenues and gross margin.

In the generic drug industry, when a company first introduces a generic drug, it may, under certain circumstances, be granted exclusivity by the FDA to market the product for a period of time before any other generic manufacturer may enter the market. At the expiration of such exclusivity period, other generic manufacturers may enter the market and, as a result, the price of the drug may decline significantly (in some prior year instances, price declines have exceeded 90%). As a result of price declines the Company may at its discretion provide price adjustments to its customers for the difference between the Company’s new price and the price at which the Company sold to the customers the product with respect to the customers’ remaining inventory. There are circumstances under which the Company may not provide price adjustments to certain customers and consequently, as a matter of business strategy, may lose future sales volume to competitors rather than reduce its pricing.
 
The principal competitive factors in the generic pharmaceutical market include: (i) introduction of other generic drug manufacturers’ products in direct competition with the Company’s products, (ii) introduction of authorized generic products in direct competition with the Company’s products, particularly during exclusivity periods, (iii) consolidation among distribution outlets through mergers and acquisitions and the formation of buying groups, (iv) ability of generic competitors to quickly enter the market after the expiration of patents or exclusivity periods, diminishing the amount and duration of significant profits, (v) the willingness of generic drug customers, including wholesale and retail customers, to switch among pharmaceutical manufacturers, (vi) pricing pressures and product deletions by competitors, (vii) a company’s reputation as a manufacturer and distributor of quality products, (viii) a company’s level of service (including maintaining sufficient inventory levels for timely deliveries), (ix) product appearance and labeling and (x) a company’s breadth of product offerings.

RAW MATERIALS

The raw materials essential to the Company’s manufacturing business are purchased primarily from U.S. distributors of bulk pharmaceutical chemicals manufactured by foreign companies. To date, the Company has experienced no significant difficulties in obtaining raw materials and expects that raw materials will generally continue to be available in the future. However, since the federal drug application process requires specification of raw material suppliers, if raw materials from a specified supplier were to become unavailable, FDA approval of a new supplier would be required. A delay of six months or more in the manufacture and marketing of the drug involved while a new supplier becomes qualified by the FDA and its manufacturing process is determined to meet FDA standards could, depending on the particular product, have a material adverse effect on the Company’s results of operations and financial condition. Generally, the Company attempts to mitigate the potential effects of any such situation by providing for, where economically and otherwise feasible, two or more suppliers of raw materials for the drugs that it manufactures. In addition, the Company may attempt to enter into a contract with a raw material supplier in an effort to ensure adequate supply for its products.

EMPLOYEES

At December 31, 2007, the Company had 716 employees. None of the Company’s employees are covered by any collective bargaining agreement. The Company considers its employee relations to be good.

GOVERNMENT REGULATION

The development, manufacturing, sales, marketing and distribution of the Company’s products are subject to extensive governmental regulation by the U.S. federal government, principally the FDA, and, as applicable, the Drug Enforcement Administration, Federal Trade Commission (the “FTC”) and state and local governments. For both currently marketed and future products, failure to comply with applicable regulatory requirements can, among other things, result in suspension of regulatory approval and possible civil and criminal sanctions. There is uncertainty around changes in regulations, enforcement positions, statutes and legal interpretations, all which could have a material adverse effect on the Company’s financial condition and results of operation.
 
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Various legislative proposals at the federal and state levels could bring about major changes in the affected health care systems. The Company cannot predict the outcome of such initiatives, but such initiatives, if passed, could result in significant costs to the Company in terms of costs of compliance and penalties associated with failure to comply.

The FFDC Act, the Controlled Substances Act and other federal statutes and regulations govern the development, testing, manufacture, safety/effectiveness, labeling, storage, record keeping, approval, advertising and promotion of the Company’s products. Non-compliance with applicable regulations can result in judicially and/or administratively imposed sanctions, including the initiation of product seizures, injunctions, fines and criminal prosecutions. Administrative enforcement measures may involve the recall of products, as well as the refusal of an applicable government authority to enter into supply contracts or to approve new drug applications. The FDA also has the authority to withdraw its approval of drugs in accordance with its regulatory due process procedures.
 
Pricing Regulation
 
Successful commercialization of the Company’s products depends, in part, on the availability of governmental and third-party payor reimbursement for the cost of the Company’s products. Government authorities and third-party payors increasingly are challenging the price of medical products and services. On the government side, there is a heightened focus, at both the federal and state levels, on decreasing costs and reimbursement rates in Medicaid, Medicare and other government insurance programs. This has led to an increase in federal and state legislative initiatives around drug prices which could significantly influence the purchase of pharmaceutical products, resulting in lower prices and changes in product demand. With respect to the Medicaid program, certain proposed provisions of the Deficit Reduction Act of 2005 went into effect January 1, 2007, and a final rule went into effect as of October 1, 2007 that resulted in changes to certain formulas used to calculate pharmacy reimbursement under Medicaid. These changes could lead to reduced payments to pharmacies.  Many states have also created preferred drug lists and include drugs on those lists only when the manufacturers agree to pay a supplemental rebate.  If the Company’s products or future drug candidates are not included on these preferred drug lists, physicians may not be inclined to prescribe them to their Medicaid patients, thereby diminishing the potential market for the Company’s products.
 
Moreover, government regulations regarding reporting and payment obligations are complex and the Company is continually evaluating the methods we use to calculate and report the amounts owed with respect to Medicaid and other government pricing programs. Our calculations are subject to review and challenge by various government agencies and authorities and it is possible that any such review could result either in material changes to the method used for calculating the amounts owed to such agency or the amounts themselves. Because the process for making these calculations, and our judgments supporting these calculations, involve subjective decisions, these calculations are subject to the risk of errors. In the event that a government authority finds errors or ambiguity with regard to the Company’s report of payments, such authority may impose civil and/or criminal sanctions which could have a material adverse effect on the Company’s business.

Fraud and Abuse Regulation
 
Pharmaceutical companies are subject to various federal and state laws relating to sales and marketing practices intended to combat health care fraud and abuse. These include anti-kickback laws, false claims laws and FDA regulation of advertising and promotion of pharmaceutical products. The Company has and will continue to incur costs to comply with these laws. While the Company intends to comply in all respects with fraud and abuse laws, there has been an increase in government enforcement efforts at both the federal and state level and, due to the breadth of regulation and the absence of guidance in some cases, it is possible that our practices might be challenged by government authorities. Violations of fraud and abuse laws may be punishable by civil and/or criminal sanctions including fines, civil monetary penalties, as well as the possibility of exclusion from federal health care programs. Any such violations could have a material adverse effect on the Company’s business.

AWP Litigation
 
Many government and third-party payors reimburse the purchase of certain prescription drugs based on a drug’s Average Wholesale Price or “AWP.” In the past several years, state and federal government agencies have conducted ongoing investigations of manufacturers’ reporting practices with respect to AWP, which they have suggested have led to excessive payments for prescription drugs. The Company, as well as numerous other pharmaceutical companies, was named as a defendant in various state and federal court actions alleging improper or fraudulent practices related to the reporting of AWP and additional actions are anticipated. These actions, if successful, could adversely affect the Company and may have a material adverse effect on the Company’s business. Refer to Notes to Consolidated Financial Statements – Note 17 – “Commitments, Contingencies and Other Matters” for further information.

Drug Pedigree Laws
 
State and federal governments are enforcing drug pedigree laws which require the tracking of all transactions involving prescription drugs from the manufacturer to the pharmacy (or other dispensing) level. Companies are required to maintain records documenting the chain of custody of prescription drug products beginning with the purchase of such products from the manufacturer. Compliance with these pedigree laws requires implementation of extensive tracking systems as well as heightened documentation and coordination with customers and manufacturers. While the Company fully intends to comply with these laws, there is uncertainty around future changes in legislation and government enforcement of these laws. Failure to comply could result in fines or penalties, as well as loss of business that have a material adverse effect on the Company’s business.
 
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Federal Regulation of Authorized Generic Arrangements
 
As part of the Medicare Prescription Drug Improvement and Modernization Act of 2003, companies are required to file with the FTC and the Department of Justice certain types of agreements entered into between brand and generic pharmaceutical companies related to the manufacture, marketing and sale of generic versions of brand drugs. This requirement could affect the manner in which generic drug manufacturers resolve intellectual property litigation and other disputes with brand pharmaceutical companies, and could result generally in an increase in private-party litigation against pharmaceutical companies or additional investigations or proceedings by the FTC or other governmental authorities.

New Drug Applications and Abbreviated New Drug Applications
 
FDA approval is required before any new drug, including a generic equivalent of a previously approved brand name drug, may be marketed. To obtain FDA approval for a new drug, a prospective manufacturer must, among other things, as discussed below, demonstrate that its manufacturing facilities comply with the FDA’s current Good Manufacturing Practices (“cGMP”) regulations. The FDA may inspect the manufacturer’s facilities to ensure such compliance prior to approval or at any other time. The manufacturer is required to comply with cGMP regulations at all times during the manufacture and processing of drugs. To comply with the standards set forth in these regulations, the Company must continue to expend significant time, money and effort in the areas of production, quality control and quality assurance.

In order to obtain FDA approval of a new drug, a manufacturer must demonstrate the safety and effectiveness of such drug. There currently are two basic ways to satisfy the FDA’s safety and effectiveness requirements:

 
1.
New Drug Applications: Unless the procedure discussed in paragraph 2 below is permitted under the FFDC Act, a prospective manufacturer must submit to the FDA a NDA containing complete pre-clinical and clinical safety and efficacy data or a right of reference to such data. The pre-clinical data must provide an adequate basis for evaluating the safety and scientific rationale for the initiation of clinical trials. Clinical trials are conducted in three sequential phases and may take up to several years to complete. At times, the phases may overlap. Data from pre-clinical testing and clinical trials is submitted to the FDA as a NDA for marketing approval.

 
2.
Abbreviated New Drug Applications: The Hatch-Waxman amendments established a statutory procedure for submission, FDA review and approval of ANDAs for generic versions of brand name drugs previously approved by the FDA (such previously approved drugs are hereinafter referred to as “listed drugs”). Because the safety and efficacy of listed drugs have already been established by the innovator company, the FDA waives the requirement for complete clinical trials. However, a generic manufacturer is typically required to conduct bioavailability/bioequivalence studies of its test product against the listed drug. The bioavailability/bioequivalence studies assess the rate and extent of absorption and concentration levels of a drug in the blood stream required to produce a therapeutic effect. Bioequivalence is established when the rate of absorption and concentration levels of a generic product are substantially equivalent to the listed drug. For some drugs (e.g., topical anti-fungals), other means of demonstrating bioequivalence may be required by the FDA, especially where rate and/or extent of absorption are difficult or impossible to measure. In addition to the bioequivalence data, an ANDA must contain patent certifications, chemistry, manufacturing, labeling and stability data.

The Hatch-Waxman amendments also established certain statutory protections for listed drugs. Under the Hatch-Waxman amendments, approval of an ANDA for a generic drug may not be made effective for interstate marketing until all relevant patents for the listed drug have expired or been determined to be invalid or not infringed by the generic drug. Prior to enactment of the Hatch-Waxman amendments, the FDA did not consider the patent status of a previously approved drug. In addition, under the Hatch-Waxman amendments, statutory non-patent exclusivity periods are established following approval of certain listed drugs, where specific criteria are met by the drug. If exclusivity is applicable to a particular listed drug, the effective date of approval of ANDAs for the generic version of the listed drug is usually delayed until the expiration of the exclusivity period, which, for newly approved drugs, can be either three or five years. The Hatch-Waxman amendments also provide for extensions of up to five years for certain patents covering drugs to compensate the patent holder for the reduction in the effective market life of the patented drug resulting from the time spent in the federal regulatory review process.

During 1995, patent terms for a number of listed drugs were extended when the Uruguay Round Agreements Act (the “URAA”) went into effect in order to implement the General Agreement on Tariffs and Trade (the “GATT”) to which the United States became a treaty signatory in 1994. Under GATT, the term of patents was established as 20 years from the date of patent application. In the United States, the patent terms historically have been calculated at 17 years from the date of patent grant. The URAA provided that the term of issued patents be either the existing 17 years from the date of patent grant or 20 years from the date of application, whichever was longer. The effect generally was to extend the patent life of already issued patents, thus delaying FDA approvals of applications for generic products.
 
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The Medicare Prescription Drug Improvement and Modernization Act of 2003 streamlined the generic drug approval process by limiting a drug company to only one 30-month stay of a generic drug’s entry into the market for resolution of a patent challenge for ANDAs filed after August 18, 2003. This rule was designed to help maintain a balance between the innovator companies’ intellectual property rights and the desire to allow generic drugs to be brought to the market in a timely fashion.

The FDA issued a final rule on June 18, 2003 (the “final rule”), clarifying the types of patents that innovators must submit for listing and prohibiting the submission of patents claiming packaging, intermediates or metabolite innovations. Patents claiming a different polymorphic form of the active ingredient described in a NDA must be submitted if the NDA holder has test data demonstrating that the drug product containing the polymorph will perform in the same way as the drug product described in the NDA. These changes are consistent with concerns raised in 2002 by the FTC in its report on generic drugs. The final rule also clarifies the type of patent information that is required to be submitted and revises the declaration that NDA applicants must provide regarding their patents to help ensure that NDA applicants submit only appropriate patents.

The final rule was intended to make the patent submission and listing process more efficient, as well as to enhance the ANDA and 505(b)(2) application approval process. The changes were designed to enable consumers to save billions of dollars each year by making it easier for generic drug manufacturers to get safe and effective products on the market when the appropriate patent protection expires.

Section 505(b)(2) was added to the FFDC Act by the Hatch-Waxman amendments. This provision permits the FDA to rely, for approval of a NDA, on data not developed by the applicant. A 505(b)(2) application must include identification of the listed drug for which the FDA has made a finding of safety and effectiveness and on which finding the applicant relies in seeking approval of its proposed drug product. A 505(b)(2) application may rely on studies published in scientific literature or an FDA finding of safety and/or efficacy for an approved product for support, in addition to clinical studies performed by the applicant.

The approval of a 505(b)(2) application may result in three years of exclusivity under the Hatch-Waxman amendments if one or more of the clinical studies (other than bioavailability/bioequivalency studies) were essential to the approval of the application and was conducted by the applicant. The approval of a 505(b)(2) application may result in five years of exclusivity if it is for a new chemical entity. If appropriated under U. S. patent laws, 505(b)(2) NDAs are eligible for the FDA’s patent certification protection. Such approvals have the potential to be delayed due to patent and exclusivity rights that apply to the listed drug. 

Other
 
In addition to the U.S. federal government, various states and localities have laws regulating the manufacture and distribution of pharmaceuticals, as well as regulations dealing with the substitution of generic drugs for brand name drugs. The Company’s operations are also subject to regulation, licensing requirements and inspection by the states and localities in which its operations are located and/or it conducts business.

Certain activities of the Company are also subject to FTC enforcement. The FTC enforces a variety of antitrust and consumer protection laws designed to ensure that the nation’s markets function competitively, are vigorous, efficient and free of undue restrictions.

The Company also is governed by federal and state laws of general applicability, including laws regulating matters of environmental quality, working conditions, health and safety, and equal employment opportunity.

As a public company, the Company is subject to the Sarbanes-Oxley Act of 2002 (the “SOX Act”), and the regulations promulgated thereunder. The SOX Act contains a variety of provisions affecting public companies, including the relationship with its auditors, prohibiting loans to executive officers and requiring an evaluation of its internal disclosure controls and procedures.

MANAGEMENT INFORMATION SYSTEMS

The Company’s Management Information Systems (“MIS”) vision is to contribute innovative ideas to accelerate business performance, develop business-driven solutions that drive profitable growth, and maintain best-in-class infrastructure for reliable and sustainable operations.

The Company’s MIS Department is organized into two major groups: business systems and technical operations. The business systems team purchases, develops, and maintains application business systems jointly with internal business department members. Major business systems are grouped by business area as follows:

Major scientific systems include IBM SCORE electronic submissions, Waters Empower data acquisition, Labware LIMS, and TrackWise compliance tracking. Major Commercial Systems include JDEdwards financials, Hyperion financial consolidation, and iMany wholesaler chargebacks. Major Supply Chain Systems include JDEdwards enterprise resource planning and Inovis electronic data interchange. Major Human Resource Systems include PeopleSoft human resources and ADP payroll.
 
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The Business Systems team follows industry practices in the areas of Project Management, Systems Development Life Cycle, IT Change Management, Account Management, Computer Systems Validation, and Data Archiving.

The Technical Operations team purchases, develops, and maintains technical infrastructure systems to support the Company. Major infrastructure areas addressed are electronic mail, multiple data centers, network management, telecommunications, and web services. The Technical Operations team follows industry best practices (e.g., IT Infrastructure Library – ITIL) in the areas of configuration management, incident/problem management, capacity planning, disaster recovery, backup and restore, data center operations, and security management.

COMPANY STRENGTHS AND STRATEGIES

It is the Company’s intention to successfully manage both its generic and proprietary businesses for the long term. The Company is striving to achieve sustainable long-term growth with enhanced profitability and improved cash flow.

The Company’s Generic Products Division is committed to providing high-quality pharmaceuticals that are affordable and accessible to patients. The Company ranked 6th in U.S. sales among all generic drug companies in 2007, according to IMS Health, and currently manufactures, markets or licenses approximately 80 prescription drugs.

The Company’s pipeline includes approximately 45 products awaiting FDA approval and approximately 35 others under active development. In recent years, the Company introduced generic versions of several major pharmaceutical products, including Toprol-XL®, Flonase®, Ultracet®, Paxil®, Prozac® and Megace® Oral Suspension. In January 2007, the Company received approval for and launched propranolol extended release capsules, a generic version of Inderal® LA. The Company’s was the first generic version of this modified release product to be approved and reach the marketplace.

Developing and Marketing Higher-Margin Generic Pharmaceuticals

Internally, the Company’s generic products division is focused on developing products with limited competition, significant barriers to entry and longer life cycles. Its success is also predicated on business development, including in-licensing, alliances and acquisitions, and cost efficiencies derived from global sourcing initiatives and operations.

Building a Leading Proprietary Pharmaceutical Business Focused on Specialty Markets

In 2005, the Company received approval for and introduced the appetite stimulant Megace® ES (megestrol acetate) 625 mg/5 mL oral suspension, its first proprietary pharmaceutical product. In the near term, it is the Company’s intention to support the continued sales growth of Megace® ES, and to add to its portfolio of branded, single-source prescription drug products through in-licensing and the acquisition of late-stage development or currently marketed products. In July 2007, the Company announced it entered into an exclusive licensing agreement under which the Company will receive commercialization rights in the U.S. to BioAlliance’s Loramyc (miconazole Lauriad®), an antifungal therapy currently in Phase III development for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immunocompromised patients, including those with HIV and cancer. The ongoing pivotal Phase III trial for Loramyc involves 540 patients at 40 sites in the U.S., Canada and South Africa. In August 2007, the Company announced that it acquired the North American commercial rights to ZensanaTM (ondansetron HCl) Oral Spray from Hana. Ondansetron is used to prevent nausea and vomiting after chemotherapy, radiation and surgery, and following successful development and approval, ZensanaTM could be among the first in its class of 5-HT3 antagonist anti-emetic therapies to be available in an oral spray form. The Company also announced that it has entered into an agreement with NovaDel, to collaborate in the reformulation of ZensanaTM. Following completion of reformulation efforts already under way, the Company will reconfirm the product's pharmacokinetic profile and resubmit the NDA to the FDA. On January 14, 2008, the Company entered into an exclusive license agreement with Alfacell under which the Company received the exclusive U.S. commercialization rights to Alfacell’s ONCONASE® (ranpirnase).  ONCONASE® is currently in Phase III clinical development for the treatment of inoperable malignant mesothelioma, a rare cancer affecting the lungs usually associated with exposure to asbestos.  Under a separate supply agreement between Alfacell and the Company, Alfacell will supply commercial quantities of ONCONASE® to the Company.  
 
ITEM 1A. Risk Factors

The pharmaceutical industry is a fast-paced, highly competitive environment with various factors that influence the ability of a company to successfully commercialize a product. Many of these factors are beyond the control of the Company and are, therefore, difficult to predict. The following section sets forth the principal risks to the Company’s business activities and condition (financial or otherwise) and prospects. These risks, along with others, have the potential to materially and adversely affect the Company’s business, financial position, results of operations and prospects.
 
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Risks Related to the Company’s Business

If the Company is unable to successfully develop or commercialize new products, its operating results will suffer.

Developing and commercializing a new product is time consuming, costly and subject to numerous factors that may delay or prevent the development and commercialization of new products. The Company’s future results of operations will depend to a significant extent upon its ability to successfully commercialize new brand and generic products in a timely manner. There are numerous difficulties in developing and commercializing new products, including:

the development and manufacture of products in compliance with regulatory standards in a timely manner;
the clinical testing process to assure that new products are safe and effective;
the risk that any of the Company’s products presently under development, if and when fully developed and tested, will not perform as expected;
the receipt of requisite regulatory approvals for such products in a timely manner;
the availability, on commercially reasonable terms, of raw materials, including active pharmaceutical ingredients and other key ingredients;
legal actions brought by our brand competitors and challenges to our intellectual property rights by generic competitors;
delays or unanticipated costs, including delays associated with the FDA listing and/or approval process; and
the avoidance of competitors’ intellectual property rights.

As a result of these and other difficulties, products currently in development by the Company may or may not receive timely regulatory approvals, or approvals at all, necessary for marketing by the Company or other third-party partners. This risk particularly exists with respect to the development of proprietary products because of the uncertainties, higher costs and lengthy time frames associated with research and development of such products and the inherent unproven market acceptance of such products. If any of the Company’s products, when acquired or developed and approved, cannot be successfully or timely commercialized, the Company’s operating results could be adversely affected. The Company cannot guarantee that any investment it makes in developing products will be recouped, even if it is successful in commercializing those products.

The Company faces intense competition in the pharmaceutical industry from brand name and generic manufacturers, which could significantly limit its growth and materially adversely affect its financial results.

The pharmaceutical industry is highly competitive. Many of the Company’s competitors have longer operating histories and greater financial, research and development, marketing and other resources than the Company. Consequently, many of its competitors may be able to develop products and/or processes competitive with, or superior to, its own. Furthermore, the Company may not be able to differentiate its products from those of its competitors, successfully develop or introduce new products that are less costly than those of its competitors or offer purchasers of its products payment and other commercial terms as favorable as those offered by its competitors. The markets in which the Company competes and intends to compete are undergoing, and are expected to continue to undergo, rapid and significant change. The Company expects competition to intensify as technological advances and consolidations continue. New developments by other manufacturers could render its products uncompetitive or obsolete.

The Company believes that its principal generic competitors are Actavis, Mylan, Teva, Watson, Barr, Apotex, Sandoz, Roxane and Ranbaxy. These companies, among others, collectively compete with the majority of the Company’s products. The Company also faces price competition generally as other generic manufacturers enter the market, and as a result of consolidation among wholesalers and retailers and the formation of large buying groups, any of which, in turn, could result in reductions in sales prices and gross margin. This price competition has led to an increase in customer demands for downward price adjustments by the manufacturers of generic pharmaceutical products, including the Company, for certain products that have already been delivered. The Company cannot provide assurance that such price reductions will not continue, or even increase, with a consequent material adverse effect on its revenues and gross margin.

The Company’s principal strategy in addressing its competition is to offer its customers a consistent supply of a broad line of generic drugs at competitive pricing and attempt to develop products with limited competition. The Company cannot provide assurance, however, that this strategy will enable it to compete successfully in its industry or that the Company will be able to develop and implement any new viable strategies.

Competition in the generic drug industry has also increased due to the proliferation of authorized generic pharmaceutical products. These products compete with the Company’s products when manufacturers of brand name drugs and/or their affiliates introduce generic pharmaceutical products equivalent to their brand name drugs at relatively lower prices or partner with generic companies to introduce generic products. An authorized generic product is not subject to the 180-day exclusivity period granted by the Hatch-Waxman Act. The sale of authorized generics greatly impacts the market share of a generic product that has been granted 180 days of market exclusivity. This is a significant source of competition for the Company because brand-name companies do not face any regulatory barriers when attempting to introduce a generic version of their proprietary brand. Additionally, authorized generics may be sold during the Company’s exclusivity period, which can materially affect the profits that the Company could receive as an exclusive marketer of a product. Such actions have the effect of reducing the potential market share and profitability of generic products developed by the Company and may inhibit it from developing and introducing generic pharmaceutical products corresponding to certain brand name drugs.
 
15

 
As its competitors introduce their own generic equivalents of the Company’s generic pharmaceutical products, the Company’s revenues and gross margin from such products generally decline.

Revenues and gross margin derived from generic pharmaceutical products often follow a pattern based on regulatory and competitive factors believed to be unique to the generic pharmaceutical industry. As the patent(s) for a brand name product and the exclusivity period expires, the first generic manufacturer to receive regulatory approval for a generic equivalent of the product often is able to capture a substantial share of the market. However, as other generic manufacturers receive regulatory approvals for competing products, that market share, and the price of that product, will typically decline depending on several factors, including the number of competitors, the price of the brand product and the pricing strategy of the new competitors. The Company cannot provide assurance that it will be able to continue to develop such products or that the number of competitors with such products will not increase to such an extent that the Company may stop marketing a product for which it previously obtained approval, which will have a material adverse impact on its revenues and gross margin.

The Company’s operating results are affected by a number of factors, including competition, and may fluctuate significantly on a quarterly basis.

The Company’s operating results may vary substantially from quarter to quarter. Revenues for any given period may be greater or less than revenues in the immediately preceding period or in the comparable period of the prior year. Factors that may cause quarterly results to vary include, but are not limited to, the following:

the amount of new product introductions;
marketing exclusivity, if any, which may be obtained on certain new products;
the level of competition in the marketplace for certain products;
availability of raw materials and finished products from suppliers;
the scope and outcome of governmental regulatory action;
the dependence on a small number of products for a significant portion of net revenue or income;
legal actions brought by our brand competitors and challenges to our intellectual property rights by generic competitors; 
• price erosion/customer consolidation; and
significant payments (such as milestones) earned under collaboration, licensing, and development agreements by our partners before the related product has received FDA approval.

The profitability of the Company’s product sales is also dependent upon the prices it is able to charge for its products, the costs to purchase products from third parties, and its ability to manufacture its products in a cost-effective manner. If its revenues decline or do not grow as anticipated, the Company may not be able to correspondingly reduce its operating expenses. Failure to achieve anticipated levels of revenues could, therefore, significantly harm its operating results for a particular fiscal period.

In certain circumstances, the Company issues price adjustments and other sales allowances to its customers. Although the Company establishes reserves in connection with these credits, if estimates of the reserves are inadequate, it may result in adjustments to these reserves that may have a material adverse effect on the Company’s financial position and results of operations.

In the generic drug industry, when a company first introduces a generic drug, it may, under certain circumstances, be granted exclusivity by the FDA to market the product for a period of time before any other generic manufacturer may enter the market. At the expiration of such exclusivity period, other generic manufacturers may enter the market and, as a result, the price of the drug may decline significantly (in some instances, price declines have exceeded 90%). The Company will at its discretion provide a credit to its customers for the difference between the Company’s new price at the expiration of the exclusivity period and the price at which the Company sold the customers the product with respect to the customer’s remaining inventory. There are circumstances under which the Company may not provide price adjustments to certain customers and consequently, as a matter of business strategy, may lose future sales volume to competitors rather than reduce its pricing. In addition, the Company’s reported revenues are net of estimated chargebacks (i.e., the difference between a product’s negotiated price with a given customer, such as a drug store chain, and the invoice price that the Company charges to a wholesaler that resells the product to such customer), rebates and incentives, returns, cash discounts and other sales allowances.
 
16

 
The Company establishes reserves for chargebacks, rebates and incentives, and other sales allowances, as well as product returns at the time of sale. Although the Company believes its reserves are adequate as of the date of this report, it cannot provide assurances that its reserves will prove to be adequate. Increases in sales allowances may exceed what was estimated due to a variety of reasons, including unanticipated competition or an unexpected change in one or more of its contractual relationships. The Company will continue to evaluate the effects of competition and will record a price adjustment reserve if and when it deems it necessary. Any failure to establish adequate reserves with respect to sales allowances may result in a material adverse effect on its financial position and results of operations.

The use of legal, regulatory and legislative strategies by brand name competitors, including authorized generics and citizen’s petitions, as well as the potential impact of proposed legislation, may increase the Company’s costs associated with the introduction or marketing of its generic products, delay or prevent such introduction and/or significantly reduce its profit potential.

The Company’s brand name competitors often pursue strategies that may serve to prevent or delay competition from generic alternatives to brand products. These strategies include, but are not limited to:

entering into agreements whereby other generic companies will begin to market an authorized generic product at the same time generic competition initially enters the market;
filing “citizen’s petitions” with the FDA, including timing the filings so as to thwart generic competition by causing delays of the Company’s product approvals;
seeking to establish regulatory and legal obstacles that would make it more difficult to demonstrate bioequivalence and/or “sameness”;
initiating legislative and administrative efforts in various states to limit the substitution of generic versions of brand pharmaceuticals;
filing suits for patent infringement that automatically delay FDA approval of generic products;
introducing “next-generation” products prior to the expiration of market exclusivity for the reference product, which often materially reduces the demand for the first generic product for which the Company seeks FDA approval;
obtaining extensions of market exclusivity by conducting clinical trials of brand drugs in pediatric populations or by other potential methods as discussed below;
persuading the FDA to withdraw the approval of brand name drugs for which the patents are about to expire, thus allowing the brand name company to obtain new patented products serving as substitutes for the products withdrawn;
seeking to obtain new patents on drugs for which patent protection is about to expire;
seeking temporary restraining orders and injunctions against generics who have received final approval and attempt to "launch at risk”;
reducing the sales force detailing the product to healthcare providers, thereby reducing the brand drug's commercial exposure and market growth rate; and
converting brand prescription drugs that are facing potential generic competition to over-the-counter varieties, thereby significantly impeding the growth of the generic market.

The Food and Drug Modernization Act of 1997 includes a pediatric exclusivity provision that may provide an additional six months of market exclusivity for indications of new or currently marketed drugs if certain agreed upon pediatric studies are completed by the applicant. Brand companies are utilizing this provision to extend periods of market exclusivity. Some companies have lobbied Congress for amendments to the Waxman-Hatch legislation that would give them additional advantages over generic competitors. For example, although the term of a company’s drug patent can be extended to reflect a portion of the time a NDA is under regulatory review, some companies have proposed extending the patent term by a full year for each year spent in clinical trials, rather than the one-half year that is currently permitted. If proposals like these were to become effective, the Company’s entry into the market and its ability to generate revenues associated with new products may be delayed, reduced or eliminated, which could have a material adverse effect on its business.

If the Company fails to obtain exclusive marketing rights for its generic pharmaceutical products or fails to introduce these generic products on a timely basis, its revenues, gross margin and operating results may decline significantly.

As a result of the 180-day marketing exclusivity period granted to generic pharmaceutical companies that are first to file an ANDA, generic pharmaceutical products, at their launch, often are priced to yield relatively high gross margins. During certain periods, a large portion of the Company’s revenues have been derived from the sales of generic drugs during the 180-day marketing exclusivity period and from the sale of generic products with which it has limited competition. ANDAs containing certifications challenging patents, however, generally become the subject of patent infringement and validity litigation that can be both lengthy and costly. In addition, there is no certainty that the ANDA applicant will prevail in the litigation or that the applicant will be the first to file and, therefore, be a candidate for the 180-day marketing exclusivity period. Furthermore, timely commencement of the litigation by the patent owner imposes an automatic stay of ANDA approval by the FDA for up to 30 months, unless the case is decided in an ANDA applicant’s favor during that period. Finally, if the court decision is adverse to the ANDA applicant, the ANDA approval will be delayed until the challenged patent expires, and the applicant will not receive the 180-day marketing exclusivity period.
 
17

 
The future profitability of the Company depends, to a significant extent, upon its ability to introduce, on a timely basis, new generic products for which it is either the first to market (or among the first to market) or otherwise can gain significant market share. The timing of the introduction of its products is dependent upon, among other things, the timing of regulatory approval of the Company’s products as well as that of competing products. As additional manufacturers introduce comparable generic pharmaceutical products, price competition and access to market intensifies and sales prices and product gross margins decline, often significantly. Accordingly, the Company’s revenues and future profitability are dependent, in large part, upon its ability to file ANDAs timely and effectively with the FDA or to enter into contractual relationships with other parties that have obtained marketing exclusivity. No assurances can be given that the Company will be able to develop and introduce successful products in the future within the time constraints necessary to be successful. If the Company is unable to continue timely and effectively to file ANDAs with the FDA first or to partner with other parties that have obtained marketing exclusivity, its revenues, gross margin and operating results may decline significantly and its prospects and business may be materially adversely affected.

FDA policy and guidance may result in the Company’s generic products not being able to utilize fully the 180-day marketing exclusivity period, which would adversely affect its results of operations.

As a result of litigation against the FDA, in March 2000, the FDA issued a new policy and guidance document regarding the timing of approval of ANDAs following court decisions on patent infringement and validity and the start of the 180-day marketing exclusivity period. As a result of this FDA policy and guidance document and other relevant litigation, the Company may not be able to utilize all or any portion of any 180-day marketing exclusivity period on ANDA products on which it was first to file, depending on the timing and results of court decisions in patent litigation (either its litigation or another ANDA applicant’s litigation), which could adversely affect its results of operations and future profitability. The Medicare Prescription Drug Improvement and Modernization Act of 2003 also changed the scope and timing of some ANDA approvals and the start of the 180-day marketing exclusivity period after a court decision. The Company is presently unable to predict the magnitude of the impact, if any, the FDA’s current policy and guidance or the pending legislation, if adopted, may have on its business, prospects or financial condition. Any inability to use fully the 180-day marketing exclusivity period for any of its products, however, will adversely affect its results of operations.

The Company’s brand pharmaceutical expenditures may not result in commercially successful products.

Commercializing brand pharmaceutical products is more costly than generic products. The Company has made significant investments in the development of the brand side of its business. This has led to increased infrastructure costs. The Company cannot be certain that these business expenditures will result in the successful development or launch of brand products that will prove to be commercially successful or will improve the long-term profitability of the Company’s business.
 
Just as the Company competes against companies selling branded products when it sells generic products, the Company will confront the same competitive pressures when it sells its branded products. Specifically, generics are generally sold at a significantly lower cost than the branded version, and, where available, may be required or encouraged in preference to the branded version under third party reimbursement programs, or substituted by pharmacies for branded versions by law. Competition from generic equivalents, accordingly, could have an adverse effect on the Company’s brand segment.
 
The Company continues to pursue product or business acquisitions or licensing arrangements to expand its brand product line. Any growth of the brand segment of the Company’s business will largely be based on the in-licensing of new compounds and approval of existing new compounds licensed. The Company’s current and future investments in license arrangements may not lead to expected, adequate or any returns on investment. For example, in 2007, the Company invested in license arrangements for three products under development, and the development program for one of the three, parfuramidine maleate, has already been terminated as of February 2008. The Company may also not be able to execute future license agreements on reasonable or favorable terms in order to continue to grow or sustain its brand business segment.

Due to its dependence on a limited number of products, the Company’s business will be materially adversely affected if these products do not perform as well as expected.

The Company generates a significant portion of its total revenues and gross margin from the sale of a limited number of products. For the year ended December 31, 2007, the Company’s top selling products, metoprolol (Toprol-XL®), fluticasone (Flonase®), propranolol ER (Inderal LA®), cabergoline (Dostinex®), various amoxicillin products (Amoxil®), ibuprofen Rx (Advil®, Nuprin®, Motrin®), tramadol HCl and acetaminophen tablets (Ultracet® ), megestrol oral suspension (generic) and Megace® ES (brand), fluoxetine (Prozac®), and methimazole (Tapazole®) accounted for approximately 70% of its total net revenues and a significant portion of its gross margin. Any material adverse developments, including increased competition, with respect to the sale or use of these products, or the failure of the Company to successfully introduce other key products, could have a material adverse effect on its revenues and gross margin.
 
18

 
The Company’s profitability depends on its major customers. If these relationships do not continue as expected, the Company’s business, condition (financial and otherwise), prospects and results of operation could materially suffer.

The Company has approximately 86 customers, some of which are members of larger buying groups. For 2007, its largest customers, McKesson Drug Co., AmerisourceBergen Corporation, Cardinal Health, Inc., and Walgreen Co., accounted for approximately 22%, 12%, 11% and 10%, respectively, of its total revenues. The loss of any one or more of these customers or the substantial reduction in orders from any one or more of such customers could have a material adverse effect upon its operating results and financial condition.

The Company’s ability to market successfully any product depends, in large part, upon the acceptance of the product by independent third parties.

The Company’s ability to market successfully any generic or proprietary pharmaceutical product depends, in large part, upon the acceptance of the product by independent third parties (including physicians, pharmacies, government formularies and other retailers) as well as patients. The Company’s success will, therefore, depend in large part on brand acceptance of its proprietary products, and on its ability to convince such third parties that its generic versions of brand name products are manufactured as safely and with the same efficacy as their brand name counterparts or other generic equivalents. In addition, some of its generic products are manufactured in different forms than their brand name counterparts (e.g., tablet versus capsule). Therefore, the Company must also convince third parties to use a product in a form different from what they are accustomed to using.

The Company depends on distribution and marketing agreements, and any failure by it to maintain these arrangements or enter into similar arrangements with new partners could result in a material adverse effect.

The Company has broadened its product line by entering into distribution and marketing agreements, as well as contract manufacturing agreements, through which it distributes generic pharmaceutical products manufactured by others. The Company has entered into distribution agreements with several companies to develop, distribute and promote such generic pharmaceutical products. For the year ended December 31, 2007, approximately 53% of its total net product sales were generated from distributed products which consist of products manufactured under contract and licensed products. The Company cannot provide assurance that the efforts of its contractual partners will continue to be successful or that it will be able to renew such agreements or that it will be able to enter into new agreements with additional companies. Any alteration to or termination of its current material distribution and marketing agreements, any failure to enter into new and similar agreements, or the interruption of the supply of the products to the Company under the distribution and marketing agreements, could materially adversely affect its business, condition (financial and other), prospects or results of operations.

The Company’s reporting and payment obligations under the Medicaid rebate program and other governmental purchasing and rebate programs are complex and may involve subjective decisions. Any determination of failure to comply with those obligations could subject it to penalties and sanctions, which could have a material adverse effect.

The regulations regarding reporting and payment obligations with respect to Medicaid reimbursement and rebates and other governmental programs are complex and, as discussed elsewhere in this Annual Report on Form 10-K, the Company and other pharmaceutical companies are defendants in a number of suits filed by state attorneys general and have been notified of an investigation by the U.S. Department of Justice with respect to Medicaid reimbursement and rebates. The Company’s calculations and methodologies are subject to review and challenge by the applicable governmental agencies, and it is possible that such reviews could result in material changes. In addition, because the Company’s processes for these calculations and the judgments involved in making these calculations involve, and will continue to involve, subjective decisions and complex methodologies, these calculations are subject to the risk of errors.

Any governmental agencies that have commenced, or may commence, an investigation of the Company could impose, based on a claim of violation of fraud and false claims laws or otherwise, civil and/or criminal sanctions, including fines, penalties and possible exclusion from federal health care programs (including Medicaid and Medicare). Some of the applicable laws may impose liability even in the absence of specific intent to defraud. Furthermore, should there be ambiguity with regard to how to properly calculate and report payments and even in the absence of any such ambiguity a governmental authority may take a position contrary to a position that the Company has taken, and may impose civil and/or criminal sanctions. Any such penalties or sanctions could have a material adverse effect on the Company’s business, financial position and results of operations and could cause the market value of its common stock to decline.
 
19

 
Healthcare reform and a reduction in the reimbursement levels by governmental authorities, HMOs, MCOs or other third-party payers may adversely affect the Company’s business.

In order to assist the Company in commercializing products, it has obtained from government authorities and private health insurers and other organizations, such as HMOs and MCOs, authorization to receive reimbursement at varying levels for the cost of certain products and related treatments. Third party payers increasingly challenge pricing of pharmaceutical products. The trend toward managed healthcare in the U.S., the growth of organizations such as HMOs and MCOs, and legislative proposals to reform healthcare and government insurance programs could significantly influence the purchase of pharmaceutical products, resulting in lower prices and a reduction in product demand. Such cost containment measures and healthcare reform could affect the Company’s ability to sell its products and may have a material adverse effect on its business, results of operations and financial condition. Additionally, there is uncertainty surrounding the implementation of the provisions of the Medicare Part D Prescription Drug Benefit as authorized by the Medicare Prescription, Improvement, and Modernization Act of 2003. Part D established a voluntary outpatient prescription drug benefit for Medicare beneficiaries (primarily the elderly over 65 and the disabled). These beneficiaries may enroll in private drug plans. There are multiple types of Part D plans and numerous plan sponsors, each with its own formulary and product access requirements. The plans have considerable discretion in establishing formularies and tiered co-pay structures and in placing prior authorization and other restrictions on the utilization of specific products. In addition, Part D plan sponsors are permitted and encouraged to negotiate rebates with manufacturers. The program, which went into effect January 1, 2006, is administered by the Centers for Medicare & Medicaid Services, or CMS, within the Department of Health and Human Services, or HHS. CMS has issued extensive regulations and other sub-regulatory guidance documents implementing the new benefit, and the HHS Office of Inspector General has issued regulations and other guidance in connection with the program. The federal government can be expected to continue to issue guidance and regulations regarding the obligations of Part D sponsors and their subcontractors. Participating drug plans may establish drug formularies that exclude coverage of specific drugs, and payment levels for drugs negotiated with Part D drug plans may be lower than reimbursement levels available through private health plans or other payers. Moreover, beneficiary co-insurance requirements could influence which products are recommended by physicians and selected by patients. There is no assurance that any drug that the Company markets will be offered by drug plans participating under the Medicare Part D program that, if covered, the terms of any such coverage, or that covered drugs will be reimbursed at amounts that reflect current or historical levels. Depending on how such provisions are implemented, reimbursement may not be available for some of the Company’s products. Additionally, any reimbursement granted may not be maintained or limits on reimbursement available from third-party payers may reduce the demand for, or negatively affect the price of, those products and could harm significantly the Company’s business, results of operations, financial condition and cash flows. The Company may also be subject to lawsuits relating to reimbursement programs that could be costly to defend, divert management’s attention and adversely affect its operating results.
 
Most state Medicaid programs have established preferred drug lists (“PDLs”), and the process, criteria and timeframe for obtaining placement on the PDL varies from state to state. Under the Medicaid drug rebate program, a manufacturer must pay a rebate for Medicaid utilization of a product. The rebate is based on the greater of (1) a specified percentage of the product’s average manufacturer price (“AMP”) or (2) the difference between the product’s AMP and the best price offered by the manufacturer. In addition, many states have established supplemental rebate programs as a condition for including a drug product on a PDL. The profitability of the Company’s products may depend on the extent to which they appear on the PDLs of a significant number of state Medicaid programs and the amount of the rebates that must be paid to such states. In addition, there is significant fiscal pressure on the Medicaid program, and amendments to lower the pharmaceutical costs of the program are possible. Such amendments could adversely affect our anticipated revenues and results of operations, possibly materially.

Due to extensive regulation and enforcement in the pharmaceutical industry, we face significant uncertainties and potentially significant costs associated with our efforts to comply with applicable regulations. Failure to comply could result in our experiencing material adverse effects to our business, financial position and results of operations and the market value of our common stock could decline.
 
The pharmaceutical industry is subject to regulation by various governmental authorities at the federal, state and local levels with respect to the development, manufacture, labeling, sale, distribution, marketing, advertising and promotion of pharmaceutical products. Failure to comply with governmental regulations can result in fines, disgorgement, unanticipated compliance expenditures, recall or seizure of products, total or partial suspension of production and/or distribution, suspension of the FDA’s review of NDAs or ANDAs, enforcement actions, injunctions and criminal prosecution. Although we have developed compliance programs to address the regulatory environment there is no guarantee that these programs, as currently designed, will meet regulatory agency standards now or in the future. Additionally, despite our efforts at compliance, there is no guarantee that we may not be deemed to be deficient in some manner in the future. If we were deemed to be deficient in any significant way, our business, financial position and results of operations could be materially affected, and the market value of our common stock could decline.
 
20

 
The Company expends a significant amount of resources on research and development, including milestones on in-licensed products that may not lead to successful product introductions.

Much of the Company’s development effort is focused on technically difficult-to-formulate products and/or products that require advanced manufacturing technology. It conducts research and development primarily to enable it to manufacture and market FDA-approved pharmaceuticals in accordance with FDA regulations. Typically, research expenses related to the development of innovative compounds and the filing of NDAs are significantly greater than those expenses associated with ANDAs. The Company has entered into, and may, in the future, enter into, additional agreements which require the Company to make significant milestone payments upon achievement of various research and development events and regulatory approvals. As it continues to develop and in-license new products, the Company will likely incur increased research and licensing expenses.
 
Because of the inherent risk associated with research and development efforts in its industry, particularly with respect to new drugs, its research and development expenditures may not result in the successful introduction of FDA approved new pharmaceutical products. Also, after it submits an ANDA or NDA, the FDA may request that the Company conducts additional studies and as a result, it may be unable to reasonably determine the total research and development costs to develop a particular product. Finally, it cannot be certain that any investment made in developing products will be recovered, even if it is successful in commercialization. To the extent that the Company expends significant resources on research and development efforts and is not able, ultimately, to introduce successful new products as a result of those efforts, its business, financial position and results of operations may be materially adversely affected, and the market value of its common stock could decline.

A significant number of the Company’s products are produced at one location that could experience business interruptions, which could have a material adverse effect on the Company’s business, financial position and results of operations.

The Company produces all of its internally manufactured products at a single manufacturing facility. A significant disruption at that facility, even on a short-term basis, could impair its ability to produce and ship products to the market on a timely basis, which could have a material adverse effect on its business, financial position and results of operations.

The Company may experience declines in the sales volume and prices of its products as a result of the continuing trend of consolidation of certain customer groups, which could have a material adverse effect on the Company’s business, financial position and results of operations.
 
The Company makes a significant amount of its sales to a relatively small number of drug wholesalers and retail drug chains. These customers represent an essential part of the distribution chain of the Company’s pharmaceutical products. Drug wholesalers and retail drug chains have undergone, and are continuing to undergo, significant consolidation. This consolidation may result in these groups gaining additional purchasing leverage and consequently increasing the product pricing pressures facing our business. Additionally, the emergence of large buying groups representing independent retail pharmacies and other drug distributors, and the prevalence and influence of managed care organizations and similar institutions, potentially enable those groups to demand larger price discounts on the Company’s products. The result of these developments may have a material adverse effect on the Company’s business, financial position and results of operations.

The Company may experience significant inventory losses related to “At Risk” product launches, which could have a material adverse effect on the Company’s business, financial position and results of operations.
 
There are situations in which the Company may make business and legal judgments to market and sell products that are subject to claims of alleged patent infringement prior to final resolution of those claims by the courts, based upon its belief that such patents are invalid, unenforceable, or would not be infringed. This is referred to in the pharmaceutical industry as an “at risk” launch. The risk involved in an at risk launch can be substantial because, if a patent holder ultimately prevails, the remedies available to such holder may include, among other things, damages measured by the profits lost by the holder, which can be significantly higher than the profits the Company makes from selling the generic version of the product. The Company could face substantial damages from such adverse decisions of the court. The Company would also be at risk for the value of such inventory that is unable to be marketed or sold.

The indenture for the Company’s Notes imposes significant operating and financial restrictions, which may prevent it from capitalizing on business opportunities and taking some actions.

The indenture for the Company’s Notes imposes significant operating and financial restrictions. These restrictions limit the ability of the Company to, among other things, incur additional indebtedness, make investments, sell assets, incur certain liens or merge or consolidate. The Company cannot provide assurance that these restrictions will not adversely affect its ability to finance its future operations or capital needs or to pursue available business opportunities.
 
21

 
The Company is subject to pending litigations in connection with the restatement of certain of its financial statements for prior periods that will likely divert substantial amounts of management time from the Company’s operations and could result in significant expense and liabilities.

The Company and certain of its executive officers have been named as defendants in several purported stockholder class action lawsuits filed on behalf of purchasers of common stock of the Company between April 29, 2004 and July 5, 2006. The lawsuits followed the Company’s July 5, 2006 announcement regarding the restatement of certain of its financial statements and allege that the Company and certain members of its management engaged in violations of the Securities Exchange Act of 1934, as amended, by issuing false and misleading statements concerning the Company’s financial condition and results. Additionally, on August 14, 2006, individuals claiming to be stockholders of the Company filed a derivative action in the U.S. District Court for the Southern District of New York, purportedly on behalf of the Company, against the current and certain former directors and certain current and former officers of the Company as a nominal defendant. The plaintiffs in that action allege that, among other things, the named defendants breached their fiduciary duties to the Company based on substantially the same factual allegations as the purported class actions referenced above. The Company intends and each of the individuals named as a defendant has stated an intention to vigorously defend against these allegations.

The outcomes and consequences of the above referenced actions are inherently uncertain. Such litigation is often costly and time-consuming, and could result in the Company experiencing an adverse impact to its business, results of operations, financial position and cash flows. The defense of any such actions or investigations will likely cause the diversion of management’s attention and resources, and the Company may be required to pay damages if any such proceedings are not resolved in its favor. Further, any litigation or regulatory proceedings, even if resolved in the Company’s favor, could cause it to incur significant legal and other expenses, including modifying or adopting new controls and procedures. Such events could harm the Company’s business, affect its ability to raise capital and adversely affect the trading price of its securities.

If actions taken to remediate material weaknesses in the Company’s internal controls over financial reporting are insufficient or if the Company fails to maintain all of the controls necessary for continued compliance, current stockholders and potential investors could lose confidence in the Company’s financial reporting, which would harm its business prospects and the trading price of its stock.

As described below in Item 9A, the Company’s management has concluded that the Company did not maintain effective internal controls over its financial reporting as of December 31, 2007. Effective internal controls are necessary for the Company to provide reliable financial reports. If it cannot provide reliable financial reports, stockholder and investor confidence in the Company’s business and operating results could be negatively impacted. The Company has discovered, and may in the future discover, areas of its internal control that need improvement.

Section 404 of the Sarbanes-Oxley Act of 2002 requires the Company to evaluate the effectiveness of its internal controls over financial reporting as of each year-end. Management concluded that its internal control over financial reporting were not effective as a result of material weakness identified and did not provide reasonable assurance regarding the reliability of its financial reporting or the preparation of its financial statements in accordance with GAAP. In addition the Company may identify additional and/or different control deficiencies in the future that, individually or in the aggregate, could constitute one or more additional material weaknesses.

If the Company fails to implement and maintain the improvements in internal controls over its financial reporting that are intended to remediate the material weakness identified, the Company could fail to meet its reporting obligations, including issuing financial statements in future periods that contain errors. The failure to maintain the improvements in internal controls over financial reporting that are intended to remediate any identified weaknesses also could cause investors to lose confidence in the Company’s reported financial information and possibly have a negative impact on the trading prices of its securities and could lead to additional litigation claims and/or regulatory proceedings against the Company. The defense of any such claims or proceedings may cause the diversion of management’s attention and resources, and the Company may be required to pay damages if any such claims or proceedings are not resolved in its favor. Any litigation or regulatory proceeding, even if resolved in the Company’s favor, could cause it to incur significant legal and other expenses. Such events could harm the Company’s business, negatively affect its ability to raise capital and adversely affect the trading price of its securities.
 
22

 
The Company has received a notice of default and notice of acceleration with respect to its convertible notes and a lawsuit has commenced.

The Company received a notice of default from the Trustee of the Company’s 2.875% Senior Subordinated Convertible Notes due 2010 (the “Notes”). The Trustee claims, in essence, that the Company’s failure to include financial statements in its Quarterly Report on Form 10-Q for the second quarter of 2006 constitutes a default under Section 6.2 of the Indenture, dated as of September 30, 2003 (the “Indenture”), between the Company, as issuer, and American Stock Transfer and Trust Company, as trustee (the “Trustee”), relating to the Notes. The notice of default asserted that if the purported default continues unremedied for 30 days after the receipt of the notice, an “event of default” would occur under the Indenture. Under the Indenture, the occurrence of an event of default would give the Trustee or certain holders of the Notes the right to declare all unpaid principal and accrued and unpaid interest on the Notes immediately due and payable. On October 2, 2006, the Company received a notice from the Trustee purporting to accelerate payment of the principal of and accrued interest on the Notes. The Company believes that it has complied with its obligations under the Indenture relating to the Notes. Therefore, the Company believes that the abovementioned notice of default and notice of acceleration are invalid and without merit. After the Company communicated its position to the Trustee, the Trustee filed a lawsuit, on October 19, 2006, on behalf of the holders of the Notes, in the Supreme Court of the State of New York, County of New York, alleging a breach of the Indenture and an alleged breach of an alleged covenant of good faith and fair dealing. The lawsuit demands, among other things, that the Company pay the holders of the Notes either the principal, any accrued and unpaid interest and Additional Interest (as such term is defined in the Indenture), if any, of the Notes, or the difference between the fair market value of the Notes on October 2, 2006 and par, whichever the Trustee elects, or in the alternative, damages to be determined at trial, alleged to exceed $30 million. The Company filed a Notice of Removal to remove the lawsuit to the U.S. District Court for the Southern District of New York and has filed its answer to the complaint in that Court. On January 19, 2007, the Trustee filed a motion for summary judgment along with supporting documentation. On February 16, 2007, the Company filed its response to the Trustee’s motion for summary judgment and cross-moved for summary judgment in its favor. The Court has not yet ruled on the motions.

If the Trustee’s position is upheld and an “event of default” in fact has occurred, the Company could be obligated to immediately pay all outstanding principal and accrued and unpaid interest on the Notes due and payable to the holders of the Notes. The lawsuit also demands, among other things, that the Company pay the holders of the Notes Additional Interest (as such term is defined in the Indenture), if any, or the difference between the fair market value of the Notes on October 2, 2006 and par, whichever the Trustee elects, or in the alternative, damages to be determined at trial. Such an event could require the Company to obtain alternative financing that may not be available to the Company on favorable terms or at all, and could have a material adverse impact on the Company’s operations, prospects, liquidity and the trading prices of its securities.

Risks Common to the Company’s Industry

Litigation is common in the Company’s industry, and can be protracted and expensive, and could delay and/or prevent entry of its products into the market, which, in turn, could have a material adverse effect on its business. 

Litigation concerning patents and proprietary rights can be protracted and expensive. Pharmaceutical companies with patented brand products are increasingly suing companies that produce generic forms of their patented brand name products for alleged patent infringement or other violations of intellectual property rights, which may delay or prevent the entry of such generic products into the market. Generally, a generic drug may not be marketed until the applicable patent(s) on the brand name drug expires or is held not infringed, invalid, or unenforceable. When an ANDA is submitted to the FDA for approval of a generic drug, the submitting person may either certify that (1) there is no patent information filed, (2) that any patent submitted has expired, (3) that the patent listed by the FDA as covering the generic product will expire prior to the marketing of the generic product, in which case the ANDA will not be finally approved until the expiration of such patent, or (4) that any patent listed as covering the generic drug is invalid or will not be infringed by the manufacture, sale or use of the new drug for which the ANDA is submitted. Under any circumstance in which an act of infringement is alleged to occur, there is a risk that a brand pharmaceutical company may sue the filing person for alleged patent infringement or other violations of intellectual property rights. Also, other companies that compete with the Company by manufacturing, developing and/or selling the same generic pharmaceutical products similarly may file lawsuits against the Company or its strategic partners claiming patent infringement or file declaratory judgment actions of non-infringement, invalidity, or unenforceability against the Company in view of the Company’s patents. Because substantially all of the Company’s current business involves the marketing and development of patented products, the threat of litigation, the outcome of which is inherently uncertain, is always present. Such litigation is often costly and time-consuming and could result in a substantial delay in, or prevent, the introduction and/or marketing of its products, which could have a material adverse effect on the business, condition (financial and other), prospects and results of operations of the Company. The Company’s strategic partners and others are also parties to several lawsuits, the outcome of which may have a material impact on the Company. For more information on the Company’s material pending litigation, please see Item 3 of this Annual Report on Form 10-K.
 
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The Company is susceptible to product liability claims that may not be covered by insurance, which, if successful, could require it to pay substantial sums. 

Like all pharmaceutical companies, the Company faces the risk of loss resulting from, and the adverse publicity associated with, product liability lawsuits, whether or not such claims are valid. The Company likely cannot avoid such claims. Unanticipated side effects or unfavorable publicity concerning any of its products would likely have an adverse effect on its ability to achieve acceptance by prescribing physicians, managed care providers, pharmacies and other retailers, customers and patients. Even unsuccessful product liability claims could require it to spend money on litigation, divert management’s time, damage its reputation and impair the marketability of its products. In addition, although the Company believes that it has adequate product liability insurance coverage, it cannot be certain that its insurance will, in fact, be sufficient to cover such claims or that it will be able to maintain adequate insurance coverage in the future at acceptable costs. A successful product liability claim that is excluded from coverage or exceeds its policy limits could require the Company to pay substantial sums. In addition, insurance coverage for product liability may become prohibitively expensive in the future.

The Company is subject to extensive governmental regulation, the non-compliance with which may result in fines and/or other sanctions, including product seizures, product recalls, injunctive actions and criminal prosecutions.

As a member of the pharmaceutical manufacturing industry, the Company is subject to extensive regulation by the federal government, principally the FDA and the Drug Enforcement Administration, and, to a lesser extent, by state governments. The FFDC Act, the Controlled Substances Act, the Generic Drug Enforcement Act of 1992 (the “Generic Act”), and other federal statutes and regulations govern the testing, manufacture, safety, labeling, storage, recordkeeping, approval, advertising and promotion (including the healthcare community) of the Company’s products. The Generic Act, a result of legislative hearings and investigations into the generic drug approval process, is particularly relevant to the Company’s business. Under the Generic Act, the FDA is authorized to impose debarment and other penalties on individuals and companies that commit illegal acts relating to the generic drug approval process. In some situations, the Generic Act requires the FDA not to accept or review for a period of time ANDAs from a company or an individual that has committed certain violations and provides for temporary denial of approval of applications during its investigation. Additionally, non-compliance with other applicable regulatory requirements may result in fines, perhaps significant in amount, and other sanctions imposed by courts and/or regulatory bodies, including the initiation of product seizures, product recalls, injunctive actions and criminal prosecutions. From time to time, the Company has voluntarily recalled its products. In addition, administrative remedies may involve the refusal of the government to enter into supply contracts with, and/or to approve new drug applications of, a non-complying entity. The FDA also has the authority to withdraw its approval of drugs in accordance with statutory procedures.

Because of the chemical ingredients of pharmaceutical products and the nature of the manufacturing process, the pharmaceutical industry is subject to extensive environmental regulation and the risk of incurring liability for damages and/or the costs of remedying environmental problems. In the future, the Company may be required to increase expenditures in order to remedy environmental problems and/or comply with applicable regulations. Additionally, if the Company fails to comply with environmental regulations to use, discharge or dispose of hazardous materials appropriately or otherwise to comply with the provisions of its operating licenses, the licenses could be revoked and the Company could be subject to criminal sanctions and/or substantial civil liability or be required to suspend or modify its manufacturing operations. The Company operates in New Jersey, a State often recognized for having very aggressive public health and environmental protection laws.

Finally, as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, companies are now required to file with the FTC and the Department of Justice certain types of agreements entered into between brand and generic pharmaceutical companies related to the manufacture, marketing and sale of generic versions of brand drugs. This requirement could affect the manner in which generic drug manufacturers resolve intellectual property litigation and other disputes with brand pharmaceutical companies and could result generally in an increase in private-party litigation against pharmaceutical companies or additional investigations or proceedings by the FTC or other governmental authorities. The impact of this requirement, and the potential private-party lawsuits associated with arrangements between brand name and generic drug manufacturers, is uncertain and could adversely affect the Company’s business.

The testing required for the regulatory approval of the Company’s products is conducted by independent third parties. Any failure by any of these third parties to perform this testing properly and in a timely manner may have an adverse effect upon the Company’s ability to obtain regulatory approvals.

The Company’s applications for the regulatory approval of its products, including in-licensed products, incorporate the results of testing and other information that is conducted or gathered by independent third parties (including, for example, manufacturers of raw materials, testing laboratories, contract research organizations or independent research facilities). The ability of the products being tested to receive regulatory approval is dependent upon the quality of the work performed by these third parties, the quality of the third parties’ facilities and the accuracy of the information provided by third parties. The Company has little or no control over any of these factors. If this testing is not performed properly, the Company’s ability to obtain regulatory approvals could be restricted or delayed.
 
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The future success of the Company depends on its ability to attract and retain key employees and consultants, including skilled scientists.

The future success of the Company will depend, to a substantial degree, upon the continued service of the key members of its management team. The loss of the services of key members of its management team, or their inability to perform services on the Company’s behalf, could have a material adverse effect on its business, condition (financial and other), prospects and results of operations.

The Company’s success also will depend, to a large extent, upon the contributions of its sales, marketing, scientific and quality assurance staff. The Company competes for qualified personnel against brand pharmaceutical manufacturers, who may offer more favorable employment opportunities, as well as other generic pharmaceutical manufacturers. If the Company were not able to attract and retain the necessary personnel to accomplish its business objectives, it could experience constraints that would adversely affect its ability to sell and market effectively its products, to meet the demands of its strategic partners in a timely fashion or to support internal research and development programs. In particular, product development programs depend on the ability to attract and retain highly skilled scientists, including PhD-educated molecular biologists, biochemists and engineers, and sales and marketing efforts depend on the ability to attract and retain skilled and experienced sales, marketing and quality assurance representatives. Although the Company believes that it has been successful in attracting and retaining skilled personnel in all areas of its business, it cannot provide assurance that it can continue to attract, train and retain such personnel. Any failure in this regard could limit the rates at which the Company generates sales and develops new products.

The raw materials essential to the Company’s manufacturing business are purchased primarily from distributors of bulk pharmaceutical chemicals by foreign companies. Any significant supply interruption could have a material adverse effect on its business, condition (financial and other), prospects and results of operation.

The raw materials essential to the Company’s manufacturing business are purchased primarily from U.S. distributors of bulk pharmaceutical chemicals manufactured by foreign companies. Although the Company has not experienced difficulty in obtaining these raw materials and products, it cannot provide assurance that supply interruptions or delays will not occur in the future or that it will not have to obtain substitute materials or products, which would require additional regulatory approvals. In addition, changes in its raw material suppliers could result in delays in production, higher raw material costs and loss of sales and customers because regulatory authorities must generally approve raw material sources for pharmaceutical products. Any significant supply interruption could have a material adverse effect on the business, condition (financial and other), prospects and results of operation of the Company.

The Company may make acquisitions of, or investments in, complementary businesses, which may not be made on commercially acceptable terms, may require additional debt or equity financing and may involve numerous risks, including its inability to integrate successfully the acquired business and its assumption of liabilities.

The Company regularly reviews the potential acquisition of technologies, products and product rights and complementary businesses. In the future, the Company may choose to enter into such transactions at any time. Nonetheless, the Company cannot provide assurance that it will be able to identify suitable acquisition or investment candidates, or if the Company does identify suitable candidates, that it will be able to make such acquisitions or investments on commercially acceptable terms or at all.

If the Company makes any acquisitions or investments, it may finance such acquisitions or investments through its cash reserves, debt financing or by issuing additional equity securities, which could dilute the holdings of its then existing stockholders. If the Company requires financing, it cannot provide assurance that it will be able to obtain required financing when needed on acceptable terms or at all. Any such acquisitions or investments could also result in an increase in goodwill, intangible assets and amortization expenses that could negatively impact its profitability. Under new accounting rules, goodwill amortization expense has been eliminated. Therefore, if the fair value of its goodwill is determined at some future date to be less than its recorded value, a charge to earnings may be required. Such a charge could be in an amount that is material to the results of operations and net worth of the Company.

Additionally, acquisitions involve numerous risks, including difficulties in the assimilation of the personnel, operations and products of the acquired companies, the diversion of management’s attention from other business concerns, risks of entering markets in which the Company has no, or limited, prior experience and the potential loss of key employees of the acquired company. There may be overlap between the Company’s products or customers and an acquired entity that may create conflicts in relationships or other commitments detrimental to the integrated businesses. As a result of acquiring businesses, the Company may incur significant transaction costs, including substantial fees for investment bankers, attorneys, accountants and financial printing costs. Any acquisition could result in its assumption of unknown and/or unexpected, perhaps material, liabilities. Additionally, in any acquisition agreement, the negotiated representations, warranties and agreements of the selling parties may not entirely protect the Company, and liabilities resulting from any breaches could exceed negotiated indemnity limitations.

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The Company depends on its ability to protect its intellectual property and proprietary rights. The Company cannot be certain of the confidentiality and protection of such rights.

The success of the Company depends on its ability to protect its current and future products and to defend its intellectual property rights. If the Company fails to protect its intellectual property adequately, competitors may manufacture and market products similar to, or confused with, the Company’s products.

Some patent applications in the United States are maintained in secrecy or not published until the resulting patents issue. Because the publication of discoveries or inventions tends to follow their actual discovery or invention by several months, the Company cannot be certain that it was the first to invent and reduce to practice any of its discoveries or inventions. The Company also cannot be certain that patents will be issued with respect to any of its patent applications or that any existing or future patents issued to or licensed by it will provide competitive advantages for its products or will not be challenged, invalidated, circumvented or held unenforceable in proceedings commenced by its competitors. Furthermore, its patent rights may not prevent or limit its present and future competitors from developing, making, importing, using or commercializing products that are functionally similar to its products.

The Company relies particularly on trade secrets, trademarks, unpatented proprietary expertise and continuing innovation that it seeks to protect, in part, by registering and using marks, and, with regard to other intellectual property, entering into confidentiality agreements with licensees, suppliers, employees, consultants and other parties. This is done in large part because few of the Company’s products are protected by patents. The Company cannot provide assurance that these agreements will not be breached or circumvented. The Company also cannot be certain that there will be adequate remedies in the event of a breach. Disputes may arise concerning the ownership of intellectual property or the applicability of confidentiality agreements. The Company cannot be sure that its trade secrets and proprietary technology will not otherwise become known or be independently developed by its competitors or, if patents are not issued with respect to products arising from research, that it will be able to maintain the confidentiality of information relating to these products. In addition, efforts to ensure its intellectual property rights can be costly, time-consuming and/or ultimately unsuccessful.

The Company’s stock price is volatile and the value of your investment could decline in value.

The market prices for securities of pharmaceutical companies like the Company’s have been and are likely to continue to be highly volatile. As a result, investors in these companies often buy at high prices only to see the prices drop substantially later, resulting in an extreme drop in value in the holdings of these investors. Factors such as announcements of fluctuations in the Company’s or its competitors’ operating results, changes in its prospects and general market conditions for pharmaceutical stocks could have a significant impact on the future trading prices of its common stock. In particular, the trading price of the common stock of many pharmaceutical companies, including the Company, has experienced extreme price and volume fluctuations, which have at times been unrelated to the operating performance of the companies whose stocks were affected. Some of the factors that may cause volatility in the price of the Company’s securities include:

 
·
the timing of new product introductions,
 
·
quarterly variations in results,
 
·
clinical trial results and regulatory developments,
 
·
competition, including both brand and generic,
 
·
business and product market cycles,
 
·
fluctuations in customer requirements,
 
·
the availability and utilization of manufacturing capacity,
 
·
the timing and amounts of royalties paid to us by third parties,
 
·
issues with the safety or effectiveness of the Company’s products, and
 
·
developments in pending litigation matters or new litigation matters.

The price of the Company’s common stock may also be adversely affected by the estimates and projections of the investment community, general economic and market conditions, and the cost of operations in the Company’s product markets. These factors, individually or in the aggregate, could result in significant variations in the trading prices of its common stock. Volatility in the trading prices of its common stock could result in additional securities class action litigations. Any litigation would likely result in substantial costs, and divert its management’s attention and resources.

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ITEM 2. Properties  
 
The Company owns an approximately 120,000 square foot facility built in 1986 that contains manufacturing and packaging operations. The facility is located in Spring Valley, New York, on an approximately 26 acre parcel of land, of which approximately 15 acres are available for future uses.

The Company owns a second facility in Spring Valley, New York, across the street from its manufacturing facility, occupying approximately 34,000 square feet on two acres. This property was acquired in 1994 and was remodeled in 2003 for use as research and quality control laboratories and additional office space.

The Company leases 190,000 square feet for its primary warehousing operation in Suffern, New York. The lease expires in September 2012.

The Company occupies approximately 55,000 square feet in two buildings located in Spring Valley, New York for administrative offices, research and development labs and warehouse space under a lease that expires in December 2014.

The Company leases office space in Woodcliff Lake, New Jersey covering approximately 61,000 square feet. The lease expires in March 2011. This facility houses the majority of the Company’s corporate and administrative functions.

In 2004, the Company executed a lease for an additional 27,000 square foot research and development facility located in Franklin Township, New Jersey. The lease expires in July 2010.

In 2007 the Company ceased all operations and vacated a 45,000 square foot facility used for research and development and manufacturing located in Somerset, New Jersey.

The Company believes that its owned and leased properties are sufficient in size, scope and nature to meet its anticipated needs for the reasonably foreseeable future. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations-Financial Condition” and Notes to Consolidated Financial Statements — Note 17 — “Commitments, Contingencies and Other Matters.”

ITEM 3. Legal Proceedings 

Contractual Matters
 
On May 3, 2004, Pentech Pharmaceuticals, Inc. (“Pentech”) filed an action against the Company in the United States District Court for the Northern District of Illinois. This action alleges that the Company breached its contract with Pentech relating to the supply and marketing of paroxetine (PaxilÒ) and that the Company breached fiduciary duties allegedly owed to Pentech. The Company and Pentech are in dispute over the amount of gross profit share due to them. Discovery in this case has concluded. The Court denied cross motions for summary judgment relating to the construction of the contract, and denied Pentech’s motion for summary judgment against the Company’s fraudulent inducement counterclaim. The Company also filed a motion for summary judgment against Pentech’s breach of fiduciary duty claim, and that motion was granted. A trial date has not yet been set. The Company intends to defend vigorously this action.

Corporate Litigation
 
The Company and certain of its executive officers have been named as defendants in several purported stockholder class action lawsuits filed on behalf of purchasers of common stock of the Company between April 29, 2004 and July 5, 2006. The lawsuits followed the Company’s July 5, 2006 announcement regarding the restatement of certain of its financial statements and allege that the Company and certain members of its management engaged in violations of the Securities Exchange Act of 1934, as amended, by issuing false and misleading statements concerning the Company’s financial condition and results. The class actions have been consolidated and are pending in the United States District Court, District of New Jersey. The Court has appointed co-lead plaintiffs and co-lead counsel. Co-lead plaintiffs filed a Consolidated Amended Complaint on April 30, 2007, purporting to represent purchasers of common stock of the Company between July 23, 2001 and July 5, 2006. Defendants filed a motion to dismiss the Amended Complaint on June 29, 2007. The Company intends and the members of management named as defendants have stated their intentions to vigorously defend the lawsuits and any additional lawsuits that may hereafter be filed with respect to the restatement. Additionally, the Company has been informed by a letter from the Staff of the SEC dated July 7, 2006, that the SEC is conducting an informal investigation of the Company related to its restatement. The Company intends to fully cooperate with and assist the SEC in this investigation. The letter from the SEC states that the investigation should not be construed as an indication by the SEC or its Staff that any violation of law has occurred or as a reflection upon any person, entity or security. In addition, on September 6, 2006, in connection with this informal investigation, the SEC also requested certain information with respect to the Company’s internal review of its accounting for historical stock option grants. The Company has provided the information that the SEC has requested in December 2006. The SEC has not contacted the Company about its informal investigation since the Company filed its Annual Report on Form 10-K/A for 2005 on March 13, 2007.
 
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On August 14, 2006, individuals claiming to be stockholders of the Company filed a derivative action in the U.S. District Court for the Southern District of New York, purportedly on behalf of the Company, against the current and certain former directors and certain current and former officers of the Company and the Company as a nominal defendant. The plaintiffs in this action allege that, among other things, the named defendants breached their fiduciary duties to the Company based on substantially the same factual allegations as the class action lawsuits referenced above. The plaintiffs also alleged that certain of the defendants have been unjustly enriched based on their receipt of allegedly backdated options to purchase shares of common stock of the Company, and seek to require those defendants to disgorge any profits made in connection with their exercise of such options and additional attendant damages relating to allegedly backdated options during the period from January 1, 1996 to the present. The action has been transferred to the United States District Court, District of New Jersey. On June 29, 2007, the plaintiffs filed their amended complaint and in connection therewith, dropped their claims related to alleged stock option backdating. Defendants have made a motion to dismiss the complaint, which motion has been fully briefed. The Company intends and each of the individuals named as defendants have stated their intentions to vigorously defend against the remaining allegations.

On September 1, 2006, the Company received a notice of default from the American Stock Transfer & Trust Company, as trustee (the “Trustee”) of the Company’s 2.875% Senior Subordinated Convertible Notes due 2010 (the “Notes”). The Trustee claims, in essence, that the Company’s failure to include financial statements in its Quarterly Report on Form 10-Q for the second quarter of 2006 constituted a default under Section 6.2 of the Indenture, dated as of September 30, 2003 (the “Indenture”), between the Company, as issuer, and the Trustee, relating to the Notes. The notice of default asserted that if the purported default continued unremedied for 30 days after the receipt of the notice, an “event of default” would occur under the Indenture. Under the Indenture, the occurrence of an event of default would give the Trustee or certain holders of the Notes the right to declare all unpaid principal and accrued interest on the Notes immediately due and payable. On October 2, 2006, the Company received a notice of acceleration from the Trustee purporting to accelerate payment of the Notes.
 
The Company believes that it has complied with its obligations under the Indenture relating to the Notes. Therefore, the Company believes that the above-mentioned notice of default and notice of acceleration are invalid and without merit. Under the Indenture, the Company is required only to provide the Trustee with copies of its annual and other reports (or copies of such portions of such reports as the SEC may by rules and regulations prescribe) that it is required to file with the SEC pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, within 15 calendar days after it files such annual and other reports with the SEC. Moreover, the Company’s Indenture specifically contemplates providing the Trustee with portions of reports. On August 24, 2006 (within 15 days of filing with the SEC), the Company provided to the Trustee a copy of its Quarterly Report on Form 10-Q for the second quarter of 2006. The Company’s Form 10-Q did not include the Company’s financial statements for the second quarter of 2006 and related Management’s Discussion and Analysis due to the Company’s work to restate certain of its past financial statements, and, therefore, in accordance with SEC rules, the Company filed a Form 12b-25 Notification of Late Filing disclosing the omissions. The Company’s Form 12b-25 also was provided to the Trustee on August 24, 2006. Accordingly, the Company believes that it complied with the Indenture provision in question.
 
After the Company communicated its position to the Trustee, the Trustee filed a lawsuit, on October 19, 2006, on behalf of the holders of the Notes in the Supreme Court of the State of New York, County of New York, alleging a breach of the Indenture and of an alleged covenant of good faith and fair dealing. The lawsuit demands, among other things, that the Company pay the holders of the Notes either the principal, any accrued and unpaid interest and additional interest (as such term is defined in the Indenture), if any, or the difference between the fair market value of the Notes on October 2, 2006 and par, whichever the Trustee elects, or in the alternative, damages to be determined at trial, alleged by the Trustee to exceed $30.0 million. The Company filed a Notice of Removal to remove the lawsuit to the U.S. District Court for the Southern District of New York and has filed its answer to the complaint in that Court. On January 19, 2007, the Trustee filed a motion for summary judgment along with supporting documentation. On February 16, 2007, the Company filed its response to the Trustee’s motion for summary judgment and cross-moved for summary judgment in its favor. The Court has not yet ruled on the motions. Until the matter is resolved, the Company is recording the payment obligations as a current liability on the condensed consolidated balance sheets because the Court in the matter could (i) rule against the Company’s position and (ii) determine that the appropriate remedy would be the accelerated payment of the convertible notes.
 
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Patent Related Matters

On November 25, 2002, Ortho-McNeil Pharmaceutical, Inc. (“Ortho-McNeil”) filed a lawsuit against Kali, a wholly owned subsidiary of the Company, in the United States District Court for the District of New Jersey (the "2002 Litigation"). Ortho-McNeil alleged that Kali infringed U.S. Patent No. 5,336,691 (the “‘691 patent”) by submitting a Paragraph IV certification to the FDA for approval of tablets containing tramadol HCl and acetaminophen. Kali denied Ortho-McNeil’s allegation, asserting that the ‘691 patent was not infringed and is invalid and/or unenforceable, and that the lawsuit is barred by unclean hands. Kali also counterclaimed for declaratory judgments of non-infringement, invalidity and unenforceability of the ‘691 patent. Ortho-McNeil amended its complaint on July 27, 2005 to assert infringement against the Company, and to include a claim for damages against the Company and Kali. The Company and Kali have answered and counterclaimed, alleging that the ‘691 patent is not infringed, and is invalid and unenforceable for inequitable conduct. On August 1, 2006, the Patent and Trademark Office reissued the ‘691 patent as U.S. Patent No. RE 39,221 (the "'221 Patent"), containing original claim 6 from the '691 Patent and several additional new claims. On August 1 and August 4, 2006, Ortho-McNeil filed a complaint and then an amended complaint against Kali, the Company, and two other companies, Barr and Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”) (the "2006 Litigation"). Ortho-McNeil alleged infringement and willful infringement of the claims of the re-issue patent (other than claim 6, which is the subject of the 2002 Litigation) against the Company through the Company’s marketing of its tramadol HCl and acetaminophen tablets. Ortho-McNeil made similar allegations against Barr and Caraco. On April 4, 2007, the United States District Court for the District of New Jersey granted Kali's and the Company's motions for summary judgment that claim 6 of the '221 Patent, the only claim at issue in the 2002 Litigation, was invalid and was not infringed by the Company's ANDA product. Ortho-McNeil filed a motion requesting permission to immediately appeal this decision, and the Court denied Ortho-McNeil's motion and entered an order consolidating the 2002 and 2006 litigations. The Company has requested permission from the Court to file immediate summary judgment motions as to all of the remaining '221 Patent claims at issue, and also has requested that the Court proceed to trial on the Company's counterclaims for invalidity, unenforceability and intervening rights as to the '221 Patent. Ortho-McNeil has opposed the Company's requests, and the parties are awaiting a decision by the Court on these requests. On July 18, 2007, the Company entered into a settlement and license agreement with Ortho-McNeil that resolves patent litigation related to the Company’s sales of its generic tramadol HCl and acetaminophen product. Under the terms of the settlement, the Company will pay Ortho-McNeil a royalty on sales of its generic product commencing with sales from August 2006.  In accordance with the settlement and license agreement, the pending patent litigation between Ortho-McNeil, the Company and Kali in the United States District Court for the District Court of New Jersey will be concluded. As part of the settlement, the Company is entering into a consent judgment on the validity, enforceability and infringement of the ‘221 Patent.
 
On July 15, 2003, the Company filed a lawsuit against Roxane Laboratories, Inc. (“Roxane”) in the United States District Court for the District of New Jersey. The Company alleged that Roxane had infringed the Company’s U.S. Patents numbered 6,593,318 and 6,593,320 and that the infringement was willful. Roxane has denied these allegations and has counterclaimed for declaratory judgments of non-infringement and invalidity of both patents. On September 8, 2006, the Court issued a claim construction ruling on certain claim terms in dispute between the parties. Based on that construction, the Court ruled in favor of the Company and dismissed Roxane’s motion for summary judgment of non-infringement. On November 8, 2006, the Court ruled that the claims at issue in these patents were invalid as non-enabled on summary judgment. On December 8, 2006, the Company appealed the ruling to the Federal Circuit Court of Appeals, highlighting the district court’s failure to apply its own claim construction and to consider the testimony of the Company’s experts before awarding summary judgment to Roxane. On October 26, 2007, the U.S. Circuit Court of Appeals for the Federal Circuit affirmed the New Jersey District Court's ruling of invalidity for non-enablement. In January 2008, the District Court conducted a hearing on Roxane’s application for attorneys’ fees under 35 U.S.C. section 285. That issue is now being briefed.
 
On July 7, 2004, Xcel Pharmaceuticals, Inc. (now known as Valeant Pharmaceuticals, North America (“Valeant”)) filed a lawsuit against Kali Laboratories, Inc. (“Kali”), a wholly owned subsidiary of the Company, in the United States District Court for the District of New Jersey. Valeant alleged that Kali infringed U.S. Patent No. 5,462,740 (“the ‘740 patent”) by submitting a Paragraph IV certification to the FDA for approval of a generic version of Diastat brand of diazepam rectal gel. Kali has denied Valeant’s allegation, asserting that the ‘740 patent was not infringed and is invalid and/or unenforceable. Kali also has counterclaimed for declaratory judgments of non-infringement, invalidity and unenforceability of the ‘740 patent as well as a judgment that the ‘740 patent was unenforceable due to patent misuse. The parties conducted fact and expert discovery through April 2006. The parties submitted their proposed final pretrial order in June 2006 and appeared before the Court for pretrial conferences on June 13, 2006 and November 16, 2006. Under applicable law and regulations, the filing of the lawsuit triggered an automatic 30-month stay of FDA approval of Kali’s Abbreviated New Drug Application, or ANDA. That stay expired on November 29, 2006. The parties appeared before the Court for settlement conferences on May 17, 2007 and June 28, 2007. At the June 28 settlement conference the parties entered into an agreement in principle to settle the action. Immediately thereafter, the Court entered an order dismissing the action without prejudice to its being reinstated if the parties have not finalized their settlement agreement within 60 days. On October 16, 2007, the parties submitted a stipulated dismissal of the litigation which was entered on October 23, 2007, terminating the lawsuit. The settlement terms also permitted the Company, through its marketing partner Barr Laboratories, Inc., ("Barr") to introduce generic versions of the Diastat products on or after September 1, 2010. Profits from the sale of these products will be split between the Company and Barr.
 
On November 1, 2004, Morton Grove Pharmaceuticals, Inc. (“Morton Grove”) filed a lawsuit against the Company in the United States District Court for the Northern District of Illinois, seeking a declaratory judgment that four Company patents relating to megestrol acetate oral suspension are invalid, unenforceable and not infringed by a Morton Grove product that was launched in the fourth quarter of 2004. Morton Grove acknowledges that its product is covered by the Company’s patent claims. The Company asserted counterclaims that the Morton Grove product infringed three patents and that such infringement was willful. Morton Grove amended its complaint to allege antitrust violations. On November 29, 2007, a stipulated dismissal with prejudice was signed by the judge with each party only liable for its own costs and attorneys’ fees. 
 
In February 2006, the Company entered into a collaborative agreement with Spectrum Pharmaceuticals, Inc. (“Spectrum”) to develop and market generic drugs, including sumatriptan succinate injection. In 2004, Spectrum filed an ANDA containing a Paragraph IV certification with the FDA seeking marketing clearance for sumatriptan injection. On February 18, 2005, GlaxoSmithKline (“GSK”) filed a lawsuit against Spectrum in the United States District Court for the District of Delaware. GSK alleged that Spectrum’s October 2004 ANDA for sumatriptan succinate injection 6mg/0.5ml infringed GSK’s U.S. Patent No. 5,037,845 and that the infringement was willful. Spectrum denied the allegations and counterclaimed for declaratory judgments of invalidity, non-infringement and unenforceability. The non-infringement counterclaim was subsequently withdrawn. The lawsuit was resolved by settlement in November 2006. The confidential terms of the settlement, which remain subject to government review, permit the Company to sell generic versions of certain sumatriptan injection products with an expected launch no later than November 2008.
 
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On March 10, 2006, Apotex Inc. and Apotex Corp. (“Apotex”) filed a lawsuit against the Company in the United States District Court for New Jersey, seeking a declaratory judgment that four of the Company’s patents relating to megestrol acetate oral suspension are invalid, unenforceable and not infringed by an Apotex product that was launched in the third quarter of 2006. The Company has moved for a preliminary injunction against Apotex pending resolution of the litigation and has asserted counterclaims that the Apotex product infringes at least one claim of U.S. Patent 6,593,318. The Company was granted a stay and the action was terminated without prejudice on April 9, 2007 pending final resolution of the Roxane appeal. On February 6, 2008, a joint stipulation of dismissal and order with prejudice was signed by the Judge in the case.
 
On April 28, 2006, CIMA Labs, Inc. (“CIMA”) and Schwarz Pharma, Inc. (“Schwarz Pharma”) filed separate lawsuits against the Company in the United States District Court for the District of New Jersey (CIMA Labs, Inc. et al. v. Par Pharmaceutical Companies, Inc. et al., (Civil Action Nos. 06-CV-1970, 1999 (DRD)(ES)). CIMA and Schwarz Pharma each have alleged that the Company infringed U.S. Patent Nos. 6,024,981 (the “’981 patent”) and 6,221,392 (the “’392 patent”) by submitting a Paragraph IV certification to the FDA for approval of alprazolam orally disintegrating tablets. CIMA owns the ’981 and ’392 patents and Schwarz Pharma is CIMA’s exclusive licensee. The two lawsuits were consolidated on January 29, 2007. In response to the lawsuit, the Company has answered and counterclaimed denying CIMA’s and Schwarz Pharma’s infringement allegations, asserting that the ’981 and ’392 patents are not infringed and are invalid and/or unenforceable. The parties have exchanged written discovery. All 40 claims in the ’981 patent were rejected in a non-final office action in a reexamination proceeding at the United States Patent and Trademark Office (“PTO”) on February 24, 2006. The PTO again rejected all 40 claims in a second non-final office action dated February 24, 2007. The ‘392 patent is also the subject of a reexamination proceeding. The Company will continue to monitor these ongoing reexamination proceedings. CIMA has moved to stay this lawsuit pending the outcome of the reexamination proceedings and to consolidate this lawsuit with another lawsuit in the same district involving the same patents (CIMA Labs, Inc. et al. v. Actavis Group hf et al., (Civil Action No. 07-CV-0893 (DRD) (ES)). A hearing on these motions was held on May 30, 2007. The Company intends to vigorously defend this lawsuit and pursue its counterclaims.
 
The Company entered into a licensing agreement with developer Paddock Laboratories, Inc. (“Paddock”) to market testosterone 1% gel, a generic version of Unimed Pharmaceuticals, Inc.’s (“Unimed”) product Androgel®. Pursuant to this agreement, the Company is responsible for management of any litigation and payment of all legal fees associated with this product. The product, if successfully brought to market, would be manufactured by Paddock and marketed by the Company. Paddock has filed an ANDA (that is pending with the FDA) for the testosterone 1% gel product. As a result of the filing of the ANDA, Unimed and Laboratories Besins Iscovesco (“Besins”), co-assignees of the patent-in-suit, filed a lawsuit against Paddock in the United States District Court for the Northern District of Georgia, alleging patent infringement on August 22, 2003. The Company has an economic interest in the outcome of this litigation by virtue of its licensing agreement with Paddock. Unimed and Besins sought an injunction to prevent Paddock from manufacturing the generic product. On November 18, 2003, Paddock answered the complaint and filed a counterclaim, seeking a declaration that the patent-in-suit is invalid and/or not infringed by Paddock’s product. On September 13, 2006, the Company acquired from Paddock all rights to the ANDA for testosterone 1% gel, a generic version of Unimed’s product Androgel® for $6 million. The lawsuit was resolved by settlement. The settlement and license agreement terminates all on-going litigation. The settlement and license agreement also permits the Company to launch the generic version of the product no later than February 28, 2016, assuring the Company’s ability to market a generic version of Androgel® well before the expiration of the patents at issue. On March 7, 2007, the Company was issued a Civil Investigative Demand seeking information and documents in connection with the court-approved settlement in 2006 of the patent infringement case, Unimed v. Paddock, in the U.S. District Court for Northern District of Georgia. The Bureau of Competition for the Federal Trade Commission (“FTC”) is investigating whether the settlement of the litigation constituted unfair methods of competition in a potential violation of Section 5 of the FTC Act. The Company believes it has complied with all applicable laws in connection with the court-approved settlement and it intends to co-operate with the FTC in this matter.
 
On October 4, 2006, Novartis Corporation, Novartis Pharmaceuticals Corporation, and Novartis International AG (collectively “Novartis”) filed a lawsuit against the Company in the United States District Court for the District of New Jersey. Novartis alleged that the Company and Kali infringed U.S. Patent No. 6,162,802 (the “’802 patent”) by submitting a Paragraph IV certification to the FDA for approval of amlodipine and benazepril hydrochloride combination capsules. The Company and its subsidiaries denied Novartis’ allegation, asserting that the ’802 patent is not infringed and is invalid. The Company also counterclaimed for declaratory judgments of non-infringement and invalidity of the ’802 patent. The parties are currently engaged in discovery regarding the claims. The Company intends to defend vigorously this action and pursue its counterclaims against Novartis.
 
On December 19, 2006, Reliant Pharmaceuticals, Inc. (“Reliant”) filed a lawsuit against the Company in the United States District Court for the District of Delaware (Reliant Pharmaceuticals, Inc. v. Par Pharmaceutical Inc., (Civil Action Nos. 06-CV-774-JJF)). Reliant alleged, in its Complaint, that the Company infringed U.S. Patent No. 5,681,588 (the “’588 patent”) by submitting a Paragraph IV certification to the FDA for approval to market generic 325 mg Propafenone HCl SR capsules. On January 26, 2007, Reliant amended its complaint to add the additional allegation that the Company infringed the ‘588 patent by submitting a Paragraph IV certification to the FDA for approval to market generic 225 mg and 425 mg—in addition to the 325 mg—Propafenone HCl SR capsules. The Company has answered and counterclaimed denying Reliant’s infringement allegations, and asserting that the ’588 patent is invalid and unenforceable. A scheduling order has been entered under which all fact and expert discovery will be completed by May 30, 2008. The parties have begun discovery and Reliant has filed a motion to disqualify the Company’s counsel, a motion that was denied in September 2007 with ongoing written discovery on the issue. The Company intends to vigorously defend this lawsuit and pursue its counterclaims.
 
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On April 10, 2007, Abbott Laboratories (“Abbott”) and Astellas Pharma Inc. (“Astellas”), filed an amended complaint against the Company and six other defendants, seeking judgment alleging that U.S. Patent Nos. 4,599,334 (the “’334 patent”) and 4,935,507 (the “’507 patent”) are, or will be, infringed by the defendants’ planned production of cefdinir products. The Company denied Abbott and Astellas’ allegations, asserting that the ’334 and ’507 patents are not infringed and are invalid. The Company counterclaimed for declaratory judgments of non-infringement and invalidity of the patents. On September 27, 2007, the Company's motion for stipulated substitution of Orchid Chemicals & Pharmaceuticals Ltd for the Company was entered and the Company's involvement in the case was terminated.
 
On May 9, 2007, Purdue Pharma Products L.P., Napp Pharmaceutical Group Ltd., Biovail Laboratories International SRL, and Ortho-McNeil, Inc. filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent No. 6,254,887 (the “’887 patent”) because the Company submitted a Paragraph IV certification to the FDA for approval of 200mg extended release tablets containing tramadol hydrochloride. On May 30, 2007, the Company filed its answer and counterclaim to the complaint seeking a declaration of noninfringement and invalidity of the '887 patent. A subsequent complaint was served on July 2, 2007 in the same District Court. The new complaint alleges that the Company's 100mg and 200mg extended release tablets containing tramadol hydrochloride infringe the ‘887 patent. The Company filed its answer and counterclaim on July 23, 2007 and will assert all available defenses in addition to seeking a declaration of noninfringement and invalidity of the '887 patent. On October 24, 2007, plaintiffs filed an amended complaint in the Delaware District Court in view of the Company's amendment of its ANDA to include the 300 mg strength of extended release tramadol. The Company filed its answer and counterclaims on November 13, 2007. It is anticipated that fact discovery will be completed in May 2008, and expert discovery completed in August 2008 with a trial date set for October/November of 2008. The Company intends to defend this action vigorously and pursue its counterclaims against Purdue, Napp, Biovail and Ortho-McNeil. 
 
On July 6, 2007, Sanofi-Aventis and Debiopharm, S.A. filed a lawsuit against the Company and its development partner, MN Pharmaceuticals ("MN"), in the United States District Court for the District of New Jersey. The complaint alleges infringement of U.S. Patent Nos. 5,338,874 and 5,716,988 because the Company and MN submitted a Paragraph IV certification to the FDA for approval of 50 mg/10 ml, 100 mg/20 ml, and 200 mg/40 ml oxaliplatin by injection. The Company and MN filed their answer and counterclaims on October 10, 2007. On January 14, 2008, following MN's amendment of its ANDA to include oxaliplatin injectable 5 mg/ml, 40 ml vial, Sanofi-Aventis filed a complaint asserting infringement of the '874 and the '998 patents. The Company has not yet answered this complaint. The Company and MN intend to defend these actions vigorously and pursue their counterclaims against Sanofi and Debiopharm.  
 
On September 21, 2007, Sanofi-Aventis and Sanofi-Aventis U.S., LLC (“Sanofi-Aventis”) filed a lawsuit against the Company and its development partner, Actavis South Atlantic LLC ("Actavis"), in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent Nos. 4,661,491 and 6,149,940 because the Company and Actavis submitted a Paragraph IV certification to the FDA for approval of 10 mg alfuzosin hydrochloride extended release tablets. The Company filed its answer and counterclaims on October 24, 2007. The Company filed its amended answer and counterclaims on November 19, 2007. The Company intends to defend this action vigorously and pursue its counterclaims against Sanofi-Aventis.
 
On October 1, 2007, Elan Corporation, PLC filed a lawsuit against the Company and its development partner, IntelliPharmaCeutics Corp., and IntelliPharmaCeutics Ltd. ("IPC") in the United States District Court for the District of Delaware. On October 5, 2007, Celgene and Novartis filed a lawsuit against IPC in the United States District Court for the District of New Jersey. The complaint in the Delaware case alleged infringement of U.S. Patent Nos. 6,228,398 and 6,730,325 because the Company submitted a Paragraph IV certification to the FDA for approval of 5, 10, 15, and 20 mg dexmethylphenidate hydrochloride extended release capsules. Elan filed an amended Complaint on October 15, 2007. The original complaint in the New Jersey case alleged infringement of U.S. Patent Nos. 6,228,398; 6,730,325; 5,908,850; 6,355,656; 6,528,530; 5,837,284; and 6,635,284 because the Company and IPC submitted a Paragraph IV certification to the FDA for approval of 5, 10, 15, and 20 mg dexmethylphenidate extended release capsules. The Company and IPC filed their answer and counterclaims in the Delaware case on November 19, 2007. Celgene and Novartis filed an amended complaint on October 15, 2007 and the Company and IPC filed their answer and counterclaims in the New Jersey case on November 20, 2007. The Company and IPC filed an amended answer in Delaware December 12, 2007, and Elan filed their answer and motion to consolidate the cases on January 2, 2008. The Company intends to defend these actions vigorously and pursue its counterclaims against Elan, Celgene and Novartis.
 
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On September 13, 2007, Santarus, Inc. (“Santarus”), and The Curators of the University of Missouri (“Missouri”) filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent Nos. 6,699,885; 6,489,346; and 6,645,988 because the Company submitted a Paragraph IV certification to the FDA for approval of 20 mg and 40 mg omeprazole/sodium bicarbonate capsules. The Company filed its answer and counterclaims on October 17, 2007. The Company intends to defend this action vigorously and pursue its counterclaims against Santarus and Missouri. 
 
On December 11, 2007, AstraZeneca Pharmaceuticals, LP, AstraZeneca UK Ltd., IPR Pharmaceuticals, Inc. and Shionogi Seiyaku Kabushiki Kaisha filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges patent infringement because the Company submitted a Paragraph IV certification to the FDA for approval of 5 mg, 10 mg, 20 mg and 40 mg rosuvastatin calcium tablets. The Company filed its answer and counterclaims on January 31, 2008. The Company intends to defend these actions vigorously and pursue its counterclaims against AstraZeneca Pharmaceuticals, LP, AstraZeneca UK Ltd., IPR Pharmaceuticals, Inc. and Shionogi Seiyaku Kabushiki Kaisha. 
 
On December 20, 2007, Santarus, Inc. (“Santarus”), and The Curators of the University of Missouri (“Missouri”) filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent Nos. 6,699,885; 6,489,346; 6,780,882; and 6,645,988 because the Company submitted a Paragraph IV certification to the FDA for approval of 20 mg and 40 mg omeprazole/sodium bicarbonate powders for oral suspension. The Company filed its answer on January 10, 2008 and filed its amended answer and counterclaims on January 30, 2008. The Company intends to defend this action vigorously against Santarus and Missouri.

Industry Related Matters

On September 10, 2003, the Company and a number of other generic and brand pharmaceutical companies were sued by Rockland County in New York State (the suit has since been joined by additional New York counties) that has alleged violations of laws (including the Racketeer Influenced and Corrupt Organizations Act, common law fraud and obtaining funds by false statements) related to participation in the Medicaid program. The complaint seeks declaratory relief; actual, statutory and treble damages, with interest; punitive damages; an accounting and disgorgement of any illegal profits; a constructive trust and restitution; and attorneys’ and experts’ fees and costs. On August 4, 2004, the Company and a number of other generic and brand pharmaceutical companies were also sued by the City of New York, which has alleged violations of laws (including common law fraud and obtaining funds by false statements) related to participation in its Medicaid program. On June 15, 2005, a consolidated complaint was filed on behalf of a number of the New York counties and the City of New York. This case was transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. The complaint filed by Erie County in New York was not included in the consolidated complaint and has been removed to federal district court. In addition, on September 25, 2003, the Office of the Attorney General of the Commonwealth of Massachusetts filed a complaint in the District of Massachusetts against the Company and 12 other leading generic pharmaceutical companies, alleging principally that the Company and such other companies violated, through their marketing and sales practices, state and federal laws, including allegations of common law fraud and violations of Massachusetts false statements statutes, by inflating generic pharmaceutical product prices paid for by the Massachusetts Medicaid program. The complaint seeks injunctive relief, treble damages, disgorgement of excessive profits, civil penalties, reimbursement of investigative and litigation costs (including experts’ fees) and attorneys’ fees. On January 29, 2004, the Company and the other defendants involved in the litigation brought by the Office of the Attorney General of the Commonwealth of Massachusetts filed a motion to dismiss, which was denied on August 15, 2005. The Commonwealth of Massachusetts subsequently filed an amended complaint, and the defendants, including the Company, have filed a motion to dismiss the amended complaint. In addition to Massachusetts, the Commonwealth of Kentucky, the State of Illinois and the State of Alabama have filed similar suits in their respective jurisdictions, all of which have been removed to federal district court. The lawsuit brought by the State of Alabama was remanded to the Alabama state court on August 11, 2005. Following the remand, on October 13, 2005, the Court denied the defendants’ motion to dismiss, but granted in part the defendants’ motion for a more definite statement, and further ruled that the State may amend its complaint within 90 days. On October 20, 2005, the State of Mississippi filed in the Chancery Court for Hinds County, Mississippi a complaint naming the Company (among other companies) as a defendant. The Company intends to defend vigorously these actions.

On April 27, 2006, the State of Hawaii filed a complaint naming the Company as a defendant that has alleged violations of laws related to participation in the Medicaid program. The Hawaii complaint pleads causes of action for (i) false claims; (ii) unfair or deceptive acts or practices; (iii) unfair competition; (iv) violation of the Deceptive Trade Practices Act; (v) non-disclosure; and (vi) unjust enrichment. The complaint seeks general and special damages; treble damages, or in the alternative, punitive damages; costs, pre-judgment and post-judgment interest, and attorneys’ fees; injunctive relief; and such other and further relief or equitable relief as the Court deems just and proper. The Company intends to defend this action vigorously.
 
On May 8, 2006, the County of Oswego filed a complaint against the Company and certain other pharmaceutical companies. This complaint pleads causes of action for (i) fraud; (ii) violation of New York Social Services Law § 366-b; (iii) violation of New York Social Services Law § 145-b; (iv) violation of New York General Business Law § 349; (v) unjust enrichment; and (vi) fraudulent concealment. The County of Schenectady filed a similar complaint on May 9, 2006. The Company intends to defend these actions vigorously.
 
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With respect to the Erie action, on September 7, 2006, the New York Supreme Court for the County of Erie granted the defendants' joint motion to dismiss in part and denied it in part. The defendants then removed the Erie action for a second time to the United States District Court for the Western District of New York on October 11, 2006, and the case was subsequently transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. A motion to remand to State Court is currently pending.
 
The County of Nassau, New York filed a Second Amended Complaint in its action against a number of other generic and brand pharmaceutical companies, naming the Company as a defendant on January 30, 2006. The case has been consolidated, for purposes of discovery and briefing, with the action filed by a number of other New York counties and the City of New York. The matters are presently in the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. On March 3, 2006, the Company and the other defendants filed motions to dismiss the Second Amended Complaint filed by Nassau County and the consolidated complaint brought by the other counties and the City of New York. These motions were granted in part and denied in part on April 2, 2007. On June 8, 2007, the City of New York and various other New York counties, this time including Nassau County, filed a First Amended Consolidated Complaint. On June 22, 2007, the defendants filed a joint motion to dismiss the First Amended Consolidated Complaint. The Court granted the defendants' motion in part and denied it in part on July 30, 2007. On October 5, 2007, the City of New York and various other New York counties filed a Revised First Amended Consolidated Complaint, which the Company answered on October 26, 2007.
 
With respect to the Oswego and Schenectady matters, the cases have been transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. On September 17, 2007, the United States District Court for the District of Massachusetts granted the motions filed by Erie, Oswego, and Schenectady Counties to remand their respective cases to New York state court. Each of these three matters was subsequently remanded to the New York Supreme Courts for the Counties of Erie, Oswego, and Schenectady, respectively. On November 28, 2007, the defendants filed a joint motion, with the State of New York Litigation Coordinating Panel, to coordinate the three actions. This motion is currently pending.
 
The Company's motion to dismiss the Commonwealth of Massachusetts' First Amended Complaint was denied on August 15, 2005. The Company answered the Commonwealth's First Amended Complaint on November 14, 2005.
 
With respect to the Alabama action, the Company filed an answer to the Second Amended Complaint on January 30, 2006. On October 11, 2006, the defendants for the second time removed the case to the United States District Court for the Middle District of Alabama. On November 2, 2006, the matter was again remanded to State court. Certain defendants, including the Company, filed motions in September 2006 to sever or for separate trials. The trial court denied these motions. On June 1, 2007, upon the petitions of certain defendants, including the Company, the Supreme Court of Alabama granted a writ of mandamus and ordered the trial court to sever the claims against all defendants.
 
With respect to the Illinois action, the United States District Court for the District of Massachusetts granted the State of Illinois's motion to remand on September 17, 2007. The case was remanded to the Circuit Court of Cook County, Illinois. On November 19, 2007, certain defendants, including the Company, filed a new joint motion to dismiss the First Amended Complaint. This motion is currently pending.
 
The court denied the defendants’ motions to dismiss in the action brought by the Commonwealth of Kentucky on June 23, 2006. The Company answered the First Amended Complaint on July 19, 2006. The Commonwealth of Kentucky filed a Second Amended Complaint on September 28, 2007. The Company answered the Second Amended Complaint on October 15, 2007.
 
With respect to the Mississippi action, the Special Masters assigned to the case recommended the denial of the defendants' motion to dismiss on September 22, 2006. On October 2, 2006, the defendants objected to the Special Masters' recommendation. The Court had not ruled on this objection at the time the case was removed to federal district court. Also, after removal, the matter was transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings, where the State's motion to remand is pending. The case was remanded to the Chancery Court of Hinds County, Mississippi. On December 13, 2007, the Court denied the defendants’ pending motion to dismiss. The defendants appealed the trial court's decision to the Supreme Court of Mississippi on January 3, 2008. This appeal is currently pending.
 
With respect to the Hawaii matter, the State's motion to remand the action was granted on November 30, 2006. On January 12, 2007, the defendants filed a joint motion to dismiss the State's First Amended Complaint. This motion was denied on April 11, 2007, and the Company answered the First Amended Complaint on April 23, 2007.
 
The State of Alaska filed an Amended Complaint on October 17, 2006, naming the Company and other pharmaceutical companies as defendants. The Alaska complaint pleads causes of action for (i) violation of the Alaska Unfair Trade Practices and Consumer Protection Act and (ii) unjust enrichment. The complaint seeks monetary damages; declarative relief; injunctive relief; compensatory, restitution, and/or disgorgement damages; civil penalties; punitive damages; costs, attorneys' fees, and prejudgment interest; and other relief deemed just and equitable by the Court. The defendants filed a joint motion to dismiss the State's Amended Complaint on January 5, 2007. This motion was denied on May 7, 2007. The Company intends to defend this action vigorously.
 
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The State of South Carolina filed two related actions against the Company and other pharmaceutical companies on December 1, 2006. One of these Complaints seeks relief on behalf of the South Carolina Medicaid Agency and the other seeks relief on behalf of the South Carolina State Health Plan. Both South Carolina Complaints plead causes of action for (i) violation of the South Carolina Unfair Trade Practices Act; (ii) unjust enrichment; and (iii) injunctive relief. Both Complaints seek monetary damages and prejudgment interest; treble damages, attorneys' fees, and costs; civil penalties; disgorgement; injunctive relief; and other relief deemed just and equitable by the Court. On January 26, 2007, the Company moved to dismiss each Complaint or, in the alternative, for a more definite statement with respect to each Complaint. These motions are currently pending.
 
The State of Idaho filed a Complaint against the Company and various other pharmaceutical companies on January 26, 2007. The Idaho Complaint pleads causes of action for (i) violation of the Idaho Consumer Protection Act; and (ii) unjust enrichment. The State seeks declaratory and injunctive relief; monetary damages; civil penalties; disgorgement; attorneys' fees and costs; and other relief deemed just and equitable by the Court. On March 30, 2007, the defendants filed a joint motion to dismiss the State's Complaint. On August 31, 2007, the Court granted in part the defendants' joint motion to dismiss and denied it in part. On October 1, 2007, the Company answered the State's Complaint.
 
On April 5, 2007, the County of Orange, New York, filed a Complaint against the Company and various other pharmaceutical companies. The Orange County Complaint pleads causes of action for (i) violations of the Racketeer Influenced and Corrupt Practices Act; (ii) violation of various federal and state Medicaid laws; (iii) unfair trade practices; and (iv) common law claims for breach of contract, unjust enrichment, fraud, and fraudulent concealment. The County seeks actual, statutory, and treble damages, including interest; declaratory relief; disgorgement; restitution; attorneys' fees, experts' fees, and costs; and other relief deemed just and equitable by the Court. The Orange County action was transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pretrial proceedings. On September 6, 2007, that Court entered an order adding Orange County to the First Amended Consolidated Complaint filed by the City of New York and various other New York counties.
 
On September 21, 2007, the State of Utah filed a Complaint against the Company and various other pharmaceutical companies. The Utah Complaint pleads causes of action for (i) violations of the Utah False Claims Act and (ii) common law fraudulent misrepresentation. The State seeks actual, statutory, and treble damages, including prejudgment interest; restitution; attorneys' fees, experts' fees, and costs; and other relief deemed just and equitable by the Court. On November 20, 2007, the Judicial Panel on Multidistrict Litigation issued an order conditionally transferring the case to the United States District Court for the District of Massachusetts for coordinated and consolidated pretrial proceedings. The State then filed a motion to remand the case to state court, on December 7, 2007, and a motion to vacate the conditional transfer order, on December 12, 2007. These motions are currently pending.
 
Finally, on October 9, 2007, the State of Iowa filed a Complaint against the Company and various other pharmaceutical companies. The Iowa Complaint pleads causes of action for (i) violations of the Iowa Consumer Fraud Act, (ii) common law fraudulent misrepresentation, (iii) common law unjust enrichment and (iv) reporting of false best price information in violation of 42 USC Sec 1396R-8. The State seeks (i) a declaration that the Company committed the alleged violations, (ii) injunctive relief against the continuation of the alleged violations, (iii) actual, statutory damages, including prejudgment interest for the claim of unjust enrichment, (iv) actual, statutory damages, including prejudgment interest for the claim of fraudulent misrepresentation, (v) actual and punitive damages for alleged fraud, and (vi) an accounting of alleged illegal profits and a disgorgement of same, restitution, attorneys' fees, experts' fees, and costs and other relief deemed just and equitable by the Court. The Iowa action has been transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pretrial proceedings.

Other

The Company is, from time to time, a party to certain other litigations, including product liability litigations. The Company believes that these litigations are part of the ordinary course of its business and that their ultimate resolution will not have a material adverse effect on its financial condition, results of operations or liquidity. The Company intends to defend or, in cases where the Company is plaintiff, to prosecute these litigations vigorously.

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ITEM 4. Submission of Matters to a Vote of Security Holders

The Company held its Annual Meeting of Stockholders on October 16, 2007. The following matters were voted upon at the Annual Meeting of Stockholders.

PROPOSAL 1

The stockholders voted in favor of the proposal to elect the two Company nominees for Class II directors for a term expiring at the Annual Meeting of Stockholders to be held in 2010. 
 
VOTES
VOTES
 
FOR
WITHHELD
John D. Abernathy
25,271,166
5,014,830
Dr. Melvin Sharoky
26,663,841
3,622,155
 
PROPOSAL 2

The stockholders approved the Company’s amendment and restatement of the 1997 Directors’ Stock and Deferred Fee Plan. 15,761,743 shares voted in favor of the amendment and restatement of the 1997 Plan, 7,114,224 voted against and 34,565 shares abstained. In addition, there were 7,375,464 non-voted Broker shares.

PROPOSAL 3

The firm of Deloitte & Touche LLP was ratified as the Company’s independent registered public accounting firm for the 2007 fiscal year. 30,210,383 shares voted in favor of the ratification of the selection of Deloitte & Touche LLP, 51,447 shares voted against, and 24,166 shares abstained.

PROPOSAL 4

The stockholder proposal concerning benchmarking executive compensation against peer group company performance was approved. 12,031,339 voted in favor of the proposal concerning benchmarking executive compensation, 10,555,759 shares voted against, and 323,435 shares abstained. In addition there were 7,375,463 non-voted Broker shares.

PROPOSAL 5

The stockholder proposal concerning an advisory vote on named executive officer compensation was approved. 12,308,886 shares voted in favor of the proposal concerning an advisory vote on named executive officer compensation, 9,363,548 shares voted against, and 1,238,099 shares abstained. In addition, there were 7,375,463 non-voted Broker shares.
 
PART II

ITEM 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

(a)   Market information.  The Company’s Common Stock is traded on the New York Stock Exchange (the “NYSE”) (ticker symbol: PRX). The following table shows the range of the closing prices for the Common Stock, as reported by the NYSE, for each fiscal quarter during the Company’s two most recent years.
   
2007
 
2006
 
Quarter ended (approximately)
 
High
 
Low
 
High
 
Low
 
March 31
 
$
27.40
 
$
23.11
 
$
36.31
 
$
26.93
 
June 30
   
29.46
   
25.03
   
28.18
   
18.19
 
September 30
   
30.30
   
18.56
   
19.86
   
13.47
 
December 31
   
24.32
   
16.97
   
22.50
   
17.65
 

(b) Holders.  As of February 15, 2008, there were 1,549 holders of record of the Company’s common stock.
 
(c) Dividends.  During 2007, 2006 and 2005, the Company did not pay any cash dividends on its common stock. The payment of future dividends on its Common Stock is subject to the discretion of the Board and is dependent upon many factors, including the Company’s earnings, its capital needs, the terms of any financing agreements and its financial condition.
 
35

 
(d) Securities authorized for issuance under equity compensation plans.

   
Number of Securities
to be Issued Upon
Exercise of
Outstanding Options,
Warrants and Rights 
 
Weighted Average
Exercise Price of
Outstanding Options,
Warrants and Rights
 
Number of
Securities
Remaining
Available for
Future Issuance
 
Plan Category
             
Equity compensation plans approved by stockholders: 
                   
2004 Performance Equity Plan (1)
   
1,955,000
 
$
29.76
   
4,777,000
 
2001 Performance Equity Plan (2)
   
2,122,000
   
41.27
   
1,005,000
 
1997 Directors Stock Option Plan (3)
   
274,000
   
37.66
   
233,000
 
1990 Stock Incentive Plan
   
1,000
   
4.13
   
-
 
Equity compensation plans not approved by stockholders:
                   
2000 Performance Equity Plan (2)
   
174,000
   
7.16
   
110,000
 
Total
   
4,526,000
 
$
34.76
   
6,125,000
 

 
(1)
For the 2004 Plan the maximum number of stock options available for future issuance is 4,777,000. Of the total number of shares available for future grant 1,344,000 shares are available for the issuance of restricted stock and/or restricted stock units.

 
(2)
For the 2000 and 2001 Plans the total number of securities available for future issuance is all stock options.

 
(3)
For the 1997 Plan, the indicated total number of securities remaining available for future issuance may be any combination of stock options and restricted stock units.

(e) Performance graph
 
The following graph compares the total cumulative stockholder return on our Common Stock for the period December 31, 2002, through December 31, 2007, with the cumulative total return of (a) the S&P 400 Mid-Cap Index and (b) the Dow Jones US Pharmaceuticals Index. The comparison assumes that $100 was invested on December 31, 2002, in our Common Stock and in each of the comparison indices. In addition, the comparison assumes that any dividends paid were reinvested.
 
COMPARE 5-YEAR CUMULATIVE TOTAL RETURN
AMONG PAR PHARMACEUTICAL COMPANIES, INC.,
S&P MID-CAP 400 INDEX AND DOW JONES US PHARMACEUTICALS INDEX
 

Company/Index
 
12/31/2002
 
12/31/2003
 
12/31/2004
 
12/31/2005
 
12/31/2006
 
12/31/2007
 
Par Pharmaceutical Companies, Inc.
 
$
100.00
 
$
218.62
 
$
138.86
 
$
105.17
 
$
75.07
 
$
80.54
 
S&P 400 Mid-Cap
 
$
100.00
 
$
134.02
 
$
154.33
 
$
171.72
 
$
187.15
 
$
199.68
 
Dow Jones US Pharmaceuticals
 
$
100.00
 
$
109.45
 
$
100.39
 
$
98.73
 
$
112.93
 
$
117.98
 
 
36

 
(f) Issuer Purchases of Equity Securities (1)
 
Quarter Ending December 31, 2007

Period
 
Total Number
of Shares of
Common Stock
Purchased (2)
 
Average
Price Paid
per Share of
Common
Stock
 
Total Number of Shares
of Common Stock
Purchased as Part of
Publicly Announced
Plans or Programs
 
Maximum Number of
Shares of Common
Stock that May Yet Be
Purchased Under the
Plans or Programs (3)
 
September 30, 2007 through October 27, 2007
   
149
   
N/A
   
-
   
-
 
October 28, 2007 through November 24, 2007
   
1,646,517
 
$
19.14
   
1,643,094
   
-
 
November 25, 2007 through December 31, 2007
   
15,595
   
N/A
   
-
   
1,814,958
 
Total
   
1,662,261
 
$
19.14
   
1,643,094
       

(1) In April 2004, the Board authorized the repurchase of up to $50.0 million of the Company’s common stock. Repurchases are made, subject to compliance with applicable securities laws, from time to time in the open market or in privately negotiated transactions, whenever it appears prudent to do so. Shares of common stock acquired through the repurchase program are available for reissuance for general corporate purposes. On September 28, 2007, the Company announced that its Board approved an expansion of its share repurchase program allowing for the repurchase of up to $75 million of the Company’s common stock, inclusive of the $17.8 million remaining from the April 2004 authorization. The authorized amount remaining for stock repurchases under the repurchase program was $43.6 million, as of December 31, 2007. The repurchase program has no expiration date. 
 
(2) The total number of shares purchased includes 19,167 shares surrendered to the registrant to satisfy tax withholding obligations in connection with the vesting of restricted stock issued to employees and issuance of stock in connection with restricted stock units issued to employees.
 
(3) Based on the closing price of the Company’s common stock on the New York Stock Exchange of $24.00 at December 31, 2007.

 ITEM 6. Selected Financial Data
 

   
As of and for the years ended
 
(In thousands, except per share amounts)
 
12/31/07
 
12/31/06(a)
 
12/31/05(a)
 
12/31/04
 
12/31/03
 
INCOME STATEMENT DATA:
                               
Revenues:
                               
Net product sales
 
$
739,020
 
$
705,378
 
$
412,126
 
$
626,477
 
$
609,534
 
Other product related revenues
   
30,646
   
19,790
   
20,130
   
21,498
   
22,490
 
Total revenues
   
769,666
   
725,168
   
432,256
   
647,975
   
632,024
 
Cost of goods sold
   
501,147
   
507,220
   
277,554
   
435,988
   
375,760
 
Gross margin
   
268,519
   
217,948
   
154,702
   
211,987
   
256,264
 
                                 
Operating expenses (income):
                               
Research and development
   
77,659
   
62,442
   
62,497
   
47,533
   
21,109
 
Selling, general and administrative
   
138,217
   
148,488
   
92,309
   
67,954
   
56,043
 
Acquired in-process research and development
   
-
   
-
   
-
   
84,000
   
-
 
Intangible assets impairment
   
-
   
1,100
   
6,999
   
-
   
-
 
Settlements, net
   
(945
)
 
1,250
   
-
   
(2,846
)
 
-
 
Gain on sale of facility
   
-
   
-
   
-
   
(2,812
)
 
-
 
Total operating expenses
   
214,931
   
213,280
   
161,805
   
193,829
   
77,152
 
Gain on sale of product rights
   
20,000
   
3,054
   
-
   
-
   
-
 
Operating income (loss)
   
73,588
   
7,722
   
(7,103
)
 
18,158
   
179,112
 
 
37

 


   
As of and for the years ended
 
(In thousands, except per share amounts)
 
12/31/07
 
12/31/06(a)
 
12/31/05(a)
 
12/31/04
 
12/31/03
 
Other income (expense), net
   
(56
)
 
126
   
(831
)
 
63
   
(35
)
Equity in loss of joint venture
   
(387
)
 
(663
)
 
(534
)
 
(795
)
 
(1,521
)
Net investment (loss) gain
   
(1,583
)
 
(583
)
 
16,013
   
-
   
-
 
Interest income
   
13,673
   
8,974
   
5,343
   
4,869
   
2,292
 
Interest expense
   
(6,803
)
 
(6,781
)
 
(6,793
)
 
(6,804
)
 
(2,748
)
Income from continuing operations before provision (benefit) for income taxes
   
78,432
   
8,795
   
6,095
   
15,491
   
177,100
 
Provision (benefit) for income taxes
   
27,322
   
2,054
   
(5,726
)
 
4,918
   
68,928
 
Income from continuing operations
   
51,110
   
6,741
   
11,821
   
10,573
   
108,172
 
Loss from discontinued operations and loss from disposal before benefit for income taxes
   
-
   
-
   
(42,975
)
 
(4,942
)
 
(2,603
)
Provision (benefit) for income taxes
   
1,212
   
894
   
3,220
   
(1,927
)
 
(1,015
)
Loss from discontinued operations
   
(1,212
)
 
(894
)
 
(46,195
)
 
(3,015
)
 
(1,588
)
Net income (loss)
 
$
49,898
 
$
5,847
 
$
(34,374
)
$
7,558
 
$
106,584
 
                                 
Net income (loss) per share of common stock:
                               
Basic:
                               
Income from continuing operations
 
$
1.48
 
$
0.20
 
$
0.35
 
$
0.31
 
$
3.23
 
Loss from discontinued operations
   
(0.04
)
 
(0.03
)
 
(1.35
)
 
(0.09
)
 
(0.05
)
Net income (loss)
 
$
1.44
 
$
0.17
 
$
(1.00
)
$
0.22
 
$
3.18
 
                                 
Diluted:
                               
Income from continuing operations
 
$
1.47
 
$
0.19
 
$
0.35
 
$
0.30
 
$
3.12
 
Loss from discontinued operations
   
(0.04
)
 
(0.03
)
 
(1.35
)
 
(0.09
)
 
(0.05
)
Net income (loss)
 
$
1.43
 
$
0.16
 
$
(1.00
)
$
0.21
 
$
3.07
 
                                 
Weighted average number of common shares outstanding:
                               
Basic:
   
34,494
   
34,422
   
34,191
   
34,142
   
33,483
 
Diluted
   
34,718
   
34,653
   
34,435
   
34,873
   
34,638
 
                                 
BALANCE SHEET DATA:
                               
Working capital
 
$
210,514
 
$
105,209
 
$
288,545
 
$
292,833
 
$
433,378
 
Property, plant and equipment, net
   
82,650
   
89,155
   
87,570
   
60,001
   
47,208
 
Total assets
   
781,523
   
814,677
   
736,030
   
714,647
   
743,720
 
Long-term debt, less current portion
   
-
   
-
   
202,001
   
202,308
   
200,489
 
Total stockholders’ equity
   
437,755
   
401,050
   
358,123
   
368,772
   
371,912
 
 
(a)   In preparing its consolidated financial statements for year ended December 31, 2007, the Company identified a balance sheet reclassification and accounting errors related to its discontinued operations reported in the Company’s 2006 and 2005 financial information contained in its Annual Report on Form 10-K for the year ended December 31, 2006 and filed on September 6, 2007. See Note 1 - “Restatement of Previously Issued Financial Statements” to the consolidated financial statements contained elsewhere in this Form 10-K.

38


ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Certain statements in this Report constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including those concerning management’s expectations with respect to future financial performance, trends and future events, particularly relating to sales of current products and the introduction of new manufactured and distributed products. Such statements involve known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. These statements are often, but not always, made using words such as “estimates,” “plans,” “projects,” “anticipates,” “continuing,” “ongoing,” “expects,” “intends,” “believes,” “forecasts” or similar words and phrases. Factors that might affect such forward-looking statements set forth in this Report include: (i) increased competition from new and existing competitors, and pricing practices from such competitors (particularly upon completion of exclusivity periods), (ii) pricing pressures resulting from the continued consolidation by the Company’s distribution channels, (iii) the amount of funds available for internal research and development and research and development joint ventures, (iv) research and development project delays and unanticipated costs in obtaining regulatory approvals, (v) continuation of distribution rights under significant agreements, (vi) the continued ability of distributed product suppliers to meet future demand, (vii) the costs, delays involved in and outcome of any threatened or pending litigations, including patent and infringement claims, (viii) unanticipated costs, delays and liabilities in integrating acquisitions, (ix) obtaining or losing 180-day marketing exclusivity periods on products, and future new product launches, and (x) general industry and economic conditions. To the extent that any statements made in this Report contain information that is not historical, such statements are essentially forward-looking and are subject to certain risks and uncertainties, including the risks described above as well as the risks and uncertainties discussed under Item 1A Risk Factors and from time to time in other of the Company's filings with the SEC, including its Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements included in this Annual Report on Form 10-K are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

The financial data contained in this section is in thousands or as otherwise noted.

The following discussion should be read in conjunction with the Company’s consolidated financial statement and related notes to consolidated financial statements contained elsewhere in this Form 10-K.

In preparing its consolidated financial statements for year ended December 31, 2007, the Company identified an accounting error related to its discontinued operations reported in the Company’s 2006 and 2005 financial information contained in its Annual Report on Form 10-K for the year ended December 31, 2006 and filed on September 6, 2007. See Note 1 - “Restatement of Previously Issued Financial Statements” in the notes to consolidated financial statements contained elsewhere in this Form 10-K. The effects of the restatement on the consolidated financial statements are reflected in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” below.

OVERVIEW

Critical to the growth of the Company is its introduction of new manufactured and distributed products at selling prices that generate adequate gross margins. The Company, through its internal generic development program and various strategic alliances and relationships, seeks to introduce new products that have less competition and to broaden its product list. The Company plans to continue to invest in its generic internal research and development efforts, brand marketing strategy and its strategic alliances and relationships throughout 2008 and beyond. Also, the Company will continue seeking additional products for sale through new and existing distribution agreements or acquisitions of complementary products and businesses, additional first-to-file opportunities and unique dosage forms to differentiate its products in the marketplace. The Company pays a percentage of the gross profits or sales to its strategic partners on sales of products covered by its distribution agreements. Generally, products that the Company develops internally, and to which it is not required to split any profits with strategic partners, contribute higher gross margins than products covered by distribution agreements.

These efforts resulted in new product introductions in 2007, including propranolol HCl extended release (“ER”) capsules, which is an outcome of the Company’s strategic partnership with Nortec Development Associates, Inc, ranitidine HCl syrup, pursuant to a supply and distribution agreement with GSK and the launch of metoprolol succinate ER 25 mg in the fourth quarter of 2006 and additional strengths (50mg, 100mg, and 200mg) in the third quarter 2007, pursuant to a supply and distribution agreement with AstraZeneca (“AZ”). Additionally, in accordance with the development, sales, marketing and supply agreement with Barr, the Company receives royalties from the sales of ondansetron tablets, which launched in the fourth quarter of 2006.

In 2006, the Company’s efforts resulted in higher sales from new product introductions, including fluticasone pursuant to a supply and distribution agreement with GSK, several other products pursuant to agreements with Teva, Ivax, and Orchid Chemicals & Pharmaceuticals Ltd. including amoxicillin products and cefprozil, and the launch of cabergoline in December of 2005.

39

 
The Company’s business plan includes developing and marketing branded drugs as part of its effort to add products with longer life cycles and higher profitability to the Company’s product line. In July 2005, the Company received FDA approval for its first New Drug Application (“NDA”), filed pursuant to Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, and immediately began marketing megestrol acetate oral suspension NanoCrystal® Dispersion (“Megace® ES”). Megace® ES is indicated for the treatment of anorexia, cachexia or any unexplained significant weight loss in patients with a diagnosis of AIDS and is utilizing the Megace® brand name that the Company has licensed from Bristol-Myers Squibb Company (“BMS”). In September 2006, the Company entered into an extended-reach agreement with Solvay Pharmaceuticals, Inc. (“Solvay”) that provides for the Company’s branded sales force to co-promote Androgel®, as well as future versions of the product or other products that are mutually agreed upon, for a period of six years. As compensation for its marketing and sales efforts, the Company will receive $10 million annually, paid quarterly, for the six-year period. The Company has progressed on its business plan during 2007 by acquiring the rights to additional branded products currently in Phase III clinical trials. In July 2007, the Company also acquired an exclusive licensing agreement under which the Company will receive commercialization rights in the U.S. to BioAlliance Pharma's Loramyc (miconazole Lauriad®), an antifungal therapy for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immunocompromised patients, including those with HIV and cancer. In August 2007, the Company also acquired the North American commercial rights to ZensanaTM (ondansetron HCl) Oral Spray from Hana Biosciences, Inc. (“Hana”). Ondansetron is used to prevent nausea and vomiting after chemotherapy, radiation and surgery, and following successful development and approval, ZensanaTM could be among the first in its class of 5-HT3 antagonist anti-emetic therapies to be available in an oral spray form. The Company also announced that it has entered into an agreement with NovaDel, to collaborate in the reformulation of ZensanaTM. Following completion of reformulation efforts already under way, the Company will reconfirm the product's pharmacokinetic profile and resubmit the NDA to the FDA. Another Phase III candidate to which the Company acquired U.S. commercialization rights in 2007, pafuramidine maleate, had its development program terminated in February 2008. Due to the termination, the Company has no further monetary obligations under its agreement with Immtech Pharmaceuticals, Inc. (“Immtech”), the developer of the product. The Company had paid a $3.0 million licensing fee to acquire the U.S. commercialization rights from Immtech in June 2007. In January 2008, the Company announced that it entered into an exclusive licensing agreement with Alfacell Corporation (“Alfacell”) to acquire the commercialization rights in the United States and its territories for Onconase® (ranpirnase). Onconase is in Phase III development for the treatment of inoperable malignant mesothelioma, a rare cancer affecting the lungs usually associated with exposure to asbestos. Onconase was previously granted orphan drug status as well as fast-track development status by the FDA for the treatment of malignant mesothelioma. For additional information on these agreements and other similar matters, refer to Notes to Consolidated Financial Statements - Note 11 - “Research and Development Agreements” and Note 22 - “Subsequent Events.”

In addition to the substantial costs of product development, the Company may incur significant legal costs in bringing certain products to market. Litigation concerning patents and proprietary rights is often protracted and expensive. Pharmaceutical companies with patented brand products are increasingly suing companies that produce generic forms of their patented brand name products for alleged patent infringement or other violations of intellectual property rights, which could delay or prevent the entry of such generic products into the market. Generally, a generic drug may not be marketed until the applicable patent(s) on the brand name drug expires. When an ANDA is filed with the FDA for approval of a generic drug, the filing person may certify either that the patent listed by the FDA as covering the branded product is about to expire, in which case the ANDA will not become effective until the expiration of such patent, or that the patent listed as covering the branded drug is invalid or will not be infringed by the manufacture, sale or use of the new drug for which the ANDA is filed. In either case, there is a risk that a branded pharmaceutical company may sue the filing person for alleged patent infringement or other violations of intellectual property rights. Because a substantial portion of the Company’s current business involves the marketing and development of generic versions of brand products, the threat of litigation, the outcome of which is inherently uncertain, is always present. Such litigation is often costly and time-consuming, and could result in a substantial delay in, or prevent, the introduction and/or marketing of products, which could have a material adverse effect on the Company’s business, financial condition, prospects and results of operations.

Sales and gross margins of the Company’s products depend principally on the: (i) introduction of other generic drug manufacturers’ products in direct competition with the Company’s significant products; (ii) ability of generic competitors to quickly enter the market after patent or exclusivity period expirations, or during exclusivity periods with authorized generic products, diminishing the amount and duration of significant profits to the Company from any one product; (iii) pricing practices of competitors and the removal of competing products from the market; (iv) continuation of existing distribution agreements; (v) introduction of new distributed products; (vi) consolidation among distribution outlets through mergers, acquisitions and the formation of buying groups; (vii) willingness of generic drug customers, including wholesale and retail customers, to switch among generic pharmaceutical manufacturers; (viii) approval of ANDAs, introduction of new manufactured products, and future new product launches, (ix) granting of potential marketing exclusivity periods; (x) extent of market penetration for the existing product line; (xi) level, quality and amount of customer service; and (xii) market acceptance of the Company’s recently introduced branded product and the successful development to commercialization of the Company's in-licensed branded product pipeline.

40

 
The Company divested FineTech effective December 31, 2005 and, as such, its results are being reported as discontinued operations for all periods presented (see Notes to Consolidated Financial Statements - Note 18 - “Discontinued Operations-Related Party Transaction”).

Effective January 1, 2006, the Company adopted SFAS 123R, which requires the Company to measure and recognize compensation expense for all stock-based payments at their fair-value. SFAS 123R is being applied on the modified prospective basis. Prior to its adoption of SFAS 123R, the Company accounted for its stock-based compensation plans in accordance with provisions of APB 25, “Accounting for Stock Issued to Employees,” as permitted by SFAS 123. Prior to 2006, compensation costs related to stock options granted at fair value under those plans were not recognized in the consolidated statements of operations. Compensation costs related to restricted stock and restricted stock units were recognized in the statements of operations (see Notes to Consolidated Financial Statements - Note 3 - “Share-Based Compensation”).

The following table shows the revenues, gross margin, and operating income by segment for the years ended December 31, 2007, 2006, and 2005:

   
2007
 
2006
 
2005
 
Revenues:
                   
Generic
 
$
684,917
 
$
675,938
 
$
417,384
 
Brand
   
84,749
   
49,230
   
14,872
 
Total revenues
 
$
769,666
 
$
725,168
 
$
432,256
 
                     
Gross Margin:
                   
Generic
 
$
204,130
 
$
183,543
 
$
143,736
 
Brand
   
64,389
   
34,405
   
10,966
 
Total gross margin
 
$
268,519
 
$
217,948
 
$
154,702
 
                     
Operating income (loss):
                   
Generic
 
$
73,357
 
$
39,028
 
$
34,159
 
Brand
   
231
   
(31,306
)
 
(41,262
)
Total operating income (loss)
 
$
73,588
 
$
7,722
 
$
(7,103
)

Total revenues and gross margin dollars increased $44,498, or 6.1% and $50,571, or 23.2%, respectively, for the year ended December 31, 2007 compared to the same period in 2006. For the year ended December 31, 2006, the Company’s total revenues and gross margin dollars increased $292,912, or 67.8% and $63,246, or 40.9%, respectively, when compared to 2005. Generic revenues and gross margin dollars increased $8,979, or 1.3% and $20,587, or 11.2%, respectively, for the year ended December 31, 2007 compared to the same period in 2006. Generic revenues and gross margin dollars increased $258,554, or 61.9% and $39,807, or 27.7%, respectively, for the year ended December 31, 2006 from the year ended December 31, 2005. Increased generic sales in 2007 were primarily due to product introductions including metoprolol succinate ER (25mg, 50mg, 100mg, and 200mg), propranolol HCl ER caps and ranitidine HCl syrup, and royalties earned related to the sales of ondansetron tablets, which launched in the fourth quarter of 2006. These increases were partially offset by lower sales of existing products including fluticasone, various amoxicillin products, quinapril, cefprozil, tramadol HC1 and acetaminophen tablets, lovastatin, paroxetine, fluoxetine and glyburide metformin. The increase in generic gross margin was primarily due to the introduction of new product launches including propranolol HCl ER and metoprolol succinate ER, royalties earned from the sales of ondansetron tablets, which launched in the fourth quarter of 2006, and lower inventory write-offs for the year ended December 31, 2007 compared with the same period in 2006. Branded revenues and gross margin dollars for the year ended December 31, 2007 increased $35,519 or 72.1% and $29,984 or 87.2%, respectively, driven by increased sales of Megace® ES and fees received related to the co-promotion of Androgel®. Brand revenues and gross margin dollars for the year ended December 31, 2006 increased $34,358 or 231.0% and $23,439 or 213.7%, respectively, primarily due to the July 2005 launch of Megace® ES.

Net sales and gross margins derived from generic pharmaceutical products often follow a pattern based on regulatory and competitive factors that are believed by the Company’s management to be unique to the generic pharmaceutical industry. As the patent(s) for a brand name product and the related exclusivity period(s) expire, the first generic manufacturer to receive regulatory approval from the FDA for a generic equivalent of the product is often able to capture a substantial share of the market. At that time, however, the branded company may license an authorized generic product to a competing generic company. As additional generic manufacturers receive regulatory approvals for competing products, the market share and the price of that product have typically declined, often significantly, depending on several factors, including the number of competitors, the price of the brand product and the pricing strategy of the new competitors.

41

 
Operating income from the generic business was impacted in 2007 by the sales and gross margins discussed above, including a reduction in inventory write-offs of $6,155 driven by improved inventory management and the non-recurrence of the 2006 write-off of pre-launch inventories ($2,145) related to the delayed launch of clonidine, as well as by increased investment in generic research and development projects ($5,889), and costs associated with the Company’s tender offer for certain eligible unvested stock options ($2,898) - see Notes to Consolidated Financial Statements - Note 3 - “Share-Based Compensation,” partially offset by the non-recurrence of the 2006 write-off of invalid customer deductions ($10,000). Brand operating loss was favorably impacted in 2007 due to higher gross margin on higher sales, the co-promotion fees for Androgel® ($6,931), the sale of Par 101 ($20,000) and the cancellation of the development programs for PAR 101 and the Megace® ES oncology clinical program (approximately $5,700), tempered by higher costs incurred in connection with the in-license of several late stage compounds in support of the Company’s strategy to expand its brand segment ($19,150) and the costs of the Company’s tender offer for certain eligible unvested stock options ($1,717).

RESULTS OF OPERATIONS

Revenues

Total revenues for the year ended December 31, 2007 were $769,666, increasing $44,498, or 6.1%, from total revenues of $725,168 for the year ended December 31, 2006. Revenues for generic products for the year ended December 31, 2007 were $684,917, increasing $8,979, or 1.3% from revenues for generic products of $675,938 for the year ended December 31, 2006, due primarily to the introduction of new products. Among the top-selling products in 2007 that did not have sales in 2006 was metoprolol succinate ER 50mg, 100mg, and 200mg (net sales of $82,250), propranolol HCl ER caps (net sales of $57,459), and ranitidine HCl syrup (net sales of $12,243). Among the top-selling products in 2007 that were introduced in the fourth quarter of 2006 was metoprolol succinate ER 25mg (net sales of $59,627), which increased by $51,343. Partially offsetting these increases were lower sales in 2007 of certain existing products, including fluticasone (net sales of $130,475), which decreased $104,979, various amoxicillin products (net sales of $27,714), which decreased by $31,543, quinapril (net sales of $1,851), which decreased by $18,198, cefprozil (net sales of $1,165), which decreased $10,714, tramadol HCl and acetaminophen tablets (net sales of $16,024), which decreased by $10,500, lovastatin (net sales of $7,360), which decreased $8,954 and paroxetine (net sales of $2,773), which decreased $8,261 from 2006. Increased competition adversely affected both the volume and pricing on the above existing products. Net sales of distributed products, which consist of products manufactured under contract and licensed products, were approximately 53% of the Company’s total revenues in 2007 and approximately 66% of the Company’s total revenues in 2006. Revenues for the Company’s brand segment were $84,749 for the year ended December 31, 2007, increasing $35,519, or 72.1%, from Brand revenues of $49,230 for the year ended December 31, 2006. The increase in 2007 is driven by increased sales of Megace® ES and fees received related to the co-promotion of Androgel®.

Generic drug pricing at the wholesale level can create significant differences between the invoice price and the Company’s net selling price. Wholesale customers purchase product from the Company at invoice price, then resell the product to specific healthcare providers on the basis of prices negotiated between the Company and the providers, and the wholesaler submits a chargeback credit to the Company for the difference. The Company records estimates for these chargebacks, sales returns, rebates and incentive programs, and other sales allowances, for all its customers at the time of sale, as reductions to gross revenues, with corresponding adjustments to its accounts receivable reserves and allowances. 

The Company’s gross revenues before deductions for chargebacks, rebates and incentive programs (including rebates paid under federal and state government Medicaid drug reimbursement programs), sales returns and other sales allowances were $1,409,651 for the year ended December 31, 2007 compared to $1,379,347 for the year ended December 31, 2006. Deductions from gross revenues were $639,985 in 2007 and $654,179 in 2006. These deductions are discussed in the Notes to Consolidated Financial Statements - Note 6 - “Accounts Receivable.” The total gross-to-net sales adjustments as a percentage of gross sales decreased to 45.4% in 2007 compared to 47.4% in 2006, primarily due to a decrease in wholesaler acquisition costs in 2006, less price competition for new products, higher sales of Megace® ES, lower non-expiry returns, and higher royalties and co-promotion fees in 2007, which are not impacted by deductions, tempered by pricing pressure for certain existing products. The top selling products that did not have sales in the prior year were metoprolol succinate ER (50mg, 100mg and 200mg), propranolol HCl ER and ranitidine HCl syrup.

Total revenues for the year ended December 31, 2006 were $725,168, increasing $292,912, or 67.8%, from total revenues of $432,256 for the year ended December 31, 2005. Revenues for generic products for the year ended December 31, 2006 were $675,938, increasing $258,554, or 61.9% from revenues from generic products of $417,384 for the year ended December 31, 2005, due primarily to the introduction of new products. Among the top-selling products in 2006 that did not have sales in 2005 were fluticasone (net sales of $235,454), and various amoxicillin products (net sales of $59,257), introduced in the first quarter of 2006. Among the top-selling products in 2006 that were introduced in the fourth quarter of 2005 were cabergoline (net sales of $34,824), which increased by $32,477, and cefprozil (net sales of $11,879), which increased by $11,316. Partially offsetting these increases were lower sales in 2006 of certain existing products, including tramadol HCl and acetaminophen tablets (net sales of $26,524), which decreased by $41,293, and paroxetine (net sales of $11,034), which decreased by $26,415 from 2005. Increased competition adversely affected both the volume and pricing on the above existing products. Product revenues in the year ended December 31, 2005 also included a $6,000 payment from a business partner to compensate the Company for lost revenues on a terminated product manufacturing and supply agreement. Net sales of distributed products, which consist of products manufactured under contract and licensed products, were approximately 66% of the Company’s total revenues in 2006 and approximately 50% of the Company’s total revenues in 2005. The Company is substantially dependent upon distributed products for its overall sales and any inability by its suppliers to meet demand could adversely affect the Company’s future sales. Revenues for the Company’s brand segment were $49,230 for the year ended December 31, 2006, increasing $34,358, or 231.0%, from Brand revenues of $14,872 for the year ended December 31, 2005. The increase in 2006 is driven by the third quarter 2005 launch of Megace® ES.

42

 
The Company’s gross revenues before deductions for chargebacks, rebates and incentive programs (including rebates paid under federal and state government Medicaid drug reimbursement programs), sales returns and other sales allowances were $1,379,347 for the year ended December 31, 2006 compared to $1,184,659 for the year ended December 31, 2005. Deductions from gross revenues were $654,179 in 2006 and $752,403 in 2005. These deductions are discussed in the Notes to Condensed Consolidated Financial Statements Note 6 – “Accounts Receivable.” The total gross-to-net sales adjustments as a percentage of gross sales decreased to 47.4% in 2006 compared to 63.5% in 2005, primarily due to less competition for new products, mainly fluticasone and cabergoline, and reductions of wholesale invoice prices on certain of the Company’s existing products. The top selling products that did not have sales in the prior year were fluticasone and various amoxicillin products.

The Company recognizes revenue for product sales when title and risk of loss have transferred to its customers when reliable estimates of rebates, chargebacks, returns and other adjustments can be made, and when collectibility is reasonably assured. This is generally at the time that products are received by the customers. Upon recognizing revenue from a sale, the Company records estimates for chargebacks, rebates and incentives, returns, cash discounts and other sales allowances that reduce accounts receivable or increase other liabilities.

Gross Margin

The Company’s gross margin of $268,519 (34.9% of total revenues) in the year ended December 31, 2007 increased $50,571 from $217,948 (30.1% of total revenues) in the year ended December 31, 2006. Generic product gross margins of $204,130 (29.8% of generic revenues) in the year ended December 31, 2007 increased $20,587 from $183,543 (27.2% of generic revenues) in 2006 primarily due to the introduction of new product launches including propranolol HCl ER and metoprolol succinate ER, royalties earned from the sales of ondansetron tablets, which launched in the fourth quarter of 2006, and lower inventory write-offs ($6,155). The branded products gross margin of $64,389 (76.0% of branded revenues) for the year ended December 31, 2007 increased by $29,984 from $34,405 (69.9% of branded revenues) for the year ended December 31, 2006 due to higher sales of Megace® ES and co-promotion fees for selling Androgel®, which was commenced in the fourth quarter of 2006. The rate of gross margin as a percentage of net product sales in 2007 reflects the launch of higher margin propranolol HC1 ER, lower inventory write-offs of finished product, lower sales of lower margin existing products including fluticasone and lovastatin, increased sales of higher margin Megace® ES, the co-promotion fee for Androgel®, and royalties earned from the sales of ondansetron tablets, which launched in the fourth quarter 2006, tempered by the launch of lower margin metoprolol succinate ER.

The Company’s gross margin of $217,948 (30.1% of total revenues) in the year ended December 31, 2006 increased $63,246 from $154,702 (35.8% of total revenues) in the year ended December 31, 2005. Generic product gross margins of $183,543 (27.2% of generic revenues) in the year ended December 31, 2006 increased $39,807 from $143,736 (34.4% of generic revenues) in 2005. The increase in generic gross margins was due primarily to the introduction of fluticasone and amoxicillin products, which have significantly lower gross margin percentages after profit splits with partners, the launch of cabergoline, offset by lower sales of higher margin tramadol HCl and acetaminophen tablets, higher inventory write-offs ($8,248) related to a delayed product launch for clonidine of $2,145 and for write-offs of finished products for which inventory levels exceed forecasted sales, a non-recurring 2005 payment of $6,000 from a business partner related to the termination of a manufacturing and supply agreement, and higher intangibles amortization on new product acquisitions of $4,187. Gross margin from brand products was $34,405 for the year ended December 31, 2006 due primarily to Megace® ES, which was launched in the third quarter of 2005, tempered by increased royalties.

Operating Expenses

 Stock Option Tender Offer

In November 2007, the Company issued a tender offer to repurchase certain eligible stock options in exchange for a one-time cash payment in the range of $3.08 to $5.96 per option. Eligible options were certain unvested stock options with exercise prices in excess of $33.61 per share. The tender offer was completed in December 2007 with approximately 181 stock options cash settled and resulted in $4,615 of additional share-based compensation expense in the fourth quarter of 2007, that otherwise would have been recognized ratably in 2008 and 2009, of which $3,323, $923, and $369 was charged to selling, general and administrative expense, research and development expense, and costs of goods sold, respectively.

43

 
 Research and Development

The Company’s research and development expenses of $77,659 (10.1 % of total revenues) for the year ended December 31, 2007 increased $15,217 or 24.4% from $62,442 (8.6% of total revenues) from the year ended December 31, 2006. The increase was primarily attributable to costs incurred in support of the Company’s strategy to expand its brand segment, principally the in-license of three compounds in late-stage development. In June 2007, the Company executed an exclusive licensing agreement with Immtech for the U.S. commercial rights to parfuramidine maleate for the treatment of pneumocystis pneumonia in AIDS patients. The Company paid Immtech $3,000 upon the execution of this agreement. As discussed above the parfuramidine program was discontinued in February 2008. In July 2007, the Company acquired the U.S. commercialization rights from BioAlliance Pharma (“BioAlliance”) to Loramyc (micronazole Lauriad®), an innovative antifungal therapy for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immunocompromised patients, including those with HIV and cancer. The Company paid BioAlliance $15,000 upon the execution of the agreement. In August 2007, the Company acquired the North American commercial rights from Hana Biosciences, Inc. (“Hana”) to ZensanaTM (ondansetron HCl) oral spray, which is used to prevent nausea and vomiting after chemotherapy, radiation and surgery. Under the terms of this agreement, the Company made a $5,000 equity investment in Hana at a contractually agreed premium to the prevailing market price. Of this amount, $1,150, representing the premium paid, was charged to research and development expense in 2007. In addition to these up-front costs, the Company incurred an additional $1,121 in outside development costs related to these products. These increases were tempered by $4,143 relating to the 2006 termination of the Megace ES clinical development program for oncology, and $1,585 relating to the first quarter 2007 termination of Par 101.

In support of its generic segment, the Company entered into an agreement with IntelliPharmaCeutics Ltd (“IPC”), a privately held corporation, in August 2007, to develop and market four controlled release generic drug products. Under the terms of this agreement, the Company made a $5,000 private placement equity investment, of which $2,500 was charged to research and development expense in 2007, based on the estimated fair value of the investment in IPC. In addition, on-going development and material costs associated with the generic portfolio increased $2,217.

The net increases referenced above were partially offset by an overall reduction in personnel cost of $4,041, principally the result of the restructuring of the R&D organization which occurred during the first half of 2007, tempered by costs associated with the fourth quarter 2007 stock option tender offer detailed above.

The Company’s research and development expenses of $62,442 for the year ended December 31, 2006 decreased $55 from the year ended December 31, 2005. The decrease was primarily attributable to lower expenses for outside development projects of $12,886, primarily due to the termination of an agreement with Advancis in 2005, pursuant to which the Company had paid $14,250 in the year ended December 31, 2005. The decrease in 2006 was partially offset by increased operating costs related to new R&D facilities of $2,775 and additional personnel costs of $8,383 including stock option expense related to the Company’s implementation of SFAS 123R ($2,217).

As a result of its product development program, the Company or its strategic partners currently have approximately 45 ANDAs pending with the FDA. No assurances can be given that the Company or any of its strategic partners will successfully complete the development of any of these products either under development or proposed for development, that they will obtain regulatory approvals for any such product, that any approved product will be produced in commercial quantities or that any approved product will be sold profitably.

Although there can be no such assurance, research and development expenses for 2008, including payments to be made to unaffiliated companies, and expected milestone payments under currently executed brand licensing arrangements (refer to Notes to Consolidated Financial Statements – Note 11 – “Research and Development Agreements” and Note 22 – “Subsequent Events”) are expected to decrease by approximately 20% to 25% from 2007.

Selling, General and Administrative

Total selling, general and administrative expenses of $138,217 (18.0% of total revenues) for the year ended December 31, 2007 decreased $10,271 or 6.9% from $148,488 (20.5% of total revenues) for the year ended December 31, 2006. The decrease in 2007 was primarily due to the non-recurrence of the second quarter 2006 write-off of approximately $10,000 in bad debts for invalid customer deductions that the Company determined would not be pursued for collection, lower severance costs associated with executive officers of $11,052, partially offset by the expansion of the finance and accounting functions, higher other compensation related costs, including the fourth quarter 2007 stock option tender offer (detailed above), and increased professional costs related to the Company’s restatement of prior periods.

44

 
Total selling, general and administrative expenses of $148,488 (20.5% of total revenues) for the year ended December 31, 2006 increased $56,179, or 60.9%, from $92,309 (21.4% of total revenues) for the year ended December 31, 2005. The increase in 2006 was primarily attributable to higher selling and marketing costs of $17,628 due to the Company’s launch of its first branded product, Megace® ES, in the third quarter of 2005, increased stock compensation expense driven by the Company’s implementation of SFAS 123R ($8,229), the second quarter 2006 write-off of approximately $10.0 million in bad debts for invalid customer deductions that the Company determined would not be pursued for collection, severance cost associated with the termination of executive officers of $11,052, including $3,811 of stock option expense, and increased finance and accounting costs.

Although there can be no such assurance, selling, general and administrative expenses in 2008 are expected to decrease by approximately 2% to 4% from 2007 expenses.

Intangible Asset Impairment

In July 2004, the Company entered into a license agreement with NovaDel Pharma Inc. (“NovaDel”) whereby the Company has the exclusive rights to market, sell and distribute NovaDel’s nitroglycerin lingual spray, NitroMistTM, in the United States and Canada. In November 2006, the FDA approved the nitroglycerin lingual spray and the Company paid NovaDel a $1,000 milestone payment, which was capitalized. The Company continued to evaluate the potential market for this product and determined that based upon competitive factors, it would not yield sufficient profits and that the product no longer fit the Company’s long-term strategy. This product was never launched by the Company. As a result, the Company recorded an impairment charge of approximately $1,100 in 2006. In the third quarter of 2005, the Company recorded an impairment charge related to two intangible assets totaling $6,999. Both assets related to the generic drug latanoprost. The Company had been in litigation relating to patent infringement due to its filing of an ANDA for latanoprost. During the third quarter of 2005, the Company was informed that it had received an unfavorable ruling in the lawsuit. As a result of these facts, the Company determined that these intangibles were fully impaired at that time.

Settlements, net
 
Settlements, net of $945 during 2007 is comprised of a $367 gain related to the settlement of a class action law suit against a former supplier of raw materials that was found guilty of anti-competitive activities; a $378 gain relating to the termination of a product development manufacturing and supply agreement entered into in 2003 between the Company and Perrigo Pharmaceuticals; and a $200 gain relating to the termination of a development, manufacture and marketing agreement entered into in 1999 between the Company and Resolution Chemicals.

The loss of $1,250 for the year ended December 31, 2006, relates to the settlement with Genpharm that resolved disputes related to distribution and other agreements between the companies. The Company recorded approximately $1,502 of expenses in the second quarter of 2006 as a result of the settlement, of which $1,250 was recorded in settlements, net. The remaining $252 was recorded in research and development expenses.
 
Gain on Sales of Product Rights

In May 2005, the Company and Optimer entered into a joint development and collaboration agreement to commercialize Difimicin (PAR 101), an investigational drug to treat Clostridum difficle-associated diarrhea. On February 27, 2007 in exchange for $20,000 the Company returned the marketing rights to Optimer, and recorded a corresponding gain on the sale of product rights.

In September 2006 the Company sold the Company’s rights associated with ribavirin products, including certain assets and the assumption of certain liabilities, to Three Rivers Pharmaceuticals LLC for $6,604. The Company recorded a gain of $3,054 in 2006 relating to this agreement.

Other Income / (Expense), net
 
Other income (expense), net was ($56), $126, and ($831), respectively, for 2007, 2006 and 2005, respectively. In 2005, the other expense was primarily realized losses on the sale of short-term investments.

Loss on marketable securities, net

In February 2007, the Company sold approximately 1.1 million shares of its investment in Optimer stock for $6,836 and recognized a pre-tax gain of $1,398 for the three month period ended March 31, 2007. The Company held 1.3 million shares of Optimer common stock as of September 29, 2007. During the fourth quarter of 2007, the Company sold its remaining investment in Optimer common stock for approximately $9,621 and recognized a corresponding pre-tax gain of $3,059. These realized gains of $4,457 were more than offset by a $6,040 realized investment loss relating to the complete loss of an investment recognized in the second quarter of 2007 that the Company held, as a limited partner, in a fund that invested in various floating rate structured finance securities.

45

 
In November 2006, Abrika agreed to be purchased by a wholly owned subsidiary of the Actavis group. Based on the terms of the merger agreement, the Company received approximately $4,589 for its equity stake in Abrika in 2007. The Company wrote down its investment in Abrika by $3,773 in the second quarter of 2006 based on the terms of the merger agreement between Abrika and Actavis that indicated that the investment was impaired. This loss is partially offset by a gain in the fourth quarter of 2006 on the sale of Advancis Pharmaceutical Corporation (“Advancis”) common stock in the amount of $3,190.

During the year ended December 31, 2005, the Company sold all of its investment in New River Pharmaceuticals, Inc. (“New River”) common stock for $31,299 and recorded a gain on the sale of $24,293. In the second quarter of 2005, the Company recorded an investment impairment of $8,280 related to its investment in Advancis. On October 16, 2003, the Company purchased 1,000 shares of the common stock of Advancis for approximately $10.0 million. In June and July 2005, Advancis announced that it had failed to achieve the desired microbiological and clinical endpoints in its Amoxicillin PULSYS phase III clinical trials for the treatment of pharyngitis/tonsillitis. Due to the results of the clinical trial, and the continued significant decline in the stock price of Advancis, which is publicly traded, the Company determined that the significant decline in fair market value of its investment was other-than-temporary and as such wrote the investment down to its fair market value, based on the market value of the Advancis common stock at July 2, 2005.
 
Equity in Loss of Joint Venture
 
Equity loss from joint venture was $387, $663 and $534 for the years ended December 31, 2007, 2006 and 2005, respectively. The amounts represent the Company’s share of loss in the joint venture created with Rhodes Technology (“Rhodes”) which primarily relates to research and development costs incurred by the joint venture to develop ANDAs.

Interest Income

Interest income was $13,673, $8,974 and $5,343 for the years ended December 31, 2007, 2006 and 2005, respectively, and principally includes interest income derived primarily from money market and other short-term investments.  

Interest Expense

Interest expense was $6,803, $6,781, and $6,793 for the years ended December 31, 2007, 2006 and 2005, respectively, and principally includes interest payable on the Company’s convertible notes.

Income Taxes

The Company recorded a provision (benefit) for income taxes of $27,322, $2,054, and ($5,726) for the years ended December 31, 2007, 2006 and 2005, respectively. The provisions were based on the applicable federal and state tax rates for those periods (see Notes to Consolidated Financial Statements - Note 16 - “Income Taxes”). The Company’s effective tax rates for years ended 2007, 2006 and 2005 were 35%, 23% and (94%) respectively. In 2006, the tax rate was impacted by income amounts taxable in different state jurisdictions and other permanent items. In 2005, the Company reduced its tax reserves and recorded a credit to tax expense of $7,218 due to the closing of statutory periods related to net operating loss carry forwards and tax credits, which was partially offset by the tax provision on the current period income of $1,492.

Discontinued Operations

In January 2006, the Company announced the divestiture of FineTech, effective as of December 31, 2005. As a result, this business is being reported as a discontinued operation for all periods presented. The Company transferred the business for no consideration to Dr. Arie Gutman, president and chief executive officer of FineTech. Dr. Gutman also resigned from the Company’s Board. The Company had pre-tax loss from discontinued operations for the year ended December 31, 2005 of $4,957. For the year ended December 31, 2005, the Company recorded a pre-tax loss on the divestiture of $38,018 due primarily to the write-off of goodwill and intangibles, the impairment of fixed assets, severance payments and the acceleration of restricted stock and stock options.

46


FINANCIAL CONDITION

Liquidity and Capital Resources


Cash and cash equivalents of $200,132 at December 31, 2007 increased $79,141 from $120,991 at December 31, 2006. Cash provided by operations was $100,783 for the year ended December 31, 2007 driven by net income from continuing operations of $51,110 (inclusive of a non-recurring gain of $20,000, pre-tax, related to sale of marketing / product rights of PAR 101 to Optimer) and adjusted primarily for depreciation and amortization of $25,625 and share-based compensation of $23,503. The decrease in net accounts receivable of $34,861 is driven primarily by cash collections and lower fourth quarter net sales when compared to the same period in 2006, tempered by lower overall accounts receivable reserves. The decrease in accounts receivable reserves is driven mainly by net improvements in the Company's lag for processing customer credits, as well as lower trade inventory for future chargebacks and the improvements in the gross to net rate discussed previously. Inventories declined $21,435 driven by improved inventory turns for purchased finished goods, the sell-out of launch quantities on hand at the end of 2006 including for metoprolol succinate ER and propranolol HCl ER and inventory related to products terminated during 2007, and increased material usage of megestrol raw materials from higher sales. The factors that increased operating cash flows in the year ended December 31, 2007 were partially offset by a decrease in payables due to distribution agreement partners of $53,106 due to payments to partners as well as lower sales of distributed products, $19,150 payments related to the in-license of three compounds in late stage development in support of Strativa, and a decrease in income taxes payable mainly due to the payment of 2006 taxes in 2007. Cash flows provided by investing activities of $16,024 were driven by proceeds of $16,457 from the sale of Optimer common stock, $12,000 from Abrika related to the repayment of an advance and the redemption of a promissory note and $4,588 relating to the sale of the Company’s remaining stake in Abrika, tempered by capital investments of $8,585 and equity investments in Hana and IPC, worth $6,350. Cash used in financing activities of $37,666 was primarily due to the purchase of treasury stock of $33,217 and the repayment of short-term debt related to financed insurance premiums of $4,391.

The Company’s working capital, current assets minus current liabilities, of $210,514 at December 31, 2007 increased $105,305 from $105,209 at December 31, 2006. The working capital ratio, which is calculated by dividing current assets by current liabilities, was 1.67x at December 31, 2007 compared to 1.25x at December 31, 2006. The Company believes that its working capital ratio indicates the ability to meet its ongoing and foreseeable obligations for the next 12 fiscal months.

In 2004, the Board authorized the repurchase of up to $50,000 of the Company’s common stock. Repurchases are made, subject to compliance with applicable securities laws, from time to time in the open market or in privately negotiated transactions. Shares of common stock acquired through the repurchase program are available for general corporate purposes. On September 28, 2007, the Company announced that its Board approved an expansion of its share repurchase program allowing for the repurchase of up to $75,000 of the Company’s common stock, inclusive of the $17,800 remaining from the April 2004 authorization. The Company repurchased 1,643 shares of its common stock for approximately $31,400 pursuant to the expanded program in the fourth quarter of 2007. The authorized amount remaining for stock repurchases under the repurchase program was $43,600, as of December 31, 2007.

In addition to its cash and cash equivalents, the Company had $85,375 of available for sale debt securities classified as current assets on the consolidated balance sheet as of December 31, 2007. These available for sale debt securities were all available for immediate sale. The Company intends to continue to use its current liquidity to support the expansion of its business, increasing its generic research and development activities, entering into product license arrangements, potentially acquiring other complementary businesses and products and for general corporate purposes.

As of December 31, 2007, the Company had payables due to distribution agreement partners of $36,479 related primarily to amounts due under profit sharing agreements, particularly including an amount owed to Pentech with respect to paroxetine. The Company paid substantially all of these amounts, with the exception of the payable due to Pentech, which is being disputed in current litigation with Pentech, out of its working capital during the first two months of 2008. In 2004, Pentech filed a legal action against the Company alleging that the Company breached its contract with Pentech. The Company and Pentech are in dispute over the amount of gross profit share. The decrease in payables due to distribution agreement partners from December 31, 2006 can be primarily attributed to lower payables associated with fluticasone and amoxicillin.

47

 
The dollar values of the Company’s material contractual obligations and commercial commitments as of December 31, 2007 were as follows, in thousands:

       
Amounts Due by Period
 
Obligation
 
Total Monetary
Obligations
 
2008
 
2009 to
2010
 
2011 to
2012
 
2013 and
thereafter
 
Operating leases
 
$
19,387
 
$
5,572
 
$
9,751
 
$
3,144
 
$
920
 
Convertible notes*
   
200,000
   
200,000
   
-
   
-
   
-
 
Interest payments**
   
15,813
   
5,750
   
10,063
   
-
   
-
 
Purchase obligations***
   
75,034
   
75,034
   
-
   
-
   
-
 
Long-term tax liability****
   
30,975
   
-
   
-
   
-
   
30,975
 
Other
   
1,984
   
1,984
   
-
   
-
   
-
 
Total obligations
 
$
343,193
 
$
288,340
 
$
19,814
 
$
3,144
 
$
31,895
 

* The Notes mature on September 30, 2010, unless earlier converted, accelerated or repurchased. See “Legal Proceedings” in Note 17 to Consolidated Financial Statements, “Commitments, Contingencies and Other Matters” for discussion involving notices of default and acceleration the Company received from the Trustee of the Company’s 2.875% Senior Subordinated Convertible Notes due 2010 and related litigation. Until the matter is resolved, the Company is recording the payment obligations as a current liability as of December 31, 2007 because the Court in the matter could (i) rule against the Company’s position and (ii) determine that the appropriate remedy would be the accelerated payment of the Notes.

** Interest payments represent the total interest due under the Notes until their contractual maturity on September 30, 2010. A portion of these amounts would not be payable if the Notes are earlier converted, accelerated or repurchased.

*** Purchase obligations consist of both cancelable and non-cancelable inventory and non-inventory items.

**** The cumulative effect of applying the provisions of FIN 48 resulted in a reclassification of $26.7 million of certain tax liabilities from current to non-current as of January 1, 2007. The difference between a tax position taken or expected to be taken in a tax return and the benefit recognized and measured pursuant to FIN 48 represents an unrecognized tax benefit.  An unrecognized tax benefit is a liability that represents a potential future obligation to the taxing authorities. The total amount of unrecognized tax benefits as of January 1, 2007 was $21.8 million, excluding interest and penalties, and increased to $24.1 million, excluding interest and penalties, as of December 31, 2007 based on evaluation of tax positions. As of January 1, 2007, the Company had accrued $4.9 million of interest and penalties related to uncertain tax positions. As of December 31, 2007, $6.9 million of interest and penalties related to uncertain tax positions is included in other long-term liabilities in the Company’s consolidated balance sheet. We do not expect to make a significant tax payment related to these other long-term liabilities within the next year, however, the Company cannot estimate in which period thereafter such tax payments may occur. For presentation on the table above, the Company included the related long-term liability in the “2013 and thereafter” column.  

In addition to its internal research and development costs, the Company, from time to time, enters into agreements with third parties for the development of new products and technologies. To date, the Company has entered into agreements and advanced funds and has commitments or contingent liabilities with several non-affiliated companies for products in various stages of development. These contingent payments or commitments are generally dependent on the third party achieving certain milestones or the timing of third-party research and development or legal expenses. Due to the uncertainty of the timing and/or realization of such contingent commitments, these obligations are not included in the contractual obligations table above presented as of December 31, 2007. Payments made pursuant to these agreements are either capitalized or expensed in accordance with the Company’s accounting policies. The total amount that ultimately could be due under agreements with contingencies was approximately $34,000 as of December 31, 2007, excluding the potential milestones of $29,000 related to the Immtech licensing agreement due to the termination of the parfuramidine program detailed above. This amount is exclusive of contingencies tied to the achievement of sales milestones, which will be funded through future revenue streams. The agreements that contain such commitments that the Company believes are material are described in Notes to Consolidated Financial Statements - Note 11 - “Research and Development Agreements” elsewhere in this Form 10-K and in “Subsequent Events” below.

The Company expects to continue to fund its operations, including its research and development activities, capital projects and obligations under its existing distribution and development arrangements discussed herein, out of its working capital. Implementation of the Company’s business plan or an adverse decision in the litigation relating to the Company’s Notes may require additional debt and/or equity financing; there can be no assurance that the Company will be able to obtain any such additional financing when needed on terms acceptable or favorable to it.

48

 
Financing

At December 31, 2007, the Company’s total outstanding short and long-term debt, including the current portion, was $200,000. The amount consisted solely of senior subordinated convertible notes. In 2003, the Company sold an aggregate principal amount of $200,000 of senior subordinated convertible notes pursuant to Rule 144A under the Securities Act.  The notes bear interest at an annual rate of 2.875%, payable semi-annually on March 30 and September 30 of each year. The Notes are convertible into shares of common stock of the Company at an initial conversion price of $88.76 per share, only upon the occurrence of certain events. Upon redemption, the Company has agreed to satisfy the conversion obligation in cash in an amount equal to the principal amount of the Notes converted. The Notes mature on September 30, 2010, unless earlier converted, accelerated or repurchased.  The Company may not redeem the Notes prior to the maturity date. The Trustee under the Indenture governing the Notes has alleged that the Company has defaulted in the performance of its obligations under the Indenture and has initiated a lawsuit in connection therewith. Accordingly, until the matter is resolved, the Company is recording the payment obligations under the Notes as a current liability on the Company’s consolidated balance sheet as of December 31, 2007. Refer to Item 3 – Legal Proceedings and Notes to Consolidated Financial Statements – Note 17 – “Commitments, Contingencies and Other Matters” elsewhere in this Form 10-K.

Off-Balance Sheet Arrangements
 
The Company has no off-balance sheet arrangements.

Subsequent Events
 
On January 14, 2008, the Company entered into an exclusive license agreement with Alfacell.  Under the agreement, the Company received the exclusive U.S. commercialization rights to Alfacell’s ONCONASE® (ranpirnase).  ONCONASE® is currently in Phase III clinical development for the treatment of inoperable malignant mesothelioma, a rare cancer affecting the lungs usually associated with exposure to asbestos.  In exchange for the U.S. commercialization rights, the Company made an initial payment to Alfacell of $5 million and will make a subsequent payment of up to $30 million upon (and subject to) Alfacell’s receipt of FDA approval for the product.  If ONCONASE® receives FDA approval, the Company will commercialize the product in the United States and pay Alfacell royalties on net sales of the product. Alfacell will also be eligible to receive additional milestone payments if net sales reach certain threshold amounts in any given calendar year.  In addition, Alfacell may be eligible to receive milestone payments upon the achievement of certain development and regulatory milestones with respect to future indications for ONCONASE®.  Under a separate supply agreement between Alfacell and the Company, Alfacell will supply commercial quantities of ONCONASE® to the Company.  

Critical Accounting Policies and Use of Estimates

Critical accounting policies are those policies that are most important to the portrayal of the Company’s financial condition and results of operations, and require management’s most difficult, subjective and complex judgments, resulting from the need to make estimates about the effect of matters that are inherently uncertain. The Company’s most critical accounting policies, as discussed below, pertain to revenue recognition and the determination of deductions from gross revenues, the determination of whether certain costs pertaining to the Company’s significant development and marketing agreements are to be capitalized or expensed as incurred, the valuation and assessment of impairment of intangible assets, the determination of depreciable and amortizable lives and issues related to legal proceedings. In applying such policies, management often must use amounts that are based on its informed judgments and estimates. Because of the uncertainties inherent in these estimates, actual results could differ from the estimates used in applying the critical accounting policies. The Company is not aware of any likely events or circumstances that would result in different amounts being reported that would materially affect its financial condition or results of operations.

Revenue Recognition and Provisions for Deductions from Gross Revenues
The Company recognizes revenues for product sales when title and risk of loss have transferred to its customers, when reliable estimates of rebates, chargebacks, returns and other adjustments can be made, and when collectibility is reasonably assured. This is generally at the time products are received by the customers. Upon recognizing revenue from sales, the Company records estimates for the following items that reduce gross revenues:
 
·
Chargebacks
 
·
Rebates and incentive programs
 
·
Product returns
 
·
Cash discounts and other
 
·
Medicaid rebates

49


The following table summarizes the activity for the years ended December 31, 2007, 2006 and 2005 in the accounts affected by the estimated provisions described below, in thousands:

   
For the year ended December 31, 2007
 
Accounts receivable reserves 
 
Beginning
balance (3)
 
Provision
recorded
for current
period
sales
 
(Provision)
reversal
recorded
for prior
period sales
 
Credits
processed
 
Ending
balance
 
Chargebacks
 
$
(51,891
)
$
(345,526
)
$
-
(1)
$
351,411
 
$
(46,006
)
Rebates and incentive programs
   
(85,888
)
 
(175,775
)
 
2,075
   
216,729
   
(42,859
)
Returns
   
(42,905
)
 
(29,312
)
 
(220
)
 
25,335
   
(47,102
)
Cash discounts and other
   
(18,038
)
 
(71,552
)
 
211
   
73,221
   
(16,158
)
Total
 
$
(198,722
)
$
(622,165
)
$
2,066
 
$
666,696
 
$
(152,125
)
                                 
Accrued liabilities (2)
 
$
(10,412
)
$
(17,567
)
$
(2,319
)
$
13,483
 
$
(16,815
)
 
   
For the year ended December 31, 2006 
 
Accounts receivable reserves 
 
Beginning
balance
 
Provision
recorded
for current
period
sales
 
(Provision)
reversal
recorded
for prior
period sales
 
Credits
processed
 
Ending
balance (3)
 
Chargebacks
 
$
(102,256
)
$
(339,711
)
$
-
(1)
$
390,076
 
$
(51,891
)
Rebates and incentive programs
   
(50,991
)
 
(201,993
)
 
-
   
167,096
   
(85,888
)
Returns
   
(32,893
)
 
(36,609
)
 
(7,686
)
 
34,283
   
(42,905
)
Cash discounts and other
   
(15,333
)
 
(48,734
)
 
-
   
46,029
   
(18,038
)
Total
 
$
(201,473
)
$
(627,047
)
$
(7,686
)
$
637,484
 
$
(198,722
)
                                 
Accrued liabilities (2)
 
$
(9,040
)
$
(19,528
)
$
82
 
$
18,074
 
$
(10,412
)
 
   
For the year ended December 31, 2005
 
Accounts receivable reserves 
 
Beginning
balance
 
Provision
recorded
for current
period
sales
 
(Provision)
reversal
recorded
for prior
period sales
 
Credits
processed
 
Ending
balance
 
Chargebacks
 
$
(91,986
)
$
(486,113
)
$
-
(1)
$
475,843
 
$
(102,256
)
Rebates and incentive programs
   
(49,718
)
 
(154,727
)
 
1,489
   
151,965
   
(50,991
)
Returns
   
(61,986
)
 
(24,010
)
 
(5,568
)
 
58,671
   
(32,893
)
Cash discounts and other
   
(13,287
)
 
(60,628
)
 
-
   
58,582
   
(15,333
)
Total
 
$
(216,977
)
$
(725,478
)
$
(4,079
)
$
745,061
 
$
(201,473
)
                                 
Accrued liabilities (2)
 
$
(8,755
)
$
(22,847
)
$
-
 
$
22,562
 
$
(9,040
)

(1) The amount of provision or reversal of reserves related to prior periods for chargebacks is not determinable on a product or customer specific basis; however, based upon historical analysis and analysis of activity in subsequent periods, the Company has determined that its chargeback estimates remain reasonable.

(2) Includes amounts due to customers for which no underlying accounts receivable exists, including Medicaid rebates.

(3) Restated to reflect a reclassification to accrued expenses of $4.3 million for discounts due to customers for which no underlying accounts receivable existed as of December 31, 2006.
 
50

The Company sells its products directly to wholesalers, retail drug store chains, drug distributors, mail order pharmacies and other direct purchasers and customers that purchase its products indirectly through the wholesalers, including independent pharmacies, non-warehousing retail drug store chains, managed health care providers and other indirect purchasers. The Company has entered into agreements at negotiated contract prices with those health care providers that purchase products through the Company’s wholesale customers at those contract prices. Chargeback credits are issued to wholesalers for the difference between the Company’s invoice price to the wholesaler and the contract price through which the product is resold to health care providers. Approximately 61% and 50% of the Company’s net product sales were derived from the wholesale distribution channel for the years ended December 31, 2007 and 2006, respectively. The information that the Company considers when establishing its chargeback reserves includes contract and non-contract sales trends, average historical contract pricing, actual price changes, processing time lags and customer inventory information from its three largest wholesale customers. The Company’s chargeback provision and related reserve vary with changes in product mix, changes in customer pricing and changes to estimated wholesaler inventory.

Customer rebates and incentive programs are generally provided to customers as an incentive for the customers to continue to carry the Company’s products or replace competing products in their distribution channels with those products sold by the Company. Rebate programs are based on a customer’s dollar purchases made during an applicable monthly, quarterly or annual period. The Company also provides indirect rebates, which are rebates paid to indirect customers that have purchased our products from a wholesaler under a contract with the Company. The incentive programs include stocking or trade show promotions where additional discounts may be given on a new product or certain existing products as an added incentive to stock the Company’s products. The Company may, from time to time, also provide price and/or volume incentives on new products that have multiple competitors and/or on existing products that confront new competition in order to attempt to secure or maintain a certain market share. The information that the Company considers when establishing its rebate and incentive program reserves are rebate agreements with and purchases by each customer, tracking and analysis of promotional offers, projected annual sales for customers with annual incentive programs, actual rebates and incentive payments made, processing time lags, and for indirect rebates, the level of inventory in the distribution channel that will be subject to indirect rebates. The Company does not provide incentives designed to increase shipments to its customers that it believes would result in out-of-the ordinary course of business inventory for them. The Company regularly reviews and monitors estimated or actual customer inventory information at its three largest wholesale customers for its key products to ascertain whether customer inventories are in excess of ordinary course of business levels.

Pursuant to a drug rebate agreement with the Centers for Medicare and Medicaid Services and similar supplemental agreements with various states, the Company provides such states with a rebate on drugs dispensed under the Medicaid program. The Company determines its estimate of 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 that might impact the Company’s provision for Medicaid rebates. In determining the appropriate accrual amount the Company considers historical payment rates; processing lag for outstanding claims and payments and levels of inventory in the distribution channel. The Company reviews the accrual and assumptions on a quarterly basis against actual claims data to help ensure that the estimates made are reliable.

The Company accepts returns of product according to the following criteria: (i) the product returns must be approved by authorized personnel in writing or by telephone with the lot number and expiration date accompanying any request and (ii) the Company generally will accept returns of products from any customer and will provide the customer with a credit memo for such returns if such products are returned within six months prior to, and until 12 months following, such products’ expiration date. The Company records a provision for product returns based on historical experience, including actual rate of expired and damaged returns, average remaining shelf-lives of products sold, which generally range from 12 to 36 months, and estimated return dates. Additionally the Company considers other factors when estimating its current period return provision, including levels of inventory in the distribution channel, significant market changes that may impact future expected returns, and actual product returns and may record additional provisions for specific returns that it believes are not covered by the historical rates.

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. The Company accounts for cash discounts by reducing accounts receivable by the full amount of the discounts that the Company expects its customers to take. In addition to the significant gross-to-net sales adjustments described above, the Company periodically makes other sales adjustments. The Company generally accounts for these other gross-to-net adjustments by establishing an accrual in the amount equal to its estimate of the adjustments attributable to the sale.

The Company may at its discretion provide price adjustments due to various competitive factors, through shelf-stock adjustments on customers’ existing inventory levels. There are circumstances under which the Company may not provide price adjustments to certain customers and consequently, as a matter of business strategy, may lose future sales volume to competitors rather than reduce its pricing.

As detailed above, the Company has the experience and access to relevant information that it believes are necessary to reasonably estimate the amounts of such deductions from gross revenues. Some of the assumptions used by the Company for certain of its estimates are based on information received from third parties, such as wholesale customer inventories and market data, or other market factors beyond the Company’s control. The estimates that are most critical to the establishment of these reserves, and therefore, would have the largest impact if these estimates were not accurate, are estimates related to contract sales volumes, average contract pricing, customer inventories and return volumes. The Company regularly reviews the information related to these estimates and adjusts its reserves accordingly, if and when actual experience differs from previous estimates. With the exception of the product returns allowance, the ending balances of accounts receivable reserves and allowances generally are processed during a two-month to four-month period.
 
51

 
Use of Estimates in Reserves
The Company believes that its reserves, allowances and accruals for items that are deducted from gross revenues are reasonable and appropriate based on current facts and circumstances. It is possible, however, that other parties applying reasonable judgment to the same facts and circumstances could develop different allowance and accrual amounts for items that are deducted from gross revenues. Additionally, changes in actual experience or changes in other qualitative factors could cause the Company’s allowances and accruals to fluctuate, particularly with newly launched or acquired products. The Company reviews the rates and amounts in its allowance and accrual estimates on a quarterly basis. If future estimated rates and amounts are significantly greater than those reflected in its recorded reserves, the resulting adjustments to those reserves would decrease the Company’s reported net revenues; conversely, if actual product returns, rebates and chargebacks are significantly less than those reflected in its recorded reserves, the resulting adjustments to those reserves would increase its reported net revenues. If the Company were to change its assumptions and estimates, its reserves would change, which would impact the net revenues that the Company reports. The Company regularly reviews the information related to these estimates and adjusts its reserves accordingly, if and when actual experience differs from previous estimates.

 Research and Development Agreements
The Company capitalizes or expenses amounts related to the development of new products and technologies through agreements with third parties based on the Company’s determination of its ability to recover in a reasonable period of time its cost from the estimated future cash flows anticipated to be generated pursuant to each agreement. Accordingly, amounts related to the Company’s funding of the research and development efforts of others or to the purchase of contractual rights to products that have not been approved by the FDA, and where the Company has no alternative future use for the product, are expensed and included in research and development costs. Amounts for contractual rights acquired by the Company to a process, product or other legal right having multiple or alternative future uses that support its realizability, as well as to an approved product, are capitalized and included in intangible assets on the consolidated balance sheets.

Goodwill and Intangible Assets
The Company determines the estimated fair values of goodwill and certain intangible assets with definitive lives based on valuations performed by the Company at the time of their acquisition in accordance with Statement of Financial Accounting Standards (“SFAS”) No. 142, “Accounting for Goodwill and Other Intangible Assets.” In addition, the fair value of certain amounts paid to third parties related to the development of new products and technologies, as described above, are capitalized and included in intangible assets on the accompanying consolidated balance sheets.

Goodwill is reviewed for impairment annually, or when events or other changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Intangible assets are reviewed quarterly, or when events or other changes in circumstances indicate that the carrying amount of the assets may not be recoverable. Impairment of goodwill and indefinite-lived intangibles is determined to exist when the fair value is less than the carrying value of the net assets being tested. Impairment of definite-lived intangibles is determined to exist when undiscounted cash flows related to the assets are less than the carrying value of the assets being tested.

As discussed above with respect to determining an asset’s fair value and useful life, because this process involves management making certain estimates and because these estimates form the basis of the determination of whether or not an impairment charge should be recorded, these estimates are considered to be critical accounting estimates. As of December 31, 2007, the Company determined through its estimates that no impairment of goodwill or intangible assets existed. The Company will continue to assess the carrying value of its goodwill and intangible assets in accordance with applicable accounting guidance.

As discussed in Notes to Consolidated Financial Statements – Note 9 – “Intangible Assets,” the Company impaired intangible assets of $1,100 in 2006. As a result of the acquisition of Kali in 2004, the Company had amounts recorded as goodwill of $63,729 at December 31, 2007 and December 31, 2006. In addition, intangible assets with definite lives, net of accumulated amortization, totaled $36,059 and $47,880, respectively, at December 31, 2007 and 2006.
 
52

 
Recent Accounting Pronouncements that may have a material impact on future consolidated financial statements
In December 2007, the Financial Accounting Standards Board (“FASB”) ratified Emerging Issue Task Force Issue No. 07-1 (“EITF 07-1”), Accounting for Collaborative Arrangements. The key elements of EITF 07-1 relate to: (a) the scope of the issue; (b) the income statement presentation of transactions with third parties; (c) the income statement presentation of payments between parties to the collaborative arrangement; (d) the disclosures about collaborative arrangements that should be required in the financial statements of the parties to the collaborative arrangements; and (e) the transition method. A contractual arrangement falls within the scope of EITF 07-1 if the arrangement requires the parties to be active participants and the arrangement exposes the parties to significant risks and rewards that are tied to the commercial success of the endeavor. Costs incurred and revenue generated on sales to third parties should be reported in the statement of operations based on the guidance in EITF Issue No. 99-19, Reporting Revenue Gross as a Principal versus Net as an Agent. The equity method of accounting should not be applied to a collaborative arrangement within the scope of this issue without the creation of a separate legal entity for the arrangement. Payments between parties to the collaborative arrangement should be presented in the statement of operations based on the nature of the arrangement and each entity's business operations, the contractual terms of the arrangement as well as if existing GAAP is applicable. EITF 07-1 requires companies to disclose the nature and purpose of the arrangement, its rights and obligations under the arrangement, the accounting policy applied to the arrangement, and the amounts attributable to transactions between other participants to the collaborative arrangement and where in the statement of operations these amounts have been classified. EITF 07-1 requires that companies comply in its first fiscal year beginning after December 15, 2008 and transition to the guidance in this issue by retrospectively applying the guidance to all periods presented for all arrangements existing at the effective date, unless it is impracticable to do so. The impracticability assessment should be made on an arrangement-by-arrangement basis and certain disclosures would be required if a company utilized the impracticability exception. The Company is currently evaluating the potential impact of adopting EITF 07-1 on its consolidated financial statements.

In December 2007, the FASB issued FASB Statement No. 141 (Revised 2007) (“SFAS 141R”), Business Combinations. SFAS 141R will significantly change the accounting for business combinations. Under SFAS 141R, an acquiring entity will be required to recognize all the assets acquired and liabilities assumed in a transaction at the acquisition date fair value with limited exceptions. SFAS 141R will change the accounting treatment for certain specific items, including; acquisition costs will be generally expensed as incurred, minority interests will be valued at fair value at the acquisition date, acquired contingent liabilities will be recorded at fair value at the acquisition date and subsequently measured at either the higher of such amount or the amount determined under existing guidance for non-acquired contingencies, in-process research and development will be recorded at fair value as an indefinite-lived intangible asset at the acquisition date, restructuring costs associated with a business combination will be generally expensed subsequent to the acquisition date, and changes in deferred tax asset valuation allowances and income tax uncertainties after the acquisition date generally will affect income tax expense. SFAS 141R also includes a substantial number of new disclosure requirements. SFAS 141R applies prospectively to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. Earlier adoption is prohibited. The Company will be required to record and disclose business combinations following existing GAAP until January 1, 2009.

In June 2007, the FASB ratified Emerging Issue Task Force Issue No. 07-3 (“EITF 07-3”), Accounting for Non-Refundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities, which requires nonrefundable advance payments for goods and services that will be used or rendered for future research and development activities to be deferred and capitalized. These amounts will be recognized as expense in the period that the related goods are delivered or the related services are performed or when an entity does not expect the goods to be delivered or services to be rendered. EITF 07-3 is effective for the fiscal years beginning after December 31, 2007, including interim periods within those fiscal years. Earlier adoption is not permitted. The Company will adopt the provisions of EITF 07-3 prospectively, beginning January 1, 2008.

ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk

Available for sale debt securities   
 
  The primary objectives for the Company’s investment portfolio are liquidity and safety of principal. Investments are made with the intention to achieve the best available rate of return on traditionally low risk investments. The Company’s investment policy limits investments to certain types of instruments issued by institutions with investment-grade credit ratings, the U.S. government and U.S. governmental agencies. The Company is subject to market risk primarily from changes in the fair values of its investments in debt securities including governmental agency securities and auction rate securities. These instruments are classified as available for sale securities for financial reporting purposes. A 10% increase in interest rates would cause the fair value of the Company’s investments in available for sale debt securities to decline by approximately $0.5 million. Additional investments are made in overnight deposits and money market funds. These instruments are classified as cash and cash equivalents for financial reporting purposes, and generally also have lower interest rate risk relative to its investments in debt securities and changes in interest rates generally have little or no impact on their fair values. For cash, cash equivalents and available for sale debt securities, a 10 percent decrease in interest rates would decrease interest income by approximately $1.3 million. The Company does not have any financial obligations exposed to variability in interest rates.
53

 
The following table summarizes the available for sale securities that subject the Company to market risk as of December 31, 2007 and 2006:

   
December 31, 2007
 
December 31, 2006
 
Securities issued by government agencies
  $
46,201
  $
65,897
 
Debt securities issued by various state and local municipalities and agencies
   
24,223
   
13,755
 
Other debt securities
   
13,991
   
15,870
 
Marketable equity securities available for sale
   
2,650
   
-
 
Auction rate securities
   
5,000
   
4,250
 
Total
  $
92,065
  $
99,772
 

Marketable equity securities available for sale
 
     In addition to the investments described above, the Company is also subject to market risk in respect to its investment in Hana. In August 2007, the Company made an equity investment in Hana for $5.0 million at a contractually agreed premium to the prevailing market price. Of this amount, $1.2 million was charged to research and development expense in the third quarter of 2007. The Company has classified its investment in Hana as a noncurrent asset on its consolidated balance sheet as of December 31, 2007 due to its contractual obligations with Hana and its ability and intent to hold the investment for a reasonable period of time (not anticipated to be less than 12 months) sufficient for a recovery of fair value up to (or beyond) the cost of the investment. The Company recorded an unrealized loss of $1.2 million for the year ended December 31, 2007, which was included in other comprehensive income to reflect the estimated fair value of its investment in Hana. A 10% adverse change in the market price of Hana common stock would impact the fair value of the investment by approximately $0.2 million.
 
ITEM 8. Consolidated Financial Statements and Supplementary Data

See “Index to Consolidated Financial Statements, Item 15.”
 
ITEM 9. Changes In and Disagreements With Accountants on Accounting and Financial Disclosure

During 2007, there were no disagreements with Deloitte & Touche, LLP (“Deloitte & Touche”) on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedures that, if not resolved to Deloitte & Touche’s satisfaction, would have caused them to make reference to the subject matter in connection with their report on the Company’s consolidated financial statements for 2007 and there were no reportable events, as listed in Item 304(a)(1)(v) of Regulation S-K.
 
ITEM 9A. Controls and Procedures

The Company maintains disclosure controls and procedures that are designed to ensure that information required to be disclosed in the Company’s filings with the SEC is recorded, processed, summarized and reported within the time period specified in the SEC’s rules and forms, and that such information is accumulated and communicated to management, including the Company’s Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), as appropriate, to allow timely decisions regarding required disclosure based on the definition of “disclosure controls and procedures” as defined in Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In designing and evaluating disclosure controls and procedures, the Company has recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply judgment in evaluating its controls and procedures.

The Company evaluated its disclosure controls and procedures under the supervision and with the participation of Company management, including its CEO and CFO, to assess the effectiveness of the design and operation of its disclosure controls and procedures (as defined under the Exchange Act). Based on this evaluation, the Company’s management, including its CEO and CFO, concluded that the Company’s disclosure controls and procedures were not effective as of December 31, 2007 due to the restatement of the consolidated financial statements for the years ended December 31, 2006 and 2005 to record the proper income tax benefits from discontinued operations. See Note 1 “Restatement of Previously Issued Financial Statements.”
 
54

 
Management Report on Internal Control Over Financial Reporting
 
Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. The Company’s internal control over financial reporting is designed, under the supervision of the Company’s CEO and CFO, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP.

All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP.

A material weakness is defined as a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the registrant’s annual or interim financial statements will not be prevented or detected on a timely basis.
 
The Company assessed the effectiveness of its internal controls over financial reporting as of December 31, 2007. The Company based the evaluation on the framework in “Internal Control - Integrated Framework” issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company’s management has concluded that the Company did not maintain effective internal controls over financial reporting as of December 31, 2007 due to the restatement of the consolidated financial statements for the years ended December 31, 2006 and 2005 to properly determine the income tax benefits from discontinued operations and related interest expense, as a result of a material weakness that existed at that time. The Company lacked a formal process to identify, analyze and communicate non-routine tax matters and lacked sufficient oversight by management for non-routine tax matters.

The Company has taken the following steps to remediate the weakness mentioned above: 1) replaced members of senior management and managers responsible for the oversight of income tax matters, 2) formalized a policy and procedure for the communication and review of non-routine tax matters by senior management, and 3) as appropriate the Company will engage external tax advisors for advice with respect to non-routine tax matters.
 
Remediation of Prior Year Material Weaknesses
 
As of the date of the filing of our prior year Annual Report on form 10-K, the Company did not maintain effective controls over accounting for certain non-routine transactions related to the completeness, valuation and presentation of certain stock option compensation transactions, financial statement classification of certain non-routine transactions, and initially accounting for certain subsequent events in the proper financial reporting period. The Company’s sales cutoff procedures did not take into consideration all appropriate assumptions and inputs. The level of interdepartmental communication for the approval of granting price adjustments to customers was not adequate. The Company’s process for accruing rebate reserves inadvertently reserved a rebate for a specific customer that had previously been processed. The Company did not maintain effective spreadsheet controls for certain components of the calculation of rebate reserves and accrued expenses.

The following measures have been taken to address the weaknesses mentioned above:
  
·
Increased the size, expertise and training of the finance and accounting staff to include adequate resources for ensuring GAAP compliance, particularly in the areas of accounts receivable reserves and the accounting for certain of the Company’s non-routine transactions.
 
·
Revised its methodologies with respect to sales cut-off procedures and enhanced controls around spreadsheets used for calculating certain components of its rebate reserves.
 
·
Formalized the level of approval and communication required for granting and estimating price protection to customers.
 
Changes in Internal Control over Financial Reporting
 
Other than the changes related to the material weaknesses above, no change in the Company’s internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) occurred during the fourth quarter of 2007, that has materially affected, or is reasonably likely to materially affect the Company’s internal control over financial reporting.
 
ITEM 9B. Other Information 

In accordance with New York Stock Exchange rules, the Company filed our CEO’s annual certification on October 19, 2007 and an interim certification on November 9, 2007, and that as of the dates of the certifications, he was unaware of any violation by the Company of the corporate listing standards of the New York Stock Exchange.

55


PART III

ITEM 10. Directors, Executive Officers and Corporate Governance

 The Company hereby incorporates by reference the information set forth under the caption "Election of Directors" from its definitive proxy statement to be delivered to stockholders of the Company in connection with its 2008 Annual Meeting of Stockholders scheduled to be held on May 20, 2008.
 
ITEM 11. Executive Compensation

The Company hereby incorporates by reference the information set forth under the caption "Executive Compensation" from its definitive proxy statement to be delivered to stockholders of the Company in connection with its 2008 Annual Meeting of Stockholders scheduled to be held on May 20, 2008.
 
ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

 The Company hereby incorporates by reference the information set forth under the caption "Security Ownership" from its definitive proxy statement to be delivered to stockholders of the Company in connection with its 2008 Annual Meeting of Stockholders scheduled to be held on May 20, 2008.

ITEM 13. Certain Relationships and Related Transactions, and Director Independence

 The Company hereby incorporates by reference the information set forth under the caption "Certain Relationships and Related Transactions" from its definitive proxy statement to be delivered to stockholders of the Company in connection with its 2008 Annual Meeting of Stockholders scheduled to be held on May 20, 2008.
 
ITEM 14. Principal Accountant Fees and Services

The Company hereby incorporates by reference the information set forth under the caption "Independent Auditors" from its definitive proxy statement to be delivered to stockholders of the Company in connection with its 2008 Annual Meeting of Stockholders scheduled to be held on May 20, 2008.
 
PART IV

ITEM 15. (a) (1) FINANCIAL STATEMENTS
 
 
Page
Number
Report of Independent Registered Public Accounting Firm
F-2
Consolidated Balance Sheets as of December 31, 2007 and 2006 (as restated)
F-3
Consolidated Statements of Operations for the years ended December 31, 2007, 2006 (as restated) and 2005 (as restated)
F-4
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2007, 2006 (as restated) and 2005 (as restated)
F-5
Consolidated Statements of Cash Flows for the years ended December 31, 2007, 2006 (as restated) and 2005 
(as restated)
F-6
Notes to Consolidated Financial Statements
F-8
 
ITEM 15. (a) (2) FINANCIAL STATEMENT SCHEDULES

All schedules are omitted because they are not applicable, or not required because the required information is included in the consolidated financial statements or notes thereto.

56


ITEM 15. (a) (3) EXHIBITS 
 
3.1
Agreement and Plan of Merger, dated as of May 12, 2003 – previously filed as an exhibit to the Company’s Report on Form 8-K, dated July 9, 2003, and incorporated herein by reference.

3.2
Certificate of Incorporation of the Company, dated May 9, 2003 – previously filed as an exhibit to the Company’s Report on Form 8-K, dated July 9, 2003, and incorporated herein by reference.
 
3.3
Certificate of Amendment of Certificate of Incorporation of the Registrant, as filed with the Secretary of State of the State of Delaware on May 27, 2004 – previously filed as an exhibit to the Company’s Registration Statement on Form S-8 filed on December 5, 2005 (File No. 333-130140), and incorporated herein by reference.
 
3.4
Certificate of Designations of Series A Junior Participating Preferred Stock of the Registrant, as filed with the Secretary of State of the State of Delaware on October 27, 2004 – previously filed as an exhibit to the Company’s Registration Statement on Form S-8 filed on December 5, 2005 (File No. 333-130140), and incorporated herein by reference.
 
3.5
By-Laws of the Company, as last amended on November 20, 2007 – previously filed as an exhibit to the Company’s Report on Form 8-K, dated November 21, 2007, and incorporated herein by reference.

4.1
Rights Agreement, dated as of October 27, 2004, by and between the Company and American Stock Transfer & Trust Company – previously filed as an exhibit to the Company’s Current Report on Form 8-K, dated October 27, 2004, and incorporated herein by reference.

10.1
1989 Employee Stock Purchase Program of the Company, as amended and restated effective January 1, 2008 (attached herewith). ***

10.2
1990 Stock Incentive Plan of the Company, as amended – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 1997 and incorporated herein by reference. ***

10.3
Amended and Restated 1997 Directors’ Stock Option Plan – previously filed on July 1, 2003 as an exhibit to the Company’s Registration Statement on Form S-8 (File No. 333-106685) and incorporated herein by reference. ***

10.3.1
Amended and Restated 1997 Directors’ Stock and Deferred Fee Plan – previously filed on September 6, 2007 with the Company’s Proxy Statement dated September 12, 2007 and incorporated herein by reference. ***

10.3.2
Terms of Stock Option Agreement under the Amended and Restated 1997 Directors’ Stock and Deferred Fee Plan (attached herewith). ***

10.3.3
Terms of Restricted Unit Award Agreement under the Amended and Restated 1997 Directors’ Stock and Deferred Fee Plan (attached herewith). ***

10.4
2000 Performance Equity Plan – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2000 and incorporated herein by reference. ***

10.5
2001 Performance Equity Plan (as amended on April 26, 2002, January 14, 2003, May 6, 2003 and June 18, 2003) – previously filed on June 30, 2003 as an exhibit to the Company’s Registration Statement on Form S-8 (File No. 333-106681) and incorporated herein by reference. ***

10.6
2004 Performance Equity Plan, as amended and restated as of May 24, 2005 – previously filed on April 14, 2005 with the Company’s Proxy Statement dated April 15, 2005 and incorporated herein by reference.***

10.6.1
Terms of Stock Option Agreement under the 2004 Performance Equity Plan (attached herewith). ***

10.6.2
Terms of Restricted Stock Award Agreement under the 2004 Performance Equity Plan (attached herewith). ***

10.6.3
Terms of Restricted Unit Award Agreement under the 2004 Performance Equity Plan (attached herewith). ***

10.6.4
Terms of Performance Share Award Agreement under the 2004 Performance Equity Plan (attached herewith). ***
 
57

 
10.7
Annual Executive Incentive Plan, effective January 1, 2004 – previously filed on April 13, 2004 with the Company’s Proxy Statement dated April 13, 2004 and incorporated herein by reference. ***

10.8
Form of Retirement Savings Plan of Par Pharmaceutical, Inc. – previously filed as an exhibit to the Company’s Registration Statement on Form S-1 (File No. 2-86614) and incorporated herein by reference.

10.8.1
Amendment to Par Pharmaceutical, Inc.’s Retirement Savings Plan, dated July 26, 1984 – previously filed as an exhibit to the Company’s Registration Statement on Form S-1 (File No. 33-4533) and incorporated herein by reference.***

10.8.2
Amendment to Par Pharmaceutical, Inc.’s Retirement Savings Plan, dated November 1, 1984 – previously filed as an exhibit to the Company’s Registration Statement on Form S-1 (File No. 33-4533) and incorporated herein by reference.***

10.8.3
Amendment to Par Pharmaceutical, Inc.’s Retirement Savings Plan, dated September 30, 1985 – previously filed as an exhibit to the Company’s Registration Statement on Form S-1 (File No. 33-4533) and incorporated herein by reference.***

10.9.1
Employment Agreement, dated as of August 9, 2007, by and between Par Pharmaceutical, Inc. and the Company and Patrick LePore – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2006 and incorporated herein by reference. ***

10.9.2
Employment Agreement, dated as of June 20, 2007, by and between Par Pharmaceutical, Inc. and Gerard Martino – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2006 and incorporated herein by reference.***

10.9.3
Employment Agreement, dated as of September 15, 2005, by and between Par Pharmaceutical, Inc. and Thomas Haughey – previously filed as an exhibit to the Company’s Current Report on Form 8-K, dated September 21, 2005, and incorporated herein by reference. ***

10.9.4
Employment Agreement, dated as of June 29, 2007, by and between Par Pharmaceutical, Inc. and Veronica Lubatkin – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2006 and incorporated herein by reference.***

10.9.5
Employment Agreement, dated as of March 27, 2007, by and between Par Pharmaceutical, Inc. and Paul Campanelli – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2006 and incorporated herein by reference.***

10.9.6
Employment Agreement, dated as of January 6, 2006, by and between the Company and John MacPhee – previously filed as an exhibit to the Company’s Current Report on Form 8-K, dated April 12, 2006, and incorporated herein by reference.***
 
10.9.7
Separation and Release Agreement by and between Par Pharmaceutical, Inc. and the Company and Scott Tarriff – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2006 and incorporated herein by reference.*/***

10.9.8
Separation Agreement, dated as of November 10, 2006, by and between the Company and Michael Graves – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2006 and incorporated herein by reference.***

10.9.9
Separation Agreement, dated as of November 2, 2006, by and between the Company and Shankar Hariharan – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2006 and incorporated herein by reference. ***

10.9.10
Separation Agreement, dated as of October 30, 2006, by and between Par Pharmaceutical, Inc. and the Company and Mark Auerbach – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2006 and incorporated herein by reference.***

10.9.11
Separation and Release Agreement by and between the Company and Dennis O’Connor – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2006 and incorporated herein by reference.***
 
58

 
10.10
Lease Agreement, dated as of January 1, 1993, between Par Pharmaceutical, Inc. and Ramapo Corporate Park Associates – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 1996 and incorporated herein by reference.

10.11
Lease Extension and Modification Agreement, dated as of August 30, 1997, between Par Pharmaceutical, Inc. and Ramapo Corporate Park Associates – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 1997 and incorporated herein by reference.

10.12
Lease Agreement, dated as of May 24, 2002, between Par Pharmaceutical, Inc. and 300 Tice Realty Associates L.L.C. – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ended 2003 and incorporated herein by reference.

10.12.1
Second Amendment to Lease Agreement, dated as of December 19, 2002, between Par Pharmaceutical, Inc. and 300 Tice Realty Associates L.L.C. – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ended 2003 and incorporated herein by reference.

10.12.2
Third Amendment to Lease Agreement, dated as of December 20, 2002, between Par Pharmaceutical, Inc. and 300 Tice Realty Associates L.L.C. – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ended 2003 and incorporated herein by reference.

10.13
Distribution Agreement, dated March 25, 1998, between the Company and Genpharm, Inc. – previously filed as an exhibit to the Company’s Current Report on Form 8-K, dated June 30, 1998, and incorporated herein by reference.*

10.14
Letter Agreement, dated as of January 21, 1999, between the Company and Genpharm, Inc. – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended April 3, 1999 and incorporated herein by reference.*

10.15
Development and Supply Agreement, dated as of April 17, 2001, between Par Pharmaceutical, Inc., Dr. Reddy’s Laboratories Limited and Reddy-Cheminor, Inc. – previously filed as an exhibit to Amendment No. 1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 29, 2001 and incorporated herein by reference.*

10.16
License and Supply Agreement, dated as of April 26, 2001, between Elan Transdermal Technologies, Inc. and Par Pharmaceutical, Inc. – previously filed as an exhibit to Amendment No. 1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 29, 2001 and incorporated herein by reference. *

10.17
License Agreement, dated as of July 9, 2001, between Breath Easy Limited and Par Pharmaceutical, Inc. – previously filed as an exhibit to Amendment No. 1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 29, 2001 and incorporated herein by reference.

10.18
Supply and Marketing Agreement, dated as of November 19, 2001, between Pentech Pharmaceuticals, Inc. and Par Pharmaceutical, Inc. – previously filed as an exhibit to Amendment No. 1 to the Company’s Quarterly Report on Form 10-Q/A for the quarter ended September 29, 2001 and incorporated herein by reference.

10.18.1
First Amendment dated as of November 12, 2002, to the Supply and Marketing Agreement dated November 19, 2001, between Pentech Pharmaceuticals, Inc. and Par Pharmaceutical, Inc. – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2002 and incorporated herein by reference. *

10.19
11 Product Development Agreement, effective April 2002, between the Company and Genpharm, Inc. – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2002 and incorporated herein by reference.
 
10.19.1
Settlement Agreement and Release of Claims between the Company and Genpharm, Inc. dated as of August 14, 2006 (attached herewith). *
 
10.20
Patent and Know How License Agreement, dated May 24, 2002, between Nortec Development Associates, Inc. and Par Pharmaceutical, Inc – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q/A Amendment No. 1 for the quarter ended June 30, 2002 and incorporated herein by reference.*
 
59

 
10.20.1
Amendment No. 1 to the Patent and Know How License Agreement, dated May 24, 2002, between Nortec Development Associates, Inc. and Par Pharmaceutical, Inc. – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q/A Amendment No. 1 for the quarter ended June 30, 2002 and incorporated herein by reference.*

10.21
Patent and Know How License Agreement, dated June 14, 2002, between Nortec Development Associates, Inc. and Par Pharmaceutical, Inc. – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q/A Amendment No. 1 for the quarter ended June 30, 2002 and incorporated herein by reference.*

10.22
License and Distribution Agreement, dated July 3, 2002, between Par Pharmaceutical, Inc. and Three Rivers Pharmaceuticals, LLC. – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2002 and incorporated herein by reference. *

10.22.1
First Amendment to License and Distribution Agreement, dated October 18, 2002, between Par Pharmaceutical, Inc. and Three Rivers Pharmaceuticals, LLC. – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2002 and incorporated herein by reference.
 
10.23
Supply and Distribution Agreement, dated as of December 20, 2002, between Genpharm, Inc., Leiner Health Products, LLC and Par Pharmaceutical, Inc. – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2002 and incorporated herein by reference. *
 
10.24
Amended and Restated License and Supply Agreement, dated as of April 16, 2003, among SB Pharmco Puerto Rico Inc., SmithKline Beecham Corporation, Beecham Group p.l.c. and Par Pharmaceutical, Inc. – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 29, 2003 and incorporated herein by reference.*
 
10.25
Amended and Restated Settlement Agreement, dated as of April 16, 2003, among SmithKline Beecham Corporation, Beecham Group p.l.c., Par Pharmaceutical, Inc. and Pentech Pharmaceuticals, Inc. – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 29, 2003 and incorporated herein by reference.*
 
10.26
License Agreement, dated as of August 12, 2003, by and between Mead Johnson & Company, Bristol-Myers Squibb Company and Par Pharmaceutical, Inc. – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 28, 2003 and incorporated herein by reference.*

10.27
Supply and Distribution Agreement, dated as of September 4, 2003, by and between Advancis Pharmaceutical Corporation and Par Pharmaceutical, Inc. – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 28, 2003 and incorporated herein by reference.*

10.28
Product Development and Patent License Agreement, dated as of October 22, 2003, by and between Nortec Development Associates, Inc. and Par Pharmaceutical, Inc. – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2003 and incorporated herein by reference.*
 
10.29
Development and Commercialization Agreement, dated May 28, 2004, by and between Par Pharmaceutical, Inc. and Advancis Pharmaceutical Corporation – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended October 3, 2004 and incorporated herein by reference.*
 
10.29.1
First Amendment dated December 14, 2004 to the Development and Commercialization Agreement dated May 28, 2004, by and between the Company and Advancis Pharmaceutical Corporation - previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2004 and incorporated herein by reference.*
 
10.30
License Agreement, dated as of July 2, 2007, between BioAlliance Pharma SA and Par Pharmaceutical, Inc. – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2006 and incorporated herein by reference. *

10.31
License Agreement dated January 14, 2008 between the Company and Alfacell Corporation (attached herewith). *
 
10.32
Asset Purchase Agreement between Bristol-Myers Squibb Company and Par Pharmaceutical, Inc. in respect of the sale of the Capotenâ, Capozideâ, Questranâ and Questran Lightâ Brands dated as of March 1, 2002 – previously filed as an exhibit to the Company’s Current Report on Form 8-K, dated March 7, 2002, and incorporated herein by reference.
 
60

 
10.33
Asset Purchase Agreement between Bristol-Myers Squibb Company and Par Pharmaceutical, Inc. in respect of the sale of the Sumycinâ Brand dated as of March 1, 2002 – previously filed as an exhibit to the Company’s Current Report on Form 8-K, dated March 7, 2002, and incorporated herein by reference.
 
10.34
SVC Pharma LP Limited Partnership Agreement, dated April 2002, among Par SVC, LLC, SVC Pharma Inc., UDF LP and the other parties named therein – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2002 and incorporated herein by reference.
 
10.35
Stock Purchase and Shareholders Agreement, dated as of October 22, 2003, by and between Nortec Development Associates, Inc., Nortec Holding LLC and Par Pharmaceutical, Inc. – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2003 and incorporated herein by reference.*
 
10.36
Stock Purchase Agreement, dated as of April 2, 2004, by and among the Company, Kali Laboratories, Inc., VGS Holdings, Inc. and the shareholders of Kali Laboratories, Inc. – previously filed as an exhibit to the Company’s Current Report on Form 8-K, dated April 13, 2004, and incorporated herein by reference.
 
10.36.1
First Amendment, dated as of June 9, 2004, to Stock Purchase Agreement, dated as of April 2, 2004, by and among the Company, Kali Laboratories, Inc., VGS Holdings, Inc. and the shareholders of Kali Laboratories, Inc. – previously filed as an exhibit to the Company’s Current Report on Form 8-K, dated June 14, 2004, and incorporated herein by reference.
 
10.37
Securities Purchase Agreement, dated as of November 18, 2004, by and between the Company and Abrika, LLLP – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2004 and incorporated herein by reference.
 
10.37.1
Termination of Investors Rights Agreement between Abrika, LLLP, ACFP LLLP and the Company dated as of January 22, 2007 (attached herewith).
 
10.38
Asset Purchase Agreement, dated as of December 21, 2004, by and between FSC Laboratories, Inc. and Par Pharmaceutical, Inc. – previously filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year 2004 and incorporated herein by reference.*
 
10.39
Series C Preferred Stock Purchase Agreement, dated May 2, 2005, by and between the Company and Optimer Pharmaceuticals, Inc. – previously filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended July 3, 2005 and incorporated herein by reference.
 
10.40
Share Transfer Agreement, dated as of January 20, 2006 and effective December 31, 2005, by and between the Company and Dr. Arie Gutman – previously filed as an exhibit to the Company’s Current Report on Form 8-K, dated January 25, 2006, and incorporated herein by reference.
 
10.41.1
Purchase Agreement between the Company, Bear, Stearns & Co. Inc., CIBC World Markets Corp. and U.S. Bancorp Piper Jaffray Inc., dated September 25, 2003 – previously filed on December 24, 2003 as an exhibit to the Company’s Registration Statement on Form S-3 (File No. 333-111567) and incorporated herein by reference.
 
10.41.2
Indenture between the Company and American Stock Transfer & Trust Company, dated September 30, 2003 – previously filed on December 24, 2003 as an exhibit to the Company’s Registration Statement on Form S-3 (File No. 333-111567) and incorporated herein by reference.
 
10.41.3
First Supplemental Indenture between the Company and American Stock Transfer & Trust Company, dated March 31, 2006 – previously filed as an exhibit to the Company’s Current Report on Form 8-K, dated March 31, 2006, and incorporated herein by reference.
 
10.41.4
Registration Rights Agreement between the Company, Bear, Stearns & Co. Inc., CIBC World Markets Corp. and U.S. Bancorp Piper Jaffray Inc., dated September 30, 2003 - previously filed on December 24, 2003 as an exhibit to the Company’s Registration Statement on Form S-3 (File No. 333-111567) and incorporated herein by reference.
 
21
List of subsidiaries of the Company (attached herewith).
 
31.1
Certification of Principal Executive Officer (attached herewith).
 
61

 
31.2
Certification of Principal Financial Officer (attached herewith).
 
32.1
Certification by 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 (filed herewith).**

32.2
Certification by 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 (filed herewith).**
 
*
Certain portions have been omitted and have been filed with the SEC pursuant to a request for confidential treatment thereof.

**
The certifications attached as Exhibits 32.1 and 32.2 that accompany this Annual Report on Form 10-K are not deemed to be filed with the SEC and are not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation language contained in any such filing.

***
Each of these exhibits constitutes a management contract, compensatory plan or arrangement required to be filed as an exhibit pursuant to Item 15 (b).
 
62

 
SIGNATURES

Pursuant to the requirements of Section 13 of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Dated: February 29, 2008
PAR PHARMACEUTICAL COMPANIES, INC.
 
(Company)
   
 
/s/ Patrick G. LePore
 
Patrick G. LePore
 
Chairman, President and Chief Executive Officer
 
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf of the Company in the capacities and on the dates indicated.
 
Signature
 
Title
 
Date
         
/s/ Joseph E. Smith
 
Lead Director
 
February 29, 2008
Joseph E. Smith
       
         
/s/ Patrick G. LePore
 
President, Chief Executive Officer and
 
February 29, 2008
Patrick G. LePore
  Chairman of the Board of Directors    
    (Principal Executive Officer)     
         
/s/ Gerard A. Martino
 
Executive Vice President and Chief Operating Officer
 
February 29, 2008
Gerard A. Martino
       
         
/s/ Veronica A. Lubatkin
 
Executive Vice President and Chief Financial Officer
 
February 29, 2008
Veronica A. Lubatkin 
  (Principal Accounting and Financial Officer)    
         
/s/ Peter S. Knight
 
Director
 
February 29, 2008
Peter S. Knight  
       
         
/s/ Ronald M. Nordmann
 
Director
 
February 29, 2008
Ronald M. Nordmann
       
         
/s/ L. William Seidman
 
Director
 
February 29, 2008
L. William Seidman
       
         
/s/ John D. Abernathy
 
Director
 
February 29, 2008
John D. Abernathy 
       
         
/s/ Dr. Melvin Sharoky
 
Director
 
February 29, 2008
Dr. Melvin Sharoky
       
 
63


PAR PHARMACEUTICAL COMPANIES, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
FILED WITH THE ANNUAL REPORT OF THE
COMPANY ON FORM 10-K

FOR THE YEARS ENDED DECEMBER 31, 2007, 2006 AND 2005
 
   
Page
     
Report of Independent Registered Public Accounting Firm
 
F-2
     
Consolidated Balance Sheets as of December 31, 2007 and 2006 (as restated)
 
F-3
     
Consolidated Statements of Operations for the years ended December 31, 2007, 2006 (as restated) and 2005 (as restated)
 
F-4
     
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2007, 2006 (as restated) and 2005 (as restated)
 
F-5
     
Consolidated Statements of Cash Flows for the years ended December 31, 2007, 2006 (as restated) and 2005 (as restated)
 
F-6
     
Notes to Consolidated Financial Statements
 
F-8




 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders of
Par Pharmaceutical Companies, Inc.

We have audited the internal control over financial reporting of Par Pharmaceutical Companies, Inc. and subsidiaries (the "Company") as of December 31, 2007, based on the criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. The Company's management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying management’s report on the internal control over financial reporting. Our responsibility is to express an opinion on the Company's internal control over financial reporting based on our audit.

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

A company's internal control over financial reporting is a process designed by, or under the supervision of, the company's principal executive and principal financial officers, or persons performing similar functions, and effected by the company's board of directors, management, and other personnel 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. A company's internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.

Because of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls, material misstatements due to error or fraud may not be prevented or detected on a timely basis. Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis. The following material weakness has been identified and included in management's assessment:

The Company did not maintain effective internal controls over financial reporting as of December 31, 2007 due to the restatement of the consolidated financial statements for the years ended December 31, 2006 and 2005 to properly determine the income tax benefits from discontinued operations and related interest expense, as a result of a material weakness that existed at that time. The Company lacked a formal process to identify, analyze and communicate non-routine tax matters and lacked sufficient oversight by management for non-routine tax matters.

This material weakness was considered in determining the nature, timing, and extent of audit tests applied in our audit of the consolidated financial statements as of and for the year ended December 31, 2007, of the Company and this report does not affect our report on such financial statements.

In our opinion, because of the effect of the material weakness identified above on the achievement of the objectives of the control criteria, the Company has not maintained effective internal control over financial reporting as of December 31, 2007, based on the criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated financial statements of the Company as of and for the year ended December 31, 2007, and our report dated February 29, 2008 expressed an unqualified opinion on those financial statements and included explanatory paragraphs regarding the restatement and the Company’s adoption of FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109, effective January 1, 2007.

/s/ Deloitte & Touche LLP
 
Parsippany, NJ
February 29, 2008


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders of
Par Pharmaceutical Companies, Inc.

We have audited the accompanying consolidated balance sheets of Par Pharmaceutical Companies, Inc. and subsidiaries (the "Company") as of December 31, 2007 and 2006, and the related consolidated statements of operations, stockholders' equity, and cash flows for each of the three years in the period ended December 31, 2007. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, such consolidated financial statements present fairly, in all material respects, the financial position of Par Pharmaceutical Companies, Inc. and subsidiaries as of December 31, 2007 and 2006, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2007, in conformity with accounting principles generally accepted in the United States of America.

As discussed in Note 1, the consolidated financial statements as of December 31, 2006 and 2005 and for each of the two years in the period ended December 31, 2006 have been restated.

As discussed in Note 2 to the consolidated financial statements, the Company changed its method of accounting for stock-based compensation to adopt the provisions of Statement of Financial Accounting Standards No. 123(R), Share-Based Payment, effective January 1, 2006.

As discussed in Note 2 to the consolidated financial statements, the Company changed its method of accounting for uncertainty in income taxes to adopt the provisions of FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109, effective January 1, 2007.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company's internal control over financial reporting as of December 31, 2007, based on the criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated, February 29, 2008 expressed an adverse opinion on the Company's internal control over financial reporting.

/s/ Deloitte & Touche LLP

Parsippany, NJ
February 29, 2008
F-2

 
PAR PHARMACEUTICAL COMPANIES, INC.
CONSOLIDATED BALANCE SHEETS
DECEMBER 31, 2007 AND 2006
(In Thousands, Except Share Data)

   
December 31,
 
December 31,
 
 
 
2007
 
2006
 
 
         
(Restated see
Note 1)
 
ASSETS
             
Current assets: 
             
Cash and cash equivalents
 
$
200,132
  $
120,991
 
Available for sale debt and marketable equity securities
   
85,375
   
92,120
 
Accounts receivable, net
   
64,182
   
99,043
 
Inventories
   
84,887
   
106,322
 
Prepaid expenses and other current assets
   
14,294
   
15,833
 
Deferred income tax assets
   
56,921
   
72,105
 
Income taxes receivable
   
17,516
   
12,422
 
Total current assets
   
523,307
   
518,836
 
               
Property, plant and equipment, at cost less accumulated depreciation and amortization
   
82,650
   
89,155
 
Available for sale debt and marketable equity securities
   
6,690
   
7,652
 
Investment in joint venture
   
6,314
   
5,292
 
Other investments
   
2,500
   
16,588
 
Intangible assets, net
   
36,059
   
47,880
 
Goodwill
   
63,729
   
63,729
 
Deferred financing costs and other assets
   
2,544
   
16,000
 
Non-current deferred income tax assets, net
   
57,730
   
49,545
 
Total assets
  $
781,523
  $
814,677
 
               
LIABILITIES AND STOCKHOLDERS’ EQUITY
             
Current liabilities:
             
Short-term and current portion of long-term debt
  $
200,000
  $
204,469
 
Accounts payable
   
32,200
   
48,297
 
Payables due to distribution agreement partners
   
36,479
   
89,585
 
Accrued salaries and employee benefits
   
16,596
   
15,510
 
Accrued expenses and other current liabilities
   
27,518
   
18,833
 
Income taxes payable
   
-
   
36,933
 
Total current liabilities
   
312,793
   
413,627
 
               
Long-term debt, less current portion
   
-
   
-
 
Other long-term liabilities
   
30,975
   
-
 
               
Commitments and contingencies
             
               
Stockholders’ equity:
             
Preferred Stock, par value $0.0001 per share, authorized 6,000,000 shares; none issued and outstanding
   
-
   
-
 
Common Stock, par value $0.01 per share, authorized 90,000,000 shares, issued 36,460,461 and 35,901,276 shares
   
364
   
359
 
Additional paid-in-capital
   
274,963
   
254,013
 
Retained earnings
   
230,195
   
180,297
 
Accumulated other comprehensive loss
   
(1,362
)
 
(431
)
Treasury stock, at cost 2,604,977 and 889,245 shares
   
(66,405
)
 
(33,188
)
Total stockholders’ equity
   
437,755
   
401,050
 
Total liabilities and stockholders’ equity
  $
781,523
  $
814,677
 

The accompanying notes are an integral part of these consolidated financial statements.
 
F-3

 
PAR PHARMACEUTICAL COMPANIES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE YEARS ENDED DECEMBER 31, 2007, 2006 AND 2005
(In Thousands, Except Per Share Amounts)

   
2007
 
2006
 
2005
 
               
Revenues:
                   
Net product sales
  $
739,020
  $
705,378
  $
412,126
 
Other product related revenues
   
30,646
   
19,790
   
20,130
 
Total revenues
   
769,666
   
725,168
   
432,256
 
Cost of goods sold
   
501,147
   
507,220
   
277,554
 
Gross margin
   
268,519
   
217,948
   
154,702
 
Operating expenses:
                   
Research and development
   
77,659
   
62,442
   
62,497
 
Selling, general and administrative
   
138,217
   
148,488
   
92,309
 
Intangible assets impairment
   
-
   
1,100
   
6,999
 
Settlements, net
   
(945
)
 
1,250
   
-
 
Total operating expenses
   
214,931
   
213,280
   
161,805
 
Gain on sale of product rights
   
20,000
   
3,054
   
-
 
                     
Operating income (loss)
   
73,588
   
7,722
   
(7,103
)
                     
Other (expense) income, net
   
(56
)
 
126
   
(831
)
Equity in loss of joint venture
   
(387
)
 
(663
)
 
(534
)
Loss on marketable securities, net
   
(1,583
)
 
(583
)
 
16,013
 
Interest income
   
13,673
   
8,974
   
5,343
 
Interest expense
   
(6,803
)
 
(6,781
)
 
(6,793
)
Income from continuing operations before provision (benefit) for income taxes
   
78,432
   
8,795
   
6,095
 
Provision (benefit) for income taxes
   
27,322
   
2,054
   
(5,726
)
Income from continuing operations
   
51,110
   
6,741
   
11,821
 
Discontinued operations:
                   
Loss from discontinued operations
   
-
   
-
   
(4,957
)
Loss from disposal
   
-
   
-
   
(38,018
)
Provision for income taxes (Restated see Note 1)
   
1,212
   
894
   
3,220
 
Loss from discontinued operations (Restated see Note 1)
   
(1,212
)
 
(894
)
 
(46,195
)
                     
Net income (loss) (Restated see Note 1)
  $
49,898
  $
5,847
  $
(34,374
)
                     
Basic earnings (loss) per share of common stock:
                   
Income from continuing operations
  $
1.48
  $
0.20
  $
0.35
 
Loss from discontinued operations (Restated see Note 1)
   
(0.04
)
 
(0.03
)
 
(1.35
)
Net income (loss) (Restated see Note 1)
  $
1.44
  $
0.17
  $
(1.00
)
                     
Diluted earnings (loss) per share of common stock:
                   
Income from continuing operations
  $
1.47
  $
 0.19
  $
 0.35
 
Loss from discontinued operations (Restated see Note 1)
   
(0.04
)
 
(0.03
)
 
(1.35
)
Net income (loss) (Restated see Note 1)
  $
1.43
  $
0.16
  $
(1.00
)
                     
Weighted average number of common shares outstanding:
                   
Basic
   
34,494
   
34,422
   
34,191
 
Diluted
   
34,718
   
34,653
   
34,435
 

The accompanying notes are an integral part of these consolidated financial statements.
 
F-4

 
PAR PHARMACEUTICAL COMPANIES, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR THE YEARS ENDED DECEMBER 31, 2007, 2006 AND 2005
(In Thousands)

   
Common Stock
 
Additional paid-in capital
 
Retained earnings
 
Accumulated other comprehensive income/(loss)
 
Treasury stock
 
Total stockholders’ equity
 
   
Shares
 
Amount
     
(Restated, see Note 1)
         
(Restated, see Note 1)
 
Balance, December 31, 2004
   
34,759
 
$
348
 
$
192,230
 
$
208,824
 
$
(604
)
$
(32,026
)
$
368,772
 
Comprehensive loss:
                                           
Net loss
   
-
   
-
   
-
   
(34,374
)
 
-
   
-
   
(34,374
)
Defined benefit pension plan, $218 net of tax of $84
   
-
   
-
   
-
   
-
   
(134
)
 
-
   
(134
)
Unrealized loss on available for sale securities, $1,926 net of tax of $761
   
-
   
-
   
-
   
-
   
(1,165
)
 
-
   
(1,165
)
Total comprehensive loss
   
-
   
-
   
-
   
-
   
-
   
-
   
(35,673
)
Exercise of stock options
   
114
   
1
   
2,203
   
-
   
-
   
-
   
2,204
 
Resolution of tax contingencies
   
-
   
-
   
16,819
   
-
   
-
   
-
   
16,819
 
Tax benefit from exercise of stock options
   
-
   
-
   
591
   
-
   
-
   
-
   
591
 
Employee stock purchase program
   
18
   
-
   
448
   
-
   
-
   
-
   
448
 
Purchase of treasury stock
   
-
   
-
   
-
   
-
   
-
   
(152
)
 
(152
)
Compensatory arrangements
   
-
   
-
   
4,791
   
-
   
-
   
-
   
4,791
 
Restricted stock grants
   
223
   
2
   
(2
)
 
-
   
-
   
-
   
-
 
Other
   
-
   
-
   
323
   
-
   
-
   
-
   
323
 
Balance, December 31, 2005
   
35,114
 
$
351
 
$
217,403
 
$
174,450
 
$
(1,903
)
$
(32,178
)
$
358,123
 
 
                                           
Comprehensive income:
                                           
Net income
   
-
   
-
   
-
   
5,847
   
-
   
-
   
5,847
 
Defined benefit pension plan, $435 net of tax of $168
   
-
   
-
   
-
   
-
   
267
   
-
   
267
 
Unrealized gain on available for sale securities, $1,994 net of tax of $789
   
-
   
-
   
-
   
-
   
1,205
   
-
   
1,205
 
Total comprehensive income
   
-
   
-
   
-
   
-
   
-
   
-
   
7,319
 
Exercise of stock options
   
402
   
4
   
8,568
   
-
   
-
   
-
   
8,572
 
Tax benefit from exercise of stock options
   
-
   
-
   
741
   
-
   
-
   
-
   
741
 
Resolution of tax contingencies
   
-
   
-
   
2,495
   
-
   
-
   
-
   
2,495
 
Employee stock purchase program
   
15
   
-
   
392
   
-
   
-
   
-
   
392
 
Purchase of treasury stock
   
-
   
-
   
-
   
-
   
-
   
(1,010
)
 
(1,010
)
Compensatory arrangements
   
-
   
-
   
24,001
   
-
   
-
   
-
   
24,001
 
Restricted stock grants
   
471
   
4
   
(4
)
 
-
   
-
   
-
   
-
 
Forfeiture of restricted stock
   
(101
)
 
-
   
-
   
-
   
-
   
-
   
-
 
Other
   
-
   
-
   
417
   
-
   
-
   
-
   
417
 
Balance, December 31, 2006
   
35,901
 
$
359
 
$
254,013
 
$
180,297
 
$
(431
)
$
(33,188
)
$
401,050
 
Comprehensive income:
                                           
Net income
   
-
   
-
   
-
   
49,898
   
-
   
-
   
49,898
 
Unrealized loss on available for sale securities, $1,500 net of tax of $569
   
-
   
-
   
-
   
-
   
(931
)
 
-
   
(931
)
Total comprehensive income
   
-
   
-
   
-
   
-
   
-
   
-
   
48,967
 
Exercise of stock options
   
68
   
-
   
379
   
-
   
-
   
-
   
379
 
Tax benefit from exercise of stock options
   
-
   
-
   
501
   
-
   
-
   
-
   
501
 
Tax deficiency related to the expiration of stock options
   
-
   
-
   
(708
)
 
-
   
-
   
-
   
(708
)
Tax deficiency related to the vesting of restricted stock
   
-
   
-
   
(739
)
 
-
   
-
   
-
   
(739
)
Purchase of treasury stock
   
-
   
-
   
-
   
-
   
-
   
(33,217
)
 
(33,217
)
Compensatory arrangements
   
-
   
-
   
23,503
   
-
   
-
   
-
   
23,503
 
Restricted stock grants
   
605
   
6
   
(6
)
 
-
   
-
   
-
   
-
 
Forfeiture of restricted stock
   
(132
)
 
(1
)
 
1
   
-
   
-
   
-
   
-
 
Cash settlement for certain unvested stock options
   
-
   
-
   
(872
)
 
-
   
-
   
-
   
(872
)
Tax effect on cash settlement for certain unvested options
   
-
   
-
   
(1,422
)
 
-
   
-
   
-
   
(1,422
)
Other
   
19
   
-
   
313
   
-
   
-
   
-
   
313
 
Balance, December 31, 2007
   
36,461
 
$
364
 
$
274,963
 
$
230,195
 
$
(1,362
)
$
(66,405
)
$
437,755
 

The accompanying notes are an integral part of these consolidated financial statements.
 
F-5

 
PAR PHARMACEUTICAL COMPANIES, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 2007, 2006 AND 2005
(In Thousands)

   
2007
 
2006
 
2005
 
Cash flows from operating activities:
     
(Restated
see Note 1)
 
(Restated
see Note 1)
 
Net income (loss)
 
$
49,898
 
$
5,847
 
$
(34,374
)
Deduct: Loss from discontinued operations, net of tax
   
(1,212
)
 
(894
)
 
(46,195
)
Income from continuing operations
   
51,110
   
6,741
   
11,821
 
                     
Adjustments to reconcile net income to net cash provided by operating activities:
                   
Deferred income taxes
   
8,347
   
(3,438
)
 
(748
)
Resolution of tax contingency
   
-
   
-
   
(7,218
)
Depreciation and amortization
   
25,625
   
22,583
   
15,251
 
Loss (gain) on marketable securities, net
   
1,583
   
549
   
(16,013
)
Equity in loss of joint venture
   
387
   
663
   
534
 
Intangible asset impairments
   
-
   
1,100
   
16,177
 
Allowances against accounts receivable
   
(49,042
)
 
(2,133
 
(15,504
)
Share-based compensation expense
   
23,503
   
24,001
   
4,791
 
Loss on disposal of fixed assets
   
638
   
-
   
-
 
Tax benefits on exercise of nonqualified stock options
   
501
   
741
   
591
 
Excess tax benefits on exercise of nonqualified stock options
   
(501
)
 
(726
)
 
-
 
Other
   
313
   
795
   
157
 
                     
Changes in assets and liabilities:
                   
Decrease (increase) in accounts receivable
   
83,903
   
(34,548
)
 
22,466
 
Decrease (increase) in inventories
   
21,435
   
(9,929
)
 
(8,078
)
Decrease in prepaid expenses and other assets
   
3,152
   
4,841
   
1,310
 
(Decrease) increase in accounts payable, accrued expenses and other liabilities
   
(1,156
)
 
(10,358
)
 
19,142
 
(Decrease) increase in payables due to distribution agreement partners
   
(53,106
)
 
42,648
   
11,873
 
(Decrease) increase in income taxes payable/receivable
   
(15,909
)
 
17,228
   
(16,686
)
 Net cash provided by operating activities
   
100,783
   
60,758
   
39,866
 
Net cash provided by operating activities from discontinued operations
   
-
   
-
   
7,980
 
                     
Cash flows from investing activities:
                   
Capital expenditures
   
(8,585
)
 
(18,856
)
 
(33,801
)
Purchases of intangibles
   
(600
)
 
(26,135
)
 
(13,000
)
Purchases of available for sale debt securities
   
(279,211
)
 
(9,673
)
 
(51,988
)
Purchases of available for sale marketable equity securities
   
(3,850
)
 
-
   
-
 
Proceeds from maturity and sale of available for sale debt and marketable equity securities
   
299,682
   
18,395
   
95,359
 
Purchases of other investments
   
(2,500
)
  -    
(12,000
)
Proceeds from sale of other investments, advance for product rights and the redemption of a promissory note
   
16,588
   
(4,090
)
 
31,299
 
Acquisition of subsidiary, net of cash acquired
   
-
   
-
   
98
 
Acquisition of subsidiary, contingent payment
   
(5,000
)
 
(2,500
)
 
(2,500
)
Capital contributions to joint venture
   
(2,051
)
 
(557
)
 
(2,158
)
Proceeds from sale of fixed assets
   
1,551
   
38
   
35
 
Net cash provided by (used in) investing activities
   
16,024
   
(43,378
)
 
11,344
 
Net cash used in investing activities from discontinued operations
   
-
   
-
   
(3,145
)
 
F-6


   
2007
 
2006
 
2005
 
Cash flows from financing activities:
             
Proceeds from issuances of common stock upon exercise of stock options
   
379
   
8,572
   
2,204
 
Proceeds from the issuance of common stock under the Employee Stock Purchase Program
   
-
   
392
   
448
 
Cash settlement of certain unvested stock options
   
(872
)
 
-
   
-
 
Excess tax benefits on exercise of nonqualified stock options
   
501
   
726
   
-
 
Purchase of treasury stock
   
(33,217
)
 
(1,010
)
 
(152
)
Borrowings related to financed insurance premium liabilities
   
-
   
7,234
   
5,909
 
Payments of short-term debt related to financed insurance premiums
   
(4,391
)
 
(5,521
)
 
(7,359
)
Principal payments under long-term and other borrowings
   
(66
)
 
(259
)
 
(300
)
 Net cash (used in) provided by financing activities
   
(37,666
)
 
10,134
   
750
 
                     
Net increase in cash and cash equivalents
   
79,141
   
27,514
   
56,795
 
Cash and cash equivalents at beginning of year
   
120,991
   
93,477
   
36,682
 
Cash and cash equivalents at end of year
 
$
200,132
 
$
120,991
 
$
93,477
 
Supplemental disclosure of cash flow information:
             
Cash paid during the year for:
                   
Income taxes, net
 
$
36,500
 
$
890
 
$
4,682
 
Interest
 
$
5,883
 
$
5,862
 
$
5,749
 
                     
Non-cash transactions:
                   
Increase (decrease) in fair value of available for sale debt and marketable equity securities
 
$
(1,444
)
$
1,994
 
$
(4,751
)
Capital expenditures incurred but not yet paid
 
$
1,394
 
$
922
 
$
4,564
 
Capital contribution to joint venture not yet paid
 
$
590
 
$
1,244
 
$
-
 
Acquired intangibles not yet paid
 
$
-
 
$
-
 
$
2,000
 
 
The accompanying notes are an integral part of these consolidated financial statements.
 
F-7


PAR PHARMACEUTICAL COMPANIES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2007
(In thousands, except per share amounts or as otherwise noted)

Par Pharmaceutical Companies, Inc. operates primarily through its wholly owned subsidiary, Par Pharmaceutical, Inc. (collectively referred to herein as the “Company”), in two business segments, for the development, manufacture and distribution of generic pharmaceuticals and branded pharmaceuticals in the United States. The Company also wholly owns Kali Laboratories, Inc. (“Kali”), a generic pharmaceutical research and development company located in Somerset, New Jersey. Marketed products are principally in the solid oral dosage form (tablet, caplet and two-piece hard-shell capsule). The Company also distributes several oral suspension products and certain products in the semi-solid form of a cream.

In January 2006, the Company announced the divestiture of FineTech Laboratories, Ltd (“FineTech”), effective December 31, 2005. The Company transferred FineTech to a former officer and director of the Company for no consideration.

Note 1 – Restatement of Previously Issued Financial Statements 
 
Balance sheet reclassification
 
Subsequent to the filing of the Company’s Annual Report on Form 10-K for the year ended December 31, 2006, the Company identified a balance sheet reclassification whereby the Company had included certain discounts due to customers for which no underlying receivables exist in accounts receivable, rather than presenting such amounts in accrued expenses. Accordingly, such presentation in the accompanying consolidated financial statements has been restated to increase accounts receivable, net and accrued expenses and other current liabilities in the consolidated balance sheet as of December 31, 2006 by $4.3 million. This restatement had no effect on the consolidated statements of operations nor on the overall consolidated statements of cash flows as previously reported.

Discontinued operations
 
In preparing its consolidated financial statements for year ended December 31, 2007, the Company identified accounting errors related to its discontinued operations reported in the Company’s 2006 and 2005 financial information contained in its Annual Report on Form 10-K for the year ended December 31, 2006 and filed on September 6, 2007. Management determined that the benefit for income taxes on discontinued operations for the year ended December 31, 2005 was overstated because the Company did not properly determine the income tax benefits from discontinued operations. This error resulted in the understatement of the Company’s net loss for 2005 by the same amount. Management also determined that the 2006 provision for income taxes from discontinued operations did not consider the impact of interest expense. As a result of these errors, the provision (benefit) for income taxes on discontinued operations, loss from discontinued operations, net income (loss), income taxes payable, other long term liabilities and certain other items included in the financial statements as of and for the year ended December 31, 2006 and 2005 have been restated.  The related impact of the restatement errors on the Company’s consolidated financial statements is detailed below.

The table below sets forth the effect of the balance sheet reclassification and discontinued operations restatement adjustments on the applicable line items within the Company’s consolidated balance sheet as of December 31, 2006:
 
(Amounts in thousands)
 
As previously
reported
 
Restatement
Adjustments
 
As restated
 
Current assets:
                   
Accounts receivable, net
 
$
94,784
 
$
4,259
 
$
99,043
 
Total current assets
 
$
514,577
 
$
4,259
 
$
518,836
 
Total assets
 
$
810,418
 
$
4,259
 
$
814,677
 
                     
Liabilities and stockholders’ equity:
                   
 Current liabilities:
                   
Accrued expenses and other current liabilities
 
$
14,574
 
$
4,259
 
$
18,833
 
 Income taxes payable
 
$
16,974
 
$
19,959
 
$
36,933
 
Total current liabilities
 
$
389,409
 
$
24,218
 
$
413,627
 
Retained earnings
 
$
200,256
 
$
(19,959
)
$
180,297
 
Total stockholders’ equity
 
$
421,009
 
$
(19,959
)
$
401,050
 
Total liabilities and stockholders’ equity
 
$
810,418
 
$
4,259
 
$
814,677
 
 
F-8

 
The following tables set forth the effect of the discontinued operations restatement adjustments on the applicable line items within the Company’s consolidated statement of operations for the period ending December 31, 2006:
 
(Amounts in thousands)
 
As previously
reported
 
Restatement
Adjustments
 
 
As restated
 
Discontinued operations:
                   
Provision for income taxes
 
$
-
 
$
894
 
$
894
 
Loss from discontinued operations
 
$
-
 
$
(894
)
$
(894
)
Net income (loss)
 
$
6,741
 
$
(894
)
$
5,847
 
                     
Basic earnings (loss) per share of common stock:
                   
Loss from discontinued operations
 
$
-
 
$
(0.03
)
$
(0.03
)
Net income (loss)
 
$
0.20
 
$
(0.03
)
$
0.17
 
                     
Diluted earnings (loss) per share of common stock:
                   
Loss from discontinued operations
 
$
-
 
$
(0.03
)
$
(0.03
)
Net income (loss)
 
$
0.19
 
$
(0.03
)
$
0.16
 

The following tables set forth the effect of the discontinued operations restatement adjustments on the applicable line items within the Company’s consolidated statement of operations for the period ending December 31, 2005:
 
(Amounts in thousands)
 
As previously
reported
 
Restatement
Adjustments
 
 
As restated
 
Discontinued operations:
                   
Provision (benefit) for income taxes
 
$
(15,845
)
$
19,065
 
$
3,220
 
Loss from discontinued operations
 
$
(27,130
)
$
(19,065
)
$
(46,195
)
Net income (loss)
 
$
(15,309
)
$
(19,065
)
$
(34,374
)
                     
Basic earnings (loss) per share of common stock:
                   
Loss from discontinued operations
 
$
(0.79
)
$
(0.56
)
$
(1.35
)
Net income (loss)
 
$
(0.44
)
$
(0.56
)
$
(1.00
)
                     
Diluted earnings (loss) per share of common stock:
                   
Loss from discontinued operations
 
$
(0.79
)
$
(0.56
)
$
(1.35
)
Net income (loss)
 
$
(0.44
)
$
(0.56
)
$
(1.00
)
 
The table below sets forth the effect of the balance sheet reclassification and discontinued operations restatement adjustments on the applicable line items within the Company’s consolidated statements of cash flows for the period ending December 31, 2006:
 
(Amounts in thousands)
 
As previously
reported
 
Restatement
Adjustments
 
As restated
 
Net income (loss)
 
$
6,741
 
$
(894
)
$
5,847
 
Loss from discontinued operations, net of tax
 
$
-
 
$
(894
)
$
(894
)
Allowances against accounts receivable
 
$
2,126
 
$
(4,259
)
$
(2,133
)
Decrease in accounts payable, accrued expenses and other current liabilities
 
$
(14,617
)
$
4,259
 
$
(10,358
)
 
The table below sets forth the effect of the discontinued operations restatement adjustments on the applicable line items within the Company’s consolidated statements of cash flows for the period ending December 31, 2005:
 
(Amounts in thousands)
 
As previously
reported
 
Restatement
Adjustments
 
As restated
 
Net income (loss)
 
$
(15,309
)
$
(19,065
)
$
(34,374
)
Loss from discontinued operations, net of tax
 
$
(27,130
)
$
(19,065
)
$
(46,195
)
 
Note 2 – Summary of Significant Accounting Policies:

Principles of Consolidation:
The consolidated financial statements include the accounts of Par Pharmaceutical Companies, Inc. and its wholly owned subsidiaries. All intercompany transactions are eliminated in consolidation.

The FineTech divestiture is being reported as a discontinued operation in all applicable periods presented (see Note 18 - “Discontinued Operations – Related Party Transaction”).

Basis of Financial Statement Presentation:
The accounting and reporting policies of the Company conform to the generally accepted accounting principles in the United States of America (U.S. GAAP).
 
Use of Estimates:
The consolidated financial statements include certain amounts that are based on management’s best estimates and judgments. Estimates are used in determining such items as provisions for sales returns, rebates and incentives, chargebacks, and other sales allowances, depreciable/amortizable lives, asset impairments, excess inventory, and amounts recorded for contingencies and accruals. Because of the uncertainties inherent in such estimates, actual results may differ from these estimates. Management periodically evaluates estimates used in the preparation of the consolidated financial statements for continued reasonableness. Appropriate adjustments, if any, to the estimates used are made prospectively based on such periodic evaluations.

F-9

 
 Cash and Cash Equivalents:
The Company considers all highly liquid money market instruments with an original maturity of three months or less when purchased to be cash equivalents. These amounts are stated at cost, which approximates fair value. At December 31, 2007, cash equivalents were deposited in financial institutions and consisted of immediately available fund balances. The majority of the Company’s money market funds at December 31, 2007 were maintained with one financial institution. The Company maintains its cash deposits and cash equivalents with well-known and stable financial institutions. However, it has significant amounts of cash and cash equivalents at these financial institutions that are in excess of federally insured limits. This represents a concentration of credit risk. The Company has not experienced any losses on its deposits of cash and cash equivalents to date.

Concentration of Credit Risk:
Financial instruments that potentially subject the Company to credit risk consist of trade receivables. The Company markets its products primarily to wholesalers, drug store chains, supermarket chains, mass merchandisers, distributors, managed health care organizations, mail order accounts and drug distributors. The Company believes the risk associated with this concentration is somewhat limited due to the number of wholesalers, drug store chains, supermarket chains, mass merchandisers, distributors, managed health care organizations, mail order accounts and drug distributors, and their geographic dispersion and its performance of certain credit evaluation procedures (see Note 6 -“Accounts Receivable – Major Customers”).

Investments in Debt and Marketable Equity Securities:
The Company determines the appropriate classification of all debt and marketable equity securities as held-to-maturity, available-for-sale or trading at the time of purchase, and re-evaluates such classification as of each balance sheet date in accordance with SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities (“SFAS 115”). Investments in equity securities that have readily determinable fair values are classified and accounted for as available for sale. The Company, in accordance with FASB Staff Position Nos. FAS 115-1/ 124-1, "The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments,” assesses whether temporary or other-than-temporary unrealized losses on its marketable securities have occurred due to increases or declines in fair value or other market conditions based on the extent and duration of the decline, as well as other factors. Because the Company has determined that all of its debt and marketable equity securities are available for sale, unrealized gains and losses are reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity. Any other-than-temporary unrealized losses would be recorded in the consolidated statement of operations.
 
Inventories:
Inventories are stated at the lower of cost (first-in, first-out basis) or market value. The Company establishes reserves for its inventory to reflect situations in which the cost of the inventory is not expected to be recovered. In evaluating whether inventory is stated at the lower of cost or market, management considers such factors as the amount of inventory on hand, estimated time required to sell such inventory, remaining shelf life and current expected market conditions, including level of competition. The Company records provisions for inventory to cost of goods sold.

Property, Plant and Equipment:
Property, plant and equipment are carried at cost less accumulated depreciation. The costs of repairs and maintenance are expensed when incurred, while expenditures for refurbishments and improvements that significantly add to the productive capacity or extend the useful life of an asset are capitalized.
 
Depreciation and Amortization:
Property, plant and equipment are depreciated on a straight-line basis over their estimated useful lives. Leasehold improvements are amortized over the shorter of their estimated useful life or the term of the lease. The following is the estimated useful life for each applicable asset group:
 
Buildings
30 to 40 years
Machinery and equipment
4 to 10 years
Office equipment, furniture and fixtures
5 to 7 years
Computer software and hardware
3 to 7 years
 
Impairment of Long-lived Assets:
The Company evaluates long-lived assets, including intangible assets with definite lives, for impairment periodically or whenever events or other changes in circumstances indicate that the carrying value of an asset may no longer be recoverable. An evaluation of recoverability is performed by comparing the carrying values of the assets to projected future cash flows, in addition to other quantitative and qualitative analyses. Upon indication that the carrying values of such assets may not be recoverable, the Company recognizes an impairment loss as a charge against current operations. Judgments made by the Company related to the expected useful lives of long-lived assets and the ability of the Company to realize undiscounted cash flows in excess of the carrying amounts of such assets are affected by factors such as ongoing maintenance and improvements of the assets, changes in economic conditions and changes in operating performance. In addition, the Company regularly evaluates its other assets and may accelerate depreciation over the revised useful life if the asset has limited future value.
 
F-10

 
Costs of Computer Software:
The Company capitalizes certain costs associated with computer software developed or obtained for internal use in accordance with the provisions of Statement of Position No. 98-1, Accounting for the Costs of Computer Software Developed or Obtained for Internal Use (SOP 98-1), issued by the American Institute of Certified Public Accountants (AICPA). The Company capitalizes those costs from the acquisition of external materials and services associated with developing or obtaining internal use computer software. The Company capitalizes certain payroll costs for employees that are directly associated with internal use computer software projects once specific criteria of SOP 98-1 are met. Those costs that are associated with preliminary stage activities, training, maintenance, and all other post-implementation stage activities are expensed as they are incurred. All costs capitalized in connection with internal use computer software projects are amortized on a straight-line basis over a useful life of three to seven years, beginning when the software is ready for its intended use.

Research and Development Agreements:
Research and development costs are expensed as incurred. These expenses include the costs of the Company’s internal product development efforts, acquired in-process research and development, as well as costs incurred in connection with the Company’s third party collaboration efforts. Pre-approved milestone payments made under contract research and development arrangements or product licensing arrangements prior to regulatory approval are expensed when the milestone is achieved. Once the product receives regulatory approval the Company records any subsequent milestone payments as intangible assets. The Company makes the determination to capitalize or expense amounts related to the development of new products and technologies through agreements with third parties based on its ability to recover its cost in a reasonable period of time from the estimated future cash flows anticipated to be generated pursuant to each agreement. Market, regulatory and legal factors, among other things, may affect the realizability of the projected cash flows that an agreement was initially expected to generate. The Company regularly monitors these factors and subjects all capitalized costs to periodic impairment testing.

Costs for Patent Litigation and Legal Proceedings:
Costs for patent litigation or other legal proceedings are expensed as incurred and included in selling, general and administrative expenses. 

Goodwill and Intangible Assets:
The Company determines the estimated fair values of goodwill and certain intangible assets with definitive lives based on valuations performed by the Company at time of their acquisition in accordance with SFAS No. 142, “Accounting for Goodwill and Other Intangible Assets.” In addition, certain amounts paid to third parties related to the development of new products and technologies, as described above, are capitalized and included in intangible assets on the accompanying consolidated balance sheets.

The Company reviews the carrying value of its long-term assets for impairment periodically and whenever events and circumstances indicate that the carrying value of an asset may not be recoverable from the estimated future cash flows expected to result from its use and eventual disposition. In cases where undiscounted expected future cash flows are less than the carrying value, an impairment loss is recognized equal to an amount by which the carrying value exceeds the fair value of assets.

As discussed above with respect to determining an asset’s fair value and useful life, because this process involves management making certain estimates and because these estimates form the basis of the determination of whether or not an impairment charge should be recorded, these estimates are considered to be critical accounting estimates. The Company determined through its evaluation that goodwill and intangible assets were recoverable at December 31, 2007. The Company will continue to assess the carrying value of its goodwill and intangible assets in accordance with applicable accounting guidance.
 
Income Taxes:
The Company accounts for income taxes in accordance with SFAS No. 109, Accounting for Income Taxes. Deferred taxes are provided using the asset and liability method, whereby deferred income taxes result from temporary differences between the reported amounts in the financial statements and the tax basis of assets and liabilities, as measured by presently enacted tax rates. The Company establishes valuation allowances against deferred tax assets when it is more likely than not that the realization of those deferred tax assets will not occur.
 
In June 2006, the FASB issued FIN No. 48 (“FIN 48”), Accounting for Uncertainty in Income Taxes — an interpretation of FASB Statement No. 109, which is effective as of January 1, 2007.  FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with SFAS No. 109 Accounting for Income Taxes.  FIN 48 prescribes a recognition threshold and measurement attribute for financial statement recognition, measurement and disclosure of tax positions that a company has taken or expects to be taken in a tax return.  Additionally, FIN 48 provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods and transition.  Upon adoption on January 1, 2007, the Company analyzed filing positions in the federal and state jurisdictions where it is required to file income tax returns, as well as all open tax years in these jurisdictions. See Note 16, “Income Taxes”.
 
F-11

 
Pension Benefits:
The determination of the Company’s obligations and expenses for pension benefits is dependent on its application of certain assumptions used by actuaries in calculating such amounts. Those assumptions are described in Note 17 -“Commitments, Contingencies and Other Matters” to the consolidated financial statements and include, among others, the discount rate, expected long-term rate of return on plan assets and rates of increase in compensation. In accordance with accounting principles generally accepted in the U.S., actual results that differ from the Company’s assumptions are accumulated and amortized over future periods and, therefore, generally affect the recognized expense and recorded obligation in future periods. The Company believes that its assumptions are appropriate. The Company, upon the recommendation of the Audit Committee of its Board of Directors (the “Board”), determined that it was in the best interests of the Company to terminate the Pension Plan, effective as of December 31, 2005, in accordance with its terms and conditions and with the rules and regulations promulgated by the Pension Benefit Guaranty Corporation and by the Internal Revenue Service. The termination is further discussed in Note 17 -“Commitments, Contingencies and Other Matters.”

Revenue Recognition and Accounts Receivable Reserves and Allowances:
The Company recognizes revenues for product sales when title and risk of loss transfer to its customers, when reliable estimates of rebates, chargebacks, returns and other adjustments can be made, and collectibility is reasonably assured. Included in the Company’s recognition of revenues are estimated provisions for sales allowances, the most significant of which include rebates, chargebacks, product returns, and other sales allowances, recorded as reductions to gross revenues, with corresponding adjustments to the accounts receivable reserves and allowances (see Note 6 – “Accounts Receivable”). In addition, the Company records estimates for rebates paid under federal and state government Medicaid drug reimbursement programs as reductions to gross revenues, with corresponding adjustments to accrued liabilities. The Company has the experience and access to relevant information that it believes are necessary to reasonably estimate the amounts of such deductions from gross revenues. Some of the assumptions used by the Company for certain of its estimates are based on information received from third parties, such as customers’ inventories at a particular point in time and market data, or other market factors beyond the Company’s control. The estimates that are most critical to the Company’s establishment of these reserves, and therefore would have the largest impact if these estimates were not accurate, are its estimates of non-contract sales volumes, average contract pricing, customer inventories, processing time lags, and return volumes. The Company regularly reviews the information related to these estimates and adjusts its reserves accordingly, if and when actual experience differs from previous estimates.

Distribution Costs:
The Company records distribution costs related to shipping product to the Company’s customers, primarily through the use of common carriers or external distribution services, in selling, general and administrative expenses. Distribution costs for 2007, 2006 and 2005 were approximately $3.0 million, $3.7 million and $2.6 million, respectively.

Earnings / (Loss) Per Common Share Data:
Earnings / (loss) per common share were computed by dividing net income by the weighted average number of common shares outstanding. Earnings / (loss) per common share assuming dilution were computed assuming that all potentially dilutive securities, including “in-the-money” stock options, were converted into common shares under the treasury stock method.

 Fair Value of Financial Instruments:
The carrying amounts of the Company’s cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate fair market values based upon the relatively short-term nature of these financial instruments. The fair value of the senior subordinated convertible notes is discussed in Note 13 – “Short-Term and Long-Term Debt.”

Concentration of Suppliers of Distributed Products and Internally Manufactured Products:
The Company has entered into distribution agreements with several companies to develop, distribute and promote certain generic pharmaceutical products. For the year ended December 31, 2007, approximately 53% of its total net product sales were generated from distributed products which consist of products manufactured under contract and licensed products. The Company cannot provide assurance that the efforts of its contractual partners will continue to be successful or that it will be able to renew such agreements or that it will be able to enter into new agreements with additional companies. Any alteration to or termination of its current material distribution and marketing agreements, any failure to enter into new and similar agreements, or the interruption of the supply of the products to the Company under the distribution and marketing agreements could materially adversely affect its business, condition (financial and other), prospects or results of operations.

The Company produces all of its internally manufactured products at a single manufacturing facility. A significant disruption at that facility, even on a short-term basis, could impair its ability to produce and ship products to the market on a timely basis, which could have a material adverse effect on the Company’s business, financial position and results of operations.
 
F-12

 
Stock-Based Compensation:
As more fully discussed below in Note 3, the Company adopted SFAS No. 123R, Share-Based Payment (“SFAS No. 123R”), effective January 1, 2006.  The Company adopted the modified prospective transition method provided under SFAS No. 123R and, consequently, has not retroactively adjusted results for prior periods. Under this method, compensation expense is recorded for all non-vested options over the related vesting period beginning in the quarter of adoption based on their grant-date fair values estimated in accordance with the provisions of SFAS 123. The Company previously applied the intrinsic value based method prescribed in Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (“APB 25”), in accounting for employee stock-based compensation and complied with the disclosure provisions of SFAS No. 123, Accounting For Stock-Based Compensation (“SFAS 123”).
 
Segments of an Enterprise:
SFAS No. 131, “Disclosures about Segments of an Enterprise and Related Information” establishes standards for reporting of financial information about operating segments in annual financial statements. The Company’s management considers its business to be in two reportable business segments, generic and brand pharmaceuticals.
 
Recent Accounting Pronouncements:
In December 2007, the Financial Accounting Standards Board (“FASB”) ratified Emerging Issue Task Force Issue No. 07-1 (“EITF 07-1”), Accounting for Collaborative Arrangements. The key elements of EITF 07-1 relate to: (a) the scope of the issue; (b) the income statement presentation of transactions with third parties; (c) the income statement presentation of payments between parties to the collaborative arrangement; (d) the disclosures about collaborative arrangements that should be required in the financial statements of the parties to the collaborative arrangements; and (e) the transition method. A contractual arrangement falls within the scope of EITF 07-1 if the arrangement requires the parties to be active participants and the arrangement exposes the parties to significant risks and rewards that are tied to the commercial success of the endeavor. Costs incurred and revenue generated on sales to third parties should be reported in the statement of operations based on the guidance in EITF Issue No. 99-19, Reporting Revenue Gross as a Principal versus Net as an Agent. The equity method of accounting should not be applied to a collaborative arrangement within the scope of this issue without the creation of a separate legal entity for the arrangement. Payments between parties to the collaborative arrangement should be presented in the statement of operations based on the nature of the arrangement and each entity's business operations, the contractual terms of the arrangement as well as if existing GAAP is applicable. EITF 07-1 requires companies to disclose the nature and purpose of the arrangement, its rights and obligations under the arrangement, the accounting policy applied to the arrangement, and the amounts attributable to transactions between other participants to the collaborative arrangement and where in the statement of operations these amounts have been classified. EITF 07-1 requires that companies comply in its first fiscal year beginning after December 15, 2008 and transition to the guidance in this issue by retrospectively applying the guidance to all periods presented for all arrangements existing at the effective date, unless it is impracticable to do so. The impracticability assessment should be made on an arrangement-by-arrangement basis and certain disclosures would be required if a company utilized the impracticability exception. The Company is currently evaluating the potential impact of adopting EITF 07-1 on its consolidated financial statements.

In December 2007, the FASB issued FASB Statement No. 141 (Revised 2007) (“SFAS 141R”), Business Combinations. SFAS 141R will significantly change the accounting for business combinations. Under SFAS 141R, an acquiring entity will be required to recognize all the assets acquired and liabilities assumed in a transaction at the acquisition date fair value with limited exceptions. SFAS 141R will change the accounting treatment for certain specific items, including; acquisition costs will be generally expensed as incurred, minority interests will be valued at fair value at the acquisition date, acquired contingent liabilities will be recorded at fair value at the acquisition date and subsequently measured at either the higher of such amount or the amount determined under existing guidance for non-acquired contingencies, in-process research and development will be recorded at fair value as an indefinite-lived intangible asset at the acquisition date, restructuring costs associated with a business combination will be generally expensed subsequent to the acquisition date, and changes in deferred tax asset valuation allowances and income tax uncertainties after the acquisition date generally will affect income tax expense. SFAS 141R also includes a substantial number of new disclosure requirements. SFAS 141R applies prospectively to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. Earlier adoption is prohibited. The Company will be required to record and disclose business combinations following existing GAAP until January 1, 2009.

In December 2007, SFAS No. 160, Noncontrolling Interests in Consolidated Financial Statements – an amendment of ARB No. 51(“SFAS 160”), was issued. SFAS 160 requires entities to report noncontrolling (minority) interests as a component of stockholders’ equity on the balance sheet; include all earnings of a consolidated subsidiary in consolidated results of operations; and treat all transactions between an entity and noncontrolling interest as equity transactions between the parties. SFAS 160 is effective for the Company’s fiscal year beginning 2009 and adoption is prospective only; however, presentation and disclosure requirements described above must be applied retrospectively.

F-13


In June 2007, the FASB ratified Emerging Issue Task Force Issue No. 07-3 (“EITF 07-3”), Accounting for Non-Refundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities, which requires nonrefundable advance payments for goods and services that will be used or rendered for future research and development activities to be deferred and capitalized. These amounts will be recognized as expense in the period that the related goods are delivered or the related services are performed or when an entity does not expect the goods to be delivered or services to be rendered. EITF 07-3 is effective for the fiscal years beginning after December 31, 2007, including interim periods within those fiscal years. Earlier adoption is not permitted. The Company will adopt the provisions of EITF 07-3 prospectively, beginning January 1, 2008.

In February 2007, the FASB issued SFAS No. 159 The Fair Value Option for Financial Assets and Financial Liabilities — Including an Amendment of FASB Statement No. 115 (“SFAS 159”), which becomes effective for fiscal periods beginning after November 15, 2007.  Under SFAS 159, companies may elect to measure specified financial assets and liabilities at fair value that are not otherwise measured at fair value, with changes in fair value recognized in earnings each subsequent reporting period.  This election, called the “fair value option”, will enable some companies to reduce volatility in reported earnings caused by measuring related assets and liabilities differently.  SFAS 159 also establishes presentation and disclosure requirements designed to draw a comparison between the different measurement attributes a company elects for similar types of assets and liabilities. The Company does not intend to elect the “fair value option” for any of its eligible financial assets or liabilities and therefore the Company does not expect the adoption of SFAS 159 to have a material impact on its consolidated financial statements.
 
In September 2006, the FASB issued SFAS No. 157 Fair Value Measurements (“SFAS 157”).  SFAS 157 establishes a common definition for fair value to be applied to GAAP guidance requiring use of fair value, establishes a framework for measuring fair value, and expands disclosure about such fair value measurements.  SFAS 157 applies to fair value measurements that are already required or permitted by other accounting standards, except for measurements of share-based payments and measurements that are similar to, but not intended to be, fair value. The FASB has previously concluded in those accounting pronouncements that fair value is the relevant measurement attribute. Accordingly, this Statement does not require any new fair value measurements. SFAS 157 is effective for fiscal years beginning after November 15, 2007.  In November 2007, FASB granted a one year deferral for the implementation of SFAS 157 for non-financial assets and liabilities. The Company does not expect the adoption of SFAS 157 to have a material impact on its consolidated financial statements.
 
Note 3 – Share-Based Compensation:

The Company adopted Statement of Financial Accounting Standards No. 123 (Revised 2004), Share-Based Payment (“SFAS 123R”), effective January 1, 2006. SFAS 123R requires companies to recognize compensation expense in the amount equal to the fair value of all share-based payments granted to employees. The Company elected the modified prospective transition method and, therefore, adjustments to prior periods were not required as a result of adopting SFAS 123R. Under this method, the provisions of SFAS 123R apply to all awards granted after the date of adoption and to any unrecognized expense of awards not vested at the date of adoption based on the grant date fair value. Under SFAS 123R, the Company will recognize share-based compensation ratably over the service period applicable to the award. SFAS 123R also amends SFAS No. 95, “Statement of Cash Flows,” to require that excess tax benefits that have been reflected as operating cash flows be reflected as financing cash flows. In accordance with SFAS 123R, $0.5 million and $0.7 million of excess tax benefits for the year ended December 31, 2007 and 2006 has been classified as both an operating cash outflow and financing cash inflow, respectively.

The Company grants share-based awards under its various plans, which provide for the granting of non-qualified stock options, restricted stock and restricted stock units to the employees of the Company and others. Stock options, restricted stock and restricted stock units generally vest ratably over four years and stock options have a maximum term of ten years.

As of December 31, 2007, there were approximately 6.1 million shares of common stock available for future stock option grants. The Company issues new shares of common stock when stock option awards are exercised. Stock option awards outstanding under the Company’s current plans have been granted at exercise prices that were equal to the market value of the Company’s common stock on the date of grant.

F-14


The following table illustrates the effects on net loss and net loss per share of common stock had the Company accounted for stock-based compensation in accordance with SFAS 123 for the year ended December 31, 2005:

   
December 31,
 
   
2005
 
       
Net loss
 
$
(34,374
)
Add: Stock-based employee compensation expense included in reported net loss, net of related tax effects
   
2,546
 
Deduct: Stock-based employee compensation expense determined under the fair-value based method, net of related taxes
   
(34,862
)
Pro forma net loss
 
$
(66,690
)
         
Net loss per share of common stock :
       
         
As reported – basic
 
$
(1.00
)
As reported – diluted
 
$
(1.00
)
         
Pro forma – basic
 
$
(1.95
)
Pro forma – diluted
 
$
(1.95
)
 
In February 2005, the Company accelerated the vesting of 820 outstanding, non-vested stock options, which represented all of its stock option grants with per share exercise prices exceeding $60. The fair value of these options, using the Black-Scholes stock option pricing model and the Company’s stock option assumptions at the date of their grant, was approximately $27.9 million. This action increased pro forma compensation expense in the first quarter of 2005 by approximately $16.6 million, net of related tax effects. In September 2005, the Company accelerated the vesting of an additional 424 outstanding, non-vested stock options. The fair value of these options, using the Black-Scholes stock option pricing model and the Company’s stock option assumptions at the date of their grants, was approximately $7.3 million. This action increased pro forma compensation expense in the third quarter of 2005 by approximately $3.1 million, net of related tax effects. The Company considered a number of factors in making this decision, including the issuance and anticipated implementation of SFAS 123R.
 
As part of the FineTech divestiture, the Company also accelerated the vesting of 6 shares of nonvested restricted stock and approximately 139 outstanding non-vested stock options, effective December 31, 2005. The Company recorded pre-tax expense of approximately $0.2 million in loss on the sale of discontinued operations in 2005 due to the acceleration of the restricted stock. The exercise prices of 120 of the accelerated stock options were below the closing price of the Company’s common stock on December 31, 2005 and, as such, the Company recorded pre-tax expense of approximately $1.1 million in loss on sale of discontinued operations which represented the difference between the closing price of the Company’s common stock on December 31, 2005 and the exercise price. The Company also accelerated approximately 19 stock options whose exercise price was above the then closing price. The acceleration of these options increased pro forma compensation expense by approximately $0.3 million, net of related tax expense.
 
During 2006, the Company accelerated the vesting of 394 outstanding non-vested stock options and extended the exercise period of 783 vested shares in connection with the termination of certain executives. For the year ended December 31, 2006, the Company recorded a total of approximately $4.3 million additional compensation expense as a result of these modifications. The Company also modified 172 vested and non-vested options in connection with revised employment agreements for certain executives. The Company recorded total compensation expense of $1.1 million, of which $0.8 million was recorded for the year ended December 31, 2006. The Company recorded the remaining $0.3 million in the year ended December 31, 2007 to match the remaining vesting period of the modified options.
 
In November 2007, the Company announced a tender offer for certain unvested stock options granted to employees having an exercise price in excess of $33.61 per option. The tender offer was completed in December 2007 with approximately 181 stock options cash settled. The Company recognized approximately $4.6 million pre-tax compensation expense in the fourth quarter of 2007 that otherwise would have been recognized ratably in 2008 and 2009. The cash outlay of the tender offer was approximately $0.9 million on a pre-tax basis.

F-15


Stock Options

The Company uses the Black-Scholes stock option pricing model to estimate the fair value of stock option awards with the following weighted average assumptions:
 
   
For the year ended December 31,
 
   
2007
 
2006
 
2005
 
Risk-free interest rate
   
4.6
%
 
4.5
%
 
3.8
%
Expected life (in years)
   
6.2
   
6.2
   
5.0
 
Expected Volatility
   
52.5
%
 
57.9
%
 
58.6
%
Dividend
   
0
%
 
0
%
 
0
%

The Black-Scholes option pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. The Company compiled historical data on an employee-by-employee basis from the grant date through the settlement date. The results of analyzing the historical data showed that there were three distinct populations of optionees, the Executive Officers Group, the Outside Directors Group, and the All Others Group. The expected life of options represents the period of time that the options are expected to be outstanding and is based generally on historical trends. However, because only a small number of the Company’s existing options have reached their full 10-year term, and also because the majority of such options granted are out-of-the-money and the expected life of out-of-the-money options is uncertain, the Company opted to use the “simplified” method for “plain vanilla” options described in SAB 107. The “simplified method” calculation is the average of the vesting term plus the original contractual term divided by 2. The Company generally granted options with four-year graded vesting; and Outside Directors stock option grants had one-year vesting. The Company will revisit this assumption at least annually or sooner if circumstances warrant. The risk-free rate is based on the yield on the Federal Reserve treasury rate with a maturity date corresponding to the expected term of the option granted. The expected volatility assumption is based on the historical volatility of the Company’s common stock over a term equal to the expected term of the option granted. SFAS 123R also requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. It is assumed that no dividends will be paid during the entire term of the options. All option valuation models require input of highly subjective assumptions. Because the Company's employee stock options have characteristics significantly different from those of traded options, and because changes in subjective input assumptions can materially affect the fair value estimate, the actual value realized at the time the options are exercised may differ from the estimated values computed above. The weighted average per share fair values of options granted in 2007, 2006, and 2005 were $13.10, $16.95 and $18.57, respectively.

Set forth below is the impact on the Company’s results of operations of recording share-based compensation from its stock options for the year ended December 31, 2007:
 
   
Year Ended
 
Year Ended
 
   
December 31, 2007
 
December 31, 2006
 
           
Cost of sales
 
$
1,137
 
$
886
 
Research and development
   
2,842
   
2,217
 
Selling, general and administrative
   
10,230
   
12,040
 
Total, pre-tax
   
14,209
   
15,143
 
Tax benefit of share-based compensation
   
(5,399
)
 
(5,906
)
Total, net of tax
 
$
8,810
 
$
9,237
 
 
The share-based compensation expense decreased both basic and diluted earnings per share by $0.25 and $0.27 per share for the year ended December 31, 2007 and December 31, 2006, respectively.

The following is a summary of the Company’s stock option activity (shares in thousands):
 
       
Weighted
 
Weighted
 
Aggregate
 
       
Average
 
Average
 
Intrinsic
 
   
Shares
 
Exercise Price
 
Remaining Life
 
Value
 
                   
Balance at December 31, 2006
   
5,470
 
$
36.00
             
Granted
   
592
   
23.41
             
Exercised
   
(68
)
 
5.60
             
Forfeited
   
(1,468
)
 
36.16
             
Balance at December 31, 2007
   
4,526
 
$
34.76
   
5.9
 
$
5,358
 
Exercisable at December 31, 2007
   
3,399
 
$
37.68
   
4.9
 
$
3,412
 
Vested and expected to vest at December 31, 2007
   
4,372
 
$
34.95
   
5.7
 
$
5,187
 

F-16

 
The total fair value of shares vested during the twelve-month periods ended December 31, 2007 and December 31, 2006, was $10.3 million and $9.1 million, respectively. As of December 31, 2007, the total compensation cost related to all non-vested stock options granted to employees but not yet recognized was approximately $10.5 million. This cost will be amortized on a straight-line basis over the remaining weighted average vesting period of 2.5 years.

Restricted Stock/Restricted Stock Units

Outstanding restricted stock and restricted stock units generally vest ratably over four years. The related share-based compensation expense is recorded over the requisite service period, which is the vesting period. The fair value of restricted stock is based on the market value of the Company’s common stock on the date of grant.

In the year ended December 31, 2006, the Company accelerated the vesting of 129 outstanding non-vested restricted shares in connection with the termination of certain executives. The effect of these accelerations resulted in additional compensation expense of approximately $3.7 million in the year ended December 31, 2006.

The Company accelerated the vesting of 67 outstanding non-vested restricted shares in connection with the termination of certain executives and 6 outstanding non-vested restricted stock units in connection with the termination of a member of the Board of Directors in 2007. The effect of these accelerations resulted in additional compensation expense of $1.7 million in the year ended December 31, 2007.

The impact on the Company’s results of operations of recording share-based compensation from restricted stock for the years ended December 31, 2007, 2006 and 2005 was as follows:
 
   
For the year ended
 
   
December 31,
 
December 31,
 
December 31,
 
   
2007
 
2006
 
2005
 
               
Cost of sales
 
$
626
 
$
342
 
$
185
 
Research and development
   
1,565
   
1,348
   
619
 
Selling, general and administrative
   
7,102
   
7,107
   
2,155
 
Total, pre-tax
   
9,293
   
8,797
   
2,959
 
Tax benefit of stock-based compensation
   
(3,531
)
 
(3,430
)
 
(1,120
)
Total, net of tax
 
$
5,762
 
$
5,367
 
$
1,839
 
 
The following is a summary of the Company’s restricted stock activity (shares in thousands):
 
       
Weighted
 
Aggregate
 
       
Average
 
Intrinsic
 
   
Shares
 
Grant Price
 
Value
 
Non-vested balance at December 31, 2006
   
495
 
$
32.92
       
Granted
   
541
   
23.71
       
Vested
   
(205
)
 
34.58
       
Forfeited
   
(133
)
 
27.36
       
Non-vested balance at December 31, 2007
   
698
 
$
26.35
 
$
16,748
 

The following is a summary of the Company’s restricted stock unit activity (shares in thousands):
 
       
Weighted
 
Aggregate
 
       
Average
 
Intrinsic
 
   
Shares
 
Grant Price
 
Value
 
Non-vested balance at December 31, 2006
   
245
 
$
23.46
       
Granted
   
25
   
25.23
       
Vested
   
(86
)
 
24.06
       
Forfeited
   
(11
)
 
21.68
       
Non-vested balance at December 31, 2007
   
173
 
$
23.53
 
$
4,145
 

As of December 31, 2007, the total compensation cost related to all non-vested restricted stock and restricted stock units granted to employees but not yet recognized was approximately $17.5 million; this cost will be amortized on a straight-line basis over the remaining weighted average vesting period of approximately 2.8 years. At December 31, 2007, approximately 1.6 million shares remain available for restricted stock and restricted stock unit grants.

F-17


Employee Stock Purchase Program:

 The Company maintains an Employee Stock Purchase Program (the “Program”). The Program is designed to qualify as an employee stock purchase plan under Section 423 of the Internal Revenue Code of 1986, as amended. It enables eligible employees to purchase shares of the Company’s common stock at a discount to the fair market value. An aggregate of 1,000 shares of common stock has been reserved for sale to employees under the Program. As of July 5, 2006, the Program was suspended by the Company. As a result, there was no Program activity during the year ended December 31, 2007. Employees purchased 15 shares and 18 shares during the years ended December 31, 2006 and December 31, 2005, respectively. No expense was recorded for the year ended December 31, 2007 as a result of the suspension of the Program throughout this period. The Company recorded expense of $0.06 million reflecting their 15% discount from fair market value, in accordance with the terms of the Program at that time for the year ended December 31, 2006. No expense was recorded for the year ended December 31, 2005, which was prior to the adoption of 123R.

Note 4 – Available for Sale Debt and Marketable Equity Securities:

At December 31, 2007 and 2006, all of the Company’s investments in debt and marketable equity securities were classified as available for sale and, as a result, were reported at their fair values on the consolidated balance sheets. The following is a summary of the amortized cost and estimated fair value of the Company’s debt and marketable equity securities available for sale at December 31, 2007:
           
Estimated
 
       
Unrealized
 
Fair
 
   
Cost
 
Gain
 
(Loss)
 
Value
 
Securities issued by government agencies
 
$
46,177
 
$
24
 
$
-
 
$
46,201
 
Debt securities issued by various state and local municipalities and agencies
   
24,226
   
-
   
(3
)
 
24,223
 
Other debt securities
   
15,020
   
-
   
(1,029
)
 
13,991
 
Auction rate securities
   
5,000
   
-
   
-
   
5,000
 
Available for sale debt securities
   
90,423
   
24
   
(1,032
)
 
89,415
 
                           
Marketable equity securities available for sale
                         
Hana Biosciences, Inc.
   
3,850
   
-
   
(1,200
)
 
2,650
 
                           
Total
 
$
94,273
 
$
24
 
$
(2,232
)
$
92,065
 

Of the $1.0 million of unrealized loss on available for sale debt securities as of December 31, 2007, the majority of it has been in an unrealized loss position for greater than a year. The Company believes that these losses are not other-than-temporary in accordance with FASB Staff Position Nos. FAS 115-1/ 124-1, "The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments,” due to its assessment that all amounts due according to the contractual terms of the related debt security will be collected and its ability and intent to hold the related debt security for a reasonable period of time sufficient for a recovery of fair value up to (or beyond) the cost of the investment.
 
The Company recorded an unrealized loss of $1.2 million for the year ended December 31, 2007, which was included in other comprehensive income to reflect the estimated fair value of its investment in Hana Biosciences, Inc. (“Hana”). The Company evaluated the near-term prospects of Hana in relation to the severity and duration of the period that the investment has been in an unrealized loss position, which has been for less than three months as of December 31, 2007. Based on that evaluation and the Company's ability and intent to hold those investments for a reasonable period of time sufficient for a forecasted recovery of fair value, the Company does not consider the investment to be other-than-temporarily impaired at December 31, 2007.
 
In August 2007, the Company announced that it acquired the North American commercial rights to ZensanaTM Oral Spray from Hana. Refer to Note 11 – “Research and Development Agreements” for further details. The terms of the agreement included a $5.0 million investment in Hana at a contractually agreed $1.2 million premium. The Company recorded its investment in Hana at $3.8 million based on the prevailing market price of Hana’s common stock at the date of the agreement and charged $1.2 million, which represents a non-refundable upfront license payment, to research and development expense in the third quarter of 2007. The Company has classified its investment in Hana as a noncurrent asset on its consolidated balance sheet as of December 31, 2007 due to its intent to hold the investment for a period of time greater than 12 months.
 
The Company held an investment, as a limited partner, in a fund that invested in various floating rate structured finance securities that experienced a rapid and severe reduction in value in the second quarter of 2007. In August 2007, the Company received notice from the fund manager that based on the liquidating procedures, there was no remaining equity for limited partners. The Company recorded a realized investment loss in 2007 of $6.0 million for the carrying value of the related investment.

F-18

 
Auction Rate Securities
 
Auction rate securities have been classified as short-term available for sale debt securities. Auction rate securities are variable rate bonds and preferred stock tied to short-term interest rates with maturities on the face of the securities in excess of 90 days. Auction rate securities have interest rate resets through a modified Dutch auction, at predetermined short-term intervals, usually every 7, 28 or 35 days. Interest paid during a given period is based upon the interest rate determined during the prior auction. Although these securities are issued and rated as long-term securities, they are priced and traded as short-term instruments because of the historical liquidity provided through the interest rate reset. All of the Company’s auction rate securities are tax-exempt or tax-advantaged. All of the Company’s auction rate securities are tied to debt securities issued by various state and local municipalities and agencies and the auction rate securities are insured by insurance companies. Given the current negative liquidity conditions in the global credit markets, there have been reports of failed auctions and related impairments relating to auction rate securities in late 2007 and in January and February 2008, including those auction rate securities tied to various municipalities. The Company’s auction rate securities did not experience any failed auctions.

The following is a summary of amortized cost and estimated fair value of the Company’s investments in debt and marketable equity securities available for sale at December 31, 2006:

           
Estimated
 
       
Unrealized
 
Fair
 
   
Cost
 
Gain
 
(Loss)
 
Value
 
Securities issued by government agencies
 
$
66,238
 
$
-
 
$
(341
)
$
65,897
 
Debt securities issued by various state and local municipalities and agencies
   
13,945
   
-
   
(190
)
 
13,755
 
Other debt securities
   
16,103
   
211
   
(444
)
 
15,870
 
Auction rate securities
   
4,250
   
-
   
-
   
4,250
 
Available for sale debt securities
 
$
100,536
 
$
211
 
$
(975
)
$
99,772
 

The following is a summary of the contractual maturities of the Company’s available for sale debt securities at December 31, 2007:
 
       
Estimated
 
   
Cost
 
Fair Value
 
Less than one year
 
$
40,195
 
$
40,179
 
Due between 1-2 years
   
32,078
   
32,110
 
Due between 2-5 years
   
13,083
   
13,086
 
Due after 5 years
   
5,067
   
4,040
 
Total
 
$
90,423
 
$
89,415
 

Note 5 – Other Investments:

       
Balance at December 31, 2007
   
Carrying Value
 
IntelliPharmaCeutics Ltd.
 
$
2,500
 
Total other investments
 
$
2,500
 

       
Balance at December 31, 2006
   
Carrying Value
 
Abrika Pharmaceuticals, LLLP
 
$
4,588
 
Optimer Pharmaceuticals, Inc.
   
12,000
 
Total other investments
 
$
16,588
 

The Company assesses whether temporary or other-than-temporary losses on its investments have occurred due to declines in fair value or other market conditions. At December 31, 2007 and December 31, 2006, the Company believed the carrying values of its cost method investments was equal to their fair values.

In August 2007, the Company announced that it entered into a stock purchase agreement to acquire an equity interest in IntelliPharmaCeutics Ltd. (“IPC Ltd.”), a privately held Delaware company. Refer to Note 11 – “Research and Development Agreements” for further details. The terms of the agreement included a $5.0 million private placement investment that represents a 4.2 percent equity interest in IntelliPharmaCeutics Corp. (“IPC Corp.”), the operating subsidiary of IPC Ltd. The Company recorded its investment in IPC Corp. at $2.5 million based on the Company’s assessment of the fair value of its investment and charged $2.5 million, which represents a non-refundable upfront license payment, to research and development expense in the third quarter of 2007. Because IPC Ltd. is privately-held and accounted for under the cost method, the Company monitors the investment on a periodic basis to evaluate whether any declines in value becomes other-than-temporary.

F-19


In April 2005, the Company acquired shares of the Series C preferred stock of Optimer Pharmaceuticals, Inc. (“Optimer”), a privately-held biotechnology company located in San Diego, California, for $12.0 million. In February 2007, Optimer became a public company via an initial public offering (“IPO”). On February 20, 2007, the Company sold 1.1 million shares for $6.8 million and recognized a pre-tax gain of $1.4 million in the first quarter of 2007. In October 2007, the Company sold its remaining investment in Optimer common stock for $9.6 million and recognized a pre-tax gain on the sale of $3.1 million in the fourth quarter of 2007. On February 27, 2007 in exchange for $20.0 million the Company returned the marketing rights to Difimicin (PAR 101), an investigational drug to treat Clostridium difficle-associated diarrhea to Optimer. The Company recognized a gain on the sale of product rights of $20.0 million related to this transaction in the three month period ended March 31, 2007.

In December 2004, the Company acquired a 5% limited partnership interest in Abrika Pharmaceuticals, LLLP, (“Abrika”), a privately-held specialty generic pharmaceutical company located in Sunrise, Florida for $8.4 million, including costs. Additionally, the Company entered into an agreement with Abrika to collaborate on the marketing of five products to be developed by Abrika. The first product was a transdermal fentanyl patch for the management of chronic pain. This patch is a generic version of Duragesic® marketed by Janssen Pharmaceutica Products, L.P., a division of Johnson & Johnson. Pursuant to an amended agreement in February 2006, the Company advanced $9.0 million to Abrika. Under the amended agreement, Abrika would earn the advance only upon the Food and Drug Administration’s (“FDA”) final and unconditional approval of the transdermal fentanyl patch. Abrika agreed to repay the advance if it did not receive FDA approval within two years of the amendment. The Company also held a convertible promissory note in the principal amount of $3.0 million, plus interest accruing at 8.0% annually for money loaned to Abrika. In July 2007, the Company and Abrika amended their collaboration agreement to remove all of the Company’s rights in, benefits from, and obligations arising as a result of the development and commercialization of the transdermal fentanyl patch. As a result of this amendment, the Company was no longer obligated to pay Abrika the $9.0 million upon FDA approval of the transdermal fentanyl patch. Both the $9.0 million advance and the $3.0 million promissory note were recorded in deferred charges and other assets, and were collected by the Company in the second quarter of 2007. In November 2006, Abrika agreed to be purchased by a wholly-owned subsidiary of the Actavis group. The Company wrote down its investment by approximately $3.8 million in the second quarter of 2006 based on the terms of the merger agreement between Abrika and Actavis that indicated that its investment was impaired. The merger transaction was completed in April 2007. Based on the terms of the merger agreement in the second quarter of 2007, the Company received approximately $4.6 million for its equity stake in Abrika. As part of the merger agreement, the Company has the potential to earn future “Earnout” payments. The “Earnout” payments would be triggered if the post merger entity achieves certain gross profit targets in each of the calendar years 2008 and/or 2009. The maximum potential “Earnout” payments that the Company could receive are $5.5 million as of December 31, 2007. The Company does not attribute any value to the potential “Earnout” payments.

Note 6 – Accounts Receivable:

The Company recognizes revenue for product sales when title and risk of loss have transferred to its customers, when reliable estimates of rebates, chargebacks, returns and other adjustments can be made, and when collectibility is reasonably assured. This is generally at the time that products are received by the customers. Upon recognizing revenue from a sale, the Company records estimates for chargebacks, rebates and incentive programs, product returns, cash discounts and other sales reserves that reduce accounts receivable.
 
   
December 31,
 
December 31,
 
   
2007
 
2006
 
       
(a)
 
Gross trade accounts receivable
 
$
216,327
 
$
300,230
 
Chargebacks
   
(46,006
)
 
(51,891
)
Rebates and incentive programs
   
(42,859
)
 
(85,888
)
Returns
   
(47,102
)
 
(42,905
)
Cash discounts and other
   
(16,158
)
 
(18,038
)
Doubtful accounts
   
(20
)
 
(2,465
)
Accounts receivable, net
 
$
64,182
 
$
99,043
 
 
(a)
Restated to reflect a reclassification to accrued expenses of $4.3 million for discounts due to customers for which no underlying accounts receivable existed as of December 31, 2006.
 
Allowance for doubtful accounts
 
Year Ended
 
   
December 31, 2007
 
December 31, 2006
     
December 31, 2005
 
Balance at beginning of period
 
$
(2,465
)
$
(1,847
)
     
$
(1,847
)
Additions – charge to expense
   
-
   
(10,458
)
 
(b)
 
 
-
 
Adjustments and/or deductions
   
2,445
   
9,840
         
-
 
Balance at end of period
 
$
(20
)
$
(2,465
)
     
$
(1,847
)

F-20

 
(b)
The Company records estimated customer credits for chargebacks, rebates, product returns, cash discounts and other credits at the time of sale. Customers often take deductions for these items from their payment of invoices. The Company validates the customer deductions and for valid deductions a credit is issued. For invalid deductions the Company pursues collection from its customers. In the second quarter of 2006, the Company determined that approximately $10.0 million of invalid customer deductions would not be pursued for collection. Accordingly, the related $10.0 million was reserved for in the second quarter of 2006 and subsequently written off.
 
The following tables summarize the activity for the years ended December 31, 2007, 2006 and 2005 in the accounts affected by the estimated provisions described below: 
 
   
For the year ended December 31, 2007
 
Accounts receivable reserves
 
Beginning
 balance (3)
 
Provision 
recorded
for current 
period 
sales
 
(Provision) 
reversal 
recorded
for prior 
period sales
     
Credits 
processed
 
Ending 
balance
 
Chargebacks
 
$
(51,891
)
$
(345,526
)
$
-
   
(1)
 
$
351,411
 
$
(46,006
)
Rebates and incentive programs
   
(85,888
)
 
(175,775
)
 
2,075
         
216,729
   
(42,859
)
Returns
   
(42,905
)
 
(29,312
)
 
(220
)
       
25,335
   
(47,102
)
Cash discounts and other
   
(18,038
)
 
(71,552
)
 
211
         
73,221
   
(16,158
)
Total
 
$
(198,722
)
$
(622,165
)
$
2,066
       
$
666,696
 
$
(152,125
)
                                       
Accrued liabilities (2)
 
$
(10,412
)
$
(17,567
)
$
(2,319
)
     
$
13,483
 
$
(16,815
)
   
 
For the year ended December 31, 2006
 
Accounts receivable reserves
 
Beginning 
balance
 
Provision 
recorded
for current 
period sales
 
(Provision) 
reversal 
recorded
for prior 
period sales
     
Credits 
processed
 
Ending 
balance (3)
 
Chargebacks
 
$
(102,256
)
$
(339,711
)
$
-
   
(1)
 
$
390,076
 
$
(51,891
)
Rebates and incentive programs
   
(50,991
)
 
(201,993
)
 
-
         
167,096
   
(85,888
)
Returns
   
(32,893
)
 
(36,609
)
 
(7,686
)
       
34,283
   
(42,905
)
Cash discounts and other
   
(15,333
)
 
(48,734
)
 
-
         
46,029
   
(18,038
)
Total
 
$
(201,473
)
$
(627,047
)
$
(7,686
)
     
$
637,484
 
$
(198,722
)
                                       
Accrued liabilities (2)
 
$
(9,040
)
$
(19,528
)
$
82
       
$
18,074
 
$
(10,412
)

   
For the year ended December 31, 2005
 
Accounts receivable reserves
 
Beginning 
balance
 
Provision 
recorded
for current 
period sales
 
(Provision) 
reversal 
recorded
for prior 
period sales
     
Credits 
processed
 
Ending 
balance
 
Chargebacks
 
$
(91,986
)
$
(486,113
)
$
-
   
(1)
 
$
475,843
 
$
(102,256
)
Rebates and incentive programs
   
(49,718
)
 
(154,727
)
 
1,489
         
151,965
   
(50,991
)
Returns
   
(61,986
)
 
(24,010
)
 
(5,568
)
       
58,671
   
(32,893
)
Cash discounts and other
   
(13,287
)
 
(60,628
)
 
-
         
58,582
   
(15,333
)
Total
 
$
(216,977
)
$
(725,478
)
$
(4,079
)
     
$
745,061
 
$
(201,473
)
                                       
Accrued liabilities (2)
 
$
(8,755
)
$
(22,847
)
$
-
       
$
22,562
 
$
(9,040
)

(1) The amount of provision or reversal of reserves related to prior periods for chargebacks is not determinable on a product or customer specific basis; however, based upon historical analyses and analyses of activity in subsequent periods, the Company has determined that its chargeback estimates remain reasonable.

(2) Includes amounts due to customers for which no underlying accounts receivable exists, including Medicaid rebates.

(3) Restated to reflect a reclassification to accrued expenses of $4.3 million for discounts due to customers for which no underlying accounts receivable existed as of December 31, 2006.

F-21


The Company sells its products directly to wholesalers, retail drug store chains, drug distributors, mail order pharmacies and other direct purchasers and customers that purchase its products indirectly through the wholesalers, including independent pharmacies, non-warehousing retail drug store chains, managed health care providers and other indirect purchasers. The Company has entered into agreements at negotiated contract prices with those health care providers that purchase products through the Company’s wholesale customers at those contract prices. Chargeback credits are issued to wholesalers for the difference between the Company’s invoice price to the wholesaler and the contract price through which the product is resold to health care providers. Approximately 61% and 50% of the Company’s net product sales were derived from the wholesale distribution channel for the years ended December 31, 2007 and 2006, respectively. The information that the Company considers when establishing its chargeback reserves includes contract and non-contract sales trends, average historical contract pricing, actual price changes, processing time lags and customer inventory information from its three largest wholesale customers. The Company’s chargeback provision and related reserve vary with changes in product mix, changes in customer pricing and changes to estimated wholesaler inventory.

Customer rebates and incentive programs are generally provided to customers as an incentive for the customers to continue to carry the Company’s products or replace competing products in their distribution channels with those products sold by the Company. Rebate programs are based on a customer’s dollar purchases made during an applicable monthly, quarterly or annual period. The Company also provides indirect rebates, which are rebates paid to indirect customers that have purchased our products from a wholesaler under a contract with the Company. The incentive programs include stocking or trade show promotions where additional discounts may be given on a new product or certain existing products as an added incentive to stock the Company’s products. The Company may, from time to time, also provide price and/or volume incentives on new products that have multiple competitors and/or on existing products that confront new competition in order to attempt to secure or maintain a certain market share. The information that the Company considers when establishing its rebate and incentive program reserves are rebate agreements with and purchases by each customer, tracking and analysis of promotional offers, projected annual sales for customers with annual incentive programs, actual rebates and incentive payments made, processing time lags, and for indirect rebates, the level of inventory in the distribution channel that will be subject to indirect rebates. The Company does not provide incentives designed to increase shipments to its customers that it believes would result in out-of-the ordinary course of business inventory for them. The Company regularly reviews and monitors estimated or actual customer inventory information at its three largest wholesale customers for its key products to ascertain whether customer inventories are in excess of ordinary course of business levels.

Pursuant to a drug rebate agreement with the Centers for Medicare and Medicaid Services and similar supplemental agreements with various states, the Company provides such states with a rebate on drugs dispensed under the Medicaid program. The Company determines its estimate of 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 that might impact the Company’s provision for Medicaid rebates. In determining the appropriate accrual amount the Company considers historical payment rates; processing lag for outstanding claims and payments; and levels of inventory in the distribution channel. The Company reviews the accrual and assumptions on a quarterly basis against actual claims data to help ensure that the estimates made are reliable.

The Company accepts returns of product according to the following criteria: (i) the product returns must be approved by authorized personnel in writing or by telephone with the lot number and expiration date accompanying any request and (ii) the Company generally will accept returns of products from any customer and will provide the customer with a credit memo for such returns if such products are returned within six months prior to, and until 12 months following, such products’ expiration date. The Company records a provision for product returns based on historical experience, including actual rate of expired and damaged returns, average remaining shelf-lives of products sold, which generally range from 12 to 36 months, and estimated return dates. Additionally the Company considers other factors when estimating its current period return provision, including levels of inventory in the distribution channel, significant market changes that may impact future expected returns, and actual product returns, and may record additional provisions for specific returns that it believes are not covered by the historical rates.

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. The Company accounts for cash discounts by reducing accounts receivable by the full amount of the discounts that the Company expects its customers to take. In addition to the significant gross-to-net sales adjustments described above, the Company periodically makes other sales adjustments. The Company generally accounts for these other gross-to-net adjustments by establishing an accrual in the amount equal to its estimate of the adjustments attributable to the sale.

The Company may at its discretion provide price adjustments due to various competitive factors, through shelf-stock adjustments on customers’ existing inventory levels. There are circumstances under which the Company may not provide price adjustments to certain customers and consequently, as a matter of business strategy, may lose future sales volume to competitors rather than reduce its pricing.

As detailed above, the Company has the experience and access to relevant information that it believes are necessary to reasonably estimate the amounts of such deductions from gross revenues. Some of the assumptions used by the Company for certain of its estimates are based on information received from third parties, such as wholesale customer inventories and market data, or other market factors beyond the Company’s control. The estimates that are most critical to the establishment of these reserves, and therefore, would have the largest impact if these estimates were not accurate, are estimates related to contract sales volumes, average contract pricing, customer inventories and return volumes. The Company regularly reviews the information related to these estimates and adjusts its reserves accordingly, if and when actual experience differs from previous estimates. With the exception of the product returns allowance, the ending balances of accounts receivable reserves and allowances generally are processed during a two-month to four-month period.

F-22


Use of Estimates in Reserves
The Company believes that its reserves, allowances and accruals for items that are deducted from gross revenues are reasonable and appropriate based on current facts and circumstances. It is possible, however, that other parties applying reasonable judgment to the same facts and circumstances could develop different allowance and accrual amounts for items that are deducted from gross revenues. Additionally, changes in actual experience or changes in other qualitative factors could cause the Company’s allowances and accruals to fluctuate, particularly with newly launched or acquired products. The Company reviews the rates and amounts in its allowance and accrual estimates on a quarterly basis. If future rates and amounts are significantly greater than those reflected in its recorded reserves, the resulting adjustments to those reserves would decrease the Company’s reported net revenues; conversely, if actual product returns, rebates and chargebacks are significantly less than those reflected in its recorded reserves, the resulting adjustments to those reserves would increase its reported net revenues. If the Company were to change its assumptions and estimates, its reserves would change, which would impact the net revenues that the Company reports. The Company regularly reviews the information related to these estimates and adjusts its reserves accordingly, if and when actual experience differs from previous estimates.

In February 2007 and in August 2007, the Company launched propranolol HCl ER and metoprolol succinate ER, respectively. As is customary and in the ordinary course of business, the Company’s first quarter shipments for propranolol and the third quarter shipments for metoprolol included initial trade inventory stocking that the Company believed was commensurate with new product introductions. At the time of each launch, the Company was able to make reasonable estimates of product returns, rebates, chargebacks and other sales reserves by using historical experience of similar generic product launches and significant existing demand for the products.

Major Customers
The amounts due from the Company’s four largest customers, McKesson Corporation, AmerisourceBergen Corporation, Cardinal Health Inc., and Walgreen Co., accounted for approximately 31%, 21%, 17%, and 7%, respectively, of the gross accounts receivable balance at December 31, 2007 and approximately 29%, 10%, 17%, and 14%, respectively, of the gross accounts receivable balance at December 31, 2006.

Other
In June 2007, the Company terminated the agreements related to certain cephalosporin and non-cephalosporin products. The Company wrote off certain receivable and inventory amounts totaling approximately $1.2 million in the second quarter of 2007, which was reflected as part of cost of goods sold.

Note 7 -Inventories:

   
December 31,
 
December 31,
 
   
2007
 
2006
 
           
Raw materials and supplies
 
$
22,815
 
$
32,713
 
Work-in-process
   
2,630
   
5,779
 
Finished goods
   
59,442
   
67,830
 
   
$
84,887
 
$
106,322
 
 
Inventory write-offs were $18.3 million and $24.4 million for the years ended December 31, 2007 and December 31, 2006, respectively. The Company capitalizes inventory costs associated with certain products prior to regulatory approval and product launch, based on management's judgment of reasonably certain future commercial use and net realizable value. The Company could be required to permanently write down previously capitalized costs related to pre-launch inventories upon a change in such judgment, or due to a denial or delay of approval by regulatory bodies, or a delay in commercialization, or other potential factors. As of December 31, 2007, the Company had inventories related to products that were not available to be marketed of $8.1 million, comprised of pre-launch inventories of $6.4 million and research and development inventories of $1.7 million.

F-23


Note 8 – Property, Plant and Equipment, net:

   
December 31,
 
December 31,
 
   
2007
 
2006
 
           
Land
 
$
1,882
 
$
1,888
 
Buildings 
   
25,947
   
27,372
 
Machinery and equipment
   
49,302
   
55,210
 
Office equipment, furniture and fixtures
   
5,476
   
6,524
 
Computer software and hardware
   
28,989
   
29,464
 
Leasehold improvements
   
14,865
   
15,393
 
Construction in progress
   
8,205
   
1,250
 
     
134,666
   
137,101
 
Less accumulated depreciation and amortization
   
52,016
   
47,946
 
   
$
82,650
 
$
89,155
 
 
Depreciation and amortization expense related to the property, plant and equipment was $13.2 million, $11.2 million and $9.4 million, for the years ended December 31, 2007, 2006 and 2005, respectively. In September 2007, the Company sold the assets related to its Somerset Facility for $1.5 million, which approximated its net book value.

Note 9 – Intangible Assets, net:
 
   
December 31,
 
December 31,
 
   
2007
 
2006
 
           
Trademark licensed from Bristol-Myers Squibb Company, net of accumulated amortization of $2,155 and $917
 
$
7,846
 
$
9,084
 
Teva Pharmaceutical Industries, Inc. Asset Purchase Agreement, net of accumulated amortization of $3,193 and $1,421
   
5,294
   
7,067
 
Ivax License Agreement, net of accumulated amortization of $5,068 and $1,845
   
2,932
   
6,155
 
Paddock Licensing Agreement, net of accumulated amortization of $1,250 and $250
   
4,750
   
5,750
 
Spectrum Development and Marketing Agreement, net of accumulated amortization of $0 and $0
   
5,000
   
5,000
 
Genpharm, Inc. Distribution Agreement, net of accumulated amortization of $6,860 and $6,138
   
3,973
   
4,695
 
Bristol-Myers Squibb Company Asset Purchase Agreement, net of accumulated amortization of $9,749 and $8,078
   
1,950
   
3,621
 
FSC Laboratories Agreement, net of accumulated amortization of $3,814 and $2,756
   
2,008
   
3,066
 
Intellectual property, net of accumulated amortization of $940 and $667
   
1,751
   
2,023
 
Other intangible assets, net of accumulated amortization of $4,693 and $3,229
   
555
   
1,419
 
   
$
36,059
 
$
47,880
 

Intangible assets include estimated fair values of certain distribution rights acquired by the Company for equity instruments or in legal settlements, amounts paid for contractual rights acquired by the Company to a process, product or other legal right having multiple or alternative future uses that support its realizability and intellectual property and are capitalized and amortized over the estimated useful lives in which the related cash flows are expected to be generated or on a straight-line basis over the products’ estimated useful lives of three to 15 years if estimated cash flows method approximates straight-line basis. The Company evaluates all intangible assets for impairment quarterly or whenever events or other changes in circumstances indicate that the carrying value of an asset may no longer be recoverable. As of December 31, 2007, the Company believes its net intangible assets are recoverable. The Company’s intangible assets included on its consolidated balance sheet at December 31, 2007 include the following:

Trademark licensed from BMS
The Company entered into an agreement with Mead Johnson & Company and BMS, dated August 6, 2003, to license the use of the MegaceÒ trademark in connection with a new product developed by the Company in exchange for $5.0 million paid by the Company in August 2003. In July 2005, the Company made an additional milestone payment of $5.0 million to BMS related to the trademark license above.

Teva Pharmaceutical Industries, Inc. Asset Purchase Agreement
In January 2006, the Company reached an agreement with Teva Pharmaceutical Industries, Inc. (“Teva”) and Ivax Corporation (“Ivax”) to purchase eight products that are currently marketed in the United States by Teva or Ivax for approximately $8.5 million.

F-24


Ivax License Agreement
In December 2005, the Company paid $8.0 million to purchase from Ivax the rights to distribute various dosage forms of the immediate release antibiotics amoxicillin/clavulanate potassium and amoxicillin. These products are to be supplied by a GlaxoSmithKline, plc (“GSK”) subsidiary and are fully substitutable for corresponding formulations of Augmentin®, Augmentin ES-600® and Amoxil®.

Paddock Licensing Agreement
In September 2006, the Company entered into a licensing agreement with developer Paddock Laboratories, Inc. (“Paddock”) to market testosterone gel 1%, a generic version of Unimed Pharmaceutical (“Unimed”), a wholly-owned subsidiary of Solvay Pharmaceuticals, Inc. (“Solvay”), product Androgel®. Androgel® is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Under the terms of the agreement with Paddock, the Company paid $6.0 million in the fourth quarter of 2006 for all rights to Paddock’s ANDA for testosterone gel 1%, including all intellectual property associated with the product. The license agreement also permits the Company to launch the generic version of the product no later than February 28, 2016, assuring the Company’s ability to market a generic version of Androgel® well before the expiration of the related patent issue. This license will be amortized over the six-year term of the associated co-promotion arrangement with Solvay.

Spectrum Development and Marketing Agreement
In November 2006, the Company and Spectrum Pharmaceuticals (“Spectrum”) amended their Development and Marketing Agreement (the “Marketing Agreement”). The Company agreed to purchase and distribute sumatriptan products and GSK supplied products on behalf of Spectrum. The Company paid Spectrum $5.0 million during the fourth quarter of 2006. Spectrum granted the Company an exclusive royalty-free irrevocable license to market, promote, distribute and sell sumatriptan products and GSK supplied product. This license will be amortized over a useful life of three years commencing with the launch of the product.

Genpharm Distribution Agreement
On June 30, 1998, the Company completed a strategic alliance with Merck KGaA, a pharmaceutical and chemical company located in Darmstadt, Germany. Pursuant to a Stock Purchase Agreement, dated March 25, 1998, the Company issued 10,400 shares of the Company’s common stock to a Merck KGaA subsidiary, EMD, Inc. (“EMD” formerly known as Lipha Americas, Inc.), in exchange for cash of $20.8 million and the exclusive U.S. distribution rights to a set of products covered by a distribution agreement with Genpharm (the “Genpharm Distribution Agreement”) (see Note 12 – “Distribution and Supply Agreements”). The Company determined the fair value of the common stock sold to Merck KGaA to be $27.3 million, which exceeded the cash consideration of $20.8 million received by the Company by $6.5 million. That $6.5 million was assigned to the Genpharm Distribution Agreement, with a corresponding increase in stockholders’ equity. Additionally, the Company recorded a deferred tax liability of approximately $4.3 million and a corresponding increase in the financial reporting basis of the Genpharm Distribution Agreement to account for the difference between the basis in the Genpharm Distribution Agreement for financial reporting and income tax purposes as required by SFAS No. 109, Accounting for Income Taxes. The aggregate amount of approximately $10.8 million assigned to the Genpharm Distribution Agreement is being amortized on a straight-line basis over 15 years.
 
BMS Asset Purchase Agreement
In March 2002, the Company entered into an agreement with BMS (the “BMS Asset Purchase Agreement”) and acquired the U.S. rights to five of BMS’s brand products. Pursuant to the BMS Asset Purchase Agreement, the Company terminated its outstanding litigation against BMS involving megestrol acetate oral suspension (Megace Oral SuspensionÒ) and buspirone (BusSparÒ) and paid BMS approximately $1.0 million in March 2002 and approximately $1.0 million in April 2003. The Company determined the fair value of the product rights received to be $11.7 million, which exceeded the cash consideration of approximately $2.0 million and associated costs of $0.6 million by approximately $9.0 million. The approximately $9.0 million value was assigned to the litigation settlements and included in settlement income in the first quarter of 2002. The fair value of the product rights received is being amortized on a straight-line basis over seven years, which period began in March 2002.

FSC Laboratories Agreement
In December 2004, the Company entered into an agreement with FSC and purchased the New Drug Application (“NDA”) for Isoptin® SR for $15.0 million. The Company and FSC also entered into an economic sharing agreement related to sales of Isoptin® SR and other verapamil hydrochloride sustained release products. In the fourth quarter of 2005, the Company recorded an impairment charge of approximately $9.2 million related to this intangible asset. The impairment charge was included in cost of goods sold. The Company introduced this product based on a projected market share of approximately 20%. Upon introduction, the two main competitors continually reduced their pricing in order to maintain their shares of the market. At the same time, the Company failed to capture any significant portion of the market. Based on the Company’s long-term projections for sales and gross margins of the drug, the Company determined the recoverability of this asset was impaired as of December 31, 2005. The fair market value as of December 31, 2005 of approximately $3.7 million was determined based on the discounted expected future cash flows of the asset.

F-25


Intellectual property
The intellectual property was acquired in the purchase of Kali in 2004 and is being amortized on a straight-line basis over its estimated useful life of ten years.

Other
During the first quarter of 2007, the Company made a $0.6 million milestone payment to Nortec Development, Inc. related to the commercialization of propranolol HCl ER that was recorded in other intangible assets.

In January 2006, the Company acquired the rights to three products for $1.5 million from Dr. Arie Gutman, president and chief executive officer of FineTech and a former member of the Board of Directors. The Company was marketing these products and Dr. Gutman was entitled to royalties under a prior agreement with FineTech.

In July 2004, the Company entered into a license agreement with NovaDel Pharma Inc. (“NovaDel”) whereby the Company has the exclusive rights to market, sell and distribute NovaDel’s nitroglycerin lingual spray, NitroMist®, in the United States and Canada. In November 2006, the FDA approved the nitroglycerin lingual spray and the Company paid NovaDel the $1.0 million milestone payment. The Company evaluated the potential market for this product and determined that the level of competition would not yield sufficient profits and that the product no longer fit the Company’s long-term strategy and therefore the Company recorded an impairment charge for approximately $1.0 million in the generic business during the fourth quarter of 2006.

In 2004, the Company acquired the rights to distribute Fluticasone in the U.S., including the Commonwealth of Puerto Rico for $2.0 million. GSK has agreed to manufacture Fluticasone and the Company will pay GSK a percentage of the Company’s net sales of the product.

The Company recorded amortization expense related to intangible assets of approximately $12.4 million, $11.4 million and $5.8 million, for 2007, 2006 and 2005, respectively and such expense is included in cost of goods sold. Amortization expense related to intangibles is expected to total approximately $12.2 million in 2008, $7.4 million in 2009, $6.8 million in 2010, $5.6 million in 2011, $3.3 million in 2012 and $0.8 million thereafter.

Note 10 – Goodwill:

On June 10, 2004, the Company acquired all of the capital stock of Kali, a generic pharmaceutical research and development company, for approximately $142.8 million in cash and warrants to purchase 150,000 shares of the Company’s common stock valued at approximately $2.5 million. The former Kali stockholders earned an additional $10.0 million for meeting certain product-related performance criteria. As of December 31, 2005, the former Kali stockholders had earned $5.0 million of these contingent payments which were included in the December 31, 2005 goodwill balance. In December 2006, the former Kali shareholders completed the performance criteria and earned the remaining $5.0 million, which the Company recorded as additional goodwill. This amount was subsequently paid in January 2007.

In accordance with SFAS 142, the goodwill which totaled $63,729 at December 31, 2007 and December 31, 2006 is not being amortized, but is tested at least annually, on or about December 31st or whenever events or changes in business circumstances necessitate an evaluation, for impairment using a fair value approach. Impairment of goodwill is determined to exist when the fair value is less than the carrying value of the net assets being tested. As of December 31, 2007, the Company determined through its estimates that no impairment of goodwill existed.

Note 11 – Research and Development Agreements:

To supplement its own internal development program, the Company seeks to enter into development and license agreements with third parties with respect to the development and marketing of new products and technologies. To date, the Company has entered into several of these types of agreements and advanced funds to several non-affiliated companies for products in various stages of development. Payments made related to these agreements have been expensed as incurred in accordance with the Company’s significant accounting policies. The Company believes that the following product development agreements are those that are the most significant to its business.
 
Generic Business Related
 
Aveva Drug Delivery Systems Inc. (formerly Elan Transdermal Technologies, Inc.)
In April 2001, the Company entered into a licensing agreement with Aveva Drug Delivery Systems Inc. (formerly Elan Transdermal Technologies, Inc.) (“Aveva”), a U.S. subsidiary of Nitto Denko, to market a clonidine transdermal patch, a generic version of Boehringer Ingelheim’s Catapres TTS®. Aveva filed an ANDA for the product with the FDA earlier in 2001, including a Paragraph IV certification, certifying that the product did not infringe the branded product’s formulation patent, which expired in May 2003. Under the agreement, Aveva is responsible for the development and manufacture of the product, while the Company is responsible for the marketing, sales and distribution. The Company has agreed to reimburse Aveva for research and development costs and Aveva will receive a royalty from the sale of the product. In addition, the Company has agreed to pay to Aveva $1.0 million upon FDA approval of the product, and a royalty on all future sales of the product.

F-26


In October 2007, the Company entered into a product development, manufacturing and supply agreement with Aveva under which the Company received an exclusive license to commercialize in the United States a generic drug product to be developed by Aveva. Under the terms of the agreement, the Company paid Aveva an initial development payment. The Company will also pay Aveva milestone payments if certain development milestones are achieved. The total milestone payments could be up to $2.2 million under the agreement. Aveva is responsible for all development costs, except for the bioequivalence costs which shall be equally shared with the Company. The Company incurred $0.7 million in 2007 which was charged to research and development expense. In addition, the Company has agreed to share profits on future sales of the product. The agreement is set for a ten year term from commercial launch of the product.

Actavis Group (formerly Abrika Pharmaceuticals) 
The Company executed a collaboration agreement with Abrika Pharmaceuticals (now Actavis Group ) in November 2004 for the development of four extended release generic products – Nifedipine XR (Addalat CC®), Methylphenidate LA (Ritalin LA®), Zolpidem CR (Ambien CR®) and Alfuzosin (Uroxatral®). Initial development costs included a down-payment of $0.4 million for each development project and if research and development costs exceeded $0.8 million, the Company would reimburse 50% of such developmental costs. The Company incurred approximately $2.2 million in 2007 which was charged to research and development expense. Alfuzosin and Nifedipine XL are to be developed and marketed by Actavis Group and Methylphenidate LA and Zolpidem CR will be marketed by the Company. The agreement is set for a fifteen year term from commercial launch. Net profits are to be split equally between the parties.

Intellipharmaceutics Corp
In November 2005, the Company executed a license and commercialization agreement with Intellipharmaceutics Corp. (“IPC”) for the development of Dexmethylphenidate XR (Focalin XR®). Initial development costs included a milestone payment of $0.25 million, paid in January 2006. Subsequent milestones for $0.25 million are payable upon passing all bioequivalence studies and another $0.25 million upon FDA’s acceptance for filing the ANDA. IPC is responsible for all development costs except for bioequivalence costs, API costs and scale up and stability costs. The Company incurred approximately $1.1 million in 2007 which was charged to research and development expense. Upon launch, IPC can earn up to a maximum of $2.5 million depending on the number of parties, generic equivalents and their introduction of the product during the first 180 days from launch. In addition the Company has agreed to share profits on all future sales of the product. The agreement is set for a ten year term from commercial launch of the product.

In December 2006, the Company executed a license and commercialization agreement with IPC for the development of one controlled release generic product. Initial development costs included a milestone payment of $0.5 million upon execution of the agreement. Subsequent milestones for $0.5 million is payable upon successful completion of all bioequivalence studies necessary for filing the ANDA, $0.5 million upon FDA’s acceptance for filing the ANDA and $0.5 million if IPC is first to file. IPC is responsible for all development costs except for bioequivalence costs, API costs and scale up and stability costs. The Company incurred approximately $1.7 million in 2007 which was charged to research and development. Upon launch, IPC can earn up to a maximum of $2.5 million depending on the number of parties, generic equivalents and their introduction of the product during the first 180 days from launch. In addition the Company has agreed to share profits on all future sales of the product. The agreement is set for a ten year term from commercial launch of the product.

In August 2007, the Company executed a license and commercialization agreement with IPC for the development of four controlled release generic products. Under the terms of this agreement, the Company made a $5.0 million private placement equity investment of which $2.5 million was charged to research and development expense. IPC is responsible for all development costs and expenses for the collaboration products except for bioequivalence costs, API costs and scale up and stability costs. In addition to the above mentioned $2.5 million, the Company incurred $0.3 million in 2007 which was charged to research and development. For each collaboration product which is first to file, the Company shall pay IPC either $0.5 million if the first to file applies to all strengths of the Brand product or the pro-rated portion corresponding to the number of strengths for which the first to file status applies. Upon launch, IPC can earn up to a maximum of $2.5 million depending on the number of parties, generic equivalents and their introduction of the product during the first 180 days from launch. In addition, the Company has agreed to share profits on future sales of the products. The agreement is set for a ten year term from commercial launch of the collaboration products.
 
SigmaPharm Laboratories, LLC
In August 2007, the Company entered into a product development agreement with SigmaPharm Laboratories, LLC (“SigmaPharm”) for the development of one generic product. The total milestone payments could be up to $1.5 million under the agreement. SigmaPharm is responsible for all development costs, except for bioequivalence costs and API costs. The Company incurred $0.5 million in 2007 which was charged to research and development expense. In addition, the Company has agreed to share profits on future sales of the product. The agreement is set for a fifteen year term from commercial launch of the product.

F-27


Cipla Limited
In December 2007, the Company executed a development and supply agreement with Cipla Limited (“Cipla”) for the development of one generic product. The total milestone payments could be up to $0.6 million under the agreement. The Company is responsible for the clinical costs, API costs, stability testing and process validation. The Company incurred $0.5 million in 2007 which was charged to research and development expense. The agreement is set for a ten year term from commercial launch of the product.
 
Strativa Business Related
BioAlliance Pharma SA
In July 2007, the Company announced it entered into an exclusive licensing agreement under which the Company will receive commercialization rights in the U.S. to BioAlliance Pharma's Loramyc (miconazole Lauriad®), an antifungal therapy currently in Phase III development for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immunocompromised patients, including those with HIV and cancer. Under the terms of the agreement, the Company paid BioAlliance an initial payment of $15.0 million. The Company will also pay BioAlliance $20.0 million upon FDA approval. In addition to royalties on sales, BioAlliance may receive milestone payments on future sales.
 
Hana Biosciences, Inc
In August 2007, the Company announced that it acquired the North American commercial rights to ZensanaTM (ondansetron HCl) Oral Spray from Hana Biosciences, Inc. (“Hana”). Ondansetron is used to prevent nausea and vomiting after chemotherapy, radiation and surgery. The terms of the agreement contain multiple elements, including a $5 million investment in Hana at a contractually agreed $1.2 million premium. The Company recorded its investment in Hana at $3.8 million based on the prevailing market price of Hana common stock at the date of the agreement and charged the $1.2 million, which represents a non-refundable upfront license payment, to research and development expense in the third quarter of 2007. In addition, Hana will receive milestone payments and royalties on future sales of ZensanaTM. The Company is responsible for all development costs. A subsequent milestone for $6.0 million is payable upon NDA approval by the FDA. In addition to the above mentioned $1.2 million the Company incurred $1.1 million in 2007 which was charged to research and development expense.
 
Optimer Pharmaceutical Corporation
In April 2005, the Company and Optimer entered into a joint development and collaboration agreement for an antibiotic compound (“PAR-101”). Under the terms of the joint development and collaboration agreement, Optimer agreed to fund all expenses associated with the clinical trials of PAR-101, while the Company would have been responsible for the clinical development, submission of the NDA and coordination of legal and regulatory responsibilities associated with PAR-101. In the event that PAR-101 was ultimately cleared for marketing, the Company would have manufactured and would have had exclusive rights to market, sell and distribute PAR-101 in the U.S. and Canada. The Company was to pay Optimer a royalty on sales of PAR-101 and also had an option to extend the agreement to include up to three additional drug candidates from Optimer. In February 2007, in exchange for $20.0 million, the Company terminated the agreement and returned the marketing rights to Optimer. The Company has the possibility to receive royalty payments on any future global sales of the product.

Immtech Pharmaceuticals, Inc.
In June 2007, the Company entered into an exclusive licensing agreement under which it received the U.S. commercialization rights to Immtech Pharmaceuticals’ lead oral drug candidate, pafuramidine maleate, for the treatment of pneumocystis pneumonia in AIDS patients. The Company made an initial payment of $3.0 million, with additional payments subject to pafuramidine advancing successfully through Phase III clinical trials and regulatory approval. In December 2007, Immtech announced that the pafuramidine program had been placed on clinical hold, due to preliminary findings of abnormal laboratory values found in several volunteers following treatment with pafuramidine in an ongoing safety study. In February 2008, Immtech announced that it had chosen to discontinue the development program for pafuramidine, due to additional reports of adverse events in several volunteers in the safety study. Due to Immtech’s termination of the development program, the Company has no further monetary obligations under the licensing agreement.
 
Note 12 – Distribution and Supply Agreements:
The Company enters into marketing and license agreements with third parties to market new products and technologies in an effort to broaden its product line. To date, the Company has entered into and is selling product through several of these agreements. The Company recognizes the expense associated with these agreements as part of cost of goods sold. The Company believes that the following agreements are those that are the most significant to its business.

Glaxo Wellcome Manufacturing PTE Limited (“GSK”)
On November 14, 2006, the Company and Glaxo GSK entered into a Supply and Distribution Agreement (the “GSK Ranitidine HCl Syrup Agreement”), pursuant to which the Company would market Ranitidine HCl Syrup, supplied and licensed from GSK. Ranitidine HCl Syrup is the generic equivalent to GSK’s Zantac® Syrup Product. Under the GSK Ranitidine HCl Syrup Agreement, GSK has agreed to manufacture the product and the Company has agreed to pay GSK a percentage of the Company’s net sales of the product, as defined in the agreement. The Company commenced sales of the product in March 2007 once another fully substitutable generic version of the drug became available in the U.S.

F-28


Nortec Development Associates, Inc. (“Nortec”)
On June 14, 2002, the Company and Nortec entered into a Patent and Know How License Agreement (the “Nortec Propranolol Agreement”) pursuant to which the Company would license to use and sell Nortec’s sustained release propranolol product using the Know-how to further develop and register the product. Propranolol HCl ER is the generic equivalent of Wyeth Pharmaceuticals’ Inderal® LA. Under the Nortec Propranolol Agreement, the Company will market, sell and distribute the product and will pay Nortec a percentage of the net sales, as defined in the agreement. The Company received final approval from the FDA in January 2007, at which time it commenced sales of the product.

AstraZeneca LP (“AstraZeneca”)
On August 10, 2006, the Company and AstraZeneca entered into a distribution agreement (“the AstraZeneca Agreement”), pursuant to which the Company is marketing Metoprolol Succinate (“Metoprolol”), supplied and licensed from AstraZeneca. Under this agreement, AstraZeneca has agreed to manufacture the product and the Company has agreed to pay AstraZeneca a percentage of the Company’s profit for the product, as defined in the agreement.

Ivax/Teva agreements
 In December 2005, the Company paid $8.0 million to purchase from Ivax the rights to distribute various dosage forms of the immediate release antibiotics amoxicillin/clavulanate potassium and amoxicillin. In December 2005, the Company also announced that it entered into agreements with Teva, Ivax and an affiliate of Teva to purchase eight products that were marketed in the United States by Ivax or Teva for $8.5 million. The closing of the purchase agreements was contingent upon the closing of Teva's acquisition of Ivax, which occurred in January 2006.

GlaxoSmithKline plc (“GSK”)
In December 2005, in conjunction with Ivax/Teva agreements, the Company was also assigned a supply agreement (the “GSK Amoxicillin Supply Agreement”) with GSK, dated June 22, 2004. Under the GSK Amoxicillin Supply Agreement, GSK has agreed to manufacture the product and the Company has agreed to pay GSK a percentage of the Company’s net sales of the product, as defined in the agreement.

On July 14, 2004, the Company and GSK and certain of its affiliates entered into a supply and distribution agreement (the “GSK Fluticasone Supply Agreement”), pursuant to which the Company is marketing Fluticasone, supplied and licensed from GSK, in the U.S., including the Commonwealth of Puerto Rico. Under the GSK Fluticasone Agreement, GSK has agreed to manufacture the product and the Company has agreed to pay GSK a percentage of the Company’s net sales of the product, as defined in the agreement.

The Company and GSK and certain of its affiliates entered into a license and supply agreement (the “GSK Paroxetine Supply Agreement”), dated April 16, 2003, pursuant to which the Company is marketing paroxetine, supplied and licensed from GSK, in the U.S., including the Commonwealth of Puerto Rico. Under the GSK Paroxetine Supply Agreement, GSK has agreed to manufacture the product and the Company has agreed to pay GSK a percentage of the Company’s net sales of the product, as defined in the agreement. Pursuant to the GSK Paroxetine Supply Agreement, GSK is entitled to suspend the Company’s right to distribute paroxetine if at any time another generic version of Paxil® is not being marketed. Effective January 15, 2007, the GSK Paroxetine Supply Agreement was terminated. The Company’s obligation to pay GSK a percentage of net sales of the product terminated on September 30, 2007.

Pentech Pharmaceuticals, Inc.
In November 2002, the Company amended its agreement (the “Pentech Supply and Marketing Agreement”) with Pentech Pharmaceuticals, Inc. (“Pentech”), dated November 2001, to market paroxetine capsules. Pursuant to the Pentech Supply and Marketing Agreement, the Company paid all legal expenses up to $2.0 million, which were expensed as incurred, to obtain final regulatory approval. Legal expenses in excess of $2.0 million were fully creditable against profit payments to Pentech. Pursuant to the Pentech Supply and Marketing Agreement, the Company had agreed to pay Pentech a percentage of the gross profits, as defined in such agreement, on all its sales of paroxetine. The Company and Pentech are currently in litigation regarding a dispute over the gross profit share amount. See Note 17 -“Commitments, Contingencies and Other Matters.”
 
Dr. Reddy’s Laboratories Ltd.
In April 2001, the Company and Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy”), a producer of bulk active ingredients for the pharmaceutical industry and a developer and manufacturer of finished dosage forms located in India, entered into a broad-based co-marketing and development agreement (the “Reddy Development and Supply Agreement”) covering up to 14 generic pharmaceutical products to be marketed exclusively by the Company in the U. S. and certain U.S. territories. Four products covered under this agreement are being marketed by the Company. Dr. Reddy is required to use commercially reasonable efforts to develop the products covered by the Reddy Development and Supply Agreement, and is responsible for the completion of product development and for obtaining all applicable regulatory approvals. The products covered by the Reddy Development and Supply Agreement are in addition to four products being marketed by the Company under prior agreements with Dr. Reddy. Pursuant to these agreements, the Company has agreed to pay Dr. Reddy a certain percentage of the gross profits, as defined in each agreement, on sales of products covered by such agreements.

F-29


Genpharm, Inc.
Pursuant to the Genpharm Distribution Agreement, the Company had the exclusive distribution rights within the U.S. and certain U.S. territories to approximately 40 generic pharmaceutical products. In August 2006, the Company and Genpharm entered into a settlement agreement and release of claims (“Settlement Agreement”), pursuant to which 19 products have been terminated. Refer to Note 17 below. To date, 14 of such remaining products have obtained FDA approval and are currently being marketed by the Company. The remaining products are either being developed, have been identified for development or have been submitted to the FDA for approval. Currently, there are five ANDAs for potential products (four of which have been tentatively approved) that are covered by the Genpharm Distribution Agreement pending with, and awaiting approval from, the FDA. Genpharm is required to use commercially reasonable efforts to develop the products and is responsible for the completion of product development and obtaining all applicable regulatory approvals. The Company has agreed to pay Genpharm a percentage of the gross profits, as defined in the agreement, on sales of products covered by the Genpharm Distribution Agreement.
 
Payables Due To Supply and Distribution Agreement Partners
Pursuant to these distribution agreements, the Company pays its partners a percentage of gross profits or a percentage of net sales, in accordance with contractual terms of the underlying agreements. As of December 31, 2007 and 2006, the Company had payables due to distribution agreement partners of $36.5 million and $89.6 million, respectively.

Note 13 – Short-Term and Long-Term Debt:

Short-Term Debt

Previously, the Company financed a portion of its insurance premiums and classified the amounts due as short-term debt. As of December 31, 2007 and 2006, the Company had recorded $0 and $4.4 million, respectively, as short-term debt related to financing these insurance premiums.
 
Long-Term Debt

   
December 31,
 
December 31,
 
   
2007
 
2006
 
Senior subordinated convertible notes (a)
 
$
200,000
 
$
200,000
 
Other (b)
   
-
   
65
 
   
$
200,000
   
200,065
 
Less current portion
   
(200,000
)
 
(200,065
)
 
   -  
$
-
 

 
(a)
Senior subordinated convertible notes in the aggregate principal amount of $200.0 million. The notes bear interest at an annual rate of 2.875%, payable semi-annually on March 30 and September 30 of each year. The notes are convertible into common stock at an initial conversion price of $88.76 per share, upon the occurrence of certain events. Upon conversion, the Company has agreed to satisfy the conversion obligation in cash in an amount equal to the principal amount of the notes converted. The notes mature on September 30, 2010, unless earlier converted, accelerated or repurchased.  The Company may not redeem the notes prior to their maturity date. On December 31, 2007, the senior subordinated convertible notes had a quoted market value of $180.8 million. See “Legal Proceedings” in Note 17 – “Commitments, Contingencies and Other Matters” for discussion involving notices of default and acceleration the Company received from the Trustee of the Company’s 2.875% Senior Subordinated Convertible Notes due 2010 and the subsequent related litigation. Until the matter is resolved, the Company is recording the payment obligations as a current liability because the Court in the matter could (i) rule against the Company’s position and (ii) determine that the appropriate remedy would be the accelerated payment of the Notes. Accordingly, the Company cannot consider the possibility of accelerated payment to be remote.

(b)
Includes primarily amounts due under capital leases for computer equipment.
 
During 2007, 2006 and 2005, the Company incurred interest expense of $6.8 million each fiscal year. Interest accrued on the senior subordinated convertible notes since September 30, 2007 is payable on March 31, 2008.

F-30


Note 14 – Earnings Per Share:

The following is a reconciliation of the amounts used to calculate basic and diluted earnings per share:

   
For the Years Ended December 31,
 
   
2007
 
2006
 
2005
 
               
Income from continuing operations
 
$
51,110
 
$
6,741
 
$
11,821
 
                     
Loss from discontinued operations
   
-
   
-
   
(4,957
)
Loss from disposal
   
-
   
-
   
(38,018
)
Provision for income taxes
   
1,212
   
894
   
3,220
 
Loss from discontinued operations
   
(1,212
)
 
(894
)
 
(46,195
)
Net income (loss)
 
$
49,898
 
$
5,847
 
$
(34,374
)
                     
Basic:
                   
Weighted average number of common shares outstanding
   
34,494
   
34,422
   
34,191
 
                     
Income from continuing operations
 
$
1.48
 
$
0.20
 
$
0.35
 
Loss from discontinued operations
   
(0.04
)
 
(0.03
)
 
(1.35
)
Net income (loss) per share of common stock
 
$
1.44
 
$
0.17
 
$
(1.00
)
                     
Assuming dilution:
                   
Weighted average number of common shares outstanding
   
34,494
   
34,422
   
34,191
 
Effect of dilutive securities
   
224
   
231
   
244
 
Weighted average number of common and common equivalent shares outstanding
   
34,718
   
34,653
   
34,435
 
                     
Income from continuing operations
 
$
1.47
 
$
0.19
 
$
0.35
 
Loss from discontinued operations
   
(0.04
)
 
(0.03
)
 
(1.35
)
Net income (loss) per share of common stock
 
$
1.43
 
$
0.16
 
$
(1.00
)
 
Outstanding options of 4,066, 4,950, and 3,612 as of December 31, 2007, 2006 and 2005, respectively, were not included in the computations of diluted earnings per share because their exercise prices were greater than the average market price of the common stock and would, therefore, have been anti-dilutive. In addition, outstanding warrants sold concurrently with the sale of the subordinated convertible notes and issued in conjunction with the acquisition of Kali were not included in the computation of diluted earnings per share as of December 31, 2007. The warrants related to the notes are exercisable for an aggregate of 2,253 shares of common stock at an exercise price of $105.20 per share and the warrants related to the Kali acquistion are exercisable for an aggregate of 150 shares of common stock at an exercise price of $47.00 per share. 

Note 15 – Stockholders’ Equity:

 Preferred Stock
In 1990, the Company’s stockholders authorized 6,000 shares of preferred stock, par value $0.0001 per share. The preferred stock is issuable in such classes and series and with such dividend rates, redemption prices, preferences, and conversion and other rights as the Board may determine at the time of issuance. At December 31, 2007 and 2006, the Company did not have any preferred stock issued and outstanding.

Dividends
The Company did not pay any dividends to holders of its common stock in 2007, 2006 or 2005. The Company has never declared or paid cash dividends on its common stock. The Company currently intends to retain its future earnings and available cash to fund the growth of its business and does not expect to pay dividends in the foreseeable future. However, payment of dividends is within the discretion of its Board of Directors.

F-31


Comprehensive income (loss)
 
   
For the Years Ended December 31,
 
   
2007
 
2006
 
2005
 
Net income (loss)
 
$
49,898
 
$
5,847
 
$
(34,374
)
                     
Other comprehensive gains (losses):
                   
Defined benefit pension plan, net of tax
   
-
   
267
   
(134
)
Unrealized gain (loss) on available for sale securities, net of tax
   
(931
)
 
1,205
   
(1,165
)
Other comprehensive gains (losses)
   
(931
)
 
1,472
   
(1,299
)
                     
Comprehensive income (loss)
 
$
48,967
 
$
7,319
 
$
(35,673
)

The following table summarizes the reclassification adjustments for gains (losses) on available for sale securities that were realized for each year and included in net income:

   
2007
 
2006
 
2005
 
Unrealized (loss) gain on marketable securities, net of tax
 
$
(1,912
)
$
3,171
 
$
8,603
 
Add: reclassification adjustment for net losses (gains) included in net income, net of tax
   
981
   
(1,966
)
 
(9,768
)
Net unrealized (loss) gain on marketable securities, net of tax
 
$
(931
)
$
1,205
 
$
(1,165
)

The reconciliation of the unrealized gains and losses on available for sale securities for years ended December 31, 2007 and 2006 is as follows:
 
   
Unrealized (Loss) / Gain on Available for Sale Securities
 
   
Before-Tax Amount
 
Tax Benefit (Expense)
 
Net-of-Tax Amount
 
Balance, December 31, 2005
 
$
(2,698
)
$
1,062
 
$
(1,636
)
Unrealized gain on available for sale securities
   
1,994
   
(789
)
 
1,205
 
Balance, December 31, 2006
 
$
(704
)
$
273
 
$
(431
)
Unrealized loss on available for sale securities
   
(1,500
)
 
569
   
(931
)
Balance, December 31, 2007
 
$
(2,204
)
$
842
 
$
(1,362
)
 
Treasury Stock
In April 2004, the Company’s Board of Directors (the “Board”) authorized the repurchase of up to $50.0 million of the Company’s common stock. The repurchases may be made, subject to compliance with applicable securities laws, from time to time in the open market or in privately negotiated transactions. Shares of common stock acquired through the repurchase program are and will be available for general corporate purposes. The Company had repurchased 849 shares of its common stock for approximately $32.2 million pursuant to the April 2004 authorization. On September 28, 2007, the Company announced that its Board approved an expansion of its share repurchase program allowing for the repurchase of up to $75.0 million of the Company’s common stock, inclusive of the $17.8 million remaining from the April 2004 authorization. The Company repurchased 1,643 shares of its common stock for approximately $31.4 million pursuant to the expanded program in 2007. The authorized amount remaining for stock repurchases under the repurchase program was $43.6 million, as of December 31, 2007. The repurchase program has no expiration date. 

Purchased Call Options
Concurrently with the sale of the subordinated convertible notes described above, the Company purchased call options on its common stock (the “purchased call options”) designed to mitigate the potential dilution from conversion of the convertible notes.  Under the terms of the purchased call options, the Company has the right to purchase the aggregate number of shares of its common stock that the Company would be obligated to issue upon conversion of the convertible notes, up to a maximum of 2,253 shares, from an affiliate of one of the initial purchasers (the “Counterparty”) at a purchase price of $88.76 per share, the initial conversion price of the notes.  The Company has the option to settle the purchased call options with the Counterparty through a net share settlement or net cash settlement, either of which would be based on the extent to which the then-current market price of the common stock exceeds $88.76 per share.  The cost of the purchased call options of $49,368 was charged to additional paid-in-capital on the Company’s consolidated balance sheets.  The cost of the purchased call options was partially offset by the sale of warrants to acquire shares of the common stock (the “sold warrants”) by the Counterparty. The sold warrants are exercisable for an aggregate of 2,253 shares at an exercise price of $105.20 per share.  The sold warrants may be settled, at the Company’s option, either through a net share settlement or a net cash settlement, either of which would be based on the extent to which the then-current market price of the common stock exceeds $105.20 per share.  The gross proceeds from the sold warrants of $32,563 were recognized as additional paid-in-capital on the Company’s consolidated balance sheets.  The net effect of the purchased call options and the sold warrants is to either reduce the potential dilution from the conversion of the convertible notes if the Company elects a net share settlement or to increase the net cash proceeds of the offering, if a net cash settlement is elected and the convertible notes are converted at a time when the market price of the common stock exceeds $88.76 per share. If the market price of the common stock at the maturity of the sold warrants exceeds $105.20, the dilution mitigation under the purchased call options will be capped, meaning that there would be dilution from the conversion of the convertible notes only to the extent that the then market price per share of the common stock exceeds $105.20 at the time of conversion.

F-32


Stock Options
The following is a summary of stock option activity in each of the periods as indicated:

   
For the Years Ended December 31,
 
   
2007
 
2006
 
2005
 
   
Shares
 
Weighted Average
 Exercise
Price
 
Shares
 
Weighted Average
Exercise
Price
 
Shares
 
Weighted Average
Exercise
Price
 
Outstanding at beginning of year
   
5,470
 
$
36.00
   
5,134
 
$
37.86
   
4,217
 
$
37.78
 
Granted
   
592
   
23.41
   
1,348
   
28.35
   
1,218
   
37.21
 
Exercised
   
(68
)
 
5.60
   
(402
)
 
21.26
   
(113
)
 
19.24
 
Canceled
   
(1,468
) (a)
 
36.16
   
(610
)
 
44.56
   
(188
)
 
43.08
 
Outstanding at end of year
   
4,526
 
$
34.76
   
5,470
 
$
36.00
   
5,134
 
$
37.86
 
 
(a) Includes approximately 181 stock options cash settled in the fourth quarter of 2007. Refer to Note 3 — “Share-Based Compensation.”
 
At December 31, 2007, 2006 and 2005, exercisable options amounted to 3,399, 3,549 and 3,392, respectively. The weighted average exercise prices of the options for these periods were $37.68, $38.33 and $39.37, respectively. Exercise price ranges and additional information regarding the 4,526 options outstanding at December 31, 2007 is as follows:

   
Outstanding Options
 
Exercisable Options
 
Exercise
 
Number
 
Weighted Average
 
Weighted Average
 
Number
 
Weighted Average
 
Price Range
 
of Options
 
Exercise Price
 
Remaining Life
 
of Options
 
Exercise Price
 
$4.13 to $7.63
   
172
 
$
6.81
   
2.8 years
   
172
 
$
6.81
 
$15.10 to $19.70
   
295
 
$
17.61
   
8.8 years
   
71
 
$
17.63
 
$20.00 to $25.00
   
494
 
$
23.17
   
9.1 years
   
35
 
$
23.99
 
$25.85 to $29.90
   
462
 
$
26.93
   
6.6 years
   
272
 
$
26.68
 
$30.55 to $34.29
   
1,797
 
$
31.80
   
5.4 years
   
1,651
 
$
31.71
 
$36.06 to $53.40
   
608
 
$
42.95
   
6.7 years
   
513
 
$
43.10
 
$60.85 to $71.01
   
698
 
$
62.75
   
6.0 years
   
687
 
$
62.78
 

In 2004, the Company’s stockholders approved the 2004 Performance Equity Plan (the “2004 Plan”) and in 2005 approved the amendment and restatement of the 2004 Plan. The 2004 Plan provides for the granting of incentive and non-qualified stock options, stock appreciation rights, restricted stock and restricted stock units or other stock based awards to employees of the Company or others. The 2004 Plan became effective on May 26, 2004 and will continue until May 26, 2014 unless terminated sooner. The Company has reserved up to 4,777 shares of common stock for issuance of stock options and up to 1,344 shares of common stock for issuance of restricted stock and restricted stock units under the 2004 plan as of December 31, 2007. Vesting and option terms are determined in each case by the Compensation and Management Development Committee of the Board. The maximum term of the stock options and the stock appreciation rights are ten years. The restricted stock and the restricted stock units vest over four years.

In 2001, the Company’s stockholders approved the 2001 Performance Equity Plan (the “2001 Plan”), which was subsequently amended at the Company’s 2003 Annual Meeting of Shareholders. The 2001 Plan provides for the granting of incentive and non-qualified stock options to employees of the Company and to others. The 2001 Plan became effective July 12, 2001 and will continue until July 11, 2011 unless earlier terminated. As of December 31, 2007, the Company has reserved 1,005 shares of common stock for issuance under the 2001 Plan. The maximum term of an option under the 2001 Plan is ten years. Vesting and option terms are determined in each case by the Compensation and Management Development Committee of the Board.

In 2000, the Board adopted the 2000 Performance Equity Plan (the “2000 Plan”), which plan was subsequently amended, making it a non-qualified, broad-based plan not subject to stockholder approval. The 2000 Plan provides for the granting of incentive and non-qualified stock options to employees of the Company and to others. The 2000 Plan became effective March 23, 2000 and will continue until March 22, 2010 unless earlier terminated. The Company has reserved 110 shares of common stock for issuance under the 2000 Plan as of December 31, 2007. The maximum term of an option under the 2000 Plan is ten years. Vesting and option terms are determined in each case by the Compensation and Management Development Committee of the Board. The maximum term of the option is reduced to five years if an incentive stock option is granted to a holder of more than 10% of the total combined voting power of all the classes of capital stock of the Company.

F-33


In 1998, the Company’s stockholders approved the 1997 Directors’ Stock Option Plan (the “1997 Directors’ Plan”), which was subsequently amended at the 2003 Annual Meeting of Stockholders and again at the 2007 Annual Meeting of Stockholders, pursuant to which options are granted to non-employee directors of the Company. The 1997 Directors’ Plan became effective October 28, 1997 and will continue until December 31, 2017 unless earlier terminated. Options granted under the 1997 Directors’ Plan become exercisable in full on the first anniversary of the date of grant, so long as the eligible director has not been removed “for cause” as a member of the Board on or prior to the first anniversary of the date of grant. The maximum term of an option under the 1997 Directors’ Plan is ten years. The 1997 Directors’ Plan also allows for the granting of restricted stock units that vest over 4 years. Pursuant to the amendment and restatement to the 1997 Directors’ Plan approved by the stockholders in 2007, non-employee directors, effective January 1, 2008, will receive an annual grant of restricted stock units equal to the fair market value of $100,000, which vest one year from the anniversary of the date of grant unless the director has been removed “for cause”. The restricted stock units are not issued or otherwise distributed to the director until the director terminates service on the Board. As of December 31, 2007, the Company has reserved 233 shares of common stock for issuance under the 1997 Directors’ Plan.  

Under all the Company’s stock option plans, the stock option exercise price of all the options granted equaled the market price on the date of grant.

In October 2004, the Board adopted a stockholder rights plan designed to ensure that all stockholders of the Company receive fair and equal treatment in the event of an unsolicited attempt to acquire the Company. The adoption of the rights plan is intended to deter partial and “two step” tender offers or other coercive takeover tactics, and to prevent an acquirer from gaining control of the Company without offering a fair price to all of the Company’s stockholders. The rights plan was not adopted in response to any known offers for the Company and is similar to stockholder rights plans adopted by many other public companies.
 
To implement the rights plan, the Board declared a distribution of one preferred stock purchase right per share of common stock, payable to all stockholders of record as of November 8, 2004. The rights will be distributed as a non-taxable dividend and expire on October 27, 2014. The rights will be evidenced by the underlying Company common stock, and no separate preferred stock purchase rights certificates will presently be distributed. The rights to acquire preferred stock are not immediately exercisable and will become exercisable only if a person or group acquires or commences a tender offer for 15% or more of the Company’s common stock.

If a person or group acquires or commences a tender offer for 15% or more of the Company’s common stock, each holder of a right, except the acquirer, will be entitled, subject to the Company’s right to redeem or exchange the right, to exercise, at an exercise price of $225, the right for one one-thousandth of a share of the Company’s newly-created Series A Junior Participating Preferred Stock, or the number of shares of the Company’s common stock equal to the holder’s number of rights multiplied by the exercise price and divided by 50% of the market price of the Company’s common stock on the date of the occurrence of such an event. The Board may terminate the rights plan at any time or redeem the rights, for $0.01 per right, at any time before a person or group acquires 15% or more of the Company’s common stock.

Note 16 – Income Taxes:

The components of the Company’s (benefit) provision for income taxes on income from continuing operations for the years ended December 31, 2007, 2006 and 2005 are as follows:

   
For the Years Ended December 31,
 
   
2007
 
2006
 
2005
 
Current income tax (benefit) provision:
                   
Federal
 
$
17,683
 
$
3,016
 
$
(4,197
)
State
   
1,292
   
2,476
   
(781
)
     
18,975
   
5,492
   
(4,978
)
Deferred income tax (benefit) provision:
                   
Federal
   
5,320
   
(1,301
)
 
(931
)
State
   
3,027
   
(2,137
)
 
183
 
     
8,347
   
(3,438
)
 
(748
)
   
$
27,322
 
$
2,054
 
$
(5,726
)

F-34


Deferred tax assets and (liabilities) as of December 31, 2007 and 2006 are as follows:

   
December 31,
 
December 31,
 
   
2007
 
2006
 
Deferred tax assets:
             
Accounts receivable
 
$
34,857
 
$
52,546
 
Inventories
   
7,990
   
9,133
 
Accrued expenses
   
-
   
2,109
 
Purchased call options
   
8,526
   
11,523
 
Intangible assets
   
33,556
   
29,153
 
Net operating loss carryforwards
   
6,751
   
4,297
 
Investments
   
2,226
   
275
 
Asset impairments
   
6,161
   
6,738
 
BMS asset purchase agreement
   
2,161
   
1,648
 
Stock options and restricted shares
   
13,449
   
10,535
 
Investment in joint venture
   
3,702
   
1,609
 
Deferred income
   
346
   
688
 
Other
   
7,969
   
2,703
 
Total deferred tax assets
   
127,694
   
132,957
 
               
Deferred tax liabilities:
             
Fixed assets
   
(5,633
)
 
(5,658
)
Distribution agreements
   
(1,510
)
 
(1,831
)
Total deferred tax liabilities
   
(7,143
)
 
(7,489
)
               
Less valuation allowance
   
(5,900
)
 
(3,818
)
Net deferred tax asset
 
$
114,651
 
$
121,650
 
 
The Company had net operating loss (“NOL”) carryforwards at December 31, 2007 of approximately $99 million for state income tax purposes, which begin expiring in 2010. A valuation allowance has been established due to the uncertainty of realizing certain NOL carryforwards. The valuation allowance, which consists of state NOLs, was increased in 2007 by $2.1 million for state NOL carryforwards which may not be realizable due to expected operations of certain subsidiaries in those states.
 
The exercise of stock options in 2007 and 2006 resulted in tax benefits of $501 and $741, respectively, which were credited to additional paid-in capital. In 2006, the Company recorded a credit of $2,495 in additional paid-in-capital due to the resolution of certain tax contingencies. In 2005, the Company recorded a tax benefit of $7,218 and recorded a credit in additional paid-in-capital of $16,819 due to the resolution of certain tax contingencies.  The Company has certain reserves for tax contingencies for other specified matters.

The table below provides reconciliation between the statutory federal income tax rate and the effective rate of income tax expense for each of the years shown as follows:

   
For the Years Ended December 31,
 
   
2007
 
2006
 
2005
 
Federal statutory tax rate
   
35
%
 
35
%
 
35
%
State tax – net of federal benefit
   
3
   
3
   
4
 
Research and development tax credit benefit
   
(2
)
 
(19
)
 
(3
)
Resolution of tax contingencies
   
-
   
-
   
(118
)
Other
   
(1
)
 
4
   
(12
)
                     
Effective tax rate
   
35
%
 
23
%
 
(94
)%

Tax Contingencies
 
At December 31, 2007, the total amount of gross unrecognized tax benefits (excluding the federal benefit received from state positions) was $24.1 million. Of this total, $11.3 million (net of the federal benefit on state issues) represents the amount of unrecognized tax benefits that, if recognized, would favorably affect the effective tax rate in future periods. The total amount of accrued interest and penalties resulting from such unrecognized tax benefits was $6.9 million at December 31, 2007 and $4.9 million at December 31, 2006.

Significant judgment is required in evaluating the Company’s tax positions and determining its provision for income taxes. During the ordinary course of business, there are many transactions and calculations for which the ultimate tax determination is uncertain. The Company establishes reserves for tax-related uncertainties based on estimates of whether, and the extent to which, additional taxes will be due. These reserves are established when the Company believes that certain positions might be challenged despite its belief that the Company’s tax return positions are fully supportable. The Company adjusts these reserves in light of changing facts and circumstances, such as the outcome of tax audits. The provision for income taxes includes the impact of reserve provisions and changes to reserves that are considered appropriate. Accruals for tax contingencies are provided for in accordance with the requirements of FIN 48. The Company has elected to retain its existing accounting policy with respect to the treatment of interest and penalties attributable to income taxes in accordance with FIN 48, and continues to reflect interest and penalties attributable to income taxes, to the extent they arise, as a component of its income tax provision or benefit as well as its outstanding income tax assets and liabilities.

F-35


A reconciliation of the beginning and ending amount of gross unrecognized tax benefits as of December 31, 2007 was as follows:
 
 
 
(In thousands)
 
 
 
 
 
Gross balance at January 1, 2007
 
$
21,768
 
Additions based on tax positions related to the current year
   
1,558
 
Additions for tax positions of prior years
   
824
 
Reductions for tax positions of prior years
   
-
 
Reductions due to lapse of applicable statute of limitations
   
-
 
Audit settlements paid during 2007
   
-
 
 
     
Gross balance at December 31, 2007
   
24,150
 
Interest and penalties
   
6,825
 
 
     
Balance at December 31, 2007
 
$
30,975
 

The Company recorded an adjustment to the gross balance of unrecognized tax benefits at January 1, 2007 of $12.3 million comprised of FIN 48 liabilities in connection with the restatement of income taxes on discontinued operations for the year ended December 31, 2005, as discussed in Note 1 – “Restatement of Previously Issued Financial Statements.” Previously the Company had reported $9.4 million as the gross balance of unrecognized tax benefits at January 1, 2007. Further, the Company is unaware of any positions for which it is reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the next twelve months.
 
The IRS is currently examining the Company’s 2003-2005 federal income tax returns. Prior periods have either been audited or are no longer subject to IRS audit. The Company is currently under audit in one state jurisdiction for the years 2003-2005. In most other state jurisdictions, the Company is no longer subject to examination by tax authorities for years prior to 2003.

Note 17 – Commitments, Contingencies and Other Matters:

 Leases
At December 31, 2007, the Company had minimum rental commitments aggregating $19.4 million under non-cancelable operating leases expiring through 2014. Amounts payable there under are $5.6 million in 2008, $5.1 million in 2009, $4.7 million in 2010, $2.1 million in 2011, $1.0 million in 2012 and $0.9 million thereafter. Rent expense charged to operations in 2007, 2006 and 2005 was $5.9 million, $6.1 million and $4.1 million, respectively.

Retirement Savings Plan
The Company has a Retirement Savings Plan (the “Retirement Savings Plan”) whereby eligible employees are permitted to contribute annually from 1% to 25% of their compensation to the Retirement Savings Plan. The Company contributes an amount equal to 50% of up to the first 6% of compensation contributed by the employee (“401(k) matching feature”). Participants in the Retirement Savings Plan become vested with respect to 20% of the Company’s contributions for each full year of employment with the Company and thus become fully vested after five full years. The Company also may contribute additional funds each year to the Retirement Savings Plan, the amount of which, if any, is determined by the Board in its sole discretion. The Company incurred expenses related to the 401(k) matching feature of the Retirement Savings Plan of $0.6 million in 2007, $1.2 million in 2006, and $1.0 million in 2005. The Company did not make a discretionary contribution to the Retirement Savings Plan for 2007 or 2006. The Company did make discretionary contributions to the Retirement Savings Plan of approximately $2.7 million for 2005.

Defined Benefit Plan
The Company maintained a defined benefit plan (the “Pension Plan”) that covered eligible employees, as defined in the Pension Plan. The Pension Plan has been frozen since October 1, 1989. Since the benefits under the Pension Plan are based on the participants’ length of service and compensation (subject to the Employee Retirement Income Security Act of 1974 and Internal Revenue Service limitations), service costs subsequent to October 1, 1989 are excluded from benefit accruals under the Pension Plan.

The Company, upon the recommendation of the Audit Committee of its Board, determined that it was in the best interests of the Company to terminate the Pension Plan, effective as of December 31, 2005, in accordance with its terms and conditions and with the rules and regulations promulgated by the Pension Benefit Guaranty Corporation and by the Internal Revenue Service.

F-36


The Pension Plan was settled in the second quarter of 2007. During the second quarter of 2007, the Company received a favorable determination on the termination of the Pension Plan from the Internal Revenue Service and filed the appropriate notice with the Pension Benefit Guaranty Corporation. Concurrent with the approval of the termination, the Company distributed benefits or purchased annuities to cover each of the participants in the Pension Plan. Finally, the Company met the advance notification requirements set forth in the Single-Employer Pension Plan Amendment Act of 1986 (the “SEPPAA”) and notified each party affected by this termination, as required by the SEPPAA. The Company recorded a loss of $0.09 million in the fourth quarter of 2006 related to the settlement. No further financial impacts are anticipated related to the settlement.
 
Legal Proceedings
 
Contractual Matters
 
On May 3, 2004, Pentech Pharmaceuticals, Inc. (“Pentech”) filed an action against the Company in the United States District Court for the Northern District of Illinois. This action alleges that the Company breached its contract with Pentech relating to the supply and marketing of paroxetine (PaxilÒ) and that the Company breached fiduciary duties allegedly owed to Pentech. The Company and Pentech are in dispute over the amount of gross profit share due to them. Discovery in this case has concluded. The Court denied cross motions for summary judgment relating to the construction of the contract, and denied Pentech’s motion for summary judgment against the Company’s fraudulent inducement counterclaim. The Company also filed a motion for summary judgment against Pentech’s breach of fiduciary duty claim, and that motion was granted. A trial date has not yet been set. The Company intends to defend vigorously this action.

Unless otherwise indicated in the details provided below, the Company cannot predict with certainty the outcome or the effects on the Company of the litigations described below. The outcome of these litigations could include substantial damages, the imposition of substantial fines, penalties, and injunctive or administrative remedies, however unless otherwise indicated, the Company at this time is not able to estimate the possible loss or range of loss, if any, associated with these legal proceedings.
 
Corporate Litigation
 
The Company and certain of its executive officers have been named as defendants in several purported stockholder class action lawsuits filed on behalf of purchasers of common stock of the Company between April 29, 2004 and July 5, 2006. The lawsuits followed the Company’s July 5, 2006 announcement regarding the restatement of certain of its financial statements and allege that the Company and certain members of its management engaged in violations of the Securities Exchange Act of 1934, as amended, by issuing false and misleading statements concerning the Company’s financial condition and results. The class actions have been consolidated and are pending in the United States District Court, District of New Jersey. The Court has appointed co-lead plaintiffs and co-lead counsel. Co-lead plaintiffs filed a Consolidated Amended Complaint on April 30, 2007, purporting to represent purchasers of common stock of the Company between July 23, 2001 and July 5, 2006. Defendants filed a motion to dismiss the Amended Complaint on June 29, 2007. The Company intends and the members of management named as defendants have stated their intentions to vigorously defend the lawsuits and any additional lawsuits that may hereafter be filed with respect to the restatement. Additionally, the Company has been informed by a letter from the Staff of the SEC dated July 7, 2006, that the SEC is conducting an informal investigation of the Company related to its restatement. The Company intends to fully cooperate with and assist the SEC in this investigation. The letter from the SEC states that the investigation should not be construed as an indication by the SEC or its Staff that any violation of law has occurred or as a reflection upon any person, entity or security. In addition, on September 6, 2006, in connection with this informal investigation, the SEC also requested certain information with respect to the Company’s internal review of its accounting for historical stock option grants. The Company has provided the information that the SEC has requested in December 2006. The SEC has not contacted the Company about its informal investigation since the Company filed its Annual Report on Form 10-K/A for 2005 on March 13, 2007.
 
On August 14, 2006, individuals claiming to be stockholders of the Company filed a derivative action in the U.S. District Court for the Southern District of New York, purportedly on behalf of the Company, against the current and certain former directors and certain current and former officers of the Company and the Company as a nominal defendant. The plaintiffs in this action allege that, among other things, the named defendants breached their fiduciary duties to the Company based on substantially the same factual allegations as the class action lawsuits referenced above. The plaintiffs also alleged that certain of the defendants have been unjustly enriched based on their receipt of allegedly backdated options to purchase shares of common stock of the Company, and seek to require those defendants to disgorge any profits made in connection with their exercise of such options and additional attendant damages relating to allegedly backdated options during the period from January 1, 1996 to the present. The action has been transferred to the United States District Court, District of New Jersey. On June 29, 2007, the plaintiffs filed their amended complaint and in connection therewith, dropped their claims related to alleged stock option backdating. Defendants have made a motion to dismiss the complaint, which motion has been fully briefed. The Company intends and each of the individuals named as defendants have stated their intentions to vigorously defend against the remaining allegations.

On September 1, 2006, the Company received a notice of default from the American Stock Transfer & Trust Company, as trustee (the “Trustee”) of the Company’s 2.875% Senior Subordinated Convertible Notes due 2010 (the “Notes”). The Trustee claims, in essence, that the Company’s failure to include financial statements in its Quarterly Report on Form 10-Q for the second quarter of 2006 constituted a default under Section 6.2 of the Indenture, dated as of September 30, 2003 (the “Indenture”), between the Company, as issuer, and the Trustee, relating to the Notes. The notice of default asserted that if the purported default continued unremedied for 30 days after the receipt of the notice, an “event of default” would occur under the Indenture. Under the Indenture, the occurrence of an event of default would give the Trustee or certain holders of the Notes the right to declare all unpaid principal and accrued interest on the Notes immediately due and payable. On October 2, 2006, the Company received a notice of acceleration from the Trustee purporting to accelerate payment of the Notes.

F-37


The Company believes that it has complied with its obligations under the Indenture relating to the Notes. Therefore, the Company believes that the above-mentioned notice of default and notice of acceleration are invalid and without merit. Under the Indenture, the Company is required only to provide the Trustee with copies of its annual and other reports (or copies of such portions of such reports as the SEC may by rules and regulations prescribe) that it is required to file with the SEC pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, within 15 calendar days after it files such annual and other reports with the SEC. Moreover, the Company’s Indenture specifically contemplates providing the Trustee with portions of reports. On August 24, 2006 (within 15 days of filing with the SEC), the Company provided to the Trustee a copy of its Quarterly Report on Form 10-Q for the second quarter of 2006. The Company’s Form 10-Q did not include the Company’s financial statements for the second quarter of 2006 and related Management’s Discussion and Analysis due to the Company’s work to restate certain of its past financial statements, and, therefore, in accordance with SEC rules, the Company filed a Form 12b-25 Notification of Late Filing disclosing the omissions. The Company’s Form 12b-25 also was provided to the Trustee on August 24, 2006. Accordingly, the Company believes that it complied with the Indenture provision in question.
 
After the Company communicated its position to the Trustee, the Trustee filed a lawsuit, on October 19, 2006, on behalf of the holders of the Notes in the Supreme Court of the State of New York, County of New York, alleging a breach of the Indenture and of an alleged covenant of good faith and fair dealing. The lawsuit demands, among other things, that the Company pay the holders of the Notes either the principal, any accrued and unpaid interest and additional interest (as such term is defined in the Indenture), if any, or the difference between the fair market value of the Notes on October 2, 2006 and par, whichever the Trustee elects, or in the alternative, damages to be determined at trial, alleged by the Trustee to exceed $30.0 million. The Company filed a Notice of Removal to remove the lawsuit to the U.S. District Court for the Southern District of New York and has filed its answer to the complaint in that Court. On January 19, 2007, the Trustee filed a motion for summary judgment along with supporting documentation. On February 16, 2007, the Company filed its response to the Trustee’s motion for summary judgment and cross-moved for summary judgment in its favor. The Court has not yet ruled on the motions. Until the matter is resolved, the Company is recording the payment obligations as a current liability on the condensed consolidated balance sheets because the Court in the matter could (i) rule against the Company’s position and (ii) determine that the appropriate remedy would be the accelerated payment of the convertible notes.

Patent Related Matters

On November 25, 2002, Ortho-McNeil Pharmaceutical, Inc. (“Ortho-McNeil”) filed a lawsuit against Kali, a wholly owned subsidiary of the Company, in the United States District Court for the District of New Jersey (the "2002 Litigation"). Ortho-McNeil alleged that Kali infringed U.S. Patent No. 5,336,691 (the “‘691 patent”) by submitting a Paragraph IV certification to the FDA for approval of tablets containing tramadol HCl and acetaminophen. Kali denied Ortho-McNeil’s allegation, asserting that the ‘691 patent was not infringed and is invalid and/or unenforceable, and that the lawsuit is barred by unclean hands. Kali also counterclaimed for declaratory judgments of non-infringement, invalidity and unenforceability of the ‘691 patent. Ortho-McNeil amended its complaint on July 27, 2005 to assert infringement against the Company, and to include a claim for damages against the Company and Kali. The Company and Kali have answered and counterclaimed, alleging that the ‘691 patent is not infringed, and is invalid and unenforceable for inequitable conduct. On August 1, 2006, the Patent and Trademark Office reissued the ‘691 patent as U.S. Patent No. RE 39,221 (the "'221 Patent"), containing original claim 6 from the '691 Patent and several additional new claims. On August 1 and August 4, 2006, Ortho-McNeil filed a complaint and then an amended complaint against Kali, the Company, and two other companies, Barr and Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”) (the "2006 Litigation"). Ortho-McNeil alleged infringement and willful infringement of the claims of the re-issue patent (other than claim 6, which is the subject of the 2002 Litigation) against the Company through the Company’s marketing of its tramadol HCl and acetaminophen tablets. Ortho-McNeil made similar allegations against Barr and Caraco. On April 4, 2007, the United States District Court for the District of New Jersey granted Kali's and the Company's motions for summary judgment that claim 6 of the '221 Patent, the only claim at issue in the 2002 Litigation, was invalid and was not infringed by the Company's ANDA product. Ortho-McNeil filed a motion requesting permission to immediately appeal this decision, and the Court denied Ortho-McNeil's motion and entered an order consolidating the 2002 and 2006 litigations. The Company has requested permission from the Court to file immediate summary judgment motions as to all of the remaining '221 Patent claims at issue, and also has requested that the Court proceed to trial on the Company's counterclaims for invalidity, unenforceability and intervening rights as to the '221 Patent. Ortho-McNeil has opposed the Company's requests, and the parties are awaiting a decision by the Court on these requests. On July 18, 2007, the Company entered into a settlement and license agreement with Ortho-McNeil that resolves patent litigation related to the Company’s sales of its generic tramadol HCl and acetaminophen product. Under the terms of the settlement, the Company will pay Ortho-McNeil a royalty on sales of its generic product commencing with sales from August 2006.  In accordance with the settlement and license agreement, the pending patent litigation between Ortho McNeil, the Company and Kali in the United States District Court for the District Court of New Jersey will be concluded. As part of the settlement, the Company is entering into a consent judgment on the validity, enforceability and infringement of the ‘221 Patent.

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On July 15, 2003, the Company filed a lawsuit against Roxane Laboratories, Inc. (“Roxane”) in the United States District Court for the District of New Jersey. The Company alleged that Roxane had infringed the Company’s U.S. Patents numbered 6,593,318 and 6,593,320 and that the infringement was willful. Roxane has denied these allegations and has counterclaimed for declaratory judgments of non-infringement and invalidity of both patents. On September 8, 2006, the Court issued a claim construction ruling on certain claim terms in dispute between the parties. Based on that construction, the Court ruled in favor of the Company and dismissed Roxane’s motion for summary judgment of non-infringement. On November 8, 2006, the Court ruled that the claims at issue in these patents were invalid as non-enabled on summary judgment. On December 8, 2006, the Company appealed the ruling to the Federal Circuit Court of Appeals, highlighting the district court’s failure to apply its own claim construction and to consider the testimony of the Company’s experts before awarding summary judgment to Roxane. On October 26, 2007, the U.S. Circuit Court of Appeals for the Federal Circuit affirmed the New Jersey District Court's ruling of invalidity for non-enablement. In January 2008, the District Court conducted a hearing on Roxane’s application for attorneys’ fees under 35 U.S.C. section 285. That issue is now being briefed.
 
On July 7, 2004, Xcel Pharmaceuticals, Inc. (now known as Valeant Pharmaceuticals, North America (“Valeant”)) filed a lawsuit against Kali Laboratories, Inc. (“Kali”), a wholly owned subsidiary of the Company, in the United States District Court for the District of New Jersey. Valeant alleged that Kali infringed U.S. Patent No. 5,462,740 (“the ‘740 patent”) by submitting a Paragraph IV certification to the FDA for approval of a generic version of Diastat brand of diazepam rectal gel. Kali has denied Valeant’s allegation, asserting that the ‘740 patent was not infringed and is invalid and/or unenforceable. Kali also has counterclaimed for declaratory judgments of non-infringement, invalidity and unenforceability of the ‘740 patent as well as a judgment that the ‘740 patent was unenforceable due to patent misuse. The parties conducted fact and expert discovery through April 2006. The parties submitted their proposed final pretrial order in June 2006 and appeared before the Court for pretrial conferences on June 13, 2006 and November 16, 2006. Under applicable law and regulations, the filing of the lawsuit triggered an automatic 30-month stay of FDA approval of Kali’s Abbreviated New Drug Application, or ANDA. That stay expired on November 29, 2006. The parties appeared before the Court for settlement conferences on May 17, 2007 and June 28, 2007. At the June 28 settlement conference the parties entered into an agreement in principle to settle the action. Immediately thereafter, the Court entered an order dismissing the action without prejudice to its being reinstated if the parties have not finalized their settlement agreement within 60 days. On October 16, 2007, the parties submitted a stipulated dismissal of the litigation which was entered on October 23, 2007, terminating the lawsuit. The settlement terms also permitted the Company, through its marketing partner Barr Laboratories, Inc., ("Barr") to introduce generic versions of the Diastat products on or after September 1, 2010. Profits from the sale of these products will be split between the Company and Barr.
 
On November 1, 2004, Morton Grove Pharmaceuticals, Inc. (“Morton Grove”) filed a lawsuit against the Company in the United States District Court for the Northern District of Illinois, seeking a declaratory judgment that four Company patents relating to megestrol acetate oral suspension are invalid, unenforceable and not infringed by a Morton Grove product that was launched in the fourth quarter of 2004. Morton Grove acknowledges that its product is covered by the Company’s patent claims. The Company asserted counterclaims that the Morton Grove product infringed three patents and that such infringement was willful. Morton Grove amended its complaint to allege antitrust violations. On November 29, 2007, a stipulated dismissal with prejudice was signed by the judge with each party only liable for its own costs and attorneys’ fees. 
 
In February 2006, the Company entered into a collaborative agreement with Spectrum Pharmaceuticals, Inc. (“Spectrum”) to develop and market generic drugs, including sumatriptan succinate injection. In 2004, Spectrum filed an ANDA containing a Paragraph IV certification with the FDA seeking marketing clearance for sumatriptan injection. On February 18, 2005, GlaxoSmithKline (“GSK”) filed a lawsuit against Spectrum in the United States District Court for the District of Delaware. GSK alleged that Spectrum’s October 2004 ANDA for sumatriptan succinate injection 6mg/0.5ml infringed GSK’s U.S. Patent No. 5,037,845 and that the infringement was willful. Spectrum denied the allegations and counterclaimed for declaratory judgments of invalidity, non-infringement and unenforceability. The non-infringement counterclaim was subsequently withdrawn. The lawsuit was resolved by settlement in November 2006. The confidential terms of the settlement, which remain subject to government review, permit the Company to sell generic versions of certain sumatriptan injection products with an expected launch no later than November 2008.
 
On March 10, 2006, Apotex Inc. and Apotex Corp. (“Apotex”) filed a lawsuit against the Company in the United States District Court for New Jersey, seeking a declaratory judgment that four of the Company’s patents relating to megestrol acetate oral suspension are invalid, unenforceable and not infringed by an Apotex product that was launched in the third quarter of 2006. The Company has moved for a preliminary injunction against Apotex pending resolution of the litigation and has asserted counterclaims that the Apotex product infringes at least one claim of U.S. Patent 6,593,318. The Company was granted a stay and the action was terminated without prejudice on April 9, 2007 pending final resolution of the Roxane appeal. On February 6, 2008, a joint stipulation of dismissal and order with prejudice was signed by the Judge in the case.

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On April 28, 2006, CIMA Labs, Inc. (“CIMA”) and Schwarz Pharma, Inc. (“Schwarz Pharma”) filed separate lawsuits against the Company in the United States District Court for the District of New Jersey (CIMA Labs, Inc. et al. v. Par Pharmaceutical Companies, Inc. et al., (Civil Action Nos. 06-CV-1970, 1999 (DRD)(ES)). CIMA and Schwarz Pharma each have alleged that the Company infringed U.S. Patent Nos. 6,024,981 (the “’981 patent”) and 6,221,392 (the “’392 patent”) by submitting a Paragraph IV certification to the FDA for approval of alprazolam orally disintegrating tablets. CIMA owns the ’981 and ’392 patents and Schwarz Pharma is CIMA’s exclusive licensee. The two lawsuits were consolidated on January 29, 2007. In response to the lawsuit, the Company has answered and counterclaimed denying CIMA’s and Schwarz Pharma’s infringement allegations, asserting that the ’981 and ’392 patents are not infringed and are invalid and/or unenforceable. The parties have exchanged written discovery. All 40 claims in the ’981 patent were rejected in a non-final office action in a reexamination proceeding at the United States Patent and Trademark Office (“PTO”) on February 24, 2006. The PTO again rejected all 40 claims in a second non-final office action dated February 24, 2007. The ‘392 patent is also the subject of a reexamination proceeding. The Company will continue to monitor these ongoing reexamination proceedings. CIMA has moved to stay this lawsuit pending the outcome of the reexamination proceedings and to consolidate this lawsuit with another lawsuit in the same district involving the same patents (CIMA Labs, Inc. et al. v. Actavis Group hf et al., (Civil Action No. 07-CV-0893 (DRD) (ES)). A hearing on these motions was held on May 30, 2007. The Company intends to vigorously defend this lawsuit and pursue its counterclaims.
 
The Company entered into a licensing agreement with developer Paddock Laboratories, Inc. (“Paddock”) to market testosterone 1% gel, a generic version of Unimed Pharmaceuticals, Inc.’s (“Unimed”) product Androgel®. Pursuant to this agreement, the Company is responsible for management of any litigation and payment of all legal fees associated with this product. The product, if successfully brought to market, would be manufactured by Paddock and marketed by the Company. Paddock has filed an ANDA (that is pending with the FDA) for the testosterone 1% gel product. As a result of the filing of the ANDA, Unimed and Laboratories Besins Iscovesco (“Besins”), co-assignees of the patent-in-suit, filed a lawsuit against Paddock in the United States District Court for the Northern District of Georgia, alleging patent infringement on August 22, 2003. The Company has an economic interest in the outcome of this litigation by virtue of its licensing agreement with Paddock. Unimed and Besins sought an injunction to prevent Paddock from manufacturing the generic product. On November 18, 2003, Paddock answered the complaint and filed a counterclaim, seeking a declaration that the patent-in-suit is invalid and/or not infringed by Paddock’s product. On September 13, 2006, the Company acquired from Paddock all rights to the ANDA for testosterone 1% gel, a generic version of Unimed’s product Androgel® for $6 million. The lawsuit was resolved by settlement. The settlement and license agreement terminates all on-going litigation. The settlement and license agreement also permits the Company to launch the generic version of the product no later than February 28, 2016, assuring the Company’s ability to market a generic version of Androgel® well before the expiration of the patents at issue. On March 7, 2007, the Company was issued a Civil Investigative Demand seeking information and documents in connection with the court-approved settlement in 2006 of the patent infringement case, Unimed v. Paddock, in the U.S. District Court for Northern District of Georgia. The Bureau of Competition for the Federal Trade Commission (“FTC”) is investigating whether the settlement of the litigation constituted unfair methods of competition in a potential violation of Section 5 of the FTC Act. The Company believes it has complied with all applicable laws in connection with the court-approved settlement and it intends to co-operate with the FTC in this matter.
 
On October 4, 2006, Novartis Corporation, Novartis Pharmaceuticals Corporation, and Novartis International AG (collectively “Novartis”) filed a lawsuit against the Company in the United States District Court for the District of New Jersey. Novartis alleged that the Company and Kali infringed U.S. Patent No. 6,162,802 (the “’802 patent”) by submitting a Paragraph IV certification to the FDA for approval of amlodipine and benazepril hydrochloride combination capsules. The Company and its subsidiaries denied Novartis’ allegation, asserting that the ’802 patent is not infringed and is invalid. The Company also counterclaimed for declaratory judgments of non-infringement and invalidity of the ’802 patent. The parties are currently engaged in discovery regarding the claims. The Company intends to defend vigorously this action and pursue its counterclaims against Novartis.
 
On December 19, 2006, Reliant Pharmaceuticals, Inc. (“Reliant”) filed a lawsuit against the Company in the United States District Court for the District of Delaware (Reliant Pharmaceuticals, Inc. v. Par Pharmaceutical Inc., (Civil Action Nos. 06-CV-774-JJF)). Reliant alleged, in its Complaint, that the Company infringed U.S. Patent No. 5,681,588 (the “’588 patent”) by submitting a Paragraph IV certification to the FDA for approval to market generic 325 mg Propafenone HCl SR capsules. On January 26, 2007, Reliant amended its complaint to add the additional allegation that the Company infringed the ‘588 patent by submitting a Paragraph IV certification to the FDA for approval to market generic 225 mg and 425 mg—in addition to the 325 mg—Propafenone HCl SR capsules. The Company has answered and counterclaimed denying Reliant’s infringement allegations, and asserting that the ’588 patent is invalid and unenforceable. A scheduling order has been entered under which all fact and expert discovery will be completed by May 30, 2008. The parties have begun discovery and Reliant has filed a motion to disqualify the Company’s counsel, a motion that was denied in September 2007 with ongoing written discovery on the issue. The Company intends to vigorously defend this lawsuit and pursue its counterclaims.
 
On April 10, 2007, Abbott Laboratories (“Abbott”) and Astellas Pharma Inc. (“Astellas”), filed an amended complaint against the Company and six other defendants, seeking judgment alleging that U.S. Patent Nos. 4,599,334 (the “’334 patent”) and 4,935,507 (the “’507 patent”) are, or will be, infringed by the defendants’ planned production of cefdinir products. The Company denied Abbott and Astellas’ allegations, asserting that the ’334 and ’507 patents are not infringed and are invalid. The Company counterclaimed for declaratory judgments of non-infringement and invalidity of the patents. On September 27, 2007, the Company's motion for stipulated substitution of Orchid Chemicals & Pharmaceuticals Ltd for the Company was entered and the Company's involvement in the case was terminated.

F-40


On May 9, 2007, Purdue Pharma Products L.P., Napp Pharmaceutical Group Ltd., Biovail Laboratories International SRL, and Ortho-McNeil, Inc. filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent No. 6,254,887 (the “’887 patent”) because the Company submitted a Paragraph IV certification to the FDA for approval of 200mg extended release tablets containing tramadol hydrochloride. On May 30, 2007, the Company filed its answer and counterclaim to the complaint seeking a declaration of noninfringement and invalidity of the '887 patent. A subsequent complaint was served on July 2, 2007 in the same District Court. The new complaint alleges that the Company's 100mg and 200mg extended release tablets containing tramadol hydrochloride infringe the ‘887 patent. The Company filed its answer and counterclaim on July 23, 2007 and will assert all available defenses in addition to seeking a declaration of noninfringement and invalidity of the '887 patent. On October 24, 2007, plaintiffs filed an amended complaint in the Delaware District Court in view of the Company's amendment of its ANDA to include the 300 mg strength of extended release tramadol. The Company filed its answer and counterclaims on November 13, 2007. It is anticipated that fact discovery will be completed in May 2008, and expert discovery completed in August 2008 with a trial date set for October/November of 2008. The Company intends to defend this action vigorously and pursue its counterclaims against Purdue, Napp, Biovail and Ortho-McNeil. 
 
On July 6, 2007, Sanofi-Aventis and Debiopharm, S.A. filed a lawsuit against the Company and its development partner, MN Pharmaceuticals ("MN"), in the United States District Court for the District of New Jersey. The complaint alleges infringement of U.S. Patent Nos. 5,338,874 and 5,716,988 because the Company and MN submitted a Paragraph IV certification to the FDA for approval of 50 mg/10ml, 100 mg/20 ml, and 200 mg/40 ml oxaliplatin by injection. The Company and MN filed their answer and counterclaims on October 10, 2007. On January 14, 2008, following MN's amendment of its ANDA to include oxaliplatin injectable 5 mg/ml, 40 ml vial, Sanofi-Aventis filed a complaint asserting infringement of the '874 and the '998 patents. The Company has not yet answered this complaint. The Company and MN intend to defend these actions vigorously and pursue their counterclaims against Sanofi and Debiopharm. 
 
On September 21, 2007, Sanofi-Aventis and Sanofi-Aventis U.S., LLC (“Sanofi-Aventis”) filed a lawsuit against the Company and its development partner, Actavis South Atlantic LLC ("Actavis"), in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent Nos. 4,661,491 and 6,149,940 because the Company and Actavis submitted a Paragraph IV certification to the FDA for approval of 10 mg alfuzosin hydrochloride extended release tablets. The Company filed its answer and counterclaims on October 24, 2007. The Company filed its amended answer and counterclaims on November 19, 2007. The Company intends to defend this action vigorously and pursue its counterclaims against Sanofi-Aventis.
 
On October 1, 2007, Elan Corporation, PLC filed a lawsuit against the Company and its development partner, IntelliPharmaCeutics Corp., and IntelliPharmaCeutics Ltd. ("IPC") in the United States District Court for the District of Delaware. On October 5, 2007, Celgene and Novartis filed a lawsuit against IPC in the United States District Court for the District of New Jersey. The complaint in the Delaware case alleged infringement of U.S. Patent Nos. 6,228,398 and 6,730,325 because the Company submitted a Paragraph IV certification to the FDA for approval of 5, 10, 15, and 20 mg dexmethylphenidate hydrochloride extended release capsules. Elan filed an amended Complaint on October 15, 2007. The original complaint in the New Jersey case alleged infringement of U.S. Patent Nos. 6,228,398; 6,730,325; 5,908,850; 6,355,656; 6,528,530; 5,837,284; and 6,635,284 because the Company and IPC submitted a Paragraph IV certification to the FDA for approval of 5, 10, 15, and 20 mg dexmethylphenidate extended release capsules. The Company and IPC filed their answer and counterclaims in the Delaware case on November 19, 2007. Celgene and Novartis filed an amended complaint on October 15, 2007 and the Company and IPC filed their answer and counterclaims in the New Jersey case on November 20, 2007. The Company and IPC filed an amended answer in Delaware December 12, 2007, and Elan filed their answer and motion to consolidate the cases on January 2, 2008. The Company intends to defend these actions vigorously and pursue its counterclaims against Elan, Celgene and Novartis.
 
On September 13, 2007, Santarus, Inc. (“Santarus”), and The Curators of the University of Missouri (“Missouri”) filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent Nos. 6,699,885; 6,489,346; and 6,645,988 because the Company submitted a Paragraph IV certification to the FDA for approval of 20 mg and 40 mg omeprazole/sodium bicarbonate capsules. The Company filed its answer and counterclaims on October 17, 2007. The Company intends to defend this action vigorously and pursue its counterclaims against Santarus and Missouri. 
 
On December 11, 2007, AstraZeneca Pharmaceuticals, LP, AstraZeneca UK Ltd., IPR Pharmaceuticals, Inc. and Shionogi Seiyaku Kabushiki Kaisha filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges patent infringement because the Company submitted a Paragraph IV certification to the FDA for approval of 5 mg, 10 mg, 20 mg and 40 mg rosuvastatin calcium tablets. The Company filed its answer and counterclaims on January 31, 2008. The Company intends to defend these actions vigorously and pursue its counterclaims against AstraZeneca Pharmaceuticals, LP, AstraZeneca UK Ltd., IPR Pharmaceuticals, Inc. and Shionogi Seiyaku Kabushiki Kaisha. 
 
On December 20, 2007, Santarus, Inc., and The Curators of the University of Missouri (“Missouri”) filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent Nos. 6,699,885; 6,489,346; 6,780,882; and 6,645,988 because the Company submitted a Paragraph IV certification to the FDA for approval of 20 mg and 40 mg omeprazole/sodium bicarbonate powders for oral suspension. The Company filed its answer on January 10, 2008 and filed its amended answer and counterclaims on January 30, 2008. The Company intends to defend this action vigorously against Santarus and Missouri.

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Industry Related Matters

On September 10, 2003, the Company and a number of other generic and brand pharmaceutical companies were sued by Rockland County in New York State (the suit has since been joined by additional New York counties) that has alleged violations of laws (including the Racketeer Influenced and Corrupt Organizations Act, common law fraud and obtaining funds by false statements) related to participation in the Medicaid program. The complaint seeks declaratory relief; actual, statutory and treble damages, with interest; punitive damages; an accounting and disgorgement of any illegal profits; a constructive trust and restitution; and attorneys’ and experts’ fees and costs. On August 4, 2004, the Company and a number of other generic and brand pharmaceutical companies were also sued by the City of New York, which has alleged violations of laws (including common law fraud and obtaining funds by false statements) related to participation in its Medicaid program. On June 15, 2005, a consolidated complaint was filed on behalf of a number of the New York counties and the City of New York. This case was transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. The complaint filed by Erie County in New York was not included in the consolidated complaint and has been removed to federal district court. In addition, on September 25, 2003, the Office of the Attorney General of the Commonwealth of Massachusetts filed a complaint in the District of Massachusetts against the Company and 12 other leading generic pharmaceutical companies, alleging principally that the Company and such other companies violated, through their marketing and sales practices, state and federal laws, including allegations of common law fraud and violations of Massachusetts false statements statutes, by inflating generic pharmaceutical product prices paid for by the Massachusetts Medicaid program. The complaint seeks injunctive relief, treble damages, disgorgement of excessive profits, civil penalties, reimbursement of investigative and litigation costs (including experts’ fees) and attorneys’ fees. On January 29, 2004, the Company and the other defendants involved in the litigation brought by the Office of the Attorney General of the Commonwealth of Massachusetts filed a motion to dismiss, which was denied on August 15, 2005. The Commonwealth of Massachusetts subsequently filed an amended complaint, and the defendants, including the Company, have filed a motion to dismiss the amended complaint. In addition to Massachusetts, the Commonwealth of Kentucky, the State of Illinois and the State of Alabama have filed similar suits in their respective jurisdictions, all of which have been removed to federal district court. The lawsuit brought by the State of Alabama was remanded to the Alabama state court on August 11, 2005. Following the remand, on October 13, 2005, the Court denied the defendants’ motion to dismiss, but granted in part the defendants’ motion for a more definite statement, and further ruled that the State may amend its complaint within 90 days. On October 20, 2005, the State of Mississippi filed in the Chancery Court for Hinds County, Mississippi a complaint naming the Company (among other companies) as a defendant. The Company intends to defend vigorously these actions.

On April 27, 2006, the State of Hawaii filed a complaint naming the Company as a defendant that has alleged violations of laws related to participation in the Medicaid program. The Hawaii complaint pleads causes of action for (i) false claims; (ii) unfair or deceptive acts or practices; (iii) unfair competition; (iv) violation of the Deceptive Trade Practices Act; (v) non-disclosure; and (vi) unjust enrichment. The complaint seeks general and special damages; treble damages, or in the alternative, punitive damages; costs, pre-judgment and post-judgment interest, and attorneys’ fees; injunctive relief; and such other and further relief or equitable relief as the Court deems just and proper. The Company intends to defend this action vigorously.
 
On May 8, 2006, the County of Oswego filed a complaint against the Company and certain other pharmaceutical companies. This complaint pleads causes of action for (i) fraud; (ii) violation of New York Social Services Law § 366-b; (iii) violation of New York Social Services Law § 145-b; (iv) violation of New York General Business Law § 349; (v) unjust enrichment; and (vi) fraudulent concealment. The County of Schenectady filed a similar complaint on May 9, 2006. The Company intends to defend these actions vigorously.
 
With respect to the Erie action, on September 7, 2006, the New York Supreme Court for the County of Erie granted the defendants' joint motion to dismiss in part and denied it in part. The defendants then removed the Erie action for a second time to the United States District Court for the Western District of New York on October 11, 2006, and the case was subsequently transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. A motion to remand to State Court is currently pending.
 
The County of Nassau, New York filed a Second Amended Complaint in its action against a number of other generic and brand pharmaceutical companies, naming the Company as a defendant on January 30, 2006. The case has been consolidated, for purposes of discovery and briefing, with the action filed by a number of other New York counties and the City of New York. The matters are presently in the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. On March 3, 2006, the Company and the other defendants filed motions to dismiss the Second Amended Complaint filed by Nassau County and the consolidated complaint brought by the other counties and the City of New York. These motions were granted in part and denied in part on April 2, 2007. On June 8, 2007, the City of New York and various other New York counties, this time including Nassau County, filed a First Amended Consolidated Complaint. On June 22, 2007, the defendants filed a joint motion to dismiss the First Amended Consolidated Complaint. The Court granted the defendants' motion in part and denied it in part on July 30, 2007. On October 5, 2007, the City of New York and various other New York counties filed a Revised First Amended Consolidated Complaint, which the Company answered on October 26, 2007.
 
With respect to the Oswego and Schenectady matters, the cases have been transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. On September 17, 2007, the United States District Court for the District of Massachusetts granted the motions filed by Erie, Oswego, and Schenectady Counties to remand their respective cases to New York state court. Each of these three matters was subsequently remanded to the New York Supreme Courts for the Counties of Erie, Oswego, and Schenectady, respectively. On November 28, 2007, the defendants filed a joint motion, with the State of New York Litigation Coordinating Panel, to coordinate the three actions. This motion is currently pending.

F-42

 
The Company's motion to dismiss the Commonwealth of Massachusetts' First Amended Complaint was denied on August 15, 2005. The Company answered the Commonwealth's First Amended Complaint on November 14, 2005.
 
With respect to the Alabama action, the Company filed an answer to the Second Amended Complaint on January 30, 2006. On October 11, 2006, the defendants for the second time removed the case to the United States District Court for the Middle District of Alabama. On November 2, 2006, the matter was again remanded to State court. Certain defendants, including the Company, filed motions in September 2006 to sever or for separate trials. The trial court denied these motions. On June 1, 2007, upon the petitions of certain defendants, including the Company, the Supreme Court of Alabama granted a writ of mandamus and ordered the trial court to sever the claims against all defendants.
 
With respect to the Illinois action, the United States District Court for the District of Massachusetts granted the State of Illinois's motion to remand on September 17, 2007. The case was remanded to the Circuit Court of Cook County, Illinois. On November 19, 2007, certain defendants, including the Company, filed a new joint motion to dismiss the First Amended Complaint. This motion is currently pending.
 
The court denied the defendants’ motions to dismiss in the action brought by the Commonwealth of Kentucky on June 23, 2006. The Company answered the First Amended Complaint on July 19, 2006. The Commonwealth of Kentucky filed a Second Amended Complaint on September 28, 2007. The Company answered the Second Amended Complaint on October 15, 2007.
 
With respect to the Mississippi action, the Special Masters assigned to the case recommended the denial of the defendants' motion to dismiss on September 22, 2006. On October 2, 2006, the defendants objected to the Special Masters' recommendation. The Court had not ruled on this objection at the time the case was removed to federal district court. Also, after removal, the matter was transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings, where the State's motion to remand is pending. The case was remanded to the Chancery Court of Hinds County, Mississippi. On December 13, 2007, the Court denied the defendants’ pending motion to dismiss. The defendants appealed the trial court's decision to the Supreme Court of Mississippi on January 3, 2008. This appeal is currently pending.
 
With respect to the Hawaii matter, the State's motion to remand the action was granted on November 30, 2006. On January 12, 2007, the defendants filed a joint motion to dismiss the State's First Amended Complaint. This motion was denied on April 11, 2007, and the Company answered the First Amended Complaint on April 23, 2007.
 
The State of Alaska filed an Amended Complaint on October 17, 2006, naming the Company and other pharmaceutical companies as defendants. The Alaska complaint pleads causes of action for (i) violation of the Alaska Unfair Trade Practices and Consumer Protection Act and (ii) unjust enrichment. The complaint seeks monetary damages; declarative relief; injunctive relief; compensatory, restitution, and/or disgorgement damages; civil penalties; punitive damages; costs, attorneys' fees, and prejudgment interest; and other relief deemed just and equitable by the Court. The defendants filed a joint motion to dismiss the State's Amended Complaint on January 5, 2007. This motion was denied on May 7, 2007. The Company intends to defend this action vigorously.
 
The State of South Carolina filed two related actions against the Company and other pharmaceutical companies on December 1, 2006. One of these Complaints seeks relief on behalf of the South Carolina Medicaid Agency and the other seeks relief on behalf of the South Carolina State Health Plan. Both South Carolina Complaints plead causes of action for (i) violation of the South Carolina Unfair Trade Practices Act; (ii) unjust enrichment; and (iii) injunctive relief. Both Complaints seek monetary damages and prejudgment interest; treble damages, attorneys' fees, and costs; civil penalties; disgorgement; injunctive relief; and other relief deemed just and equitable by the Court. On January 26, 2007, the Company moved to dismiss each Complaint or, in the alternative, for a more definite statement with respect to each Complaint. These motions are currently pending.
 
The State of Idaho filed a Complaint against the Company and various other pharmaceutical companies on January 26, 2007. The Idaho Complaint pleads causes of action for (i) violation of the Idaho Consumer Protection Act; and (ii) unjust enrichment. The State seeks declaratory and injunctive relief; monetary damages; civil penalties; disgorgement; attorneys' fees and costs; and other relief deemed just and equitable by the Court. On March 30, 2007, the defendants filed a joint motion to dismiss the State's Complaint. On August 31, 2007, the Court granted in part the defendants' joint motion to dismiss and denied it in part. On October 1, 2007, the Company answered the State's Complaint.
 
On April 5, 2007, the County of Orange, New York, filed a Complaint against the Company and various other pharmaceutical companies. The Orange County Complaint pleads causes of action for (i) violations of the Racketeer Influenced and Corrupt Practices Act; (ii) violation of various federal and state Medicaid laws; (iii) unfair trade practices; and (iv) common law claims for breach of contract, unjust enrichment, fraud, and fraudulent concealment. The County seeks actual, statutory, and treble damages, including interest; declaratory relief; disgorgement; restitution; attorneys' fees, experts' fees, and costs; and other relief deemed just and equitable by the Court. The Orange County action was transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pretrial proceedings. On September 6, 2007, that Court entered an order adding Orange County to the First Amended Consolidated Complaint filed by the City of New York and various other New York counties.
 
On September 21, 2007, the State of Utah filed a Complaint against the Company and various other pharmaceutical companies. The Utah Complaint pleads causes of action for (i) violations of the Utah False Claims Act and (ii) common law fraudulent misrepresentation. The State seeks actual, statutory, and treble damages, including prejudgment interest; restitution; attorneys' fees, experts' fees, and costs; and other relief deemed just and equitable by the Court. On November 20, 2007, the Judicial Panel on Multidistrict Litigation issued an order conditionally transferring the case to the United States District Court for the District of Massachusetts for coordinated and consolidated pretrial proceedings. The State then filed a motion to remand the case to state court, on December 7, 2007, and a motion to vacate the conditional transfer order, on December 12, 2007. These motions are currently pending.

F-43

 
Finally, on October 9, 2007, the State of Iowa filed a Complaint against the Company and various other pharmaceutical companies. The Iowa Complaint pleads causes of action for (i) violations of the Iowa Consumer Fraud Act, (ii) common law fraudulent misrepresentation, (iii) common law unjust enrichment and (iv) reporting of false best price information in violation of 42 USC Sec 1396R-8. The State seeks (i) a declaration that the Company committed the alleged violations, (ii) injunctive relief against the continuation of the alleged violations, (iii) actual, statutory damages, including prejudgment interest for the claim of unjust enrichment, (iv) actual, statutory damages, including prejudgment interest for the claim of fraudulent misrepresentation, (v) actual and punitive damages for alleged fraud, and (vi) an accounting of alleged illegal profits and a disgorgement of same, restitution, attorneys' fees, experts' fees, and costs and other relief deemed just and equitable by the Court. The Iowa action has been transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pretrial proceedings.

Other

The Company is, from time to time, a party to certain other litigations, including product liability litigations. The Company believes that these litigations are part of the ordinary course of its business and that their ultimate resolution will not have a material adverse effect on its financial condition, results of operations or liquidity. The Company intends to defend or, in cases where the Company is plaintiff, to prosecute these litigations vigorously.

Note 18 – Discontinued Operations – Related Party Transaction:

In January 2006, the Company announced the divestiture of FineTech, effective December 31, 2005. The Company transferred the business for no proceeds to Dr. Arie Gutman, president and chief executive officer of FineTech. Dr. Gutman also resigned from the Company’s Board of Directors. The transfer included all the assets and liabilities of FineTech, including $2.7 million of cash. The transfer resulted in a pre-tax loss on sale of $38.0 million, due primarily to the write-off of goodwill and intangibles, and the impairment of fixed assets. Also included in the loss were severance payments of $0.6 million, which were made in January 2006, and the acceleration of restricted stock and stock options that resulted in an additional loss of $1.3 million. The results of FineTech operations have been classified as discontinued for all periods presented. All expenses incurred by FineTech from January 1, 2006 through the date of transfer were the responsibility of the acquirer.

The following table shows revenues and pre-tax loss from the discontinued operations:

   
December 31,
 
   
2005
 
Revenues
 
$
150
 
Pre-tax loss from operations
   
(4,957
)
Pre-tax loss on sale of discontinued operations
   
(38,018
)

Note 19 – Segment Information:

Starting in the third quarter of 2005, the Company operates in two reportable business segments: generic pharmaceuticals and branded pharmaceuticals. Branded products are marketed under brand names through marketing programs that are designed to generate physician and consumer loyalty. Branded products generally are patent protected, which provides a period of market exclusivity during which they are sold with little or no competition. Generic pharmaceutical products are the chemical and therapeutic equivalents of reference brand drugs. The Drug Price Competition and Patent Term Restoration Act of 1984 provides that generic drugs may enter the market upon the approval of an ANDA and the expiration, invalidation or circumvention of any patents on corresponding brand drugs, or the expiration of any other market exclusivity periods related to the brand drugs.

F-44

 
The business segments of the Company were determined based on management’s reporting and decision-making requirements in accordance with SFAS No. 131, “Disclosures about Segments of an Enterprise and Related Information.” The Company believes that its generic products represent a single operating segment because the demand for these products is mainly driven by consumers seeking a lower cost alternative to brand name drugs. The Company’s generic drugs are developed using similar methodologies, for the same purpose (e.g., seeking bioequivalence with a brand name drug nearing the end of its market exclusivity period for any reason discussed above). The Company’s generic products are produced using similar processes and standards mandated by the FDA, and the Company’s generic products are sold to similar customers. Based on the economic characteristics, production processes and customers of the Company’s generic products, the Company has determined that its generic pharmaceuticals are a single reportable business segment. The Company’s chief operating decision maker does not review the generic segment in any more granularity, such as at the therapeutic or other classes or categories. Certain of the Company’s expenses, such as the direct sales force and other sales and marketing expenses and specific research and development expenses, are charged directly to either of the two segments. Other expenses, such as general and administrative expenses and non-specific research and development expenses are allocated between the two segments based on assumptions determined by the Company’s management.
 
The financial data for the two business segments are as follows:

   
2007
 
2006
 
2005
 
Revenues:
                   
Generic
 
$
684,917
 
$
675,938
 
$
417,384
 
Brand
   
84,749
   
49,230
   
14,872
 
Total revenues
   
769,666
   
725,168
   
432,256
 
                     
Gross margin:
                   
Generic
   
204,130
   
183,543
   
143,736
 
Brand
   
64,389
   
34,405
   
10,966
 
Total gross margin
   
268,519
   
217,948
   
154,702
 
                     
Operating income (loss):
                   
Generic
   
73,357
   
39,028
   
34,159
 
Brand
   
231
   
(31,306
)
 
(41,262
)
Total operating income (loss)
   
73,588
   
7,722
   
(7,103
)
Other income (expense), net
   
(56
)
 
126
   
(831
)
Equity loss from joint venture
   
(387
)
 
(663
)
 
(534
)
Net investment (loss) gain
   
(1,583
)
 
(583
)
 
16,013
 
Interest income
   
13,673
   
8,974
   
5,343
 
Interest expense
   
(6,803
)
 
(6,781
)
 
(6,793
)
Provision (benefit) for income taxes
   
27,322
   
2,054
   
(5,726
)
Income from continuing operations
 
$
51,110
 
$
6,741
 
$
11,821
 

The Company’s chief operating decision maker does not review the Company’s assets, depreciation or amortization by business segment at this time as they are not material to its branded operations. Therefore, such allocations by segment are not provided.

F-45

 
Total revenues of the Company’s top selling products were as follows:

Product
 
2007
 
2006
 
2005
 
Generic
                   
Metoprolol (Toprol-XL®)
 
$
141,877
 
$
8,284
 
$
-
 
Fluticasone (Flonase®)
   
130,475
   
235,454
   
-
 
Propranolol HCL (Inderal LA®)
   
57,459
   
-
   
-
 
Cabergoline (Dostinex®)
   
34,252
   
34,824
   
2,347
 
Various amoxicillin products (Amoxil®)
   
27,714
   
59,257
   
-
 
Ibuprofen Rx (Advil®, Nuprin®, Motrin®)
   
17,248
   
17,224
   
18,308
 
Tramadol HCl and acetaminophen tablets (Ultracet®)
   
16,024
   
26,524
   
67,817
 
Megestrol oral suspension (Megace® )
   
14,344
   
14,990
   
24,699
 
Fluoxetine (Prozac®)
   
13,229
   
19,315
   
23,463
 
Methimazole (Tapazole®)
   
12,343
   
10,999
   
10,362
 
Ranitidine syrup (Zantac®)
   
12,243
   
-
   
-
 
Mercatopurine (Purinethol®)
   
9,930
   
10,652
   
16,107
 
Ranitidine (Zantac®)
   
8,513
   
6,058
   
7,713
 
Lovastatin (Mevacor®)
   
7,360
   
16,314
   
16,650
 
Paroxetine (Paxil®)
   
2,773
   
11,034
   
37,449
 
Glyburide & Metformin HCl (Glucovance®)
   
2,313
   
7,613
   
8,023
 
Quinapril (Accupril®)
   
1,851
   
20,049
   
15,372
 
Metformin ER (Glucophage XR®)
   
1,776
   
6,347
   
4,751
 
Cefprozil (Cefzil®)
   
1,165
   
11,879
   
563
 
Other product related revenues (2)
   
21,214
   
17,290
   
20,130
 
Other (1)
   
150,810
   
141,831
   
143,630
 
Total generic revenues
 
$
684,917
 
$
675,938
 
$
417,384
 
                     
Brand
                   
Megace® ES
 
$
75,317
 
$
43,379
 
$
13,908
 
Other
   
-
   
3,351
   
964
 
Other product related revenues (2)
   
9,432
   
2,500
   
-
 
Total brand revenues
 
$
84,749
 
$
49,230
 
$
14,872
 

(1) The further detailing of annual revenues of the other approximately 60 generic products is impracticable due to the low volume of revenues associated with each of these generic products. No single product in the other category is in excess of 3% of total generic revenues for any year in the three-year period ended December 31, 2007.
(2) Other product related revenues represents licensing and royalty related revenues from profit sharing agreements related to products such as ondansetron ODT, the generic version of Zofran ODT®, doxycycline monohydrate, the generic version of Adoxa®, and quinapril, the generic version of Accupril®. Other product related revenues included in the Brand business relate to a co-promotion arrangement with Solvay.

Major Customers
The Company’s four largest customers, McKesson Corporation, AmerisourceBergen Corporation, Cardinal Health Inc., and Walgreen Co., accounted for approximately 22%, 12%, 11% and 10%, respectively, of its total revenues in 2007, 14%, 7%, 12% and 10%, respectively, of its total revenues in 2006 and 14%, 9%, 9% and 8%, respectively, of its total revenues in 2005.

Note 20 – Investment in Joint Venture:

On April 15, 2002, Rhodes Technology (“Rhodes”) and the Company created a joint venture, SVC Pharma (“SVC”), to research, develop, commercialize and market pharmaceutical preparations for human therapy. The parties agreed to capitalize the joint venture with equal contributions and all profits or losses are to be shared equally between Rhodes and the Company. The Company accounts for this investment under the equity method of accounting in accordance with APB No. 18, the Equity Method of Accounting for Investments in Common Stock. The Company recognized losses based on its share of the equity in SVC of $0.4 million, $0.7 million, and $0.5 million for the years ended December 31, 2007, 2006 and 2005, respectively. As of December 31, 2007, the Company’s net investment in SVC totaled $6.3 million. The investment in SVC is reviewed for impairment each reporting period. Any impairment deemed to be “other-than temporary” will be recognized in the appropriate period and the basis will be adjusted. As of December 31, 2007, the Company believed its investment in SVC was not impaired.

F-46


Note 21 – Restructuring Costs:

In the fourth quarter of 2006, the Company made the decision to restructure its business operations and as a result, terminate approximately 10% of its workforce. The restructuring plan met the criteria outlined in SFAS 146 Accounting for Costs Associated with Exit or Disposal Activities. During the fourth quarter of 2006, the Company recorded a restructuring charge primarily to its generic business of approximately $1.0 million related to employee termination benefits. During the year ended December 31, 2007, no additional restructuring charges were incurred and substantially all of the benefits were paid out.

Note 22 – Subsequent Events:
 
On January 14, 2008, the Company entered into an exclusive license agreement with Alfacell Corporation (“Alfacell”).  Under the agreement, the Company received the exclusive U.S. commercialization rights to Alfacell’s ONCONASE® (ranpirnase).  ONCONASE® is currently in Phase III clinical development for the treatment of inoperable malignant mesothelioma, a rare cancer affecting the lungs usually associated with exposure to asbestos.  In exchange for the U.S. commercialization rights, the Company made an initial payment to Alfacell of $5 million and will make a subsequent payment of up to $30 million upon (and subject to) Alfacell’s receipt of FDA approval for the product.  If ONCONASE® receives FDA approval, the Company will commercialize the product in the United States and pay Alfacell royalties on net sales of the product, and Alfacell will be eligible to receive additional milestone payments if net sales reach certain threshold amounts in any given calendar year.  In addition, Alfacell may be eligible to receive milestone payments upon the achievement of certain development and regulatory milestones with respect to future indications for ONCONASE®.  Under a separate supply agreement between Alfacell and the Company, Alfacell will supply commercial quantities of ONCONASE® to the Company.  

In February 2008, Immtech announced that it had chosen to discontinue the development program for pafuramidine maleate, the Phase III oral drug candidate for the treatment of pneumocystis pneumonia in AIDS patients to which the Company had acquired U.S. commercialization rights in June 2007 for $3 million. See Note 11 – “Research and Development Agreements.”

Note 23 – Unaudited Selected Quarterly Financial Data:

Unaudited selected quarterly financial data for 2007 and 2006 are summarized below:

   
Fiscal Quarters Ended
 
   
March 31,
2007
 
June 30,
2007
 
September 29,
2007
 
December 31,
2007
 
Total revenues
 
$
234,210
 
$
167,640
 
$
212,676
 
$
155,140
 
Gross margin
   
87,689
   
56,555
   
66,428
   
57,847
 
Total operating expenses
   
46,018
   
48,276
   
66,358
   
54,279
 
Operating income
   
61,671
   
8,279
   
70
   
3,568
 
Income from continuing operations
 
$
41,514
 
$
2,798
 
$
1,269
 
$
5,529
 
Loss from discontinued operations
   
-
   
-
   
-
   
(1,212
)
Net income
 
$
41,514
 
$
2,798
 
$
1,269
 
$
4,317
 
Net income (loss) per common share
                         
Basic:
                         
Income for continuing operations
 
$
1.20
 
$
0.08
 
$
0.04
 
$
0.16
 
Loss from discontinued operations
   
-
   
-
   
-
   
(0.04
)
Net income
 
$
1.20
 
$
0.08
 
$
0.04
 
$
0.12
 
Diluted:
                         
Income for continuing operations
 
$
1.19
 
$
0.08
 
$
0.04
 
$
0.16
 
Loss from discontinued operations
   
-
   
-
   
-
   
(0.04
)
Net income
 
$
1.19
 
$
0.08
 
$
0.04
 
$
0.12
 

F-47


   
Fiscal Quarters Ended
     
   
April 1,
2006
 
July 1,
2006
 
September 30, 2006
 
December 31, 2006
     
                       
Total revenues
 
$
172,318
 
$
195,238
 
$
173,979
 
$
183,633
       
Gross margin
   
49,168
   
54,767
   
55,060
   
58,953
       
Total operating expenses
   
42,194
   
61,748
   
49,573
   
56,711
       
Operating income (loss)
   
6,974
   
(6,981
)
 
5,487
   
2,242
       
Income (loss) from continuing operations
 
$
4,514
 
$
(7,205
)
$
4,387
 
$
5,045
       
Loss from discontinued operations
   
-
   
-
   
-
   
(894
)
 
(a)
 
Net income (loss)
 
$
4,514
 
$
(7,205
)
$
4,387
 
$
4,151
   
(a)
 
Net income (loss) per common share
                               
Basic:
                               
Income (loss) for continuing operations
 
$
0.13
 
$
(0.21
)
$
0.13
 
$
0.15
       
Loss from discontinued operations
   
-
   
-
   
-
   
(0.03
)
 
(a)
 
Net income (loss)
 
$
0.13
 
$
(0.21
)
$
0.13
 
$
0.12
   
(a)
 
Diluted:
                               
Income (loss) for continuing operations
 
$
0.13
 
$
(0.21
)
$
0.13
 
$
0.15
       
Loss from discontinued operations
   
-
   
-
   
-
   
(0.03
)
 
(a)
 
Net income (loss)
 
$
0.13
 
$
(0.21
)
$
0.13
 
$
0.12
   
(a)
 

(a) Restated as per Note 1.
Loss from discontinued operations was previously reported as $0.
Net income for the quarter ended December 31, 2006 was previously reported as $5,045.
Net income (loss) per common share – Basic: Loss from discontinued operations for the quarter ended December 31, 2006 was previously reported as $0.00.
Net income (loss) per common share – Basic: Net income (loss) for the quarter ended December 31, 2006 was previously reported as $0.15.
Net income (loss) per common share – Diluted: Loss from discontinued operations for the quarter ended December 31, 2006 was previously reported as $0.00.
Net income (loss) per common share – Diluted: Net income (loss) for the quarter ended December 31, 2006 was previously reported as $0.15.

F-48

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EXHIBIT 10.1

1989 EMPLOYEE STOCK PURCHASE PROGRAM
OF
PAR PHARMACEUTICAL COMPANIES, INC.
AS AMENDED AND RESTATED EFFECTIVE JANUARY 1, 2008


1.  Purpose and effect of the Program.

The purpose of the Par Pharmaceutical Companies, Inc. Employee Stock Purchase Program (“Stock Purchase Program” or “Program”) is to secure for Par Pharmaceutical Companies, Inc., a Delaware corporation (the “Company”), and its stockholders the benefits of the incentives inherent in the ownership of the Company’s capital stock by present and future employees of the Company and its subsidiaries. The Stock Purchase Program is intended to comply with the provisions of Sections 421, 423 and 425 of the Internal Revenue Code of 1986, as amended (the “Code”), and the Program shall be administered, interpreted and construed in accordance with such provisions. The Program was originally approved by the stockholders September 28, 1990 (“Effective Date”). The Program, as amended and restated herein, has been approved by the Board of Directors to be effective as of January 1, 2008 (“Restated Effective Date”).

2.  Shares reserved for the Program.

There shall be reserved for issuance and purchase by employees under the Stock Purchase Program an aggregate of 1,000,000 shares of Common Stock, par value $.01 per share, of the Company (“Common Stock”), subject to adjustment as provided in Section 12. Shares subject to the Program may be shares now or hereafter authorized but unissued, or shares that were once issued and subsequently reacquired by the Company. If and to the extent that any right to purchase reserved shares shall not be exercised by any employee for any reason or if such right to purchase shall terminate as provided herein, such shares which have not been so purchased hereunder shall again become available for the purposes of the Program (subject to adjustment as provided in Section 12).

3.  Administration of the Program.

Subject to the general control of, and superseding action by the Company’s Board of Directors (the “Board of Directors”) the Company’s Benefits Committee (“Committee”) shall have the full power to administer and interpret the Program. Except as otherwise expressly provided in this Program, the Committee shall prescribe, amend and rescind rules and regulations relating to it, and to make all other determinations necessary or advisable in administering the Program, all of which determinations shall be final and binding upon all Participating Employees unless otherwise determined by the Board of Directors. A quorum of the Board of Directors or Committee for purposes of the Program shall consist of a majority of its members. Any action may be taken by the Board of Directors or Committee at a meeting duly called, at which a quorum shall be present, or without a meeting by a written consent to their action taken signed by all members of the Board of Directors or Committee, as the case may be.
 
_____________
Approved by stockholders September 28, 1990
As amended by the Board, effective January 1, 2008
 
1

 
4.  Eligible Employees.
 
Each current and future employee of the Company and those of its subsidiaries (which subsidiaries are designated by the Board of Directors or Committee) shall be eligible to participate in the Program, provided, each of such employees,

(a)  
is actively employed by the Company and/or any of its subsidiaries (or any predecessor thereof) on the Enrollment Date (as hereinafter defined), and
 
(b)  
does not own, immediately after the Investment Date (as defined in Section 8 below), stock possessing five (5%) percent or more of the total combined voting power or value of all classes of stock of the Company and/or of a subsidiary thereof.
 
In determining whether a company is a subsidiary, the rules of Section 425(f) of the Code shall be followed, and in determining stock ownership under this paragraph, the rules of Section 425(d) of the Code shall apply and stock which the employee may purchase under outstanding options shall be treated as stock owned by the employee. Employees whose employment terminated or are retired, at the date the Program becomes effective or on the first day of each calendar quarter (“Enrollment Date”), are not eligible to participate on such date. Employees eligible to participate in the Program pursuant to the provisions of this Section 4 are hereinafter referred to as “Eligible Employees.”

5.  Election to participate and payroll deductions.

Each Eligible Employee, at the effective date of the Program and each Enrollment Date thereafter, may participate in the Program by enrolling during the ten-day period prior to such effective date or Enrollment Date, as the case may be, (an “Enrollment Period”) authorizing specified regular payroll deductions (“Payroll Deductions”) during each calendar year expressed in whole percentages in multiples of one (1%) percent not to exceed ten (10%) percent of his/her Eligible Compensation (as hereinafter defined). Such Payroll Deductions shall be made regularly and in equal amounts commencing on the effective date or the Enrollment Date, as the case may be, by the Company and shall be credited, as promptly as practicable, to an account in the name of each Participating Employee (as hereinafter defined). The Board of Directors or Committee, in lieu of Payroll Deductions, may approve equivalent direct payments by an Eligible Employee, which shall be deemed to be Payroll Deductions. Pending the purchase of shares, all Payroll Deductions may be used by the Company for any corporate purpose. Eligible Employees who so elect to participate in the Program are referred to herein as “Participating Employees.” A Participating Employee may increase or decrease his/her Payroll Deduction only during an Enrollment Period. If a Participating Employee withdraws from the Program, he or she will not be eligible to participate again until an Enrollment Date not earlier than six months after the date of his/her withdrawal from the Program.
 
2

 
For the purpose of the Program, “Eligible Compensation” shall mean base salary plus overtime and shift differential actually paid in each pay period. Eligible Compensation shall not include any payments for or reimbursement of expenses, finders’ fees, suggestion awards, bonuses, deferred profit-sharing distributions or similar non-regular payments unless otherwise determined by the Board of Directors or the Committee.

6.  Limitation on employee share purchases.

No right to purchase shares under this Program shall permit an employee to purchase stock under all employee stock purchase plans of the Company and its subsidiaries (as defined in Section 423 of the Code) at a rate which in the aggregate exceeds $25,000 of the Fair Market Value (as defined in Section 7 below) of such stock as determined on the Investment Date for each calendar year in which the right is outstanding at any time.

7.  Purchase price.

The purchase price for each whole and fractional share of Common Stock shall be determined by the Board of Directors for each Investment Date but in no event shall the purchase price be less than eighty-five percent (85%) of the Fair Market Value of such whole or fractional share on the Investment Date. “Fair Market Value” shall be the mean of the high and low sales prices of a share of Common Stock on the New York Stock Exchange on the Investment Date, or if the Common Stock shall have not been traded on such date, for the first day prior thereto on which the Common Stock was so traded, or such other amount as the Board of Directors may determine by any other fair and reasonable means.

8.  Methods of purchase and Investment Accounts.

As of the last Friday in each calendar quarter (each of such dates being known as an “Investment Date”), each Participating Employee shall purchase the number of whole and fractional shares of Common Stock determined by dividing the amount of his/her Payroll Deductions not theretofore invested by the purchase price as determined in Section 7. All whole and fractional shares purchased shall be maintained by the broker designated by the Board of Directors or Committee (“Designated Broker”) in separate investment accounts (“Investment Account”) for each Participating Employee, which account shall represent the sum of shares, fractional shares and any Payroll Deductions not theretofore invested as allocated to each individual Participating Employee. All dividends paid with respect to the whole and fractional shares in the Investment Account shall be credited to each Participating Employee’s respective interest in the Investment Account, and dividends credited to his or her Investment Account will be automatically applied by the Designated Broker to the purchase of whole and fractional shares of Common Stock as of the next Investment Date.
 
3

 
9.  Title of Investment Accounts.

Each Investment Account may be in the name of the Participating Employee or, if he/she so indicates, in his/her name jointly with a member of his/her family, with right of survivorship. A Participating Employee who is a resident of a jurisdiction that does not recognize such a joint tenancy may have an Investment Account in his/her name as tenant in common with a member of his/her family, without right of survivorship.

10.  Rights as a stockholder.

When a Participating Employee’s Investment Account shall be charged with the amount of the purchase price of the Common Stock, he or she shall have all the rights or privileges of a stockholder of the Company with respect to shares purchased under the Program whether or not certificates representing full shares have been issued.

11.  Rights not transferable.

Rights under the Program are not transferable by a Participating Employee other than by will or the laws of descent and distribution and are exercisable during his or her lifetime only by him or her.

12.  Adjustments in case of changes affecting the Company’s Common Stock.

In the event of a subdivision of outstanding shares of Common Sock, or the payment of a stock dividend thereon, the number of shares reserved or authorized to be reserved under this Program shall be increased proportionately, and such other adjustments shall be made as may be deemed necessary or equitable by the Board of Directors. In the event of any other change affecting the Common Stock, such adjustment shall be made as may be deemed equitable by the Board of Directors to give proper effect to such event subject to the limitations of Section 425 of the Code.

13.  Withdrawal, retirement, termination and death.

A Participating Employee may withdraw from the Program only during an Enrollment Period, and such withdrawal shall become effective on the ensuing Enrollment Date, except as the Committee may otherwise determine. If a Participating Employee withdraws from the Program, he/she will not be eligible to participate again until an Enrollment Date not earlier than six months after the date of his/her withdrawal from the Program.
 
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In the event of a Participating Employee’s withdrawal from the Program, retirement or termination of employment or death during a calendar year in which the Program is in effect, the amount of his/her Payroll Deductions not theretofore invested shall be used to purchase whole or fractional shares of Common Stock on the next occurring Investment Date.

14.  Amendment of the Program.

The Board of Directors may at any time, or from time to time, amend the Program in any respect, provided, however, that the Program may not be amended in any way that will cause rights issued under it to fail to meet the requirements for employee stock purchase plans as defined in Section 423 of the Code, including stockholder approval if required.

15.  Termination of the Program.

The Program and all rights of employees hereunder shall terminate:

(a)  
on the Investment Date that Participating Employees become entitled to purchase a number of shares greater than the number of reserved shares remaining available for purchase; or
 
(b)  
at any time, at the discretion of the Board of Directors.
 
In the event that the Program terminates under circumstances described in (a) above, reserved shares remaining as of the termination date shall be issued to Participating Employees on a pro rata basis.

16.  Effective Date of the Program.

The Program originally became effective on September 28, 1990. The Program, as amended and restated herein, shall be effective January 1, 2008. For purposes of the operation and administration of the Program, the original Stock Purchase Program shall govern for any time period prior to the Restated Effective Date.

17.  Governmental and other regulations.

The Program, and the grant and exercise of the rights to purchase shares hereunder, and the Company’s obligation to sell and deliver shares upon the exercise of rights to purchase shares, shall be subject to all applicable Federal, State and foreign laws, rules and regulations, and to such approvals by any regulatory or governmental agency as may, in the opinion of counsel for the Company, be required.

18.  Indemnification of Committee.

Each person who is or shall have been a member of the Board of Directors or the Committee shall be indemnified and held harmless by the Company against and from any loss, cost, liability, or expense that may be imposed upon or reasonably incurred by him or her in connection with or resulting from any claim, action, suit, or proceeding to which he or she may be a party or in which he or she may be involved by reason of any action taken or failure to act under the Program and against and from any and all amounts paid by him or her in settlement thereof, with the Company’s approval, or paid by him or her in satisfaction of any judgment in any such action, suit, or proceeding against him or her, provided he or she shall give the Company an opportunity, at its own expense, to handle and defend the same before he or she undertakes to handle and defend it on his or her own behalf, unless such loss, cost, liability, or expense is a result of his or her own willful misconduct or except as expressly provided by statute. The foregoing right of indemnification shall not be exclusive of any other rights of indemnification to which such persons may be entitled under the Company’s Certificate of Incorporation or Bylaws, as a matter of law, or otherwise, or any power that the Company may have to indemnify them or hold them harmless.
 
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EX-10.31 4 v104574_ex10-31.htm
EXHIBIT 10.31
 
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LICENSE AGREEMENT
 
This License Agreement (the “Agreement”) is made and entered into as of January 14, 2008 (the “Effective Date”), between Alfacell Corporation, a Delaware corporation with its principal place of business at 300 Atrium Drive, Somerset, New Jersey 08873 (“Alfacell”), and Par Pharmaceutical, Inc., a Delaware corporation with its principal place of business at 300 Tice Boulevard, Woodcliff Lake, New Jersey 07677 (“Par”). Alfacell and Par may be referred to herein individually as a “Party”, or together as the “Parties”.
 
Recitals
 
Whereas, Alfacell has expertise developing pharmaceutical products and has developed and owns certain proprietary technology and know-how relating to the design and manufacture of the Product (as defined in Section 1.1) in the Field; and
 
Whereas, Par has expertise in developing, manufacturing and marketing certain pharmaceutical products and wishes to develop and market the Product in the Field in the Territory as further described herein, and Alfacell agrees to grant Par the rights to do so pursuant to the terms of this Agreement.
 
Now, Therefore, in consideration of the foregoing and the covenants and promises contained herein, the Parties hereby agree as follows:
 
ARTICLE I
 
DEFINITIONS
 
1.1 Definitions. For the purposes of this Agreement, the following defined terms have the respective meanings set forth below:
 
Accelerated Approval” means approval of a Product NDA pursuant to 21 C.F.R. Part 314 Subpart H (a) in which the FDA evaluation of the NDA is performed on the basis of a surrogate marker (a measurement intended to be a substitute for the clinical measurement of interest) that is considered likely to predict patient benefit and (b) that may be a provisional approval, with a required written commitment to complete clinical studies that formally demonstrate patient benefit.
 
Affiliate” means, with respect to a Party and for so long as the relationship exists, any other entity that directly or indirectly controls, is controlled by, or is under common control with, such Party. An entity shall be regarded as in control of another entity if it owns, or directly or indirectly controls, greater than fifty percent (50%) of the voting stock or other ownership interest of such entity, or if it directly or indirectly possesses the power to direct or cause the direction of the management and policies of the other entity by any means whatsoever.
 
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AG Product” means a generically-labeled version of the Product (i.e., such Product does not bear the Trade Name) supplied by Alfacell and sold by Par and/or its Sub-distributors or permitted sublicensees.
 
Agreement” has the meaning set forth in the introductory paragraph.
 
Alfacell” has the meaning set forth in the introductory paragraph.
 
Alfacell Indemnitee” has the meaning set forth in Section 12.2.
 
Alfacell Information” means any Product-related information Owned or Controlled by Alfacell as of the Effective Date or Owned or Controlled by Alfacell after the Effective Date that, with respect to a Product in the Field in the Territory, (a) is directly related to use or sale of the Commercialized Product, (b) is included in an Alfacell NDA filing for the Product within the scope of this Agreement, (c) is otherwise reasonably requested by Par and provided by Alfacell in its sole discretion, or (d) is lawfully obtained by Alfacell from a Third Party without restriction on disclosure to Par, but only to the extent that such Product-related information is necessary or useful for, and is specific to use, utilization, or sale of the Product, and is disclosed to Par by Alfacell pursuant to this Agreement. Program Developments Owned or Controlled by Alfacell that are not Alfacell Patents, shall be Alfacell Information. For the avoidance of doubt, Alfacell shall have no obligation to disclose to Par any Ranpirnase or Product manufacturing Know-How Owned or Controlled by Alfacell, except in connection with Section 4.2 of this Agreement.
 
Alfacell Patents” means any United States patents and patent applications Owned or Controlled by Alfacell as of the Effective Date or Owned or Controlled by Alfacell after the Effective Date that cover Ranpirnase or Product, the importation, use or making of Ranpirnase or Product, or any part of the foregoing or that in Par’s opinion may cover Competing Products, the importation, use or making of Competing Product, or any part thereof. Such Alfacell patents and patent applications as of the Effective Date are set forth on Schedule 1.1, which is attached hereto and made part of this Agreement. Schedule 1.1 shall be amended from time to time during the Term to reflect any such patents Owned or Controlled by Alfacell after the Effective Date. The term “Alfacell Patents” shall include continuations, divisions, provisionals or any substitute applications of the patents and patent applications set forth on Schedule 1.1, any patent issued with respect to any such patent applications, and any reissue, reexamination, renewal or extension (whether by patent law or regulation, or any other law or regulation, for example FDA related extensions) of any such patent.
 
Alfacell Technology” means Alfacell Patents and Alfacell Information.
 
“Amphinase(s)” means all pharmaceutical agents disclosed or claimed in one or more of the following:
 
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Patent No. US 7,229,824 B1

U.S. Patent Application No. 11/759,247 filed 7 JUN 2007

U.S. Patent Application No. 11/759,249 filed 7 JUN 2007

U.S. Patent Application No. 11/759,250 filed 7 JUN 2007

U.S. Patent Application No. 11/759,251 filed 7 JUN 2007

U.S. Patent Application No. 11/759,952 filed 8 JUN 2007

U.S. Patent Application No. 11/759,953 filed 8 JUN 2007

U.S. Patent Application No. 11/759,954 filed 8 JUN 2007

U.S. Patent Application No. 11/759,955 filed 8 JUN 2007

The term “Amphinase” also means and includes all pharmaceutical agents disclosed or claimed in any patents issuing on any of the above-referenced patent applications, and all pharmaceutical agents disclosed or claimed in any continuation, division, reexamination, or reissue thereof.
 
cGMP” means the regulatory requirements for current good manufacturing practices promulgated by the FDA under authority of the U.S. Food, Drug and Cosmetic Act, particularly 21 C.F.R. Section 210 et seq., as the same may be amended from time to time.
 
“Change of Control” means, in respect of either Party, an event in which: (a) any other person or group of persons (as the term “person” is used for purposes of Section 13(d) or 14(d) of the Exchange Act) not then beneficially owning more than fifty percent (50%) of the voting power of the outstanding securities of such Party acquires or otherwise becomes the beneficial owner (within the meaning of Rule 13d-3 promulgated under the Exchange Act) of securities of such Party representing more than fifty percent (50%) of the voting power of the then outstanding securities of such Party with respect to the election of directors of such Party; or (b) such Party (i) consummates a merger, consolidation or similar transaction with another person where the voting securities of such Party outstanding immediately preceding such transaction (or the voting securities issued with respect to the voting securities of such Party outstanding immediately preceding such transaction) represent less than fifty percent (50%) of the voting power of such Party or surviving entity, as the case may be, immediately following such transaction, or (ii) disposes by sale, assignment, exclusive license or otherwise of all or substantially all of its intellectual property rights, except for licenses under such intellectual property rights in the ordinary course of business and any isolated sale or assignment of specific items of intellectual property.
 
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Clinical Supplies” means supplies of the Product, manufactured, packaged and labeled in compliance with cGMP and applicable law, in such form and dosage as is determined by Alfacell pursuant to the Development Program, and suitable for use in the conduct of pre-clinical and/or human clinical trials of the Product in the United States pursuant to the Development Program.
 
CMC Section” means the Chemistry, Manufacturing and Controls section of an NDA submission.
 
Code” has the meaning set forth in Section 13.3.
 
Commercialization” means the marketing, promotion, advertising, selling and/or distribution of the Product in the Field in the Territory after Regulatory Approval has been obtained; and the term “Commercialize” has a corresponding meaning.
 
Commercialization Committee” has the meaning set forth in Section 2.2.
 
Commercially Reasonable Efforts” means, with respect to each Party, the continuous and diligent efforts and commitment of resources of a degree and kind in accordance with such Party’s reasonable business, legal, medical and scientific judgment that are consistent with the efforts and resources such Party uses for other products owned by it or to which it has similar rights, which are of similar market potential and at a similar stage in their life cycle, taking into account the competitiveness of the marketplace, the regulatory structure involved and other relevant factors; and the term “Commercially Reasonable” has a corresponding meaning. For a Product other than an AG Product, Par’s efforts and commitments for purposes of this definition will be determined by comparison to Par’s branded products; for an AG Product, Par’s efforts and commitments for purposes of this definition will be determined by comparison to Par’s other authorized generic products.
 
Competing Product” means any pharmaceutical product containing (a) Ranpirnase or (b) any compound or moiety that includes Ranpirnase or is derived from, or substantially similar to, Ranpirnase or its nucleic acid sequences as a starting material, intermediate or base material and, in either case (i) for parenteral administration or (ii) in the Field; provided, however, that (x) no Amphinase shall be considered a Competing Product, and (y) on and after the date that a Third Party sells or offers for sale a generically-labeled version of the Product, the definition of the term “Competing Product” will be limited to a pharmaceutical product containing Ranpirnase and any generic equivalent thereof (as determined by the FDA).
 
Confidential Information” means information of a Party that is disclosed to or obtained by the other Party (including information obtained by a Party as a result of access to the facilities of the other Party) either prior to or during the Term, which information is non-public, confidential or proprietary in nature, including trade secrets, financial data, product information, manufacturing methods, market research data, marketing plans, identity of customers, nature and source of raw materials, product formulation and methods of producing, testing and packaging; provided, however, that Confidential Information shall not include information that a Party can demonstrate by written evidence: (a) is in the public domain other than as a result of a breach by such Party (or any of its Sub-distributors) of its obligations of confidentiality contained herein; (b) was known by the receiving Party prior to receipt from the disclosing Party; (c) has been developed by the receiving Party independent of any Confidential Information of the disclosing Party; or (d) was subsequently, lawfully and in good faith, obtained by the receiving Party on a non-confidential basis from a Third Party that was not under an obligation to treat such information in a confidential manner and had a lawful right to make such disclosure. Without limiting the foregoing, the terms of this Agreement shall constitute “Confidential Information” of both Parties hereunder.
 
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Contract Year” means (a) if the Initial Commercial Sale occurs during the first 45 days of a calendar quarter, a twelve (12) month period starting on the first day of the calendar quarter in which the Initial Commercial Sale (or an anniversary thereof, as the case may be) occurs or (b) if the Initial Commercial Sale occurs other than during the first 45 days of a calendar quarter, a twelve (12) month period starting on the first day of the calendar quarter immediately following the calendar quarter in which the Initial Commercial Sale (or an anniversary thereof, as the case may be) occurs; provided, however, that if a Contract Year is triggered pursuant to the foregoing clause (b), then, for purposes of computing Net Sales during the initial Contract Year, the Parties will include the Net Sales during the forty-five (45) days immediately prior to thereto.
 
CPR” has the meaning set forth in Section 14.5.
 
Damages” has the meaning set forth in Section 9.3(e).
 
Detail” means, with respect to the Product, a face-to-face contact between a sales representative and a physician or other medical professional licensed in the Territory to prescribe drugs, during which a First Position Detail or Secondary Position Detail is made to such person, in each case as measured by each Party’s internal recording of such activity; provided, that such meeting is consistent with and in accordance with the requirements of applicable laws and this Agreement.
 
Development Committee” has the meaning set forth Section 2.1(a).
 
Development Costs” means all direct and indirect costs and expenses incurred by Alfacell in connection with the Development Program, which may include (a) costs associated with designing, planning and conducting Phase III Clinical Trials and/or the Phase IIB studies for the Product and all subsequent clinical testing and trials, including all third-party costs and expenses of any and all Phase IIIB and Phase IV studies with respect to the Product that are required by the FDA, and including all costs associated with meeting with the ODAC and/or completion of any studies as a result of such meetings, (b) costs in connection with seeking, obtaining and maintaining Regulatory Approval, including all FDA filing fees, (c) payments made to Third Parties in connection with the Development Program, (d) materials and supplies, and (e) license or acquisition fees and other costs and expenses associated with Alfacell’s obtaining from a Third Party any trademarks, tradenames, logos, trade dress or similar intellectual property rights licensed or acquired by Alfacell after the Effective Date for use in connection with Commercialization of the Product in the Field in the Territory.
 
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Development Program” means Alfacell’s activities associated with Alfacell’s development of the Product in the Field for sale in the Territory by Par pursuant to this Agreement, including (a) research and development of a recombinant version of Ranpirnase; (b) manufacture and formulation of the Product for preclinical and clinical studies; (c) planning, implementation, evaluation and administration of human clinical trials of the Product in the Field in the Territory; (d) manufacturing process development and scale-up for the manufacture of the Product; (e) preparation and submission of applications for Regulatory Approval in the Field in the Territory; and (f) post-market surveillance of approved Product Indications.
 
Direct Cost” means the actual costs and expenses paid by Alfacell to Third Party manufacturers for Product in finished form, filled, labeled and packaged for commercial sale, such costs and expenses not to exceed $*** per 1 mg vial except with the prior written consent of Par, which consent shall not be unreasonably withheld; provided, however, that if the Parties determine to launch a Product where Ranpirnase has been obtained from a recombinant source, then the Direct Cost shall be amended as the Parties mutually agree.
 
Effective Date” means the date set forth in the introductory paragraph.
 
Ex-U.S. Shipping Costs” means, if Alfacell’s manufacturing facility or that of its Third Party Manufacturer (as defined in the Supply Agreement) as designated by Alfacell pursuant to Section 5.1 of the Supply Agreement is located outside of the continental United States, all charges and fees for freight, shipping, customs, duties, and insurance incurred by Par for shipment of Product from such facility.
 
Fair Market Value” means, when determined on an annual basis, the total annual cost per sales representative including salary, commission, benefits, car allowance and legitimate reimbursable travel and/or home office expenses, divided by the number of annual Details delivered by the sales representative, multiplied by the percentage of Product presentation time per Detail (based on the Product presentation position in the Detail, e.g., 60% for First Position Details, 40% for Secondary Position Details). The Fair Market Value may also be determined on a calendar quarter basis, as applicable.
 
FDA” means The Food and Drug Administration of the United States Department of Health and Human Services, or any successor agency(ies) thereof performing similar functions.
 
Field” means all uses for cancer in humans.
 
First Position Detail” means a Detail in which no more than three (3) products are presented, in which key attributes of the Product are verbally presented consistent with the terms of this Agreement and applicable laws, and where the Product receives *** percent (***%) or more of the total call time and is given primary emphasis (i.e., an emphasis that is more important than the emphasis given to any other product presented).
 
Force Majeure Event” has the meaning set forth in Section 14.7.
 
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Future Indication” means an Indication of the Product for the treatment of *** any other specific disease or condition in the Field to which the Parties mutually agree in writing.
 
Full Approval” means, in respect of the Product for the Primary UMM Indication, Secondary UMM Indication or any Future Indication, Regulatory Approval upon which the FDA has granted full approval (i.e., any FDA approval that is not Accelerated Approval) to market the Product for such Indication in the United States.
 
“GAAP” means generally accepted accounting principles in the United States, as in effect from time to time.
 
“Governmental Authority” means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of (a) any government of any country, (b) a federal, state, province, county, city or other political subdivision thereof or (c) any supranational body. The term “Governmental Authority” includes the FDA.
 
Indemnitor” has the meaning set forth in Section 12.3.
 
Indication” means any approved human therapeutic use(s) for the Product in the Field.
 
Initial Commercial Sale” means the first sale of the Product by Par or a Sub-distributor to a Third Party in the Field in the Territory following Regulatory Approval for the Primary UMM Indication, the Secondary UMM Indication or a Future Indication (whichever Indication is approved for the first Product sale in the Territory).
 
Insolvent Party” has the meaning set forth in Section 13.3.
 
Knowledge” of Alfacell means the actual knowledge of Kuslima Shogen, Lawrence A. Kenyon, Andrew P. Aromando and/or Diane Scudiery, in each case after due and reasonable inquiry.
 
Losses” has the meaning set forth in Section 12.1.
 
Material Commercialization Decision” has the meaning set forth in Section 2.2(d).
 
Material Development Decision” has the meaning set forth in Section 2.1(b)(iii).
 
Modified Targeted Ranpirnase” means Targeted Ranpirnase other than for UMM or any Future Indication.
 
Net Margin” means Net Sales minus Ex-U.S. Shipping Costs (if applicable).
 
Net Sales” means, ***.
 
NDA” means the New Drug Application and all amendments and supplements thereto for the Product submitted by Alfacell to the FDA, including all documents, data and other information included in an accepted NDA submission for Regulatory Approval to market and sell the Product in the Field in the Territory.
 
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ODAC” has the meaning set forth in Section 3.1.
 
Owned or Controlled by” means, with respect to any patent or other intellectual property right, the possession of the ability, whether directly or indirectly, and whether by ownership, license or otherwise, to grant a license, sublicense or other right to or under such Patent or right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party (and in the case of United States Patent Nos. 6,649,392 and 6,649,393, subject to the interests of the U.S. Government therein).
 
Par” has the meaning set forth in the introductory paragraph.
 
Par Indemnitee” has the meaning set forth in Section 12.1.
 
Par Promoted Products” means all FDA-approved branded products that Par is promoting or co-promoting in the Territory for their approved indications.
 
Party” and “Parties” have the meaning set forth in the introductory paragraph.
 
Phase III Clinical Trials” means that portion of the Development Program that provides for human clinical studies in the Field that (a) are conducted in a number of patients that is intended to be sufficient to obtain a definitive evaluation of the therapeutic efficacy and safety of a Product in patients for a given Indication as required by 21 C.F.R. §312.21(c), and (b) are needed to evaluate the overall risk-benefit relationship of the Product and to provide adequate basis for obtaining requisite Regulatory Approvals.
 
Primary UMM Indication” means the Indication of the Product for the treatment of patients with UMM whose disease is either unresectable or who are otherwise not candidates for surgery, wherein (a) the labeling for such Indication recites “ONCONASE® (ranpirnase) in combination with doxorubicin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery” or a substantially equivalent or broader label for such Indication, (b) neither the indication nor clinical pharmacology section of the label is limited to use only in patients who have first used and/or failed Altima, and (c) such Indication is supported by data from a pivotal study that demonstrates a statistically significant survival benefit of at least two months.
 
Product” means any pharmaceutical product containing Ranpirnase for parenteral administration that has been developed by Alfacell or is developed by Alfacell pursuant to this Agreement, including as the Product may be modified to obtain Regulatory Approval thereof, including the AG Product.
 
Product Infringement” has the meaning set forth in 9.3(c).
 
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Product Studies” means clinical studies, pre-clinical studies, safety studies, epidemiological studies, modeling and pharmacoeconomic studies, in each case including any ancillary or incidental development, investigation or research pertaining thereto, that are designed (a) to support Regulatory Approval for the Product in the Field in the Territory, or (b) to support publications, promotional and educational activities, future labeling changes or new Indications for Ranpirnase. Unless otherwise expressly provided herein or agreed to by the Parties, all “Product Studies” shall be owned by Alfacell.
 
Program Developments” means all inventions, discoveries, patents, patent applications, know-how, copyrights and works of authorship and other intellectual property that are related to Ranpirnase in the Field and are made, developed, created, conceived or reduced to practice during the Term of this Agreement by Alfacell in connection with its work in the Development Program, regardless of whether the invention, discovery, patent application, know-how, or work is patentable.
 
Ranpirnase” means the active pharmaceutical ingredient described in Exhibit A, which may be obtained from natural sources or a recombinant source. For the sake of clarity, sequence variants, and fusion proteins and conjugates that incorporate Ranpirnase, are expressly excluded, but various formulations of the active pharmaceutical ingredient described in Exhibit A are included.
 
Regulatory Approval” means all approvals (including, where applicable, pricing and reimbursement approval and schedule classifications), product and/or establishment licenses, registrations or authorizations of any Governmental Authority, necessary for the commercialization, use, storage, import, export, transport, offer for sale, or sale of a pharmaceutical product for human use in a regulatory jurisdiction within the Territory, including, if and as applicable, the issuance by the FDA of an action letter indicating approval of the NDA; provided, however, that Regulatory Approval for the Product in any Future Indication can occur following issuance by the FDA of an action letter indicating Accelerated Approval of the NDA.
 
Representatives has the meaning set forth in Section 8.1.
 
Royalty” has the meaning set forth in Section 6.3(a).
 
SEC” has the meaning set forth in Section 14.13.
 
Secondary Position Detail” shall mean a Detail in which no more than three products are presented, in which key attributes of the Product are verbally presented consistent with the terms of this Agreement and applicable laws, and where the Product is given significant emphasis (i.e., an emphasis that is more important than the emphasis given to any other product presented (other than the product that is presented as the First Position Detail)).
 
Secondary UMM Indication” means an Indication of the Product for the treatment of UMM, other than the Primary UMM Indication.
 
Solvent Party” has the meaning set forth in Section 13.3.
 
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Sub-distributor” has the meaning set forth in Section 4.3.
 
Supply Agreement” has the meaning set forth in Section 2.4.
 
Targeted Ranpirnase” means any Competing Product that is designed to act, and does act, or is reasonably understood to act, only in a specific manner on only a particular cell, tissue or organ system, for an indication in the Field.
 
Territory” means the United States of America, including its territories, possessions, protectorates and the Commonwealth of Puerto Rico and any United States military base or installation located outside of the United States of America.
 
Term” has the meaning set forth in Section 13.1.
 
Third Party” means any person or entity other than Alfacell or Par or an Affiliate of Alfacell or Par.
 
Third Party Product Event” has the meaning set forth in Section 7.4.
 
Trademark” means the trademark under which the Product may be sold in the Field in the Territory, including as set forth in Exhibit B, as may be amended by the Parties from time to time.
 
Trade Name” means each trade name (i.e., Trademark) established for the Product under this Agreement.
 
Transfer Price” means ***.
 
UMM” means unresectable malignant mesothelioma or mesothelioma presented in a patient who otherwise is not a candidate for surgery.
 
Valid Claim means (a) an unexpired claim of an issued patent within the Alfacell Patents that has not been held to be unpatentable, invalid or unenforceable by a United States court, the United States Patent and Trademark Office, or other authority in the United States, from which decision no appeal is taken or can be taken; and (b) a claim of a pending application within the Alfacell Patents.
 
1.2 Certain Rules of Construction.
 
(a) As used in this Agreement, unless the context otherwise requires: Section, Schedule, Article and Exhibit references are intended to refer to this Agreement; words describing the singular number shall include the plural and vice versa; words denoting any gender shall include all genders; words denoting natural persons shall include corporations, partnerships and other entities, and vice versa; the words “hereof”, “herein” and “hereunder”, and words of similar import, shall refer to this Agreement as a whole, and not to any particular provision of this Agreement; the term “include” and derivations thereof are not intended to apply any limitation to the item(s) specified; and terms such as licensor, licensee and license will be interpreted broadly to refer also to sub-licensing arrangements and/or the Parties thereto.
 
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(b) This Agreement is between financially sophisticated and knowledgeable entities and is entered into by the Parties in reliance upon the economic and legal bargains contained herein, the language used in this Agreement has been negotiated by the Parties hereto and shall be interpreted and construed in a fair and impartial manner without regard to such factors as the Party who prepared, or caused the preparation of, this Agreement or the relative bargaining power of the Parties.
 
ARTICLE II

MANAGEMENT OF THE COLLABORATION
 
2.1 Development Committee.
 
(a) Establishment. The Parties hereby establish a committee consisting of such even number as shall be agreed by the Parties, fifty percent (50%) of whom shall be Par designees and fifty percent (50%) of whom shall be Alfacell designees (the “Development Committee”). Each of the Development Committee members shall have appropriate expertise to perform the functions assigned to the Development Committee pursuant to this Agreement. The initial Development Committee shall consist of a total of six (6) members who shall be designated by each Party within ten (10) business days after the Effective Date. Each Party shall have the right at any time and from time to time to designate a replacement, on a permanent or temporary basis, for any or all of its previously-designated members of the Development Committee. At the beginning of each calendar year during the Term, each Party shall appoint one of its designees to serve as a Co-Chair of the Development Committee. The initial Co-Chairs shall be designated by each Party within ten (10) business days after the Effective Date.
 
(b) Meetings and Procedures.
 
(i) The Development Committee shall meet at least once per calendar quarter, and more frequently at the reasonable request of either Party or as required to discuss and make efforts to resolve disputes, disagreements or deadlocks of the Development Committee, on such dates, and at such places and times, as the Parties shall agree; provided, however, that the Parties shall use their Commercially Reasonable Efforts to cause the first meeting of the Development Committee to occur within thirty (30) days after the Effective Date. The two Co-Chairs shall cooperate to send a notice and agenda for each meeting of the Development Committee to all members of the Development Committee reasonably in advance of the meeting. The location of regularly-scheduled Development Committee meetings shall alternate between the offices of the Parties, unless otherwise agreed. The members of the Development Committee also may convene or be polled or consulted from time to time by means of telephone conference, video conference, electronic mail or correspondence and the like, as deemed necessary or appropriate by the Co-Chairs. The Party hosting any Development Committee meeting shall appoint one person (who need not be a member of the Development Committee) to attend the meeting and record the minutes of the meeting in writing. Such minutes shall be circulated to the members of the Development Committee promptly following the meeting for review and comment.
 
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(ii) Alfacell agrees to keep the Development Committee reasonably informed in respect of its conduct of the Development Program pursuant to its authority and responsibility set forth in Section 3.1, and in particular Alfacell shall provide the Development Committee with information related to the overall progress of the Development Program. Upon the request of Par’s members, Alfacell shall provide copies and updates of its development plans to the Development Committee. Par’s members shall provide advice, suggestions and constructive feedback on the Development Program. Additionally, Alfacell shall promptly notify the Development Committee if, during the Term, it discovers any new, reproducible uses for Ranpirnase in the Field which have been confirmed by Alfacell and/or are the subject of an invention disclosure or draft patent application, and relevant information related thereto (as such information provided by Alfacell shall be deemed Alfacell Information hereunder).
 
(iii) The Development Committee has no decision-making authority except as expressly set forth herein. Subject to Section 3.7, the final protocol design for any Phase III Clinical Trials for any Future Indication, including any material modification thereof (the “Material Development Decision”), shall be determined by a vote of the Development Committee. All decisions of the Development Committee shall be made by unanimous vote or unanimous written consent of both Parties, with each Party having, collectively among its respective designees, one vote in all decisions. The members of the Development Committee shall use Commercially Reasonable Efforts to decide all matters assigned to the Development Committee under this Agreement or otherwise referred to it by mutual agreement of the Parties; provided, however, that if the members of the Development Committee are unable to make a decision by unanimous vote or unanimous written consent within ten (10) days after commencing discussions regarding such decision, or if Development Program timing constraints make submission of any matter to the Development Committee impracticable, then Alfacell shall have the final decision-making authority with respect to such decision, except (A) in respect of the Material Development Decision, and/or (B) in respect of the Development Committee’s recommendation that Alfacell should not pursue a recombinant source of Ranpirnase, wherein any final decision not to pursue a recombinant source of Ranpirnase shall require the written approval of both Parties.
 
(c) Purposes and Powers. The principal purpose of the Development Committee shall be to provide a forum for open communication between the Parties with respect to development and manufacturing of the Product in general, and for Par to act in an advisory and consultative capacity with respect to the Development Program. The Development Committee shall make recommendations regarding the overall strategy for the Development Program, and shall provide advice, guidance, direction and other recommendations with respect to the Development Program. Subject to the express rights of the Parties as set forth herein, the functions of the Development Committee shall include:
 
(i) Acting as liaison between the Parties to ensure open and regular communication channels, and more particularly to ensure that the Parties are informed of, and have a forum to discuss, the ongoing progress of the Development Program;
 
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(ii) Reviewing and recommending (or declining to recommend) proposed amendments to the Development Program;
 
(iii) Reviewing, consulting on and providing input in respect of activities related to the manufacturing of the Product and the selection of manufacturer(s) of the Product (provided that Alfacell shall not be required to renegotiate any previously negotiated terms and conditions with any such Product manufacturer(s), and further provided that such consultation and input shall not unreasonably delay Alfacell’s negotiation and completion of its Product contract manufacturing arrangements, wherein the reasonableness of any delay shall be determined by Alfacell in good faith after consultation with Par);
 
(iv) Reviewing and recommending (or declining to recommend), in consultation with the Commercialization Committee, activities (A) related to the publication and/or dissemination of the clinical data and reports related to Product Studies, including publications, posters, abstracts and presentations, and (B) with respect to other matters that intersect or overlap with Commercialization activities; and
 
(v) Performing such other activities and discharging such other responsibilities as may be assigned to the Development Committee by the Parties pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
 
2.2 Commercialization Committee.
 
(a) The Parties hereby establish a committee, separate from the Development Committee, which shall provide a forum for open communication between the Parties regarding Product Commercialization activities in the Field, and which shall be responsible for such matters related to Commercialization of the Products in the Field in the Territory as may be described below. The Commercialization Committee shall consist of such even number as shall be agreed by the Parties, fifty percent (50%) of whom shall be Par designees and fifty percent (50%) of whom shall be Alfacell designees (the “Commercialization Committee”). Each Party shall have the right at any time and from time to time to designate a replacement, on a permanent or temporary basis, for any or all of its previously-designated members of the Commercialization Committee. At the beginning of each calendar year during the Term, each Party shall appoint one of its designees to serve as a Co-Chair of the Commercialization Committee. The initial Commercialization Committee shall consist of six (6) members (including the Co-Chairs of such Committee), who shall be designated by each Party within ten (10) business days after the Effective Date. For the sake of clarity, an individual may serve on both the Development Committee and the Commercialization Committee. The Commercialization Committee shall meet at least once per calendar quarter, and more frequently as mutually agreed by the Parties, on such dates, and at such places and times, as the Parties shall agree.
 
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(b) Par agrees to keep the Commercialization Committee reasonably informed in respect of its Commercialization of Products in the Field in the Territory pursuant to its authority and responsibility set forth in Section 5.1, and in particular Par shall (a) provide the Commercialization Committee at its regularly scheduled meetings with copies of Par’s annual Product marketing plans, information regarding Par’s Commercialization strategy, and updates regarding the foregoing and the progress of Par’s Commercialization activities, (b) promptly advise the Commercialization Committee of any unforeseen material problems or delays encountered since the date of its last report in connection with the Commercialization activities, and (c) provide Alfacell as soon as reasonably practicable with such other material information as Alfacell’s Commercialization Committee members may reasonably request in writing from time to time with respect to the status of the Commercialization activities and progress. Alfacell’s members shall provide advice, suggestions and constructive feedback on such Commercialization strategy, plans and activities (especially in view of Alfacell’s retained rights regarding Product commercialization outside of the Field and outside of the Territory, and Alfacell’s desire to achieve (to the extent appropriate) global harmonization of Product commercialization (including branding) worldwide). Par will reasonably and in good faith consider any comments and recommendations that the Commercialization Committee may have with respect to the Commercialization of the Product.
 
(c) The Commercialization Committee shall (i) review and recommend (or decline to recommend), in consultation with the Development Committee, (A) activities related to the publication and/or dissemination of the clinical data and reports related to Product Studies, including publications, posters, abstracts and presentations and (B) matters that intersect or overlap with Product development and/or manufacturing activities, (ii) support Par’s strategy and plans regarding Commercialization (to the extent that such strategy and plans have been provided to the Commercialization Committee), and (iii) perform such other activities and discharge such other responsibilities as may be assigned to the Commercialization Committee by the Parties pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. Par will reasonably and in good faith consider any comments and recommendations that the Commercialization Committee may have with respect to the Commercialization of the Product.
 
(d) The Commercialization Committee has no decision-making authority except as expressly set forth herein. All Commercialization issues related to the initial medical claims for the core launch materials for the Product that will be submitted to the FDA for pre-clearance review (the “Material Commercialization Decision”) shall be determined by a vote of the Commercialization Committee. If the Commercialization Committee is unable to agree on the Material Commercialization Decision, such dispute or disagreement shall be referred to the CEO of Alfacell and the CEO of Par for resolution, and the CEOs shall resolve the matter (without resort to Section 14.5). All decisions of the Commercialization Committee shall be made by unanimous vote or unanimous written consent of both Parties, with each Party having, collectively among its respective designees, one vote in all decisions. The members of the Commercialization Committee shall use Commercially Reasonable Efforts to decide all matters assigned to the Commercialization Committee under this Agreement or otherwise referred to it by mutual agreement of the Parties; provided, however, that if the members of the Commercialization Committee are unable to make a decision by unanimous vote or unanimous written consent within ten (10) days after commencing discussions regarding such decision, then, except in respect of any Material Commercialization Decision, Par shall have the final decision-making authority with respect to such decision (subject to any limitations on such authority expressly set forth herein); provided, however, that if Commercialization timing constraints make submission of the matter to the Commercialization Committee impracticable, then Par shall have the discretion to make such determination.
 
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2.3 Expenses. Each Party shall be responsible for all travel and related costs and expenses for its members and approved invitees to attend meetings of, and otherwise participate on, the Development Committee and/or Commercialization Committee.
 
2.4 Ancillary Agreements. All designees of each Party serving on the Development Committee and/or the Commercialization Committee shall as a condition to such service execute a nondisclosure agreement in form and substance reasonably satisfactory to the Parties. Additionally (i) as of the Effective Date, the Parties shall enter into a Supply Agreement which is attached hereto as Exhibit C (the “Supply Agreement”), and (ii) within sixty (60) days of the date that the first NDA is submitted to the FDA by Alfacell, the Parties shall enter into a Quality Agreement on mutually agreeable and customary terms, and (iii) within sixty (60) days after Alfacell’s election to co-promote Product pursuant to Section 5.3 or 5.4, the Parties shall enter into a definitive, written Co-Promotion Agreement on mutually agreeable terms in accordance with Section 5.4.
 
ARTICLE III
 
DEVELOPMENT PROGRAM
 
3.1 Alfacell Responsibility and Control. Subject to Sections 2.1(b)(iii) and 3.7, Alfacell shall have final decision-making authority and primary responsibility for the Development Program and all non-Commercialization strategies, plans and activities regarding the Product. Alfacell shall use its Commercially Reasonable Efforts to conduct the Development Program, to obtain Regulatory Approval for the Product, and to manufacture the Product, all in accordance with this Agreement. More specifically, Alfacell shall use its Commercially Reasonable Efforts to (a) develop the Product for the Primary UMM Indication and, subject to Section 3.7, at least one Future Indication, (b) prepare and submit all required application(s) for Regulatory Approval in the Field in the Territory in respect of the Product for such Indications, including the applicable NDA(s), and (c) if necessary, and subject to Section 6.2(a)(ii), work in consultation with the Development Committee to prepare for any meeting before, and comply with any action plans negotiated by Alfacell and the FDA in response to requests of, the Oncologic Drugs Advisory Committee to the FDA (the “ODAC”). Subject to Section 3.7, Alfacell has the sole right to develop the Product for Future Indications. Subject to the terms and conditions contained in this Agreement, Alfacell shall have sole responsibility and control over development and manufacture of the Product for use in the Field for the Territory and, subject to Section 3.3(b), all regulatory matters related thereto, including control over and responsibility for executing all aspects of the Development Program, including planning, strategy, administrative management, and fiscal control; provided, however, that, subject to Section 6.2(a)(ii), Alfacell shall include Par (through the Development Committee) in such efforts in an advisory and consultative capacity. As of the Effective Date, the Parties anticipate that the Development Program shall be conducted at and coordinated from the facilities of Alfacell. Alfacell shall comply, and shall require all of its Third Party agents and contractors, if any, to comply, with all applicable laws in the conduct of the Development Program.
 
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3.2 Development Program. Subject to the provisions of this Agreement, Alfacell shall determine the development plan(s) and the Development Program, and the execution thereof shall be within Alfacell’s decision-making authority and control (subject to Section 2.1(b)(iii)). Notwithstanding the foregoing or any other provision of this Agreement, Par acknowledges and agrees that (a) the Development Program is experimental in nature; and (b) Alfacell does not guarantee that the Development Program will be successful or that Regulatory Approval will be obtained for the Product in the Field in the Territory. During the Term, subject to the other provisions of this Agreement, Alfacell may revise the development plan(s) and/or the Development Program at any time and from time to time, provided that (y) Alfacell provides the Development Committee with a reasonable opportunity to review and comment on any proposed revision to the development plan(s) and/or the Development Program, and (z) Alfacell shall consider in good faith any such comments prior to the adoption and implementation of such revisions.
 
3.3 Clinical and Regulatory Approval.
 
(a) Conduct by Alfacell. The Parties acknowledge that Alfacell has initiated Phase III Clinical Trials in the Territory in respect of the Product for the Primary UMM Indication. Alfacell shall use Commercially Reasonable Efforts to (i) conduct required clinical trials of the Product for the Primary UMM Indication in the Territory and, subject to Section 3.7, for the Future Indications in the Territory agreed to be pursued by the Parties, and undertake steps to obtain Regulatory Approval in accordance with this Agreement and in a manner consistent with the Development Program; and (ii) through the Development Committee, include Par in such efforts in an advisory and consultative capacity. Alfacell acknowledges that certain Product-related activities undertaken by Alfacell outside of the Territory may trigger material reporting obligations to the FDA and may materially affect the Commercialization of the Product by Par in the Territory, and with respect to such activities that Alfacell determines in good faith are likely to trigger such materially reporting obligations and/or are likely to materially affect such Commercialization by Par, Alfacell shall disclose such Product-related activities outside of the Territory to Par and permit Par to promptly review them and provide comments and suggestions that would enable both Parties to achieve their objectives under this Agreement. If the Parties are unable to reach mutual agreement regarding a fair and reasonable approach that would avoid or minimize any material reporting obligations and material effects on Commercialization of the Product by Par, such dispute or disagreement regarding such fair and reasonable approach shall be referred to the CEO of Alfacell and the CEO of Par for resolution, and the CEOs shall resolve the matter (without resort to Section 14.5); provided, however, that this dispute resolution provision shall not empower Par’s CEO with any decision-making authority regarding Alfacell’s Product-related activities outside the Territory, including the right to veto any such activities.
 
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(b) Regulatory Submissions.
 
(i) The Parties acknowledge that no Product has been reviewed or approved for sale or use as a human therapeutic product by any Governmental Authority. Subject to Section 3.1, Alfacell shall prepare any required application(s) for Regulatory Approval in the Field in the Territory. Unless otherwise agreed by the Parties, Alfacell shall own, in its entirety, all clinical data and reports related to Product Studies including clinical trials for the Product; provided, however, that, during the Term, Par shall have the right to (i) obtain copies of, and to use, Alfacell Information that is included in Alfacell’s NDA for the Product for an Indication, as Par reasonably determines is necessary or desirable to further the Commercialization of the Product in the Field in the Territory, and (ii) request copies of, and to use, Alfacell Information that is not included in Alfacell’s NDA for the Product for an Indication, with Alfacell’s consent (such consent not to be unreasonably withheld) as Par reasonably determines is necessary or desirable to further the Commercialization of the Product in the Field in the Territory. At all times both prior to and following Regulatory Approval of the Product in the Field in the Territory, Alfacell shall (A) inform Par of all substantive communications from the FDA concerning the NDA and any other material communications from the FDA concerning the Product in the Field within forty-eight (48) hours of receipt thereof, such substantiality and materiality to be solely based on Alfacell’s reasonable evaluation, and (B) provide copies of proposed material FDA communications and submissions concerning the Product to the Development Committee and Par prior to their submission to the FDA, subject to the extent practicable, as described below. Except to the extent that Alfacell must respond to the FDA or make a submission to the FDA before receipt of the Development Committee’s and/or Par’s comments, Alfacell will not respond substantively in writing to any FDA communication or otherwise make any written submissions to the FDA concerning, in either case, the Product in the Field without first giving Par a reasonable opportunity to review and comment thereon. Such opportunity shall not exceed ten (10) days, unless otherwise required by the FDA, in which case Alfacell shall use Commercially Reasonable Efforts to provide Par with an opportunity to review and comment to the extent practicable, but Par agrees that Alfacell shall be entitled to respond in any manner as Alfacell determines in its reasonable discretion is appropriate given the timing of the FDA regulatory review process. Alfacell shall review and consider in good faith any comments received from Par related to such FDA communications or submissions related to the Product in the Field, and any comments or suggestions timely received from Par that are otherwise related to Regulatory Approvals for the Product in the Field in the Territory. For the sake of clarity, the Parties recognize that the FDA regulatory review process may involve both non-Commercialization (i.e., development and/or manufacturing) and Commercialization aspects of the Product in the Field in the Territory (for example, proposed labeling of the Product for a given Indication). If any such intersection or overlap of Alfacell’s final decision-making authority regarding development and manufacturing and Par’s final decision-making authority regarding Commercialization results in a dispute or disagreement, such dispute or disagreement shall be referred to the CEO of Alfacell and the CEO of Par for resolution, and the CEOs shall resolve the matter (without resort to Section 14.5).
 
(ii) The Parties shall cooperate in good faith with respect to obtaining, and Alfacell shall use Commercially Reasonable Efforts to enable representatives of Par to attend, if and as requested by Par and as permitted by the FDA, formal meetings with the FDA relating to Regulatory Approval of the Product in the Field in the Territory. The Parties shall cooperate in good faith with respect to the conduct of any inspections by the FDA or equivalent foreign regulatory authority of a Party’s site and facilities related to the Product. To the extent either Party receives any material written or oral communication from the FDA or equivalent foreign regulatory authority relating to the Regulatory Approval process with respect to the Product in the Field in the Territory, the Party receiving such communication shall promptly notify the other Party and provide a copy of such written communication and/or a written summary of such oral communication as soon as reasonably practicable.
 
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(iii) If “ONCONASE®” is not approved by the FDA as the Product Trade Name, Alfacell shall not submit any other Trade Name(s) for the Product for approval by the FDA unless such other Trade Name(s) has (have) been mutually agreed by the Parties. Subject to the license rights granted herein, Alfacell shall own all right, title, and interest to ONCONASE and all such Trade Names and intellectual property rights related thereto (including trademark and copyright), and Par shall (A) assign any right, title, and interest it has in any Trade Names (including intellectual property rights related thereto (including trademark and copyright)) to Alfacell, free and clear of all liens, claims, and encumbrances, and (B) take any and all actions reasonably requested by Alfacell in furtherance of the foregoing. *** related to the choosing of any new Trade Name for the Product in the Field in the Territory, including any market research studies conducted by Par pertaining to ONCONASE or any new proposed Trade Name(s) for the Product.
 
3.4 Development Program Funding. Except as otherwise expressly provided herein or as otherwise expressly agreed by the Parties in writing, Alfacell shall be solely responsible for payment of all Development Costs.
 
3.5 Development Program Reporting. Alfacell shall (a) provide Par at regularly scheduled meetings of the Development Committee with summary updates regarding the progress of the Development Program and Regulatory Approval process, (b) promptly advise Par of any unforeseen material problems or delays encountered since the date of its last report in connection with the Development Program, and (c) provide Par as soon as reasonably practicable with such other material information as Par may reasonably request in writing from time to time with respect to the status of the Development Program.
 
3.6 Post-Regulatory Approval. Alfacell shall, at its sole cost and expense and under its control and responsibility, (a) maintain Regulatory Approval(s) of the Product in the Field in the Territory at all times during the Term following receipt of the same, subject to Par’s cooperation with such efforts as may be required to maintain such Regulatory Approval(s) and (b) conduct any post-Regulatory Approval development programs for the Product that are required by or negotiated with the FDA as a condition to obtaining or maintaining Regulatory Approval of the Product. If mutually determined by the Parties to be beneficial to the development and/or Commercialization of Product in the Field in the Territory, the Parties shall collaborate and cooperate in conducting any post-Regulatory Approval development programs for the Product in the Field in the Territory that are not required by or negotiated with the FDA, ***. Such post-Regulatory Approval development programs shall be conducted in accordance with a written agreement and budget which are accepted in writing by both Parties.
 
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3.7 Future Indications Programs. Notwithstanding the scope of Alfacell’s decision-making authority set forth herein (including in Section 3.1), (a) without the prior consent of the Development Committee, Alfacell will not initiate a Phase III Clinical Trial on the Product for any Future Indication in the Territory unless the Development Committee has agreed to the design of such trial, and (b) even with such prior consent by the Development Committee, without the prior written consent of Par, (i) in any consecutive twenty-four (24) month period Alfacell shall not initiate first Phase III Clinical Trials on, and Par shall have no financial obligations in Section 6.2(b) (Future Indication Milestones) for, more than two (2) ongoing Future Indications in the Territory (where the initiation of a first Phase III Clinical Trial in a Future Indication in the Territory shall be deemed to occur on the date of administration of the first dose of the Product to the first patient in such first Phase III Clinical Trial), and (ii) Alfacell shall not initiate, in the aggregate, first Phase III Clinical Trials on more than three (3) Future Indications in the Territory. As of the Effective Date, the Indications recited in clauses (a)-(c) of the definition of “Future Indications” have been mutually agreed by the Parties to be Indications eligible for study by Alfacell pursuant to this Section 3.7. Upon the determination of the design of the Phase III Clinical Trials for any Future Indication in the Territory by the Development Committee, Alfacell shall use Commercially Reasonable Efforts to develop the Product for such Future Indication in the Territory. In the event that the Development Committee is unable to agree as to the design of such trial described in clause (a) above, such dispute or disagreement shall be referred to the CEO of Alfacell and the CEO of Par for resolution, and the CEOs shall use their best efforts to resolve the matter in good faith within thirty (30) days after such referral, subject to Section 14.5.
 
3.8 Recombinant Source. Unless otherwise agreed by the Parties, during the Term, Alfacell shall use its Commercially Reasonable Efforts to pursue a recombinant source of Ranpirnase. As of the Effective Date, the Parties agree that obtaining such recombinant source would be advantageous and would further the objectives of both Parties under this Agreement. Notwithstanding the foregoing or any other provision of this Agreement, (i) Par acknowledges and agrees that Alfacell does not guarantee that such pursuit will be successful or that Regulatory Approval in the Field in the Territory will be obtained for any Product containing recombinant Ranpirnase and (ii) Alfacell shall not use in the manufacturer of the Product Ranpirnase that has been obtained from a recombinant source without Par’s prior written consent.
 
ARTICLE IV
 
LICENSE
 
4.1 Grant to Par.
 
(a) License Generally; Appointment as Exclusive Distributor. Alfacell hereby grants to Par the following rights and licenses:
 
(i) an exclusive (even as to Alfacell, but subject to the co-exclusive rights provided for or referred to in Section 4.1(c)(iii) and 5.4), royalty-bearing license under the Alfacell Patents and under any and all applicable Regulatory Approvals in the Field to promote, market, have marketed, distribute, sell, offer for sale and otherwise Commercialize Product in the Field in the Territory and to do such other things necessary to comply with Par’s obligations under this Agreement.
 
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(ii) as further provided in, and subject to Article IX, in order to protect the Product in the Field, an exclusive (even as to Alfacell but subject to Alfacell’s rights in Article IX) license to enforce the Alfacell Patents against any potential Third Party infringement that could reasonably be expected to adversely affect the Commercialization or value of the Product in the Territory.
 
(b) Restriction on Right to Sublicense. Notwithstanding the license grants provided in Section 4.1(a), Par (i) shall have the right to market, sell, offer for sale, and have sold AG Product only beginning (a) on the date on or, with Alfacell’s prior written consent, immediately prior to the anticipated date that a Third Party sells or offers for sale a generically-labeled version of the Product or (b) if applicable, upon (or as part of) settlement of a litigation under Section 9.3 that allows a Third Party to sell or offer for sale a generically-labeled version of the Product and (ii) shall not have a general right to sublicense, but shall have the limited right to grant sublicenses only under its rights to market, sell, offer for sale, and have sold AG Product and only in connection with settlement of a litigation under Section 9.3 that allows a Third Party to sell or offer for sale a generically-labeled version of the Product, provided, that Par has obtained the consent of Alfacell to such settlement to the extent required under Section 9.3. Par will at all times remain responsible to Alfacell for all of its obligations under this Agreement and shall be responsible for the acts or omissions of its sublicensees in exercising rights granted hereunder. Each sublicense granted by Par shall be consistent with the terms of this Agreement, and Par shall furnish Alfacell a copy of any such sublicense it grants.
 
(c) Reservation of Rights.
 
(i) Alfacell hereby retains any and all rights which are not expressly granted to Par hereunder.
 
(ii) Nothing in Section 4.1(a) limits Alfacell from exercising its co-promote rights under Section 5.4.
 
(iii) Nothing in Section 4.1(a) limits Alfacell’s ability to perform its obligations under this Agreement, the Supply Agreement, the Quality Agreement and the Co-Promotion Agreement (if Alfacell exercises its co-promote right).
 
(iv) For purposes of clarity and without limitation, Alfacell has exclusively retained (even as to Par) the right to perform (alone or with Third Parties) any and all activities related to the use, research, manufacture and development of Products within and outside the Field and the Territory, and to Commercialize the Products outside the Field in the Territory and in all fields outside the Territory.
 
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(v) Alfacell has retained the right to enforce the Alfacell Patents as it sees fit against any potential Third Party infringement that could not reasonably be expected to adversely affect the Commercialization or value of the Product under this Agreement, including any patent rights not related to Ranpirnase, Product or Competing Product. For purposes of clarity, Par shall not have any right to enforce, and Alfacell shall exclusively have the right to enforce, each patent claim covering one or more Amphinases. Similarly, with respect to each Modified Targeted Ranpirnase that becomes subject to an Option granted to Par under Section 4.5, if Par rejects its Option under Section 4.5, or if Par does not inform Alfacell of its exercise of the Option within the required time period, or if the Parties have not executed a New License Agreement within the prescribed period under Section 4.5(b) after Par’s exercise of the Option, then thereafter Par shall not have any right to enforce, and Alfacell shall exclusively have the right to enforce, patent claims covering the particular Modified Targeted Ranpirnase that was subject to the Option. In all events, prior to the enforcement of any Alfacell Patent against any Third Party in the Territory, Par and Alfacell shall confer in good faith regarding such enforcement.
 
(d) Trademark and Trade Name License.
 
(i) Alfacell hereby grants to Par an exclusive (even as to Alfacell, subject to the co-promote right provided to Alfacell in Section 5.4), royalty-bearing (but at no additional consideration except as expressly provided herein) license in the Field in the Territory, without the right to sublicense, under the Trademark and each Trade Name that has obtained or hereafter obtains Regulatory Approval for use in connection with the Product, to promote, market, offer for sale, sell and have sold Product in the Field in the Territory; provided, however, that Alfacell retains the right to exercise the foregoing rights only as and to the extent required to permit Alfacell to exercise its co-promote right under Section 5.4 and to perform its obligations under this Agreement. To the extent required by applicable law in the Territory, Alfacell shall make applications to the applicable Governmental Authority for the registration of Par as a registered user of the Trademark and each Trade Name that has obtained or hereafter obtains Regulatory Approval for use in connection with the Product, respectively, in respect of each respective registration of the Trademark or such Trade Name(s), and Par shall cooperate with Alfacell in making such applications. For the avoidance of doubt, Alfacell retains all rights to the Trademark and each Trade Name except to the extent explicitly granted to Par hereunder, and all goodwill associated with the use of the Trademark and each Trade Name will inure exclusively to the benefit of Alfacell.
 
(ii) Par shall comply with the guidelines attached hereto (or to be attached hereto after the Effective Date by Alfacell, subject to Par's consent, not to be unreasonably withheld) as Schedule 4.1(d) in respect of the size, form, and manner of the use of the Alfacell name and logo, and the Trademark and Trade Name(s) in the Commercialization of the Product in the Field in the Territory, subject to any reasonable future revisions thereto requested by Alfacell in writing, provided that any such material revisions thereto shall not be effective unless and until consented to by Par, such consent not to be unreasonably withheld (however, if Par does not so consent, such dispute shall be resolved by the CEO of Alfacell and the CEO of Par (without resort to Section 14.5)). All packaging, inserts, labels, promotional or other materials for the Product sold or to be sold by Par and its Sub-distributors in the Territory shall display the name and Trademark of Alfacell and each such Trade Name (except in respect of the AG Product), and shall identify Alfacell as licensor and manufacturer of the Product. Any failure by Par or its Sub-distributors to comply with this Section 4.1(d) shall be a material breach of this Agreement.
 
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(e) Challenge. If Par or any of its Affiliates or Sub-distributors directly challenges, or directly assists any Third Party in challenging, in any forum the validity, enforceability, scope or any other elements of the Alfacell Patents, then Alfacell may terminate this Agreement on thirty (30) days’ notice to Par if Par or any of its Affiliates or Sub-distributors shall not cease such challenge within such 30-day period. Without limiting the generality of the foregoing, Par specifically agrees that filing a request for reexamination, attempting to institute an interference, or filing an opposition with respect to any Alfacell Patent(s) or foreign counterparts thereof will be deemed a “challenge” under this Section 4.1(e).
 
4.2 Information Transfer.  
 
(a) Promptly after the Effective Date, Alfacell shall, at its own cost, disclose to Par in writing, or via mutually acceptable electronic media, copies or reproductions of all Alfacell Information, but only to the extent not previously disclosed to Par, that are reasonably necessary or useful for Par and its Sub-distributors to market, sell or have sold the Product in the Field in the Territory. In addition, during the Term of this Agreement, Alfacell shall promptly disclose to Par in writing, or via mutually acceptable electronic media, on an ongoing basis, copies or reproductions of all new Alfacell Information that is reasonably necessary for Par and its Sub-distributors to market, sell or have sold the Product in the Field in the Territory. Such disclosed Alfacell Information shall be automatically deemed to be within the scope of the licenses granted to Par under Section 4.1 without payment of any additional compensation.
 
(b) During the Term of this Agreement, (i) when either Party becomes aware of a potential infringement of the Alfacell Patents by a Third Party in the Field in the Territory, (ii) during the course of a Third Party infringement action brought by or against the Parties as a result of the Party’s (Parties’) activities pursuant to this Agreement, or (iii) on Par’s reasonable request, Alfacell shall promptly disclose to Par in writing, or via mutually acceptable electronic media, copies or reproductions of all new Alfacell Information described in Section 4.2(a) which has not been previously disclosed to Par and which is reasonably necessary for Par to exploit its rights under Article IX. Such disclosed Alfacell Information shall be automatically deemed to be within the scope of the licenses granted to Par under Section 4.1 without payment of any additional compensation.
 
4.3 Appointment of Sub-distributors. Par may, with the prior written consent of Alfacell in its sole discretion (such consent not to be withheld for any potential sub-distributor that is an Affiliate of Par), appoint sub-distributors (which may be Par’s Affiliates or non-Affiliates; each a “Sub-distributor”) to distribute Product for use in the Field in the Territory, subject to the following clauses (a-e) and the other terms and conditions of this Agreement:
 
(a) each agreement with a Sub-distributor shall be in writing and shall state that the Sub-distributor’s rights under such agreement are subject to all relevant terms and conditions of this Agreement, including (without limitation) provisions and restrictions relating to Field, Territory, price, payment, reporting, audit of books and records, promotional materials, trade name, and termination;
 
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(b) if this Agreement terminates, in whole or in part, the rights of any Sub-distributors shall automatically be terminated in accordance therewith;
 
(c) Par shall promptly notify Alfacell in writing of any breaches of this Agreement that are due to any act or omission by any Sub-distributor(s), and shall report to Alfacell the full details of such breach and the actions to be taken by Par to cure such breach;
 
(d) Par shall ensure that each Sub-distributor complies with all applicable terms and conditions of this Agreement, and shall be liable to Alfacell for any failure of any Sub-distributor to do so; and
 
(e) Par shall provide Alfacell with the names and primary business addresses of all Sub-distributors and, within fifteen (15) days of the effective date of each agreement with a Sub-distributor, Par shall provide a copy of each such agreement to Alfacell.
 
For the avoidance of doubt, (i) any act or omission of a Sub-distributor that would be a breach of this Agreement if performed by Par will be deemed to be a breach by Par of this Agreement, and (ii) Par’s customers (e.g., wholesalers) shall not be considered Sub-distributors for purposes of this Agreement.
 
4.4 Exclusivity.
 
(a) Alfacell agrees that, during the Term, it will not, and it will not enable or contract with any Third Party to, (i) market, sell or distribute the Product in the Field in the Territory or develop or supply the Product for sale in the Field in the Territory, except in accordance with Section 5.4 and/or for the development and supply of the Product in the Field in the Territory pursuant to this Agreement, (ii) market, sell or distribute any Competing Product in the Territory or develop or supply any Competing Product for sale in the Territory; or (iii) use the Trademark in connection with any product in the Territory other than the Product pursuant to this Agreement; provided, however, that, subject to Section 4.5, the foregoing restrictions provided in this Section 4.4(a) shall not restrict Alfacell, directly or through a Third Party, from developing, manufacturing, importing, marketing, selling or distributing Modified Targeted Ranpirnase.
 
(b) Par agrees that, and shall cause its Sub-distributors to agree that, during the Term, Par and its Sub-distributors will not, and will not enable or contract with any Third Party to manufacture, import, market, sell or distribute any Competing Product in the Territory. To the fullest extent permitted by applicable law, Par is prohibited from selling (and Par shall not permit its Sub-distributors to sell), and Par and its Sub-distributors shall not sell, Product (i) outside the Territory, (ii) to customers in the Territory that Par or its Sub-distributors know, or have reason to know, plan to resell or in the past have resold the Product for use outside the Territory, and Par shall not during the Term actively approach, or accept or fill orders from, customers outside the Territory. This prohibition includes detailing, visiting, calling, mailing, or marketing Product to such customers. If Par or its Sub-distributors knowingly sell the Product outside of the Territory, Par shall provide full details of such Product sale to Alfacell and pay Alfacell, at Alfacell’s option, in addition to any other remedies available to Alfacell, for each Product thus sold, ***. In addition, Alfacell may terminate this Agreement on sixty (60) days’ notice to Par if Par does not cease such sales, and cause its Sub-distributors to cease such sales, outside the Territory within such 60-day period. Additionally, Par agrees that, and shall cause its Sub-distributors to agree that, during the Term, Par and its Sub-distributors will not, and will not enable or contract with any Third Party to, promote, market, have marketed, distribute, offer for sale, sell or have sold the Product outside of the Field.
 
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4.5 Right of First Negotiation.
 
(a) If, following the Effective Date, Alfacell determines that a particular Modified Targeted Ranpirnase compound demonstrates activity across one or more tumor cell types and has commercial viability (and such determination is reasonably supported by reasonable non-clinical or pre-clinical data in respect of such cell type(s)), Alfacell shall, prior to instituting any Phase III development program in respect thereof, provide Par with a one time written notice of information that Alfacell possesses or that Alfacell has a contractual right with any Third Party to obtain, subject to any corresponding contractual obligation, including copies of such data, and an estimate of the cost for developing and obtaining regulatory approval therefor, that is reasonably required by Par to determine whether or not to enter into negotiations for a license agreement with Alfacell with respect to such Modified Targeted Ranpirnase. The delivery of such notice shall automatically grant to Par an exclusive option (the “Option”) to enter into an agreement with Alfacell for an exclusive license to permit Par to market, sell and have sold such Modified Targeted Ranpirnase in respect of the applicable indications (the “New License Agreement”). Par shall determine and notify Alfacell of its determination in writing, as soon as practicable, and in any event no more than *** days after the grant of such Option by Alfacell, to (i) exercise the Option by delivery of written notice to Alfacell of its exercise of such Option, or (ii) reject the Option. The exercise, or determination not to exercise, by Par of its rights under this Section 4.5(a) in respect of any granted Option shall not affect its rights in respect of any other Modified Targeted Ranpirnase compound that was not subject to such Option. Any data or other information provided by Alfacell to Par pursuant to this Section 4.5(a) shall be deemed and treated as Confidential Information in accordance with and subject to Section 8.1. If Par fails to exercise its Option within such *** period, or if Par rejects its Option, or if the Parties do not execute a New License Agreement despite their good faith efforts during the *** described in subsection (b) below, then within ten (10) business days after such failure, rejection or absence of execution (as applicable), Par shall return to Alfacell all documentation containing Confidential Information of Alfacell that was received by Par pursuant to this Section 4.5(a).
 
(b) If Par exercises its Option, the Parties shall, during the *** from the date of exercise of the Option, negotiate exclusively a New License Agreement with one another in good faith. If, following such ***, the Parties have not executed the New License Agreement despite their good faith efforts, Alfacell may, but shall not be obligated to, offer such license for Modified Targeted Ranpirnase for the applicable indication(s) to a Third Party. If Par rejects the Option, or does not inform Alfacell of its exercise of the Option within the *** after the grant of such Option by Alfacell, (i) Alfacell may, but shall not be obligated to, negotiate and enter into a license agreement with a Third Party, and (ii) thereafter the particular Modified Targeted Ranpirnase that had been subject to such Option shall be deemed to no longer be a “Competing Product” for purposes of this Agreement.
 
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ARTICLE V
 
COMMERCIALIZATION
 
5.1 Par Responsibility and Control. Except as otherwise expressly set forth herein, subject to the input of the Commercialization Committee, Par shall have responsibility for all Commercialization activities in the Field in the Territory, including developing strategies and tactics related to the advertising, promotion, pricing, marketing and selling the Product. Par shall have final decision-making authority and primary responsibility for all Commercialization strategies, plans and activities regarding the Product in the Field in the Territory. Par shall use its Commercially Reasonable Efforts to Commercialize the Product in the Primary UMM Indication, the Secondary UMM Indication and any Future Indications that have obtained Regulatory Approval in the Territory. Par shall include Alfacell in such efforts in an advisory and consultative capacity. Par shall comply, shall cause its Sub-distributors to comply, and shall require all of its Third Party agents and contractors, if any, to comply, with all applicable laws in Commercializing the Product in accordance with this Agreement.
 
5.2 Certain Present Intentions and General Obligations of Par. As of the Effective Date, Par intends on or before the Initial Commercial Sale to assign a dedicated product manager for Commercialization of the Product. In addition, following the Initial Commercial Sale, Par shall (if it has not theretofore) employ or engage a sales training manager (such position may be filled by an employee or a consultant experienced in oncology) and a reimbursement specialist (who shall be knowledgeable about Part B).
 
5.3 Specific Commercialization Rights and Obligations of Par.
 
(a) Following Regulatory Approval for the Product for the Primary UMM Indication, Secondary UMM Indication and any Future Indication, Par shall use Commercially Reasonable Efforts to Commercialize the Product for each such applicable Indication in accordance with this Agreement and in a manner consistent with the then-current Commercialization plan(s), and shall include Alfacell in such efforts in an advisory and consultative capacity. Subject to any conditions or limitations set forth herein, it shall be Par’s sole right and responsibility to (a) determine the commercially reasonable launch dates for the Product, (b) develop advertising and promotional materials related to the Product, (c) book sales for the Product, (d) handle all returns of the Product, (e) handle all aspects of order processing, invoicing and collection of receivables for the Product, (f) collect data regarding sales to hospitals and other end users of the Product, (g) monitor inventory levels of the Product, (h) provide first line customer support and pharmacovigilance (and after such initial support, pharmacovigilance support shall be handled in accordance with Article X), (i) warehouse the Product, and (j) determine the prices for the Product and any discounts and rebates that may be offered thereto, including decisions relating to customer allowances and credits. Par shall determine the Commercialization plan(s) and Commercialization activities, and the execution thereof shall be within Par’s decision-making authority and control. Par shall use Commercially Reasonable Efforts to achieve an Initial Commercial Sale within *** after Alfacell obtains Regulatory Approval for the Primary UMM Indication, Secondary UMM Indication and/or any Future Indication (as applicable). Par shall utilize proactive and continuous Product Commercialization efforts (which may be subject to factors that are beyond the reasonable control of Par) by Par during the first *** after Initial Commercial Sale to advance the objectives and optimize the financial returns of both Parties under this Agreement (i.e., during such ***, Par shall not cease Commercializing, or engage in di minimis Commercialization of, the Product).
 
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(b) On no less than ninety (90) days’ written notice to Par given on or after the *** of the Initial Commercial Sale, Alfacell may elect to add up to *** sales representatives under Alfacell’s control, at Alfacell’s expense, to co-promote the Product for the approved Indication(s), subject to a mutually agreeable co-promote agreement. If Alfacell so elects, then such co-promotion by Alfacell of the Product for the approved Indication(s) (including UMM Indications) shall be deemed to be an accelerated exercise by Alfacell of its co-promote right pursuant to Section 5.4; provided, however, that Alfacell shall continue to pay for such additional sales representatives only until such time as its co-promote right could have otherwise been exercised pursuant to Section 5.4 (subject to Section 5.4(a)(z)).
 
5.4 Co-promote.
 
(a) Subject to Section 5.4(b) and Alfacell’s right to elect an accelerated exercise of Alfacell’s co-promote right with respect to all approved Indications pursuant to Section 5.3(b), Alfacell shall have the right to co-promote the Product on the approval of any Future Indication in the Territory (i) by providing written notice to Par at least *** in advance of Alfacell’s planned commencement of such co-promote activities and (ii) by entering into a mutually agreeable, definitive, written co-promotion agreement with Par setting forth the particulars of the Parties’ rights and obligations concerning co-promotion of the Product. The Parties shall use good faith to enter into, prior to the Initial Commercial Sale, such co-promotion agreement, which shall, among other things, include (x) an obligation of Par to pay Alfacell only the Fair Market Value per Detail for Alfacell’s sales representatives for such co-promotion, which Details provided by Alfacell’s sales representatives shall not exceed *** percent (***%) of all of the Details for the Product for the applicable Future Indication, (y) if Alfacell intends use such Alfacell sales representatives to promote or co-promote a pharmaceutical product (other than the Product) that shares an FDA-approved, labeled indication with any Par Promoted Product, Alfacell shall be entitled to promote or co-promote such pharmaceutical product if, and only if, Alfacell provides written notice of such intention to Par, and (z) if Alfacell provides such written notice indicating its intent to promote or co-promote such pharmaceutical product, or if Alfacell in fact promotes or co-promotes such pharmaceutical product, then Par shall no longer be obligated to pay to Alfacell the Fair Market Value per Detail for co-promotion by Alfacell of the Product, and such co-promotion by Alfacell of the Product shall thereafter be at Alfacell’s sole cost and expense (until such time as Alfacell no longer promotes or co-promotes such pharmaceutical product, which shall not occur prior to 60 days following the delivery by Alfacell of written notice to Par in respect thereof). Alfacell shall not be entitled to initiate any co-promotion activities for the Product unless and until the Parties enter into such co-promotion agreement.
 
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(b) If the Product obtains Regulatory Approval for a Future Indication prior to the Regulatory Approval of the Product for the Primary UMM Indication or Secondary UMM Indication, and if the Parties do not waive the pre-condition related thereto set forth in Section 6.2(b), then, subject to Section 5.3, Alfacell’s right to co-promote the Product may not be exercised by Alfacell until the later of (i) *** following the initial commercial sale of the Product for such Future Indication and (ii) the earlier to occur of (a) Regulatory Approval of the Product for the Primary UMM Indication or Secondary UMM Indication, or (b) the *** of Regulatory Approval related to the Product for such Future Indication.
 
ARTICLE VI
 
PAYMENTS
 
6.1 Upfront Payment. In consideration for the execution and delivery of this Agreement by Alfacell, Par shall pay Alfacell a fully earned, non-refundable, non-creditable license fee in the amount of US$5,000,000 by wire transfer of immediately available funds upon execution and delivery of this Agreement.
 
6.2 Milestone Payments.
 
(a) UMM Indication Milestone Payments.
 
(i) Subject to the terms and conditions of this Agreement, including Section 6.2(a)(ii):
 
(1) if Alfacell obtains Full Approval for the Product for the Primary UMM Indication on or before July 31, 2010, Par shall pay to Alfacell US$30,000,000;
 
(2) if Alfacell obtains Full Approval for the Product for the Primary UMM Indication after July 31, 2010, then in lieu of the milestone payment provided in Section 6.2(a)(i)(1), Par shall instead pay to Alfacell US$***; and
 
(3) if Alfacell has not obtained Full Approval for the Product for the Primary UMM Indication at the time that it obtains Full Approval for the Product for a Secondary UMM Indication, then, in lieu of any milestone payment provided in Section 6.2(a)(i)(1) or 6.2(a)(i)(2), Par shall pay to Alfacell US$***; provided, however, that if Alfacell subsequently obtains Full Approval for the Product for the Primary UMM Indication, then Par shall pay to Alfacell either US$*** (if such Full Approval for the Product for the Primary UMM Indication is obtained on or before July 31, 2010) or US$*** (if such Full Approval for the Product for the Primary UMM Indication is obtained after July 31, 2010), as applicable.
 
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(ii) If a meeting with the ODAC is called for by the FDA or if Par reasonably believes that the FDA will have outstanding review issues and/or questions relevant to the CMC Section, then Par may, in its sole discretion, make a partial prepayment of the amounts provided in Section 6.2(a)(i) in an amount not to exceed US$***; provided, however, that (A) any such prepayment amount shall be used exclusively in the preparation of the CMC Section or, as applicable, preparation for the meeting with, or in compliance with any requests of, the ODAC, and (B) in consideration of such prepayment, Par and Alfacell shall be entitled to jointly control, subject to Section 14.5, the preparation for any meeting with the ODAC or preparation of the CMC Section, as applicable, the compliance with any requests of the ODAC and the allocation of funds related thereto.
 
(b) Future Indication Milestones. Provided Alfacell shall have received Full Approval for either the Primary UMM Indication or the Secondary UMM Indication, or provided that each of the Parties agrees in writing, in its sole discretion, to waive the foregoing pre-condition due to unexpected and/or unavoidable delays in receipt of such Full Approval for a UMM Indication despite Alfacell’s Commercially Reasonable Efforts to obtain such receipt, then and in addition to the milestones payments set forth in Section 6.2(a) and subject to Section 3.7, upon the achievement of certain milestones, Par shall make fully earned, non-refundable, non-creditable payments to Alfacell by wire transfer of immediately available funds as follows:
 
(i) Upon the administration of the first dose of the Product to the first patient in a first Phase III Clinical Trial for each Future Indication, Par shall pay to Alfacell US$***;
 
(ii) Upon the acceptance for filing by the FDA of Alfacell’s NDA subject to a Special Protocol Assessment (as described as of the Effective Date at http://www.fda.gov/cber/gdlns/protocol.htm#i) for each Future Indication, Par shall pay to Alfacell US$***; provided, however, that in the event a Special Protocol Assessment is not used, then, prior to filing of the applicable Alfacell NDA with the FDA, up to two (2) experts shall be retained by each Party (for a total of four (4) experts), and if such experts reasonably agree that the Phase III Clinical Trial data package is unlikely to support FDA approval for such Future Indication, then Par shall not be obligated to pay to Alfacell such amount; and
 
(iii) Upon a Regulatory Approval of each Future Indication, Par shall pay to Alfacell US$***.
 
(c) Sales Milestone Payments. In addition to the milestone payments set forth above, following the Initial Commercial Sale, on the terms and subject to the conditions contained herein, Par shall additionally be obligated as follows:
 
(i) Subject to Section 6.2(c)(ii), Par will pay to Alfacell the following one-time only milestone payments:
 
***
 
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(ii) The milestone payments set forth in Section 6.2(c)(i) (“Sales Milestone Payments”) are subject to the following: (A) each such Sales Milestone Payment is available to Alfacell on a one-time basis, such that once achieved and paid, such Sales Milestone Payment shall not be payable again regardless of the amount of Net Sales in any future Contract Year; (B) if more than one milestone is achieved for the first time in any given Contract Year, then Par shall make each Sales Milestone Payment, and each such achieved milestone shall be forever satisfied hereunder; and (C) the aggregate of all Sales Milestone Payments under this Section 6.2(c) during the Term shall not exceed an amount equal to US$***.
 
6.3 Royalty.
 
(a) Royalty Payment. In addition to the milestone payments set forth above in Section 6.2, following the Initial Commercial Sale of the Product, in respect of any Contract Year, Par shall pay to Alfacell an amount equal to (i) *** (amounts owed to Alfacell pursuant to this Section 6.3(a), the “Royalty”).
 
(b) Royalty Step Down. Upon expiration of the last to expire Valid Claim within the Patents licensed to Par during the Term pursuant to Section 4.1, each of the royalty rates set forth in Section 6.3(a) shall be reduced as follows ***; and further provided, in the event that, after such expiration of the last to expire Valid Claim, a subsequent Valid Claim should come into existence during the Term, then the royalty rates set forth in Section 6.3(a) shall again apply without reduction pursuant to this Section 6.3(b).
 
(c) Termination of Royalty. Unless otherwise expressly provided herein, the obligation of Par to pay Royalties to Alfacell pursuant to Section 6.3(a) shall cease upon expiration or termination of this Agreement.
 
6.4 Other Payment Obligations of Par. Par shall pay to Alfacell the amounts set forth in Section 5.4 (Co-promote) and Section 7.2 (Pricing), in each case subject to the terms set forth therein.
 
6.5 Payment Procedures.
 
(a) Manner of Payment. Remittance of payments to Alfacell hereunder will be made in immediately available funds by means of wire or electronic transfer to an Alfacell account in a bank in the United States to be designated by Alfacell.
 
(b) Payments and Reports. All amounts payable to Alfacell under this Agreement shall be paid in U.S. Dollars. Milestone Payments under Section 6.2 shall be made no later than ten (10) days after the satisfaction of the milestone giving rise to the applicable payment. The Royalty shall accrue at the time of sale of the Product by Par or a Sub-distributor to a Third Party. Royalty obligations that accrue during a calendar quarter shall be paid within forty-five (45) days after the end of such calendar quarter, and other payments owing shall be made as specified herein. Each payment of Royalties due to Alfacell shall be accompanied by a report listing the number of units of Product sold, the gross invoiced sales amounts of the Product sold during such period, the calculation of Net Sales based on such sales, the applicable royalty rate, the Royalties payable, all other information necessary to determine the appropriate amount of such Royalty payments, and any additional information or reports required under this Agreement or reasonably requested by Alfacell.
 
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(c) Records and Audit.
 
(i) For a period of three (3) years after the calendar year to which the records relate, Par shall keep, and shall cause its Sub-distributors to keep, complete and accurate records pertaining to the sale or other disposition of the Product in sufficient detail to permit Alfacell to confirm the accuracy of all payments due hereunder. Alfacell shall have the right to cause an independent, certified public accountant to which Par has no reasonably, well-founded objection to audit such records to confirm the gross invoiced sales amounts, the Net Sales, Net Margin and Royalty payments; provided, however, that such auditor shall not disclose Par’s Confidential Information to Alfacell, except to the extent such disclosure is necessary to verify the amount of Royalties and other payments due under this Agreement, and such auditor shall enter into a non-disclosure agreement reasonably acceptable to Par. Such audits may be exercised once a year on reasonable advance notice to Par and during normal business hours, within three (3) years after the Royalty period to which such records relate. Any amounts shown to be owing by such audits shall be paid promptly. Alfacell shall bear the cost of such audit unless such audit discloses a variance in the amounts paid by Par of more than five percent (5%) from the amount of Royalties and/or other payments actually owed to Alfacell for the period audited. In such case, Par shall bear the reasonable cost of such audit.
 
(ii) For a period of three (3) years after the calendar year to which the records relate or such longer period as may be required by applicable law, Alfacell shall keep records pertaining to calculation of Direct Cost in sufficient detail to permit Par to confirm the accuracy of Direct Cost (and thus accuracy of the Transfer Price), as well as records pertaining to any other amounts charged to or reimbursed by Par hereunder. Par shall have the right to cause an independent, certified public accountant to which Alfacell has no reasonably, well-founded objection to audit such records to confirm Direct Cost and any such other amounts charged to or reimbursed by Par pursuant to the terms hereof; provided, however, that such auditor shall not disclose Alfacell’s Confidential Information to Par, except to the extent such disclosure is necessary to verify the amount of any overpayments made by Par to Alfacell, and such auditor shall enter into a non-disclosure agreement reasonably acceptable to Alfacell. Such audits may be exercised once a year on reasonable advance notice and during normal business hours, within three (3) years after the date of payment to which such records relate, upon notice to Alfacell and during normal business hours. Any amounts shown to be owing by such audits shall be paid promptly. Par shall bear the cost of such audit unless such audit discloses an overpayment by Par of more than five percent (5%) as compared to the amount of payments and/or reimbursements actually owed to Alfacell for the period audited. In such case, Alfacell shall bear the reasonable cost of such audit.
 
(iii) The terms of this Section 6.5(c) shall survive any termination or expiration of this Agreement for a period of three (3) years following the calendar year in which the relevant payment obligation hereunder expires or terminates.
 
(d) Withholding of Taxes. Par may withhold from milestones, royalties or other amounts due to Alfacell under this Agreement such amounts for payment of any withholding tax that is required by law to be paid to any taxing authority with respect to such amounts payable to Alfacell; provided, however, that in regard to any such tax withholding, Par shall give Alfacell such documents and provide any other cooperation or assistance on a reasonable basis as may reasonably be requested by Alfacell by to enable Alfacell to claim exemption therefrom, to receive a full refund of such withholding tax or to claim a foreign tax credit and shall, upon Alfacell’s request, give proper evidence from time to time as to the payment of such tax.
 
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(e) Late Payment and Interest. Any payments due under this Agreement by either Party that are not paid by the date such payments are due shall bear interest at one percent (1%) per month from the date such payments are due. The foregoing interest shall be due from the Party owing the payment amount without any special notice and shall be in addition to any other remedies that the Party entitled to such payment may have pursuant to this Agreement.
 
ARTICLE VII
 
MANUFACTURE AND SUPPLY
 
7.1 Clinical and Commercial Supplies. Alfacell shall manufacture or cause to be manufactured all Clinical Supplies of the Product for the Development Program, including the completion of pre-clinical work and human clinical trials. Subject to the terms of the Supply Agreement, Alfacell will establish a commercial manufacturing process for manufacturing or causing to be manufactured Commercial supplies of the Product at the scale and in the amounts required to meet Par’s sales forecast, and Alfacell will exclusively supply Par with Par’s requirements of commercial supplies of the Product pursuant to the Supply Agreement.
 
7.2 Pricing. Subject to the terms and conditions of this Agreement and the Supply Agreement, Par shall acquire the Product from Alfacell at the Transfer Price, as provided in the Supply Agreement. The Parties acknowledge and agree that both would benefit from any commercially reasonably, achievable reduction in the Direct Cost, but only if the corresponding cost reduction does not negatively impact Product yields, output, quality, purity and the like.
 
7.3 Par Labeling and Packaging. The Parties agree that the label for the Product in the Field in the Territory shall be, and all packaging and presentations concerning such Product shall display, a Par label in accordance with Par’s customary practices, subject to Section 4.1(b), and the Parties shall use Commercially Reasonable Efforts to cooperate in gaining Regulatory Approval to sell Products in the Field in the Territory under the Par label.
 
7.4 Citizen’s Petitions. Each Party shall notify the other in writing if it becomes aware of a Third Party product under development, or a regulatory filing by a Third Party with respect to a product, that in either case incorporates Ranpirnase, including, with respect to any such regulatory filing, any 505(j) filing, 505(b)(2) filing or other form of application for approval (such development or filing, a “Third Party Product Event”). Par shall, following Regulatory Approval of the Product, have the first right to institute a citizen’s petition addressing the safety and/or efficacy of such Third Party Product Event, and, to the extent Par exercises its right in respect thereof, shall reasonably control all aspects of such citizen’s petition in a commercially reasonable manner, including correspondence and/or negotiations with the FDA; provided, however, that Par shall include Alfacell in such efforts in a consultative capacity. In the event Par does not exercise its rights above with respect to such a Third Party Product Event within three (3) months of the notice referenced above, then Alfacell shall have the exclusive right to institute a citizen’s petition addressing the safety and/or efficacy of such Third Party Product Event, and, to the extent Alfacell exercises its right in respect thereof, shall control all aspects of such citizen’s petition in a Commercially Reasonable fashion, including correspondence and/or negotiations with the FDA, provided, however, that Alfacell shall include Par in such efforts in a consultative capacity.
 
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ARTICLE VIII
 
CONFIDENTIAL AND TECHNICAL INFORMATION
 
8.1 Treatment of Confidential Information. Each Party agrees to retain in strict confidence and not to disclose, divulge or otherwise communicate to any Third Party any Confidential Information of the other Party, whether received prior to or after the Effective Date, and further agrees not to use any such Confidential Information for any purpose, except pursuant to, and in order to carry out, the terms and objectives of this Agreement, except that each Party may disclose Confidential Information of the other Party to the officers, directors, employees, agents, accountants, attorneys, consultants, subcontractors or other representatives of the receiving Party or its Affiliates (the “Representatives”), who, in each case, (a) need to know such Confidential Information for purposes of the implementation and performance by the receiving Party of this Agreement and (b) will use the Confidential Information only for such limited purposes. Each Party hereby agrees to use at least the same standard of care in complying with its confidentiality obligations hereunder as it uses to protect its own Confidential Information of comparable sensitivity and to exercise reasonable precautions to prevent and restrain the unauthorized disclosure of such Confidential Information by any of its Representatives. Each Party warrants that each of its Representatives to whom any Confidential Information is revealed shall previously have been informed of the confidential nature of the Confidential Information and shall have agreed to maintain its confidentiality under terms no less restrictive than those set forth in this Article VIII. Without limiting the generality of any of the foregoing, the Parties agree not to make any disclosure of Confidential Information that would be reasonably likely to impair the Parties’ ability to obtain U.S. or foreign patents on any patentable invention or discovery described or otherwise embodied in such Confidential Information. The Confidential Information of each Party includes information from Third Parties disclosed by one Party to this Agreement to the other Party to this Agreement.
 
8.2 Release from Restrictions.
 
(a) The provisions of Section 8.1 shall not apply to any Confidential Information disclosed hereunder to the extent that such Confidential Information is required to be disclosed by the receiving Party to defend or prosecute litigation or to comply with applicable laws or regulations, including filing an Information Disclosure Statement with the U.S. Patent and Trademark Office or any other patent office, or pursuant to an order of a court or regulatory agency; provided, however, that the receiving Party shall provide prior written notice of such disclosure to the other Party and shall take actions as are reasonable and lawful to avoid and/or minimize the degree of such disclosure, including assisting the other Party in seeking a protective order or other means for preventing disclosure or use. To the extent, if any, that a Party concludes in good faith that it is required by applicable laws or regulations to file or register this Agreement or a notification thereof with any governmental authority, including the U.S. Securities and Exchange Commission, such Party may do so, and the other Party shall cooperate in such filing or notification and shall execute all documents reasonably required in connection therewith. In such situation, the filing Party shall request confidential treatment of sensitive provisions of the Agreement to the extent permitted by law. The Parties shall promptly inform each other as to the activities or inquiries of any such governmental authority relating to this Agreement, and shall cooperate to respond to any request for further information therefrom.
 
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(b) A Party may disclose this Agreement to a Third Party in connection with or in conjunction with a proposed merger, consolidation, sale of assets that include those related to this Agreement, an assignment of this Agreement or loan financing, raising of capital, or sale of securities; provided, however, that the disclosing Party obtains an agreement for confidential treatment thereof.
 
8.3 No Implied Rights. Except as otherwise set forth in this Agreement, nothing herein shall be construed as giving either Party any right, title, interest in or ownership of the Confidential Information of the other Party. For the purposes of this Agreement, specific information disclosed as part of Confidential Information shall not be deemed to be in the public domain or in the prior possession of the receiving Party merely because it is embraced by more general information in the public domain or by more general information in the prior possession of the receiving Party.
 
8.4 Survival of Confidentiality Obligations. The confidentiality obligations of the Parties contained in this Article VIII shall remain binding on both Parties during the Term and for a period of five (5) years after the expiration or termination of this Agreement, regardless of the cause of such termination. The Parties acknowledge that breach of this Article VIII may constitute irreparable harm, and that the non-breaching Party shall be entitled to seek specific performance or injunctive relief to enforce this Article VIII in addition to whatever remedies such Party may otherwise be entitled to at law or in equity.
 
8.5 Superseding Prior Confidentiality Agreement. The provisions of this Article VIII shall supersede the Confidentiality Agreement between the Parties dated September 17, 2007, with respect to the subject matter hereof, and shall establish the sole obligations of confidentiality and nonuse of Confidential Information received by a Party prior to or after the Effective Date.
 
ARTICLE IX
 
PATENT PROSECUTION AND ENFORCEMENT
 
9.1 Program Developments. All Program Developments shall be the sole and exclusive property of Alfacell. All United States patent applications covering Program Developments and all United States patents issuing thereon will immediately, and without further action of the Parties, (a) be deemed to be Alfacell Patents and listed in Schedule 1.1 and (b) be exclusively licensed to Par in accordance with the terms of this Agreement. 
 
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9.2 Patent Prosecution and Maintenance.
 
(a) The Parties shall cooperate in good faith to determine whether to seek or continue to seek or to maintain patent protection in the Territory with respect to any Alfacell Patent, Alfacell Information and any Program Development or such other things that that could reasonably be expected to affect the Commercialization or value of the Product in the Territory. In connection therewith, Alfacell shall promptly provide Par with copies of all correspondence to and from the U.S. Patent and Trademark Office, as well as any related demand, notice and summons, that relates to such Alfacell Patent or Program Development. Each Party, and its employees and agents, shall provide the other Party and its legal representatives with reasonable assistance and cooperation with respect to such Patent prosecution, including entering into any joint defense and/or joint privilege agreement that may be reasonably requested by such Party and Alfacell shall consider in good faith all reasonable suggestions of Par and its patent counsel related thereto. Alfacell’s patent prosecution and maintenance expenses associated with Alfacell Patents including the filing of any patent term extensions, shall be borne by Alfacell; prosecution- and maintenance-related expenses incurred by Par in connection with its review and consultation concerning any Alfacell Patents, including Alfacell’s filing of any patent term extensions, shall be borne by Par. Alfacell will timely apply for any applicable patent term extensions.
 
(b) Par agrees to cooperate fully in the preparation, filing, prosecution and maintenance of any Alfacell Patents in the Territory under this Agreement, and in the obtaining and maintenance of any patent extensions and the like with respect to any Alfacell Patent.
 
(c) If Alfacell elects (i) to abandon the prosecution or maintenance of any Alfacell Patent under which Par has a license hereunder, or (ii) elects not to file a patent application in the Territory for any invention within Program Developments that could reasonably be expected to affect the Commercialization or value of the Product in the Territory under this Agreement, then Alfacell shall promptly notify Par in writing at least sixty (60) days before the abandonment or applicable filing deadline therefore, and Par shall have the right, upon providing written notice to Alfacell of Par’s election to do so, at Par’s expense, to file, prosecute, continue prosecution and/or maintenance, as applicable, of such Alfacell Patent or Patent within Program Developments. In such case, Par shall keep Alfacell reasonably informed on matters regarding such filing, prosecution and maintenance, including by providing Alfacell with a copy of any and all correspondence between Par and the U.S. Patent and Trademark Office, providing Alfacell with sufficient time to review and comment on such communications (excluding any non-substantive correspondence or communications), and Par shall consider in good faith the requests and suggestions of Alfacell with respect to such communications with the U.S. Patent and Trademark Office. With respect to the activities set forth in this Section 9.2 that are continued by Par, Alfacell shall provide a power of attorney and relevant files and other information Owned or Controlled by Alfacell pertaining to such Alfacell Patents or Program Developments, as soon as reasonably practical after receiving such written election by Par.
 
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9.3 Infringement by a Third Party.
 
(a) Par and Alfacell shall inform each other promptly in writing of any alleged or suspected infringement by a Third Party in the Territory of any of Alfacell Patent that could reasonably be expected to have an adverse effect on the Commercialization or value of the Product in the Territory, and of any available evidence thereof.
 
(b) Subject to Sections 9.3(c), 9.3(d), and 9.3(e), Par shall have the first right, but not the obligation, at its sole option and expense, to prosecute the infringement by a Third Party in the Territory of any Alfacell Patent that could reasonably be expected to have an adverse effect on the Commercialization or value of the Product in the Territory.
 
(c) If a Third Party so infringes (or constructively infringes by filing an application for regulatory approval with the FDA) an Alfacell Patent, or if a declaratory judgment action alleging invalidity, unenforceability or non-infringement of any Alfacell Patent, shall be brought by a Third Party in the Territory against Par or against Alfacell or both of them (applicable to Ranpirnase, Product or Competing Product), or a Citizen’s Petition in respect of the Product shall have been filed with the FDA (each of the foregoing, a “Product Infringement”), then the Parties shall discuss whether or not to institute an infringement action (and/or defend against applicable declaratory judgment actions) with respect to such Product Infringement (and any legally or commercially relevant belief by Alfacell that it is in the Parties’ interest to not institute such action shall be considered in good faith by Par). Subject to Sections 9.3(b) and 9.3(d), Par shall have the first right to institute such a suit and control the prosecution, settlement or compromise thereof (including defense of applicable declaratory judgment actions); provided, however, that no such settlement, compromise, consent judgment or other voluntary final disposition of any Product Infringement action which invalidates or restricts any Valid Claim(s) Owned or Controlled by Alfacell may be entered into by Par without the prior written consent of Alfacell, which consent shall not be unreasonably withheld. At Par’s option, Alfacell shall agree to be joined as a party, or otherwise initiate suit if necessary, in such Product Infringement action and Par and Alfacell shall execute all papers and perform such acts as may be reasonably required to accomplish the same, at the sole expense of Par; provided, however, that Alfacell’s joining of or participation in such action shall not affect Par’s control thereof in accordance with this Section 9.3(c). Alfacell shall, at the reasonable request of Par, provide reasonable cooperation and use its Commercially Reasonable Efforts to have its employees testify when requested and make available relevant records, papers, information, samples, specimens and the like that Alfacell’s counsel agrees should be provided to Par, regardless of whether Alfacell has joined such suit. Alfacell shall have the right to join such action and/or select, at Alfacell’s expense, separate counsel to participate in such suit on Alfacell’s behalf.
 
(d) Within ninety (90) days of being notified of alleged or suspected Product Infringement, Par shall either (i) institute a suit for Product Infringement pursuant to Section 9.3(c) or (ii) notify Alfacell that it has a good faith belief that it is in the Parties’ interest to not institute such suit within such time and Par shall provide to Alfacell a reasoned legal and/or commercial basis for not instituting such a suit at that time. If Alfacell disagrees with such reasoned legal and/or commercial basis, then such dispute or disagreement shall be referred to the CEO of Alfacell and the CEO of Par for resolution, and the CEOs shall resolve the matter (without resort to Section 14.5). If Par takes neither action provided in the foregoing clause (i) or (ii) above within such ninety (90)-day period, or if within such ninety (90)-day period Par notifies Alfacell that it does not intend to institute such a suit, then thereafter Alfacell shall have the exclusive right to institute an action and control the prosecution, settlement or compromise thereof. At Alfacell’s option Par shall agree to be joined as a party in such litigation; provided, however, that Par’s joining of such action shall not affect Alfacell’s control thereof in accordance with this Section 9.3(d). Par shall, at the reasonable request of Alfacell, provide reasonable cooperation and, to the extent practicable, Par shall use its Commercially Reasonable Efforts to have its employees testify when requested and make available relevant records, papers, information, samples, specimens and the like that Par’s counsel agrees should be provided to Alfacell, regardless of whether Par has joined such suit. Par shall have the right to join such action and/or select, at Par’s expense, separate counsel to participate in such suit on Par’s behalf.
 
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(e) Any payments that represent royalties for sales of infringing products, other payments, damages, expenses, fees or other awards (collectively “Damages”), received by Par and/or Alfacell as a result of a Product Infringement suit, whether through judgment or settlement, shall first be used to reimburse each Party for its expenses associated with such infringement suit. Thereafter, (i) if Par shall have instituted and controlled a suit in accordance with Section 9.3(c), then any remainder *** and (ii) if Alfacell shall have instituted and controlled a suit in accordance with Section 9.3(d), then any remainder ***.
 
9.4 Infringement of Third Party Rights.
 
(a) If either Party becomes aware of a patent or patent application that, when issued, might provide a basis for a Third Party argument that its valid rights are being infringed by the use, offer for sale or sale of the Product in the Territory, then such Party shall promptly inform the other Party of such patent or patent application, and the Parties shall cooperate with each other so that each Party can determine whether valid rights of a Third Party are likely to be so infringed.
 
(b) In the event that a Third Party institutes any suit against Par and/or Alfacell for patent infringement that could reasonably be expected to have an adverse effect on the Commercialization or value of the Product in the Territory, the Party sued shall promptly notify the other Party in writing. Par shall assume the defense of such suit at Par’s expense; provided, however, that if Alfacell is also a defendant in such action and Alfacell shall have reasonably concluded that there may be legal defenses available to it that are different from or additional to those available to Par, Alfacell shall have the right to select, at Alfacell’s expense, separate counsel to participate in such legal defenses on Alfacell’s behalf; provided, further that notwithstanding any such different or additional legal defenses of Alfacell, Par shall have the first right to control the defense of any such patent infringement suit pursuant to this Section 9.4 and Par may settle or compromise such suit with the prior written consent of Alfacell, which consent shall not be unreasonably withheld. To the extent that any Damages become payable to any Third Party whether as a result of judgment or through settlement of such suit, ***.
 
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(c) If either Party becomes aware of a patent or patent application of a Third Party that could reasonably be expected to have an adverse effect on the Commercialization or value of the Product in the Territory and for which pursuit of a license would be reasonable in connection with Commercialization of the Product in the Territory, the Commercialization Committee shall: (A) determine whether or not Alfacell should seek such a license, (B) recommend whether or not to enter into such a license as negotiated by Alfacell, (C) determine how the expenses of such a license shall be borne by the Parties and (D) insure that Par is a beneficiary thereof consistent with the licenses granted herein. If the Commercialization Committee cannot agree with regard to any item set forth in the preceding sentence, such issue shall be determined by the CEOs of the Parties.
 
9.5 Trademark Infringement. Alfacell and Par shall promptly notify the other in writing of any alleged or threatened infringement or any challenge to the validity of the Trademark or any challenge to Alfacell’s ownership of or Par’ s right to use the Trademark in the Territory of which they become aware. Both Parties shall use their reasonable efforts in cooperating with each other to terminate such infringement without litigation. Alfacell shall have the sole right to bring and control any action or proceeding with respect to infringement of any of the Trademark at its own expense and by counsel of its own choice, subject to the following provisions. With respect to infringement of any of the Trademark in the Territory, if Alfacell fails to bring an action or proceeding within (i) thirty (30) days following the notice of alleged infringement or (ii) ten (10) days before the time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions, whichever comes first, Par shall have the right to bring and control any such action at its own expense and by counsel of its own choice, and Alfacell shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. In the event a Party brings an infringement action, the other Party shall cooperate fully, including if required to bring such action, the furnishing of a power of attorney or being named as a party. Neither Party shall have the right to settle any infringement litigation under this Section 9.5 relating to the Trademark in a manner that diminishes the rights or interests of the other Party without the prior written consent of the other Party, which shall not be unreasonably withheld, delayed or conditioned. Except as otherwise agreed to by the Parties as part of a cost-sharing arrangement, any recovery realized as a result of such litigation, after reimbursement of any litigation expenses of Alfacell and Par, ***.
 
ARTICLE X
 
ADVERSE EXPERIENCES
 
10.1 Notification. The Parties shall, during the Term, keep each other promptly and fully informed of all of their pharmacological, toxicological and clinical trials, investigations and findings relating to the Product in the Field in the Territory in accordance with a pharmacovigilance agreement. To the extent required, Alfacell will notify appropriate Governmental Authorities in accordance with applicable law with respect thereto and notify Par promptly after receipt of information with respect to any adverse reaction directly or indirectly attributable to the use or application of the Product in the Field in the Territory. In such a case, the Parties shall meet as soon as possible to define, according to applicable law, appropriate procedures and actions to address the difficulty. Each Party also shall forward to the other Party, on a regular basis, information on adverse reactions and any material difficulty associated with clinical use, studies, investigations, tests and prescriptions of the Product in the Field in the Territory. Par will forward all ADE reports related to the Product in the Field in the Territory received by Par or its Sub-distributors to Alfacell within five days of receipt of the applicable event. The information forwarded will be the initial event information obtained from Par’s call center. Par will not make any medical evaluation of the event. Alfacell will be responsible for any follow-up activities with the reporting party and all tracking, trending and signal detection for the Product. The Parties will use their Commercially Reasonable Efforts to inform each other without delay of any other governmental action which may adversely impact, in a direct manner, Commercialization of the Product in the Field in the Territory, and will furnish each other copies of any relevant documents relating thereto.
 
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10.2 Reporting. Alfacell, as the NDA holder, is responsible for preparing, processing, assessment, and submitting aggregate and periodic reports and individual case safety reports within the Territory as required by regulatory authorities. Alfacell shall also hold and maintain reports of all adverse events and adverse drug reactions, both serious and non-serious, and reports of pregnancies in a database for the Product for preparing and submitting aggregate, periodic, and single case reports to the FDA for the Product in the Field in the Territory. Par shall reasonably cooperate at its own expense.
 
10.3 Literature Reports. Alfacell shall be responsible for screening published scientific and medical literature for ADEs/ICSRs related to the Product in the Field. A copy of any such relevant literature reports and/or articles shall be promptly provided to the other Party. To the extent of additional obligations contained in Section 8.1.3 of the Supply Agreement, such obligations are hereby incorporated by reference herein.
 
ARTICLE XI
 
REPRESENTATIONS AND WARRANTIES
 
11.1 Representations and Warranties.
 
(a) Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party that: (i) it has full corporate power and authority under the laws of the state of its incorporation to enter into this Agreement and to carry out the provisions hereunder; (ii) this Agreement is a legal and valid obligation binding upon it and is enforceable in accordance with its terms; (iii) the execution, delivery and performance of this Agreement by it does not materially conflict with any agreement, oral or written, to which it is a party or by which it may be bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority over it; and (iv) to the knowledge of such Party as of the Effective Date (without undertaking any special investigation), there is no claim, action, suit, proceeding or investigation pending or threatened against or affecting the transaction contemplated hereby.
 
(b) Alfacell Representations, Warranties and Covenants. Alfacell hereby represents, warrants and covenants to Par that:
 
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(i) neither Alfacell nor any of its Affiliates has granted or, during the Term, will grant to any Third Party any rights under the Alfacell Patents, or any rights, that are in conflict with or prevent the grant of the rights granted by Alfacell to Par in this Agreement;
 
(ii) the Alfacell Patents constitute all of the patents and patent applications Owned or Controlled by Alfacell as of the Effective Date that are necessary or are useful to Commercialize the Product in the Field in the Territory (as the Product is known to Alfacell as of the Effective Date, and if such Product were to be Commercialized as of the Effective Date);
 
(iii) Schedule 1.1 sets forth a true and complete list of all patents and patent applications Owned or Controlled by Alfacell that claim Ranpirnase, the Product or their uses in the Field in the Territory as of the Effective Date, which Schedule 1.1 will be updated periodically during the Term by Alfacell to reflect additions thereto;
 
(iv) Alfacell Owns or Controls the Patents listed on Schedule 1.1, and it has the right and authority to enter into this Agreement and to grant the license under Section 4.1(a) hereof;
 
(v) Alfacell has received no notice alleging infringement of a Third Party patent in connection with its development and/or manufacture of the Product in the Field in the Territory;
 
(vi) Alfacell has provided to Par copies of all material correspondence with the FDA related to the Product;
 
(vii) as of the Effective Date, the molecule for the Primary UMM Indication has been granted orphan drug designation by the FDA under the Orphan Drug Act, as amended;
 
(viii) as of the Effective Date, (A) there is no action or proceeding pending or, to Alfacell’s Knowledge, threatened in the Territory with respect to use, development, manufacture or importation of the Product in the Field in the Territory in accordance with this Agreement, including with respect to infringement of any Third Party patent in the Field in the Territory, the conduct of any clinical trials, manufacturing activities or development activities involving the Product, or that reasonably calls into question the validity of this Agreement or any action taken by Alfacell in connection with the execution of this Agreement, and (B) there are no unsatisfied judgments or outstanding orders, injunctions, decrees, stipulations or awards (whether rendered by a court, an administrative agency or by an arbitrator) against Alfacell with respect to the Product or the Alfacell Patents in the Field in the Territory;
 
(ix) Alfacell has not as of the Effective Date, and will not during the Term, grant or place any liens, security interests, other encumbrances and/or licenses in or on, or otherwise divest, the Alfacell Patents that would conflict or interfere with the licenses granted to Par in the Field in the Territory, as set forth herein;
 
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(x) Alfacell has not violated and will not, during the Term, violate the trade secrets and has not misappropriated, and will not, during the Term, misappropriate, the confidential information or intellectual property of any Third Party in connection with the development or manufacturing of the Product for use in the Field in the Territory;
 
(xi) none of the Alfacell Patents is currently involved in any interference, reissue, or reexamination proceeding, and neither Alfacell nor any of its Affiliates has received any written notice from any person of such actual or threatened proceeding;
 
(xii) based on its calculations as of the Effective Date, Alfacell has in its possession, or has access to, a sufficient egg inventory as of the Effective Date to manufacture enough Product to complete the current Phase III Clinical Trial for UMM and to supply *** vials of the Product after anticipated Initial Commercial Sale in the Field in the Territory and Alfacell shall not, without the prior consent of Par, utilize such egg inventory other than in respect of the Products under this Agreement;
 
(xiii) to Alfacell’s Knowledge, as of the Effective Date, there is no unauthorized use, infringement or misappropriation of any of the Alfacell Patents by any Third Party in the Field in the Territory, including any current or former employee or consultant of Alfacell and its Affiliates; and
 
(xiv) as of the Effective Date, any Alfacell research or development programs for potential follow-on RNase products (including sequence variants of Ranpirnase) are pre-IND programs.
 
ARTICLE XII
 
INDEMNIFICATION AND LIMITATION ON LIABILITY; INSURANCE
 
12.1 Indemnification by Alfacell. Subject to Section 12.3, Alfacell shall defend, indemnify and hold harmless each of Par and its directors, officers and employees and the successors and assigns of any of the foregoing (each a “Par Indemnitee”) from and against any and all liabilities, damages, settlements, penalties, fines, costs or expenses (including reasonable attorneys’ fees and other expenses of litigation) (collectively, “Losses”) arising, directly or indirectly, out of or in connection with Third Party claims, suits, actions, demands or judgments to the extent relating to or based on Alfacell’s gross negligence, willful misconduct, or breach of its representations, warranties or obligations under this Agreement, except, in each case, to the extent Par has an obligation to indemnify Alfacell under Section 12.2.
 
12.2 Indemnification by Par. Subject to Section 12.3, Par shall defend, indemnify and hold harmless each of Alfacell and its directors, officers and employees and the successors and assigns of any of the foregoing (each an “Alfacell Indemnitee”) from and against any and all Losses arising, directly or indirectly, out of or in connection with Third Party claims, suits, actions, demands or judgments to the extent relating to or based on Par’s gross negligence, willful misconduct, or breach of its representations, warranties or obligations under this Agreement, except, in each case, to the extent Alfacell has an obligation to indemnify Par under Section 12.1.
 
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12.3 Notice and Procedures. If an Alfacell Indemnitee or a Par Indemnitee (the “Indemnitee”) intends to claim indemnification under this Article XII, it shall promptly notify the other Party (the “Indemnitor”) in writing of any such alleged Losses promptly after it becomes aware of the basis for such indemnification. The Indemnitor shall have the right to control the defense thereof with counsel of its choice, provided, however, that such counsel is reasonably acceptable to Indemnitee; and, provided, further, that any Indemnitee shall have the right to retain its own counsel at its own expense, for any reason, including if representation of any Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other Party reasonably represented by such counsel in such proceeding. The Indemnitee, its employees and agents, shall reasonably cooperate with the Indemnitor and its legal representatives in the investigation of any Losses covered by this Article XII. The obligations of this Section 12.3 shall not apply to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld, conditioned or delayed unreasonably. The failure to deliver prompt written notice to the Indemnitor shall relieve the Indemnitor of any obligation to the Indemnitee of liability under this Section 12.3 to the extent it is prejudiced thereby. It is understood that only Alfacell or Par may claim indemnity under this Article XII (on its own behalf or on behalf of its Indemnitees), and other Indemnitees may not directly claim indemnity hereunder.
 
12.4 Limitation of Damages. EXCEPT IN RESPECT OF (A) ANY CLAIM RELATED TO THE WILLFUL MISCONDUCT OF A PARTY OR INTENTIONAL BREACH OF A REPRESENTATION, WARRANTY OR OBLIGATION BY A PARTY UNDER THIS AGREEMENT OR (B) ANY THIRD PARTY CLAIMS UNDER ARTICLE XII, NEITHER PARTY NOR ANY OF ITS REPRESENTATIVES (AS DEFINED IN SECTION 8.1) OR AFFILIATES SHALL BE LIABLE TO THE OTHER PARTY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGE OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER SUCH PARTY SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING.
 
12.5 Insurance.  During the Term and a period of three (3) years thereafter, each Party shall have and maintain, at its own expense, with a reputable and financially secure insurance carrier or carriers, (a) general liability insurance coverage for the manufacture, supply, use and sale of the Product and such Party's activities related to this Agreement as is reasonable, normal and customary in the pharmaceutical industry generally for parties similarly situated and as is appropriate to such activities, and (b) product liability insurance coverage as is reasonable, normal and customary in the pharmaceutical industry generally for the manufacture, supply, use and sale of pharmaceutical products of similar risk profile to the Product.  Subject to the foregoing, each Party shall have in place prior to the Initial Commercial Sale product liability insurance coverage in an amount of not less than *** US dollars ($***) per occurrence, and Alfacell shall have a maximum self-insured retention or deductible of *** US dollars ($***) with respect thereto.  Upon the request of the other Party, each Party shall provide a certificate of insurance evidencing such coverage to the other Party.
 
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ARTICLE XIII
 
TERM AND TERMINATION
 
13.1 Term. The term of this Agreement (the “Term”) shall commence on the Effective Date and shall expire, unless earlier terminated as provided under Sections 13.2, 13.3, 13.4 or 13.5, on the earlier to occur of
 
(a) January 1, 2015, if no Full Approval has been obtained for the Product for the Primary UMM Indication or Secondary UMM Indication in the Territory by such date; provided, however, that if Par agrees to waive the precondition in respect thereof pursuant to Section 6.2 and becomes obligated to make a payment to Alfacell of $*** upon the administration of the first dose of the Product to the first patient in a first Phase III Clinical Trial for any Future Indication, then the Term shall automatically be extended until the seventh (7th) anniversary of such payment; or
 
(b) the latest to occur of the following: (i) in respect of any Indication, the twelfth (12th) anniversary of the initial commercial sale for the Product with such Indication, (ii) the date of expiration of the last Valid Claim within the Alfacell Patents; and (iii) a date later than the foregoing (i) or (ii), which shall be mutually agreed by the Parties in writing, if the Parties agree that Product sales in the Field in the Territory should be continued; provided, however, that if Par becomes obligated to make a payment to Alfacell of $*** upon the administration of the first dose of the Product to the first patient in a first Phase III Clinical Trial for any Future Indication, then the Term shall automatically be extended until the seventh (7th) anniversary of such payment.
 
13.2 Termination for Breach. If either Party commits a material breach or material default in the performance or observance of any of its obligations under this Agreement, and such breach or default continues for a period of sixty (60) days after delivery by the other Party of written notice reasonably detailing such breach or default and demanding its cure, then the non-breaching or non-defaulting Party shall have the right to terminate this Agreement, with immediate effect, by giving written notice to the breaching or defaulting Party. The Parties shall retain all rights and remedies (at law or in equity) in respect of any breach hereof. In the event that Par reasonably believes that Alfacell has materially breached or materially defaulted under this Agreement and failed to cure such breach or default as provided above, and Par does not wish to terminate its license hereunder, then Par may, in its discretion, retain its license and seek to have a court or an arbitrator (a) determine whether Alfacell has materially breached or defaulted under this Agreement and failed to timely cure such material breach or default, and (b) if such court or arbitrator determines that Alfacell has so materially breached or defaulted and has failed to timely cure such material breach or default, and that Par has suffered Losses arising, directly or indirectly, out of or in connection with or relating to or based on such uncured material breach or default, then such court or arbitrator may either (i) award monetary damages or (ii) prospectively reduce royalty rates and/or other payments hereunder (including reduction in milestone payments), where (i) or (ii) would be objectively determined by such court or arbitrator to be a fair and reasonable remedy for any actual damages determined to have been suffered by Par by such material breach or default by Alfacell.
 
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13.3 Termination for Bankruptcy.  Each Party (the “Insolvent Party”) shall promptly notify the other Party (the “Solvent Party”) in writing upon the initiation of any proceeding in bankruptcy, reorganization, dissolution, liquidation or arrangement for the appointment of a receiver or trustee to take possession of the assets of the Insolvent Party or similar proceeding under the law for release of creditors by or against the Insolvent Party or if the Insolvent Party shall make a general assignment for the benefit of its creditors. If the applicable circumstance described above shall have continued for sixty (60) days undismissed, unstayed, unbonded and undischarged, the Solvent Party may terminate this Agreement upon written notice to the Insolvent Party within ninety (90) days of the Insolvent Party providing the notice referenced above; provided, however, if the Insolvent Party provides for the cure of all of its defaults under this Agreement (if any) and provides adequate assurance of its future performance of its obligations to the Solvent Party’s reasonable satisfaction, then the Solvent Party shall not have the right to terminate this Agreement pursuant to this Section 13.3. All licenses and rights to licenses granted under or pursuant to this Agreement and the Supply Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code (the “Code”), licenses of rights to “intellectual property” as defined under Section 101(35A) of the Code. Par, as the licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Code. The foregoing provisions of this Section 13.3 are without prejudice to any rights Par may have arising under the Code or other applicable law.
 
13.4 Termination for Failure to Meet UMM Milestones. Par shall have the right to terminate this Agreement on ninety days’ written notice to Alfacell if (a) the Product for the Primary UMM Indication shall not obtain Full Approval on or before January 1, 2012, or (b) the Product for the Primary UMM Indication receives a Not Approvable communication from the FDA.
 
13.5 Other Grounds for Termination. A Party may terminate this Agreement pursuant to the terms and conditions of Sections 4.1(e) and/or 4.4(b).
 
13.6 Effects of Termination.
 
(a) If Par elects to terminate this Agreement in accordance with Section 13.2, all rights and licenses granted to Par shall automatically and immediately terminate and shall revert to Alfacell (unless otherwise expressly set forth herein).
 
(b) If Alfacell elects to terminate this Agreement in accordance with Section 13.2, (i) all rights and licenses granted to Par pursuant to this Agreement shall automatically and immediately terminate and Par immediately shall discontinue Commercialization of Product and all use of the Product Trademarks, Trade Names and the Alfacell Technology (without any right to sell inventory pursuant to subsection (d) below); and (ii) Par shall pay within thirty (30) days after such termination: (x) all accrued and unpaid amounts due to Alfacell in accordance with the terms of this Agreement (including, if such termination shall occur following the grant of Regulatory Approval, any payments under Section 6.2 that have been achieved but not yet paid by Par, any unpaid Royalties and the Transfer Price for Product manufactured or in process pursuant to Par’s binding sales forecast but not yet delivered to Par, as well as raw materials purchased therefor, but only to the extent that Alfacell is unable to sell such Product); and (y) any other amounts that will become due to Alfacell through or after the effective date of such termination in accordance with the terms hereof. The remedies set forth in this Section 13.6(b) are in addition to any rights and remedies otherwise available to Alfacell at law or in equity.
 
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(c) Upon the termination or expiration of this Agreement each Party shall return to the other Party, or destroy, all Confidential Information of the other Party.
 
(d) Except in the case of termination of this Agreement by Alfacell under Section 13.2, Par may continue to sell inventory of Product then on hand for an additional period not to exceed six (6) months, and the sale of such Product shall be subject to the terms and conditions of this Agreement.
 
13.7 Surviving Rights. The expiration or termination of this Agreement shall not affect the obligations and rights of the Parties which from their context are intended to survive such expiration or termination. Without limiting the foregoing sentence, the provisions of Section 6.5; Section 10.1 (with respect to Par’s obligation to forward all ADE reports); Sections 12.1 through 12.4; Sections 13.3 (with respect to Par’s rights under the Code) and 13.6; this Section 13.7; and Section 13.8; and Articles I, VIII and XIV, shall survive termination or expiration of this Agreement.
 
13.8 Accrued Rights and Surviving Obligations. The termination or expiration of this Agreement for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either Party prior to such termination or expiration, including any damages arising from any breach hereunder. Such termination or expiration shall not relieve either Party from obligations which are expressly indicated to survive termination or expiration of this Agreement.
 
ARTICLE XIV
 
MISCELLANEOUS
 
14.1 Entire Agreement; Modification. This Agreement, together with the Schedules attached hereto and incorporated herein, constitutes the entire understanding and agreement of the Parties with respect to the subject matter hereof and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether verbal or written, between the Parties with respect to the subject matter hereof. No modification or amendment of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party.
 
14.2 Assignment. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their successors and permitted assigns; provided, however, that neither Party shall assign any of its rights and obligations hereunder without the prior written consent of the other Party except to an Affiliate or as incident to the merger, consolidation, reorganization or acquisition of stock or assets affecting substantially all of the assets or actual voting control of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 14.2 shall be null and void. In the event of a Change of Control of Par or Alfacell, the surviving entity shall promptly confirm to Alfacell or Par, as applicable, in writing its obligation to abide by the terms and conditions of this Agreement, and shall meet with Alfacell or Par, as applicable, within thirty (30) days of such Change of Control to discuss and review continued performance under this Agreement.
 
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14.3 Performance by Sub-distributors. The Parties recognize that, subject to Section 4.3, Par may perform some or all of its obligations under this Agreement through one (1) or more of its Sub-distributors, which may or may not be Affiliates of Par; provided, however, that Par shall remain responsible for and shall guarantee such performance by its Sub-distributors (whether or not Affiliates), and shall cause its Sub-distributors (whether or not Affiliates) to comply with the provisions of this Agreement in connection with such performance.
 
14.4 Notices. Any notices given under this Agreement shall be in writing, addressed to the Parties at the following addresses, and delivered by person, by facsimile followed by U.S. Mail, return receipt requested, or by FedEx or other reputable national courier service. Any such notice shall be deemed to have been given as of the day of personal delivery, one (1) business day after the date sent by facsimile service or on the day of delivery to the other Party confirmed by the courier service.
 
In the case of Alfacell:
 
Alfacell Corporation
300 Atrium Drive
Somerset, NJ 08873
Attention: Chief Executive Officer
Facsimile: (732) 652-4575
   
with a copy (which shall not
constitute notice) to:
 
Heller Ehrman LLP
Times Square Tower
7 Times Square
New York, New York 10036
Attention: Kevin T. Collins
Facsimile: (212) 763-7600
   
In the case of Par:
 
Par Pharmaceutical, Inc.
300 Tice Boulevard
Woodcliff Lake, NJ 07677
Attn: General Counsel’s Office
Fax: (201) 802-4223
 
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with a copy (which shall not
constitute notice) to:
Orrick, Herrington & Sutcliffe LLP
666 Fifth Avenue
New York, NY 10103-0001
Attn: R. King Milling, Jr., Esq.
Fax: (212) 506-5151
 
Either Party may change its address for communications by a notice to the other Party in accordance with this Section 14.4.
 
14.5 Dispute Resolution. The Parties recognize that a bona fide dispute as to certain matters may, from time to time, arise during the Term that relates to a Party’s rights and/or obligations hereunder. In the event of the occurrence of such a dispute, either Party may, by written notice to the other Party, have such dispute referred to the respective officers designated below, or their successors, for attempted resolution by good faith negotiation within thirty (30) days after such notice is received. Such designated officers are as follows:
 

For Alfacell:
Kuslima Shogen, CEO
   
For Par:
John MacPhee, President, Strativa Pharmaceuticals (a division of Par Pharmaceutical, Inc.)
 
In the event that the designated officers are not able to resolve the dispute within such thirty (30)-day period, or such other period of time as the Parties may mutually agree to in writing, the Parties shall attempt in good faith to resolve such dispute in a voluntary, amicable and expeditious manner through  non-binding mediation  in New York, New York under the International Institute for Conflict Prevention and Resolution (“CPR”) Mediation Procedure then currently in effect. Unless the Parties agree otherwise, the mediator will be selected from the JAMS panel of neutrals and each Party shall bear its own costs.  If the dispute is not resolved within sixty (60) days of a Party’s written request for mediation, there is no further obligation to mediate.  If the Parties are unable to resolve any dispute through mediation as  set forth in this Section 14.5, each Party shall have the right to pursue any and all remedies available at law or in equity.  
 
14.6 Governing Law; Waiver of Jury Trial. This Agreement shall be governed by, and construed in accordance with, the laws of the State of New York without reference to any rules of conflicts of laws. The Parties hereby consent to the exclusive jurisdiction of the Federal and State courts of New York and hereby waive any objection to venue or forum laid therein. The Parties hereby agree that service of process by certified mail, return receipt requested, shall constitute personal service for all purposes hereof. The Parties expressly reject the application of the United Nations Convention on Contracts for the International Sale of Goods and all implementing legislation thereunder. EACH PARTY HEREBY WAIVES ITS RIGHT TO A TRIAL BY JURY OF ANY CLAIM OR CAUSE OF ACTION BASED UPON, ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY, IN ANY ACTION, PROCEEDING OR OTHER LITIGATION OF ANY TYPE BROUGHT BY ANY PARTY AGAINST THE OTHER, WHETHER WITH RESPECT TO CONTRACT CLAIMS, TORT CLAIMS OR OTHERWISE. THIS WAIVER SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS AGREEMENT.
 
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14.7 Force Majeure. A Party hereto shall be excused and shall not be held liable or responsible for failure or delay in fulfilling or performing any of its obligations under this Agreement if such failure or delay is caused by acts of God, acts of the public enemy, fire, explosion, flood, drought, war, terrorists, riot, unavailability of raw material, sabotage, embargo, strikes or other labor disputes, intervention of governmental authority, or by any other event or circumstance of like or different character to the foregoing beyond the reasonable control and without the fault or negligence of the affected Party (each, a “Force Majeure Event”). Such excuse shall continue as long as the Force Majeure Event continues. Upon cessation of such Force Majeure Event, such Party shall promptly resume performance hereunder. Each Party agrees to give the other Party prompt written notice of the occurrence of any Force Majeure Event, the nature thereof and the extent to which the affected Party will be unable to perform its obligations hereunder. Each affected Party further agrees to use reasonable efforts to correct or otherwise address the Force Majeure Event as soon as practicable and to give the other Party prompt written notice when it is again fully able to perform such obligations.
 
14.8 Independent Contractors. In making and performing this Agreement, Par and Alfacell act and shall act at all times as independent contractors and nothing contained in this Agreement shall be construed or implied to create an agency, partnership or employer and employee relationship between Alfacell and Par. At no time shall one Party make commitments or incur any charges or expenses for or in the name of the other Party.
 
14.9 Severability; Waiver. If one (1) or more of the provisions of this Agreement are held by any court or authority having jurisdiction over this Agreement or either of the Parties to be invalid, illegal or unenforceable, such provision or provisions shall be validly reformed to as nearly as possible approximate the intent of the Parties and, if unreformable, shall be divisible and deleted in such jurisdiction; elsewhere, this Agreement shall not be affected so long as the Parties are still able to realize the principal benefits bargained for in this Agreement. The failure of a Party to insist upon strict performance of any provision of this Agreement or to exercise any right arising out of this Agreement shall neither impair that provision or right nor constitute a waiver of that provision or right, in whole or in part, in that instance or in any other instance. Any waiver by a Party of a particular provision or right shall be in writing, shall be as to a particular matter and, if applicable, for a particular period of time and shall be signed by such Party.
 
14.10 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
 
14.11 Cumulative Rights. The rights, powers and remedies hereunder shall be in addition to, and not in limitation of, all rights, powers and remedies provided at law or in equity, or under any other agreement between the Parties. All of such rights, powers and remedies shall be cumulative, and may be exercised successively or cumulatively.
 
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14.12 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be an original and all of which shall constitute together the same document. Counterparts may be signed and delivered by facsimile, each of which shall be binding when sent.
 
14.13 Publicity and Press Releases. Neither Party shall (a) originate any publicity, news release or other public announcement, written or oral, whether to the public press, stockholders or otherwise, relating to this Agreement, any amendment hereto or performance hereunder, or (b) use the name of the other Party in any publicity, news release or other public announcement, except (i) with the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed, or (ii) as required by applicable law or regulation, in which case the originating Party shall submit to the other Party (for review and any proposed modifications, as well as the Parties’ coordination, prior to such disclosure or use) each such required disclosure, and shall comply with the terms of Article VIII; provided, however, that if a Party determines in good faith that it is required to make a public disclosure with respect to the subject matter of this Agreement pursuant to any applicable securities laws or the rules of any securities exchange on which its securities are traded, it shall not be required to obtain the prior written approval of the contents of such public disclosure from the other Party, but it shall use its reasonable best efforts to provide the other Party with a reasonable opportunity to review such public disclosure before it is made public and will consider in good faith changes to such public disclosure suggested by the other Party. Public disclosures with respect to the subject matter of this Agreement that contain only information that is consistent with the information contained in prior public disclosures made by one of the Parties in accordance with the terms of this Section 14.13 shall not require prior review or approval by the non-disclosing Party. Par acknowledges that Alfacell will be obligated to file a copy of this Agreement with the United States Securities and Exchange Commission (“SEC”). Alfacell will seek confidential treatment of those portions of this Agreement which it deems appropriate under applicable regulations of the SEC.
 
[Signature Page Follows]
 
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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
 
 
ALFACELL CORPORATION
   
   
 
By:
/s/ Kuslima Shogen
  Name:  Kuslima Shogen
 
Title:  
Chairman & CEO
     
     
 
PAR PHARMACEUTICAL, INC.
   
   
 
By:
/s/ Patrick G. LePore
  Name:  Patrick G. LePore
 
Title: 
CEO & President
 
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EX-10.3(2) 5 v104574_ex10-32.htm
 

 
EXHIBIT 10.3.2
PAR PHARMACEUTICAL COMPANIES, INC.

TERMS OF STOCK OPTION


This document sets forth the terms of an Option (as defined below) granted by PAR PHARMACEUTICAL COMPANIES, INC. (the “Company”) pursuant to a Certificate of Stock Option (the “Certificate”) displayed at the website of Smith Barney Benefits Access®. The Certificate, which specifies the director of the Company (who is not an employee of the Company or any Subsidiary, the “Eligible Director”) to whom the Stock Option has been granted, other specific details of the grant, and the electronic acceptance of the Certificate at the website of Smith Barney, are incorporated herein by reference.

WHEREAS, the Board of Directors of the Company (the “Board”) has authorized and approved the Par Pharmaceutical Companies, Inc. 1997 Directors’ Stock and Deferred Fee Plan (the “Plan”), which has been approved by the stockholders of the Company; and

WHEREAS, the Plan, in part, provides for the annual grant of an option (the “Option”) under the Plan to the Eligible Director to purchase Five Thousand (5,000) shares of the Company's Common Stock, par value $.01 per share (the "Common Stock");

WHEREAS, pursuant to the Plan, the award to the Eligible Director of the Option is subject to the terms and conditions specified on the Certificate and as set forth in the Plan and in these Terms; and

WHEREAS, capitalized terms not otherwise defined herein shall have the meanings assigned to them under the Plan.

NOW, THEREFORE, in consideration of the mutual covenants contained herein, the parties hereto agree as follows:

1. Incorporation of the Plan. The Option is granted pursuant to the provisions of the Plan and the terms and definitions of the Plan are incorporated by reference in these Terms.

2. Grant of Option. (a) Subject to the terms and conditions of the Plan, the Company hereby grants on the date of grant (the “Date of Grant”) to the Eligible Director the right and option (the "Option") to purchase all or any part of an aggregate number of shares of the Common Stock of the Company (the "Option Shares"), as specified on the Certificate and on the terms and conditions set forth herein and therein.

(b) This Option shall not be deemed an “Incentive Stock Option” under the Internal Revenue Code (“Code”). Accordingly, the Eligible Director acknowledges that, under existing laws and regulations, exercise of this Option would be a taxable event under the Code. The Eligible Director will be subject to a withholding tax on the difference between the purchase price of the Option Shares and their market value on the date of the taxable event. Any such tax shall be paid to the Company by the Eligible Director within two days of receipt of a notice from the Company specifying the amount thereof.
 

 
3. Purchase Price. The price per share to be paid by the Eligible Director for the Option Shares shall be the grant price specified on the Certificate.

4. Exercise Terms.

(a) The Option shall be exercisable in full commencing on the first anniversary of the Date of Grant (the “Exercise Date”), provided that the Eligible Director has not been removed “for cause”, as a member of the Board on or prior to the first anniversary of the Date of Grant, and shall expire and not be exercisable after 5:00 P.M. on the tenth anniversary of the Date of Grant (the “Exercise Period”). An Option shall remain exercisable after the Exercise Date at all times during the Exercise Period, regardless of whether the Eligible Director thereafter continues to serve as a member of the Board.

(b) The Option may be exercised at any time or from time to time during the term of the Option as to any or all full shares which have become exercisable in accordance with this Section, but not as to less than 100 shares of Common Stock unless the remaining shares of Common Stock that are so exercisable are less than 100 shares of Common Stock. The Option price is to be paid in full upon the exercise of the Option. The holder of an Option shall not have any of the rights of a stockholder with respect to the shares of Common Stock subject to the Option until such shares of Common Stock have been issued or transferred to him upon the exercise of his Option.
 
(c) The Option may be exercised with respect to a specified number of shares of Common Stock by written notice of exercise to the Company stating that (i) the option price for the shares and any withholding tax due thereon will be paid to the Company directly by a broker-dealer designated by the Eligible Director and irrevocable instructions to such effect have been furnished by the Eligible Director to such broker-dealer, and (ii) an advice from the broker-dealer confirming payment to the Company will be promptly delivered to the Company. The exercise of such Option shall be irrevocable at the time of notice to the Company; provided, however, that the Company shall not be required to deliver certificates for shares of Common Stock with respect to the exercise of the Option until the Company has confirmed the receipt of good and sufficient funds in payment of the purchase price hereof.

(d) Upon a Sale (as defined below), the Board may elect either (i) to continue the Option without any payment or (ii) to cause to be paid to the Eligible Director upon consummation of the Sale, a payment equal to the excess, if any, of the sale consideration receivable by the holders of shares of Common Stock in such a Sale (the “Sale Consideration”) over the purchase price for this Option for each share of Common Stock the Eligible Director shall then be entitled to acquire under these Terms. If the Board elects to continue the Option, then the Company shall cause effective provisions to be made so that the Eligible Director shall have the right, by exercising the Option prior to the end of the Exercise Period, to purchase the kind and amount of shares of stock and other securities and property receivable upon such a Sale by a holder of the number of shares of Common Stock which might have been purchased upon exercise of the Option immediately prior to the Sale. The value of the Sale Consideration receivable by the holder of a share of Common Stock, if it shall be other than cash, shall be determined, in good faith, by the Board. Upon payment to the Optionee of the Sale Consideration, the Eligible Director shall have no further rights in connection with the Option, the Option shall be terminated and surrendered for cancellation and the Option shall be null and void.
 
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(e) “Sale” shall mean any single transaction or series of related transactions, upon the consummation of the following events: (i) a definitive agreement for the merger or other business combination of the Company with or into another corporation pursuant to which the shareholders of the Company do not own, immediately after the transaction, more than 50% of the voting power of the corporation that survives and is a publicly owned corporation and not a subsidiary of another corporation, or (b) a definitive agreement for the sale, exchange, or other disposition of all or substantially all of the assets of the Company (other than to any wholly-owned subsidiary of the Company); provided, that a Sale shall not be deemed to have occurred if there shall be an affirmative vote of a majority of the Board to suspend the provisions of Section 4.3 of the Plan with respect to any such event.

5. Option Non-Transferable. This Option may not be transferred by the Eligible Director otherwise than by will or the laws of descent and distribution, or by a Qualified Domestic Relations Order during the lifetime of the Eligible Director. This Option may be exercised only by him (or by his guardian or legal representative, should one be appointed) or by his spouse to whom the Option has been transferred pursuant to a Qualified Domestic Relations Order. The Option shall not be subject to execution, attachment or similar process, and any attempted assignment, transfer, pledge, hypothecation or other disposition of the Option contrary to the provisions hereof shall be null and void and without legal effect.

6. Notice of Exercise of Option. (a) The Option may be exercised by delivery of a written notice to the Company at its principal place of business, signed by the Eligible Director or by such other person as is authorized to affect such exercise. Any such notice shall (i) specify the number of shares of Common Stock which such person then elects to purchase hereunder and (ii) be accompanied by full payment of the total price applicable to such shares of Common Stock as provided herein. Payment of the purchase price shall be made in U.S. dollars, by delivery of securities of the Company, or by a combination of U.S. dollars and securities, as provided in Section 4(c) above. In addition, prior to the issuance of a certificate for shares of Common Stock pursuant to any Option exercise, the Eligible Director shall pay to the Company the full amount of any federal and state withholding or other taxes applicable to the taxable income of such Eligible Director resulting from such exercise.

(b) Upon receipt of any such notice and accompanying payment, and subject to the terms hereof, the Company agrees to cause to be issued one or more stock certificates for the aggregate number of shares of Common Stock specified in such notice registered in the name of the person exercising the Option. In the event the Option is being exercised by any person other than the Eligible Director, the notice shall be accompanied by appropriate proof of the right of such person to exercise the Option.
 
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7. Anti-Dilution Provisions. (a) If, after the Date of Grant and prior to the complete exercise of the Option, the outstanding shares of the Common Stock of the Company are changed into or exchanged for a different number or kind of shares or other securities of the Company or of another corporation by reason of merger, consolidation, reorganization, recapitalization, reclassification, combination of shares, stock split, or stock dividend, the Board of Directors will, in accordance with the terms of the Plan, appropriately adjust the rights under this Option pertaining to any unexercised portion thereof.

(b) In the event the Company is dissolved or liquidated or involved in any merger or combination in which the Company is not a surviving corporation, the Option shall terminate, but the Eligible Director shall have the right, immediately prior to such dissolution, liquidation, merger or combination, to exercise this Option, in whole or in part, to the extent that it shall not have been exercised, without regard to the date on which the Option would otherwise become exercisable pursuant to Section 4 hereof.

8. Representations of the Company. The Company hereby represents and warrants to the Eligible Director that:

(a) the Company, by appropriate and all required action, is duly authorized to enter into these Terms and consummate all of the transactions contemplated hereunder; and

(b) the Option Shares to be issued upon the exercise of the Option, when issued and delivered by the Company to the Eligible Director in accordance with the terms and conditions hereof, will be duly and validly issued and fully paid and non-assessable.

9. Representations of the Eligible Director. The Eligible Director hereby represents and warrants to the Company that:

(a) the Company has made available to the Eligible Director a copy of all reports and documents required to be filed by the Company with the Securities and Exchange Commission pursuant to the Securities Exchange Act of 1934 within the last twelve months and all reports issued by the Company to its shareholders during such period;

(b) the Eligible Director is acquiring the Option and will acquire the Option Shares for Eligible Director's own account and not with a view towards the distribution thereof;

(c) the Eligible Director must bear the economic risk of the investment in the Option Shares, which cannot be sold by him unless they are registered under the Securities Act of 1933, as amended (the "Act"), or an exemption therefrom is available thereunder;

(d) in Eligible Director's position with the Company, Optionee has had both the opportunity to ask questions of and receive answers from the officers and directors of the Company and all persons acting on its behalf concerning the terms and conditions of the offer made hereunder and to obtain any additional information to the extent the Company possesses or may possess such information or can acquire it without unreasonable effort or expense necessary to verify the accuracy of the information obtained pursuant to clause (a) above; and

(e) the Eligible Director is aware that the Company shall place stop-transfer orders with its transfer agent against the transfer of the Option Shares in the absence of registration under the Act or an exemption therefrom as provided herein.
 
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10. Restriction on Transfer of Option Shares. Anything in these Terms to the contrary notwithstanding, the Eligible Director hereby agrees that he shall not sell, transfer by any means or otherwise dispose of the Option Shares acquired by him without registration under the Act, or in the event that they are not so registered, unless (a) an exemption from the Act is available thereunder, and (b) the Eligible Director has furnished the Company with notice of such proposed transfer and the Company's legal counsel, in its reasonable opinion, shall deem such proposed transfer to be so exempt.

11. Amendments to Plan; Conflicts. No amendment or modification of the Plan shall be construed as to terminate the Option under these Terms. In the event of a conflict between the provisions of the Plan and the provisions of these Terms, the provisions of the Plan shall in all respects be controlling.

12. Miscellaneous.

(a) Notices. All notices, requests, deliveries, payments, demands and other communications required or permitted to be given under these Terms shall be in writing and shall be either delivered personally or sent by registered or certified mail, or by private courier, return receipt requested, postage prepaid to the parties at their respective addresses set forth below, or to such other address as either shall have specified by notice in writing to the other. Notice shall be deemed duly given hereunder when so delivered or mailed as provided herein.
 
  If to Company: Par Pharmaceutical Companies, Inc.
   
300 Tice Boulevard
Woodcliff Lake, NJ 07677
Attn: General Counsel
     
  If to Director: 
Address of Director on file with the Company
 
(b) Waiver. The waiver by any party hereto of a breach of any provision of these Terms shall not operate or be construed as a waiver of any other or subsequent breach.

(c) Entire Agreement. These Terms constitutes the entire agreement between the parties with respect to the subject matter hereof.

(d) Binding Effect; Successors. These Terms shall inure to the benefit of and be binding upon the parties hereto and, to the extent not prohibited herein, their respective heirs, successors, assigns and representatives. Nothing in these Terms, expressed or implied, is intended to confer on any person other than the parties hereto and as provided above, their respective heirs, successors, assigns and representatives, any rights, remedies, obligations or liabilities.
 
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(e) Governing Law. These Terms shall be governed by and construed in accordance with the laws of the State of Delaware.

(f) Headings. The headings contained herein are for the sole purpose of convenience of reference, and shall not in any way limit or affect the meaning of or interpretation of any of the terms or provisions of these Terms.
 
IN WITNESS WHEREOF, the parties hereunto set their hands as of the date the Certificate is accepted on the website of Smith Barney.
 
  PAR PHARMACEUTICAL COMPANIES, INC.
   
 
Thomas J. Haughey
Executive Vice President and General Counsel
   
  ELIGIBLE DIRECTOR
   
 
(Acceptance designated electronically at the
website of Smith Barney)
 
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EX-10.3(3) 6 v104574_ex10-33.htm
EXHIBIT 10.3.3
PAR PHARMACEUTICAL COMPANIES, INC.

TERMS OF RESTRICTED STOCK UNIT AWARD


This document sets forth the terms of the award of Restricted Stock Units (as defined below) granted by PAR PHARMACEUTICAL COMPANIES, INC. (the “Company”) pursuant to a Certificate of Restricted Stock Units (the “Certificate”) displayed at the website of Smith Barney Benefits Access® (“Smith Barney”). The Certificate, which specifies the director (the “Director”) to whom the Restricted Stock Units have been awarded, other specific details of the award, and the electronic acceptance of the Certificate at the website of Smith Barney are incorporated herein by reference.

W I T N E S S E T H:
 
WHEREAS, the Board of Directors of the Company (the “Board”) has authorized and approved the Par Pharmaceutical Companies, Inc. Amended and Restated 1997 Directors’ Stock and Deferred Fee Plan (the “Plan”), which has been approved by the stockholders of the Company;

WHEREAS, the Plan provides for the annual grant of restricted Stock Units (“Restricted Stock Units”) to Directors of the Company who are not employees of the Company or any of its subsidiaries, having an aggregate Fair Market Value, determined as of the Date of Grant, equal to One Hundred Thousand Dollars ($100,000);

WHEREAS, pursuant to the Plan, the award to the Eligible Director of Restricted Stock Units is subject to the terms and conditions specified on the Certificate and as set forth in the Plan and in this Agreement; and

WHEREAS, capitalized terms not otherwise defined herein shall have the meanings assigned to them under the Plan.

NOW, THEREFORE, the parties, intending to be legally bound, agree as follows:
 
 1.  RESTRICTED STOCK UNITS
 
1.1 Grant of Restricted Stock Units.

(a) Subject to the terms and conditions hereinafter set forth and set forth in the Plan, the Company grants to the Eligible Director that number of Restricted Stock Units (the “Units”) as specified on the Certificate, which represent an equivalent number of shares of the Company’s common stock, par value $.01 per share (“Common Stock”), having an aggregate Fair Market Value, determined as of the Date of Grant, of $100,000. The Units are subject to the restrictions set forth in the Certificate, Section 1.2 of this Agreement, the terms and conditions of the Plan and the other terms and conditions contained in this Agreement.
 
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(b) The Units granted under this Agreement shall be reflected in the Director’s Stock Account maintained by the Company during the Restricted Period (as defined in Section 1.3 hereof). If and when the restrictions set forth in Section 1.2 expire in accordance with the terms of this Agreement, and upon the satisfaction of all other applicable conditions as to the Units, such Units (and any related Dividend Units described in Section 1.1(c) below) not forfeited pursuant to Section 1.4 hereof shall be settled in shares of Common Stock or cash as provided in Section 1.1(e) of this Agreement and otherwise in accordance with the Plan.

(c)  With respect to each Unit, whether or not vested, that has not been forfeited (but only to the extent such award of Units has not been settled for cash or Common Stock), the Company shall, with respect to any cash dividends or distributions paid on the Common Stock, accrue and credit to the Director’s Stock Account a number of Units (or fractional Unit) having a Fair Market Value as of the date such dividend or distribution is paid equal to the cash dividends or distributions that would have been paid with respect to such Unit if it were an outstanding share of Common Stock (the “Dividend Units”). Fractional Units accruing under this provision shall be credited cumulatively to the Director’s Stock Account. These Dividend Units thereafter shall (i) be treated as Units for purposes of future dividend accruals pursuant to this Section 1.1(c); and (ii) vest in such amounts at the same time as the Units with respect to which such Dividend Units were received. Any dividends or distributions on Common Stock paid other than in cash shall accrue in the Director’s Stock Account and shall vest at the same time as the Units in respect of which they are made (in each case in the same form as such dividend or other distribution is paid on such Common Stock).
 
(d) The Company’s obligations under this Agreement shall be unfunded and unsecured, and no special or separate fund shall be established and no other segregation of assets shall be made. The rights of the Director under this Agreement shall be no greater than those of a general unsecured creditor of the Company. In addition, the Units shall be subject to such restrictions as the Company may deem advisable under the rules, regulations and other requirements of the Securities and Exchange Commission, any stock exchange upon which Common Stock is then listed, and any applicable federal or state securities law.

(e) Except as otherwise provided in this Agreement, upon the satisfaction of all applicable conditions as to the Units (including the payment by the Director of all applicable required withholding taxes, if any) settlement of the vested Units shall occur as soon as practicable after the later of (i) the first day of the seventh month following the month in which the Restricted Period ends and (ii) the first anniversary of the Date of Grant, and otherwise shall be made in accordance with the provisions of Section 6.7 of the Plan. At such time, the Company shall issue to the Director one share of Common Stock (or, in the discretion of the Company, cash equal to the Fair Market Value of one share of Common Stock) for each Unit (with any fractional Unit being rounded up to the nearest whole Unit) credited to the Director’s Stock Account. Settlement of the Director’s Stock Account may be accelerated in accordance with Section 6.8 of the Plan and otherwise in compliance with the requirements of Section 409A of the Code.

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1.2 Restrictions.

(a) The Director shall have no rights as a stockholder of the Company by virtue of any Unit unless and until such Unit vests and resulting shares of Common Stock are issued to the Director.
 
(b)   None of the Units may be sold, transferred, assigned, pledged or otherwise encumbered or disposed of during the Restricted Period, except as otherwise permitted by the Board in its sole discretion or pursuant to rules adopted by the Board in accordance with the Plan.
 
(c) Any attempt to dispose of the Units or any interest in the Units in a manner contrary to the restrictions set forth in this Agreement shall be void and of no effect.
 
1.3 Restricted Period and Vesting. 

(a) Subject to the provisions contained in Sections 1.4, 1.5 and 1.6 hereof, the restrictions set forth in Section 1.2 hereof shall apply for a period beginning on the Date of Grant and ending on the date the Director terminates service as a director of the Company for any reason (the “Restricted Period”). 

(b) Notwithstanding the provisions of Section 1.3(a) hereof, the Units shall be deemed vested and no longer subject to forfeiture under Section 1.4 hereof (but still subject to the restrictions set forth in Section 1.2 hereof) on the first anniversary of the Date of Grant.

(c) Notwithstanding Section 1.3(b) above, upon a Sale of the Company, all rights of the Director to the Units that have not vested shall immediately vest and no longer be subject to forfeiture under Section 1.4 hereof (but still subject to the restrictions set forth in Section 1.2 hereof). The Director shall be entitled to payment of the value of the Units in cash credited to the Director’s Stock Account in accordance with Section 4.3 of the Plan; provided, however, that a Sale shall not be deemed to have occurred if there shall be an affirmative vote of a majority of the Board to suspend the provisions of Section 4.3 of the Plan with respect to any such event.
 
1.4 Forfeiture. 

Subject to Section 1.6 hereof, if during the Restricted Period (i) the Director is removed “for cause” as a member of the Board, (ii) there occurs a material breach of this Agreement by the Director or (iii) the Director fails to meet the tax withholding obligations described in Section 1.5(b) hereof, all rights of the Director to the Units that have not vested in accordance with Section 1.3(b) or 1.3(c) hereof as of the date of such event shall terminate immediately and be forfeited in their entirety.
 
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1.5 Withholding.
 
(a) The Board shall determine the amount of any withholding or other tax required by law to be withheld or paid by the Company with respect to any income recognized by the Director with respect to the Units.

(b) The Director shall be required to meet any applicable tax withholding obligation in accordance with the provisions of Section 10.4 of the Plan.

(c) The Board shall be authorized, in its sole discretion, to establish such rules and procedures relating to the use of shares of Common Stock to satisfy tax withholding obligations as it deems necessary or appropriate to facilitate and promote the conformity of the Director’s transactions under the Plan and this Agreement with Rule 16b-3 under the Securities Exchange Act of 1934, as amended, if such Rule is applicable to transactions by the Director.

1.6 Board’s Discretion. Notwithstanding any provision of this Agreement to the contrary, the Board shall have discretion to waive any forfeiture of the Units as set forth in Section 1.4 hereof, the Restricted Period and any other conditions set forth in this Agreement.

1.7 Incorporation of the Plan. This award is granted pursuant to the provisions of the Plan and the terms and definitions of the Plan are incorporated by reference in this Agreement and made a part hereof.
 
2.   REPRESENTATIONS OF THE COMPANY AND THE DIRECTOR
 
2.1 Representations of the Company. The Company hereby represents and warrants to the Director that the Company, by appropriate and all required action, is duly authorized to enter into this Agreement and consummate all of the transactions contemplated hereunder. Further, the Company represents and warrants that any shares of Common Stock to be issued upon settlement of the Units, when issued and delivered by the Company to the Director in accordance with the terms and conditions hereof, will be duly and validly issued and fully paid and non-assessable.

2.2 Representations of the Director. The Director hereby represents to the Company that the Director has read and fully understands the provisions of this Agreement and the Plan and his or her decision to participate in the Plan is completely voluntary. Further, the Director acknowledges that he or she is relying solely on his or her own advisors with respect to the tax consequences of this award of Units.
 
3.  AMENDMENTS TO PLAN; CONFLICTS 
 
No amendment or modification of the Plan shall be construed as to terminate the award under this Agreement. In the event of a conflict between the provisions of the Plan and the provisions of this Agreement, the provisions of the Plan shall in all respects be controlling.
 
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4. 
MISCELLANEOUS
 
4.1 Notices. All notices, requests, deliveries, payments, demands and other communications required or permitted to be given under this Agreement shall be in writing and shall be either delivered personally or sent by registered or certified mail, or by private courier, return receipt requested, postage prepaid to the parties at the address stated below, or to such other address as either shall have specified by notice in writing to the other. Notice shall be deemed duly given hereunder when so delivered or mailed as provided herein.
 
  If to Company: 
Par Pharmaceutical Companies, Inc.
300 Tice Boulevard
Woodcliff Lake, NJ 07677
Attn: General Counsel
 
If to Director: Address to Director on file with the Company

4.2 Waiver. The waiver by any party hereto of a breach of any provision of this Agreement shall not operate or be construed as a waiver of any other or subsequent breach.

4.3 Entire Agreement. This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof.

4.4 Binding Effect; Successors. This Agreement shall inure to the benefit of and be binding upon the parties hereto and, to the extent not prohibited herein, their respective heirs, successors, assigns and representatives. Nothing in this Agreement, expressed or implied, is intended to confer on any person other than the parties hereto and as provided above, their respective heirs, successors, assigns and representatives, any rights, remedies, obligations or liabilities.

4.5 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware.

4.6 Headings. The headings contained herein are for the sole purpose of convenience of reference, and shall not in any way limit or affect the meaning of or interpretation of any of the terms or provisions of this Agreement.

4.7 Severability. Whenever possible, each provision in this Agreement shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement shall be held to be prohibited by or invalid under applicable law, then (a) such provision shall be deemed amended to accomplish the objectives of the provision as originally written to the fullest extent permitted by law and (b) all other provisions of this Agreement shall remain in full force and effect.

4.8 Effect on Other Plans. Payments received by the Director pursuant to this Agreement shall not be included in the determination of benefits under any pension, group insurance or other benefit plan of the Company, its affiliates or any of its subsidiaries in which the Director may be enrolled or for which the Director may become eligible, except as may be provided under the terms of such plans or determined by the Board.
 
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4.9 No Strict Construction. No rule of strict construction shall be implied against the Company, the Board or any other person in the interpretation of any of the terms of the Plan, this Agreement or any rule or procedure established by the Board.

4.10 Use of the Word “Director”. Wherever the word “Director” is used in any provision of this Agreement under circumstances where the provision should logically be construed to apply to the executors, the administrators, or the person or persons to whom the Units may be transferred by will or the laws of descent and distribution, the word “Director” shall be deemed to include such person or persons.

4.11 Further Assurances. The Director agrees, upon demand of the Company or the Board, to do all acts and execute, deliver and perform all additional documents, instruments and agreements (including, without limitation, stock powers with respect to shares of Common Stock issued or otherwise distributed in relation to the Units) which may be reasonably required by the Company or the Board, as the case may be, to implement the provisions and purposes of this Agreement and the Plan.
 
IN WITNESS WHEREOF, the parties hereunto set their hands as of the date the Certificate is accepted on the website of Smith Barney.
 
 
  PAR PHARMACEUTICAL COMPANIES, INC.
   
 
Thomas J. Haughey
Executive Vice President and General Counsel
   
  DIRECTOR
   
 
(Acceptance designated electronically at the
website of Smith Barney)
 
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EX-10.6(1) 7 v104574_ex10-61.htm
EXHIBIT 10.6.1
PAR PHARMACEUTICAL COMPANIES, INC.

TERMS OF STOCK OPTION

 

 
This document sets forth the terms of an Option (as defined in Section 1 below) to purchase shares of common stock granted by PAR PHARMACEUTICAL COMPANIES, INC. (the “Company”) pursuant to a Certificate of Stock Option Grant (the “Certificate”) displayed at the website of Smith Barney Benefits Access®. The Certificate, which specifies the person to whom the Option is granted (the “Optionee”) and other specific details of the grant, and the electronic acceptance of the Certificate at the website of Smith Barney, are incorporated herein by reference.
 
WHEREAS, the Board of Directors (the “Board”) of the Company has authorized and approved the Par Pharmaceutical Companies, Inc. 2004 Performance Equity Plan (the “Plan”), which has been approved by the stockholders of the Company;

WHEREAS, the Plan, in part, provides for the grant of Options to certain employees of the Company and any Subsidiary of the Company;

WHEREAS, pursuant to the Plan, the Committee has approved an award to the Optionee designated in the Certificate of an option to purchase common stock of the Company on the terms and subject to the conditions set forth in the Plan and these Terms of Stock Option. Capitalized terms used but not defined in these Terms or the Certificate shall have the meanings set forth in the Plan.

NOW, THEREFORE, in consideration of the foregoing and of the terms and conditions herein contained, the parties hereto agree as follows:
 
1.  Grant of Options. Subject to the terms and conditions hereinafter set forth and set forth in the Plan, the Company hereby grants to the Optionee, as a matter of separate agreement and not in lieu of salary, or any other compensation for services, the right and option (the “Option”) to purchase all or any part of an aggregate number of shares of Common Stock (the “Option Shares”) specified on the Certificate on the terms and conditions set forth herein and therein.
 
2.  Nonqualified Option; Withholding Tax. This Option shall not be deemed an “Incentive Stock Option” under the Internal Revenue Code (“Code”). The Company shall be entitled, if the Compensation and Management Development Committee of the Board of Directors of the Company (the “Committee”) deems it necessary or desirable, to withhold (or secure payment from the Optionee in lieu of withholding) the amount of any withholding or other tax required by law to be withheld or paid by the Company in connection with the issuance of the Option Shares.
 

 
3.  Grant Price. The grant price of each Option Share shall be the grant price specified on the Certificate.
 
4.  Exercise Period.
 
4.1  Grant Expiration Date; Vesting. The Option shall be exercisable during the period (the “Exercise Period”) commencing on the Grant Date specified on the Certificate and terminating at the close of business on the date (the “Grant Expiration Date”) specified on the Certificate. All rights to exercise the Option shall terminate on the Grant Expiration Date. Subject to this Section 4 and Section 5 hereof, this Option shall be exercisable in accordance with the vesting schedule specified on the Certificate.
 
4.2  Effect of Termination of Employment.
 
4.2.1  Termination Upon Death or Disability. Upon the termination of the Optionee's employment by reason of the death or disability (for purposes of the Plan) of the Optionee, this Option or any unexercised portion thereof, which was otherwise exercisable on the date of such termination, shall terminate unless such Option, to the extent exercisable on such date, is exercised by the Optionee or the executor or administrator of his estate, as the case may be, within one year after the date of such termination of his employment. However, should the death of the Optionee occur during the one-year period following the termination of the employment of the Optionee by reason of his disability, the Option, to the extent exercisable on the date of termination of employment, may be exercised by the executor or administrator of the Optionee's estate within one year following such death. A transfer of the Option by the Optionee by will or by laws of descent and distribution shall not be effective to bind the Company unless the Company shall have been furnished with written notice thereof and such other evidence as the Company may deem necessary or desirable to establish the validity of the transfer and the acceptance by the transferee or transferees of the terms and conditions of the Option. Notwithstanding anything herein to the contrary, in no event shall the Option be exercisable after the Grant Expiration Date.
 
4.2.2  Termination by Reason of Retirement. Should the employment of the Optionee terminate during the term of the Option by reason of retirement by the Optionee on or after age 65, or with the approval of the Committee, from active employment with the Company or any subsidiary prior to age 65 (“Retirement”), this Option or any unexercised portion thereof which was otherwise exercisable on the date of such termination, shall terminate within thirty (30) days of the date of such termination unless the Committee, at or before the time of such Retirement, shall determine that the Option shall remain exercisable by the Optionee for a period of one year following the effective date of such termination of employment; provided, however, that if the Optionee dies within such one-year period, the Option may be exercised by the executor or administrator of the Optionee's estate within one year following such death. Notwithstanding anything herein to the contrary, in no event shall the Option be exercisable after the Grant Expiration Date.
 
4.2.3  Termination by Reason of Resignation. Should the employment of the Optionee terminate during the term of the Option by reason of resignation by the Optionee (for any reason other than Retirement), this Option or any unexercised portion thereof which was otherwise exercisable on the date of such resignation, shall terminate unless such Option, to the extent exercisable on the date of such resignation, is exercised within thirty (30) days of the date on which the Optionee resigns. Notwithstanding anything herein to the contrary, in no event shall the Option be exercisable after the Grant Expiration Date.
 
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4.2.4  Termination For Cause. If the Optionee's employment is terminated “for cause,” this Option or any unexercised portion thereof shall terminate and be of no further force and effect from the date of termination. Termination “for cause” as used herein means the termination of Optionee's employment by the Company (or, if applicable, any subsidiary thereof), “for cause” as defined in any agreement between the Company (or any such subsidiary) and the Optionee or, in the event no such agreement exists, based upon objective factors determined in good faith by the Company.
 
4.2.5  Termination Without Cause. If the employment of the Optionee with the Company or any of its subsidiaries is terminated (for any reason other than death, disability, Retirement, resignation or discharge “for cause”), this Option or any unexercised portion thereof which was otherwise exercisable on the date of such termination, shall terminate unless such Option, to the extent exercisable on the date of such termination, is exercised within ninety (90) days of the date on which he ceases to be an employee. Notwithstanding anything herein to the contrary, in no event shall the Option be exercisable after the Grant Expiration Date.
 
4.2.6  Change of Control. Upon a “Change of Control” of the Company, the Optionee's right to exercise the Option shall be immediately vested and accelerated in full and the Optionee may, during the Exercise Period, exercise the Option for the remaining unexercised portion of the Option (notwithstanding that such portion of the Option had not yet otherwise become fully exercisable under Section 4.1 with respect to all or part of the Option Shares at the date of such Change of Control); provided, however, that nothing herein contained shall extend the Grant Expiration Date.
 
4.2.7  Sale of Company. Upon a Sale (as defined below), the Board of Directors or the Committee may elect either (i) to continue the Option without any payment or (ii) to cause to be paid to the Optionee, upon consummation of the Sale, a payment equal to the excess, if any, of the Sale Consideration receivable by the holders of shares of Common Stock in such a Sale (the “Sale Consideration”) over the purchase price for this Option for each share of Common Stock the Optionee shall then be entitled to acquire hereunder. If the Board of Directors of the Company elect to continue the Option, then the Company shall cause effective provisions to be made so that the Optionee shall have the right, by exercising this Option prior to the Grant Expiration Date, to purchase the kind and amount of shares of stock and other securities and property receivable upon such a Sale by a holder of the number of shares of Common Stock which might have been purchased upon exercise of the Option immediately prior to the Sale. The value of the Sale Consideration receivable by the holder of a share of Common Stock, if it shall be other than cash, shall be determined, in good faith, by the Board of Directors of the Company. Upon payment to the Optionee of the Sale Consideration, the Optionee shall have no further rights in connection with the Option granted hereunder, this Option shall be terminated and surrendered for cancellation and the Option shall be null and void. For the purposes hereof, a “Sale” shall occur, in any single transaction or series of related transactions, upon the consummation of the events set forth under subsection (c) of the definition of a “Change of Control” in Section 2.8 of the Plan.
 
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5.  Forfeiture Provisions Following a Termination of Employment. Notwithstanding any provision under these Terms or in the Plan to the contrary, in any instance where the rights of the Optionee to exercise any unexercised portion of the Option extend past the date of termination of the Optionee's employment, all of such rights shall immediately and automatically terminate and be forfeited if, in the determination of the Committee, the Optionee at any time during a twenty-four month period following his or her termination of employment, directly or indirectly, either (i) personally or (ii) as an employee, agent, partner, stockholder, officer or director of, consultant to, or otherwise of any entity or person engaged in any business in which the Company or any of its subsidiaries is engaged, or is actively proposing to engage at the time of such termination of employment, engages in conduct that breaches his or her duty of loyalty to the Company or any of its subsidiaries or that is in material competition with the Company or any of its subsidiaries or is materially injurious to the Company or any of its subsidiaries, monetarily or otherwise, which conduct shall include, but not be limited to: (i) disclosing or using any confidential information pertaining to the Company or any of its subsidiaries; (ii) any attempt, directly or indirectly, to induce any employee of the Company or any of its subsidiaries to be employed or perform services elsewhere; or (iii) any attempt, directly or indirectly, to solicit the trade of any customer or supplier or prospective customer or supplier of the Company or any or its subsidiaries; or (iv) disparaging the Company or any of its subsidiaries or any of their respective officers or directors. The determination of whether any conduct, action or failure to act falls within the scope of activities contemplated by this Section shall be made by the Committee, in its discretion, and shall be final and binding upon the Optionee. A determination that any particular conduct, action or failure falls outside the scope of activities contemplated by this Section shall not imply that, or be determinative of whether, such conduct, action or failure is otherwise lawful or appropriate. For purposes of this Section, the Optionee shall not be deemed to be a stockholder of a competing entity if the Optionee’s record and beneficial ownership of equity securities of said entity amount to not more than one percent (1%) of the outstanding equity securities of any company subject to the periodic and other reporting requirements of the 1934 Act. In the event the existence of any circumstance which would trigger the forfeiture of an award pursuant to this Section 5 but for the fact that the Optionee has previously been converted into or exercised for other securities of the Company (e.g., upon the exercise of stock options), or converted into cash or other property (e.g., upon the sale by or for the account of the Optionee of Common Stock acquired by him or her upon the exercise of Stock Options), whether before or after the termination of employment, then, in such event, said securities, or cash or other property, as the case may be, shall be deemed to be held in trust for the Company and shall be promptly paid over to the Company upon demand (net of any amounts that may have been theretofore actually paid by the Optionee to the Company in respect thereof (i.e., as the cash grant price of an option)). The Optionee further recognizes that (i) the Company would be irreparably injured in the event of a breach of any of his obligations under this Section 5; (ii) monetary damages would not be an adequate remedy for any such breach; and (iii) the Company shall be entitled to injunctive relief, in addition to any other remedies that it may have, in the event of any such breach.
 
-4-

 
6.  Nontransferability of Option. Except as provided in Section 4, this Option and the rights and privileges conferred hereby may not be transferred, assigned, pledged or hypothecated in any way (whether by operation of law or otherwise) and shall not be subject to execution, attachment or similar process. Upon any attempt to transfer, assign, pledge, hypothecate or otherwise dispose of this Option or any right or privilege conferred hereby, contrary to the provisions hereof, or upon the levy of any attachment or similar process on the rights and privileges conferred hereby, this Option and the rights and privileges conferred hereby shall immediately become null and void.
 
7.  Payment of Purchase Price. The purchase price of the shares of Common Stock as to which the Option is exercised shall be paid in full at the time of exercise, as hereinafter provided. The purchase price may be paid with (i) Common Stock of the Company already owned by, and in the possession of, the Optionee, or (ii) any combination of U.S. dollars or Common Stock of the Company. Anything herein to the contrary notwithstanding, any required withholding tax shall be paid by the Optionee in full in U.S. dollars at the time of exercise of the Option. Payments in U.S. dollars may be made by wire transfer, certified or bank check, or personal check, in each case payable to the order of the Company; provided, however, that the Company shall not deliver certificates representing any Option Shares purchased until the Company has confirmed the receipt of good and available funds in payment of the purchase price thereof. Shares of Common Stock of the Company used to satisfy the grant price of the Option shall be valued at the Fair Market Value on the date of exercise (as defined in the Plan). The Optionee shall not have any of the rights of a shareholder with respect to the Option Shares until the Option Shares have been issued after the due exercise of the Option. Payment may also be made, in the discretion of the Company, by the delivery (including, without limitation, by fax) to the Company or its designated agent of an executed irrevocable option exercise form together with irrevocable instructions to a broker-dealer to sell or margin a sufficient portion of the shares and deliver the sale or margin loan proceeds directly to the Company to pay for the grant price.
 
8.  Exercise of Option. Subject to the terms and conditions set forth herein, the Option may be exercised by written notice to the Company pursuant to Section 14.1 hereof. Such notice shall state the election to exercise the Option and the number of Option Shares with respect to which it is being exercised, and shall be signed by the person or persons so exercising the Option. Such notice may also contain such investment representations as the Company may from time to time require. Such notice shall be accompanied by payment of the full purchase price of the Option Shares, and the Company shall issue a certificate or certificates evidencing the Option Shares as soon as practicable after the notice is received (subject to receipt of good and available funds as provided in Section 7 above). Payment of the purchase price shall be made in U.S. dollars, by delivery of securities of the Company, or by a combination of U.S. dollars and securities, as provided in Section 7 above. The certificate or certificates evidencing the Option Shares shall be registered in the name of the person or persons so exercising the Option. In the event the Option is being exercised by any person or persons other than the Optionee as provided in Section 4.2 above, the notice shall be accompanied by appropriate proof of the right of such person or persons to exercise the Option.
 
-5-

 
9.  Transfer of Option Shares.
 
9.1  Restriction. Anything in these Terms to the contrary notwithstanding, the Optionee hereby agrees that he shall not sell, transfer by any means or otherwise dispose of the Option Shares acquired by him without registration under the 1933 Act, or in the event that they are not so registered, unless (i) an exemption from the 1933 Act is available thereunder, and (ii) the Optionee has furnished the Company with notice of such proposed transfer and the Company's legal counsel, in its reasonable opinion, shall deem such proposed transfer to be so exempt.
 
9.2  Notification to Company. The Optionee agrees that if he should dispose of any Option Shares, including a disposition by sale, exchange, gift or transfer of legal title within twelve (12) months from the date such Option Shares are transferred to him, he shall notify the Company promptly of such disposition or transfer.
 
10.  Anti-Dilution Provisions. In the event of a stock dividend, subdivision, combination or reclassification of shares, or any other change in the corporate structure or shares of the Company, the number of Option Shares covered by any unexercised portion of the Option and the related purchase price per share shall be adjusted proportionately; provided, however, that upon the dissolution or liquidation of the Company, or upon any merger, consolidation or other form of reorganization, the Option may be terminated and be of no further effect.
 
11.  Company Representations. The Company hereby represents and warrants to the Optionee that:
 
(a)  the Company, by appropriate and all required action, is duly authorized to enter into these Terms and consummate all of the transactions contemplated hereunder; and
 
(b)  the Option Shares, when issued and delivered by the Company to the Optionee in accordance with the terms and conditions hereof, will be duly and validly issued and fully paid and non-assessable.
 
12.  Optionee Representations. The Optionee hereby represents and warrants to the Company that:
 
(a)  The Company has made available to the Optionee a copy of all reports and documents required to be filed by the Company with the Securities and Exchange Commission pursuant to the 1934 Act within the last twelve (12) months and all reports issued by the Company to its stockholders during such period;
 
(b)  The Optionee must bear the economic risk of the investment in the Option Shares, which cannot be sold by him unless they are registered under the 1933 Act or an exemption therefrom is available thereunder;
 
(c)  The Optionee has had both the opportunity to ask questions of and receive answers from the Company and all persons acting on its behalf concerning the terms and conditions of the offer made hereunder;
 
(d)  The Optionee is aware that the Company shall place stop transfer orders with its transfer agent against the transfer of the Option Shares in the absence of registration under the 1933 Act or an exemption therefrom as provided herein; and
 
(e)  The Optionee is aware that nothing in these Terms shall confer upon the Optionee any right to continue in the employ or as a director or agent of the Company or shall affect the right of the Company to terminate the employment or relationship of the Optionee with the Company.
 
-6-

 
13.  Amendments to Plan; Conflicts. No amendment or modification of the Plan shall be construed as to terminate the Option granted under these Terms. In the event of a conflict between the provisions of the Plan and the provisions of these Terms, the provisions of the Plan shall in all respects be controlling.
 
14.  Miscellaneous.
 
14.1  Notices. All notices required or permitted hereunder shall be in writing and shall be deemed to be properly given when personally delivered to the party entitled to receive the notice or when sent by certified or registered mail, postage prepaid, properly addressed to the party entitled to receive such notice at the address stated below:
 
  If to Company:
Par Pharmaceutical Companies, Inc.
300 Tice Boulevard
Woodcliff Lake, NJ 07677
     
  If to Optionee: Address of Optionee on file with the Company.
 
14.2  Waiver. The waiver by any party hereto of a breach of any provision of these Terms shall not operate or be construed as a waiver of any other or subsequent breach.
 
14.3  Entire Agreement. The Plan is incorporated herein by reference. The Plan, these Terms and the Certificate constitute the entire agreement between the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and Optionee with respect to the subject matter hereof, and may not be modified except by means of a writing signed by the Company and Optionee.
 
14.4  Binding Effect; Successors. These Terms and the Certificate shall inure to the benefit of and be binding upon the parties hereto and to the extent not prohibited herein, their respective heirs, successors, assigns and representatives. Nothing in these Terms or the Certificate, expressed or implied, is intended to confer on any person other than the parties hereto and as provided above, their respective heirs, successors, assigns and representatives, any rights, remedies, obligations or liabilities.
 
14.5  Governing Law. These Terms shall be governed by and construed in accordance with the laws of the State of Delaware.
 
14.6  Headings. The headings contained herein are for the sole purpose of convenience of reference, and shall not in any way limit or affect the meaning of or interpretation of any of the terms or provisions of these Terms.
 
-7-

 
IN WITNESS WHEREOF, the parties hereunto set their hands as of the date the Certificate is accepted on the website of Smith Barney.
 
  PAR PHARMACEUTICAL COMPANIES, INC.
   
 
Thomas J. Haughey
Executive Vice President and General Counsel
   
   OPTIONEE
   
 
(Acceptance designated electronically
at the website of Smith Barney)
   

-8-

EX-10.6(2) 8 v104574_ex10-62.htm
EXHIBIT 10.6.2
PAR PHARMACEUTICAL COMPANIES, INC.

TERMS OF RESTRICTED SHARES AWARD


This document sets forth the terms of the award of Restricted Shares (as defined in Section 1.1 below) granted by PAR PHARMACEUTICAL COMPANIES, INC. (the “Company”) pursuant to a Certificate of Restricted Shares (the “Certificate”) displayed at the website of Smith Barney Benefits Access®. The Certificate, which specifies the person to whom the Restricted Shares have been awarded (the “Participant”), other specific details of the award, and the electronic acceptance of the Certificate at the website of Smith Barney, are incorporated herein by reference.
 

WHEREAS, the Board of Directors (the “Board”) of the Company has authorized and approved the Par Pharmaceutical Companies, Inc. 2004 Performance Equity Plan (the “Plan”), which has been approved by the stockholders of the Company;

WHEREAS, the Plan, in part, provides for the grant of Restricted Shares to certain employees of the Company and any Subsidiary of the Company;

WHEREAS, pursuant to the Plan, the Committee has approved an award to the Participant of Restricted Shares, designated in the Certificate, on the terms and conditions set forth in the Plan and in these Terms. Capitalized terms used but not defined in these Terms shall have the meanings set forth in the Plan.

NOW, THEREFORE, the parties, intending to be legally bound, agree as follows:
 
1.  RESTRICTED SHARES
 
1.1 Grant of Restricted Shares.

(a) Subject to the terms and conditions hereinafter set forth and set forth in the Plan, the Company grants as of the date of grant specified on the Certificate (the “Date of Grant”) to the Participant shares of common stock, par value $.01 per share (“Common Stock”), specified on the Certificate, and subject to the restrictions set forth in Section 1.2 of these Terms, the terms and conditions of the Plan and the other terms and conditions contained in these Terms (the “Restricted Shares”). If and when the restrictions set forth in Section 1.2 expire in accordance with these Terms, and upon the satisfaction of all other applicable conditions as to the Restricted Shares, such shares not forfeited pursuant to Section 1.4 hereof shall no longer be considered Restricted Shares for purposes of these Terms.
 
 
 

 
 
(b) As soon as practicable after the Date of Grant, the Company shall direct that a stock certificate or certificates representing the applicable Restricted Shares be registered in the name of, and issued to, the Participant. Such certificate or certificates shall be held in the custody of the Company or its designee until such Shares have vested (or such applicable portion of the Shares as may become vested) in accordance with the schedule in Section 1.3(a). On or before the date of acceptance of these Terms, the Participant has delivered to the Company one or more stock powers endorsed in blank relating to the Restricted Shares.

(c) Each certificate for the Restricted Shares shall bear the following legend (the “Legend”):

   
The ownership and transferability of this certificate and the shares of stock represented hereby are subject to the terms and conditions (including forfeiture) of the Par Pharmaceutical Companies, Inc. 2004 Performance Equity Plan and the associated Terms of Restricted Shares Award entered into between the registered owner and Par Pharmaceutical Companies, Inc. Copies of such Plan and Terms are on file in the executive offices of Par Pharmaceutical Companies, Inc., 300 Tice Boulevard, Woodcliff Lake, NJ 07677.

In addition, the stock certificate or certificates for the Restricted Shares shall be subject to such stop-transfer orders and other restrictions as the Company may deem advisable under the rules, regulations and other requirements of the Securities and Exchange Commission, any stock exchange upon which Common Stock is then listed, and any applicable federal or state securities law, and the Company may cause a legend or legends to be placed on such certificate or certificates to make appropriate reference to such restrictions.

(d) As soon as administratively practicable following the vesting of all or any portion of the Restricted Shares, and upon the satisfaction of all other applicable conditions as to such vested Restricted Shares, including the payment by the Participant of all applicable withholding taxes, the Company shall deliver or cause to be delivered to the Participant a certificate or certificates for the applicable vested Restricted Shares that shall not bear the Legend.

1.2 Restrictions.

(a) Beginning with the Date of Grant, the Participant shall have all rights and privileges of a stockholder as to the Restricted Shares, including the right to vote and receive dividends or other distributions with respect to the Restricted Shares, except that the following restrictions shall apply:

(i) the Participant shall not be entitled to delivery of the certificate or certificates for the Restricted Shares until such Restricted Shares are deemed vested in accordance with the schedule in Section 1.3(a), and are not otherwise forfeited pursuant to Section 1.4 hereof and upon the satisfaction of all other applicable conditions;

 
 

 
 
(ii)  none of the Restricted Shares may be sold, transferred, assigned, pledged or otherwise encumbered or disposed of prior to the date such Restricted Shares are deemed vested in accordance with the schedule in Section 1.3(a), except as provided in Section 8.3 of the Plan or as otherwise permitted by the Committee in its sole discretion or pursuant to rules adopted by the Committee in accordance with the Plan;
 
(iii) all shares of Common Stock distributed as a dividend or distribution, if any, with respect to the Restricted Shares prior to the date such Restricted Shares are deemed vested in accordance with the schedule in Section 1.3(a) shall be delivered to and held by the Company and subject to the same restrictions as the related Restricted Shares until the vesting of such Restricted Shares, and subject to the satisfaction of all other applicable conditions; and

(iv) all of the Restricted Shares shall be subject to forfeiture on the terms and conditions set forth in Section 1.4 hereof; if forfeited, the Restricted Shares shall be returned to the Company and all rights of the Participant with respect to the Restricted Shares shall terminate in their entirety on the terms and conditions set forth in Section 1.4 hereof.

(b) Any attempt to dispose of Restricted Shares or any interest in the Restricted Shares in a manner contrary to the restrictions set forth in these Terms shall be void and of no effect.

1.3 Vesting. 

(a) Such portion of the Restricted Shares shall be deemed vested and no longer subject to forfeiture under Section 1.4 hereof or the restrictions set forth in Section 1.2 hereof in accordance with the following schedule:
 
 Vesting Date
   Vested Percentage
   
 1st Anniversary of the Date of Grant
  25%
 2nd Anniversary of the Date of Grant 
 50%
 3rd Anniversary of the Date of Grant
  75%
 4th Anniversary of the Date of Grant
  100%
 
(b) Notwithstanding paragraph (a) above, upon a “Change of Control” of the Company, all rights of the Participant to the Restricted Shares that have not vested shall immediately vest and no longer be subject to forfeiture under Section 1.4 hereof or the restrictions set forth in Section 1.2 hereof.
 
 
 

 
 
1.4 Forfeiture. 

(a)  Subject to Section 1.6 hereof, if prior to the date such Restricted Shares are deemed vested in accordance with the schedule in Section 1.3(a), (i) the Participant’s employment with the Company, its Affiliates and/or its Subsidiaries is terminated for any reason, including termination by reason of resignation, (ii) there occurs a material breach of these Terms by the Participant or (iii) the Participant fails to meet the tax withholding obligations described in Section 1.5(b) hereof, all rights of the Participant to the Restricted Shares that have not vested in accordance with Section 1.3(a) or 1.3(b) hereof as of the date of such termination shall terminate immediately and be forfeited in their entirety.

(b) In the event that the Participant’s employment with the Company, its Affiliates and/or its Subsidiaries, is terminated due to the Participant’s death or disability, all rights of the Participant (or, in the event of the Participant’s death, the Participant’s Beneficiary) to the Restricted Shares that have not vested shall immediately vest and no longer be subject to forfeiture.

(c) In the event of any forfeiture under this Section 1.4 hereof, the certificate or certificates representing the forfeited Restricted Shares shall be canceled to the extent of any Restricted Shares that were forfeited.

1.5 Withholding.

(a) The Committee shall determine the amount of any withholding or other tax required by law to be withheld or paid by the Company with respect to any income recognized by the Participant with respect to the Restricted Shares.

(b) The Participant shall be required to meet any applicable tax withholding obligation in accordance with the provisions of Article 18 of the Plan.

(c) The Committee shall be authorized, in its sole discretion, to establish such rules and procedures relating to the use of shares of Common Stock to satisfy tax withholding obligations as it deems necessary or appropriate to facilitate and promote the conformity of the Participant’s transactions under the Plan and these Terms with Rule 16b-3 under the Securities Exchange Act of 1934, as amended, if such Rule is applicable to transactions by the Participant.

1.6 Committee’s Discretion. Notwithstanding any provision of these Terms to the contrary, the Committee shall have discretion under Section 17.1 of the Plan to waive any forfeiture of the Restricted Shares as set forth in Section 1.4 hereof, the restrictions set forth in Section 1.2 hereof and any other conditions set forth in these Terms.
 
 
 

 
 
2. REPRESENTATIONS OF THE PARTICIPANT
 
The Participant hereby represents to the Company that the Participant has read and fully understands the provisions of these Terms and the Plan and his or her decision to participate in the Plan is completely voluntary. Further, the Participant acknowledges that the Participant is relying solely on his or her own advisors with respect to the tax consequences of this restricted stock award.

3. NOTICES

All notices or communications under these Terms shall be in writing, addressed as follows:
 
 
  To the Company:
   
 
Par Pharmaceutical Companies, Inc.
300 Tice Boulevard
Woodcliff Lake, NJ 07677
Attention: General Counsel
   
  To the Participant:
   
  Address on file with the Company
 
Any such notice or communication shall be (a) delivered by hand (with written confirmation of receipt) or sent by a nationally recognized overnight delivery service (receipt requested) or (b) be sent certified or registered mail, return receipt requested, postage prepaid, addressed as above (or to such other address as such party may designate in writing from time to time), and the actual date of receipt shall determine the time at which notice was given.

4.
ASSIGNMENT; BINDING AGREEMENT

These Terms shall be binding upon and inure to the benefit of the heirs and representatives of the Participant and the assigns and successors of the Company, but neither these Terms nor any rights hereunder shall be assignable or otherwise subject to hypothecation by the Participant.

5.
ENTIRE AGREEMENT; AMENDMENT; TERMINATION
 
These Terms and the Certificate represent the entire agreement of the parties with respect to the subject matter hereof. The provisions of the Plan are incorporated in these Terms in their entirety. In the event of any conflict between the provisions of these Terms and the Certificate and the Plan, the provisions of the Certificate or the Plan, as the case may be, shall control. These Terms may be amended at any time by written agreement of the parties hereto.
 
 
 

 

 
6.
GOVERNING LAW

These Terms and their validity, interpretation, performance and enforcement shall be governed by the laws of the State of Delaware other than the conflict of laws provisions of such laws.

7.
SEVERABILITY

Whenever possible, each provision in these Terms shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of these Terms shall be held to be prohibited by or invalid under applicable law, then (a) such provision shall be deemed amended to accomplish the objectives of the provision as originally written to the fullest extent permitted by law and (b) all other provisions of these Terms shall remain in full force and effect.

8.
NO RIGHT TO CONTINUED EMPLOYMENT OR PARTICIPATION; EFFECT ON OTHER PLANS

These Terms shall not confer upon the Participant any right with respect to continued employment by the Company, its Affiliates or its Subsidiaries or continued participation under the Plan, nor shall it interfere in any way with the right of the Company, its Affiliates and its Subsidiaries to terminate the Participant’s employment at any time. Payments received by the Participant pursuant to these Terms shall not be included in the determination of benefits under any pension, group insurance or other benefit plan of the Company, its Affiliates or any Subsidiaries in which the Participant may be enrolled or for which the Participant may become eligible, except as may be provided under the terms of such plans or determined by the Board.

9.
NO STRICT CONSTRUCTION

No rule of strict construction shall be implied against the Company, the Committee or any other person in the interpretation of any of the terms of the Plan, these Terms or any rule or procedure established by the Committee.
 
10.
USE OF THE WORD “PARTICIPANT”
 
Wherever the word “Participant” is used in any provision of these Terms under circumstances where the provision should logically be construed to apply to the executors, the administrators, or the person or persons to whom the Restricted Shares may be transferred by will or the laws of descent and distribution, the word “Participant” shall be deemed to include such person or persons.
 
11. 
FURTHER ASSURANCES
 
The Participant agrees, upon demand of the Company or the Committee, to do all acts and execute, deliver and perform all additional documents, instruments and agreements (including, without limitation, stock powers with respect to shares of Common Stock issued as a dividend or distribution on Restricted Shares) that may be reasonably required by the Company or the Committee, as the case may be, to implement the provisions and purposes of these Terms and the Plan.
 
 
 

 

IN WITNESS WHEREOF, the parties have duly executed these Terms, as of the day and year first above written.
 
  PAR PHARMACEUTICAL COMPANIES, INC.
   
 
Thomas J. Haughey
Executive Vice President and General Counsel
   
  PARTICIPANT
   
 
(Acceptance designated electronically at the
website of Smith Barney)
 
 
 
 

 
EX-10.6(3) 9 v104574_ex10-63.htm
EXHIBIT 10.6.3

PAR PHARMACEUTICAL COMPANIES, INC.

TERMS OF RESTRICTED STOCK UNIT AWARD

This document sets forth the terms of the award of Restricted Stock Units (as defined in Section 1 below) granted by PAR PHARMACEUTICAL COMPANIES, INC. (the “Company”) pursuant to a Certificate of Restricted Stock Units (the “Certificate”) displayed at the website of Smith Barney Benefits Access® (“Smith Barney”). The Certificate, which specifies the person to whom the Restricted Stock Units have been awarded (the “Participant”), other specific details of the award, and the electronic acceptance of the Certificate at the website of Smith Barney, are incorporated herein by reference.

WHEREAS, the Board of Directors (the “Board”) of the Company has authorized and approved the Par Pharmaceutical Companies, Inc. 2004 Performance Equity Plan (the “Plan”), which has been approved by the stockholders of the Company;

WHEREAS, the Plan, in part, provides for the grant of Restricted Stock Units to certain employees of the Company and any Subsidiary of the Company;

WHEREAS, pursuant to the Plan, the Committee has approved an award to the Participant of Restricted Stock Units, designated in the Certificate, on the terms and conditions set forth in the Plan and in these Terms. Capitalized terms used but not defined in these Terms shall have the meanings set forth in the Plan.

NOW, THEREFORE, the parties, intending to be legally bound, agree as follows:

1.  Grant of Restricted Stock Units.

(a) As of the Grant Date set forth in the Certificate, the Company grants to the Participant the number of Restricted Stock Units set forth in the Certificate (the “Units”), which represent shares of the Company’s common stock (“Shares”). The Units are subject to the restrictions set forth in Section 2 of these Terms and the applicable provisions of the Plan.

(b) The Units granted under these Terms shall be reflected in a bookkeeping account maintained by the Company during the Restricted Period. If and when the restrictions set forth in Section 2 expire in accordance with the terms of these Terms, and upon the satisfaction of all other applicable conditions as to the Units, such Units (and any related Dividend Units described in Section 1(c) below) not forfeited pursuant to Section 4 hereof shall be settled in cash or Shares as provided in Section 1(e) of these Terms and otherwise in accordance with the Plan.

 
 

 
(c) With respect to each Unit, whether or not vested, that has not been forfeited (but only to the extent such award of Units has not been settled for cash or Shares), the Company shall, with respect to any cash dividends paid on the Shares, accrue and credit to the Participant’s bookkeeping account a number of Units having a Fair Market Value as of the date such dividend is paid equal to the cash dividends that would have been paid with respect to such Unit if it were an outstanding Share (the “Dividend Units”). These Dividend Units thereafter shall (i) be treated as Units for purposes of future dividend accruals pursuant to this Section 1(c); and (ii) vest in such amounts (rounded to the nearest whole Unit) at the same time as the Units with respect to which such Dividend Units were received. Any dividends or distributions on Shares paid other than in cash shall accrue in the Participant’s bookkeeping account and shall vest at the same time as the Units in respect of which they are made (in each case in the same form, based on the same record date and at the same time, as such dividend or other distribution is paid on such Share).

(d) The Company’s obligations under these Terms (with respect to both the Units and the Dividend Units, if any) shall be unfunded and unsecured, and no special or separate fund shall be established and no other segregation of assets shall be made. The rights of Participant under these Terms shall be no greater than those of a general unsecured creditor of the Company. In addition, the Units shall be subject to such restrictions as the Company may deem advisable under the rules, regulations and other requirements of the Securities and Exchange Commission, any stock exchange upon which Shares are then listed, any Company policy and any applicable federal or state securities law.

(e) Except as otherwise provided in these Terms, settlement of the Units in accordance with the provisions of this Section 1(e) shall be delivered as soon as practicable after the end of the Restricted Period, and upon the satisfaction of all other applicable conditions as to the Units (including the payment by the Participant of all applicable withholding taxes). The Units so payable to the Participant shall be paid solely in Shares, solely in cash based on the Fair Market Value of the Shares (determined as of the first business day next following the last day of the Restricted Period), or in a combination of the two, as determined by the Committee in its sole discretion.

2.  Restrictions.

(a) The Participant shall have no rights as a stockholder of the Company by virtue of any Unit unless and until such Unit vests pursuant to the schedule set forth in Section 3(a) and resulting Shares are issued to the Participant:

(b)   None of the Units may be sold, transferred, assigned, pledged or otherwise encumbered or disposed of until such Units are deemed vested in accordance with the schedule in Section 3(a) and are not otherwise forfeited pursuant to Section 4, except as may be permitted by the Plan or as otherwise permitted by the Committee in its sole discretion or pursuant to rules adopted by the Committee in accordance with the Plan.

(c) Any attempt to dispose of the Units or any interest in the Units in a manner contrary to the restrictions set forth in these Terms shall be void and of no effect.
 
 
-2-

 

3.      Restricted Period and Vesting. 

(a) Such portion of the Units shall be deemed vested and no longer subject to forfeiture under Section 4 hereof or the restrictions set forth in Section 2 hereof in accordance with the following schedule:
 
Vesting Date
Vested Percentage
   
1st Anniversary of the Date of Grant
25%
2nd Anniversary of the Date of Grant
50%
3rd Anniversary of the Date of Grant
75%
4th Anniversary of the Date of Grant
100%
 
(b) Notwithstanding the foregoing vesting schedule, the Restricted Stock Unit Award will be deemed fully vested and no longer subject to forfeiture in the event of a Change of Control of the Company (as defined in and subject to the provisions of the Plan).

4.  Forfeiture. 

(a) Subject to Section 6 hereof, if prior to the date such Units are deemed vested in accordance with the schedule in Section 3, (i) the Participant incurs a termination of employment or service with the Company, (ii) there occurs a material breach of the Certificate or these Terms and Conditions by the Participant, or (iii) the Participant fails to meet the tax withholding obligations described in Section 5(b) hereof, all rights of the Participant to the Units that have not vested in accordance with Section 3 as of the date of such event shall terminate immediately and be forfeited in their entirety.

(b) In the event that the Participant’s employment with the Company, its Affiliates and/or its Subsidiaries, is terminated due to the Participant’s death or disability, all rights of the Participant (or, in the event of the Participant’s death, the Participant’s Beneficiary) to the Unites that have not vested shall immediately vest and no longer be subject to forfeiture.

5.  Withholding.

(a) The Committee shall determine the amount of any withholding or other tax required by law to be withheld or paid by the Company with respect to any income recognized by the Participant with respect to the Units.

(b) The Participant shall be required to meet any applicable tax withholding obligation in accordance with the provisions of the Plan.

(c) Subject to any rules prescribed by the Committee, the Participant shall have the right to elect to meet any withholding requirement (i) by having withheld from this Award at the appropriate time that number of whole Shares whose Fair Market Value is equal to the amount of any taxes required to be withheld with respect to such Award, (ii) by direct payment to the Company in cash of the amount of any taxes required to be withheld with respect to such Award or (iii) by a combination of Shares and cash.

 
-3-

 
6.  Committee’s Discretion. Notwithstanding any provision of these Terms to the contrary, the Committee shall have discretion to waive any forfeiture of the Units as set forth in Section 4 hereof, the Restricted Period and any other conditions set forth in these Terms.

7.  Defined Terms. Capitalized terms used but not defined in these Terms shall have the meanings set forth in the Plan, unless such term is defined in the Participant’s Employment Agreement. Any terms used in these Terms, but defined in the Participant’s Employment Agreement are incorporated herein by reference and shall be effective for purposes of the Certificate and these Terms without regard to the continued effectiveness of the Employment Agreement.

8.  Nonassignability. The Units may not be sold, assigned, transferred (other than by will or the laws of descent and distribution, or to an inter vivos trust with respect to which the Participant is treated as the owner under Sections 671 through 677 of the Code), pledged, hypothecated, or otherwise encumbered or disposed of until the restrictions on such Units, as set forth in these Terms, have lapsed or been removed.

9.  Participant Representations. The Participant hereby represents to the Company that the Participant has read and fully understands the provisions of the Certificate, these Terms and the Plan and the Participant’s decision to participate in the Plan is completely voluntary. Further, the Participant acknowledges that the Participant is relying solely on his or her own advisors with respect to the tax consequences of this restricted stock award.

10.  Regulatory Restrictions on the Units. Notwithstanding any other provision of the Plan, the obligation of the Company to issue Shares in connection with this Award under the Plan shall be subject to all applicable laws, rules and regulations and such approval by any regulatory body as may be required. The Company reserves the right to restrict, in whole or in part, the delivery of Shares pursuant to these Terms prior to the satisfaction of all legal requirements relating to the issuance of such shares, to their registration, qualification or listing or to an exemption from registration, qualification or listing.

11.  Miscellaneous.

11.1
Notices. All notices, requests, deliveries, payments, demands and other communications which are required or permitted to be given under these Terms shall be in writing and shall be either delivered personally or sent by registered or certified mail, or by private courier, return receipt requested, postage prepaid to the parties at their respective addresses set forth below, or to such other address as either shall have specified by notice in writing to the other. Notice shall be deemed duly given hereunder when delivered or mailed as provided herein.
 
 
-4-

 

 
If to Company:
Par Pharmaceutical Companies, Inc.
300 Tice Boulevard
Woodcliff Lake, NJ 07677
   
If to Optionee: Address of Optionee on file with the Company.
 
11.2
Waiver. The waiver by any party hereto of a breach of any provision of the Certificate or these Terms shall not operate or be construed as a waiver of any other or subsequent breach.

11.3
Entire Agreement. These Terms, the Certificate and the Plan constitute the entire agreement between the parties with respect to the subject matter hereof.

11.4
Binding Effect; Successors. These Terms shall inure to the benefit of and be binding upon the parties hereto and to the extent not prohibited herein, their respective heirs, successors, assigns and representatives. Nothing in these Terms, express or implied, is intended to confer on any person other than the parties hereto and as provided above, their respective heirs, successors, assigns and representatives any rights, remedies, obligations or liabilities.

11.5
Governing Law. The Certificate and these Terms shall be governed by and construed in accordance with the laws of the State of Delaware.

11.6
Headings. The headings contained herein are for the sole purpose of convenience of reference, and shall not in any way limit or affect the meaning or interpretation of any of the terms or provisions of these Terms.

11.7
Conflicts; Amendment. The provisions of the Plan are incorporated in these Terms in their entirety. In the event of any conflict between the provisions of these Terms and the Certificate or the Plan, the provisions of the Certificate or the Plan, as the case may be, shall control. The Agreement may be amended at any time by written agreement of the parties hereto.

11.8
No Right to Continued Employment. Nothing in the Certificate or these Terms shall confer upon the Participant any right to continue in the employ or service of the Company or affect the right of the Company to terminate the Participant’s employment or service at any time.

11.9
Further Assurances. The Participant agrees, upon demand of the Company or the Committee, to do all acts and execute, deliver and perform all additional documents, instruments and agreements which may be reasonably required by the Company or the Committee, as the case may be, to implement the provisions and purposes of the Certificate and these Terms and the Plan.
 

 
 
-5-

 
IN WITNESS WHEREOF, the parties have duly executed these Terms, as of the day and year first above written.

PAR PHARMACEUTICAL COMPANIES, INC.

Thomas J. Haughey
Executive Vice President and General Counsel


PARTICIPANT

(Acceptance designated electronically at the
website of Smith Barney)


 
-6-

 
EX-10.6(4) 10 v104574_ex10-64.htm
EXHIBIT 10.6.4
PAR PHARMACEUTICAL COMPANIES, INC.

TERMS OF PERFORMANCE SHARES AWARD


This document sets forth the terms of the award of Performance Shares (as defined in Section 1.1 below) granted by PAR PHARMACEUTICAL COMPANIES, INC. (the “Company”) pursuant to a Certificate of Performance Shares (the “Certificate”) displayed at the website of Smith Barney Benefits Access®. The Certificate, which specifies the person to whom the Performance Shares have been awarded (the “Participant”), other specific details of the award, and the electronic acceptance of the Certificate at the website of Smith Barney, are incorporated herein by reference.
 

WHEREAS, the Board of Directors (the “Board”) of the Company has authorized and approved the Par Pharmaceutical Companies, Inc. 2004 Performance Equity Plan (the “Plan”), which has been approved by the stockholders of the Company;

WHEREAS, the Plan, in part, provides for the grant of Performance Shares to certain employees of the Company and any Subsidiary of the Company;

WHEREAS, pursuant to the Plan, the Committee has approved an award to the Participant of Performance Shares, designated in the Certificate, on the terms and conditions set forth in the Plan and in these Terms. Capitalized terms used but not defined in these Terms shall have the meanings set forth in the Plan.

NOW, THEREFORE, the parties, intending to be legally bound, agree as follows:
 
 1.  PERFORMANCE SHARES
 
1.1 Grant of Performance Shares.

(a) Subject to the terms and conditions hereinafter set forth and set forth in the Plan, the Company grants as of the date of grant specified on the Certificate (the “Date of Grant”) to the Participant shares of common stock, par value $.01 per share (“Common Stock”), specified on the Certificate and representing the number of shares to be awarded to the Participant in the event that all target performance conditions set forth in Section 1.3 of these Terms are determined to have been met (the “Target Shares”). The Target Shares are subject to the restrictions set forth in Section 1.2 of these Terms and the performance vesting conditions of Section 1.3 of these Terms, as well as all other applicable terms and conditions of the Plan and these Terms. If and when the restrictions set forth in Section 1.2 expire in accordance with these Terms, and upon the satisfaction of all other applicable conditions as to the Performance Shares, such shares not forfeited pursuant to Section 1.4 hereof shall no longer be considered restricted Target Shares for purposes of these Terms. As soon as practicable after the Date of Grant, the Company shall direct that a stock certificate or certificates representing the applicable Target Shares be registered in the name of, and issued to, the Participant. Such certificate or certificates shall be held in the custody of the Company or its designee until such Shares have vested (or such applicable portion of the Shares as may become vested) in accordance with the schedule in Section 1.3(b). On or before the date of acceptance of these Terms, the Participant has delivered to the Company one or more stock powers endorsed in blank relating to the Target Shares.
 
1

 
(b) In addition to the Target Shares, the Participant may be awarded additional shares of Common Stock equal to fifty percent (50%) of the Target Shares following the completion of the Performance Cycle (as defined in Section 1.3(a) below) in the event that the Company’s performance during the Performance Cycle is determined to have achieved the maximum performance level set forth in Section 1.3(b) (the “Maximum Performance Shares”).

(c) In addition to the Target Shares and the Maximum Performance Shares, the Participant may be awarded additional shares of Common Stock equal to twenty-five percent (25%) of the total of the Target and, if applicable, the Maximum Performance Shares ultimately awarded and payable to the Participant following the completion of the Performance Cycle in the event that the Company is determined to have met or exceeded the performance conditions relative to the S&P index set forth in Section 1.3(c) during the Performance Cycle (the “S&P Performance Shares”). For purposes of these Terms, the Target Shares, the Maximum Performance Shares and the S&P Performance Shares shall be referred to collectively as the “Performance Shares.”

(d) The Maximum Performance Shares and the S&P Performance Shares granted under these Terms shall be reflected in a bookkeeping account maintained by the Company during the Performance Cycle. If and when the Maximum Performance Shares and the S&P Performance Shares become payable in accordance with these Terms, and upon the satisfaction of all other applicable conditions as to the Maximum Performance Shares and the S&P Performance Shares, such Shares shall be settled in cash or Shares as provided in Section 1.1(g) of these Terms and otherwise in accordance with the Plan.

(e) Each certificate for the Target Shares shall bear the following legend (the “Legend”):

   
The ownership and transferability of this certificate and the shares of stock represented hereby are subject to the terms and conditions (including forfeiture) of the Par Pharmaceutical Companies, Inc. 2004 Performance Equity Plan and the associated Terms of Performance Shares Award entered into between the registered owner and Par Pharmaceutical Companies, Inc. Copies of such Plan and Terms are on file in the executive offices of Par Pharmaceutical Companies, Inc., 300 Tice Boulevard, Woodcliff Lake, NJ 07677.
 
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In addition, the stock certificate or certificates for the Target Shares shall be subject to such stop-transfer orders and other restrictions as the Company may deem advisable under the rules, regulations and other requirements of the Securities and Exchange Commission, any stock exchange upon which Common Stock is then listed, and any applicable federal or state securities law, and the Company may cause a legend or legends to be placed on such certificate or certificates to make appropriate reference to such restrictions.

(f) As soon as administratively practicable following the vesting of all or any portion of the Target Shares, and upon the satisfaction of all other applicable conditions as to such vested Target Shares, including the payment by the Participant of all applicable withholding taxes, the Company shall deliver or cause to be delivered to the Participant a certificate or certificates for the applicable vested Target Shares that shall not bear the Legend.

(g) Except as otherwise provided in these Terms, settlement of the Maximum Performance Shares and the S&P Performance Shares that become payable under these Terms shall be delivered as soon as practicable after the end of the Performance Cycle and the determination as to whether the applicable performance conditions have been met, and upon the satisfaction of all other applicable conditions (including the payment by the Participant of all applicable withholding taxes). The Maximum Performance Shares or S&P Performance Shares so payable to the Participant shall be paid solely in shares of Common Stock, solely in cash based on the Fair Market Value of the Common Stock, or in a combination of the two, as determined by the Committee in its sole discretion.

1.2 Restrictions.

(a) Beginning with the Date of Grant, the Participant shall have all rights and privileges of a stockholder as to the Target Shares, including the right to vote and receive dividends or other distributions with respect to the Target Shares, except that the following restrictions shall apply:

(i) the Participant shall not be entitled to delivery of the certificate or certificates for the Target Shares until such Target Shares are deemed vested in accordance with the schedule in Section 1.3(a), and are not otherwise forfeited pursuant to Section 1.4 hereof and upon the satisfaction of all other applicable conditions;

(ii)  none of the Target Shares may be sold, transferred, assigned, pledged or otherwise encumbered or disposed of prior to the date such Target Shares are deemed vested in accordance with the schedule in Section 1.3(a), except as provided in Section 8.3 of the Plan or as otherwise permitted by the Committee in its sole discretion or pursuant to rules adopted by the Committee in accordance with the Plan;

(iii) all shares of Common Stock distributed as a dividend or distribution, if any, with respect to the Target Shares prior to the date such Target Shares are deemed vested in accordance with the schedule in Section 1.3(a) shall be delivered to and held by the Company and subject to the same restrictions as the related Target Shares until the vesting of such Target Shares, and subject to the satisfaction of all other applicable conditions; and
 
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(iv) all of the Target Shares shall be subject to forfeiture on the terms and conditions set forth in Section 1.4 hereof; if forfeited, the Target Shares shall be returned to the Company and all rights of the Participant with respect to the Target Shares shall terminate in their entirety on the terms and conditions set forth in Section 1.4 hereof.

(b) The Participant shall have no rights as a stockholder of the Company by virtue of any Maximum Performance Shares or S&P Performance Shares unless and until such Shares become payable hereunder and resulting shares of Common Stock are issued to the Participant. Further, none of the Maximum Performance Shares or the S&P Performance Shares, or any interest in such Shares, may be sold, transferred, assigned, pledged or otherwise encumbered or disposed of unless and until such Shares become payable hereunder and resulting shares of Common Stock are issued to the Participant, except as may be permitted by the Plan or as otherwise permitted by the Committee in its sole discretion or pursuant to rules adopted by the Committee in accordance with the Plan.

(c) Any attempt to dispose of any Performance Shares or any interest in any Performance Shares in a manner contrary to the restrictions set forth in these Terms shall be void and of no effect.

1.3 Performance Cycle and Performance Vesting Conditions. 

(a) For purposes of this Performance Share Award, the “Performance Cycle” is the 3-year fiscal period of the Company commencing on January 1, 2008 and ending on December 31, 2010. At the close of the Performance Cycle, the Committee shall determine the extent to which the applicable performance conditions have been achieved and authorize settlement of the Performance Shares to the extent such Shares become issuable or payable as a result of such performance. Settlement of the Performance Shares shall occur as soon as practicable thereafter, but in any event shall be no later than March 15, 2011.

(b) The Target Shares and the Maximum Performance Shares shall vest and become issuable or payable, as the case may be, based on the following performance schedule:

4

 
Performance Measure Based on Total Shareholder
Return (TSR) Annualized over 3-Year
Performance Cycle
 
Performance Level
 
Percentage of
Performance Shares
 to be Issued
 
Meet or Exceed 75th Percentile TSR for Peer Group
 
 
 
Maximum
 
 
150%
 
Meet or Exceed Median TSR for Peer Group
 
 
 
Target
 
 
100%
 
Meet or Exceed 6% TSR
 
 
 
Threshold
 
 
25%
 
Less Than 6% TSR
 
 
 
Below Threshold
 
 
0%

For purposes of the above performance schedule only, the following terms shall have the meanings set forth below:
 
(i) “Peer Group” consists of Alpharma Inc., Angiotech Pharmaceuticals, Inc., Barr Pharmaceuticals, Inc., Biovail Corporation, Endo Pharmaceuticals Holdings Inc., K-V Pharmaceutical Company, King Pharmaceuticals, Inc., Medicis Pharmaceutical Corporation, Mylan Inc. (formerly Mylan Laboratories, Inc.), Perrigo Company, Sciele Pharma, Inc., Shire plc, Teva Pharmaceutical Industries Ltd., Valeant Pharmaceutical International, Warner Chilcott Limited, and Watson Pharmaceuticals, Inc. If during the Performance Cycle a company in the Peer Group is acquired or becomes no longer publicly traded, then that company shall be removed from the Peer Group and shall not be factored into the performance calculation. If more than four companies are removed from the Peer Group, the Committee in its discretion shall approve additional companies to be added to the Peer Group to maintain a broad comparator group.

(ii) “Total Shareholder Return” or “TSR” means the percentage equal to the annualized appreciation in the Common Stock price determined using the average stock price for the last three months of 2007 as the beginning point and the average price for the last three months of 2010 as the ending point, plus dividends (on a cumulative reinvested basis). The starting point for the Performance Cycle is $19.58, which is the average of the Company’s Common Stock price for the last three months of 2007.

(c) The S&P Performance Shares shall vest and become payable following the Performance Cycle if the Company’s TSR for the Performance Cycle exceeds the median TSR of the Standard & Poor’s 400 MidCap Index (or any equivalent index designated by the Committee in the event that the S&P 400 MidCap Index is replaced or otherwise no longer available during the Performance Cycle). The S&P Performance Shares are payable only if the Company’s performance otherwise reaches the Threshold level or above in the schedule under Section 1.3(b).
 
(d) Notwithstanding subsections (b) and (c) above, upon a “Change of Control” of the Company, the Participant shall be deemed to have vested in a number of Performance Shares based on the extent to which the Company has achieved the performance conditions in this Section 1.3 as of the date of such Change in Control (as determined by the Committee) and such Shares shall no longer be subject to forfeiture under Section 1.4 hereof or the restrictions set forth in Section 1.2 hereof and shall be issuable or payable, as the case may be, as soon as practicable following the Committee’s determination. Notwithstanding the foregoing, if the Participant is at a classification level of Senior Vice President or above at the time of such Change in Control and the Change in Control occurs before January 1, 2010, the Participant shall be required to continue in the service of the successor company for a period of six (6) months following the Change in Control in order to become vested in the applicable number of Performance Shares determined under the preceding sentence; provided, however, that such Participant shall be deemed fully vested in such Performance Shares if, prior to the expiration of such six (6)-month period, the acquiring company terminates the Participant’s employment without “Cause.” For purposes of these Terms only, the term “Cause” shall mean (i) the Participant’s conviction of, or plea of nolo contendere to, a crime that constitutes a felony; (ii) the Participant’s gross misconduct that is materially and demonstrably injurious to the Company or its successor; or (iii) the commission by the Participant of an act of fraud or embezzlement against the Company or its successor.
 
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1.4 Forfeiture. 

(a)  Subject to the applicable provisions of this Section 1.4 and Section 1.6 hereof, if prior to the date the Performance Shares are deemed vested in accordance with the schedule and conditions in Section 1.3, (i) the Participant’s employment with the Company, its Affiliates and/or its Subsidiaries is terminated for any reason other than death or disability, including termination by reason of resignation, (ii) there occurs a material breach of these Terms by the Participant or (iii) the Participant fails to meet the tax withholding obligations described in Section 1.5(b) hereof, all rights of the Participant to the Performance Shares that have not vested in accordance with Section 1.3 hereof as of the date of such termination shall terminate immediately and be forfeited in their entirety.

(b) In the event that the Participant’s employment with the Company, its Affiliates and/or its Subsidiaries, is terminated due to the Participant’s death or disability, the Participant (or, in the event of the Participant’s death, the Participant’s Beneficiary) shall be entitled to the number of Performance Shares that become issuable or payable in accordance with Sections 1.1(f) and (g), as applicable, following the Performance Cycle.

(c) In the event of any forfeiture under this Section 1.4 hereof, the certificate or certificates representing the forfeited Target Shares shall be canceled to the extent of any Target Shares that were forfeited.

1.5 Withholding.

(a) The Committee shall determine the amount of any withholding or other tax required by law to be withheld or paid by the Company with respect to any income recognized by the Participant with respect to the Performance Shares.
 
6


(b) The Participant shall be required to meet any applicable tax withholding obligation in accordance with the provisions of Article 18 of the Plan.

(c) The Committee shall be authorized, in its sole discretion, to establish such rules and procedures relating to the use of shares of Common Stock to satisfy tax withholding obligations as it deems necessary or appropriate to facilitate and promote the conformity of the Participant’s transactions under the Plan and these Terms with Rule 16b-3 under the Securities Exchange Act of 1934, as amended, if such Rule is applicable to transactions by the Participant.

1.6 Committee’s Discretion. Notwithstanding any provision of these Terms to the contrary, the Committee shall have discretion under Section 17.1 of the Plan to waive any forfeiture of the Performance Shares as set forth in Section 1.4 hereof, the restrictions set forth in Section 1.2 hereof and any other conditions set forth in these Terms.
 
 2.  REPRESENTATIONS OF THE PARTICIPANT
 
The Participant hereby represents to the Company that the Participant has read and fully understands the provisions of these Terms and the Plan and his or her decision to participate in the Plan is completely voluntary. Further, the Participant acknowledges that the Participant is relying solely on his or her own advisors with respect to the tax consequences of this award.

3. NOTICES

All notices or communications under these Terms shall be in writing, addressed as follows:
 
  To the Company:
   
 
Par Pharmaceutical Companies, Inc.
300 Tice Boulevard
Woodcliff Lake, NJ 07677
Attention: General Counsel
   
  To the Participant:
 
  Address on file with the Company
 
Any such notice or communication shall be (a) delivered by hand (with written confirmation of receipt) or sent by a nationally recognized overnight delivery service (receipt requested) or (b) be sent certified or registered mail, return receipt requested, postage prepaid, addressed as above (or to such other address as such party may designate in writing from time to time), and the actual date of receipt shall determine the time at which notice was given.
 
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4.
ASSIGNMENT; BINDING AGREEMENT

These Terms shall be binding upon and inure to the benefit of the heirs and representatives of the Participant and the assigns and successors of the Company, but neither these Terms nor any rights hereunder shall be assignable or otherwise subject to hypothecation by the Participant.

5.
ENTIRE AGREEMENT; AMENDMENT; TERMINATION

These Terms and the Certificate represent the entire agreement of the parties with respect to the subject matter hereof. The provisions of the Plan are incorporated in these Terms in their entirety. In the event of any conflict between the provisions of these Terms and the Certificate and the Plan, the provisions of the Certificate or the Plan, as the case may be, shall control. These Terms may be amended at any time by written agreement of the parties hereto.

6.
GOVERNING LAW

These Terms and their validity, interpretation, performance and enforcement shall be governed by the laws of the State of Delaware other than the conflict of laws provisions of such laws.

7.
SEVERABILITY

Whenever possible, each provision in these Terms shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of these Terms shall be held to be prohibited by or invalid under applicable law, then (a) such provision shall be deemed amended to accomplish the objectives of the provision as originally written to the fullest extent permitted by law and (b) all other provisions of these Terms shall remain in full force and effect.

8.
NO RIGHT TO CONTINUED EMPLOYMENT OR PARTICIPATION; EFFECT ON OTHER PLANS
 
These Terms shall not confer upon the Participant any right with respect to continued employment by the Company, its Affiliates or its Subsidiaries or continued participation under the Plan, nor shall it interfere in any way with the right of the Company, its Affiliates and its Subsidiaries to terminate the Participant’s employment at any time. Payments received by the Participant pursuant to these Terms shall not be included in the determination of benefits under any pension, group insurance or other benefit plan of the Company, its Affiliates or any Subsidiaries in which the Participant may be enrolled or for which the Participant may become eligible, except as may be provided under the terms of such plans or determined by the Board.
 
8

 
9.
NO STRICT CONSTRUCTION

No rule of strict construction shall be implied against the Company, the Committee or any other person in the interpretation of any of the terms of the Plan, these Terms or any rule or procedure established by the Committee.
 
10.
USE OF THE WORD “PARTICIPANT”
 
Wherever the word “Participant” is used in any provision of these Terms under circumstances where the provision should logically be construed to apply to the executors, the administrators, or the person or persons to whom the Performance Shares may be transferred by will or the laws of descent and distribution, the word “Participant” shall be deemed to include such person or persons.
 
11. 
FURTHER ASSURANCES
 
The Participant agrees, upon demand of the Company or the Committee, to do all acts and execute, deliver and perform all additional documents, instruments and agreements (including, without limitation, stock powers with respect to shares of Common Stock issued as a dividend or distribution on Target Shares) that may be reasonably required by the Company or the Committee, as the case may be, to implement the provisions and purposes of these Terms and the Plan.

IN WITNESS WHEREOF, the parties have duly executed these Terms, as of the day and year first above written.
 
  PAR PHARMACEUTICAL COMPANIES, INC.
   
 
Thomas J. Haughey
Executive Vice President and General Counsel
   
   
  PARTICIPANT
   
 
(Acceptance designated electronically at the
website of Smith Barney)
 
9

EX-10.19(1) 11 v104574_ex10-191.htm
Exhibit 10.19.1
 
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION


SETTLEMENT AGREEMENT AND RELEASE OF CLAIMS

The parties hereby agree to settle and resolve their respective claims in the Arbitration Genpharm Inc. v Par Pharmaceutical Companies, Inc., AAA Case No. 50 180 T 00007 06. By this Settlement Agreement, the parties intend to amend the Par 40 Agreement (including the Par 8 Agreement) and the Par 11 Agreement (collectively, the "Agreements") to implement the settlement terms provided herein which the parties will further memorialize in a Restatement of the Agreements consistent with terms of this Settlement Agreement. Terms used herein which are defined in the Agreement (or any of them) and not otherwise defined in this Settlement Agreement shall have the same meaning herein as in the applicable Agreement(s):

1.
Terminated Products

 
(a)
 
The Agreements are terminated by mutual consent with respect to the Products identified in Schedule "A" attached (collectively referred to as the "Terminated Products");
 
 
(b)
 
From and after July 1, 2006, there will be no sharing of negative Gross Profits earned or incurred by Par with respect to any Terminated Products; i.e. negative Gross Profits earned or incurred by Par in relation to any one or more of the Terminated Products will not be offset against positive Gross Profits earned by Par on and after July 1, 2006 in relation to any other Product or Products (whether another Terminated Product or otherwise);
 
 
(c)
 
All outstanding purchase orders issued by Par to Genpharm for undelivered Terminated Products are cancelled without any liability of either party to the other arising from such cancellation. Par shall have the right to return to Genpharm within 20 days of the date hereof, at Genpharm's cost and without payment by Par of the outstanding invoice related thereto, the following shipments of Terminated Products received by Par:

***

(d)
To simplify and finalize the relationship of the parties with respect to the Terminated Products, it is agreed that notwithstanding that the potential losses of the parties may not be equal and that each party may be able to mitigate/recover some of the losses it would otherwise incur through the sale of its existing inventory of Products or otherwise, each party will be free to dispose of its inventory of Terminated Products and raw materials related thereto without accounting or reporting to the other any revenue it receives therefrom and shall be solely responsible for all costs, expenses and losses which it incurs in relation to the sale or other disposition or utilization of such inventory or materials and that neither party shall have the right to recover from the other any part of the losses or expenses which it incurs from the sale of its inventory of Terminated Products or from the return of any Terminated Product sold by Par on or after July 1, 2006 or otherwise;
 

 
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION

 
(e)
The parties acknowledge that the reporting and sharing of Gross Profits with respect to those Terminated Products identified with an asterisk on Schedule “D” hereto (the "Cash Products") has been calculated on the cash basis without reserves or accruals for anticipated deductions to be made in calculating Net Sales and that the Gross Profits for the balance of the Terminated Products which Par has sold in the Territory (the "Accrual Products") have been calculated on an accrual basis accruing reserves for estimates of such deductions. Par represents and warrants that Schedule “D” hereto sets forth:

 
(i)
with respect to each Cash Product, Par's reasonable good faith estimate (consistent with the accruals claimed by Par in the financial statements prepared and reported by Par) of the unaccrued but anticipated deductions to be made in calculating Net Sales in relation to the Cash Products which have not been taken or recognized in previously reporting Gross Profits for such Terminated Product to Genpharm for calendar quarters ended on or prior to June 30, 2006;
 
 
(ii)
with respect to each Accrual Product, the outstanding reserve claimed by Par in calculating the Net Sales of such Terminated Product for the calendar quarter ended June 30, 2006.


The parties agree that Par shall be entitled to recover from Genpharm Genpharm's share (based on its sharing percentage under the applicable Agreement) of permitted deductions from sales (as contemplated in the definition "Net Sales") actually incurred by Par after June 30, 2006 with respect to sales of the Terminated Products by Par prior to July 1, 2006 and shall account to Genpharm for a true-up of reserves previously taken by Par with respect to Accrual Products, it being the intention of the parties that, subject to the limitation set forth below, Par recognize, recover and true-up actual Net Sales with respect to Terminated Products sold prior to July 1, 2006; provided that the aggregate amount of such deductions hereafter taken by Par with respect to previous sales of the Terminated Products, net of credits arising out of the reversal of accruals in relation to the Accrual Products, shall not exceed the positive Gross Profits reported by Par for the June 30, 2006 calendar quarter so that the net amount which Par may claim from Genpharm will not exceed ***.
 
2

 
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION
 

Par shall report to Genpharm quarterly, at the same time as Par reports to Genpharm on a quarterly basis under the applicable Agreement with respect to deductions hereafter taken from Net Sales of the Terminated Products and, to the extent Par is entitled to be paid an amount by Genpharm pursuant to the foregoing, it shall be entitled to deduct such amount from the Gross Profits otherwise payable to Genpharm in respect of a calendar quarter under the applicable Agreement provided that Par shall provide its report to Genpharm prior to making any such deduction and shall notify Genpharm in writing of the amount that it is deducting from any such payment pursuant thereto. Genpharm will have the right to audit Par's and its Affiliates' books and records to verify and confirm the claims made and adjustments which should have been made by Par pursuant to this Paragraph (e) and the audit provisions contained in the Agreements (as amended hereby) shall apply thereto.

 
(f)
Genpharm (and its Affiliates) will possess the exclusive right to the Product Information for each Terminated Product, will have the exclusive right to manufacture, promote, market, sell and distribute such Terminated Products (and to licence Third Parties to do so) and will have the right to manufacture, promote, market, sell and distribute any Competing Products thereto, in the Territory or elsewhere, without accounting for, or sharing with Par any profits or revenue from such Terminated Product or Competing Product;

 
(g)
Par will be free to manufacture, promote, market and sell a Competing Product (in relation to a Terminated Product) in the Territory or elsewhere without accounting for, or sharing with Genpharm any profit or revenue from such Competing Product, provided that the Competing Product does not use, incorporate or rely on the Product Information or Genpharm's Confidential Information;

 
(h)
Par shall promptly transfer the ANDA for the Product *** tablets to Genpharm and shall execute and deliver all directions and authorizations to the FDA to do so and shall deliver to Genpharm a complete copy of the ANDA including all supplements and records required to be kept applicable to *** (to the extent not already in the possession of Genpharm) and Par's validation reports related thereto to enable Genpharm to tech-transfer the manufacture of such products to its own facilities or to those of a third party selected by it. Par shall reasonably cooperate with Genpharm and shall, at the request of Genpharm, provide reasonable advice and assistance in connection with regulatory filings allowing Genpharm to manufacture such Terminated Products.
 
3

 
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION

 
2.
Continuing Product

Other than Terminated Product and Future Product (as defined below), Par will remain the exclusive distributor of the remaining Products (collectively, the "Continuing Products" which, for purposes of clarification are identified on Schedule "C" hereto), subject to the terms of the applicable Agreement (as amended hereby).

3.
Future Products

 
(a)
Par will be the semi-exclusive distributor of those Products identified on Schedule "'B" annexed hereto (collectively the "Future Products"), under the terms of the applicable Agreement (as amended hereby) and, with respect to which:

 
(i)
Par will continue to be obligated to report and share Gross Profits with Genpharm in accordance with the applicable Agreement;

(ii)
Genpharm (or its Affiliate) will be permitted to manufacture, sell, promote, market, sell and distribute each Future Product (or any Competing Product thereto) in the Territory, (or elsewhere) without any obligation to report or share any revenue or profits earned therefrom to or with Par.

 
(b)
With respect to each Future Product (other than ***):

(i)
Genpharm will, at least 12 months prior to the anticipated launch of such Future Product (as reasonably estimated by Genpharm) give to Par an initial notice of:

(A) its estimated Transfer Price;

(B) the estimated launch date of each strength of such Future Product (which may or may not be the same date for each strength);

(C) the proposed packaging configurations for each such strength;

Par will have 30 days within which to notify Genpharm in writing whether it is electing to terminate the applicable Agreement with respect to such Future Product. If the proposed launch date precedes the expiry of any patents applicable to such Future Product Genpharm shall consult with Par prior to delivering the notice of its estimated launch date. In this regard, the parties shall, within 10 days of a request therefor by Genpharm, meet (in person or telephonically) and shall in good faith discuss all matters reasonably relevant to the selection of the estimated launch date including the patent strategy being utilized by Genpharm in relation to such unexpired patents (subject to Par entering into a joint defence and confidentiality agreement reasonably acceptable to Genpharm). Such scheduled meeting shall occur reasonably in advance of the date by which the initial notice must be delivered, each such estimate and proposal to be made in good faith and based upon reasonable documentation in support thereof (where applicable).
 
4

 
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION
 

(ii)
Genpharm will provide a subsequent notice of its actual Transfer Price at least 6 months prior to the anticipated launch of such Future Product (which actual Transfer Price shall apply to Par's Launch Quantities [as defined below] as well as to the Future Product supplied by Genpharm to Par during the first 12 month period following receipt of the Product Approval for such Future Product provided that Genpharm may increase the Transfer Price of such Product from time to time after the 3rd month of such 12 month period, but only to reflect (1) aggregate increases over the Transfer Price at launch of *** in the cost to Genpharm [or its Affiliate] to manufacture or acquire such Future Product (excluding increases in Genpharm or its Affiliate's labour or overhead costs) and/or (2) applicable foreign currency fluctuations, in which event Par may by written notice (to be given within 30 days of the receipt of notice of the actual Transfer Price):

(A) terminate the applicable Agreement with respect to such Future Product if the actual Transfer Price is *** initial estimated Transfer Price and in such event the Initial Forecast (as defined below) and all purchase orders delivered by Par pursuant thereto will be cancelled without any liability of Par arising out of such cancellation;

(B) revoke any prior notice of termination delivered by Par with respect to such Future Product (and reinstate the applicable Agreement with respect to such Future Product) if the actual Transfer Price is ***.

(iii)
If the initial estimated Transfer Price is *** than the actual Transfer Price with respect to a Future Product in respect of which Par has previously elected to terminate the Agreement, Par may request to audit the actual Transfer Price to confirm same. If the audit determines that the initial estimated Transfer Price is *** than the actual Transfer Price Par will have the right to revoke its prior termination and to reinstate the Agreement with respect to such Future Product.

(iv)
if Par terminates the applicable Agreement with respect to a Future Product pursuant to (i) or (ii)(A) above, Par will not be responsible for Development Costs and Legal Expenses thereafter incurred, unless it revokes such termination as contemplated above. However, Par will continue to be responsible for the Development Costs and Legal Expenses incurred prior to the date of termination to the extent it would otherwise be liable herefor under the applicable Agreement and, provided Par is not otherwise in breach of the applicable Agreement, Par will not be subject to a non-compete with respect to such terminated Future Product as a result of its exercise of its right to terminate the applicable Agreement pursuant to this Paragraph (b) or Paragraph (c) below. If Par does not so terminate the applicable Agreement with respect to such Future Product, Par will, subject to Paragraph (c) below, be obligated to Launch and promote; market and distribute such Future Product in accordance with the applicable Agreement.
 
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(v)
If Genpharm (i) has delivered a good faith estimate of the Transfer Price, the launch date and the proposed packaging configurations contemplated in (b)(i) above, and (ii) has determined (acting reasonably and in good faith) that it must place an order for the API in preparation of the Launch of such Future Product, then Genpharm may make a written demand for an initial forecast (an "Initial Forecast") to initiate the Launch of such Future Product by Par. Par has 30 days to deliver such Initial Forecast, which forecast will, subject to (ii) above and to extent accepted by Genpharm as contemplated below, represent a binding commitment of Par to purchase the quantities of such Future Product contemplated therein (the "Launch Quantities").

(vi)
If Par fails to deliver the Initial Forecast with respect to the Future Product within 30 days, Genpharm may give priority to its own requirements and those of its Affiliates for the such Future Product (and is only obligated to use only commercially reasonable efforts to supply Par with its Launch Quantity of such Future Product after satisfaction of its and its Affiliate own requirements for same).

(vii)
If Par fails to deliver the Initial Forecast within 60 days, Genpharm may, at any time prior to receipt of an Initial Forecast, terminate the Agreement with respect to such Future Product on written notice to Par (in which event Genpharm shall also be free to licence any third party to sell and distribute such Future Product in the Territory).

(c)
Genpharm may terminate the applicable Agreement with respect to a Future Product if Par fails to launch such Future Product within 45 days of (A) notice from Genpharm that the Launch Quantities (or such lesser amount as Par shall accept) of Future Product is available for pick-up at its or its Affiliate's facility (if Genpharm or its Affiliate is the manufacturer), (B) receipt of Product Approval for such Future Product (if Par is the manufacturer); and (C) the expiry of the period contemplated in (c)(i) below within which Par may delay the launch of such Future Product; provided that:
 
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(i)
Par may delay the launch of such Future Product if and only for so long as (X) the sale or distribution of such Future Product in the Territory may give rise to patent infringement claim, (Y) there are regulatory issues relating to such Future Product which are likely to result in the suspension or cancellation of the Product Approval of such Future Product or a recall of Future Product released in the Territory or (Z) where Genpharm has indicated to Par that all strengths of the Future Product as contemplated in the Agreement would be launched on the same date and Genpharm has not obtained a Product Approval for all applicable strengths of such Future Product.

(ii)
Par may terminate the applicable Agreement with respect to a Future Product if:

(A) without the consent of Par or unless required by the FDA, Genpharm removes or attempts to remove prior to launch any packaging configuration for any strength of such Future Product as provided by Genpharm to Par pursuant to Paragraph (b)(i) above, provided that Par may only exercise its right of termination pursuant hereto within 30 days of being notified in writing of a removal of a packaging configuration, failing which Par shall be deemed to have consented to such change;

(B) Genpharm fails to obtain its final Product Approval for any of the strengths of such Future Product on the estimated date therefor, other than by reason of (i) the granting of a period of generic exclusivity to the manufacturer or supplier of a Competing Product by the FDA or a court (but only for the period of such exclusivity); or (ii) acts, failures to act, omissions or delays on the part of Par in connection with its development or regulatory activities with respect to such Future Product; provided that Par may only exercise its right of termination pursuant hereto within 30 days of such estimated date so missed; or

(C) a potentially enforceable patent infringement claim relating to the Future Product is outstanding at the time the final Product Approval for such Future Product has been obtained which requires Par to launch at risk; provided that Par may only terminate this Agreement with respect to such Future Product within 6 months of the receipt of such Product Approval and while such claim remains unsettled.

(d)
If Genpharm so terminates, Par must pay for (i) the Launch Quantities and (ii) the landed cost of all raw materials acquired for the purpose of manufacturing the Launch Quantities (in each case, to the extent the Launch Quantities or raw materials are not otherwise utilized) (collectively, the "Launch Termination Costs''). If Par so terminates Par shall pay to Genpharm *** of the Launch Termination Costs.
 
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(e)
Par will pay for *** of the Transfer Price of Future Products that become short dated, are unsaleable or are otherwise wasted because of (i) delays in receiving Product Approval (unless due to the gross negligence or willful misconduct of Genpharm), (ii) changes to the Specifications mutually agreed upon by the parties in order to obtain or expedite Product Approval or (iii) a good faith decision by Genpharm or by Par (as contemplated above) not to launch such Future Product in the circumstances contemplated in (c)(i)(X), (Y) or (Z)above.

(f)
If, with respect to a Future Product which is being distributed by both Par and Genpharm (or its Affiliate) in the Territory, there is a shortage of supply of such Future Product or of the active pharmaceutical ingredients or other components necessary to manufacture such Future Product for the Territory to satisfy Genpharm's obligations to Par and Genpharm's or its Affiliate's own requirements of such Future Product, then, subject to Paragraph 3(b)(vi) above, Genpharm will allocate its available supply of such Future Product for the Territory to satisfy its obligations to Par prior to meeting its own or its Affiliate's requirements for such Future Product for the Territory.

4.
Kali Competing Products

(a)
Par represents and warrants that the only Products that are or were under development by Kali Laboratories Inc. ("Kali") at the time Par acquired control of Kali or thereafter and which are Competing Products under the Agreement are set forth below:

***

(b)
Par further represents and warrants that with respect to those products (vii) through (xiv) above, as of the date of this Settlement Agreement, Kali has terminated the development of such products prior to completion thereof and that neither Kali, Par nor any of their respective Affiliates are directly or indirectly developing, manufacturing, promoting, marketing or selling such products in the Territory. Par covenants and agrees that Kali will not hereafter develop, nor will any Affiliate of Par hereafter develop utilizing the Kali product information, any such Terminated Product for a period of 2 years;

(c)
Par hereby further represents and warrants that:

(i)
Par and its Affiliate have earned profits to the date hereof (determined in accordance with US generally accepted accounting principles but excluding costs and expenses incurred in relation to the development or regulatory approval of such product) from the manufacture and\or commercialization of *** of not more than *** in the aggregate for or in the Territory; and
 
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(ii)
Par and its Affiliates have divested themselves of Kali's *** product and no longer have any interest therein (financial or otherwise) and will terminate all outstanding agreements relating to Kali's *** product by December 31, 2006, failing which Par will pay to Genpharm *** of the Gross Profits or other revenue realized by Par from and after the date hereof from the manufacture or commercialization of *** (but Genpharm shall not be required to share any losses incurred by Par or its Affiliates from such commercialization, Par to be entitled to carry forward such losses in the same manner as contemplated in Paragraph 5(d) below) and will, at Genpharm's request, enter into an agreement with Genpharm to give effect thereto, which agreement shall provide Genpharm with rights of audit and other rights similar to the parties' arrangements with respect to ***.

Based and relying upon such representations and warranties Genpharm hereby waives any claim to share in any profit or revenue arising out of the manufacture or Par's (Kali’s) *** to the date hereof.

5.
Accounting and Insufficient Gross Profits

(a)
The parties agree that the Gross Profits and Net Sales of Future Products will be determined on an accrual basis in accordance with generally accepted accounting principles, and not on a cash basis as now provided in the Agreement; provided that in calculating Gross Profits and Net Sales Par is stil1 restricted to those deductions currently permitted under Net Sales and Gross Profits (except that it may claim reasonable reserves for reasonably anticipated deductions based on generally accepted accounting principles applied in a manner consistent with Par's reporting of its financial results and taking into account Par's prior experience with respect to its customers and the Products in question). Par will continue to report Gross Profits and Net Sales of Continuing Products on a cash basis (except where Genpharm has already expressly permitted Par to accrue deductions in respect of certain of the Continuing Products).

(b)
With respect to those Continuing Products to be reported on a cash basis, Par will provide to Genpharm, at the same time as it is required to provide its quarterly report under the applicable Agreement a report indicating the difference between the Net Sales and Gross Profits reported and the Net Sales and Gross Profit that would have been reported had the same been calculated on an accrual basis to enable Genpharm to keep track of potential deductions and charges to Net Sales and Gross Profits in future periods (the difference between Gross Profits actually reported to Genpharm and the Gross Profits determined on an accrual basis as contemplated herein is hereafter referred to as the "Unrecorded Accruals"). With respect to the Future Products and those Continuing Products being reported on an accrual basis, Par shall provide to Genpharm a reconciliation of reserves and accruals on a quarterly basis (within 45 days of the close of each calendar quarter) with respect to each Continuing Product and Future Product whose Gross Sales in the prior calendar year was at least *** or if Genpharm otherwise requests and otherwise on an annual basis (within 45 days of the expiry of each calendar year).
 
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(c)
Either party may terminate the applicable Agreement with respect to a Continuing Product or a Future Product if the Gross Profit arising out of Net Sales of such Product is *** of the aggregate Transfer Price of such Product included in such calculation of Gross Profits for 2 consecutive calendar quarters. For purposes of this Paragraph (c), where, in respect of a Continuing Product which is reported on a cash basis, the reported Gross Profits for a calendar quarter exceeds the threshold herein contemplated but would fail to do so if the Unrecorded Accruals applicable to such Product for the calendar quarter in question was deducted from the reported Gross Profits, such Product shall be deemed to have Gross Profits for such calendar quarter which is less than the threshold amount contemplated herein.

(d)
From and after April 1, 2006, Par may not offset any negative Gross Profit from any of the Continuing Products or Future Products against the positive Gross Profits of any other Product or Products Par may, however, offset the negative Gross Profits of a particular Product against positive Gross Profits from such Product, but only for the two consecutive calendar quarters immediately following the calendar quarter in which such negative Gross Profit was incurred and, provided further, the losses which may be carried forward from a prior calendar quarter and applied to a subsequent calendar quarter cannot exceed the Gross Profits of such Product in such subsequent calendar quarter otherwise determined (ie. can not be carried forward to create a loss in the subsequent calendar quarter).

(e)
If the Agreement is terminated in respect of a Product (other than as a result of a breach by Par), the losses incurred in the calendar quarter in which the Agreement terminates and the losses in the immediately prior 2 calendar quarters which are still eligible to be carried forward will be shared by Genpharm and Par in accordance with the respective sharing percentages with respect to the Product in question under the applicable Agreement. In addition, the parties will share, in proportion to the applicable sharing percentages, the loss on their respective inventory of saleable Product and related raw materials that cannot otherwise be used which would arise as if such inventory and raw materials were destroyed and, within 30 days of such termination, the parties will determine, each acting reasonably and in good faith, how to deal with the then aggregate existing inventory of finished products, work in progress and raw materials to mitigate and minimize such losses and to share any revenue earned in mitigating such losses. As well, Product returns, subject to the limitations contemplated below, will similarly be shared by the parties.
 
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6.
Payments

(a)
Par will pay to Genpharm the following amounts on or before August 31, 2006:
 
(i) ***;
 
(ii)  ***;

(iii) ***

***

7.
Additional Amendments to the Agreements

(a)
Par may deduct prompt payment discounts (also referred to as cash or term discounts), ***of sales.

(b)
Section 10.8 of the Par 40 Agreement will be deleted.

(c)
Par will promptly transfer to Genpharm its ANDA for *** included in such ANDA by way of amendment) and shall execute and deliver all directions and authorizations to the FDA to implement same. Genpharm and Par shall co-operate to ensure that Par remains a site of manufacture for the *** Product under such transferred ANDA. Par acknowledges and agrees that notwithstanding the prior registration of the *** ANDA in Par's name the *** Product Information (including the Product Information relating to the ***) is proprietary and Confidential Information of Genpharm. Genpharm hereby grants to Par a license (exclusive for the Territory only to August 1, 2011 and non-exclusive for the Territory thereafter) to use such *** Confidential Information manufacture and commercialize the *** Product in the Territory, it being understood and agreed that the *** is not a Product under the Par 40 Agreement and that the licence of Genpharm to Par contemplated herein with respect to the *** is a royalty free licence in perpetuity. Par shall indemnify and hold harmless Genpharm, its Affiliates and their respective directors, officers, employees and agents from and against any and all claims, demands, actions, proceedings, regulatory enforcement, damages, costs, losses, penalties, fines and expenses (including legal fees and disbursements and other defence costs) relating to, arising out of or in any way connected with the direct or indirect manufacture, promote, marketing, sale, distribution or use of the *** by, on behalf of or through Par including, without limitation, any claim made against Genpharm with respect to such product by reason of its being the holder of the ANDA for such strength so that as between Par and Genpharm, Par shall be deemed to have the responsibility and liability of the ANDA holder (including any issues relating to product safety and design). The parties will co-operate with each other in good faith in relation to other regulatory filings and reporting with respect to the ***. The indemnities contained herein shall survive the expiration or other termination of the Par 40 Agreement.
 
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(d)
Upon termination of the Par 40 Agreement with respect to *** Agreement (each a "Par Manufactured Product")

(i)
Par shall deliver to Genpharm a complete copy of its Product Dossier including a copy of the ANDA and validation reports applicable thereto to enable Genpharm to tech-transfer the manufacture of such product to its own facilities or to those of a third party selected by it. Par shall reasonably cooperate with Genpharm and shall, at the request of Genpharm, provide reasonable advice and assistance in connection with regulatory filings allowing Genpharm to manufacture such Par Manufactured Product.

(ii)
if terminated by Genpharm (other than by reason of a breach of the applicable Agreement by Par) and Par is not otherwise in breach of such Agreement Genpharm will grant to Par a licence to use its Product Information to manufacture such Par Manufactured Product for sale in the Territory only (but not elsewhere) subject to Par paying to Genpharm a Royalty (the "Royalty") equal to *** of the Cost of Goods ("COG", being the fully burdened manufacturing cost [determined in the same manner as Manufacturing Cost] if manufactured by Par or its Affiliate or the landed cost to Par if acquired from a third party manufacturer) of such Par Manufactured Product sold in the Territory. Par will maintain appropriate, complete and accurate records of its and its Affiliate's sales of the Par Manufactured Products in the Territory and of the applicable COG'S thereof. Par shall report its sales and COG'S and shall pay the applicable Royalty quarterly (within 30 days of the end of each calendar quarter). Genpharm to have the right to audit Par's and its Affiliate's books and records to confirm accuracy of reporting and payment of such Royalty. The obligations of Par to report and pay and the rights of Genpharm to audit herein contemplated shall survive the expiration or termination of the applicable Agreement. Par will not sub-license the Product Information relating to a Par Manufactured Product to any Person or grant to any Person the right to manufacturer, sell or distribute the Par Manufactured Product without the prior written consent of Genpharm (to be granted or withheld in Genpharm's absolute discretion), provided that with Genpharm's consent, not to be unreasonably withheld. Par may sub-contract the manufacture of the Par Manufactured Product to a third party if such third party enters into a confidentiality agreement with Genpharm (satisfactory to Genpharm) restricting its use of Genpharm's Product Information to the manufacturer of the Par Manufactured Product exclusively for Par (and for Genpharm where Par is under an obligation to supply such Product to Genpharm).
 
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In the circumstance contemplated in Paragraph (d)(ii) above, the parties shall do all things reasonably necessary to enable each of Genpharm and Par to independently sell, market and distribute the Par Manufactured Product (hereafter sometimes referred to as "Parallel Product'') in the Territory under Genpharm's ANDA (which in the case of *** is currently registered in Par's name). Par will promptly following termination deliver to Genpharm a complete copy of its Product Dossier including a copy of the ANDA and validation reports applicable thereto to enable Genpharm to tech-transfer the manufacture of such product to its own facilities or to those of a third party so that there are at least 2 sites of manufacture for such product under the ANDA (the Genpharm site and Par's site of manufacture). Until the tech transfer is completed and Genpharm is able to produce commercial quantities of such Parallel Product, Par will, upon request of Genpharm, manufacture and supply such product to Genpharm for sale and distribution in the Territory. Par will supply the product in question to Genpharm at *** of the Manufacturing Cost hereof to Par and the provision of the Par 40 Agreement (as amended hereby) relating to forecasting, purchase orders, supply problems, delivery. inspection, rejection and returns and indemnification shall apply to the supply of such product by Par to Genpharm, mutatis mutandis, unless the parties otherwise agree.

Each party will be solely financially responsible for the sale and use of the Parallel Product which it releases in the Territory, and each party shall indemnify the other arising out of the manufacture (if such party is the manufacturer), sale or distribution by it of its Parallel Product or the use thereof in the Territory (unless the claim relates to or arises out of the manufacture of such Product by the other parties). Genpharm will not make any change to the Specifications for the Par Manufactured Product or otherwise amend or supplement the ANDA which would adversely affect the ability of Par to sell, release, or distribute such product in the Territory during the term of such licence. Genpharm will co-operate with Par in amending or supplementing the ANDA as regards the Parallel Product manufactured at Par's site upon written request of Par (Par to be responsible for any applicable FDA fees and charges relating thereto). The parties will co-operate with each other in good faith in relation to other regulatory filings and reporting with respect to the Parallel Products.

(e)
Non-compete provisions applicable to a party in each Agreement will only apply where such Agreement has been terminated or terminated in respect of a Product for a breach by such party or, in the case of Par, where Genpharm has terminated the Agreement with respect to a Future Product as a result of Par's breach of its obligations to launch (provided that a party cannot rely on another termination provision to avoid the non-compete if it is in breach of its obligations under the Agreement at that time). Notwithstanding the foregoing, if Par terminates an Agreement (or terminates such Agreement with respect to a Product or Products only) as a result of a breach by Genpharm to supply such Product or Products the Non-Compete provisions otherwise applicable will not apply to Genpharm unless such breach was a bad-faith, willful and intentional breach.
 
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(f)
Notwithstanding any provision of the Agreements, Par, in calculating Net Sales, shall not be entitled to deduct any amount in respect of a direct or indirect return of a Product from its customers where Par is or will be selling a Competing Product to such customer to replace the returned Product [i.e. if Par is selling a Competing Product it cannot accept a return of a Genpharm Product and replace same with the Competing Product.]

(g)
Neither party may audit the other in respect of the period prior to April 1, 2006 (except to the extent necessary to audit a period subsequent to March 31, 2006). 

(h)
The auditing provisions of each Agreement will be amended to clarify that:

(i)
"independent" means external accountants;
 
(ii)
the determination of the accountant may still be disputed by the audited party and be subject to arbitration;
 
(iii)
the audited party to provide full co-operation with accountant with a view to expediting the audit including, in the case where Par is being audited, access to customer contracts and commitments to verify compliance with Section 7.3 of the Par 40 Agreement (or equivalent provision in the Par 11 Agreement).

(i)
The parties will engage as soon as reasonably practicable (having regard to vacation schedules of the parties who will be participating therein) in good faith discussions with a view to amending the Agreements to address, in a manner mutually satisfactory to both parties, issues relating to among other things forecasting, supply and delivery provisions and shall use reasonable commercial efforts to conclude such discussions and negotiations and enter into an agreement implementing any changes mutually agreed to by the parties on or before October 30, 2006.

8.
Mutual Releases

(a)
Par Release to Genpharm

In consideration of the terms of this Settlement Agreement, and other good and valuable consideration furnished, the receipt and sufficiency of which is hereby acknowledged, Par, on its behalf and on behalf of its present or former parents, subsidiaries, members, Affiliates, directors, officers, employees, contractors, stockholders, successors and assigns, attorneys, insurers and agents, and any person acting by, through or under any of them, hereby releases and forever discharges Genpharm. and its present or former parents, subsidiaries, members, Affiliates, directors, officers, employees, stockholders, successors and assigns, attorneys, insurers and agents, or any person acting by, through or under any of them, and including in their respective individual capacities, for any and all claims, demands, obligations, actions, causes of action, rights, damages, costs, losses of service, expenses and compensation of any nature whatsoever, and without exception, whether based on statute, tort, contract. equity or law, or other theory of recovery, by reason of any and all known acts, omissions, events or facts occurring prior to the date hereof, except that this release does not apply to claims based on:
 
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(i)
the Transfer Price and Gross Profit Payment owing;

(ii)
Product Development Costs and legal expenses payable under the Agreements; and

(iii)
the parties' obligations pursuant to this Settlement Agreement.

***

(b)
Genpharm Release to Par

In consideration of the terms of this Settlement Agreement, and other good and valuable consideration furnished, the receipt and sufficiency of which is hereby acknowledged, Genpharm, on its behalf and on behalf of its present or former parents, subsidiaries, members, Affiliates, directors, officers, employees, contractors, stockholders, successors and assigns, attorneys, insurers and agents, and any person acting by, through or under any of them, hereby releases and forever discharges Par, and its present or former parents, subsidiaries, members, Affiliates, directors, officers, employees, stockholders, successors and assigns, attorneys, insurers and agents, or any person acting by, through or under any of them, and including in their respective individual capacities, for any and all claims, demands, obligations, actions, causes of action! rights, damages, costs, losses of service, expenses and compensation of any nature whatsoever, and without exception, whether based on statute, tort, contract, equity or law, or other theory of recovery, by reason of any and all known acts, omissions, events or facts occurring prior to the date hereof, except that this release does not apply to claims based on:

(i)
the Transfer Price and Gross Profit Payment owing:
 
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(ii)
Product Development Costs and legal expenses payable under the Agreements; and

(iii)
the parties’ obligations pursuant to this Settlement Agreement.

9.
Dismissal of Arbitration

Upon execution of this Settlement Agreement, the Parties shall dismiss with prejudice all of their respective claims in the Arbitration which either were or could have been brought or assessed, and concurrent with their dismissal of such claims, shall notify the AAA and the Arbitrator of this Agreement.

10.
Binding Nature

The terms of this Settlement Agreement are binding and the parties will attempt in good faith to further amend the Agreements to incorporate the provisions hereof and any additional amendments the parties deem necessary.

11.
Choice of Law

This Settlement Agreement shall be interpreted in accordance with and governed by the laws of the State of New York, applicable to contracts executed and performed entirely within New York, without reference to any choice of law principles in New York.

12.
Arbitration

Any controversy or claim arising out of, or relating to, this Settlement Agreement or the breach thereof shall be referred for decision forthwith to a senior executive of each party not involved in the dispute. If no agreement is reached within 30 days of the request by one party to the other to refer the same to such senior executive, then such controversy or claim shall be settled by arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration Association, such arbitration to be held in New York, New York on an expedited basis. Judgment upon the award rendered by the Arbitrator(s) shall be entered in the United States District Court for the Southern District of New York.

13.
Execution by Counterpart

This Settlement Agreement may be executed in one or more counterparts, each of which when so executed and delivered shall be deemed to be an original, and all of which when taken together shall be deemed to be one and the same instrument. A copy of this Settlement Agreement delivered by facsimile or other electronic means, or a photocopy of this Settlement Agreement, executed by a party in counterparts or otherwise, shall a constitute a properly executed, delivered and binding document or counterpart of the executing party.

[the next page is the signing page]
 
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DATED this 14th day of August, 2006.
 
     
  GENPHARM lNC.
 
 
 
 
 
 
  Per:   /s/ Su Cooke
 
Name: Su Cooke
  Title: Chief Financial Officer
 
     
  Per:   /s/ C. B. Gray
 
Name: C. B. Gray
  Title: VP, Legal and General Counsel
 
     
  PAR PHARMACEUTICAL COMPANIES, INC.
 
 
 
 
 
 
  Per:   /s/ Scott Tarriff
 
Name: Scott Tarriff
  Title: President &CEO
 
     
  Per:   /s/ Michael Graves
 
Name: Michael Graves
  Title: President, Generic Product Division
 
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SCHEDULE “A”
TERMINATING PRODUCTS


***
 
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SCHEDULE “B”
FUTURE PRODUCTS


***
 
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SCHEDULE “C”
CONTINUING PRODUCTS


***
 
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SCHEDULE “D”
LOSSES & TRUE-UPS


***
 
21

EX-10.37(1) 12 v104574_ex10-371.htm
EXHIBIT 10.37.1

TERMINATION AGREEMENT

This Termination Agreement (this “Termination”) is executed this 22nd day of January, 2007, to be effective as of the Effective Time (as defined below), among Abrika Pharmaceuticals, Inc., a Delaware corporation (the “Companv”), ACFP, LLLP, a Florida limited liability limited partnership (“ACFP), and Par Pharmaceutical Companies, Inc., a Delaware corporation (“Par”).

Background

A. Abrika, LLLP, the Company's predecessor in interest, ACFP and Par are parties to that certain Investors Rights Agreement, dated as of December 3, 2004, as amended (the “Agreement”);

B. The Company entered into an Agreement and Plan of Merger, dated as of November 20, 2006, by and among Actavis Inc., a Delaware corporation (“Actavis”), Panthers Acquisition Corp., a Delaware corporation and wholly owned subsidiary of Actavis (“Merger Sub”), the Company and Alan P. Cohen, solely in his capacity as securityholders' representative (the “Merger Agreement”), pursuant to which Merger Sub will be merged with and into the Company with the Company continuing as the surviving corporation and wholly-owned subsidiary of Actavis (the “Merger”);

C. Pursuant to Section 7.9 of the Merger Agreement, certain agreements are to be terminated as of the effective time of the Merger (the “Effective Time”); and

D. The parties agree that, immediately upon the Effective Time, all rights and obligations of the parties under and with respect to the Agreement shall terminate.

Terms of Agreement

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:

1. The background stated above is true and correct and is incorporated herein by reference.

2. Each of the parties agrees that all rights and obligations of the parties under and with respect to the Agreement shall be terminated effective immediately at (and subject to the occurrence of) the Effective Time.

3. This Termination may be executed in original or by facsimile and in one or more counterparts and shall inure to the benefit of, and shall be binding upon, the parties hereto and their respective successors and assigns.


 
4. This Termination contains the sole and entire agreement among the parties with respect to the subject matter hereof and supersedes all other prior agreements with respect to the subject matter hereof.

5. This Termination shall be governed by New York law, without regard to the conflict of law principles thereof (other than New York General Obligations Law Sections.5-1401 and 5-1402).

IN WITNESS WHEREOF, the parties hereto have executed this Termination to be effective as of the Effective Time.
 
 
 
ABRIKA PHARMACEUTICALS, INC.
By:
Name: Scott Lodin
Title: Senior Vice President & General Counsel

ACFP, LLLP
By:
Name: Alan Cohen
Title: Sole Member of Abrika GPNER, LLC, its
general partner

PAR PHARMACEUTICAL( COMPANIES. INC.
By: /s/ Thomas J. Haughey
Name: Thomas J. Haughey
Title: Executive Vice President and General Counsel
 

EX-21 13 v104574_ex21.htm
EXHIBIT 21

List of Subsidiaries

Par Pharmaceutical Companies, Inc.

Entity
Jurisdiction of Organization
Percentage of Voting Securities Owned by Its Immediate Parent
Par Pharmaceutical, Inc.
Delaware
100%
PRX Pharmaceuticals, Inc.
Delaware
100%
PRI-Research, Inc.
Delaware
100%
Par Pharma Group, Ltd.
Delaware
100%
ParCare Ltd.
New York
100%
Par SVC, LLC.
New York
100%
Kali Laboratories, Inc.
New Jersey
100%


Par Pharmaceutical, Inc.

Entity
Jurisdiction of Organization
Percentage of Voting Securities Owned by Its Immediate Parent
Par, Inc.
Delaware
100%
Nutriceutical Resources, Inc.
New York
100%
 
 
 

 
EX-31.1 14 v104574_ex31-1.htm
Exhibit 31.1

CERTIFICATION PURSUANT TO
EXCHANGE ACT RULES 13a−14(a) AND 15d−14(a)
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
 
I, Patrick G. LePore, Chairman, President and Chief Executive Officer of Par Pharmaceutical Companies, Inc. certify that:
 
1.  I have reviewed this annual report on Form 10-K of Par Pharmaceutical Companies, Inc.;

2.
Based on my knowledge, this annual 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 annual report;

3.
Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this annual report;

4.
The Company’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 Company 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 Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual 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 Company’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 Company’s internal control over financial reporting that occurred during the Company’s fourth fiscal quarter that has materially affected, or is reasonably likely to materially affect the Company’s internal control over financial reporting; and

5.
The Company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s board of directors:

 
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 Company’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 Company’s internal control over financial reporting.

Date: February 29, 2008
/s/ Patrick G. LePore
 
 
Patrick G. LePore
Chairman, President and Chief Executive Officer
 
 
 

 
EX-31.2 15 v104574_ex31-2.htm
Exhibit 31.2
 
CERTIFICATION PURSUANT TO
EXCHANGE ACT RULES 13a−14(a) AND 15d−14(a)
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
 
I, Veronica A. Lubatkin, Executive Vice President and Chief Financial Officer of Par Pharmaceutical Companies, Inc. certify that: 
 
1.  I have reviewed this annual report on Form 10-K of Par Pharmaceutical Companies, Inc.;

2.
Based on my knowledge, this annual 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 annual report;

3.
Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this annual report;

4.
The Company’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 Company 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 Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual 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 Company’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 Company’s internal control over financial reporting that occurred during the Company’s fourth fiscal quarter that has materially affected, or is reasonably likely to materially affect the Company’s internal control over financial reporting; and

5.
The Company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s board of directors:

 
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 Company’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 Company’s internal control over financial reporting.

Date: February 29, 2008
/s/ Veronica A. Lubatkin
 
 
Veronica A. Lubatkin
Executive Vice President and Chief Financial Officer

 
 

 
EX-32.1 16 v104574_ex32-1.htm
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 Annual Report of Par Pharmaceutical Companies, Inc. (the “Company”) on Form 10-K for the period ended December 31, 2007 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Patrick G. LePore, Chairman, President and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:

(1)
The Report fully complies with the requirements of Section 13(a) 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 result of operations of the Company.

This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933 or Securities Exchange Act of 1934 (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.

/s/ Patrick G. LePore
Patrick G. LePore
Chairman, President and Chief Executive Officer
February 29, 2008


EX-32.2 17 v104574_ex32-2.htm
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 Annual Report of Par Pharmaceutical Companies, Inc. (the “Company”) on Form 10-K for the period ended December 31, 2007 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Veronica A. Lubatkin, Executive Vice President and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:

(1)
The Report fully complies with the requirements of Section 13(a) 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 result of operations of the Company.

This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933 or Securities Exchange Act of 1934 (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.

/s/ Veronica A. Lubatkin
Veronica A. Lubatkin
Executive Vice President and Chief Financial Officer
February 29, 2008
 

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