Product Sales Agreement.docx

1、Product Sales AgreementPRODUCT SALES AGREEMENTTHIS PRODUCT SALES AGREEMENT (this Agreement) made as of the 21st dayof December, 2001, by and between Aesgen, Inc., a Delaware corporation, havingits principal place of business at 2 Research Way, Third Level East, Princeton,New Jersey 08540 (Aesgen) an

2、d aaiPharma, Inc., a Delaware corporation, havingits principal place of business at 2320 Scientific Park Drive, Wilmington, NorthCarolina 28405 (AAI).WHEREAS, Aesgen is the owner of development projects relating tocertain products, including, but not limited to the abbreviated new drugapplications w

3、hich have been filed and/or approved, as more specifically setforth below; andWHEREAS, AAI desires to purchase from Aesgen and Aesgen desires to sellto AAI such products development projects, together with all their attendantrights and obligations; andWHEREAS, AAI has agreed to assume from Aesgen ce

4、rtain liabilities andundertake certain obligations on behalf of Aesgen;NOW THEREFORE, in consideration of the mutual covenants and benefitscontained in this Agreement, the parties agree as follows:1 DEFINITIONS. In addition to the terms defined elsewhere herein, the following terms shall be defined

5、as follows:1.1 ANDA shall mean an abbreviated new drug application which issubmitted to the FDA for approval to manufacture and/or sell a pharmaceuticalproduct in the United States pursuant to the FDC Act1.2 ANDA Products shall mean (i) Acyclovir Capsules (200 mg); (ii)Acyclovir Tablets (400 mg, 800

6、 mg, UD); (iii) Etodolac Capsules (300 mg, bottleof 100); (iv) Etodolac Tablets (400 mg, bottle of 100); and (iv) KetoconazoleTablets (200 mg, bottle of 100, blister packs).1.3 cGMP shall mean current good manufacturing practices as set forthin the FDC Act.1.4 Development Products shall mean (i) Pen

7、toxifylline Tablets (400mg, bottle of 100, 5000, UD) and (ii) Selegiline Tablets/Capsules (genericdosage forms).1.5 FDA shall mean the United States Food and Drug Administration.1.6 FDC Act shall mean the Federal Food, Drug and Cosmetic Act, 21U.S.C.ss.321 et seq., as amended, and the regulations pr

8、omulgated thereunderfrom time to time.1.7 Governmental Entity shall mean any federal, state, local ornon-U.S. government or any court of competent jurisdiction, legislature,governmental agency, administrative agency or commission or other governmental authority or instrumentality.1.8 LOI shall mean

9、that certain letter of intent executed by andbetween Aesgen and AAI on or about April 20, 2001.1.9 Material Adverse Effect means a material adverse effect on thebusiness, assets, operations, prospects or condition, financial or otherwise,relating to the ANDA Products and the Development Products, ta

10、ken as a whole.2 TRANSFER OF THE ASSETS.2.1 SALE OF ASSETS. On the terms and conditions set forth in thisAgreement, Aesgen agrees to sell, assign, deliver, transfer and convey and AAIagrees to purchase, acquire and accept all of the right, title and interest ofAesgen in and to the Products (as defin

11、ed below), and more particularly theassets set forth below in subsections 2.1.1 through 2.1.5 (the Assets), freeand clear of any and all liens or encumbrances.2.1.1 THE PRODUCTS. All of Aesgens right, title and interest in and to the ANDA Products and the Development Products (collectively referred

12、to hereinas the Products).2.1.2 THE REGULATORY RECORDS. All of Aesgens right, title and interest in and to any and all regulatory files (including correspondence with regulatoryauthorities), registrations, applications, approvals, licenses and permits relating to the Products, as of the Closing Date

13、, from the FDA, or, to the extent they exist, any other applicable regulatory authority in any country, in each case to the extent transferable in light of legal, regulatory and, practical considerations;2.1.3 THE INTELLECTUAL PROPERTY. All trademarks, trademark rights, licenses, inventions, process

14、es, specifications, know-how, trade secrets, goodwill andcopyrights, which are currently owned by Aesgen and used exclusively in connection with the Products and set forth on Schedule 2.1.3.2.1.4 ACCRUED ROYALTIES. All royalties which accrue and become due and owing from MOVA to Aesgen from the date

15、 of the execution of the LOI, to be paid inaccordance with Section 6.1.3 below.2.1.5 THE INTANGIBLES. All the rights exclusively relating to the Assets set forth in 2.1.1, 2.1.2, 2.1.3 above, including all claims, counterclaims, credits, causesof action, rights of recovery and rights of setoff.2.2 E

16、XCLUDED ASSETS. AAI acknowledges and agrees that it is notacquiring any right, title or interest in or to any other assets of Aesgenincluding, by way of example, the following assets (Excluded Assets):2.2.1 CASH. All of Aesgens cash, bank accounts, certificates of deposit and other cash equivalents.

17、2.2.2 ACCOUNTS RECEIVABLE. Except as set forth in Section 2.1.4 above, all of Aesgens accounts receivable, which shall include all receivables arising from orrelating to any Products at any time prior to the close of business on the Closing Date.2.2.3 REAL ESTATE. Any real estate owned or leased by

18、Aesgen.2.2.4 TAX RECORDS AND REFUNDS. All of Aesgens tax returns and records and any tax refunds or tax credits due Aesgen attributable to the Products for tax periods prior to the Closing Date.2.2.5 OTHER ASSETS. All other assets of Aesgen except for the Assets.2.3 PRIOR OBLIGATIONS OF AAI. In conn

19、ection with the termination of theProduct Transfer, Manufacturing, Marketing and Distribution Agreement betweenMOVA Pharmaceutical Corporation (MOVA) and Aesgen (the MOVA Agreement) relating to the Products, which termination shall be effective on April 22, 2002 (the Termination Date), AAI hereby ac

20、knowledges that, in accordance with theterms of the MOVA Agreement an audit of MOVAs books and records has beenrequested by Aesgen in order to determine the final balance of outstanding anddisputed amounts due to MOVA under said MOVA Agreement (the Audit). As partial consideration for the transfer o

21、f the Assets, AAI further acknowledges andagrees that AAI is and remains obligated, responsible and liable to undertakethe following actions on behalf of Aesgen:2.3.1 AUDIT COSTS. To pay all Aesgens costs associated with the Audit which are unreimbursed by MOVA directly to the auditors conducting th

22、e Audit; and 2.3.2 INDEMNIFICATION. To indemnify, defend and hold harmless Aesgen, and its officers, directors, employees and agents, against any and all suits, claims, causes of action and liabilities, including, without limitation, attorneys fees, relating to the termination of the MOVA Agreement.

23、2.4 ASSUMPTION OF CERTAIN LIABILITIES. As partial consideration for thetransfer of the Assets, on the terms and subject to the conditions of thisAgreement, AAI shall assume and agree to pay, perform or discharge, when due,the following debts, obligations and liabilities of Aesgen (the AssumedLiabili

24、ties): 2.4.1 AMOUNTS DUE MOVA. AAI shall be solely responsible for and the payment directly to MOVA of any and all amounts determined by the Audit to be due and owing from Aesgen to MOVA under the MOVA Agreement.2.4.2 PRODUCT LIABILITY. All liabilities arising out of or relating to any product liabi

25、lity, breach of warranty or similar claim for injury to person orproperty, regardless of when asserted, which resulted from the use or misuse of the Products or otherwise related to the Products, provided, however, that Aesgen shall indemnify AAI, and its officers, directors, employees and agents ag

26、ainst any liabilities for sales of Products by MOVA to the same extent that Aesgen is indemnified against such liabilities by MOVA pursuant to the MOVA Agreement.2.4.3 PRODUCT RETURNS. Except to the extent set forth in Section 2.5.1, all liabilities arising out of or relating to the return of any Pr

27、oduct on or after the Closing Date, whether or not sold by Aesgen prior to, on, or after the Closing Date.2.4.4 ADDITIONAL LIABILITIES. All other liabilities, obligations and commitments of whatever kind and nature, primary or secondary, direct or indirect,absolute or contingent, known or unknown, w

28、hether or not accrued, arising out of or relating to, directly or indirectly, the Products or the Assets or the ownership, sale or lease of any of the Assets but only to the extent related to any period on or after the Closing Date.2.5 NO OTHER LIABILITIES ASSUMED. Except as expressly stated inSecti

29、ons 2.3 and 2.4, AAI shall not assume or agree to pay, perform or dischargeany of the debts, obligations and liabilities of Aesgen. Without limiting theforegoing AAI does not assume and will not be liable for the following (theExcluded Liabilities).2.5.1 PRODUCT RECALLS. All liabilities arising out

30、of or relating to the recall of a Product pursuant to FDA regulations or other applicable governmental authority or returned by an end user, after the Closing Date, which recall or return is a result ofadulteration, misbranding or other violation of the FDC Act by Aesgen or MOVA prior to the Closing

31、 Date.2.5.2 OTHER LIABILITIES. Except as provided elsewhere in this Agreement, any debt, obligation or liability of Aesgen, known or unknown, liquidated, unliquidated, absolute or contingent, accrued or otherwise whether arising from contract, tort or otherwise and relating to the Products prior to

32、the Closing Date.3 CONSIDERATION.3.1 As further consideration for the transfer of the Assets, AAI agrees to the following:3.1.1 TERMINATE AGREEMENTS. On the Termination Date, AAI shall, together with Aesgen, terminate the following agreements between the parties: (i) the Development Agreement dated as of April 4, 1995, (ii) the License Agreement for Selegiline Hydrochloride Capsules dated as of June 24, 1996, and (iii) all ancillarydocumen