-----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, F8d/+Xr4mj5ldJ2rwaiNDh+I72QVS8rAAXjsq+tduoZd561S8K+N9rEDuIYxWd3X Ic3r2v3XHhn5mPqKZ7B/4w== 0000950144-04-007240.txt : 20040723 0000950144-04-007240.hdr.sgml : 20040723 20040723142832 ACCESSION NUMBER: 0000950144-04-007240 CONFORMED SUBMISSION TYPE: 10-K/A PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20031231 FILED AS OF DATE: 20040723 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVEN PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000815838 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 592767632 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K/A SEC ACT: 1934 Act SEC FILE NUMBER: 000-17254 FILM NUMBER: 04928709 BUSINESS ADDRESS: STREET 1: 11960 SW 144TH ST CITY: MIAMI STATE: FL ZIP: 33186 BUSINESS PHONE: 3052535099 MAIL ADDRESS: STREET 1: 11960 SW 144TH STREET CITY: MIAMI STATE: FL ZIP: 33185 10-K/A 1 g90077e10vkza.htm NOVEN PHARMACEUTICALS 10-K/A NOVEN PHARMACEUTICALS 10-K/A
 



UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K/A

Amendment No. 1

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

 

For the fiscal year ended December 31, 2003   Commission File Number 0-17254

NOVEN PHARMACEUTICALS, INC.

     
Incorporated under the laws of the
State of Delaware
  I.R.S. Employer Identification Number
59-2767632

11960 S.W. 144th Street, Miami, Florida 33186
305-253-5099

Securities registered pursuant to Section 12(b) of the Act:          None

Securities registered pursuant to Section 12(g) of the Act:          Common Stock, Par Value $.0001

     Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.   Yes   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 registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.   o

     Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Act).   Yes   x   No    o

     As of March 1, 2004, there were 23,195,863 shares of Common Stock outstanding.

     The aggregate market value of the voting stock held by non-affiliates of the registrant on March 1, 2004, was approximately $514 million.

     The aggregate market value of such voting stock held by non-affiliates of the registrant was approximately $230 million (computed by reference to the price at which the voting stock was last sold on June 30, 2003, the last business day of the registrant’s most recently completed second fiscal quarter).

DOCUMENTS INCORPORATED BY REFERENCE:

     Part III: Portions of registrant’s Proxy Statement for its 2004 Annual Meeting of Shareholders.



 


 

EXPLANATORY NOTE

     The sole purpose of this amendment is to amend Exhibits 10.30 and 10.31 in the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2003, as filed with the SEC on March 9, 2004, to include portions of those Exhibits that had previously been omitted (“redacted”) pursuant to a request for confidential treatment. The amendment provides revised redacted versions of such Exhibits that conform with the revised redacted versions of these agreements made publicly available by Endo Pharmaceuticals, Inc. pursuant to a filing with the SEC on June 25, 2004. Accordingly, Exhibits 10.30 and 10.31 are hereby amended and restated in their entirety. In accordance with Rule 12b-15 promulgated under the Securities Exchange Act of 1934, as amended, the Registrant has included in this amendment only Item 15 of Part IV. The remainder of the information contained in the original filing is not amended hereby. This amendment does not reflect events occurring after the filing of the original Form 10-K, or modify or update the disclosures therein in any way other than as required to reflect the amendment set forth below.

PART IV

Item 15. Exhibits, Financial Statement Schedules and Reports on Form 8-K.

(a)(1) Financial Statements

     See Index to Financial Statements at page 74 of this report.

(a)(2) Financial Statement Schedules

     All schedules have been omitted because the required information is not applicable or the information is included in the financial statements or the notes thereto.

2


 

(a)(3) Exhibits

                 
    Exhibit        
    Number
  Description
  Method of Filing
    3.1     Noven’s Restated Certificate of Incorporation.   Incorporated by reference to Exhibit 3.1 of Noven’s Form 10-K for the year ended December 31, 1998 (File No. 0-17254).
 
               
    3.2     Noven’s Certificate of Amendment of Certificate of Incorporation dated June 5, 2001.   Incorporated by reference to Exhibit 3.1 of Noven’s Form 10-Q for the quarter ended June 30, 2001 (File No. 0-17254).
 
               
    3.3     Certificate of Designations of Series A Junior Participating Preferred Stock of Noven Pharmaceuticals, Inc.   Incorporated by reference to Exhibit 3.3 of Noven’s Form 10-K for the year ended December 31, 2001 (File No. 0-17254).
 
               
    3.4     Noven’s Bylaws, as amended and restated as of February 8, 2001.   Incorporated by reference to Exhibit 3.2 of Noven’s Form 10-K for the year ended December 31, 2000 (File No. 0-17254).
 
               
    4.1     Rights Agreement by and between Noven and American Stock Transfer & Trust Company dated November 6, 2001.   Incorporated by reference to Exhibit 4.1 of Noven’s Form 8-K dated November 6, 2001 (File No. 0-17254).
 
               
    10.1     Noven Pharmaceuticals, Inc. Amended and Restated Stock Option Plan.*   Incorporated by reference to Noven’s Form 10-K for the year ended December 31, 1990 (File No. 0-17254), as further amended on June 23, 1992 and incorporated by reference to the definitive Proxy Statement dated May 11, 1992, for the Annual Meeting of Shareholders held on June 23, 1992.

3


 

                 
    Exhibit        
    Number
  Description
  Method of Filing
    10.2     Amendment to Noven Pharmaceuticals, Inc. Amended and Restated Stock Option Plan.*   Incorporated by reference to Noven’s Form 10-Q for the quarter ended June 30, 1999 (File No. 0-17254).
 
               
    10.3     Noven Pharmaceuticals, Inc. 1997 Stock Option Plan.*   Incorporated by reference to Noven’s definitive Proxy Statement dated May 1, 1997, for the Annual Meeting of Shareholders held on June 3, 1997.
 
               
    10.4     Amendment to Noven Pharmaceuticals, Inc. 1997 Stock Option Plan.*   Incorporated by reference to Noven’s Form 10-Q for the quarter ended June 30, 1999 (File No. 0-17254).
 
               
    10.5     Noven Pharmaceuticals, Inc. 1999 Long-Term Incentive Plan.*   Incorporated by reference to Noven’s definitive Proxy Statement dated April 19, 1999, for the Annual Meeting of Shareholders held on June 8, 1999.
 
               
    10.6     Amended and Restated Employment Agreement between Noven and Robert C. Strauss dated as of November 5, 2003.*   Incorporated by reference to Exhibit 10.2 of Noven’s Form 10-Q for the quarter ended September 30, 2003 (File No. 0-17254).
 
               
    10.7     Form of Employment Agreement (Change in Control), between Noven and each of Eduardo G. Abrao, Diane M. Barrett, Jeffrey F. Eisenberg, W. Neil Jones and Juan A. Mantelle.*   Incorporated by reference to the Form of Employment Agreement (Change in Control) filed as Exhibit 10.7 of Noven’s Form 10-K for the year ended December 31, 1999 (File No. 0-17254).
 
               
    10.8     Form of Indemnification Agreement for Directors and Officers.   Incorporated by reference to Exhibit 10.4 of Noven’s Form 10-K for the year ended December 31, 1998 (File No. 0-17254).
 
               
    10.9     License Agreement between Noven and Ciba-Geigy Corporation dated November 15, 1991 (with certain provisions omitted pursuant to Rule 406).   Incorporated by reference to Exhibit 10.9 of Amendment No. 1 to Noven’s Registration Statement on Form S-2 (File No. 33-45784).
 
               
    10.10     Industrial Lease between Rhône-Poulenc Rorer Pharmaceuticals Inc. and Noven dated March 23, 1993 and effective February 16, 1993 (with certain provisions omitted pursuant to Rule 24b-2).   Incorporated by reference to Exhibit 10.20 of Noven’s Form 10-K for the year ended December 31, 1993 (File No. 0-17254).

4


 

                 
    Exhibit        
    Number
  Description
  Method of Filing
    10.11     Operating Agreement of Vivelle Ventures LLC (a Delaware limited liability company) dated as of May 1, 1998.   Incorporated by reference to Exhibit 10.33 to Noven’s Form 10-Q for the quarter ended March 31, 1998 (File No. 0-17254).
 
               
    10.12     Amendment to Operating Agreement between Novartis Pharmaceuticals Corporation and Noven dated March 29, 2001.   Incorporated by reference to Exhibit 10.7 to Noven’s Form 10-Q for the quarter ended March 31, 2001 (File No. 0-17254).
 
               
    10.13     Marketing and Promotional Services Agreement by and between Noven and Vivelle Ventures LLC dated as of May 1, 1998.   Incorporated by reference to Exhibit 10.4 to Noven’s Form 10-Q for the quarter ended March 31, 1998 (File No. 0-17254).
 
               
 
    10.14     First Amendment to Marketing and Promotional Services Agreement between Vivelle Ventures LLC and Noven dated March 29, 2001.   Incorporated by reference to Exhibit 10.6 to Noven’s Form 10-Q for the quarter ended March 31, 2001 (File No. 0-17254).
 
    10.15     Sublicense Agreement by and among Novartis Pharmaceuticals Corporation, Noven and Vivelle Ventures LLC dated as of May 1, 1998.   Incorporated by reference to Exhibit 10.35 to Noven’s Form 10-Q for the quarter ended March 31, 1998 (File No. 0-17254).
 
    10.16     Amended and Restated License Agreement between Noven and Rhône-Poulenc Rorer, Inc. dated September 30, 1999 (with certain provisions omitted pursuant to Rule 24b-2).   Incorporated by reference to Exhibit 10.1 of Noven’s Form 10-Q for the quarter ended September 30, 1999 (File No. 0-17254).
 
    10.17     Amended and Restated License Agreement between Noven and Rhône-Poulenc Rorer, Inc. dated September 30, 1999 (with certain provisions omitted pursuant to Rule 24b-2).   Incorporated by reference to Exhibit 10.2 of Noven’s Form 10-Q for the quarter ended September 30, 1999 (File No. 0-17254).
    10.18     Amendment No. 2 to Amended and Restated License Agreement between Rorer Pharmaceutical Products, Inc. and Noven Pharmaceuticals, Inc. dated March 29, 2001 (with certain provisions omitted pursuant to Rule 24b-2).   Incorporated by reference to Exhibit 10.2 of Noven’s Form 10-Q for the quarter ended March 31, 2001 (File No. 0-17254).

5


 

                 
    Exhibit        
    Number
  Description
  Method of Filing
    10.19     License Agreement between Noven and Novartis Pharma AG dated as of November 3, 2000 (with certain provisions omitted pursuant to Rule 24b-2).   Incorporated by reference to Exhibit 10.2 of Noven’s Form 10-Q for the quarter ended September 30, 2000 (File No. 0-17254).
 
               
    10.20     License Agreement between Noven and Vivelle Ventures LLC dated March 29, 2001 (with certain provisions omitted pursuant to Rule 24b-2).   Incorporated by reference to Exhibit 10.1 of Noven’s Form 10-Q for the quarter ended March 31, 2001 (File No. 0-17254).
 
               
    10.21     Sublicense Agreement among Rorer Pharmaceutical Products, Inc., Rhône -Poulenc Rorer Inc., Aventis Pharmaceuticals Products Inc., Rhône -Poulenc Rorer International Holdings Inc., Novartis Pharma AG and Noven dated March 29, 2001 (with certain provisions omitted pursuant to Rule 24b-2).   Incorporated by reference to Exhibit 10.3 of Noven’s Form 10-Q for the quarter ended March 31, 2001 (File No. 0-17254).
 
               
    10.22     Purchase Agreement among Rorer Pharmaceutical Products, Inc., Aventis Pharmaceuticals Products Inc. and Vivelle Ventures LLC dated March 29, 2001 (with certain provisions omitted pursuant to Rule 24b-2).   Incorporated by reference to Exhibit 10.4 of Noven’s Form 10-Q for the quarter ended March 31, 2001 (File No. 0-17254).
 
               
    10.23     Supply Agreement between Vivelle Ventures LLC and Noven dated March 29, 2001 (with certain provisions omitted pursuant to Rule 24b-2).   Incorporated by reference to Exhibit 10.5 of Noven’s Form 10-Q for the quarter ended March 31, 2001 (File No. 0-17254).
 
               
    10.24     Development Agreement between Novartis Pharma AG and Noven dated June 1, 2001.   Incorporated by reference to Exhibit 10.1 of Noven’s Form 10-Q for the quarter ended June 30, 2001 (File No. 0-17254).
 
               
    10.25     Transaction Agreement among Shire US Inc., Shire Pharmaceuticals Group PLC and Noven, dated February 26, 2003 (with certain provisions omitted pursuant to Rule 24b-2)**.   Incorporated by reference to Exhibit 10.25 of Noven’s Form 10-K for the year ended December 31, 2002 (File No. 0-17254).
 
               
    10.26     License Agreement among Shire US Inc., Shire Pharmaceuticals Group PLC and Noven, dated as April 7, 2003 (with certain provisions omitted pursuant to Rule 24b-2)**.   Incorporated by reference to Exhibit 10.25 of Noven’s Form 10-K for the year ended December 31, 2002 (File No. 0-17254).

6


 

                 
    Exhibit        
    Number
  Description
  Method of Filing
    10.27     Toll Conversion and Supply Agreement among Shire US Inc., Shire Pharmaceuticals Group PLC and Noven, dated as April 7, 2003 (with certain provisions omitted pursuant to Rule 24b-2)**.   Incorporated by reference to Exhibit 10.25 of Noven’s Form 10-K for the year ended December 31, 2002 (File No. 0-17254).
 
               
    10.28     Agreement between Shire US, Inc. and Noven, dated November 5, 2003**.   Incorporated by reference to Exhibit 10.1 of Noven’s Form 10-Q for the quarter ended September 30, 2003 (File No. 0-17254).
 
               
    10.29     Agreement between Noven and P&G Pharmaceuticals, Inc. dated April 28, 2003 (with certain provisions omitted pursuant to Rule 24b-2)**.   Incorporated by reference to Exhibit 10.29 of Noven’s Form 10-K for the year ended December 31, 2003 as filed with the Commission on March 9, 2004(File No. 0-17254).
 
               
    10.30     License Agreement between Noven and Endo Pharmaceuticals Inc. dated February 25, 2004 (with certain provisions omitted pursuant to Rule 24b-2)**.   Filed herewith.
 
               
    10.31     Supply Agreement between Noven and Endo Pharmaceuticals Inc. dated February 25, 2004 (with certain provisions omitted pursuant to Rule 24b-2)**.   Filed herewith.
 
               
    11     Computation of Earnings per Share.   Incorporated by reference to Exhibit 11 of Noven’s Form 10-K for the year ended December 31, 2003 as filed with the Commission on March 9, 2004(File No. 0-17254).
 
               
    21     Subsidiaries of the Registrant.   Incorporated by reference to Exhibit 21 of Noven’s Form 10-K for the year ended December 31, 2003 as filed with the Commission on March 9, 2004(File No. 0-17254).
 
               
    23.1     Consent of Deloitte & Touche LLP.    
 
               
    23.2     Consent of PricewaterhouseCoopers LLP.    

7


 

                 
    Exhibit        
    Number
  Description
  Method of Filing
    31.1     Certification of Robert C. Strauss, President, Chief Executive Officer and Chairman of the Board, pursuant to Securities Exchange Act Rules 13a-15(c) and 15d-15(e), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.   Filed herewith.
 
               
    31.2     Certification of Diane M. Barrett, Vice President and Chief Financial Officer, pursuant to Securities Exchange Act Rules 13a-15(c) and 15d-15(e), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.   Filed herewith.
 
               
    32.1     Certification of Robert C. Strauss, President, Chief Executive Officer and Chairman of the Board, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.   Incorporated by reference to Exhibit 32.1 of Noven’s Form 10-K for the year ended December 31, 2003 as filed with the Commission on March 9, 2004(File No. 0-17254).
 
               
    32.2     Certification of Diane M. Barrett, Vice President and Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.   Incorporated by reference to Exhibit 32.2 of Noven’s Form 10-K for the year ended December 31, 2003 as filed with the Commission on March 9, 2004(File No. 0-17254).


*   Compensation Plan or Agreement.
 
**   Certain exhibits and schedules to this document have not been filed. The Registrant agrees to furnish a copy of any omitted schedule or exhibit to the Securities and Exchange Commission upon request.

     (b) Reports on Form 8-K.

     We did not file any Current Reports on Form 8-K during the three months ended December 31, 2003.

8


 

SIGNATURES

     Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
         
Date: July 23, 2004  NOVEN PHARMACEUTICALS, INC.
 
 
  By:   /s/ Robert C. Strauss    
    Robert C. Strauss   
    President, Chief Executive Officer and Chairman of the Board   
 

     Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

         
Signature
  Title
  Date
 
By: /s/ Robert C. Strauss
Robert C. Strauss (President, CEO & Chairman of the Board)
  Principal Executive Officer and Chairman of the Board   July 23, 2004
 
 
By: /s/ Diane M. Barrett
Diane M. Barrett (Vice President & Chief Financial Officer)
  Principal Financial and Accounting Officer   July 23, 2004
 
By: /s/ Sidney Braginsky
  Director   July 23, 2004

 
       
Sidney Braginsky
       
 
 
By: /s/ John G. Clarkson
  Director   July 23, 2004

 
       
John G. Clarkson, M.D.
       
 
By: /s/ Donald A. Denkhaus
  Director   July 23, 2004

 
       
Donald A. Denkhaus
       
 
 
By: /s/ Robert G. Savage
  Director   July 23, 2004

 
       
Robert G. Savage
       
 
 
By: /s/ Wayne P. Yetter
  Director   July 23, 2004

 
       
Wayne P. Yetter
       

9

EX-10.30 2 g90077exv10w30.txt LICENSE AGREEMENT Exhibit 10.30 LICENSE AGREEMENT DATED AS OF FEBRUARY 25, 2004 BY AND BETWEEN NOVEN PHARMACEUTICALS, INC. AND ENDO PHARMACEUTICALS INC. The confidential portions of this exhibit have been filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN ***. TABLE OF CONTENTS Article I. DEFINITIONS.................................................1 Article II. LICENSE GRANTS..............................................5 Article III. REGISTRATION AND REGULATORY APPROVAL........................7 Article IV. COMMERCIALIZATION OF THE LICENSED PRODUCT...................8 Article V. CANADA AND OTHER TERRITORIES................................9 Article VI. FEES AND PAYMENTS..........................................10 Article VII. SUPPLY OF THE LICENSED PRODUCT.............................11 Article VIII. DEVELOPMENT OF ADDITIONAL PRODUCTS.........................11 Article IX. INTELLECTUAL PROPERTY MATTERS..............................12 Article X. CONFIDENTIALITY............................................16 Article XI. REPRESENTATIONS AND WARRANTIES.............................17 Article XII. INDEMNIFICATION AND LIMITATION OF LIABILITY................19 Article XIII. TERM AND TERMINATION.......................................21 Article XIV. MISCELLANEOUS..............................................23 i LIST OF EXHIBITS Exhibit A Noven Patents Exhibit B Supply Agreement Exhibit C Additional Products Exhibit D Evaluation Plan ii LICENSE AGREEMENT This LICENSE AGREEMENT (the "Agreement") is entered into as of this 25TH day of February, 2004 (the "Effective Date"), by and between NOVEN PHARMACEUTICALS, INC., a Delaware corporation ("Noven"), and ENDO PHARMACEUTICALS INC., a Delaware corporation ("Endo"). WITNESSETH: WHEREAS, Noven has developed and sought regulatory approval relating to, and is the owner of record of, an abbreviated new drug application (the "Product ANDA" as further defined below) relating to a generic fentanyl transdermal patch (the "Licensed Product" as further defined below); WHEREAS, Noven holds rights to certain intellectual property relating to the Licensed Product including without limitation certain patents, patent applications, and know-how; WHEREAS, pursuant to the terms of this Agreement Noven wishes to provide a license to Endo to commercialize the Licensed Product under its Product ANDA and its intellectual property rights; WHEREAS, pursuant to the terms of this Agreement, Endo is willing and able to accept such a license and to fully commercialize the Licensed Products; WHEREAS, Noven and Endo additionally desire to jointly identify and develop additional compounds for transdermal delivery and for eventual full scale commercialization (the "Additional Products" as further defined below); and, WHEREAS, Noven and Endo are entering into a supply agreement contemporaneously with the execution of this Agreement under which Noven will supply Licensed Product to Endo (the "Supply Agreement"). NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties, intending to be legally bound, hereby agree as follows: ARTICLE I. DEFINITIONS Section 1.01. DEFINITIONS. As used herein, the following capitalized terms have the following meanings: "ADDITIONAL PRODUCTS" means potential products comprising those compounds identified in Exhibit C. "AFFILIATE" means with respect to a Person, any legally distinct corporation, firm, individual or other form or business organization which is, directly or indirectly, controlled by, controlling, or under common control with the subject Person hereto. An entity shall be regarded as being in control of another entity if such first entity has the direct or indirect power to order or cause the direction of the management and policies of the other entity, whether through ownership of at least fifty percent (50%) of the outstanding voting securities or participating profit interest of such entity, through other dominant equity ownership or by contract, statute, regulation or otherwise. "ANDA" means an abbreviated new drug application filed with the FDA pursuant to 21 U.S.C. 355(j). "APPLICABLE LAW" means, with respect to any Person, any domestic or foreign, federal, state or local statute, treaty, law, ordinance, rule, regulation, administrative interpretation, order, writ, injunction, judicial decision, decree or other requirement of any Governmental Authority applicable to such Person or any of such Person's respective properties, assets, officers, directors, employees, consultants or agents (in connection with such officers', directors', employees', consultants' or agents' activities on behalf of such Person). "BUSINESS DAY" means a day other than a Saturday, Sunday or other day on which commercial banks in New York, New York, USA are authorized or required by law to close. "CODE OF FEDERAL REGULATIONS," or "C.F.R" means the codification of the general and permanent rules published in the Federal Register. Title 21 of the C.F.R. contains the regulations promulgated by the FDA pursuant to the FDC Act. "COMPETING PRODUCT" means any transdermal fentanyl drug product approved by a Regulatory Authority that is rated as therapeutically equivalent to Duragesic(R) or any transdermal fentanyl product that is an authorized brand generic, other than the Licensed Product and Duragesic. "CONFIDENTIAL INFORMATION" means all secret, confidential or proprietary data, know-how and related information, including, without limitation, all confidential Regulatory Applications, Regulatory and Clinical Materials and related filings, applications and data, the content of any unpublished patent applications, operating methods and procedures, marketing, manufacturing, distribution and sales methods and systems, sales figures, pricing policies and price lists and other business information and shall include all confidential information disclosed or accessed by the parties pursuant to the provisions of this Agreement. "COST OF GOODS SOLD" means the respective amount paid to Noven by Endo pursuant to the Supply Agreement for Licensed Product sold hereunder. "DAMAGES" means all liabilities, demands, obligations, assessments, judgments, levies, losses, fines, penalties, damages (including compensatory damages), costs and expenses, including reasonable attorneys', accountants', investigators', and experts' fees and expenses, reasonably sustained or incurred in connection with the defense or investigation of any Proceedings (including any Proceedings to establish insurance coverage). "FDA" means the United States Food and Drug Administration and any successor agency thereto. 2 "FDC ACT" means the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C.ss.301 et seq., as amended, and the regulations promulgated there under, as amended from time to time. "GAAP" means generally accepted accounting principles in effect in the United States from time to time. "GOVERNMENTAL AUTHORITY" means any foreign, domestic, federal, territorial, state or local governmental authority, quasi-governmental authority, instrumentality, court, government or self-regulatory organization (including any national or international securities exchange and "The NASDAQ Stock Market), commission, tribunal or organization or any regulatory, administrative or other agency, or any political or other subdivision, department or branch of any of the foregoing. "GROSS MARGIN" means Net Sales less Cost of Goods Sold. "IND" means an Investigational New Drug Application, as defined in 21 C.F.R. 312.3. "INTELLECTUAL PROPERTY RIGHTS" means any and all existing and future proprietary rights, including but not limited to property rights, know-how rights, trade secret rights, copyrights, design rights, any existing or future United States patents and patent applications and all continuations, continuations-in-part, divisions, reissues, reexaminations, extensions or other government actions which extend the subject matter of the foregoing, and any corresponding foreign patent applications, and any corresponding patents, patents of addition, or other equivalent foreign patent rights issuing, granted or registered and all other intellectual property rights (including without limitation the right, if any, to sue or bring other actions for past, present and future infringement of such Intellectual Property Rights). With respect to Noven, the foregoing shall include the Noven Patents. "LAUNCH" means the sale of product to a major retail chain or a major distributor (as those terms are commonly understood in the industry) after Regulatory Approval. "LICENSED PRODUCT" means the fentanyl transdermal patch product submitted for Regulatory Approval in the Product ANDA. "NET SALES" means the quantity of Licensed Product multiplied by the gross price per unit of Licensed Product, each as invoiced by Endo or its Approved Subdistributors to third parties (other than an Approved Subdistributor), less the total value of cash discounts and/or rebates and charge backs offered *** for the purchase of such product, and/or required payments under governmental agency programs, including Medicare and Medicaid, as well as any credits or allowances actually granted on account of price adjustments or rejection or return of such product previously sold. *** "NOVEN PATENTS" means those patents and patent applications listed in EXHIBIT A together with any and all improvement patents, reissues, confirmations, renewals, extensions, counterparts, divisions, continuations, continuations-in-part or patents-of-addition issued to or assigned to Noven, but only to the extent that they specifically read on the Licensed Product or a Competing Product, as applicable. 3 "PERSON" means an individual, a corporation, a general partnership, a limited partnership, a limited liability company, a limited liability partnership, an association, a trust or any other entity or organization, including a Governmental Authority. "PROCEEDINGS" means governmental, judicial, administrative or adversarial proceedings (public or private), litigation, suits, arbitration, disputes, claims, causes of action or investigations involving third party claims. "PRODUCT ANDA" means ANDA no. 76-804, filed by Noven pertaining to a fentanyl transdermal patch product. "REGULATORY AND CLINICAL MATERIALS" means all documents, supporting materials and other materials relating to the Regulatory Application, any Regulatory Approval or other matter required to be submitted to any Regulatory Authority in relation to the Product, including any IND, NDA, ANDA, and documents, supporting materials and other materials relating to any drug master file, investigators' brochures, clinical studies (including any Phase IV clinical studies), safety data, adverse event reports, questionnaires, consultant reports, correspondence (including correspondence with any Regulatory Authority), batch reports, protocols, specifications, quality assurance, quality control, customer queries and any responses thereto, and any compilation or evaluations thereof, and question and answer scripts. "REGULATORY APPLICATION" means the applications submitted by Noven to the FDA seeking approval for the development, manufacture, testing, storage, transport, marketing, advertisement, promotion, sale, use, distribution or other disposal of the Product in all or any portion of the Territory, including the Product ANDA. "REGULATORY APPROVAL" means final approval by the applicable Regulatory Authority to market the Product. "REGULATORY AUTHORITY" means a Governmental Authority that has the authority over the manufacture, use, storage, import, export, clinical testing transport, marketing, sale or distribution of the Licensed Product in all or any portion of the Territory, including the FDA. "SECURITIES LAWS" means the United States Securities Act of 1933, as amended, the United States Securities Exchange Act of 1934, as amended, and any other similar law or regulation of a Governmental Authority, or any successor to any such laws or regulations, together with any rules, regulations or listing standards, or agreements of any national or international securities exchange or The NASDAQ Stock Market. "TERRITORY" means the United States of America and Canada. 4 Section 1.02. OTHER DEFINITIONS. Each of the following terms is defined in the section of this Agreement referenced opposite such term. Agreement..................................................Preamble Adjusted Gross Margin.................................Schedule 2.06 Approved Subdistributor........................................2.04 Approved Subdistributor Agreement..............................2.04 Canadian Election..............................................5.06 Closing Date.............................................2.06(b)(i) Competing Assignment...........................................2.06 Disclosing Party...........................................10.01(a) Effective Date.............................................Preamble Endo.......................................................Preamble Endo Indemnitees...........................................12.01(b) Indemnified Party..........................................12.01(f) Indemnifying Party.........................................12.01(f) Infringement Indemnitees...................................12.01(d) Marketing Plan.................................................4.03 Noven......................................................Preamble Noven Indemnitees..........................................12.01(a) Reduced Launch Milestone Payment............................6.02(b) Receiving Party............................................10.01(a) SEC...........................................................14.15 Surviving Entity...............................................2.06 ARTICLE II. LICENSE GRANTS Section 2.01. LICENSE GRANT: Subject to the terms and conditions of this Agreement, Noven hereby grants to Endo an exclusive license under the Product ANDA and its Intellectual Property Rights solely to use and sell or otherwise dispose of the Licensed Product solely in the Territory. For purposes of this Agreement, the phrase use and sell, or otherwise dispose of the "Licensed Product" includes only the right to market, advertise, promote, distribute, offer to sell and sell the Licensed Product throughout the Territory pursuant to the associated obligations of Endo under this Agreement. The term "exclusive" as used in this Article means the specific rights conferred on Endo are to the exclusion of all other Persons and entities, including but not limited to Noven. Section 2.02. LIMITATIONS ON LICENSE GRANTED UNDER SECTION 2.01. No right or license other than those specifically granted to Endo herein are granted, and all rights not specifically granted to Endo herein are hereby explicitly retained by Noven including, without limitation, the right to make Licensed Product and to supply Licensed Product to Endo. Except as specifically set forth in Section 2.04 and Article V of this Agreement below, the license to Endo hereunder shall not include the right of Endo to sublicense any of the rights granted to Endo. Section 2.03. QUALITY CONTROL. Endo shall only market, promote, sell, distribute, use or otherwise dispose of the Licensed Product, and any materials used in connection with the 5 Licensed Product, including any labeling, packaging and advertising, in accordance with all Applicable Laws. Section 2.04. SUBLICENSE. Subject to Section 5.01 and to the written consent of Noven, which consent may be withheld in Noven's sole discretion, Endo shall have the right (a) to appoint any Person as a subdistributor in the Territory (and/or such other territory as the parties may agree upon from time to time) as provided herein (each such approved subdistributor, an "APPROVED SUBDISTRIBUTOR") and (b) to delegate to such Approved Subdistributor the whole or any part of its obligations; PROVIDED that (i) Endo shall remain primarily liable for the Approved Subdistributor's compliance with this Agreement, (ii) prior to or concurrently with its appointment, each Approved Subdistributor shall enter into an agreement with Endo (each, an "APPROVED SUBDISTRIBUTOR AGREEMENT") that is consistent with this Agreement, and that shall not thereafter be amended or modified in any manner inconsistent with the terms hereof, (iii) each Approved Subdistributor Agreement shall name Noven as a third party beneficiary, and (iv) no Approved Subdistributor Agreement shall permit such Approved Subdistributor to appoint or assign such agreement, or delegate any obligations, to any other subdistributor. Endo shall be solely responsible for the fees of, and any other payments to, each Approved Subdistributor. Upon Noven's request, Endo shall make available to Noven a redacted copy of each Approved Subdistributor Agreement evidencing such agreements conformance with the requirements of this Section 2.04. The foregoing notwithstanding, nothing herein shall prevent or prohibit Endo from using subcontractors to perform certain of its internal business functions, such as utilizing a contract sale force, ad agency, contract distribution services and contract safety services: provided, however, that (i) Endo shall retain strategic control over the marketing and sale of Licensed product, (ii) Endo shall remain fully liable and responsible to Noven for all actions and/or inactions of its subcontractors under this Agreement as though such actions and/or inactions were made by Endo itself; and, (iii) Endo shall be solely responsible for the fees of, and any other payments to, each subcontractor. Section 2.05. NON-COMPETE. Except as provided in Section 2.06, during the term of this Agreement, the Parties shall not make, use, sell, market or distribute any Competing Product or Duragesic(R) in the Territory, or grant to any Third Party a right to make, use, sell, market or distribute a Competing Product in the Territory. Section 2.06. CHANGE OF CONTROL. If this Agreement is assigned or transferred to any third party (the "Surviving Entity") by Noven or Endo pursuant to Section 14.04, and such third party has a Competing Product or Duragesic(R) on the market in the Territory (a "Competing Assignment") the following shall apply: (a) In the case of a Competing Assignment by Noven, in order to insure that the supply of Licensed Product to Endo is continued, the Surviving Entity shall continue to supply Licensed Product to Endo in accordance with the Supply Agreement until such time as it transfers all such supply responsibility to a qualified third party reasonably acceptable to Endo. Additionally, for so long as the Surviving Entity is selling a Competing Product and supplying Licensed Product to Endo pursuant to the Supply Agreement, the limitation on liability of Section 9.02(c) in the Supply Agreement shall not apply in the event of any breach of the supply agreement for failure 6 to supply. Noven shall be free to qualify a third party supplier that is reasonably acceptable to Endo at any time during the term of this Agreement, and the Agreement with such third party supplier shall specifically name Endo as a third party beneficiary with the right to take over all rights and obligations of the contract in the event of a Noven bankruptcy or a Competing Assignment by Noven. (b) In the case of a Competing Assignment by Endo to a party with a Competing Product on the market in the Territory, in order to insure that the sales of the Licensed Product are continued the following shall apply: (i) the Surviving Entity shall, within *** of the closing date of the Competing Assignment (the "Closing Date"), (A) cease selling Competing Product in favor of selling Licensed Product only; (B) divest either the Competing Product or the Licensed Product to a third party (which third party, in the case of Licensed Product, is reasonably acceptable to Noven); (C) promptly terminate this License Agreement and the Supply Agreement and return the Product ANDA to Noven for no additional consideration or (D) pay to Noven its share of Gross Margin per Section 6.03 and 9.03 where the applicable Gross Margin is adjusted in accordance with Schedule 2.06. Following the *** period the Surviving Entity may still take any of the foregoing actions, however, from and after the end of the *** period Noven shall be entitled to receive its share of the Gross Margin as calculated per Schedule 2.06. (ii) In no event shall the Surviving Entity be permitted to close any divestiture of the Licensed Product under Section 2.06(b)(i) during the period of time that begins *** days before *** and ends *** days following the Launch. (c) In the case of a Competing Assignment by Endo to a Surviving Entity with Duragesic(R)on the market in the Territory and no Competing Product on the Market the following shall apply: (i) if at the time of the Closing Date there has already been a conversion of Duragesic(R)sales to generic sales of at least *** (as demonstrable by IMS data) then there shall be no restriction on the "Competing Assignment" except as set forth in Section 14.04. (ii) if at the time of the Closing Date there has not yet been a conversion of Duragesic(R)sales to generic sales of at least *** (as demonstrable by IMS data) then within four months of the Closing Date the Surviving Entity shall either (A) divest the Licensed Product to a third party (which third party, in the case of Licensed Product, is reasonably acceptable to Noven); or (B) terminate this License Agreement and the Supply Agreement and return the Product ANDA to Noven for no additional consideration. ARTICLE III. REGISTRATION AND REGULATORY APPROVAL Noven will be responsible for obtaining, and will use commercially reasonable efforts to obtain, Regulatory Approval of the Product ANDA in the United States. Noven agrees to keep Endo fully informed of its progress in seeking Regulatory Approval, including providing Endo with copies of any and all correspondence between Noven and the FDA relating to the Product ANDA. Within thirty (30) days of the first commercial sale of the Licensed Product, Noven will 7 transfer the Product ANDA to Endo. Thereafter, during the term of this Agreement, Endo will be responsible for maintaining Regulatory Approval in the U.S. Noven shall provide Endo with all data and support reasonably necessary for Endo's maintenance of such Regulatory Approval. Within thirty (30) days of the expiration or termination of this Agreement, Endo shall transfer all of its right, title and interest in and to the Product ANDA back to Noven for no additional consideration. ARTICLE IV. COMMERCIALIZATION OF THE LICENSED PRODUCT Section 4.01. COMMERCIALIZATION GENERALLY. Endo shall use commercially reasonable efforts to Launch the Licensed Product promptly after Regulatory Approval of the Product ANDA and, at its own expense, to actively and diligently promote, market and sell the Licensed Product in the Territory during the term of this Agreement. Such efforts shall be no less than those efforts Endo would undertake for its own generic products with similar market potential. Section 4.02. COMMERCIAL LAUNCH. (a) Subject to subsections (b), (c) and (d) of this Section 4.02, Endo shall Launch the Licensed Product within the territory within thirty (30) days of Regulatory Approval of the Licensed Product. (b) Endo's obligation to Launch shall be suspended until such time as it has received all launch supplies of Licensed Product properly ordered from Noven pursuant to the Supply Agreement; provided that any delays or non-delivery of Licensed Product under the Supply Agreement are not a result of a breach of the Supply Agreement by Endo. (c) Endo's obligation to Launch and to sell Licensed Product shall be suspended *** (d) Endo's obligation to Launch and sell Licensed Product shall be suspended for such time as it is prevented from selling Licensed Product by a court order in the relevant territory that Licensed Product infringes a valid claim of a patent of a Third Party or Endo is prohibited from marketing the Licensed Product by any judgment, order, injunction, decree or award of any court, administrative agency, or arbitrator or government body. (e) Except as otherwise set forth in this Article IV and Section 14.14, if Endo fails to commence to market any Licensed Product in accordance with the requirements of this Article IV, and such failure continues for a period of fifteen (15) business days after written notice from Noven to Endo, then this Agreement shall immediately terminate upon notice to Endo by Noven. Thereafter, Noven shall be free to use and sell Licensed Product in the territory as it may see fit. If Noven determines to terminate this Agreement with respect to the Licensed Product, Endo shall promptly take such actions as Noven may reasonably request, in order to transfer to Noven or its designee, for no additional consideration, all of Endo's right, title, and interest in and to any Regulatory Approvals relating to the Licensed Product in such country, and all information relating to any Regulatory Approvals not previously supplied to Noven. Section 4.03 MARKETING PLAN. No later than ninety (90) days before the first commercial sale of Licensed Product, Endo shall provide Noven with a written marketing plan setting forth a detailed description of Endo's strategies and business plan with respect to the marketing, 8 distribution, and sale of the Licensed Product in the Territory (the "Marketing Plan"). Thereafter, Endo Agrees to keep Noven apprised of its strategies and business plan with respect to the marketing, distribution, and sale of the Licensed Product in the Territory, and to provide to Noven such other marketing related information as Noven shall reasonably request. Endo shall also provide Noven with an updated copy of the Marketing Plan prior to the beginning of each subsequent calendar year during the term of this Agreement. At Noven's request, designated employees of each of the parties shall confer not more than once every calendar quarter either in person at a location to be mutually agreed upon, or by teleconference, to discuss the Marketing Plan, competitive market conditions, strategic changes in the marketplace and Endo's respective actions and planned responses thereto. Section 4.04 LIMITATIONS ON ENDO'S MARKETING OF THE LICENSED PRODUCT. Endo shall be permitted to market and sell the Product as it would normally market and sell products of comparable market potential in the ordinary course of Endo's business. *** ARTICLE V. CANADA AND OTHER TERRITORIES Section 5.01. CANADA. Noven hereby authorizes Endo to appoint an Authorized Subdistributor (as defined in Article II above) to distribute Licensed Product in Canada. The terms of this Agreement and the Supply Agreement shall govern the parties' activities in Canada with respect to Licensed Product, except that in the case of a conflict between this Article V and the rest of the terms of this Agreement and/or the Supply Agreement the terms of this Article V shall govern. Section 5.02. SUPPLY. Noven shall exclusively supply Licensed Product to Endo, and Endo shall exclusively purchase from Noven Licensed Product, for sale and use in Canada per the terms of the Supply Agreement. Section 5.03. REGULATORY MATTERS. Endo, together with the Approved Subdistributor, shall be responsible for filing, obtaining and maintaining all necessary Regulatory Approvals in Canada in order to use and sell the Licensed Product in Canada. Endo, together with the Approved Subdistributor, shall use commercially reasonable efforts to obtain such Canadian Regulatory Approval within a reasonable period of time and to thereafter promote, market and sell Licensed Product in Canada. Noven will provide all such information, as reasonably requested by Endo, that Noven may have in its possession in order to support such Canadian regulatory filings. Section 5.04. FINANCIAL TERMS. *** Section 5.05. LIABILITY. As further addressed in Section 12.01(e), Endo shall be responsible for third party claims for damages associated with selling and using Licensed Product in Canada which are not due to a breach of Noven's warranties in this Agreement or the Supply Agreement. Section 5.06. TERMINATION. In the event that Endo determines at any time that it will not pursue, or continue to pursue, marketing and selling of Licensed Product in Canada, it will promptly notify Noven and return all rights related to Licensed Product in Canada to Noven for no additional consideration. Endo's rights in Canada pursuant to this Article 5 are contingent 9 upon (i) Endo evaluating the opportunity in Canada and notifying Noven in writing within one year of the Effective Date that it intends to proceed with seeking Regulatory Approval to market Licensed Product in Canada and to market Licensed Product in Canada upon receiving such Regulatory Approval (the "Canadian Election"), and (ii) that Endo makes a commercial sale of License Product in Canada within two years of the Canadian Election, provided, however, that so long as Endo is using, and continues to use, commercially reasonable efforts to develop, register or launch the Licensed Product in Canada, this contingency shall be extended for up to two additional years. Endo's foregoing obligations of commercially reasonable efforts shall be subject to notice by Noven and cure by Endo per Section 13.02(a). The foregoing notwithstanding, If Endo has not made a commercial sale of Licensed Product in Canada within *** of its Canadian Election, Endo's rights in Canada under this Agreement and the Supply Agreement shall immediately cease, all rights related to Licensed Product in Canada shall be returned to Noven for no additional consideration, and Noven shall thereafter be free to pursue the Canadian market in any fashion that it sees fit. ARTICLE VI. FEES AND PAYMENTS Section 6.01. UPFRONT PAYMENT. Endo shall pay to Noven Eight Million Dollars ($8,000,000) within three (3) business days of the execution of this Agreement. Section 6.02. MILESTONE PAYMENTS. (a) LAUNCH MILESTONE PAYMENT. Within ten (10) business days of Endo's first commercial sale of Licensed Product, Endo shall pay to Noven Ten Million Dollars ($10,000,000), if fewer than *** other generic formulations of Duragesic(R) have been approved or launched, ***. (b) REDUCED LAUNCH MILESTONE PAYMENT. Within ten (10) business days of Endo's first commercial sale of Licensed Product, Endo shall pay to Noven Seven Million Five Hundred Thousand Dollars ($7,500,000) (the "Reduced Launch Milestone Payment"), if *** or more other generic formulations of Duragesic(R) have been approved or launched, including ***. (c) In the event that Endo makes the Reduced Launch Milestone Payment and IMS data proves that fewer than *** competitors had commenced commercial shipments during the thirty (30) day period immediately following Regulatory Approval of the Licensed Product, and Endo received the launch supplies of Licensed Product properly ordered from Noven pursuant to the Supply Agreement, then Endo shall pay Noven an additional launch milestone payment of $2.5 million within fifteen (15) business days of Endo's receipt of such data. In no event shall Endo be responsible for more than Ten Million Dollars ($10,000,000) in total, aggregate launch milestone payments. For the purpose of this paragraph, a competitor to Endo shall not be deemed to have made a "commercial shipment" if they made only a single, token shipment for the purpose of triggering patent litigation. (d) DELAYED LAUNCH MILESTONE REDUCTION. In the event that (i) the final ANDA approval for the Licensed Product or (ii) the delivery to and acceptance by Endo of the Licensed Product ordered for the first month of commercial launch by Endo in accordance with the Supply Agreement (provided that shipment by Endo to its customers shall constitute acceptance and, in 10 the absence of any quality issues reasonably identified by Endo, such acceptance shall not occur later than ten business days after Endo's receipt of the Licensed Product and all required supporting documentation, including the certificate of analysis) occurs thirty (30) days or more after the first shipment of a Competing Product by ***, then the Launch Milestone or Reduced Launch Milestone otherwise due and payable shall be reduced in accordance with the following schedule: Amount of Delay Reduction in Launch Milestone --------------- ----------------------------- 30-59 days $1,000,000 60-89 days $1,500,000 90-119 days $2,000,000 120 or more days $2,500,000 Section 6.03 ***. Endo shall pay to Noven *** in the United States up to and including *** in any calendar year; and *** in the United States over *** in any calendar year. *** shall be determined on a calendar quarter by calendar quarter basis throughout the term of this Agreement. Endo shall pay to Noven its share of *** within thirty (30) days of the end of each applicable calendar quarter in which sales of Licensed Product have been made by Endo. Each *** payment shall be preceded by a statement which includes a detailed calculation of each of the applicable Net Sales, Cost of Goods Sold, *** and the share of *** due and payable. Such statement shall be provided to Noven within fifteen (15) days of the end of each calendar quarter following sales of Licensed Product under this Agreement and shall ***. Section 6.04 PAYMENTS. All payments by Endo to Noven shall be made in United States Dollars by wire transfer to such account as Noven may notify to Endo from time to time. ARTICLE VII. SUPPLY OF THE LICENSED PRODUCT Noven shall be the exclusive supplier of Licensed Product to Endo, and shall supply Licensed Product to Endo at Noven's fully loaded manufacturing cost. The supply of Licensed Product to Endo by Noven shall be governed by the Supply Agreement, which shall address, among other things, the supply price, forecasts, purchase orders and minimum orders, and a Quality Agreement, which shall delineate the regulatory responsibilities of the Parties. ARTICLE VIII. DEVELOPMENT OF ADDITIONAL PRODUCTS Section 8.01 NOVEN'S COMMITMENT REGARDING ADDITIONAL PRODUCTS. Following receipt of the Up-Front Payment of Eight Million Dollars ($8,000,000) pursuant to Section 6.01 above, Noven hereby commits to allocate One Million Five Hundred Thousand Dollars ($1,500,000) to the evaluation of, and the conduct of feasibility studies for, *** compounds identified by Endo, and mutually agreed by the parties, as candidates for transdermal delivery. Noven will not unreasonably reject a candidate proposed by Endo. The first such compound is identified in Exhibit C. Endo will nominate the additional *** candidates by July 1, 2004, and the additional agreed nominees will be added to Exhibit C by amendment upon mutual agreement of the 11 parties. Once a compound has been added to Exhibit C, Endo and Noven shall work exclusively with each other to develop that compound for transdermal delivery. Noven will conduct the evaluation and feasibility studies pursuant to the Evaluation Plan which will be mutually agreed to between the Parties and set forth in Exhibit D and Noven will use reasonable efforts to provide the deliverables described therein to Endo by December 31, 2004. Endo will establish criteria for determining whether the Additional Products thereafter progress into pilot clinical development. The parties may mutually agree to substitute candidates for development at any time, but there shall be no obligation to substitute a new candidate in place of a candidate that has failed the feasibility studies. Section 8.02 ADDITIONAL COMMITMENTS REGARDING ADDITIONAL PRODUCTS. As Noven performs its technical feasibility work, the product candidates will be evaluated by the parties against Endo's clinical development criteria. Endo will determine whether an Additional Product will move into pilot studies within *** of receiving from Noven its feasibility evaluation. Once Endo has determined that an Additional Product will move into pilot studies, Endo will conduct pilot studies on the successful candidates ***. Within *** days of the completion of human pharmacokinetic studies on each Additional Product that has been nominated for pilot studies, Endo will determine whether such Additional Product will move into full clinical development. If Endo determines that an Additional Product is to move into final clinical work then the parties will negotiate a Commercialization Agreement pursuant to Section 8.03 below. Endo will move each nominated Additional Product for which a Commercialization Agreement is entered into between the Parties into full clinical development. If Endo at any time makes a final decision not to advance an Additional Product into pilot studies or nominate it for full clinical development, Noven shall be thereafter free to develop, license and/or commercialize such compound for its own benefit. Noven agrees to work with Endo in good faith to provide additional information to aid Endo in making its determination of whether to move each Additional Product into pilot studies and thereafter into full clinical development . Endo agrees to work with Noven in good faith in determining whether to move each Additional Product into pilot studies and thereafter into full clinical development. Section 8.03. COMMERCIALIZATION AGREEMENT. Once a product is nominated for full clinical development, the parties will have *** days to establish business terms for commercialization and to establish a clinical plan and budget for that candidate. Endo will fund and conduct the clinical development. If the parties cannot agree to terms in the *** period, then neither party may develop, license, or commercialize that compound for transdermal delivery with a third party for *** under any terms and for *** under terms that are more favorable to the third party than those last offered to the other party to this Agreement. If the parties agree to commercial terms and a development plan and budget within such *** period, then the parties will work to prepare and execute a commercialization agreement within *** days. If the parties are unable to execute a commercialization agreement within such *** period, then the same restrictions on development with a third party shall apply. ARTICLE IX. INTELLECTUAL PROPERTY MATTERS Section 9.01. INFRINGEMENT BY THIRD PARTIES. 12 (a) If, at any time on or after the Effective Date, either party shall become aware of any infringement or threatened infringement of the Noven Patents or any unfair competition, inappropriate or unauthorized use, disparagement or other tortious act by any third party in relation to the Licensed Product, then the party having such knowledge shall give prompt notice thereof to the other party. (b) Subject to Section 9.02, Endo shall have the right, at its sole cost and expense, using counsel reasonably acceptable to Noven, to take such action as it deems appropriate to enforce the Noven Patents in the Territory against any Competing Product that may be infringing the Noven Patents, including initiating an appropriate Proceeding or threatening to initiate an appropriate Proceeding to prevent or eliminate the infringement of such Noven Patents with regard to any Competing Product, or the unfair competition, inappropriate or unauthorized use, disparagement or other tortious act by any third party in relation to the Licensed Product in the Territory. Subject to Section 9.01(c) below, Noven agrees to cooperate with Endo, at Noven's cost and expense (which cost and expense shall not include the fees of the attorneys that represent Endo, even if such attorneys represent Noven as well), if and to the extent reasonably requested by Endo, including joining as a party to such Proceeding, if necessary to maintain standing. (c) Endo shall consult with Noven with respect to its decision whether to take any action of the nature specified in Section 9.01(b), giving due consideration to Noven's views with respect to the necessity or desirability of taking such action and with respect to whether and how any such Proceeding should be maintained, settled, or appealed throughout the pendency of such Proceeding. In deciding whether to initiate any Proceeding brought to prevent or eliminate infringement of the Noven Patents, Endo shall give careful consideration to what extent the claims of any Noven Patent reads on the allegedly infringing article, the identity of the alleged infringers, and the extent of the alleged infringement by quantifying the harm being suffered or projected to be suffered by Endo as a result of the alleged infringement. Endo shall keep Noven apprised throughout, and until final disposition of, any Proceeding brought to prevent or eliminate infringement of the Noven Patents, and give due consideration to Noven's views in connection with such Proceeding. (d) Endo shall not enter into any settlement, agreement, consent judgment or other voluntary final disposition of a Proceeding or threatened Proceeding under this Section 9.01, in whole or in part, without the prior written consent of Noven, which shall not be unreasonably withheld. (e) All amounts awarded as damages, profits or otherwise in connection with any action specified in Section 9.01(b) taken by Endo shall be deemed to be Gross Margin under Section 6.03 and subject to split between the parties after the fees, costs and expenses of each of Noven and Endo in respect of the Proceeding have first been reimbursed. (f) If Endo elects not to take any action of the nature specified in Section 9.01(b) within sixty (60) days of becoming aware or receiving notice under Section 9.01 (a) of any infringement, threatened infringement, unfair competition, disparagement or other tortious act identified in Section 9.01(a), Endo shall give Noven notice of such decision, and Noven thereafter shall have the right to take any action of the nature specified in Section 9.01(g). In 13 such event, all amounts awarded as damages, profits or otherwise in connection with any action taken by Noven shall be paid to and become the sole property of Noven. (g) Except for the rights specifically granted to Endo pursuant to Section 9.01(b) above, Noven shall have the sole and exclusive right to protect and enforce its Intellectual Property Rights in any Proceeding. All associated fees, costs and expenses shall be borne by Noven and all amounts awarded as damages, profits or otherwise in connection with any action specified in this Section 9.01(g) taken by Noven shall be the sole property of Noven. Section 9.02. THIRD PARTY CLAIMS REGARDING THE NOVEN PATENTS. (a) If, at any time on or after the Effective Date, any party shall become aware of any Proceeding or threat of any Proceeding by a third party alleging that any of the Noven Patents (or any claims asserted in the Noven Patents) are invalid or unenforceable, or otherwise seeking to limit the scope, construction or interpretation of any of the Noven Patents (or any claims asserted in the Noven Patents), such party shall promptly notify the other party of the same. (b) In the event of any Proceeding or threatened Proceeding contemplated by Section 9.02(a), whether or not initiated as a declaratory judgment action or by counter claim, affirmative defense or otherwise in connection with a Proceeding initiated under Section 9.01, Noven shall have the right, but not the obligation, to assume control of the defense of such Proceeding or threatened Proceeding, using counsel of its own choosing. Noven shall confer with Endo concerning the Proceeding and keep Endo apprised of the progress of the Proceeding. (c) In the event of any Proceeding or threatened Proceeding contemplated by Section 9.02(a), Noven shall bear 100% of the fees, costs and expenses incurred by or on behalf of Noven in defense of such Proceeding or threatened Proceeding; PROVIDED, HOWEVER, that if the Proceeding or threatened Proceeding is in relation to a Competing Product or otherwise arises out of or follows an assertion by Endo of an affirmative claim against the third party which is asserting the claim in such Proceeding or threatened Proceeding (including by way of counterclaim or affirmative defense in a Proceeding brought by Endo under Section 9.01(b)), Endo shall bear 100% of the fees, costs and expenses incurred by or on behalf of itself and Noven in defense of such Proceeding or threatened Proceeding (excluding Noven's costs and expense in cooperation which shall not include the fees of the attorneys that represent Endo, even if such attorneys represent Noven as well), unless Noven exercises its right under 9.02(b) to assume control of the defense, in which case Noven shall be responsible for and shall pay 100% of such fees, costs and expenses associated with defending the validity and enforceability of the Noven Patents. Section 9.03. RIGHTS OF ELECTION REGARDING POTENTIAL INFRINGEMENT. It is the intention of the parties to equally share the risk of infringement of third party Intellectual Property Rights that may arise out of any and all activities associated with the Licensed Product in the Territory except as follows. If a party determines that it no longer wishes to share in such risk it may provide notice to the other party of its desire to opt out of such risk. Such notice to opt out may be provided at any time prior to Commercial Launch except that if notice of a claim of infringement is received by either party, the parties time to opt 14 out shall end with respect to such notified claim thirty days following receipt of such notice of a claim of infringement. In order to opt out the parties shall proceed as follows: (a) In the event that Noven determines that it no longer wishes to share the risk of infringement, then upon reaching such decision Noven shall promptly notify Endo of such decision. Endo shall thereafter have the choice of either terminating this Agreement and the Supply Agreement or assuming all risks of infringement of third party Intellectual Property Rights. In the event that Endo determines to assume the risk of infringement, Endo shall thereafter fully indemnify and defend Noven pursuant to Section 12.01(d) below, the split of Gross Margin per Section 6.03 shall thereafter be *** to Endo and *** to Noven, and the License Agreement and Supply Agreement shall otherwise continue unmodified and in full force and effect. In the event that Endo determines to terminate this Agreement and the Supply Agreement, such agreements shall immediately terminate, and each party shall not make use or sell Licensed Product or any Competing Product for a period of one year thereafter. Additionally, the parties may mutually agree to suspend their obligations until such time as they agree to proceed. (b) In the event that Endo determines that it no longer wishes to share the risk of infringement, then upon reaching such decision Endo shall promptly notify Noven of such decision. Noven shall thereafter have the choice of either terminating this Agreement and the Supply Agreement or assuming all risks of infringement of third Party Intellectual Property Rights. In the event that Noven determines to assume the risk of infringement, Noven shall thereafter fully indemnify and defend Endo pursuant to Section 12.01(d) below, the split of Gross Margin per Section 6.03 shall thereafter be *** to Noven and *** to Endo, and the License Agreement and Supply Agreement shall otherwise continue unmodified and in full force and effect. In the event that Noven determines to terminate this Agreement and the Supply Agreement, both agreements shall immediately terminate, and each party shall not make use or sell Licensed Product or any Competing Product for a period of one year thereafter. Additionally, the parties may mutually agree to suspend their obligations until such time as they agree to proceed. Section 9.04. INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS. (a) If, at any time on or after the Effective Date, any party shall become aware of any Proceeding or threat of any Proceeding by a third party alleging that the Licensed Product infringes the Intellectual Property Rights of any third party or otherwise seeking to prevent, or seek damages in relation to, the marketing of Licensed Product, such party shall promptly notify the other parties of the same. (b) The "Controlling Party" in the defense of any Proceeding contemplated by Section 9.04(a) shall be Noven; provided however that if Endo assumes the risk of infringement per Section 9.03(b) then Endo shall be the "Controlling Party." (c) In the event of any Proceeding or threatened Proceeding contemplated by Section 9.03(b), the Controlling Party shall assume control of the defense of such Proceeding or threatened Proceeding, using counsel of its own choosing, that is reasonably acceptable to the 15 other Party. The non-controlling party agrees to cooperate with the Controlling Party, at its own cost and expense, if and to the extent reasonably requested by the Controlling Party. (d) The Controlling Party shall consult with the other party with respect to whether and how any such Proceeding should be defended, maintained, settled, or appealed throughout the pendency of such Proceeding. The Controlling Party shall keep the other party apprised throughout, and until final disposition of, any such Proceeding and give due consideration to the other party's views in connection with such Proceeding. (e) The Controlling Party shall not enter into any settlement, agreement, consent judgment or other voluntary final disposition of a Proceeding or threatened Proceeding under this Section 9.04, in whole or in part, without the prior written consent of the other party, which shall not be unreasonably withheld. (f) Except as otherwise explicitly provided in this Article 9 , Endo and Noven shall share equally in the fees, costs, expenses and any resulting Damages associated with prosecuting and/or defending Proceedings under this Article 9. Notwithstanding the foregoing, Noven shall be solely liable for all fees, costs, expenses and Damages resulting from a breach of Section 11.02. Section 9.05. CERTAIN LITIGATION. Notwithstanding Section 9.04(f), in the event that one or both of Noven and Endo become involved in patent litigation with *** or any of its affiliates or subsidiaries involving the Licensed Product, or in a litigation concerning any counterpart patent or national phase patent corresponding to ***, Endo hereby agrees that it shall be solely responsible for the first *** in fees, costs and expenses arising out of such litigation. Such defense shall otherwise be governed by Section 9.03 above. Additionally, Noven agrees that if it unreasonably refuses a proposed settlement to a litigation under this Section 9.05 where such settlement would reduce Endo's out of pocket fees, costs and expenses to less than ***, then Endo's obligation to pay the first *** in expenses shall cease and Noven shall share the expenses as per Section 9.04(f) above. ARTICLE X. CONFIDENTIALITY Section 10.01. CONFIDENTIALITY. (a) Pursuant to the terms of this Agreement, each party (in such capacity, the "DISCLOSING PARTY"), has disclosed and will disclose to the other parties and/or their Affiliates or representatives (in such capacity, the "RECEIVING PARTY"), certain Confidential Information of the Disclosing Party. The Receiving Party shall make no use of such Confidential Information except in the exercise of its rights and the performance of its obligations set forth in this Agreement. The Receiving Party shall use the same efforts to keep secret, and prevent the disclosure to third parties of, the Confidential Information of the Disclosing Party as it would use with respect to its own Confidential Information. Confidential Information disclosed by the Disclosing Party shall remain the sole and absolute property of the Disclosing Party, subject to the rights granted herein. The above restrictions on the use and disclosure of Confidential Information shall not apply to any information which (i) is already known to the Receiving Party at the time of disclosure by the Disclosing Party, as demonstrated by competent proof, (ii) is or 16 becomes generally available to the public other than through any act or omission of the Receiving Party in breach of this Agreement, (iii) is acquired by the Receiving Party free of an obligation of confidentiality from a third party who is free to provide the information as such, or (iv) is developed independently by the Receiving Party without use, direct or indirect, of information that is required to be held confidential hereunder. (b) Notwithstanding the provisions of Section 10.01(a): (i) Endo shall be permitted to disclose to its distributors, wholesalers and other direct customers such Confidential Information relating to the Product as Endo shall reasonably determine to be necessary or useful in order to effectively market and distribute the Licensed Product; (ii) Noven shall be permitted to disclose such Confidential Information relating to the Licensed Product as Noven shall reasonably determine to be necessary or useful in order to effectively perform its obligations under this Agreement and the Supply Agreement; (iii) Noven shall be permitted to disclose such Confidential Information relating to the Licensed Product as it shall reasonably determine to be necessary or useful in order to pursue or obtain any Regulatory Approvals in respect of any other transdermal drug delivery products; (iv) each of Noven and Endo shall he permitted to disclose to a Regulatory Authority such Confidential Information relating to the Licensed Product as it shall reasonably determine (but only after consulting with the other parties to the extent practicable) to be necessary to comply with the provisions of Applicable Law; and (v) nothing in this Section 10.01 shall be interpreted to limit the ability of either Noven or Endo to disclose its own Confidential Information. (c) Each of Noven and Endo acknowledge and agree that the terms and conditions of this Agreement shall be considered Confidential Information of each party and shall be treated accordingly. (e) Each party specifically recognizes that any breach by it of this Section 10.01 MAY cause irreparable injury to the other parties and that actual damages may be difficult to ascertain, and in any event, may be inadequate. Accordingly (and without limiting the availability of legal or equitable, including injunctive, remedies under any other provisions of this Agreement), each party agrees that in the event of any such breach, notwithstanding the provisions of Section 12.02 hereof, the other parties shall be entitled to seek, by way of private litigation in the first instance, injunctive relief and such other legal and equitable remedies as may be available. ARTICLE XI. REPRESENTATIONS AND WARRANTIES Section 11.01. REPRESENTATIONS AND WARRANTIES. Each party hereby represents and warrants to the other that as of the Effective Date: 17 (a) ORGANIZATION. It is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation. As of the Closing Date, it will be duly qualified to do business in each jurisdiction where the character of its business (after giving effect to this Agreement) make such qualifications necessary to carry on its business. (b) POWER, AUTHORITY AND ENFORCEABILITY. It has full corporate power and authority to enter into and perform this Agreement and to consummate the transactions contemplated herein. This Agreement has been or shall be duly executed and delivered by duly authorized signatories. This Agreement constitutes a valid and binding obligation, enforceable against in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or other similar laws now or hereafter in effect relating to or affecting creditors' rights generally. (c) NO VIOLATION. Neither the execution and delivery of this Agreement nor the consummation of the transactions contemplated hereby, will (i) conflict with or result in a breach of any of the terms, conditions or provisions of its certificate of incorporation or other governing or charter document, or of any statute or administrative regulation, or, to the best of its knowledge, of ANY order, writ, injunction, judgment or decree of any court or governmental authority or of any arbitration award or any agreement binding upon it or its assets, or (ii) to the best of its knowledge, contravene or conflict with, or constitute a violation of, any provisions of any Applicable Law binding upon it. (d) NO DEFAULT. It is not a party to any unexpired, undischarged or unsatisfied written or oral contract, agreement, indenture, mortgage, debenture, note or other instrument under the terms of which performance by it according to the terms of this Agreement will be a default, or whereby timely performance by it according to the terms of this Agreement may be prohibited, prevented or delayed. Section 11.02 Noven hereby represents and warrants to Endo that: (a) Noven is the owner of, or has sufficient rights to, all of the Noven Intellectual Property Rights in existence on the Effective Date for the Manufacture, marketing and sale of the Products and to grant to Endo the rights granted under this Agreement (including the right to market and promote the Products). To the knowledge of Noven, as of the Effective Date, all of the Noven Intellectual Property Rights are valid, in full force and effect and have been maintained to date, and, are not the subject of any interference or opposition proceedings in the Territory. (b) As of the Effective Date, to the knowledge and belief of the executive officers and Intellectual Property Counsel of Noven, ***. (c) To the actual knowledge of the executives of Noven as of the Effective Date, Noven is not aware of any asserted or unasserted claims, interferences, oppositions or demands of any Third Party against the Noven Intellectual Property Rights or the Licensed Product in existence as of the Effective Date in the Territory. 18 ARTICLE XII. INDEMNIFICATION AND LIMITATION OF LIABILITY Section 12.01. INDEMNIFICATION. In order to allocate between themselves the responsibility for claims arising out of this Agreement, and except as otherwise specifically provided for herein, from and after the Effective Date, the parties shall indemnify each other as provided in this Section 12.01. (a) INDEMNIFICATION OBLIGATIONS OF ENDO. From and after the Effective Date, Endo shall defend, indemnify and hold Noven, its Affiliates, and each of their respective officers, directors, agents, employees and shareholders (collectively, "Noven Indemnitees'"), harmless from and against any and all Damages which Noven Indemnitees may incur or suffer, or with which any of them may be faced arising out of: (i) the breach by Endo of this Agreement including any breach of its representations, warranties, covenants or obligations under this Agreement; (ii) the enforcement by Noven Indemnitees of their rights under this Section 12.01(a); (iii) Endo's violation of any Applicable Law; and (iv) Endo's negligence or willful misconduct; PROVIDED, HOWEVER, that, in each such case, Endo shall not be liable hereunder to the extent such Damages arise from the willful misconduct or negligence of, or a violation of any Applicable Law by or from the breach of the provisions of this Agreement or the Supply Agreement by Noven, its Affiliates, agents, employees or contractors or to the extent such liability is allocated in Sections 12.01 (c), (d) or (e) below. (b) INDEMNIFICATION OBLIGATIONS OF NOVEN. From and after the Effective Date, Noven shall defend, indemnify and hold Endo, its Affiliates, and each of' their respective officers, directors, agents, employees, shareholders or members (collectively, "Endo Indemnitees") harmless from and against any and all Damages which Endo Indemnitees may incur, or suffer, or with which any of them maybe faced arising out of: (i) the breach by Noven of this Agreement including any breach of its representations, warranties, covenants or obligations under this Agreement; (ii) the enforcement by Endo Indemnitees of their rights under this Section 12.01(b); (iii) Noven's violation of any Applicable Law; and, (iv) Noven's negligence or willful misconduct; PROVIDED, HOWEVER, that, in each such case, Noven shall not be liable hereunder to the extent such Damages arise from willful misconduct or negligence of, or a violation of any Applicable Law or from the breach of the provisions of this Agreement or the Supply Agreement by Endo, its 19 Affiliates, agents, employees or contractors or to the extent such liability is allocated in Sections 12.01 (c), (d) or (e) below. (c) PRODUCT LIABILITY. Except with regard to Section 12.01(e) below, all other provisions of this Agreement notwithstanding, this Section 12.01(c) shall govern the allocation of liability with respect to torts of bodily injury related to the use of the Licensed Product. (i) From and after the Effective Date, Noven shall defend, indemnify and hold the Endo Indemnitees harmless from and against any and all Damages which the Endo Indemnitees may incur, or suffer, or with which any of them may be faced arising out of any tort claims of bodily injury relating to or arising out of any use of Licensed Product that is attributable to any negligence or willful misconduct in Noven's design of the Licensed Product or any breach of any of Noven's representations or warranties in the Supply Agreement. (ii) From and after the Effective Date, Endo shall defend, indemnify and hold the Noven Indemnitees harmless from and against any and all Damages which the Noven Indemnitees may incur, or suffer, or with which any of them may be faced arising out of the negligence or willful misconduct of Endo, its sublicensees or subcontractors, in the storing or handling the Licensed Product after it has been tendered to Endo by Noven or associated with the marketing or promotional activities of Endo, its sublicensees or subcontractors for the Product. (iii) To the extent that either the Endo Indemnitees or the Noven Indemnities incur, suffer, or are faced with Damages arising out of any tort claims of bodily injury relating to or arising out of any use of Licensed Product attributed to any reason other than those set forth in the preceding subsections (i) and (ii), Noven and Endo shall share such liability equally by reimbursing the other for one half of such actual Damages incurred. (d) INTELLECTUAL PROPERTY. To the extent that Endo or Noven shall elect to assume the risk of infringement pursuant to Section 9.03 above that party shall defend, indemnify and hold the other party, its Affiliates, and each of' their respective officers, directors, agents, employees, shareholders or members (collectively, "Infringement Indemnitees") harmless from and against any and all Damages which the Infringement Indemnitees may incur, or suffer, or with which any of them maybe faced arising out of the infringement of any Intellectual Property Rights of any third party with respect to any activities associated with the Licensed Product: (e) CANADA. Anything else in this agreement to the contrary notwithstanding, from and after the Effective Date, Endo shall defend, indemnify and hold the Noven Indemnitees harmless from and against any and all Damages which the Noven Indemnitees may incur, or suffer or with which any of them maybe faced arising out of the any and all activities associated with the Licensed Product in Canada; provided, however, that in each such case, Endo shall not be liable hereunder to the extent such Damages are due to any defect in Noven's design of the Licensed Product or any violation of Noven's representations or warranties in this Agreement or the Supply Agreement. (f) PROCEDURE. If any Proceeding arises as to which a right of indemnification provided in this Article XII applies, the Person seeking indemnification (the "INDEMNIFIED PARTY"), shall within twenty (20) days notify the party obligated under this Article XII to 20 indemnify the Indemnified Party (the "INDEMNIFYING PARTY"), thereof in writing, except to the extent that such failure to notify within 20 days does not prejudice the Indemnifying Party's ability to defend or contest any such Proceeding, and allow the Indemnifying Party and its insurers to assume direction and control of the defense against such Proceeding, at its sole expense, including the settlement thereof at the sole option of the Indemnifying Party or its insurers; PROVIDED, HOWEVER, that the Indemnifying Party may not enter into any compromise or settlement without the prior written consent of the Indemnified Party unless such compromise or settlement includes as an unconditional term thereof the giving by each plaintiff or claimant to the Indemnified Party of a release from all liability in respect of such claim and only if such compromise or settlement does not include any admission of legal wrongdoing on the part of the Indemnified Party. The Indemnified Party shall fully cooperate with the Indemnifying Party and its insurer in the disposition of any such matter and the Indemnified Party will have the right and option to participate in (but not control) the defense of any Proceeding as to which this Article VI applies, with separate counsel at its election and cost. If the Indemnifying Party fails or declines to assume the defense of any such Proceeding within thirty (30) days after notice thereof, the Indemnified Party may assume the defense thereof for the account and at the risk of the Indemnifying Party. The Indemnifying Party shall pay promptly to the Indemnified Party any Damages to which the indemnity under this Article XII applies, as incurred. Section 12.02. LIMITATION OF LIABILITY. (a) NO PARTY SHALL BE ENTITLED TO RECOVER ANY PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS FROM LOST SALES TO THIRD PARTIES) WHATSOEVER UNDER THIS AGREEMENT, EXCEPT TO THE EXTENT ANY SUCH PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARE PAYABLE TO A THIRD PARTY AND SUBJECT TO INDEMNIFICATION UNDER THIS ARTICLE 12. (b) Notwithstanding anything to the contrary contained herein, although a party may be entitled to make a claim for indemnification pursuant to more than one section of this Article 12, a party shall not be entitled to recover indemnification for the same claim under more than one section of this Article 12. ARTICLE XIII. TERM AND TERMINATION Section 13.01. TERM. This Agreement and the license granted hereunder shall take effect as of the Effective Date and continue in full force and effect in each country throughout the Territory for a period of ten (10) years from the first commercial sale of the Licensed Product . Upon expiration of this Agreement, the Parties may mutually agree to extend this Agreement on terms to be negotiated in good faith taking into account the expiration of the applicable patents by giving written notice to the other party of its intention to do so prior to the end of any such term. Section 13.02. CERTAIN TERMINATION EVENTS. (a) If either Endo or Noven should fail to discharge fully and promptly any of its material obligations under this Agreement and/or the Supply Agreement attached as Exhibit B, 21 including, without limitation, obligations to make payments, and should such party failing to discharge any of its material obligations fail to cure such failure within thirty (30) days in the case of failure to make payments or with in sixty (60) days for other failures after notice in writing thereof by the other party, which period to cure may be extended for up to sixty (60) days, upon written request, if such additional time is reasonably necessary to effect such cure and provided that such party is using diligent effort to pursue such cure, this Agreement can thereupon be terminated at the aggrieved party's option upon notice to that effect; provided, however, that such termination shall not come into effect unless and until the time period for the chief executive officers of the parties to negotiate a resolution of the dispute, pursuant to Section 14.02 has expired without the dispute having been resolved. (b) Either party may terminate this Agreement with immediate effect in the event that any proceeding under a Bankruptcy Act or any insolvency, receivership or dissolution proceeding is filed against the other party and such proceeding is not dismissed within sixty (60) days after the filing thereof. (c) Either party may terminate this Agreement with immediate effect with respect to any Licensed Product that is permanently and completely withdrawn from all markets in the Territory for serious adverse health or safety reasons. (d) If at any time during the term of this Agreement, Endo, directly or indirectly, takes any action or assists or supports any third party in taking any action challenging any of Noven' rights in the Noven Patents, including any action in connection with an opposition, reexamination, revocation or invalidation proceeding, or requests a declaration of an interference against or otherwise attacks the validity or enforceability of any Noven Patent, or contests or disputes Noven's entitlement to or ownership of the Noven Patents, Noven shall have the right to immediately terminate this Agreement. (e) Either party may terminate this Agreement with immediate effect upon notice to the other party, if the other party or their Affiliates, makes, markets, sells, or distributes any transdermal product in the Territory that is a Competing Product. (f) Following launch of the Licensed Product either party may terminate this Agreement upon ninety (90) days prior written notice to the other party if the Gross Margin to be split by the parties pursuant to Section 6.03 is less than *** of the corresponding Net Sales in any two (2) consecutive calendar quarters. In the event of such a termination, if the non-terminating party desires to continue commercializing the Licensed Product, the terminating party shall transfer to the non-terminating party sufficient rights under this Agreement to enable the non-terminating party to continue to use and sell Licensed Product under the Product ANDA and the Intellectual Property Rights. The terminating party shall have no further obligations under this Agreement but shall be entitled to a royalty of *** of net sales of Licensed Product by the non-terminating party in the event that the non-terminating party continues to commercialize the Licensed Product. (g) Either party may terminate this Agreement in accordance with the provisions of Section 9.03 immediately upon notice to the other party if such other party notifies it of its election to disavow any risk of infringement pursuant to such Section. Any termination pursuant 22 to Section 9.03 and this Section 13.02(g) shall be subject to all the terms and conditions of Section 9.03, including the restriction on making, using or selling Licensed Product or any Competing Product for a period of one year after such termination. (h) Endo may terminate this Agreement with immediate effect upon notice to Noven before the Commercial Launch of Licensed Product in the event that that the delay referred to in Section 6.02(d) exceeds 120 days. Section 13.03. EFFECT OF TERMINATION. (a) Upon termination of this Agreement for any reason, Endo shall promptly take such actions as Noven may reasonably request, in order to transfer to Noven or its designee, free of charge, all of Endo's right, title and interest in and to any Regulatory Approvals relating to the Licensed Products, and all information relating to any Regulatory Approvals not previously supplied to Noven. (b) Upon termination, this Agreement shall forthwith become void and of no further force or effect, except for the following provisions, which shall remain in full force and effect: (a) Article 10 (Confidentiality), (b) this Section 13.03, (c) Section 14.10 (Governing Law), (d) Section 14.15(Public Announcements and Publications), (e) Section 14.12 (Entire Agreement) and (f) Section 14.13 (Expenses). In addition, in the event of a termination of this Agreement by Noven related to the Licensed Product, Endo may, at its option, continue with the development of any other products in development, and this Agreement shall remain in force and effect to the extent applicable to such development products. The rights and remedies provided in this Article VII shall be cumulative and not exclusive of any rights or remedies provided by Applicable Law. Any termination of this Agreement shall not affect any right or claim hereunder that arises prior to such termination, which claims and rights shall survive any such termination. (c) NATURE OF LICENSES. All rights and licenses granted pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of 11 U.S.C. ss. 365(n) of the Bankruptcy Laws, licenses of rights to "INTELLECTUAL PROPERTY" as defined under 11 U.S.C. ss. 101(35A) of the Bankruptcy Laws. The Parties agree that Endo, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights, including any right to enforce any exclusivity provision of this Agreement, remedies, and elections under Bankruptcy Laws. To the fullest extent permitted by law, the Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against Noven under the Bankruptcy Laws, Endo shall be entitled to all applicable rights under 11 U.S.C. ss. 365(n) of the Bankruptcy Laws, including copies and access to, as appropriate, any such intellectual property and all embodiments of such intellectual property upon written request therefor by Endo, and such, if not already in its possession, shall be promptly delivered to Endo. ARTICLE XIV. MISCELLANEOUS Section 14.01. NOTICES. All notices, claims, certificates, requests, demands and other communications hereunder shall be in writing and shall be delivered personally or sent by confirmed facsimile transmission, air courier, or registered or certified mail, return receipt requested, addressed as follows: 23 if to Noven: Noven Pharmaceuticals, Inc. 11960 S. W. 144th Street Miami, Florida 33186 Attention: CEO & General Counsel Telecopy: 305-964-3340 with copies (which shall not constitute notice) to: Frommer Lawrence & Haug LLP 745 Fifth Avenue New York, New York 10151 Attention: Edgar H. Haug, Esq. Telecopy: 212-588-0500 if to Endo: Endo Pharmaceuticals Inc. 100 Painters Dr. Chadds Ford, PA 19317 Attention: General Counsel Facsimile No.: (610) 558-9684 or to such other address as the party to whom notice is to be given may have furnished to the other party in writing in accordance herewith. Any such communication shall be deemed to have been delivered (a) when delivered, if delivered personally, (b) when sent (with written confirmation received), if sent by facsimile transmission on a Business Day, (c) on the first Business Day after dispatch (with written confirmation received), if sent by facsimile transmission on a day other than a Business Day, (d) on the second Business Day after dispatch, if sent by air courier, and (e) on the fifth Business Day after mailing, if sent by mail. Section 14.02. DISPUTES. In the event of any controversy or claim arising out of, relating to or in connection with any provision of this Agreement, or the rights or obligations of the parties hereunder, the parties shall try to settle their differences amicably between themselves. Any party may initiate such informal dispute resolution by sending written notice of the dispute to the other parties, and within ten (10) days after such notice, the Chief Executive Officers of the parties shall meet for attempted resolution by good faith negotiations. If they are unable to resolve such disputed matter within thirty (30) days of initiating such negotiations, the parties agree first to try in good faith to settle the dispute by mediation in New York, New York under the Commercial Mediation Rules of the American Arbitration Association. If following any such mediation the parties still have not been able to resolve any such dispute, the parties agree to submit the dispute to final and binding arbitration before a single arbitrator in New York, New York under the Commercial Arbitration Rules of the American Arbitration Association. The parties agree that a judgment may be entered on the arbitrator's award in any court of competent jurisdiction. The arbitrator in reviewing any claim under this Agreement shall have the exclusive authority to determine any issues as to the arbitration of any such claim or related disputes under this Agreement. In reaching a decision, the arbitrator shall interpret, apply and be hound by this 24 Agreement and by Applicable Law. The arbitrator shall have no authority to add to, detract from or modify this Agreement or any Applicable Law in any respect. The arbitrator may not grant any remedy or relief that a court of competent jurisdiction could not grant, nor any relief or remedy greater than that sought by the parties, nor any punitive, incidental or consequential damages, except to the extent any such punitive, incidental or consequential damages arc payable to a third party. Any up-front costs of the arbitrator shall be home equally by the parties; PROVIDED, HOWEVER, that the non-prevailing party in any such arbitration shall pay, and to the extent applicable reimburse the prevailing party for, the costs and expenses of the arbitrator, including costs and expenses payable to the American Arbitration Association mid to the arbitrator; and PROVIDED FURTHER, that in the event each party prevails as to certain claims in connection with any such arbitration, the fees of the arbitrator shall be paid and/or reimbursed in accordance with the decision of the arbitrator. Each party shall bear its own costs incurred in connection with attorneys' fees and related expenses. Notwithstanding the foregoing provisions of this Section 8.02, nothing in this Agreement shall limit or in any way restrict the ability of any party to seek injunctive or other equitable relief in a court or other judicial body. Section 14.03. INDEPENDENT CONTRACTORS. In making and performing this Agreement, the parties are acting and shall act as independent contractors. Nothing in this Agreement shall be deemed to create all agency, joint venture or partnership relationship between the parties hereto. No party shall have the authority to obligate another party in any respect, and no party shall hold itself out as having any such authority. All personnel of Noven shall be solely employees of Noven and shall not represent themselves as employees of Endo. All personnel of Endo shall he solely employees of Endo and shall not represent themselves as employees of Noven. Section 14.04. ASSIGNMENT. Subject to Section 2.06 the parties may not assign or otherwise transfer this Agreement, in whole or in part, without the prior written consent of the other, and any such attempt to do so shall be null and void, except that each Party may assign its rights and transfer its duties hereunder without obtaining such written consent in the event of such Party's merger, consolidation or sale of all or substantially all of its assets. Section 14.05. BINDING EFFECT; BENEFIT. This Agreement shall inure to the benefit of and be binding upon the parties hereto, and their successors and permitted assigns. Nothing in this Agreement, express or implied, is intended to confer on any Person other than the parties hereto, and their respective successors and permitted assigns any rights, remedies, obligations or liabilities under or by reason of this Agreement. Section 14.06. AMENDMENTS. This Agreement shall not be modified, amended or supplemented except pursuant to an instrument in writing executed and delivered on behalf of each of the parties hereto. Section 14.07. NO WAIVER. The failure in any one or more instances of a party to insist upon performance of any of the terms, covenants or conditions of this Agreement, to exercise any right or privilege conferred in this Agreement, or the waiver by said party of any breach of any of the terms, covenants or conditions of this Agreement, shall not be construed as a subsequent waiver of any such terms, covenants, conditions, rights or privileges, but the same shall continue and remain in full force and effect as if no such forbearance or waiver had 25 occurred. No waiver shall be effective unless it is in writing and signed by an authorized representative of the waiving party. Section 14.08. COUNTERPARTS. This Agreement shall become binding when any one or more counterparts hereof, individually or taken together, shall bear the signatures of each of the parties hereto. This Agreement may he executed in any number of counterparts, each of which shall he deemed an original as against the party whose signature appears thereon, but all of which taken together shall constitute but one and the same instrument. Each party may execute this Agreement on a facsimile of the Agreement. In addition, facsimile signatures of authorized signatories of any party shall be valid and binding and delivery of a facsimile signature by any party shall constitute due execution and delivery of this Agreement. Section 14.09. INTERPRETATION. The article and section headings contained in this Agreement are for convenience of reference only and shall not affect the meaning or interpretation of this Agreement. As used in this Agreement, any reference to the masculine, feminine or neuter gender shall include all genders, the plural shall include the singular, arid singular shall include the plural. Unless the context otherwise requires, the term "party" when used herein means a party hereto. References herein to a party or other Person include their respective successors and assigns. The words "include," "includes" and "including" when used herein shall be deemed to be followed by the phrase "without limitation" unless such phrase otherwise appears. Unless the context otherwise requires, references herein to Articles, Sections, Exhibits and Schedules shall be deemed references to Articles and Sections of, and Exhibits and Schedules to, this Agreement. Unless the context otherwise requires, the words "hereof," "hereby" and "herein" and words of similar meaning when used in this Agreement refer to this Agreement in its entirely and not to any particular Article, Section or provision hereof. With regard to each and every term and condition of this Agreement, the parties understand and agree that the same have or has been mutually negotiated, prepared and drafted, and that if at any time the parties desire or are required to interpret or construe any such term or condition or any agreement or instrument subject thereto, no consideration shall be given to the issue of which party actually prepared, drafted or requested any term or condition of this Agreement. Section 14.10. GOVERNING LAW. This Agreement and any claims, disputes or causes of action relating to or arising out of this Agreement shall be construed in accordance with and governed by the substantive laws of the State of New York, without giving effect to the conflict of laws principles thereof. Section 14.11. UNENFORCEABILITY. If any provisions of this Agreement are determined to be invalid or unenforceable in any jurisdiction, such provisions shall be ineffective to the extent of such invalidity or unenforceability in such jurisdiction, without rendering invalid or unenforceable the remaining provisions hereof or affecting the validity or enforceability of any of such provisions of this Agreement in any other jurisdiction. The parties will use their best efforts to substitute the invalid or unenforceable provision with a valid and enforceable one which conforms, as nearly as possible, with the original intent of the parties. Section 14.12. ENTIRE AGREEMENT. This Agreement, together with the Supply Agreement and the Quality Agreement, embodies the entire agreement and understanding between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements, 26 commitments, arrangements, negotiations or understandings, whether oral or written, between the parties hereto and their respective Affiliates with respect thereto. There are no agreements, covenants or undertakings with respect to the subject matter of this Agreement other than those expressly set forth or referred to herein and no representations or warranties of any kind or nature whatsoever, express or implied, are made or shall be deemed to be made herein by the parties hereto, except those expressly made in this Agreement, the Supply Agreement and the Quality Agreement. Section 14.13. EXPENSES. Except as expressly set forth herein, each party hereto shall bear all fees and expenses incurred by such party in connection with, relating to or arising out of the execution, delivery and performance of this Agreement and the consummation of the Contemplated Transactions, including attorneys', accountants' and other professional fees and expenses. Section 14.14. FORCE MAJEURE. If the performance of this Agreement or any obligation hereunder (except the payment of money) by any party is prevented by reason of any cause beyond the reasonable control of the affected party, including fire, flood, riot, war, explosions, acts of God (including hurricanes and tropical storms), acts of a public enemy, labor disturbances or acts, regulations or laws of any government adopted after the date of this Agreement or subject to a new interpretation after the date of this Agreement that render impossible or illegal the performance by a Party of its obligations under this Agreement, the party so affected, upon notice to the other parties, shall be excused from such performance; PROVIDED that the party so affected shall use diligent effort to avoid or remove such cause or causes of non-performance and shall continue to perform hereunder with the utmost dispatch whenever such cause or causes are removed. Section 14.15 PUBLIC ANNOUNCEMENTS AND PUBLICATIONS. Except as required by law, governmental regulation or by the requirements of any securities exchange on which the securities of a Party hereto are listed, no Party to this Agreement shall make, or cause to be made, any press release or public announcement in respect of this Agreement, including its existence, or the transactions contemplated hereby or otherwise communicate with any news media without the prior written consent of the other Party, which consent shall not be unreasonably withheld, and the parties shall cooperate to the extent practicable as to the timing and contents of any such press release or public announcement. Notwithstanding the foregoing, the Parties hereby agree to jointly prepare a press release announcing the existence of this Agreement, such press release to be approved by each Party prior to any distribution to any media outlet. Notwithstanding the foregoing, the Parties specifically understand and agree that neither Party shall make any public announcement or disclose to any Third Party the identity of any API being investigated and developed hereunder other than fentanyl without mutual written agreement between the parties. In the event that a Party is required to file or disclose the terms of this Agreement pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (the "SEC"), such Party may file or disclose such Confidential Information to the extent it determines in its sole discretion that it is so required subject to requesting appropriate confidential treatment from the SEC. 27 IN WITNESS WHEREOF, the parties hereto have entered into this Agreement effective as of the Effective Date. NOVEN PHARMACEUTICALS, INC. ENDO PHARMACEUTICALS INC. By: /s/ ROBERT C. STRAUSS By: /s/ PETER A. LANKAU ----------------------------- -------------------------------------- Name: Robert C. Strauss Name: Peter A. Lankau Title: President, CEO, and Chairman Title: President and CEO Date: February 25, 2004 Date: February 25, 2004 28 SCHEDULE 2.06 ADJUSTED GROSS MARGIN In the event of a Competing Assignment where the Gross Margin subject to sharing with Noven under the Agreement (the "Adjusted Gross Margin") is to be calculated in accordance with this Schedule 2.06 such share shall be calculated as follows: Adjusted Gross Margin share payable to Noven = Adjusted Gross Margin Split x Gross Margin Adjusted Gross Margin Split= ***x(Applicable Gross Margin Split) *** Gross Margin = the sum of the actual Net Sales of Licensed Product and *** less the applicable Cost of Goods Sold *** Applicable Gross Margin Split = the unadjusted applicable share of the Gross Margin otherwise payable to Noven pursuant to Section 6.03 and 9.03. *** 29 EXHIBIT A NOVEN PATENTS United States Patent NO. 5,474,783 United States Patent NO. 5,958,446 United States Patent NO. 5,656,286 United States Patent NO. 6,024,976 United States Patent NO. 5,686,099 United States Patent NO. 6,638,528 30 EXHIBIT B SUPPLY AGREEMENT 31 EXHIBIT C ADDITIONAL PRODUCTS *** 32 EXHIBIT D EVALUATION PLAN [TO COME] 33 EX-10.31 3 g90077exv10w31.txt SUPPLY AGREEMENT Exhibit 10.31 SUPPLY AGREEMENT DATED AS OF FEBRUARY 25, 2004 BY AND BETWEEN NOVEN PHARMACEUTICALS, INC. AND ENDO PHARMACEUTICALS INC. THE CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST IN ACCORDANCE WITH RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN ***. SUPPLY AGREEMENT THIS SUPPLY AGREEMENT (the "AGREEMENT"), is hereby entered into as of February 25, 2004 (the "EFFECTIVE DATE"), by and between Noven Pharmaceuticals, Inc., a Delaware corporation ("Noven"), and Endo Pharmaceuticals Inc., a Delaware corporation ("Endo"). WITNESSETH WHEREAS, Noven and Endo are contemporaneously herewith entering into a License Agreement (the "License Agreement") related to a fentanyl transdermal patch product (the "Product" as further defined herein) developed by Noven; WHEREAS, Noven desires to manufacture and supply Endo with its requirements of Product; and, WHEREAS, Endo desires to purchase its requirements of the Product from Noven pursuant to the terms and conditions set forth in this Agreement. NOW, THEREFORE, in consideration of the mutual covenants and agreements of the parties contained herein and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereby agree as follows: ARTICLE I DEFINITIONS Section 1.01. DEFINITIONS. As used herein, the following capitalized terms have the following meanings: "ANDA" means an abbreviated new drug application filed with the FDA pursuant to 21 U.S.C. 355(j). "AFFILIATE" means with respect to a Person, any legally distinct corporation, firm, individual or other form or business organization which is, directly or indirectly, controlled by, controlling, or under common control with, the subject Person hereto. An entity shall be regarded as being in control of another entity if such first entity has the direct or indirect power to order or cause the direction of the management and policies of the other entity, whether through ownership of at least fifty percent (50%) of the outstanding voting securities or participating profit interest of such entity, through other dominant equity ownership or by contract, statute, regulation or otherwise. "API" means the active pharmaceutical ingredient fentanyl base. "APPLICABLE LAW" means, with respect to any Person, any domestic or foreign, federal, state or local statute, treaty, law, ordinance, rule, regulation, administrative interpretation, order, writ, injunction, judicial decision, decree or other requirement of any Governmental Authority applicable to such Person or any of such Person's respective properties, assets, officers, directors, 2 employees, consultants or agents (in connection with such officers', directors', employees', consultants' or agents' activities on behalf of such Person). "BUSINESS DAY" means a day other than a Saturday, Sunday or other day on which commercial banks in New York, New York, USA are authorized or required by law to close. "CODE OF FEDERAL REGULATIONS" or "C.F.R." means the codification of the general and permanent rules published in the Federal Register. Title 21 of the C.F.R. contains the regulations promulgated by the FDA pursuant to the FDC Act. "CONFIDENTIAL INFORMATION" means all secret, confidential or proprietary data, know-how and related information, including all regulatory applications and other regulatory filings, regulatory and clinical materials, Materials, the content of any unpublished patent applications, operating methods and procedures, marketing, manufacturing, distribution and sales methods and systems, sales figures, pricing policies and price lists and other business information and shall include all information disclosed or accessed by a party from the other in connection with this Agreement. "DAMAGES" means all liabilities, demands, obligations, assessments, judgments, levies, losses, fines, penalties, damages (including compensatory damages), costs and expenses, including reasonable attorneys', accountants', investigators', and experts' fees and expenses, reasonably sustained or incurred in connection with the defense or investigation of any Proceedings (including any Proceedings to establish insurance coverage). "FDA" means the United States Food and Drug Administration and any successor agency thereto. "FDC ACT" means the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C.ss.301 et seq., as amended, and the regulations promulgated there under, as amended from time to time. "GAAP" means generally accepted accounting principles in effect in the United States from time to time. "GMP" means the current Good Manufacturing Practices as that term is presently or hereafter defined by the FDA or other applicable Regulatory Authority. "GOVERNMENTAL AUTHORITY" means any foreign, domestic, federal, territorial, state or local governmental authority, quasi-governmental authority, instrumentality, court, government or self-regulatory organization (including any securities exchange such as The NASDAQ Stock Market), commission, tribunal or organization or any regulatory, administrative or other agency, or any political or other subdivision, department or branch of any of the foregoing. "LABEL" shall mean any package (primary or secondary container) labeling designed for use with the Product, including the package insert; and any variation of such term, such as "Labeled" or "Labeling", shall mean the act of doing the foregoing. 3 "MATERIALS" means all ingredients, items or substances (including those that may not appear in the Product) used or required for use by Noven to manufacture the Product, including the API, all other active drug ingredients, excipients, packaging components, printed materials and manufacturing materials associated with the Product. "MANUFACTURING FACILITY" means Noven's facility located at 11960 S.W. 144th Street, Miami, Florida 33186 or such other FDA-approved facility as Noven may notify to Endo from time to time. "PERSON" means an individual, a corporation, a general partnership, a limited partnership, a limited liability company, a limited liability partnership, an association, a trust or any other entity or organization, including a Governmental Authority. "PROCEEDINGS" means governmental, judicial, administrative or adversarial proceedings (public or private), litigation, suits, arbitration, disputes, claims, causes of action or investigations. "PRODUCT" or "PRODUCTS" means the products listed in Exhibit C which are the fully packaged, labeled and released fentanyl transdermal patch product that is the subject of the Product ANDA. "QUALITY AGREEMENT" means the Quality Agreement attached hereto as Exhibit B. "REGULATORY AUTHORITY" means a Governmental Authority that has the authority over the manufacture, use, storage, import, export, clinical testing, transport, marketing, sale or distribution of the Product in all or any portion of the Territory, including the FDA. "SECURITIES LAWS" means the United States Securities Act of 1933, as amended, the United States Securities Exchange Act of 1934, as amended, and any other similar law or regulation of a Governmental Authority, or any successor to any such laws or regulations, together with any rules, regulations or listing standards or agreements of any national or international securities exchange or The NASDAQ Stock Market. "SPECIFICATIONS" means, collectively, the manufacturing, packaging and testing procedures and standards for Product, including all applicable control procedures and analytical test methods, each as described in the Product ANDA as amended, supplemented or otherwise modified from time to time in accordance with Applicable Law. "TERRITORY" shall have the meaning set forth in the License Agreement as may be amended from time to time. "VALIDATION BATCHES" means the batches which Noven elects to utilize to satisfy the FDA requirements regarding validation of its commercial manufacturing process. *** 4 Section 1.02. OTHER DEFINITIONS. Each of the following terms is defined in the section of this Agreement referenced opposite such term. Term Section ---- ------- Agreement ................................................Preamble Collar........................................................4.03 Endo......................................................Preamble Effective Date ...........................................Preamble Force Majeure Event .........................................11.13 Launch Quantities ............................................3.09 License Agreement ........................................Recitals Noven.....................................................Preamble Rejection Notice ..........................................3.07(a) Tech Transfer Services....................................10.02(e) Term ........................................................10.01 ARTICLE II. COMMITMENT TO SUPPLY AND PURCHASE Section 2.01. SUPPLY. Subject to the terms and conditions of this Agreement and the license rights granted to Endo in the License Agreement, from and after the Effective Date: (1) Noven shall use commercially reasonable efforts to supply Endo with its requirements of Product as ordered by Endo pursuant to the terms of this Agreement; (2) Noven shall not supply Product to any third Party for use or sale within the Territory without the prior written consent of Endo; (3) Endo shall purchase Product exclusively from Noven; and, (4) Endo shall only use and sell Product within the Territory. Section 2.02. API. In the event that either party is able to secure a lower price for the API from a source that meets Noven's quality requirements, subject to Noven's contractual commitments with its suppliers, Noven will work with Endo in good faith to utilize such API in place of its own source of API. Once agreed to by both parties to qualify a lower price API, Endo and Noven shall equally share all out of pocket expenses in qualifying and otherwise securing such new API source. To the extent that Noven is able to use such lower priced API, the lower cost will be reflected in Noven's manufacturing costs for the Product. *** In the period prior to commercial launch of the Product, to the extent that Endo supplies Noven with the API, Endo will invoice Noven for the portion of the cost of such API for which Noven is assuming risk pursuant to Section 3.09 below. All such invoices shall be due and payable within thirty days of receipt and shall bear interest at the rate of 1% per month or the maximum allowable by law on any overdue amounts. Noven shall include such API costs in its manufacturing costs and Endo shall deduct the API costs not invoiced to Noven from the next *** payment otherwise owed Noven under the License Agreement. After the commercial launch of the Product, Endo shall deduct the cost of the API it supplies Noven from the next *** payment otherwise owed Noven under the License Agreement. Section 2.03. COMPLIANCE WITH APPLICABLE LAW. Endo hereby covenants and agrees that Endo and its Affiliates shall store, handle, transport, market, promote, sell, distribute, use and otherwise dispose of any Product supplied by Noven, and any materials used in connection with 5 such Product, including any labeling, packaging and advertising, in accordance with all Applicable Laws. ARTICLE III FORECASTS, ORDERS, DELIVERY AND ACCEPTANCE Section 3.01. FORECASTS. Within 30 days of the Effective Date, Endo shall provide to Noven a good faith, but non-binding, forecast of its requirements for Product for the following twenty-four (24) months. Beginning approximately 9 months before the anticipated commercial launch date of the Product by Endo and within ten Business Days after the first day of each calendar month thereafter during the Term, Endo will provide Noven with a non-binding (except as otherwise provided in Section 3.03), rolling 12-month forecast of its requirements of Product to be delivered by Noven. Endo shall use reasonable commercial efforts to ensure that its forecasts are as accurate as possible. Section 3.02. VALIDATION BATCHES AND INITIAL ORDER. Noven and Endo hereby acknowledge and agree that, in order to address the initial requirements for the commercial launch of the Product, the lead times associated with manufacturing Product and the general preparation for such commercial launch, Noven and Endo will consult with each other in good faith regarding the anticipated commercial launch date. In connection with such discussions Endo will provide a binding initial purchase order to Noven approximately ***; the delivery date for such purchase orders shall be between one and thirty days prior to the anticipated commercial launch date of the Product. The initial purchase orders shall be for quantities of the Product sufficient for launch and for the first month of sales of the Product; such amount of product shall be no less than ***and no greater than *** of Endo's most recent forecasted requirements for the first month of sales of the Product; provided, however, that upon request by Endo, Noven shall attempt in good faith to supply a quantity of the Product in excess of *** of the amount. Section 3.03. FUTURE ORDERS. For anticipated sales of Product by Endo in the second month following commercial launch of the Product and thereafter during the Term Endo shall submit purchase orders to Noven for such Product on a monthly basis. Each purchase order shall be submitted at least ninety (90) days prior to the expected respective sales month. Each purchase order shall specify an amount of Product that is at least *** and no greater than *** of Endo's most recent previous forecast for the applicable month; provided, however, that upon request by Endo, Noven shall attempt in good faith to supply a quantity of the Product in excess of *** of the amount previously forecasted by Endo for any such month. Each purchase order shall be binding, and shall specify a delivery date that is no sooner than ninety days after submission of the purchase order to Noven. In the event that the terms and conditions of any purchase order are inconsistent with or conflict with the terms and conditions of this Agreement, the terms and conditions of this Agreement shall govern. Section 3.04. ORDER SIZE. All purchase orders for Product placed by Endo shall be for amounts of product equal to a full manufacturing batch or multiples thereof with the amount ordered based on the estimated actual yields. An estimate of the number of units per batch is attached hereto as Exhibit A. The actual number of units delivered pursuant to any purchase order for Product shall be equal to the number of units produced in each batch thereof, subject to reduction of the number of units produced in any batch by the number of units not suitable for 6 release or otherwise retained pursuant to the provisions of the Quality Agreement. In the event that Noven shall deliver less than *** of the units ordered by Endo pursuant to any purchase order (which number shall be determined with reference to the number of units estimated to be yielded by each batch ordered by Endo as reflected on Exhibit A), Noven shall notify Endo in writing of the amount of such shortfall upon discovery of the shortfall of the Product. Endo shall, within 30 days of receipt of such delivery, either (a) accept such delivery in full satisfaction of the purchase order (as to quantity only and not in waiver of Endo's opportunity to reject under pursuant to Section 3.07), or (b) issue a replacement purchase order for an additional batch of the Product, and Noven shall use reasonable commercial efforts to deliver such Product within 60 days of the date of such replacement purchase order; provided, that in either case Endo shall accept and pay to Noven the price for the units of Product delivered. Endo's failure to issue a replacement purchase order within such 30-day period shall be deemed as an acceptance of such delivery pursuant to subsection (a) above. Any replacement Purchase order submitted by Endo to Noven pursuant to this Section 3.04 shall be subject to the same terms and conditions of this Agreement as purchase orders submitted pursuant to section 3.03. Section 3.05. DELIVERY. Product shall be delivered to Endo by Noven Ex Works (Incoterms 2000) Noven's Manufacturing Facility. All Products shall be properly prepared for safe and lawful shipment by Noven, shall be shipped to Endo's distribution center in Memphis, Tennessee or other location designated by Endo, via the common carrier selected by Endo, and shall be accompanied by appropriate transportation and other agreed upon documentation including, without limitation, DEA form 222. Noven shall ensure that the common carrier vehicles onto which the Product is loaded are environmentally controlled vehicles. Noven shall make all arrangements for shipping via the common carrier at Endo's expense. No product of any other party shall be shipped with the Products. Shipping cost actually prepaid by Noven will be billed to Endo monthly by Noven on separate invoices. Section 3.06. ACTIVE INGREDIENT QUOTA. On April 1 of each calendar year, Endo shall deliver to Noven a forecast of its requirements of the Product for the following calendar year, for the purpose of assisting Noven in projecting its demand for the Active Ingredient for such calendar year for submission to and approval by the DEA. 7 Section 3.07. ACCEPTANCE AND REJECTION OF THE PRODUCT. (a) Endo shall, (i) in the case of defects which are discovered during incoming inspection by Endo, within 30 days after Endo receives delivery of shipment of the Product, or (ii) in the case of latent defect, within 30 days from the date that Endo discovered such defect, notify Noven, in writing, of any rejection of any such Product ("REJECTION NOTICE"), on the basis of (A) any non-compliance with the Specifications or (B) failure of any such shipment to conform with any product warranty set forth in this Agreement. Failure to provide Rejection Notice to Noven within the applicable 30-day period shall constitute acceptance by Endo of the shipment. Any such possible Rejection Notice shall state in reasonable detail (sufficient to enable Noven to identify the nature of the problem for tests or studies to be conducted by or on its behalf or to dispute the same) the reason why Endo believes the Product may not be acceptable to Endo. Endo shall, within five business days of its receipt of a request by Noven for samples of rejected Product, provide samples of the Product being rejected, if appropriate, and copies of written reports relating to tests, studies or investigations performed to date by or on behalf of Endo on the Product being rejected. (b) Endo's test results or basis for rejection shall be conclusive unless Noven notifies Endo, within 30 days of receipt by Noven of the Rejection Notice, that it disagrees with such test results or basis for rejection. If Endo and Noven fail to agree within 10 days after Noven's notice to Endo as to whether any Product identified in the Rejection Notice (i) deviates from the Specifications to any extent, or (ii) breaches a representation or warranty in this Agreement to an extent that the Product is not saleable, representative samples of the batch of the Product in question shall be submitted to a mutually acceptable independent laboratory or consultant (if not a laboratory analysis issue) for analysis or review. If such laboratory needs to be qualified, then Endo and Noven will equally share the cost and expense of the qualification. The results of such evaluation shall be binding upon the parties. If Noven and Endo determine by agreement or if such evaluation certifies that the Product was properly rejected by Endo, Endo may reject the Product in the manner contemplated by Section 3.07(c). The party that is determined to have been incorrect in its determination of whether the Product should be rejected shall pay the costs of any such evaluation. Should the fees associated with the work conducted by the independent laboratory or consultant be due up front, Endo and Noven shall each pay 50% of such upfront fees; PROVIDED, that if it is determined by the independent laboratory or consultant that either party shall have been incorrect in its determination, such party shall reimburse the other party for such 50% of fees. (c) In the event an order or partial order is rejected by Endo pursuant to the provisions of this Section 3.07, Endo shall return to Noven (or, at the election of Noven, destroy and provide evidence of such destruction to Noven) any units of such rejected Product. Noven shall, at Endo's election, either (i) credit the original invoice in respect of the rejected Product and re-invoice Endo for the units that were not rejected and credit Endo any reasonable expenses incurred by it related to the shipping of the rejected Product to Endo and the return or destruction of the rejected Product against other amounts then due Noven hereunder or (ii) at Noven's cost and expense, replace such rejected Product with conforming Product as soon as practicable. Noven shall have no obligation to Endo with regard to any defective Product if it is determined 8 that any such defect is attributable to the failure by any Person to properly store, transport or care for such Product after such Product leaves Noven's possession. (d) Notwithstanding any other provision of this Agreement to the contrary (except Section 3.09 below), in the event that Endo receives Product in violation of the Product dating warranty set forth at Section 5.01(d), Endo will attempt to mitigate the damages caused by such breach by using commercially reasonable efforts to sell such Product with twelve (12) or more months of dating, provided, however, that Noven shall remain responsible for its breach of Section 5.01(d) in the event that Endo is unsuccessful in its efforts to sell such Products or its results result in the Product being sold at a reduced price. Section 3.08. NOTICES REGARDING SUPPLY. If at anytime during the Term of this Agreement Noven determines that its ability to supply Endo's requirements of Product may be hindered, Noven shall promptly notify Endo. Section 3.09 ENDO RESPONSIBILITY FOR LAUNCH QUANTITY API. In the event that any portion of the Validation Batches or orders for the first three months of commercial supply (the "Launch Quantities") become unsaleable due to delay in receiving final FDA Regulatory Approval for the Product, FDA required changes in the Product labeling (including the printed patch backing) or a Force Majeure event (including in each case where the unsaleability is due to a resulting diminished remaining shelf-life), the parties shall share the risk as follows: Endo shall be responsible for the actual API costs for such unsaleable Product as follows: (i) *** of the API cost for unsaleable validation batches, (ii) *** of the API Cost for unsaleable Product ordered for the *** and *** following launch, and (iii) *** of the API cost for unsaleable Launch Quantities above the Noven API Launch Cost Cap (as defined in this paragraph). Noven shall have not responsibility to Endo for any API costs above the Noven API Launch Cost Cap. The initial Noven API Launch Cost Cap shall be ***, and is based on the preliminary launch quantity estimates set forth on Schedule 3.09. In the event that the actual Launch Quantities ordered are in excess of the amounts set forth in Schedule 3.09, then the Noven API Launch Cost Cap shall be increased by the proportional increase in the amount of API required to make such additional quantities up to a maximum aggregate Noven API Launch Cost Cap of ***. By way of example, if Endo's orders for launch quantities require *** more API then the estimated orders set forth on Schedule 3.09, then the Noven API Launch Cost Cap would be ***. Additionally, Endo shall reimburse Noven for one-half of all of Noven's actual incremental variable costs associated with the manufacturing of the Launch Quantities in excess of the estimated quantities set forth in Schedule 3.09. Noven shall bear the risk of loss for all costs associated with manufacturing the Launch Quantities other than Endo's responsibility for Launch Quantity API and incremental manufacturing costs set forth above; and, in the event that Noven is bearing the cost of the API then Noven shall invoice Endo for the amount of the API cost for which Endo is responsible pursuant to this Section 3.09 at the time such API is received by Noven. Such invoices shall be due and payable within thirty days of receipt by Endo, and Endo shall deduct such API costs from the next Gross Margin payment otherwise owed Noven under this License Agreement. 9 ARTICLE IV PRICE AND PAYMENT Section 4.01. INVOICE. Following shipment of each order of the Product to Endo, Noven shall promptly invoice Endo for such shipment. Each invoice shall specify the amount of product shipped, the per unit invoice Price of the Product as further described in Section 4.02 below, and the total invoice amount. Subject to Section 3.07(c), Endo shall pay Noven for each shipment of Product the total invoiced amount within thirty (30) days after the date of receipt of a correct invoice, the Product and all supporting documentation (such as the certificate of analysis) required to perform an incoming quality assurance inspection; PROVIDED THAT with respect to any shipments for which Endo has identified a quality assurance issue during such thirty (30) day period, payment therefore shall be ten (10) business days from the date of resolution of such quality assurance issue. Both parties agree to provide their full cooperation with any quality assurance investigation and to use commercially reasonable efforts to achieve the prompt resolution of any such investigation. All payments required to be made hereunder shall be paid in United States dollars and made by corporate check drawn on a United States bank or a United States branch of a foreign bank, or by wire transfer of immediately available funds to the financial institution, account number and account party's name designated in writing by Noven to Endo from time to time. Should Endo dispute any portion of an invoice, it shall not be required to pay any portion of such invoice until such time as the dispute is resolved and Endo receives a fully corrected invoice; PROVIDED THAT, in such an event, Noven shall have the option of issuing a new, correct invoice for the portion of the original invoice not in dispute, and Endo shall pay such new invoice within 10 business days of the receipt of the corrected invoice (provided that Endo shall have no obligation to pay earlier than when the payment following the original invoice would have been due). Interest shall accrue on any overdue and undisputed amount due and payable to Noven at the lesser rate of 1% per month or the maximum rate permitted by law Section 4.02. INVOICE PRICE. Noven shall charge Endo for shipped Product manufactured for commercial sale in the United States on a per unit basis at Noven's actual fully loaded manufacturing cost. Noven shall charge Endo for shipped Product manufactured for commercial sale in Canada on a per unit basis at Noven's actual fully loaded manufacturing cost plus ***. Noven's fully loaded manufacturing cost shall be calculated in accordance with Section 4.03 below. A non-binding estimate of the price for the first year of commercial supply of the U.S. Product, together with a detailed allocation of the calculation of each component of Noven's fully loaded manufacturing costs, is set forth on Schedule 4.02. Noven shall provide Endo with a similar estimate within 30 days of the beginning of each subsequent contract year. The transfer price for the Product charged to Endo in each Invoice will be based on good faith estimates by Noven of the actual fully loaded manufacturing cost of Product. Semi-annually Noven shall reconcile the amount invoiced to Endo and paid by Endo with Noven's actual fully loaded manufacturing cost. Noven shall provide a copy of each reconciliation to Endo. To the extent that Noven has overcharged Endo, Noven shall credit to Endo all amounts overcharged. To the extent that Noven has undercharged Endo, Noven shall invoice Endo for the undercharged amount in accordance with the terms of this Agreement. In the event of a dispute between Endo and Noven as to the proper calculation of the Product Price, such dispute shall be referred to an independent accounting firm mutually agreeable to the parties per Section 6.01 below, whose opinion shall be final and binding. 10 Section 4.03. LIMIT ON OVERHEAD ALLOCATION. For purposes of determining Noven's fully loaded manufacturing cost of Product supplied to Endo hereunder, Noven shall include Noven's actual cost of materials and labor and an allocation of Noven's total manufacturing overhead. This allocation shall be determined using the same methodology Noven uses in determining its cost of goods for the other products it manufactures, all in accordance with GAAP consistently applied, but subject to the further limitations described in this Section 4.03. For the ***, provided that the total units shipped in such period are within the range set forth in Schedule 4.03, Noven shall allocate between *** (the "Collar") of overhead to its Product manufacturing cost. For each succeeding *** period, the Collar shall be adjusted by the change in the Producer Price Index (Pharmaceutical Preparations, ethical PCU2834#), published by the United States Department of Labor, Bureau of Labor Statistics, or comparable successor index, again provided that the total units shipped in each such period are within the range set forth in Schedule 4.03. To the extent that the total units actually shipped to Endo in any contract year fall outside of the range set forth in Schedule 4.03, the corresponding upper or lower limit of the collar will be adjusted by a percentage equal to *** of the percentage increase or decrease in shipments. For example, if Noven's shipments in a contract year were *** higher than the highest amount forecast in Schedule 4.03, the then existing upper limit of the collar would be increased by ***. If Noven's shipments in a contract year were *** lower than the lowest amount forecast in Schedule 4.03, then the lower limit of the collar would be reduced by ***. ARTICLE V MANUFACTURING STANDARDS AND QUALITY ASSURANCE Section 5.01. PRODUCT WARRANTIES. Noven hereby covenants and agrees that: (a) Noven will manufacture and deliver to Endo the Product in accordance with, and the Product will conform with, the Specifications and the Quality Agreement; all Product supplied by Noven to Endo shall be manufactured, packaged, tested, stored and handled in accordance with the then current version of the ANDA and shall not be adulterated or misbranded. (b) Noven will comply with all Applicable Laws and current good manufacturing practices relating to the Product. (c) All Product supplied by Noven hereunder shall be transferred to Endo free and clear of all liens, title claims, encumbrances and security interests. (d) Except for Product manufactured before final approval of the Product in fulfillment of Endo orders for Launch Quantities, all Product supplied by Noven shall have a minimum of *** of the shelf life set forth in the applicable Product registration still available at the time of delivery to Endo. Section 5.02. THE SPECIFICATIONS. Endo or Noven shall not change the Specifications at any time without the prior written consent of the other party; provided, however, that either party may change the Specifications upon reasonable advance notice to the other party if such change is required by an applicable Regulatory Authority. 11 Section 5.03. QUALITY AGREEMENT. Contemporaneously with the execution of this Agreement, the parties are entering into a Quality Agreement which is attached hereto as Exhibit B. Section 5.03. DISCLAIMER. NOVEN HEREBY DISCLAIMS ALL WARRANTIES NOT EXPRESSLY PROVIDED IN THIS AGREEMENT, INCLUDING ANY IMPLIED WARRANTIES, INCLUDING WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE AND WARRANTIES OF MERCHANTABILITY. ARTICLE VI AUDITS AND INSPECTION RIGHT'S Section 6.01. RECORDS AND AUDITS. Noven shall keep complete and accurate records concerning its manufacturing costs and any other costs and expenses relevant to the amounts payable to Noven hereunder. Such records shall be kept in accordance with GAAP applied on a consistent basis. Noven shall, at Endo's request and expense, make those records available during normal business hours upon ten (10) business days prior written notice for examination by independent certified public accountants or auditors designated by Endo and reasonably acceptable to Noven; PROVIDED, that Endo shall only have access to such records once in each calendar year. In the event an underpayment or overpayment is discovered, the applicable party shall make payment to the other of the respective amount within 15 days of notification of the determination. In the event that an overpayment by Endo of greater than 5% is discovered, the cost of such audit shall be borne by Noven. Notwithstanding any provision in this Agreement to the contrary, the terms of the Quality Agreement will govern all quality assurance inspections. ARTICLE VII ADDITIONAL COVENANTS AND AGREEMENTS OF THE PARTIES Section 7.01. CONFIDENTIALITY. The parties hereby agree that the terms and conditions of this Agreement and each party's activities hereunder shall be subject to the confidentiality obligations (and all applicable exceptions thereto) set forth in the License Agreement. Section 7.02. PACKAGING AND LABELING. All Products supplied hereunder shall be in finished dosage form, packaged and Labeled for commercial sale in accordance with the terms and conditions of this Agreement, the Specifications and applicable Laws. Subject to the provisions of this Section 2.03, Endo shall control the content and type of all Labeling for the Products. Endo shall supply to Noven, in a timely fashion, all artwork required to Label the Products with such trademarks, logos or designs as Endo shall select and in accordance with Applicable Laws. Noven shall have the responsibility for: (i) securing any approvals required by the FDA or other applicable Regulatory Authorities for the initial Label; (ii) securing any approvals required by the FDA or other applicable Regulatory Authorities for any changes or supplements to the Labeling requested by Endo following regulatory approval of the Product ANDA, provided that Noven is the holder of the Product ANDA at such time; and (iii) any Noven information on the Label which shall be approved in advance by Noven. In the event that Endo wishes to modify or change the Label, Endo shall provide reasonable advance notice of 12 such desired change to Noven and forward such modifications or changes to Noven for Noven's review and approval (which shall not be unreasonably withheld). Section 7.03. PRODUCT RECALL. Product recalls shall be conducted in accordance with the terms of the Quality Agreement. Each of Noven and Endo shall make a permanent, complete and accurate record of all costs incurred by its connection with any Product recall, a copy of which shall be delivered to the other party upon its request as soon after the completion of such recall or seizure as practically may be done. If the cause of, or reason for, said recall is attributable to any reason beyond the reasonable control of the parties, the total cost of the recall to the parties shall be shared equally among the parties. If the cause of, or reason for, said recall or seizure arises is both not attributable to reasons beyond the reasonable control of the parties and is attributable to the negligence or breach of this Agreement by a party hereto, such party shall reimburse the other for all reasonable costs incurred by it in effecting such recall or seizure. If Noven and Endo cannot agree which party is at fault or whether the recall was reasonably beyond the control of the parties, then an independent technical expert, acceptable to both, will be designated to make the determination. The so designated technical expert shall not be an employee, consultant, officer, director or shareholder of or otherwise associated with any party or an Affiliate of any party. The technical expert's determination shall be, in the absence of fraud or manifest error, binding and conclusive upon the parties. Section 7.04 PRODUCT SHELF LIFE. Noven shall use commercially reasonable efforts to obtain *** expiration dating, and will to continue to use such efforts even if the Product is initially approved by the FDA with less than *** expiration dating. ARTICLE VIII REPRESENTATIONS AND WARRANTIES Section 8.01. REPRESENTATIONS AND WARRANTIES. Each party hereby represents and warrants to the other that as of the Effective Date: (a) ORGANIZATION. It is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation. As of the Closing Date, it will be duly qualified to do business in each jurisdiction where the character of its business (after giving effect to the Contemplated Transactions) make such qualifications necessary to carry on its business. (b) POWER, AUTHORITY AND ENFORCEABILITY. It has full corporate power and authority to enter into and perform this Agreement and to consummate the transactions contemplated herein. This Agreement has been or shall be duly executed and delivered by duly authorized signatories. This Agreement constitutes a valid and binding obligation, enforceable against it in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or other similar laws now or hereafter in effect relating to or affecting creditors' rights generally. (c) NO VIOLATION. Neither the execution and delivery of this Agreement nor the consummation by it of the transactions contemplated hereby, will (i) conflict with or result in a breach of any of the terms, conditions or provisions of its certificate of incorporation or other 13 governing or charter document, or of any statute or administrative regulation, or, to the best of its knowledge, of any order, writ, injunction, judgment or decree of any court or Governmental Authority or of any arbitration award or any agreement binding upon it or its assets, or (ii) to the best of its knowledge, contravene or conflict with, or constitute a violation of, any provisions of any Applicable Law binding upon it. (d) NO DEFAULT. It is not a party to any unexpired, undischarged or unsatisfied written of oral contract, agreement, indenture, mortgage, debenture, note or other instrument under the terms of which performance by it according to the terms of this Agreement will be a default, or whereby timely performance by it according to the terms of this Agreement may be prohibited or delayed. ARTICLE IX INDEMNIFICATION AND LIMITATION OF LIABILITY Section 9.01 INDEMNIFICATION. Indemnification for activities related to this Agreement shall be provided pursuant to the License Agreement between the parties entered into on the same date. Section 9.02. LIMITATION OF LIABILITY. NO PARTY SHALL BE ENTITLED TO RECOVER ANY PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS FROM LOST SALES TO THIRD PARTIES) WHATSOEVER UNDER THIS AGREEMENT EXCEPT TO THE EXTENT ANY SUCH PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES SHALL BE PAYABLE TO A THIRD PARTY. Section 9.03 WAIVER OF LIMITATION OF LIABILITY. In the event that that there is a Change in Control (as defined in the License Agreement) which results in Noven being acquired or controlled by an entity with a Competing Product (as defined in the License Agreement) and Noven has not qualified a second source of supply with an independent third party pursuant to a supply agreement which allows Endo to immediately purchase its requirements of Product directly from such third party upon the same terms as Noven in the event of (i) Noven's bankruptcy or insolvency or (ii) a Change in Control of Noven to an entity with a Competing Product, then the limitation of liability set forth in Section 9.02 shall not apply to any breach of this Agreement by Noven or its successors and assigns. ARTICLE X TERM AND TERMINATION Section 10.01. TERM. This Agreement shall continue in full force and effect until the earlier of (a) the termination of the License Agreement, or (b) termination of this Agreement in accordance with Section 10.02 (the Effective Date until such termination, the "TERM"). 14 Section 10.02. CERTAIN TERMINATION EVENTS. (a) Except as otherwise contemplated by Sections 3.05 and 10.02(c), either Noven or Endo shall have the right to terminate this Agreement if the other commits any continuing or material breach of any of the provisions of this Agreement and (in the case of a breach which is capable of remedy) fails to remedy the same within 60 days after receipt of written notice giving full particulars of the breach and requiring it to be so remedied; (b) In the event that at any time during the Term Noven shall, (i) during any period of six consecutive months, fail to supply at least *** of the aggregate number of units of Product (which number of units shall be determined with reference to the number of units estimated to be yielded by each Batch ordered by Endo as reflected in Exhibit A) ordered pursuant to Purchase Orders properly submitted by Endo during such period (other than by reason of the fault of Endo), or (ii) fail to provide *** of the aggregate number of units of Product ordered during any two separate periods of three consecutive months, Endo shall (A) have the right to terminate its obligation to exclusively purchase Product from Noven and have a third party manufacture on its behalf the Product to supply and (B) have the right to withdraw any purchase orders submitted to Noven for amounts in excess of Noven's ability to supply. (c) Either party may terminate this Agreement with immediate effect if the Product is withdrawn from the market in the Territory for serious adverse health or safety reasons. (d) Either Noven or Endo may terminate this Agreement with immediate effect in the event a Force Majeure Event as to the other shall exist and be continuing for a period of 120 consecutive days. (e) Noven may terminate its obligation to supply Endo with its requirements of Product under this Agreement upon twenty-four months notice in the event that Noven's gross margins on the manufacture of Product (taking into account all Endo payments hereunder and under the License Agreement in calculating such margins--except for the milestone payments) drops to less than *** of its fully allocated manufacturing cost for the Product in two consecutive calendar quarters. Such termination notice shall contain the election of Noven to either (1) continue to be paid its share of the Gross Margin per the License Agreement, or (ii) be paid its fully loaded manufacturing costs plus *** for Product, during the period following the notice until Noven no longer supplies Product hereunder, in exchange for the immediate and permanent termination of any and all gross margin splits and royalty obligations otherwise due and payable pursuant to the License Agreement. Noven agrees to provide the technical transfer services set forth in Schedule 10.02 (the "Tech Transfer Services"), including the delivery to Endo of the Technical Transfer Documentation Package within *** of the termination notice and completion of the transfer of all analytical methods within *** of the termination notice. The termination by Noven shall become effective *** following receipt of the notice by Endo, provided, however, that the effective date of the termination shall be extended by each day of delay in excess of the corresponding time periods set forth above which it takes Noven to complete the transfer of the Technical Transfer Documentation Package and the analytical methods. The manufacturing period, however, shall not be extended to the extent such delay occurs through no fault of Noven. To the extent that such alternative manufacturer would need to use technology owned by, or 15 protected by intellectual property owned by, Noven, access to such technology would be provided on limited basis and restricted solely to use for the manufacture of Product. (f) In the event of a termination by Endo pursuant to Section 10.02 (a), (b) or (d), Noven agrees to work in good faith with Endo to qualify a suitable alternative manufacturer for the Product that has been identified by Endo and that agrees to undertake such manufacturing. Endo agrees to work in good faith with Noven regarding such transfer and ensure that the third party works in good faith with Noven as well. Noven shall, as promptly as is reasonably practicable, perform the Tech Transfer Services. In the event the delivery to Endo of the Technical Transfer Documentation Package is completed within *** of the termination notice and the transfer of all analytical methods is completed within *** of the termination notice, or such time periods are exceeded due to no fault of Noven, Endo shall reimburse Noven for the time of its technical staff in performing such transfer at the rate of *** and all reasonable travel expenses pre-approved by Endo. In the event that such services are not completed within such time periods due to the fault of Noven, Endo will reimburse Noven its reasonable pre-approved travel expenses in full but shall have no other payment obligation for the technology transfer. To the extent that such alternative manufacturer would need to use technology owned by, or protected by intellectual property owned by, Noven, access to such technology would be provided on limited basis and restricted solely to use for the manufacture of Product. Section 10.04. OBLIGATIONS ON TERMINATION. Within 30 days of any expiration or termination of this Agreement other than a termination by Endo pursuant to Section 10.02 (a), (b) or (d), or a termination by Noven pursuant to Section 10.02 (e), (i) Endo shall cease to use and shall deliver to Noven, upon written request, all Confidential Information of Noven, except for any documents or records that Endo is required to retain by Applicable Law, and (ii) Noven shall cease to use and shall deliver to Endo, upon written request, all Confidential Information of Endo except for any documents or records that Noven is required to retain by Applicable Law. In the event of a termination by Endo pursuant to Section 10.02 (a), (b) or (d), a termination by Noven pursuant to Section 10.02 (e), Endo shall be permitted to retain and use the Confidential Information in the manufacture of the Product, and to disclose such Confidential Information to its third party manufacturer, provided that such third party manufacturer is under obligations of confidentiality no less stringent than this Agreement. Section 10.05. EFFECT OF TERMINATION. Upon termination, this Agreement shall forthwith become void and of no further force or effect, except for the following provisions, which shall remain in full force and effect: (a) Section 7.01 (Confidentiality), (b) this Article 10, (c) Section 11.9 (Governing Law), (d) Section 11.11 (Entire Agreement), and (e) Section 11.12 (Expenses) and any other provisions which expressly survive termination. The rights and remedies provided in this Article X shall be cumulative and not exclusive of any rights or remedies provided by Applicable Law. Any termination of this Agreement shall not affect any right or claim hereunder that arises prior to such termination, which claims and rights shall survive any such termination. 16 ARTICLE XI MISCELLANEOUS Section 11.01. NOTICES. All notices, claims, certificates, requests, demands and other communications hereunder shall be in writing and shall be delivered personally or sent by confirmed facsimile transmission, air courier or registered or certified mail, return receipt requested, addressed as follows: if to Noven: Noven Pharmaceuticals, Inc. 11960 S. W. 144th Street Miami, Florida 33186 Attention: CEO & General Counsel Telecopy: 305-964-3340 with copies (which shall not constitute notice) to: Frommer Lawrence & Haug LLP 745 Fifth Avenue New York, New York 10151 Attention: Edgar H. Haug, Esq. Telecopy: 212-588-0500 if to Endo: Endo Pharmaceuticals Inc. 100 Painters Dr. Chadds Ford, PA 19317 Attention: General Counsel Telecopy: 610-558-9684 or to such other address as the party to whom notice is to be given may have furnished to the other party in writing in accordance herewith. Any such communication shall be deemed to have been delivered (a) when delivered, if delivered personally, by air courier or by mail, (b) when sent (with written confirmation received), if sent by facsimile transmission on a Business Day, (c) on the first Business Day after dispatch (with written confirmation received), if sent by facsimile transmission on a day other than a Business Day. Section 11.02. INDEPENDENT CONTRACTORS. In making and performing this Agreement, the parties are acting and shall act as independent contractors. Nothing in this Agreement shall be deemed to create an agency, joint venture or partnership relationship between the parties hereto. No party shall have the authority to obligate another party in any respect, and no party shall hold itself out as having any such authority. All personnel of Noven shall be solely employees of Noven and shall not represent themselves as employees of Endo. All personnel of Endo shall be solely employees of Endo and shall not represent themselves as employees of Noven. 17 Section 11.03. ASSIGNMENT. Noven shall not have the right to assign this Agreement or delegate any of its rights, interests duties or obligations hereunder without the prior written consent of Endo, which consent shall not be unreasonably withheld. Notwithstanding the foregoing, at any time during the term of this Agreement either party may assign this Agreement to any of its Affiliates without the prior written consent of the other parties; PROVIDED, that no such assignment of this Agreement shall relieve the assignor of any of its obligations or liabilities under this Agreement. Notwithstanding the foregoing, any party may assign this Agreement without the other parties' prior written consent in connection with the transfer or sale of all or substantially all of its assets or business or its merger or consolidation with another Person upon written notice to the other parties. Any attempted assignment in violation of this Section 11.04 shall be void. Section 11.04. BINDING EFFECT; BENEFIT. This Agreement shall inure to the benefit of and be binding upon the parties hereto and their successors and permitted assigns. Nothing in this Agreement, express or implied, is intended to confer on any Person other than the parties hereto and their respective successors and permitted assigns any rights, remedies, obligations or liabilities under or by reason of this Agreement. Section 11.05. AMENDMENTS. This Agreement shall not be modified, amended or supplemented except pursuant to an instrument in writing executed and delivered on behalf of each of the parties hereto. Section 11.06. NO WAIVER. The failure in any one or more instances of a party to insist upon performance of any of the terms, covenants or conditions of this AGreement, to exercise any right or privilege conferred in this Agreement, or the waiver by said party of any breach of any of the terms, covenants or conditions of this Agreement, shall not be construed as a subsequent waiver of any such terms, covenants, conditions, rights or privileges, but the same shall continue and remain in full force and effect as if no such forbearance or waiver had occurred. No waiver shall be effective unless it is in writing and signed by an authorized representative of the waiving party. Section 11.07. COUNTERPARTS. This Agreement shall become binding when any one or more counterparts hereof, individually or taken together, shall bear the signatures of each of the parties hereto. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original as against the party whose signature appears thereon, but all of which taken together shall constitute but one and the same instrument. Each party may execute this Agreement on a facsimile of the Agreement. In addition, facsimile signatures of authorized signatories of any party shall be valid and binding and delivery of a facsimile signature by any party shall constitute due execution and delivery of this Agreement. Section 11.08. INTERPRETATION. The article and section headings contained in this Agreement are for convenience of reference only and shall not affect the meaning or interpretation of this Agreement. As used fit this Agreement, any reference to the masculine, feminine or neuter gender shall include all genders, the plural shall include the singular, and singular shall include the plural. Unless the context otherwise requires, the term "party" when used herein means a party hereto. References herein to a party or other Person include their 18 respective successors and assigns. The words "include," "includes" and "including" when used herein shall be deemed to the followed by the phrase "without limitation" unless such phrase otherwise appears. Unless the context otherwise requires, references herein to Articles, Sections, Exhibits and Schedules shall be deemed references to Articles and Sections of, and Exhibits and Schedules to, this Agreement. Unless the context otherwise requires, the words "hereof," "hereby" and "herein" and words of similar meaning when used in this Agreement refer to this Agreement in its entirety and not to any particular Article, Section or provision hereof. With regard to each and every term and condition of this Agreement, the parties understand and agree that the same have or has been mutually negotiated, prepared and drafted, and that if at any time the parties desire or are required to interpret or construe any such term or condition or any agreement or instrument subject thereto, no consideration shall be given to the issue of which party actually prepared, drafted or requested any term or condition of this Agreement. Section 11.9. GOVERNING LAW. This Agreement and any claims, disputes or causes of action relating to or arising out of this Agreement shall be construed in accordance with and governed by the substantive laws of the State of New York, without giving effect to the conflict of laws principles thereof. Section 11.10. UNENFORCEABILITY. If any provisions of this Agreement are determined to be invalid or unenforceable in any jurisdiction, such provisions shall be ineffective to the extent of such invalidity or unenforceability in such jurisdiction, without rendering invalid or unenforceable the remaining provisions hereof or affecting the validity or enforceability of any of such provisions of this Agreement in any other jurisdiction. The parties will use their best efforts to substitute the invalid or unenforceable provision with a valid and enforceable one which conforms, as nearly as possible, with the original intent of the parties. Section 11.11. ENTIRE AGREEMENT. This Agreement, together with any and all schedules, exhibits and appendices hereto, embodies the entire agreement and understanding between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements, commitments, arrangements, negotiations or understandings, whether oral or written, between the parties hereto and their respective Affiliates with respect thereto. There are no agreements, covenants or undertakings with respect to the subject matter of this Agreement other than those expressly set forth or referred to herein and no representations or warranties of any kind of nature whatsoever, express or implied, are made or shall be deemed to be made herein by the parties hereto, except those expressly made in this Agreement and the other Transaction Documents. Section 11.12. EXPENSES. Except as expressly set forth herein, each party hereto shall bear all fees and expenses incurred by such party in connection with, relating to or arising out of the execution, delivery and performance of this Agreement and the consummation of the Contemplated Transactions, including attorneys', accountants' and other professional fees and expenses. Section 11.13. FORCE MAJEURE. If the performance of this Agreement or any obligation hereunder (except the payment of money) by any party is prevented or hindered, by reason of any cause beyond the reasonable control of the affected party, including fire, flood, riot, war, explosions, acts of God (including hurricanes and tropical storms), acts of a public enemy, delay 19 of carrier, shortage or failure in the supply of materials, labor disturbance or acts, regulations or laws of any government adopted after the date of this Agreement or subject to a new interpretation after the date of this Agreement that render impossible or illegal the performance by a Party of its obligations under this Agreement (a "FORCE MAJEURE EVENT"), the party so affected, upon notice to the other parties, shall be excused from such performance, provided that the party so affected shall use diligent effort to avoid or remove such cause or causes of non-performance and shall continue to perform hereunder with the utmost dispatch whenever such cause or causes are removed. Section 11.14. INSURANCE. Throughout the Term, each of Noven and Endo shall maintain commercial liability insurance, including blanket commercial liability insurance covering the obligation of that party under this Agreement through the term of this Agreement and for five years thereafter, which insurance shall afford limits of not less than US$10,000,000 per occurrence, (and in the aggregate only with respect to personal injury liability) for bodily injury liability, products liability, property damage liability, contractual liability and completed operations liability with an insurance carrier qualified to do business in the United States. Each of Noven and Endo shall promptly furnish to the other evidence of the maintenance of the insurance required hereunder and shall name the other as an "additional insured" under a broad form vendor's endorsement to such insurance policy. In case any such policies are written on a "claims made" basis, such policies shall remain in effect for a period of five years following the expiration or earlier termination of this Agreement. Notwithstanding the foregoing, the obligation of each of Noven and Endo to obtain insurance in accordance with this Section 7.04 is subject to the availability of such insurance from nationally recognized carriers at reasonable rates and on reasonable terms and conditions, which reasonableness shall be determined in the judgment of each party, respectively, in accordance with such party's past practices to the ordinary course of business. In the event either party shall be unable to obtain insurance as contemplated by this Section 7.04, such party shall notify the other party as soon as practicable and shall have the right to self-insure such coverage; PROVIDED that any party opting to so self-insure shall provide to the other party reasonable information regarding its self-insurance program. Section 11.15. NO DEBARRED PERSONS. Each of Noven and Endo covenants and agrees that it has not and will not use in any capacity the services of any Person debarred under subsections (a) or (b) of Section 306 of the FDC Act in connection with its performance of this Agreement. 20 IN WITNESS WHEREOF, the parties hereto have entered into this Agreement effective as of the Effective Date. NOVEN PHARMACEUTICALS, INC. ENDO PHARMACEUTICALS INC. By: /s/ ROBERT C. STRAUSS By: /s/ PETER A. LANKAU ----------------------------- -------------------------------------- Name: Robert C. Strauss Name: Peter A. Lankau Title: President, CEO and Chairman Title: President and CEO Date: February 25, 2004 Date: February 25, 2004 21 EX-31.1 4 g90077exv31w1.htm CERTIFICATION PURSUANT SECTION 302 CERTIFICATION PURSUANT SECTION 302
 

Exhibit 31.1

Certifications

Certification of Principal Executive Officer

I, Robert C. Strauss, President, Chief Executive Officer and Chairman of the Board of Noven Pharmaceuticals, Inc., certify that:

1) I have reviewed this annual report on Form 10-K of Noven Pharmaceuticals, 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;

/s/ Robert C. Strauss


Name: Robert C. Strauss
Title: President, Chief Executive Officer and Chairman of the Board
Date: July 23, 2004

 

EX-31.2 5 g90077exv31w2.htm CERTIFICATION PURSUANT SECTION 302 CERTIFICATION PURSUANT SECTINO 302
 

Exhibit 31.2

Certifications

Certification of Principal Financial Officer

I, Diane M. Barrett, Vice President and Chief Financial Officer of Noven Pharmaceuticals, Inc., certify that:

1) I have reviewed this annual report on Form 10-K of Noven Pharmaceuticals, 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;

/s/ Diane M. Barrett


Name: Diane M. Barrett
Title: Vice President and Chief Financial Officer
Date: July 23, 2004

 

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