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Exhibit 10.3

 

***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. Section 200.80(b)(4)
And 240.24b-2

 

Addendum to September 19, 2002

 

U.S. Co-Promotion Agreement

 

by and between

 

Amylin Pharmaceuticals, Inc.

 

and

 

Eli Lilly and Company

 

Addendum Effective as of

 

May 8th, 2008

 



 

ADDENDUM TO U.S. CO-PROMOTION AGREEMENT

 

This Addendum to the U.S. Co-Promotion Agreement (the “Addendum”) is made effective as of the 8 th day of May, 2008 (the “Effective Date”) by and between Amylin Pharmaceuticals, Inc. (“Amylin”), a Delaware corporation having its principal place of business at 9360 Towne Center Drive, San Diego, California, 92121.

 

and

 

Eli Lilly and Company, an Indiana corporation having its principal place of business at Lilly Corporate Center, Indianapolis, Indiana, 46285 (“Lilly”).

 

RECITALS:

 

Whereas, Amylin and Lilly are parties to a Collaboration Agreement dated September 19, 2002 (the “Collaboration Agreement”), regarding the development and commercialization of Product, and U.S. Co-Promotion Agreement (“Co-Promotion Agreement”) dated September 19, 2002, regarding the promotion of Product;

 

Whereas, Lilly desires to engage, PharmaBio Development, Inc d/b/a NovaQuest, having its principal place of business at 4709 Creekstone Dr., Durham NC 37703 (hereinafter “NovaQuest”) to provide contract sales services for the Product.

 

Whereas, the Parties are entering into this Addendum to set forth the terms and conditions of Lilly’s engagement of NovaQuest to promote Product pursuant to the terms and conditions of the Co-Promotion Agreement.

 

NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants contained in this Addendum, the Parties agree as follows:

 

Amylin and Lilly wish to append certain additional rights and obligations for each Party in addition to the Party’s respective rights and obligations under the Co-Promotion Agreement.  To the extent not otherwise modified in this Addendum, the rights and obligations of each Party under the Co-Promotion Agreement shall continue in full force and effect.

 

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ARTICLE I

 

DEFINITIONS

 

As used herein, the following terms shall have the meanings indicated and any capitalized terms used herein and not defined herein shall have the meanings provided in the Co-Promotion Agreement:

 

“Co-Promotion Start Date” shall mean the date on which the NovaQuest’s Sales Force has received training on the Product in accordance with this Addendum and begins making NovaQuest Details, which shall be not later than July 1, 2008.

 

“NovaQuest Detail” means a face to face presentation by a representative of the NovaQuest sales force to a healthcare professional in a setting appropriate for a meaningful medical dialogue during which presentation such representative makes a Secondary Detail relating to Product.  A delivery of Samples does not constitute a NovaQuest Detail.

 

 “Sample” shall mean quantities of Product or vouchers allowing patients to acquire Product at no charge given to authorized medical professionals for no or minimal consideration as part of the marketing, advertising and promotion of the Product.

 

“Third Priority Product”  means the third priority pharmaceutical product for which a sales representative is expected to present the uses and benefits after presenting the First Priority Product and Second Priority Product in his or her face-to-face meetings with health care professionals during which he or she presents the uses and benefits of pharmaceutical products.

 

U.S. Ops” shall mean the committee established by Amylin and Lilly as the successor, in part, of the responsibilities and obligations of the JCC.

 

ARTICLE II

 

USE OF NOVAQUEST BY LILLY

 

2.1                                Product Promotion by NovaQuest.

 

Pursuant to Section 2.3(d) of the Co-Promotion Agreement, Amylin hereby consents to Lilly’s engagement of NovaQuest as a CSO to help fulfill Product detail obligations in the Co-Promotion Territory; provided, however that Lilly shall remain liable and responsible for the performance and observance of all its duties and obligations under the Co-Promotion Agreement and the obligations of NovaQuest pursuant to this Addendum.

 

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2.2                                Compliance with Law by NovaQuest.

 

Lilly represents and warrants that NovaQuest will have prior to the Effective Date agreed that they shall comply with all applicable laws, rules and regulations including, but not limited to the Federal Equal Employment Opportunity Act, Title VII of the Civil Rights Act of 1964, the Age Discrimination in Employment Act, the Americans with Disabilities Act, the Fair Labor Standards Act, the Immigration Reform and Control Act of 1986, the Food, Drug and Cosmetic Act, Section 1128B(b) of the Social Security Act (42 U.S.C.§ 1320(a)-7(b(b), the Prescription Drug Marketing Act . NovaQuest prior to the Effective Date will agree to and shall comply with all applicable data protection laws and regulations, including without limitation, the Health Insurance Portability and Accountability Act (HIPAA) Privacy Regulations. Further, Lilly represents and warrants that NovaQuest prior to the Effective Date will have certified to Lilly that it has not and will not use in any capacity (either directly or through subcontractors) the services of any person debarred under the Generic Drug Enforcement Act of 1992 (GDEA) (specifically, under 21 USC 335a) in connection with services provided on behalf of Lilly during the term of this Addendum.

 

2.3                                Compliance with Agreements and Policies by NovaQuest.

 

Lilly shall ensure that NovaQuest, in carrying out its responsibilities and activities under this Addendum on behalf of Lilly, complies with the terms and conditions of the Co-Promotion Agreement and Collaboration Agreement as applicable and any applicable company policies outlined by the Parties.  NovaQuest’s breach of imposed duties and obligations shall be deemed to be Lilly’s breach of the Co-Promotion Agreement and/or Collaboration Agreement as applicable for purposes of this Addendum.

 

2.4                                NovaQuest Sales Force.

 

NovaQuest currently has a sales force of sales representatives, district managers and regional sales directors dedicated to promoting products on behalf of Lilly. (“NovaQuest Sales Force”).  Under this Addendum, the Parties agree that Lilly will engage NovaQuest to help fulfill Product detail obligations pursuant to the Co-Promotion Agreement and Collaboration Agreement

 

(a)                                   Lilly shall cause the NovaQuest Sales Force to Detail Product in the Co-Promotion Territory to Targeted Physicians in accordance with the Promotion Plan and the strategies established by US Ops.   Lilly will be responsible for general sales training and Product related sales training of the NovaQuest Sales Force in accordance with the procedures established by US Ops.  Lilly shall cause NovaQuest not to hold their own sales force meetings regarding Product.

 

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(b)                                  Lilly will use its Commercially Reasonable Efforts to ensure that variable pay components of NovaQuest’s compensation structure, including but not limited to incentives, for the NovaQuest Sales Force is consistent with the NovaQuest Detail position the Parties have agreed upon for Product with such sales force.  The NovaQuest Detail position of Products addressed herein and incentive weigh


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