CO-Promotion Agreement (2005)Full Document 

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CO-PROMOTION AGREEMENT

 

BY AND BETWEEN

 

SOLVAY PHARMACEUTICALS INC.

 

AND

 

CV THERAPEUTICS, INC.

 

December 6, 2004

 

Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [*]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 


 

TABLE OF CONTENTS

 

               Page

1.

   Definitions    5

2.

   Governance and Business Plan    11
     2.1    Joint Steering Committee    11
     2.2    Joint Commercialization Committee    11
     2.3    Working Groups    12
     2.4    Business Plan    13

3.

   Appointment and Obligations    14
     3.1    Exclusive Co-Promotion Arrangement    14
     3.2    Change of Exclusivity    14
     3.3    Undertaking by CV Therapeutics not to Compete    15
     3.4    Co-Promotion Obligations    15
     3.5    Responsibilities of the Parties    19
     3.6    Ownership of Product    23
     3.7    Patents    24
     3.8    No Distribution by CV Therapeutics    24

4.

   Compensation    24
     4.1    Compensation Arrangement    24
     4.2    Payment Terms    28

5.

   Record Keeping; Reporting and Audits    29
     5.1    Details and Samples    29
     5.2    Compensation Payments    29
     5.3    Manufacturing Costs for Samples Provided to CV Therapeutics    29
     5.4    Financial Audit Rights    29
     5.5    Monthly and Quarterly Reports    30

6.

   Relationship and Publicity    31
     6.1    Relationship of Parties    31
     6.2    Public Announcements    32
     6.3    Publications    32

7.

   Regulatory Compliance    32
     7.1    Marketing Authorization and Regulatory Matters    32
     7.2    Recalls    33

 


     7.3    Returns    33
     7.4    General; Adverse Drug Experiences and Product Complaints; Product Audits    33
     7.5    Product Inquiries    34
     7.6    Communications with FDA    34
     7.7    Additional Responsibilities of the Parties    34
     7.8    Reports relating to Coversyl    35

8.

   Representations and Warranties    35
     8.1    Mutual Representations and Warranties    35
     8.2    Representations and Warranties of Solvay    36

9.

   Indemnification and Insurance    36
     9.1    Indemnification by CV Therapeutics    36
     9.2    Indemnification by Solvay    37
     9.3    Defense of Actions; Settlements    37
     9.4    Limitation of Liability    38
     9.5    Insurance    38

10.

   Term and Termination    38
     10.1    Term    38
     10.2    Termination for Cause    38
     10.3    Termination Without Cause    39
     10.4    Mutual Termination    39
     10.5    Effect of Termination    39

11.

   Samples    40
     11.1    Provision of Samples    40
     11.2    Shipping of Samples    40
     11.3    Compliance with PDMA    41
     11.4    Additional Requirements    42
     11.5    No-Recruitment    42

12.

   Confidentiality    42
     12.1    Requirements    42
     12.2    Confidential Information    42
     12.3    Disclosure Required by Law    43
     12.4    Return of Confidential Information    43
     12.5    Disclosure of Agreement    43

13.

   Miscellaneous    44
     13.1    Force Majeure    44

 


     13.2    Severability    44
     13.3    Assignment    44
     13.4    Modifications and Amendments    44
     13.5    Notices    44
     13.6    Governing Law    45
     13.7    Waiver    45
     13.8    No Agency    45
     13.9    Survival of Certain Provisions    45
     13.10    Headings    45
     13.11    Counterparts    45
     13.12    Entire Agreement    45

FOR IMMEDIATE RELEASE

   57

 

EXHIBITS

 

Exhibit A – Average Sales Price and Net Sales (As of [*])

 

Exhibit B – Business Plan Outline

 

Exhibit C – Safety Agreement

 

Exhibit D – Physician Samples Cost

 

Exhibit E – Draft Press Release


* Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


 

CO-PROMOTION AGREEMENT

 

This Co-Promotion Agreement (the “Co-Promotion Agreement” or this “Agreement”), dated December 6, 2004 (the “Effective Date”), is made by and between Solvay Pharmaceuticals Inc., a corporation organized and existing under the laws of the State Georgia and having a principal place of business at 901 Sawyer Road, Marietta, Georgia 30062, U.S.A. (“Solvay”), and CV Therapeutics, Inc., a corporation organized and existing under the laws of the State of Delaware and having a principal place of business at 3172 Porter Drive, Palo Alto, California 94304, U.S.A. (“CV Therapeutics”).

 

RECITALS

 

1. Solvay has certain marketing and proprietary rights to the Product (as defined below);

 

2. Solvay and CV Therapeutics each have an internal sales and marketing organization to promote certain products to physicians and other health care professionals; and

 

3. Solvay and CV Therapeutics desire to share in marketing the Product by co-promoting and co-detailing the Product to selected physicians and other health care professionals within the Territory (as defined below) upon the terms and conditions contained herein.

 

Now, therefore, in consideration of the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereto agree as follows:

 

1. Definitions. As used in this Agreement, the following capitalized terms have the following meanings:

 

1.1 “Affiliate” of any Party means any Person, directly or indirectly, controlling, controlled by or under common control with the Party. For purposes of this definition, “control” means (a) in the case of corporate entities, direct or indirect ownership of more than fifty percent (50%) of the stock or shares having the right to vote for the election of directors and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of the non-corporate entity, provided, however, that for purposes of this Agreement, the term “Affiliate” shall not include subsidiaries in which a Party or its Affiliates owns a majority of the ordinary voting power to elect a majority of the Board of Directors, but is restricted from electing such a majority by contract or otherwise, until such time as such restrictions are no longer in effect.

 

1.2 “Alliance Manager” as to either of Solvay or CV Therapeutics, as the case may be, means a full time, senior level employee of either Solvay or CV Therapeutics, as the case may be, having primary oversight responsibility for the implementation of that Party’s obligations under this Agreement.

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