MANUFACTURING AND PACKAGING AGREEMENT
This Manufacturing and Packaging Agreement (Agreement) is made this 14th day of April, 2005, by and between Cardinal Health PTS, LLC, having a place of business at 2725 Scherer Drive, St Petersburg, Florida 33716 (Cardinal Health) and Reliant Pharmaceuticals, Inc. (Reliant), having its principal place of business at 110 Allen Road, Liberty Corner, New Jersey 07938.
BACKGROUND
Cardinal Health provides contract pharmaceutical development, manufacturing, packaging, analytical, and sales and marketing services to the pharmaceutical industry.
Reliant has rights to market certain pharmaceutical products and wants Cardinal Health to assist in the formulation, filling, packaging and testing of such products as provided in this Agreement and the attachments hereto.
Reliant desires to engage Cardinal Health to provide certain services to Reliant in connection with the processing of Reliants Product (defined below) and Cardinal Health desires to provide such services pursuant to the terms and conditions set forth in this Agreement.
The parties therefore agree as follows:
ARTICLE 1
DEFINITIONS
The following terms have the following meanings in this Agreement:
1.1 Affiliate(s) means any corporation, firm, partnership or other entity that controls, is controlled by or is under common control with a party. For purposes of this definition, control shall mean the ownership of at least fifty percent (50%) of the voting share capital of such entity or any other comparable equity or ownership interest.
1.2 API means the active pharmaceutical ingredient described in the Manufacturing Specifications, which have been released by Reliant and provided to Cardinal Health as raw material, along with a certificate of analysis, as provided in this Agreement.
1.3 Applicable Laws means all laws, ordinances, rules and regulations within the Territory applicable to the Manufacturing and Packaging of the Product or any aspect thereof and the obligations of Cardinal Health or Reliant, as the context requires under this Agreement, including, without limitation, (A) all applicable federal, state and local laws and regulations of each Territory; (B) the U.S. Federal Food, Drug and Cosmetic Act, and (C) the current Good Manufacturing Practices promulgated by the Regulatory Authorities, as amended from time to time (cGMPs).
1.4 Batch means defined quantity of finished drug product that has been or is being Manufactured and Packaged in accordance with the Specifications.
1.5 Calendar Quarter means a period of three (3) consecutive months commencing on January 1, April 1, July 1 or October 1 of any calendar year.
1.6 Cardinal Health Technology shall have the meaning set forth in Article 12.
1.7 Change Order shall have the meaning set forth in Section 4.5(A).
1.8 Confidential Information shall have the meaning set forth in Section 11.2.
1.9 Contract Year means each consecutive twelve (12) month period beginning on July 1, 2005.
1.10 Defective Product shall have the meaning set forth in Section 5.2.
1.11 Delivery Date shall mean the date on which Cardinal Health tenders the relevant Batch(es) to the carrier in accordance with Section 6.1. Each Delivery Date shall be specified by Reliant on the relevant Purchase Order and confirmed by Cardinal Health as set forth in Section 4.4.
1.12 Dispute shall have the meaning set forth in Section 19.9.
1.13 Effective Date means the date this Agreement was fully executed.
1.14 Facility or Facilities means Cardinal Healths facilities located in St. Petersburg, Florida or such other facility as agreed by the parties.
1.15 FDA means the United States Food and Drug Administration and any successor agency thereto.
1.16 Firm Commitment shall have the meaning set forth in Section 4.3.
1.17 Minimum Requirement shall have the meaning set forth in Section 4.1.
1.18 Manufacture or Manufacturing means the compounding, filling, encapsulation, producing and/or inspection of the API and Raw Materials into Product in accordance with the Specifications and the terms and conditions set forth in this Agreement.
1.19 Manufacturing Date means the day on which the Product is to be compounded by Cardinal Health, which shall not be more than forty-five (45) days prior to the Delivery Date.