Sample Business Contracts


Contract Manufacturing Agreement - ICOS Corp. and Seattle Genetics Inc.

Manufacturing Forms

CONTRACT MANUFACTURING AGREEMENT

This CONTRACT MANUFACTURING AGREEMENT (the "Agreement") is entered into as of August 1, 2001 (the "Effective Date"), by and between ICOS Corporation ("ICOS"), a corporation organized and existing under the laws of the State of Delaware and having its principal place of business at 22021 20th Avenue S E, Bothell, WA 98021 USA and Seattle Genetics, Inc. ("SGI"), a corporation organized and existing under the laws of the State of Delaware and having its principal place of business at 22215 26th Avenue S.E., Suite 3000, Bothell, WA 98021.

RECITALS

WHEREAS, ICOS is in the business of manufacturing and testing pharmaceutical products; and

WHEREAS, SGI is the proprietor of a certain hybridoma that produce the monoclonal antibody chimeric BR96 (cBR96) and other material described in Appendix B; and

WHEREAS, ICOS has expertise in the development, evaluation and production of monoclonal antibodies for therapeutic use using cell lines; and

WHEREAS, subject to the terms and conditions set forth in this Agreement, SGI wishes to have ICOS manufacture for SGI a pre-commercial pharmaceutical Product (hereinafter defined); and

WHEREAS, subject to the terms and conditions set forth in this Agreement, ICOS wishes to manufacture Product for SGI.

NOW, THEREFORE, the parties hereto, intending to be legally bound, hereby agree as follows:

1.               Definitions

For purposes of this Agreement, the following terms will have the meanings set forth below:

1.1          "Affiliates" means, with respect to any Person, another Person that, directly or indirectly, controls, is controlled by or is under common control with such Person.  The term "control" means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise.  The direct or indirect ownership of at least fifty percent (50%) or, if smaller, the maximum allowed by applicable law, of the voting securities of a business entity or of an interest in the assets, profits or earnings of a Person shall be deemed to constitute "control" of the Person.

 


1.2          "Applicable Laws" means all ordinances, rules and regulations of any kind whatsoever of any governmental or regulatory authority, including, without limitation, the FDCA, that are applicable with respect to the context in which the term is used.

1.3          "Audit" means a review by SGI or their appointed representatives (such representatives to be reasonably acceptable to ICOS) of processes, procedures and documents of ICOS that are used or maintained by ICOS to provide the Services.

1.4          "Calendar Quarter" means the three-month period ending on March 31, June 30, September 30 or December 31.  The initial Calendar Quarter will be deemed to begin on the Effective Date and end on the first to occur of March 31, June 30, September 30 or December 31 of such same year.

1.5          "Calendar Year" means the twelve (12) month period ending on December 31.  The initial Calendar Year will be deemed to begin on the Effective Date and end on December 31 of such same year.

1.6          "Cell Line" means a hybridoma expressing cBR96 antibody as described in Appendix B, and will be used to provide the Services herein.

1.7          "cGMP" means Good Manufacturing Practices and General Biologics Products Standards as promulgated under the US Federal Food Drug and Cosmetic Act at 21CFR (Chapters 210, 211, 600 and 610).

1.8          "Damages" means any and all reasonable costs, losses, claims, actions, liabilities, fines, penalties, costs and expenses, court costs, and reasonable fees and disbursements of counsel, consultants and expert witnesses incurred by a party hereto (including interest which may be imposed in connection therewith).

1.9          "FDA" means the United States Food and Drug Administration, any comparable agency in any Foreign Jurisdiction, and any successor agency or entity to any of the foregoing that may be established hereafter.

1.10        "FDCA" means the Federal Food, Drug and Cosmetic Act (21 U.S.C. ยง 301 et seq.).

1.11        "FAS" means the delivery term Free Along Side, meaning that ICOS has fulfilled its obligation to deliver when it has made the object of delivery available at its premises to SGI or SGI's agent (or to SGI's carrier).  For the avoidance of doubt, unless otherwise agreed in writing, ICOS is not responsible for loading the object of delivery on to the vehicle provided by SGI or SGI's agent (or to ICOS's nominated carrier) or for any risk of loss during shipment.

1.12        "Foreign Jurisdiction" means any jurisdiction, not governed by the United States or any political subdivision thereof, as agreed upon by the parties.


1.13        "ICOS Know-How" means unpatented and/or unpatentable technical information, including ideas, concepts, inventions, discoveries, data, designs, formulas, specifications, procedures for experiments and tests and other protocols, results of experimentation and testing, fermentation and purification techniques, and assay protocols owned by ICOS as of the Effective Date which may be necessary for the performance of the Services.  All ICOS Know-How shall be Confidential Information of ICOS.

1.14        "Manufacturing Specifications" means the specifications for manufacturing the Product.  Prior to the initiation of the first cGMP manufacturing run, an Appendix C-1 signed by both parties setting forth the initial Manufacturing Specifications shall be appended to this Agreement and shall contain at a minimum a collection of documents containing certain specifications, procedures, assay methods (QC Release Tests), personnel contacts and any other information as may be needed and agreed by the parties relating to the manufacture of Product by ICOS for SGI.  This Appendix C-1 shall also contain a statement to be agreed and acknowledged by ICOS and SGI that SGI adopts the initial Manufacturing Specifications as its own specification in conformance with Clause 6.7 herein.  Any changes or additions to the Manufacturing Specifications shall be made by the written agreement of ICOS and SGI.

1.15        "NDA" means New Drug Application or any comparable application required by a Foreign Jurisdiction filed for the Product by SGI with the FDA and all subsequent submissions, supplements or amendments related thereto.

1.16        "Person" means a natural person, a corporation, a partnership, a trust, a joint venture, a limited liability company, any governmental authority or any other entity or organization.

1.17        "Price" means the price specified in Appendix E for the Services.

1.18        "Process" means the process for the production of the Product from the Cell Line using the Manufacturing Specifications, including any improvements thereto from time to time made as a result of the Services.

1.19        "Product" means a  monoclonal antibody derived from the Cell Line manufactured through ICOS's use of the Process.

1.20        "Product Specifications" means the product specifications listed under the column "Acceptance Criteria" as listed in Appendix C.

1.21        "Services" means all or any part of the services to be provided by ICOS (or any permitted subcontractor) for the benefit of SGI pursuant to this Agreement as further described in Appendix A.

1.22        "SGI-Patent Rights" means all patents and patent applications of any kind throughout the world relating to the Process which from time to time SGI is the owner of or is entitled to use.


1.23        "SGI Information" means all confidential and proprietary technical information not in the public domain relating to the Cell Line, the Process and the Product, from time to time supplied by SGI to ICOS, or arranged by SGI to be supplied by a third party (such as a prior manufacturer) to ICOS.

1.24        "SGI Know-How" means all information relating to the Process known to SGI from time to time other than confidential SGI Information and information in the public domain.

1.25        "SGI Materials" means the Materials supplied by SGI to ICOS (if any) and identified as such by Appendix B hereto.

1.26        "SGI Technology" means all of SGI's Patent Rights,  SGI Know-How and SGI Information necessary to manufacture the Product.

1.27        "SGI Tests" means the tests to be carried out on the Product immediately following receipt of the Product by SGI, particulars of which are set out in Appendix C.

1.28        "Terms of Payment" means the terms of payment specified in Appendix E.

1.29        "Testing Laboratories" means any third party instructed by ICOS to carry out tests on the Cell Line or the Product.

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