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Title: |
Contract Manufacturing Agreement |
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Date: |
2003 |
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Preview shows 11KB of 48KB total |
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$41 |
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ID: |
#326429 |
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CONTRACT MANUFACTURING AGREEMENT
This CONTRACT MANUFACTURING AGREEMENT (the "Agreement") is entered into
as of January 3, 2003 (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 20/th/ 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 21823 30th Drive S.E., 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 DNA known as SGN-30
encoding a monoclonal antibody also known as SGN-30; 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.
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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 [***] audit pursuant to which SGI or their
appointed representatives (such representatives to be reasonably acceptable to
ICOS) may (a) review the processes, procedures and documents of ICOS that are
used or maintained by ICOS to provide the Services, (b) assess of ICOS'
compliance with cGMP, Applicable Laws and quality assurance standards associated
with performing the Services, and (c) discuss any related issues with ICOS'
personnel and management involved in performing 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 [***] known as [***], which has been [***]
with a [***] containing certain SGI Materials as described in Appendix B, and
will be used to provide the Services herein. Any cell bank provided containing
the transfected cell line will always be subject to the license granted under
Appendix G herein.
1.7 "cGMP" means Good Manufacturing Practices and General Biologics
Products Standards as promulgated under the FDCA.
1.8 "Damages" means any and all [***] costs, losses, claims, actions,
liabilities, fines, penalties, costs and expenses, court costs, and [***] 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.
(S).301 et seq.).
1.11 "Foreign Jurisdiction" means any jurisdiction, not governed by the
United States or any political subdivision thereof, as agreed upon by the
parties.
1.12 "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
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Date which may be necessary for the performance of the Services. All ICOS
Know-How shall be Confidential Information of ICOS.
1.13 "ICOS Patent Rights" mean the patent applications and patents
listed on Exhibit A to Appendix G hereto and all divisions, continuations,
continuations-in-part, and substitutions thereof; all foreign patent
applications corresponding to the preceding applications; and all U.S. and
foreign patents issuing on any of the preceding applications, including
extensions, reissues, and re-examinations.
1.14 "IND" means an Investigation 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.
1.15 "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.
1.16 "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.
1.17 "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.
1.18 "Price" means the price specified in Appendix E for the
Services.
1.19 "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.
1.20 "Product" means a monoclonal antibody derived from the Cell Line
manufactured by ICOS utilizing the Process, and incorporating technology
licensed to SGI from ICOS pursuant to the license agreement previously entered
into by the parties in the form set forth in Appendix G.
1.21 "Product Specifications" means the product specifications listed
under the column "Acceptance Criteria" as listed in Appendix C.
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1.22 "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.
1.23 "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.
1.24 "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.
1.25 "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 the SGI Patent Rights 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
Section 5 and Appendix E.
1.29 "Testing Laboratories" means any third party instructed by ICOS to
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