THIS ENBREL SUPPLY AGREEMENT ("Agreement") is made effective as of April 12,

                               ---------

2002, by and between Immunex Corporation, a Washington corporation, having its

principal place of business at 51 University Street, Seattle, Washington 98101

("Immunex"), and Genentech, Inc., a Delaware corporation, having its principal

  -------

place of business at One DNA Way, South San Francisco, California 94080

("Genentech").

  ---------



                                   BACKGROUND

                                   ----------



Immunex markets and sells a certain proprietary biological pharmaceutical

product known as ENBREL(R) (etanercept). Immunex desires to obtain additional

supply of commercial quantities of ENBREL bulk drug substance. Genentech has the

experience and expertise necessary to perform the manufacturing and related

services needed to supply ENBREL bulk drug substance, and Genentech owns a

facility that, with some modifications, could be suitable for production of

commercial quantities of ENBREL bulk drug substance.



Immunex desires to retain Genentech as a nonexclusive manufacturer of commercial

quantities of ENBREL bulk drug substance and purchase commercial quantities of

such product from Genentech, and Genentech desires to perform such services and

sell commercial quantities of such product to Immunex, all on the terms and

conditions set forth in this Agreement.



                                    AGREEMENT

                                    ---------



NOW, THEREFORE, IN CONSIDERATION OF the mutual covenants set forth in this

Agreement, and for other good and valuable consideration, the receipt and

sufficiency of which are hereby acknowledged, the Parties hereby agree as

follows:



                             ARTICLE 1. DEFINITIONS

                             ----------------------



The following terms, whether used in the singular or plural, shall have the

meanings assigned to them below for purposes of this Agreement.



1.1  "Acquisition Cost" means the actual invoiced price paid by Genentech to any

      ----------------

     Third Party for acquiring any materials used in the manufacture of the

     Product under this Agreement, including, but not limited to, shipping and

     handling costs and customs duties incurred and paid by Genentech in

     connection with the acquisition of such materials, and also including [*]

     percent ([*]%) of the above amounts to cover such



* Portions of this exhibit have been omitted pursuant to a request for

confidential treatment filed with the Securities and Exchange Commission. The

omitted portions of this exhibit have been filed separately with the SEC.



{PAGE}



     Party's storage and overhead costs. This definition, including the [*]

     percent ([*]%) markup, shall only apply in the circumstances set forth in

     Section 6.2(a)(5) and Section 19.3(d)(1) hereof.

     -----------------     ------------------



1.2  "Affiliate" means, with respect to any Party, any other corporation or

      ---------

     business entity that directly, or indirectly through one or more

     intermediaries, controls, is controlled by or is under common control with

     such Party. For purposes of this definition, the term "control" means

     direct or indirect ownership of fifty percent (50%) or more of the

     securities or other ownership interests representing the equity voting

     stock or general partnership or membership interest of such entity or the

     power to direct or cause the direction of the management or policies of

     such entity, whether through the ownership of voting securities, by

     contract, resolution or otherwise.



1.3  "Batch" or "Lot" means the quantity of Bulk Drug produced from a single

      -----      ---

     Run, and refers to a Commercial Batch or Lot, a Development Batch or Lot,

     and/or a Qualification Batch or Lot, as the context requires. A Run may

     result in more than one subbatch or sublot due to splitting into tanks

     downstream in the Manufacturing Process.



1.4  "Batch Records" shall have the meaning set forth in the Quality Agreement.

      -------------



1.5  "BIP" means Boehringer Ingelheim Pharma KG.

      ---



1.6  "BIP Confidential Information" means Immunex Confidential Information that

      ----------------------------

     has been identified in writing as confidential information of BIP, and is

     referred to in Section 17.6 hereof.

                    ------------



1.7  "Bulk Drug" means the bulk form of the Product which has been manufactured

      ---------

     by Genentech pursuant to this Agreement, which has been purified to a

     concentrated form from one or more Batches and can be stored in a liquid or

     frozen form under appropriate conditions, and, except with respect to

     Non-Conforming Bulk Drug, which has been manufactured in compliance with

     cGMP and conforms to the Bulk Drug Specifications.



1.8  "Bulk Drug Commitment" refers to the first [*] months of each binding

      --------------------

     rolling Product Manufacturing Forecast (including all amendments thereto),

     and means a commitment by Genentech to comply with and perform the number

     of Runs set forth therein. The Bulk Drug Commitment is a rolling [*] month

     commitment, and is described with more particularity in Section 4.2 hereof.

                                                             -----------



1.9. "Bulk Drug Specifications" means specifications developed by Immunex for

      ------------------------

     Bulk Drug as set forth in the Product sBLA, including, without limitation,

     testing methods and acceptance criteria for each Batch generated, a summary

     of which is attached to the Quality Agreement, as such specifications may

     be amended from time to time in accordance with Section 6.2 hereof,

                                                     -----------

     including, without limitation, such amendments as



* Portions of this exhibit have been omitted pursuant to a request for

confidential treatment filed with the Securities and Exchange Commission. The

omitted portions of this exhibit have been filed separately with the SEC.



                                     Page 2



{PAGE}



     may be required to obtain approval from the FDA and other applicable

     regulatory authorities in the United States.



1.10 "cGMP" means the regulatory requirements for current good manufacturing

      ----

     practices promulgated by the FDA under the FD&C Act, 21 C.F.R.(S)(S)210,

     211 and 600 et seq. and under the PHS Act, 21 C.F.R.(S)(S)600-610, as the

     same may be amended from time to time.



1.11 "Cell Line" means a proprietary Immunex Chinese Hamster Ovary cell line

      ---------

     that expresses the Product.



1.12 "Certificate of Analysis" means, for each Batch, a document prepared by

      -----------------------

     Immunex: (a) listing tests performed by Immunex, specifications, test

     date(s), and test results, and certifying the accuracy of the foregoing;

     (b) referring to the related Certificate of Compliance prepared by

     Genentech, listing the manufacturing date, unique Batch number, and

     quantity of Bulk Drug in such Batch, as certified by Genentech in such

     Certificate of Compliance; and (c) referring to the related Certificate of

     Testing prepared by Genentech, listing tests performed by Genentech,

     specifications, test date(s), and test results, as certified by Genentech.

     The Parties shall from time to time agree upon a format or formats for the

     Certificate of Analysis to be used under this Agreement.



1.13 "Certificate of Compliance" means, for each Batch, a document prepared by

      -------------------------

     Genentech: (a) listing the manufacturing date, unique Batch number, and

     quantity of Bulk Drug in such Batch, and (b) certifying that such Batch was

     manufactured in accordance with the Bulk Drug Specifications and cGMP. The

     Parties shall from time to time agree upon a format or formats for the

     Certificate of Compliance to be used under this Agreement.



1.14 "Certificate of Testing" means, for each Batch, a document prepared by

      ----------------------

     Genentech: (a) listing tests performed by Genentech, specifications, and

     test results, and (b) certifying the accuracy of the foregoing. The Parties

     shall from time to time agree upon a format or formats for the Certificate

Home        Intelligence        Services        Subscriptions        News        About Us

Contact Us       Terms of Use       Resend Documents       Shopping Cart

Copyright © 2008 The Consus Group LLC