2/30 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED 1.2 “Analytical Methods” shall mean...
3/30 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED 1.13 “Facility” shall mean SAFC’s facility located at [ * ]. 1.14 “Failure to Supply” shall have the meaning set forth in Section 2.10(a) hereof. 1.15 “FDA” shall mean the United States Food and Drug Administration, and any successor thereto. 1.16 “Finished Product”, “SGN-35” or “brentuximab vedotin” shall mean the finished dosage form drug product that contains the SGD-1006 as an active ingredient, in vials, labelled and packaged, ready for commercial sale. 1.17 “Fully Burdened Manufacturing Cost” shall have the meaning set forth in Section 5.5(b) hereof. 1.18 “Intellectual Property” means all inventions, discoveries, improvements, design rights, patents, trademarks, copyrights, trade secrets, know-how, and all other intellectual and industrial property rights of every kind and nature however designated, whether arising by operation of law, contract, license or otherwise, and any equivalents thereof, which are made, developed, conceived, reduced to practice, or created by or on behalf of a Party, or jointly by a Party with the other Party or with a third party, in connection with a Party’s performance under this Agreement. Intellectual Property also means and includes all applications, registrations, renewals, extensions, continuations, continuations-in-part, divisions or reissues of any of the foregoing, now or hereafter existing, made or in force, and including any and all rights in any of the foregoing. 1.19 “Laboratory” shall have the meaning set forth in Section 4.2 hereof. 1.20 “Manufacture, Manufacturing or Manufactured” means all activities related to the manufacturing of SGD-1006, or any ingredient thereof in accordance with the terms and conditions of this Agreement and the Quality Agreement, which may include manufacturing SGD-1006 or supplies for development or commercial sale, packaging SGD-1006, in-process and final testing and release of SGD-1006, or any component or ingredient thereof, quality assurance activities related to manufacturing and release of SGD-1006 and regulatory activities related to any of the foregoing. 1.21 “Manufacturing Process” shall mean the instructions, specifications for raw materials and excipients, formulae, procedures, tests and standards developed, established and described by Company or developed by or for Company’s use in Manufacturing SGD-1006. 1.22 “Marks” shall have the meaning set forth in Section 11.4 hereof. 1.23 “Minimum Lead Time” shall have the meaning set forth in Section 3.2(a) hereof. [ * ] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercial Supply - SGD-1006 3 SAFC Rev May 2006
7/30 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED (iii) mutually agrees with Company on a [ * ]. (b) In the event that SAFC intends to [ * ] at any time during the Term, then [ * ]. During the Term, Company, its Affiliates, sublicensees, Licensees, contractors, collaborators, and Third Party Designees, shall purchase SGD-1006 at the [ * ]. [ * ]. (c) Notwithstanding anything to the contrary, Company shall have the right to require SAFC to manufacture SGD-1006 for and supply SGD-1006 directly to Company’s Affiliates, sublicensees, licensee, contractors, collaborators and Third Party Designees; provided, however, that if Company requires SAFC to supply such SGD-1006, Company shall [ * ] with respect to such orders. The manufacture and supply of SGD-1006 to such Affiliates, sublicensees, licensees contractors, collaborators and Third Party Designees will be in accordance with the terms and conditions of this Agreement, including without limitation the [ * ], provided that SAFC will continue to invoice [ * ], and Company, its Affiliates, sublicensees, licensee, contractors, collaborators and Third Party Designees shall furnish SAFC with forecasts and orders which include forecasts and orders for all such Affiliates, sublicensees, collaborators and Third Party Designees. Company shall also designate the delivery destination for the SGD-1006, and Company shall pay SAFC directly for orders of SGD-1006 that have been accepted by such Affiliate, sublicensee, licensee, contractors, collaborator or Third Party Designee. All SGD-1006 supplied to Affiliate, sublicensee, licensee, contractors, collaborator or Third Party Designee shall provide such Affiliate, sublicensee, licensee, contractors, collaborator or Third Party Designee the [ * ], such as conformance to the [ * ], as is available to Company hereunder. 2.10 D elay; [ * ]. (a) If SAFC is or will be unable, for any reason (including an event of Force Majeure under Section 11.17 hereof), to supply the SGD-1006 in accordance with the quantities and/or delivery dates specified by Company in a purchase order received by SAFC (“Failure to Supply”), SAFC shall [ * ] notify Company in writing of such circumstance. If the quantities are within [ * ] of the Commercial Forecast and such delivery dates meet the [ * ] requirements herein then within [ * ] of such notice of Failure to Supply, SAFC shall provide Company the cause of such Failure to Supply and shall propose a plan of remediation. (b) If such Failure to Supply will continue or does continue for a period of [ * ], and SAFC is unable in the Facility or any Qualified Alternate Facility to Manufacture the SGD-1006 in [ * ], then Company may, at its discretion and upon written notice to SAFC (i) [ * ], without being deemed to be in [ * ] of this Agreement, and/or (ii) if such [ * ] pursuant to Section [ * ], provided that the period of Failure to Supply shall count towards the notice period requirement in such Section [ * ]. In the event of 2.10(b)(i) or (ii) above, upon Company’s request, SAFC shall [ * ], at [ * ], in order to allow Company to promptly resume its supply of SGD- 1006 by way of [ * ]. [ * ] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercial Supply - SGD-1006 7 SAFC Rev May 2006
13/30 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED (c) All SGD-1006 delivered by SAFC hereunder: will conform to the Quality Agreement, the applicable Purchase Order and the Specifications, will not be adulterated or misbranded within the meaning of the U.S. Food, Drug, & Cosmetic Act, or any other Applicable Laws and will be manufactured at the Facility which is in compliance with cGMP; and (d) SAFC will have obtained and maintained in effect all such approvals and permits as may be required under Applicable Laws to operate the Facility for the purposes of Manufacturing SGD-1006 under the Quality Agreement and under this Agreement; (e) Unencumbered title to all SGD-1006 will be conveyed to Company upon delivery; (f) The Batch Records shall conform with the Specifications; (g) If any [ * ] and/or intellectual property rights are incorporated into the Manufacturing of SGD-1006, the use of such inventions and/or rights shall not [ * ]; (h) Neither SAFC, nor any of its employees or agents working hereunder, has ever been, is currently, or is the subject of a proceeding that could lead to that party becoming, as applicable, a Debarred Entity or Individual, an Excluded Entity or Individual or a Convicted Entity or Individual. SAFC further covenants, represents and warrants that if, during the term of this Agreement, it, or any of its employees or agents working hereunder, becomes or is the subject of a proceeding that could lead to that party becoming, as applicable, a Debarred Entity or Individual, an Excluded Entity or Individual or a Convicted Entity or Individual, SAFC sh all immediately notify Company, and Company shall have the right to immediately terminate this Agreement upon notice. For purposes of this provision, the following definitions shall apply: A “Debarred Individual” is an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) (or any comparable law of the EMA or any country in the world, as each may be amended from time to time) from providing services in any capacity to a person that has an approved or pending drug product application. A “Debarred Entity” is a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) (or any comparable law of the EMA or any country in the world, as each may be amended from time to time) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of a Debarred Entity. An “Excluded Individual” or “Excluded Entity” is (i) an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of Health and Human Services, (or any comparable international programs) or (ii) an individual or entity, as applicable, who has been excluded, debarred, suspended or is [ * ] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercial Supply - SGD-1006 13 SAFC Rev May 2006
21/30 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED 10.3 A rbitration (a) Any dispute arising between the Parties out of or in connection with this Agreement, or the interpretation, breach or enforcement thereof that cannot be amicably resolved pursuant to Section 10.2 above within [ * ] as from the first notice of such dispute shall be finally settled by arbitration as set forth in this Section 10.3. (b) The arbitration shall be conducted in accordance with the Commercial Arbitration Rules of the American Arbitration Association in effect at the time of the arbitration to the extent that both Parties are domestic United States companies or in accordance with the International Arbitration Rules of the American Arbitration Association in effect at the time of the arbitration to the extent that one of the Parties is not a domestic United States company, except, in each instance, as such rules may be modified herein or by mutual agreement of the Parties. (c) The seat of the arbitration shall be [ * ], and it shall be conducted in the English language. (d) The arbitration shall be conducted by three arbitrators. The Party initiating arbitration (“Claimant”) shall appoint an arbitrator in its request for arbitration (“Request”). The other Party (“Respondent”) shall appoint an arbitrator within [ * ] of receipt of the Request and shall notify the Claimant of such appointment in writing. If within [ * ] of receipt of the Request by the Respondent, either Party has not appointed an arbitrator, then that arbitrator shall be appointed by the American Arbitration Association. The first two arbitrators appointed in accord with this provision shall appoint a third arbitrator within [ * ] after the Respondent has notified Claimant of the appointment of the Respondent’s arbitrator or, in the event of a failure by a Party to appoint, within [ * ] after the American Arbitration Association has notified the Parties and any arbitrator already appointed of its appointment of an arbitrator on behalf of the Party failing to appoint. When the third arbitrator has accepted the appointment, the two arbitrators making the appointment shall promptly notify the Parties of the appointment. If the first two arbitrators appointed fail to appoint a third arbitrator or so to notify the Parties within the time period prescribed above, then the American Arbitration Association shall appoint the third arbitrator and shall promptly notify the Parties of the appointment. The third arbitrator shall act as Chair of the tribunal. (e) The arbitral award shall be in writing, state the reasons for the award, and be final and binding on the Parties. The award may include an award of costs, including reasonable attorneys’ fees and disbursements. Judgment upon the award may be entered by any court having jurisdiction thereof or having jurisdiction over the relevant Party or its assets. [ * ] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercial Supply - SGD-1006 21 SAFC Rev May 2006
27/30 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED SAFC, an operating division of Sigma-Xxxxxxx, Inc. Seattle Genetics, Inc. By: /s/ Xxxxxx Xxxxxxx By: /s/ Xxxx X. Xxxxxxx Name: Xxxxxx Xxxxxxx Name: Xxxx X. Xxxxxxx, Ph.D. Title: President, SAFC Title: President & CEO Commercial Supply - SGD-1006 27 SAFC Rev May 2006
28/30 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED APPENDIX 1 QUALITY AGREEMENT [ * ] [ * ] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercial Supply - SGD-1006 1 SAFC Rev May 2006
29/30 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED APPENDIX 2 SPECIFICATIONS [ * ] [ * ] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercial Supply - SGD-1006 2 SAFC Rev May 2006
30/30 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED APPENDIX 3 PRICING [ * ] [ * ] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercial Supply - SGD-1006 1 SAFC Rev May 2006