Commercial Supply Agreement. For avoidance of doubt, Licensee shall be entitled to purchase API’s and License Products directly from Licensor or use any third party manufacturers to manufacture API’s and Licensed Products on behalf of Licensee. Upon Licensee’s request, Licensor shall provide such third party manufacturers with all available data, quality control information, manufacturing specifications and information, and all other material and information reasonably needed by such third party manufacturers to manufacture commercially suitable Licensed Products for Licensee.
Commercial Supply Agreement. Following execution of this Agreement, BioNumerik agrees to finalize its processes for the manufacture of Product(s) as shall be agreed from time to time between itself and ASTA Medica. Within 24 months prior to the estimated time of the first commercial sale of Product(s) in the Territory, ASTA Medica and BioNumerik shall enter into a commercial supply agreement (the "Supply Agreement") to be negotiated in good faith and to reflect such terms and conditions as shall be reasonably necessary to govern the manufacture and supply of Product(s) for sale and distribution in the Territory. The Supply Agreement will provide among other things that:
Commercial Supply Agreement. Provided that HMI is still Manufacturing Candidates and Products under the applicable Development Supply Agreement and Development Quality Assurance Agreement, at such time as directed by the JMC prior to the Initiation of the first Pivotal Clinical Trial for such Target, the Parties will negotiate in good faith the terms of a new supply agreement for Candidates and Products (“Commercial Supply Agreement(s)”), along with the associated Commercial Quality Assurance Agreement(s) to cover supply of Candidates and Products for the Pivotal Clinical Trial, Product launch, and NVS’ Commercialization requirements (which Commercial Quality Assurance Agreement will contain terms related to HMI’s rights and obligations as the Manufacturer of such Product(s) as well as terms related to NVS’ rights and obligations as the Regulatory Responsible Party for such Product(s), including each Party’s respective review, comment, and approval rights thereunder). The Commercial Supply Agreement and Commercial Quality Assurance Agreement will provide for customary terms and conditions, including quality requirements, those provisions required under Sections 8.1.3 (Objective Criteria) and 8.6.1 (Manufacturing Related Rights), forecasting, ordering, delivery, technical requirements and criteria to be met, payment, and supply and will be consistent with the terms of this Agreement, [***]. Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Homology Medicines, Inc.
Commercial Supply Agreement. The Parties shall start negotiations as soon as practical after the Effective Date and shall execute a definitive commercial supply agreement (“Commercial Supply Agreement”) for the supply by KHK of the Licensed Products to UGNX and its Affiliates for marketing and sale of such Licensed Products in Latin America. Such Commercial Supply Agreement shall contain the terms and conditions set forth in this Section 8.3, consistent with those set forth in the remainder of this Article 8 (except as provided otherwise in this Section 8.3) and other reasonable and customary terms and conditions. In the event the Parties fail to enter into such a Commercial Supply Agreement for Latin America, and without diminishing the Parties’ obligation to enter into such agreement, UGNX will be obligated to purchase from KHK, and KHK will be obligated to sell to UGNX, all of the requirements of UGNX and its Affiliates for the Licensed Products pursuant to the terms of this Article 8, and either Party may refer the matter for resolution as a Dispute under Section 16.2 (Regular Arbitration). [***] Certain information in this document 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 Agreement. Unless a Party has already exercised its Opt-Out Option or is deemed to have exercised its Opt-Out Option under Section 14.2(b), at least [ * ] prior to the anticipated commercial launch of a Collaboration Product, the Parties shall negotiate in good faith and enter into a manufacturing and supply agreement (the “Commercial Supply Agreement”) governing the commercial supply of such Collaboration Product. Such Commercial Supply Agreement shall contain customary terms governing such manufacturing and supply relationships, but shall in any event provide as follows:
Commercial Supply Agreement. No later than [**] after Initiation of the first Pivotal Study, the Parties shall use Commercially Reasonable Efforts to execute a commercial supply agreement (the “Commercial Supply Agreement”) that will set forth the terms and conditions governing the provision of commercial supply of the Licensed Compound Bulk Drug Substance and/or Licensed Compound Drug Product from MacroGenics to Incyte.
Commercial Supply Agreement. At such time as directed by the JSC, the Parties will negotiate in good faith the terms of the Commercial Supply Agreement, and a related quality agreement, which agreements will govern the terms and conditions of the Manufacturing of the MG Manufactured Components for Commercialization purposes. The Commercial Supply Agreement and the related quality agreement will include terms and conditions consistent with the principles set forth on Schedule 8.2 (Development Supply Agreement Key Terms), with such modifications that are reasonable and appropriate for a commercial supply.
Commercial Supply Agreement. At a time specified by AstraZeneca, but in any event in a reasonable period in advance of the anticipated launch date for the Product in the U.S., the Parties will negotiate in good faith and enter into separate supply and quality agreements governing the commercial supply of Product (in bulk and primary packaged forms) from FibroGen to AstraZeneca (together, the “Supply and Quality Agreement”). The Supply and Quality Agreement will include the terms and conditions set forth on Exhibit K and contain such further customary and commercially reasonable terms governing similar supply arrangements and other terms as the Parties may agree, including appropriate forecasting and firm purchase order lead times, taking into consideration the reasonable notice requirements of FibroGen as well as any other terms set forth in this Article 6. The initial Supply and Quality Agreement shall have a term of [ * ]) years for the supply of drug substance, after which AstraZeneca would have the right to extend the term for an additional [ * ] years or to assume responsibility for drug substance manufacture upon agreement of terms mutually agreed by the Parties, including [ * ] in the form of drug substance. Under the Supply and Quality Agreement, the obligation to supply drug product shall have a term of five (5) years, which will automatically renew for succeeding five (5)-year terms and will include the price applicable pursuant to Section 6.5. In the event of any inconsistency between the Supply and Quality Agreement and Article 6 of this Agreement with regard to matters relating to supply, quality control and quality assurance, the terms of the Supply and Quality Agreement shall prevail.
Commercial Supply Agreement. At least [***] prior to the anticipated date of receipt of U.S. Marketing Approval, the Parties shall negotiate a definitive commercial supply agreement (the “Commercial Supply Agreement”, and together with the Development Supply Agreement, the “Supply Agreements”) for the supply of the Commercial Supply Requirements to Kiniksa in accordance with the Commercial Plan. The Commercial Supply Agreement shall provide for customary terms, including with respect to forecasting, ordering, delivery, payment, and supply, and the terms of this Agreement. Regeneron may designate an Affiliate to enter into the Commercial Supply Agreement. Except as otherwise agreed by the Parties and set forth in the Commercial Supply Agreement, all Product supplied under the Commercial Supply Agreement shall be in the form of Formulated Bulk Product or Filled Product, as such form is determined by Kiniksa, except that after a Fill/Finish Technology Transfer requested by Kiniksa in accordance with Section 8.14.2 (Fill/Finish Transfer), the Product shall be supplied in the form of Formulated Bulk Product. At Kiniksa’s request, to the extent Product is supplied in Filled Product form, Regeneron shall request that its Third Party Fill/Finish Provider package and label such Filled Product in accordance with Kiniksa’s instructions and shall use reasonable efforts to facilitate the transfer of Kiniksa’s packaging and labeling instructions to such Third Party Fill/Finish Provider. The Parties acknowledge and agree that as of the Effective Date, the Third Party Fill/Finish Provider’s order requirements are for a minimum of [***] vials of the Product per purchase order.
Commercial Supply Agreement. If requested by Licensee, the Parties shall enter into good faith negotiations for a supply agreement governing the supply of Product by Takeda or one of its Affiliates to Licensee for Commercialization in the Field in the Territory following Licensee’s receipt of the first Regulatory Approval in the Territory (the “Commercial Supply Agreement”). The terms of any such Commercial Supply Agreement shall be negotiated in good faith by the Parties based upon reasonable and customary terms typically associated with supply of pharmaceutical products for Commercialization in the Territory. For the sake of clarity, unless *** Certain Confidential Information Omitted and until a Commercial Supply Agreement is executed by the Parties, Takeda shall not be under any obligation to supply Product to Licensee for Commercialization in the Territory.
