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. 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. 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. Following each License Grant Date, if requested by Servier, the Parties shall enter into good faith negotiations regarding the terms of a quality and supply agreement, pursuant to which MacroGenics shall provide commercial supply of Program DARTs and/or Licensed Products licensed under such Licensed Program to Servier and its Affiliates and Sublicensees (the “Commercial Supply Agreement”).
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. Subject to the terms and conditions of this Agreement, Seres shall supply, or secure the supply of, Licensee’s requirements for Collaboration 49 Products for commercial purposes for the Licensed Territory and for the purposes of any Development activities Licensee undertakes in accordance with Section 4.4(d), in accordance with the Manufacturing Standards and the terms of this Agreement, pursuant to an arm’s length supply agreement (“Supply Agreement”) between the Parties or their respective Affiliates. The Parties shall enter into the Supply Agreement within [***] after the Effective Date. The Supply Agreement will include the terms set forth on Exhibit F and other customary terms and conditions for an agreement of a similar nature. Without limiting the foregoing, the Supply Agreement shall provide that the Collaboration Product supplied thereunder shall be supplied to Licensee at a price equal to Seres’ Manufacturing Costs associated with the Collaboration Products supplied to Licensee under the Supply Agreement, plus a xxxx-up of [***] (such xxxx up [***], the “Manufacturing Markup” and such Manufacturing Markup plus Seres’ Manufacturing Costs, the “Supply Costs”). Notwithstanding the foregoing, with respect to Collaboration Product Manufactured during the Pre-Launch Period for use in Commercialization activities after the Pre-Launch Period, (a) the Supply Costs therefor (the “Pre-Launch Supply Costs”) for each such batch of such Collaboration Product shall be recalculated using Manufacturing Costs in an amount equal to [***], (b) [***] bear the portion of the Pre-Launch Supply Costs exceeding the updated Supply Costs as recalculated in (a), and (c) [***] for the excess portion in (b) no later than (i) the [***] of such date of receipt of first Regulatory Approval or (ii) [***] following the Pre-Launch Period, whichever is later. To implement the foregoing, the Parties will establish a mutually acceptable methodology, including periodic reconciliation processes to adjust the Supply Costs and, as needed, any related reconciliation of the Royalty Payment Amounts and True-Up Amounts to accommodate such adjustment to the Supply Costs.
Commercial Supply Agreement. The Parties shall timely negotiate in good faith and enter into a manufacturing and supply agreement (the "Supply Agreement") governing the supply of Bulk API, by or on behalf of Affymax, to Takeda for the manufacture of Finished Product for the Commercialization of the Product by the Parties hereunder, to execute such Supply Agreement [*] for the Product in the Licensed Territory, or [*], whichever is earlier. Such Supply Agreement shall contain customary terms governing such manufacturing and supply relationships, and shall provide as follows:
Commercial Supply Agreement. Both Parties recognize the importance of Inspire establishing and maintaining a reliable and steady source of supply of Finished Product and Delivery Systems (collectively, "Supplied Goods") for commercial marketing in the Territory by Kissei so that supply shortages do not occur. Commencing on the Effective Date, Inspire intends to work toward that goal with its Third Party Manufacturers, and will keep Kissei informed, through the Joint Development Committe, of the actions being undertaken by Inspire to do so. Inspire shall also give Kissei, through the Joint Development Committee or otherwise, as Kissei may desire, an opportunity to review Inspire's actions and provide input into other actions deemed appropriate. At such time as the Joint Development Committee determines is appropriate, the Parties shall negotiate in good faith the terms of a commerical supply agreement to be entered into by the Parties (the "Supply Agreement") pursuant to which Inspire shall provide Kissei with its commercial supply requirements of
Commercial Supply Agreement. Not later than six (6) months prior to Aura’s filing of an NDA/BLA covering a Licensed Product, upon Aura’s written request, the Parties will negotiate in good faith and execute a manufacturing and supply agreement pursuant to which Clearside will supply Aura with its requirements of microinjectors and microneedles (“Clearside Products”) for Aura’s commercial use in the Field (the “Supply Agreement”). Aura’s cost of the Clearside Products under the Supply Agreement shall equal Clearside’s Cost of Goods (as defined) (reasonably documented to Aura) plus a reasonable direct markup amount to be negotiated at the time. The Supply Agreement shall require Aura to provide written notice to Clearside with rolling quarterly forecasts of its commercial needs.
