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:
(a) Bulk API meeting the agreed specification and manufactured in accordance with the applicable laws including then current GMP shall be supplied by or on behalf of Affymax to Takeda in a timely manner consistent with established and agreed manufacturing and delivery schedules at a cost equal to [*] the manufacture of such Bulk API (which [*], with such supply to be [*] .
(b) Affymax shall establish [*] commercial Bulk API manufacture in a timely manner to ensure that Affymax meets its obligation to supply quantities of Bulk API ordered by Takeda under the Supply Agreement. Upon the material and uncured breach by Affymax of its defined supply obligations as set forth in the Supply Agreement, Takeda shall have the right to obtain transfer and Affymax shall have the obligation to give transfer free of charge to Takeda, without undue delay, of any and all manufacturing technology necessary to enable it to manufacture or have manufactured Bulk API to meet its requirements. If such transfer occurs, Affymax would grant, without prejudice to any other remedies that are available to Takeda, to Takeda any additional licenses necessary to enable Takeda to exercise the foregoing manufacturing right without requiring Takeda to pay any additional consideration for such licenses.
(c) Takeda shall be responsible for the Finished Manufacture, testing (including stability testing) and final release of the Finished Product for Commercialization in the Licensed Territory. With regard to the Finished Product manufactured by or on behalf of Takeda and used or sold for Commercialization in the U.S., the Manufacturing Cost incurred by Takeda for the Finished Manufacture of the Finished Product thus used or sold in the U.S. hereunder, as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Finished Product shall be included in the Cost o...
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 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. 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, [***].
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:
(a) Not later than the end of each calendar year that commences after execution of the Supply Agreement, ASTA Medica will supply to BioNumerik an estimate of its requirements of the amount of API or finished Product(s) in the Territory during the following [**] years, and will update this estimate at six-month intervals. BioNumerik will notify ASTA Medica within 90 days of receipt of such estimate if it (or its Affiliates) will be unable to supply the whole or any part of the requirements described in such estimate. Together with the [**] estimate, ASTA Medica will deliver to BioNumerik firm orders for its estimated requirements of Product(s) not less than 12 months in advance of the required date of delivery. Within thirty (30) days of its receipt of such firm order, BioNumerik shall confirm such order in writing and fulfill such orders in accordance with ASTA Medica's required date of delivery provided the quantities specified therein do not exceed those quantities contained in the previous estimate for the same period and provided that BioNumerik has not previously advised ASTA Medica that it will be unable to supply all or part of such quantities. [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
(b) If BioNumerik (or its Affiliates) are unable to meet the requirements of ASTA Medica and its Affiliates and sublicensees for commercial quantities of Product(s), then ASTA Medica may fill all of its remaining supply requirements in excess of the amount provided by BioNumerik (and its Affiliates) from a third party or parties. In such event, (i) BioNumerik shall grant a license to ASTA Medica under the BioNumerik Patent Rights, BioNumerik Know-How, and BioNumerik Improvements to manufacture a...
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).
Commercial Supply Agreement. [***], the Parties shall negotiate and execute a definitive commercial supply agreement (“Commercial Supply Agreement”) for the supply of Licensed Products to Kyowa Kirin and its Affiliates for marketing and sale (including post-approval studies) of such Licensed Products in the Territory. Such Commercial Supply Agreement shall contain the terms and conditions set forth in this Section 8.3, terms and conditions consistent with those set forth in the remainder of this ARTICLE VIII (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 [***], and without diminishing the Parties’ obligation to enter into such agreement, Kyowa Kirin shall be obligated to purchase from Reata, and Reata shall be obligated to sell to Kyowa Kirin, [***] of the requirements of Kyowa Kirin and its Affiliates and Permitted Sublicensees for Licensed Products pursuant to the terms of this ARTICLE VIII, and either Party may refer the matter for resolution as a Dispute under ARTICLE XVI so that any unresolved issues in the negotiation of such a Commercial Supply Agreement can be determined with the end result being a binding Commercial Supply Agreement between the Parties.
Commercial Supply Agreement. [***], the Parties shall negotiate and execute definitive commercial supply agreements for the supply of both the Finished Product (“Commercial Supply Agreement for Finished Product”) and the SDD (“Commercial Supply Agreement for SDD ”) to Kyowa Kirin and its Affiliates for marketing and sales (including post-approval studies) of such Licensed Products in the Territory (collectively, “Commercial Supply Agreements”). ” Accordingly, the word “Commercial Supply Agreement” in the Original Agreement shall be substituted with the word “Commercial Supply Agreements”.
Commercial Supply Agreement. At a time specified by Alexion, but in any event as soon as practicable after either (a) [***] or (b) [***], the Parties shall negotiate in good faith a commercial supply agreement on commercially reasonable terms for the commercial supply of Licensed Product in the Territory by Eidos to Alexion (the “Commercial Supply Agreement”).
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.
