Commercial Supply. The Parties shall use Commercially Reasonable Efforts to agree on the principal terms of a commercial supply agreement (the “Commercial Supply Agreement”) pursuant to which Zai shall purchase commercial supply of a Licensed Product from NVCR at in order to fulfill Zai’s obligations under this Agreement, which terms shall be consistent with the terms and conditions of this Agreement and the terms and conditions of any agreement between NVCR and its Third Party manufacturing partner(s), to the extent applicable to commercial supply of Licensed Product in the Field in the Territory. Zai shall purchase its commercial requirements for Licensed Product in the Territory from NVCR pursuant to the Commercial Supply Agreement.
Commercial Supply. Within days after the commencement of the first Phase III Trial in any country of the world, the Parties will negotiate in good faith and enter into, in accordance with the provisions of this [Section 3.2], a manufacturing and supply agreement governing the terms and conditions under which FATE will manufacture and supply to ONO the Collaboration Products for commercial use ("Commercial Supply Agreement" during the Term, and the Clinical Supply Agreement and Commercial Supply Agreement are collectively referred to as "Supply Agreements").
Clinical and Commercial Supply. With respect to a Co-Funding Product, the Lead Party will be responsible for and will use Commercially Reasonable Efforts to adequately and timely Manufacture or have Manufactured the Clinical Supply Requirements and Commercial Supply Requirements of Co-Funding Products worldwide in accordance with the Manufacturing Plan and in accordance with Applicable Laws, including applicable Good Practices. The Lead Party will be responsible for and will use Commercially Reasonable Efforts to perform the filling, packaging, labeling and testing of the Clinical Supply Requirements and Commercial Supply Requirements for Co-Funding Products for use under this Agreement in accordance with Applicable Laws, including applicable Good Practices. The Parties through the JMC shall discuss in good faith the Manufacture of Co-Funding Products, and reasonably cooperate with each other in all such supply matters pertaining to the Co-Funding Products under this Article 8.
Forecasting for Commercial Supply. [……] to [……] into the [……], [……] shall use [……] to [……] (see definition in Section [……]) the [……] of [……] that it [……] to [……] for the [……] of [……]. [……] will work with [……] to [……] the best [……] and [……] to [……] the [……] of [……] that it [……] to [……] on an [……] after the [……], and such [……] will be [……] into the [……].
Commercial Supply Criteria. Promptly following the date on which the first IND of a Licensed Product becomes effective in the U.S. under 21 C.F.R. 312.40, the JMC will determine whether the Planned Fate Facility or the Back-Up Fate Facility complies with the Commercial Supply Criteria as follows:
Commercial Supply Agreement. NPLH and Everest agree to negotiate in good faith within days of the initiation of the first Phase 3 Clinical Trial in the Territory a new agreement concerning the supply of the Compound and/or the Licensed Product for Everest’s Commercialization use (the “Commercial Supply Agreement”), with Everest’s cost of the Compound and/or the Licensed Product under the Commercial Supply Agreement being equal to . Notwithstanding the foregoing, nothing in this Agreement nor the Commercial Supply Agreement shall restrict, impair or otherwise limit NPLH’s ability to manufacture the Compound or Licensed Products in the Territory for use outside the Territory.
Commercial Supply Agreement. At a time specified by Alexion, but in any event as soon as practicable after either # or # , 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”).
36 Article 6 PAYMENTS
Commercial Supply Agreement. Promptly after the first submission of a BLA for a Licensed Product(s) in the Zai Lab Territory, Zai Lab and INCY will initiate and thereafter conduct negotiations in good faith for a separate commercial supply agreement for the manufacturing and supply of Licensed Product(s) to be sold for commercial purposes (after Regulatory Approval) for the Field in the Zai Lab Territory (such agreement, once mutually agreed, the “Commercial Supply Agreement”). Unless otherwise agreed or required by Applicable Law, the Commercial Supply Agreement will specify that # INCY will supply (or cause its Affiliate or a Third Party to supply) such Licensed Product(s) packaged ; # to the extent that such Licensed Product(s) are the same as Licensed Product(s) manufactured by or on behalf of INCY outside the Zai Lab Territory, such Licensed Product(s) will be compliant with all requirements of the applicable Regulatory Authority(ies) and Applicable Laws in the Zai Lab Territory as packaged or as delivered in [clause (a) of this Section 4.3]; # such Licensed Product(s) supplied by INCY to Zai Lab ; # Zai Lab will provide a Rolling Forecast; # Zai Lab will update the Rolling Forecast on the ; # of the Rolling Forecast will be binding on Zai Lab; and # Zai Lab will be responsible for applying approved labels to the Licensed Product(s) for use in the Zai Lab Territory.
Roche shall be responsible for the manufacture of commercial supplies of the Product for use in the Field in the Territory. Atea shall order all commercial supplies of the Product for use in the Field for the Atea Territory from Roche. Unless otherwise agreed by the Parties, within days after the Effective Date, the Parties will negotiate in good faith and enter into a written supply agreement for the commercial supply of Products for use in the Field by Roche to Atea, with a related quality agreement providing for commercial supply of Product for use in the Field by Roche to Atea as the primary supplier and on the terms set forth in [Appendix 8.2] hereto and other reasonable and customary terms (the “Supply Agreement”).
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