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. 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.
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”).
Commercial Supply. On [……] written request at any time after [……] of all [……] set forth in Section [……], the Parties shall use [……] to enter into a commercial supply agreement (the “Commercial Supply Agreement”) pursuant to which [……] will agree to [……] to [……] with [……] of [……] for [……] in the [……] , [……] or [……] of an [……] or [……]. The Commercial Supply Agreement shall provide for [……] at [……] of [……], as set forth in a [……] on a [……] to [……], [……] all [……], [……], and any [……] or other applicable [……], provided that any [……] in [……] shall be [……] to [……] prior to [……] of [……]. In addition, the parties [……] that the [……] may reflect [……] in [……] as a result of [……]. The Parties shall endeavor to [……] for a Commercial Supply Agreement [……] than [……] after [……] of the [……] of the [……], provided that in the event that the Parties [……] to [……] on the terms for said Commercial Supply Agreement, [……] will assist [……] in [……] a [……] of the [……] at [……]. In such a case, [……].
Commercial Supply. With respect to each [[Unknown Identifier]] Co-Co Product, reasonably in advance of, but at least prior to, the anticipated First Commercial Sale thereof, the JCC shall determine a plan for the Manufacture and supply to each Party, its Affiliates and Sublicensees of such [[Unknown Identifier]] Co-Co Product for Commercialization in the Territory. If, pursuant to such plan, Acadia will conduct some or all commercial manufacturing of the [[Unknown Identifier]] Co-Co Product (including supplying Stoke, its Affiliates or Sublicensees), then the JCC will prepare a plan (each such plan a “[[Unknown Identifier]] Co-Co Technology Transfer Plan”) and Stoke shall transfer to Acadia or its CMO (subject to [Section 2.2(b)(ii)]) the Stoke [[Unknown Identifier]] Know-How (including, for example, Know-How from Stoke’s other research programs to the extent necessary or generally useful in the manufacture of ASOs) with respect to the manufacture of such [[Unknown Identifier]] Co-Co Product as set forth in the plan, the cost of which transfer shall be shared by the Parties equally (50:50) as an Other Expense. To the extent necessary while the commercial manufacturing process for the [[Unknown Identifier]] Co-Co Product is being transferred and validated, Stoke will, upon on a transitional basis (not to exceed after first Regulatory Approval of such [[Unknown Identifier]] Co-Co Product in the Territory), provide commercial supplies of the [[Unknown Identifier]] Co-Co Product following the first Regulatory Approval thereof in the Territory, subject to the terms and conditions set forth in the relevant [[Unknown Identifier]] Co-Co Clinical Supply Agreement. As applicable, the Parties shall negotiate in good faith and enter into an agreement pursuant to which a Party would supply the [[Unknown Identifier]] Co-Co Product to the other Party, its Affiliates and Sublicensees for use in performing Commercialization activities under the applicable [[Unknown Identifier]] Co-Commercialization Plan at a transfer price equal to such Party’s Manufacturing Cost (each a “[[Unknown Identifier]] Co-Co Commercial Supply Agreement”). With respect to each [[Unknown Identifier]] Co-Co Commercial Supply Agreement, the Parties shall negotiate in good faith and enter into an agreement governing the quality control of the product Manufactured pursuant to such agreement.
Commercial Supply. Subject to [Section 5.1.5] (Second Source), GSK shall be solely responsible for all Commercial Manufacture and supply of Licensed Products throughout the Territory.
Commercial Supply. Within after the Effective Date, and in any event no later than before the expected Launch Date of a Product, the Parties shall enter into a supply agreement for the commercial supply by Aguettant of such Product to AcelRx (such agreement, the “Supply Agreement”), which shall be consistent with the terms and conditions of the Agreement. Aguettant shall supply the Products in the Territory exclusively to AcelRx. AcelRx shall purchase the Products exclusively from Aguettant. Aguettant shall supply the Finished Products to AcelRx at a price of € per Unit of Phenylephrine and € per Unit of Ephedrine, FCA St Fons ([[Address B:Address]]) Incoterms ICC 2020 (each, a “Supply Price”), provided that the Products are manufactured in Aguettant capacities.
Commercial Supply. Roche shall have the sole right and responsibility, at its own expense, for the commercial Manufacture and supply of Tier 1 Products, Optioned Tier 2 Products and Collaboration Products.
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").
Commercial Supply. Acer will supply in bulk form Acer Product to Relief for Commercialization in the Relief Territory at Acer’s Fully Burdened Manufacturing Cost. Such supply will be subject to a separate Commercial Supply and Quality Agreement (the “Commercial Supply and Quality Agreement”) to be negotiated in good faith (based on Acer’s agreements with Third Party CDMCs for the manufacture and supply of Acer Product) following the Effective Date. Relief will be responsible for packaging, labelling, serialization and distribution of Product; provided, however, that, as will be set forth in the Commercial Supply and Quality Agreement, Acer can either support content uniformity testing after packaging in pouches (all other release testing will be done on bulk drug product) or transfer the method to Relief.
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