Development Supply. In connection with the supply of any Product for non-commercial use, FibroGen shall supply Product in compliance with applicable law and regulations, including GMP requirements, and in accordance with forecasts set forth in the Development Plan or, if not specified therein, the forecasts developed by the JDC as necessary for the conduct of Clinical Trials set forth in the Development Plan. FibroGen shall use Commercially Reasonable Efforts to meet any applicable timelines for supplying Product, subject to the reasonable lead time requirements of Third Party contract manufacturers. AstraZeneca will pay FibroGen’s Fully Burdened Cost for all Product supplied for Development, within forty-five (45) days after receipt of invoice therefor. All Products supplied for a country after Regulatory Approval in such country will be considered to be for commercial use, unless used specifically for Clinical Trials under the Development Plan. The terms of supply by FibroGen to AstraZeneca for use in any Clinical Trial conducted under the sponsorship of AstraZeneca or for other non-commercial use by or on behalf of AstraZeneca, are as set forth on Exhibit J.
Development Supply. New River will Manufacture, or arrange for a Third Party Manufacturer to Manufacture, Compound and Collaboration Products in bulk and finished form for Development activities to be performed by a Party under Section 3.3 of this Agreement for the US Territory. Prior to receipt of Regulatory Approval for the first Collaboration Products for ADHD [*] in the US Territory, the costs of manufacturing quantities of such Collaboration Products (other than for the build-up of Commercial supply) in the US Territory shall be borne solely by [*]. Prior to receipt of Regulatory Approval of a Collaboration Product other than the first Collaboration Products for ADHD [*] in the US Territory, the costs of manufacturing quantities of such Collaboration Product (other than for the build-up of Commercial supply) in the US Territory shall be treated as Development Expenses and the applicable Development Plan shall designate which such costs, if any, shall be treated as Shared Expenses under Section 3.6.1.
Development Supply. New River will Manufacture, or arrange for a Third Party Manufacturer to Manufacture, bulk Compound for Development activities to be performed by Shire under this Agreement. Any such supply will be provided by New River to Shire [*] (as determined in accordance with Exhibit A).
Development Supply. Subject to the provisions set forth below in this Section 7.1 and Sections 7.3, 7.5 and 7.6 hereof, AVEO, itself or through an Affiliate or Third Party contractor, shall have the sole right to, and shall be solely responsible for, the Manufacture of supplies of Licensed Product required for all Development of Licensed Product by AVEO, Biogen Idec and their respective Affiliates and Sublicensees in the AVEO Territory and the Licensed Territory pursuant to this Agreement. AVEO shall use Commercially Reasonable Efforts to meet its Manufacturing obligations under this Section 7.1. Subject to the provisions set forth below in Sections 7.3, 7.5 and 7.6 hereof, at the written request of Biogen Idec, which request may be made at any time and from time to time after the Option Exercise Date and shall in any event be made by Biogen Idec with sufficient advance notice to be commercially reasonable (or with such other period of advance notice as the Parties may otherwise agree), AVEO, itself or through an Affiliate or Third Party contractor, shall use Commercially Reasonable Efforts to Manufacture and supply Licensed Product to Biogen Idec and its Affiliates and Sublicensees in sufficient quantities to satisfy their respective reasonable requirements for use thereof in Development activities of Licensed Product pursuant to this Agreement.
Development Supply. NVCR shall have the sole right, through a Third Party contract manufacturer, to manufacture and supply to Zai all Licensed Products required by Zai for Development use in the Territory under the Territory Development Plan and for Zai’s [***] responsibilities under the Global Development Plan, including the conduct of TT Fields Multi-Regional Clinical Studies. The Parties shall use good faith efforts to enter into an agreement pursuant to which NVCR would supply such Licensed Products for such Development use by Zai (“Clinical Supply Agreement”) within [***], pursuant to which:
Development Supply. During the term of the Development License and Option Agreement, AbbVie shall supply Receptos with its requirements of Drug Substance and Drug Product for all of its Phase 2 development and clinical activities consistent with the plan and budget set forth in Appendix 2 attached hereto (as it may be supplemented or updated from time to time upon the mutual written agreement of the Parties, “Appendix 2”) (“Development Plan Supply Services”).
Development Supply. Pursuant to the Development Supply Agreement, Onconova shall, by itself or through its Third Party contract manufacturer, supply to SymBio, and SymBio shall purchase from Onconova, all quantities of Clinical Samples required by SymBio to develop the Licensed Product in the Licensed Territory, at the Actual Unit Cost plus ** of such Actual Unit Cost as a manufacturing xxxx up. Within ** after the Effective Date, the Parties shall commence good faith negotiations of a development supply agreement which shall govern the supply by Onconova of Clinical Samples (the “Development Supply Agreement”), with a goal of entering into the Development Supply Agreement within ** after the Effective Date. Such Development Supply Agreement shall be consistent with the terms set forth in this Article 5, and shall include customary and reasonable terms and conditions commonly accepted in the pharmaceutical industry for supply of similar products at similar scale. Without limiting the foregoing, the Development Supply Agreement shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, and backup rights for SymBio to manufacture the Licensed Product.
Development Supply. The Parties shall use reasonable efforts to enter into an agreement governing the supply by Zymeworks of such Licensed Antibodies and Licensed Products for such Development use by Jazz (“Clinical Supply Agreement”), promptly after the Closing Date (and in any event, within [***] after the Closing Date), which will incorporate the terms set forth on Exhibit 7.3(b), and, pursuant to which:
Development Supply. Regeneron shall use Commercially Reasonable Efforts to Manufacture (or have Manufactured) and supply to Kiniksa (or have supplied) all Product and placebo necessary to conduct Development in accordance with the terms and conditions of the Development Supply Agreement.
Development Supply. Can-Fxxx shall transmit to KDP an invoice detailing the Manufacturing Cost for the Product delivered to KDP (or to KDP’ s designee) hereunder for development purposes, including Non-Clinical Studies and Clinical Studies, and KDP shall make payment to Can-Fxxx within thirty (30) days after receipt of each such invoice.
