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. 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. 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:
(i) Zymeworks shall supply the Licensed Antibodies and Licensed Product pursuant to the Clinical Supply Agreement as bright stock in unlabeled vials at a transfer price equal to Zymeworks’ Fully Burdened Manufacturing Cost. [***]
(ii) Delivery of Licensed Antibody and Licensed Product supplied by Zymeworks for Development will be made [***]. Jazz shall be responsible for obtaining all licenses or other authorizations for the exportation and importation of such Licensed Antibody and Licensed Product, and Jazz shall contract for shipment and insurance of such Licensed Antibody and Licensed Product from Zymeworks’ or its contract manufacturer’s facility[***]. Jazz shall also be responsible for the clinical packaging, labeling, QC/QA/QP release, storage, customs clearance and distribution of such Licensed Antibody and Licensed Product[***].
(iii) Following a Manufacturing Technology Transfer under Section 7.2 and receipt of approval from applicable Regulatory Authorities for Jazz or Jazz’s CMO to manufacture Licensed Antibody and Licensed Product, as applicable, Zymeworks shall continue to supply Jazz with, and Jazz shall continue to purchase from Zymeworks, Licensed Antibodies and Licensed Products, as applicable, as requested by Jazz in accordance with the Clinical Supply Agreement, until the Manufacturing Transition Date. The Clinical Supply Agreement shall set forth the minimum quantities of (or minimum percentages of Jazz’s requirements for) Licensed Antibody and Licensed Product that Jazz will be obligated to obtain from Zymeworks under the Clinical Supply Agreement following such Manufacturing Technology Transfer and approval, provided that Zymeworks remains in full compliance with its supply obligations under such agreement. Such minimum obligations shall not apply if Zymeworks materially breaches such obligations, subject to the terms and conditions of the Clinical Supply 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:
(a) Except as set forth in Section 7.1(b), NVCR shall supply the Licensed Products pursuant to this Section 7.1 at a transfer price equal to [***].
(b) For a TT Fields Multi-Regional Clinical Study, NVCR shall supply Licensed Products to Zai sufficient to conduct activities in the Territory contemplated under the TT Fields Multi-Regional Clinical Studies [***].
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. 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. 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. (a) From the Effective Date through [***], BioCryst will supply to Shionogi, at Shionogi‘s expense, and Shionogi agrees to purchase exclusively from BioCryst, (i) the Licensed Product (including its placebos if needed) for use in clinical studies to be conducted in the Territory by or on behalf of (subject to the terms of Section 3.4, above) Shionogi, and (ii) the Compound necessary for the Development of the Licensed Product.
(b) On [***], BioCryst will supply Shionogi with Compound (at Shionogi’s expense) and Shionogi will have established the necessary resources to formulate Licensed Product from Compound for clinical use. The Parties agree to evaluate in good faith the above arrangement on an ongoing basis to ensure the timely progression and development of the Licensed Product in the Territory.
(c) During the term of this Agreement, BioCryst shall supply to Shionogi, [***] of Compound (in such individual amounts and at such times as reasonably agreed upon by the Parties) for Shionogi to use Diligent Efforts to develop an optimized intramuscular formulation of the Compound for use by Shionogi in the Territory and for use by BioCryst outside the Territory pursuant to Section 10.2. In addition, if the Parties agree in writing that Shionogi may explore the possibility to Develop New Formulations under mutually agreed conditions, BioCryst shall also supply to Shionogi, [***] (but upon such additional terms and conditions as the Parties may agree), the Compound for Development of such New Formulation. Both Parties understand and agree that there are no assurances that Shionogi’s efforts will generate an optimized intramuscular formulation of the Compound or lead to the successful Development of New Formulations.
(d) All Licensed Product and Compound delivered by BioCryst to Shionogi shall be manufactured in accordance and in compliance with the specifications to be determined by BioCryst; provided, however that BioCryst shall give due consideration to revised specifications (if any) requested by Shionogi. BioCryst shall carry out its responsibilities hereunder in conformance with cGMPs and all other applicable Laws (all of the foregoing, in the United States). All supply of Licensed Product and Compound shall be subject to the terms and conditions set forth in this Section 3.5 and shall be subject to the terms and on prices as attached in Schedule 3.5 hereto.
(e) BioCryst shall transfer to Shionogi the formulation and manufacturing processes that (i) are ma...
Development Supply. (i) Subject to Section 7.2, Five Prime shall have the sole right, either by itself or through a Third Party contract manufacturer, to manufacture and supply to Zai all Licensed Antibody and Licensed Products required by Zai for Development use in the Territory under the Territory Development Plan and for Zai’s Development-related responsibilities under the Global Development Plan, including the conduct of the FPA144-004 Study.
(ii) Except as set forth in Section 7.1(a)(iii), Five Prime shall supply the Licensed Antibody and Licensed Products pursuant to this Section 7.1(a) at a transfer price equal to Five Prime’s Fully Burdened Manufacturing Cost. Five Prime shall invoice Zai for the Licensed Antibody and Licensed Product upon delivery in accordance with Section 7.1(a)(iv) and Zai shall pay the amount invoiced within [***] after the date of the invoice.
(iii) For the FPA144-004 Study, Five Prime shall supply Licensed Products to Zai at the following transfer price: [***]; [***] and shall pay any invoices that Five Prime sends to Zai with respect thereto within [***] of the date of the invoice. For clarity, if a patient is dosed [***], Five Prime will continue to supply Licensed Products to Zai [***] for such patient for the remainder of the FPA144-004 Study.
(iv) Delivery of Licensed Antibodies and Licensed Products supplied by Five Prime for Development use shall take place FCA (Incoterms 2010) at Five Prime’s or its contract manufacturer’s facility. Zai shall be responsible for obtaining all licenses or other authorizations for the exportation and importation of such Licensed Antibody or Licensed Product, and Zai shall contract for shipment and insurance of such Licensed Antibody or Licensed Product from Five Prime’s or its contract manufacturer’s facility, at Zai’s cost and expense. Zai shall also be responsible for the clinical packaging, labeling, QC/QA/QP release, storage, customs clearance and distribution of such Licensed Product, at Zai’s cost and expense.
