Common use of Development Supply Clause in Contracts

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. The Parties shall use reasonable efforts to enter into an agreement governing (a) From the supply by Zymeworks of such Licensed Antibodies and Licensed Products for such Development use by Jazz (“Clinical Supply Agreement”), promptly after the Closing Effective Date (and in any event, within [through ***] after the Closing Date), which BioCryst will incorporate the terms set forth on Exhibit 7.3(b)supply to Shionogi, andat Shionogi‘s expense, pursuant and Shionogi agrees to which: purchase exclusively from BioCryst, (i) Zymeworks shall supply the Licensed Antibodies and Licensed Product pursuant (including its placebos if needed) for use in clinical studies to be conducted in the Territory by or on behalf of (subject to the Clinical Supply Agreement as bright stock in unlabeled vials at a transfer price equal to Zymeworks’ Fully Burdened Manufacturing Cost. [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 (iiat Shionogi’s expense) Delivery of Licensed Antibody and Licensed Product supplied by Zymeworks for Development Shionogi will be made [***]. Jazz shall be responsible for obtaining all licenses or other authorizations for have established the exportation and importation of such Licensed Antibody and Licensed Product, and Jazz shall contract for shipment and insurance of such Licensed Antibody and necessary resources to formulate Licensed Product from Zymeworks’ or its contract manufacturer’s facility[***]Compound for clinical use. Jazz shall also be responsible for The Parties agree to evaluate in good faith the clinical packaging, labeling, QC/QA/QP release, storage, customs clearance above arrangement on an ongoing basis to ensure the timely progression and distribution development of such the Licensed Antibody and Licensed Product[***]Product in the Territory. (iiic) Following a Manufacturing Technology Transfer 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 Section 7.2 mutually agreed conditions, BioCryst shall also supply to Shionogi, *** (but upon such additional terms and receipt conditions as the Parties may agree), the Compound for Development of approval from applicable Regulatory Authorities for Jazz 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 Jazz’s CMO lead to manufacture the successful Development of New Formulations. (d) All Licensed Antibody Product and Licensed ProductCompound delivered by BioCryst to Shionogi shall be manufactured in accordance and in compliance with the specifications to be determined by BioCryst; provided, as applicable, Zymeworks however that BioCryst shall continue give due consideration to supply Jazz with, and Jazz shall continue to purchase from Zymeworks, Licensed Antibodies and Licensed Products, as applicable, as revised specifications (if any) requested by Jazz Shionogi. BioCryst shall carry out its responsibilities hereunder in accordance conformance with cGMPs and all other applicable Laws (all of the Clinical Supply Agreementforegoing, until in the Manufacturing Transition DateUnited States). The Clinical Supply Agreement shall set forth the minimum quantities All supply of (or minimum percentages of Jazz’s requirements for) Licensed Antibody and Licensed Product that Jazz will and Compound shall 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 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 maintained or subsequently developed or optimized by BioCryst and (ii) are designed to ensure the quality of Licensed Product. All transfer of such Know-How shall take place in Birmingham, Alabama unless otherwise agreed upon by the Clinical Supply AgreementParties. If the transfer is to occur wholly or partially outside of Birmingham, Alabama, then Shionogi shall promptly ***.

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 Jazz, other than supply of clinical sites for the Zymeworks Ongoing Studies and Zymeworks Korean Studies in accordance with Section 7.3(a) (“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(b7.3(c), 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 under the Clinical Supply Agreement 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 facilityfacility [***]. 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 ProductProduct [***]. (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.