Common use of General Overview Clause in Contracts

General Overview. (a) The JSC, as a Mutual JSC Matter, shall establish an overall strategy for supply of Clinical Materials and Products for Development and Commercialization purposes (the “Manufacturing Strategy”), to the extent consistent with ▇▇▇▇▇▇▇▇▇’▇ and ▇▇▇▇▇’▇ obligations and rights under this Agreement. The Manufacturing Strategy shall address manufacturing quality standards and the Parties and/or, as applicable, the Third Party Manufacturer shall enter into a separate Quality Agreement for the Product. Subject to this Article 5.1, ▇▇▇▇▇▇▇▇▇ shall be responsible in consultation with Lilly for the supply of, and shall have the right to supply, all clinical and commercial supplies of the Product for use under this Agreement. To the extent and on the timeline contemplated by the Manufacturing Strategy, ▇▇▇▇▇▇▇▇▇ shall (i) retain a Third Party Manufacturer for the supply of drug substance, (ii) take all necessary actions, with consultation from Lilly, to establish a drug product site for the clinical and commercial supply of finished Product and (iii) retain a back-up manufacturer, a Third Party Manufacturer, selected in consultation with Lilly, for the clinical and commercial supply of finished Product, such Manufacturer to be approved by Lilly, such approval not to be unreasonably withheld or delayed. (b) Notwithstanding anything to the contrary in this Agreement, Lilly may require ▇▇▇▇▇▇▇▇▇ to use a Third Party Manufacturer for all or some of the clinical supply of Products if (A) Lilly believes, reasonably and in good faith, that ▇▇▇▇▇▇▇▇▇ has not shown the capability to satisfactorily deliver sufficient quantity of Products in acceptable quality to the clinic for the Development activities contemplated under this Agreement and the Development Plan, (B) ▇▇▇▇▇▇▇▇▇ has not received necessary approval from the applicable Regulatory Authority to Manufacture clinical supplies of Products or (C) Lilly believes, reasonably and in good faith, that ▇▇▇▇▇▇▇▇▇ does not have systems in place with respect to the Manufacture of clinical supply of Products that comply with applicable quality and pharmcovigilance agreements (such as those prepared under this Agreement) and Applicable Law. (c) The Parties shall enter into a series of agreements detailing the obligations and responsibilities of each Party as it pertains to the supply of Product in the Territory. The agreements shall include supply agreements, Quality Agreements and Manufacturing Responsibilities Document (“MRD”) appropriate for the Manufacture of the Product(s). (d) Lilly will purchase all of its requirements of Products for the Territory from ▇▇▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇▇▇ agrees to supply Lilly’s forecast for Products for the Territory. ▇▇▇▇▇▇▇▇▇ agrees to supply the Product to Lilly at a transfer price that accounts for ▇▇▇▇▇▇▇▇▇’▇ COGS. Product costing must be consistent with GAAP or IFRS and as mutually agreed upon by both Parties. (e) Following the Term of the Agreement but not after an early termination, if Lilly so chooses, the Parties will enter into a continuing supply agreement for the supply of Product for the Territory or part thereof wherein the Product will be supplied at arms-length market terms.

General Overview. (a) The JSC, as a Mutual JSC Matter, shall establish an overall strategy for supply of Clinical Materials and Products for Development and Commercialization purposes (the “Manufacturing Strategy”), to the extent consistent with ▇▇▇▇▇▇▇▇▇’▇ and ▇▇▇▇▇’▇ obligations and rights under this Agreement. The Manufacturing Strategy shall address manufacturing quality standards and the Parties and/or, as applicable, the Third Party Manufacturer shall enter into a separate Quality Agreement for the Product. Subject to this Article 5.1, ▇▇▇▇▇▇▇▇▇ shall be responsible in consultation with Lilly for the supply of, and shall have the right to supply, all clinical and commercial supplies of the Product for use under this Agreement. To the extent and on the timeline contemplated by the Manufacturing Strategy, ▇▇▇▇▇▇▇▇▇ shall (i) retain a Third Party Manufacturer for the supply of drug substance, (ii) take all necessary actions, with consultation from Lilly, to establish a drug product site for the clinical and commercial supply of finished Product and (iii) retain a back-up manufacturer, a Third Party Manufacturer, selected in consultation with Lilly, for the clinical and commercial supply of finished Product, such Manufacturer to be approved by Lilly, such approval not to be unreasonably withheld or delayed. (b) Notwithstanding anything to the contrary in this Agreement, Lilly may require ▇▇▇▇▇▇▇▇▇ to use a Third Party Manufacturer for all or some of the clinical supply of Products if (A) Lilly believes, reasonably and in good faith, that ▇▇▇▇▇▇▇▇▇ has not shown the capability to satisfactorily deliver sufficient quantity of Products in acceptable quality to the clinic for the Development activities contemplated under this Agreement and the Development Plan, (B) ▇▇▇▇▇▇▇▇▇ has not received necessary approval from the applicable Regulatory Authority to Manufacture clinical supplies of Products or (C) Lilly believes, reasonably and in good faith, that ▇▇▇▇▇▇▇▇▇ does not have systems in place with respect to the Manufacture of clinical supply of Products that comply with applicable quality and pharmcovigilance agreements (such as those prepared under this Agreement) and Applicable Law. (c) The Parties shall enter into a series of agreements detailing the obligations and responsibilities of each Party as it pertains to the supply of Product in the Territory. The agreements shall include supply agreements, Quality Agreements and Manufacturing Responsibilities Document (“MRD”) appropriate for the Manufacture of the Product(s). (d) Lilly will purchase all of its requirements of Products for the Territory from [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. ▇▇▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇▇▇ agrees to supply Lilly’s forecast for Products for the Territory. ▇▇▇▇▇▇▇▇▇ agrees to supply the Product to Lilly at a transfer price that accounts for ▇▇▇▇▇▇▇▇▇’▇ COGS. Product costing must be consistent with GAAP or IFRS and as mutually agreed upon by both Parties. (e) Following the Term of the Agreement but not after an early termination, if Lilly so chooses, the Parties will enter into a continuing supply agreement for the supply of Product for the Territory or part thereof wherein the Product will be supplied at arms-length market terms.