Common use of Supply Agreements Clause in Contracts

Supply Agreements. If, in a given country or region, the Development Lead or the Commercial Lead are a different Party than the Manufacturing Lead for clinical supply of Phase III Trials or Commercialization use, then, upon either Party’s request, the Parties shall enter into separate supply and associated quality agreements (each, a “Supply and Quality Agreement”) covering the terms of supply to the Non-Manufacturing Lead for such Development or Commercialization activities. The Supply and Quality Agreement will contain terms and conditions that are reasonable and customary for agreements of such nature, including a right of the Non-Manufacturing Lead to include its Manufacturing Costs as Development Costs or Allowable Expenses, as applicable. If the Parties are unable to reach agreement on such provisions within [***] days of a request by either Party to enter into a Supply and Quality Agreement (which [***]-day period may be extended upon the mutual agreement of the Parties), upon request by either Party, the same shall be determined pursuant to Section 16.6.4. The terms of any such Supply and Quality Agreement, including the Manufacturing Lead’s rights and the Non-Manufacturing Lead’s obligations under such Supply and Quality Agreement, shall be consistent with rights of the Manufacturing Lead under the applicable CMO Supply Agreements. To the extent there is any conflict between the terms and conditions of such Supply and Quality Agreements and this Agreement with respect to the matters expressly covered by such Supply and Quality Agreements, then such Supply and Quality Agreements shall control.

Supply Agreements. If, in a given country or region, a Party (“Non‑Manufacturing Party”) requires Compound or Product for the Development Lead conduct of activities under a Program and the other Party (“Manufacturing Party”) is responsible for Manufacturing such Compound or the Commercial Lead are a different Party than the Manufacturing Lead for clinical supply of Phase III Trials or Commercialization useProduct, then, upon either Party’s request, the Parties shall enter into separate supply and associated quality agreements (each, a “Supply and Quality Agreement”) covering the terms of supply to the Non-Manufacturing Lead such Party for such Development or Commercialization activities. The Supply and Quality Agreement will contain terms and conditions that are reasonable and customary for agreements of such nature, including a right of the Non-Manufacturing Lead Party to include its Manufacturing Costs as Shared Development Costs or Allowable Expenses, as applicableapplicable and to the extent provided in Section ‎7.7 (Cost Profit Sharing), or if such Manufacturing Costs are not Shared Development Costs or Allowable Expenses in accordance with Section ‎7.7 (Cost Profit Sharing), the Non‑Manufacturing Party shall reimburse the Manufacturing Party for such Manufacturing Costs. If the Parties are unable to reach agreement on such provisions within [***] days of a request by either Party to enter into a Supply and Quality Agreement (which [***]-day ] period may be extended upon the mutual agreement of the Parties), upon request by either Party, the same shall be determined pursuant to Section 16.6.4‎15.6.3 (ADR). The terms of any such Supply and Quality Agreement, including the Manufacturing LeadParty’s rights and the Non-Manufacturing LeadParty’s respective rights and obligations under such Supply and Quality Agreement, shall be consistent with with, and limited by, rights and obligations of the Manufacturing Lead Party under the any applicable CMO Supply Agreements. To the extent there is any conflict between the terms and conditions of such Supply and Quality Agreements and this Agreement with respect to the matters expressly covered by such Supply and Quality Agreements, then such Supply and Quality Agreements shall control.

Supply Agreements. If, If during the Term in a given country or region, a Party (“Non-Manufacturing Party”) requires Licensed Compound or Licensed Product for the conduct of activities under the Global Development Lead Plan/Budget or an Independent Study Proposal and at such time the Commercial Lead are a different other Party than the (“Manufacturing Lead Party”) is responsible for clinical supply of Phase III Trials Manufacturing such Licensed Compound or Commercialization useLicensed Product, then, upon either Party’s request, the Parties shall enter into separate supply and associated quality agreements (each, a “Supply and Quality Agreement”) covering the terms of supply to the Non-Manufacturing Lead such Party for such Development or Commercialization activities. The Supply and Quality Agreement will contain terms and conditions that are reasonable and customary for agreements of such nature. In addition, including a right of the Supply and Quality Agreement will provide that if Manufacturing Costs are incurred to provide Licensed Product to the Non-Manufacturing Lead to include its Party for Independent Studies conducted by the Non-Manufacturing Costs as Development Costs or Allowable ExpensesParty, as applicablethen the Non-Manufacturing Party shall reimburse the Manufacturing Party for such Manufacturing Costs. If the Parties are unable to reach agreement on such provisions of the Supply and Quality Agreement within [***] days of a request by either Party to enter into a the Supply and Quality Agreement (which [***]-day ] period may be extended upon the mutual agreement of the Parties), upon request by either Party, the same shall be determined pursuant to Section 16.6.4[***]. The terms of any such Supply and Quality Agreement, including the Manufacturing LeadParty’s rights and the Non-Manufacturing LeadParty’s respective rights and obligations under such Supply and Quality Agreement, shall be consistent with with, and limited by, rights and obligations of the Manufacturing Lead Party under the any applicable CMO Supply Agreements. To the extent there is any conflict between the terms and conditions of such Supply and Quality Agreements and this Agreement with respect to the matters expressly covered by such Supply and Quality Agreements, then such Supply and Quality Agreements shall control.