Development Manufacturing Costs definition

Development Manufacturing Costs means, with respect to an Optioned Product (or placebo or comparator if required for the applicable Clinical Trial pursuant to this Agreement), FTE Costs incurred by either Party or any of its Affiliates and all out-of-pocket costs and expenses incurred by or on behalf of either Party or any of its Affiliates, in each case, in Manufacturing such Optioned Product (or placebo or comparator) for Development activities, including costs and expenses incurred in connection with (a); (b) […***…]; (c) […***…]; (d) […***…] (e) […***…]; (f) […***…]; (g) […***…]; (h) […***…] and (i) […***…]. “Development Manufacturing Costs” shall further include:
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Development Manufacturing Costs means, with respect to a Profit-Share Product (or placebo or comparator if required for the applicable Clinical Trial pursuant to this Agreement), FTE Costs incurred by Gilead or any of its Affiliates and all out-of-pocket costs and expenses incurred by or on behalf of Gilead or any of its Affiliates, in each case, in Manufacturing such Profit-Share Product (or placebo or comparator) for Development activities [***]. “Development Manufacturing Costs” shall further include: [***].
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Development Manufacturing Costs means […***…].
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Examples of Development Manufacturing Costs in a sentence

  • A copy of each such report at the time of its mailing to Holders shall be filed with the Commission and each stock exchange, if any, on which the Securities are listed.

  • For each Clinical IRD Product (and any ▇▇▇▇▇▇▇ Research IRD Product subject to Section 6.2(c)), commencing upon the [***] following the Effective Date and continuing thereafter so long as MeiraGTx incurs Clinical Development Manufacturing Costs under this Agreement, MeiraGTx will submit to ▇▇▇▇▇▇▇ within [***] after the conclusion of such Calendar Quarter an invoice setting forth the Clinical Development Manufacturing Costs MeiraGTx incurred in such Calendar Quarter.

  • With respect to any Calendar Quarter, in no event will a Party be responsible for any Clinical Development Manufacturing Costs that exceed the respective portion of the then-current Clinical Development Manufacturing Budget recommended and proposed by the JMC and approved by the JSC, except as otherwise provided in Section 10.4(b).

  • All Clinical Development Manufacturing Costs shall be reconciled and paid in accordance with the procedure described in Section 10.4. Notwithstanding anything herein to the contrary, [***].

  • In the case of Independent Activities, the supplying Party may charge a ▇▇▇▇-up equal to the lowest of (i) […***…] percent […***…] of the Development Manufacturing Costs, (ii) such Party’s ▇▇▇▇-up used for […***…] or (iii) the ▇▇▇▇-up agreed by the Parties in the applicable Clinical Supply Agreement.

  • All such payments of MeiraGTx’s Clinical Development Manufacturing Costs shall be non-creditable and non-refundable.

  • The Parties shall [***] share the costs and expenses of any Technology Transfer, which shall be treated as Development Manufacturing Costs.

  • For clarity, (i) all Development Manufacturing Costs will be deemed Research and Development Costs, [***]; and (ii) all costs and expenses incurred by or on behalf of the Parties in connection with the Manufacture of a Joint Product for the Commercialization of such Joint Product in the Shared Territory shall be deemed Cost of Goods Sold that is part of [***], subject to the [***].


More Definitions of Development Manufacturing Costs

Development Manufacturing Costs means, […***…].
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Development Manufacturing Costs means, with respect to an Optioned Product (or placebo or comparator if required for the applicable Clinical Trial pursuant to this Agreement), FTE Costs incurred by either Party or any of its Affiliates and all out-of-pocket costs and expenses incurred by or on behalf of either Party or any of its Affiliates, in each case, in Manufacturing such Optioned Product (or placebo or comparator) for Development activities, including [***].
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Development Manufacturing Costs shall further include: [***].
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