Medical Affairs Costs definition

Medical Affairs Costs means, with respect to a Product, FTE Costs and Out-of-Pocket Costs incurred in accordance with this Agreement and consistent with the applicable Development Plan or Commercialization Plan that are specifically identifiable and allocable to Medical Affairs Activities with respect to such Product in the Field.

Medical Affairs Costs means all Expenses incurred by the Parties in connection with the conduct of Medical Affairs Activities in accordance with the Medical Affairs Plan and the Medical Affairs Budget;

Medical Affairs Costs means all Expenses incurred by the Parties in connection with the conduct of Medical Affairs Activities in accordance with the Medical Affairs Plan and the Medical Affairs Budget.

Examples of Medical Affairs Costs in a sentence

• For the avoidance of doubt, no cost or expense shall be counted more than once in calculating Joint Development Costs, Joint Medical Affairs Costs and Joint Commercialization Costs, even if such costs or expense falls into more than one of the cost categories that comprise Joint Development Costs, Joint Medical Affairs Costs and Joint Commercialization Costs.

• Except as provided in Section 2.7.4(a) with respect to Declined Activities, fifty percent (50%) of all Research Costs and Development Costs (other than Post-Approval U.S. Development Costs and Medical Affairs Costs for Co-Promoted Products, which shall be included in the calculation of the Annual U.S. Profit/Loss) shall be borne by Astellas, and fifty percent (50%) of such costs shall be borne by Ambit.

• To the extent a Party’s aggregate Development Costs, Medical Affairs Costs or Commercialization Costs, as applicable, exceed those set forth in the Development Budget, Medical Affairs Budget or Commercialization Budget, as applicable, by more than [***], unless otherwise agreed by the Parties, such Expenses will not be shared by the Parties and the Party incurring such Expenses will be solely responsible for such Expenses.

• With respect to any Shared Program Damages incurred by a Party (or any of its Indemnified Persons) during the Term, such Shared Program Damages shall be deemed to constitute (and shall be included in) Joint Development Costs, Joint Commercialization Costs and/or Joint Medical Affairs Costs, as applicable (and the Parties shall cooperate in good faith to allocate such amount(s) to the appropriate cost category).

• Astellas and Medivation shall reconcile Joint Medical Affairs Costs incurred by each Party through the procedures in Section 9.2 or Section 9.3, as applicable.

More Definitions of Medical Affairs Costs

Medical Affairs Costs has the meaning set forth in the Financial Definitions Exhibit.

Medical Affairs Costs means all reasonable costs incurred by Astellas or its Affiliates in connection with and reasonably allocable to Medical Affairs Activities for any Co-Promoted Product in the U.S., whether prior to or after receipt of Regulatory Approvals, such allocation to be consistent with the allocation Astellas uses to allocate such costs to other Astellas products.

Medical Affairs Costs means [***].

Medical Affairs Costs means the [***].

Medical Affairs Costs means all internal costs (i.e. FTE Costs) and Out-of-Pocket Costs actually incurred by or on behalf of a Party [***]. For purposes of Exhibit E, Medical Affairs Costs shall also apply to costs incurred by or on behalf of Moderna or its Affiliates or Sublicensees with respect to each Financial PCV or Financial SAV, as applicable, mutatis mutandis. [***]

Medical Affairs Costs means, with respect to a Shared Product, all Expenses incurred by the Parties or their respective Affiliates in connection with the conduct of Medical Affairs Activities for such Shared Product, provided that, in the case of CRISPR or its Affiliates, such Expenses are incurred in the performance of activities set forth in a CRISPR Activities Plan.

Medical Affairs Costs means those FTE costs of Sanofi and direct out-of-pocket costs (wherever incurred), including costs for independent contractors engaged as permitted under this Agreement, incurred by Sanofi, its Affiliates or Sublicensees that are specifically identifiable, or reasonably allocable to Medical Affairs Activities with respect to any Product sold in the United States, including a reasonable allocation of Sanofi’s global Medical Affairs personnel and Medical Affairs personnel specifically allocated to the United States and out-of-pocket costs incurred with respect to such personnel.