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 [***].

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.

• Astellas shall be solely responsible for all costs and expenses incurred by or on behalf of Astellas for Medical Affairs Activities in support of Products in the Licensed Territory if such costs are not included in the Joint Medical Affairs Costs.

• Subject to this Section 7.7, each Party shall be responsible for and shall reimburse the other Party, as applicable, for Commercialization Costs and Medical Affairs Costs reasonably incurred after the Effective Date in connection with the performance of Commercialization activities in accordance with the cost-sharing principles set forth below and the Commercialization Plan, unless otherwise agreed by the Parties and set forth in the Commercialization Plan.

More Definitions of Medical Affairs Costs

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 all costs incurred by or on behalf of either Party that are reasonably and directly attributable to Medical Affairs Activities, whether prior to or after receipt of Regulatory Approvals. Notwithstanding the foregoing, Medical Affairs Costs shall exclude […***…].

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 has the meaning set forth in the Financial Definitions Exhibit.

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 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.

Medical Affairs Costs has the meaning set forth in Exhibit C.