Joint Medical Affairs Costs definition

Joint Medical Affairs Costs means the FTE Costs and Out-of-Pocket Costs that are directly or reasonably allocable to the performance of Medical Affairs activities by or on behalf of a Party or any of its Affiliates for the Licensed Products in the Profit-Share Territory and incurred by or on behalf of a Party or any of its Affiliates in accordance with the applicable Joint Medical Affairs Plan and the amounts budgeted for the performance of such activities in the applicable Joint Medical Affairs Budget plus applicable Allowable Overruns. Joint Medical Affairs Costs specifically exclude any FTE Costs, Out-of-Pocket Costs and other costs and expenses [**]. If any cost or expense is directly or reasonably allocable to more than one Joint Medical Affairs Cost category above, then such cost or expense will only be counted once (i.e., as a Joint Medical Affairs Cost with respect to only one such category). No cost or expense included as a Joint Medical Affairs Cost will: (i) also be included as a Joint Development Cost or a Joint Commercialization Cost; or (ii) be an amount for which one Party or the other is solely responsible under this Agreement. Joint Medical Affairs Costs will be recognized and calculated in accordance with GAAP.
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Joint Medical Affairs Costs means any and all costs, to the extent approved by the JMAC and reasonably and directly allocable to activities conducted pursuant to the Agreement and the Joint Medical Affairs Plan then in effect, incurred by the Parties and that support Medical Affairs Activities in support of Products in the Shared Territory, whether prior to or after receipt of Regulatory Approvals, including Manufacturing Costs to be treated as Joint Medical Affairs Costs pursuant to Section 7.5 and Damages from Third Party Claims to be treated as Joint Medical Affairs Costs pursuant to Section 12.4. Notwithstanding the foregoing, Joint Medical Affairs Costs shall exclude: (a) Medical Affairs Costs incurred solely with respect to the Licensed Territory; (b) any Development Costs or Commercialization Costs; and (c) each of the following (except to the extent included in Manufacturing Costs): (i) any tax liabilities, overhead or other indirect cost allocations from either Party; and (ii) [*] other than [*] of [*] in support of [*] and the [*] of [*]. For clarity, Joint Medical Affairs Costs exclude any costs or expenses incurred by Medivation prior to the Effective Date.
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Joint Medical Affairs Costs means with respect to a Licensed Product in the Shared Territory, [**].
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Examples of Joint 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.

  • 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.

  • The Parties will reconcile such Joint Medical Affairs Costs they have incurred to reflect the foregoing applicable allocation of Joint Medical Affairs Costs according to the procedures in Section 9.3.1 (Reconciliation/Reimbursement Prior to First Commercial Sale) or Section 9.3.3 (Profit Sharing Commercialization), as applicable.

  • Each such report shall specify in reasonable detail all deductions allowed in the calculation of such Net Sales and all expenses included in Joint Development Costs, Joint Medical Affairs Costs, and Joint Commercialization Costs, and, if requested by Medivation or AUS, any invoices or other supporting documentation for any payments to a Third Party that individually exceed [*] or with respect to which documentation is otherwise reasonably requested shall be promptly provided.

  • The rate of exchange to be used in computing the amount of currency equivalent in U.S. dollars of Net Sales invoiced and Joint Development Costs, Joint Commercialization Costs and Joint Medical Affairs Costs incurred in other currencies shall be made at the average T.T.M. rate published by the Bank of Tokyo Mitsubishi UFJ, Ltd.

  • Within [*] days after the end of each calendar quarter prior to the calendar quarter in which the First Commercial Sale of a Product occurs in the Shared Territory, Medivation and AUS shall submit to a finance officer designated by Medivation and a finance officer designated by AUS (the “Finance Officers”) a report setting forth the Joint Development Costs, Joint Medical Affairs Costs and Joint Commercialization Costs it incurred in such calendar quarter with respect to each Product.

  • 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.

  • All calculations of Joint Development Costs, Joint Medical Affairs Costs, Joint Commercialization Costs, Operating Profit and Operating Loss hereunder shall be made in accordance with GAAP, including the provisions thereof regarding expense recognition, as applied by Medivation and AUS consistently with their application in their respective external financial reporting.

  • Within [*] after the end of each calendar quarter beginning with the calendar quarter in which the First Commercial Sale of a Product occurs in the Shared Territory, AUS shall report to the Finance Officers its Net Sales, and Medivation and AUS shall each report to the Finance Officers its Joint Development Costs, Joint Medical Affairs Costs and Joint Commercialization Costs incurred by it in such calendar quarter for each Product.

  • 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).

Related to Joint Medical Affairs Costs

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • Development Activities means those activities which are normally undertaken for the development, construction, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Development Costs means costs incurred to obtain access to reserves and to provide facilities for extracting, treating, gathering and storing the oil and gas from reserves. More specifically, development costs, including applicable operating costs of support equipment and facilities and other costs of development activities, are costs incurred to:

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Development Expenses means, with respect to SAIL Developments as well as HOME Developments when the HOME Development is also at least partially financed with a MMRB Loan (as defined in rule Chapter 67-21, F.A.C.), usual and customary operating and financial costs, such as the compliance monitoring fee, the financial monitoring fee, replacement reserves, the servicing fee and the debt service reserves. As it relates to SAIL Developments as well as HOME Developments when the HOME Development is also at least partially financed with a MMRB Loan (as defined in rule Chapter 67-21, F.A.C.) and to the application of Development Cash Flow described in subsections 67-48.010(5) and (6), F.A.C., as it relates to SAIL Developments or in paragraph 67-48.020(3)(b), F.A.C., as it relates to HOME Developments, the term includes only those expenses disclosed in the operating pro forma on an annual basis included in the final credit underwriting report, as approved by the Board, and maximum of 20 percent Developer Fee per year.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Development Plan has the meaning set forth in Section 3.2.

  • Project Management Plan means the management plan that (i) sets out a high level workplan to describe the manner in which the Design-Builder will manage the Project, including to address related matters such as traffic management and communications, and (ii) is prepared by or for the Design-Builder and submitted to the Owner;