Joint Medical Affairs Costs definition

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 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 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.

  • 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.

  • The terms and conditions of this Section 9.3.2 (Reconciliation/Reimbursement Prior to First Commercial Sale) will govern the rights and obligations of Biogen and Sage with respect to sharing the Joint Medical Affairs Costs and the Joint Commercialization Costs prior to the First Commercial Sale of a Licensed Product in the Product Class in the Profit-Share Territory, unless and until Sage exercises an Opt-Out Right in accordance with Section 9.4 (Sage Opt-Out) for such particular Product Class.

  • Ms Bush advised that a number of audits and inspections have been undertaken in 2008.

  • 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.

  • 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 Assessment Team has now evaluated the submission and supporting evidence and consider that Ayrshire Valuation Joint Board continue to take their statutory obligations seriously and are working hard to bring all the elements of their records management arrangements into full compliance with the Act and fulfil the Keeper’s expectations.

  • Within [*] Business Days after receipt of such reports, the Finance Officers shall confer and agree in writing on whether a reconciliation payment is due from Medivation to AUS or AUS to Medivation, and if so, the amount of such reconciliation payment, so that Medivation and AUS share Joint Development Costs, Joint Medical Affairs Costs and Joint Commercialization Costs in accordance with this Agreement.

  • 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.


More Definitions of Joint Medical Affairs Costs

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 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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Related to Joint Medical Affairs Costs

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • 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.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, 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.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • 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;

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Participating Clinical Professional Counselor means a Clinical Professional Counselor who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Specialist medical practitioner means a specialist as defined in section 3 of the Health Insurance Act 1973.

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

  • continuing professional development means the continuing professional development contemplated in section 32;

  • 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.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • 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.

  • Development Officer means the Development Officer appointed by the Council of the Municipality.

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

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

  • Direct medical education costs means costs directly associated with the medical education of interns and residents or other medical education programs, such as a nursing education program or allied health programs, conducted in an outpatient setting, that qualify for payment as medical education costs under the Medicare program. The amount of direct medical education costs is determined from the hospital base-year cost reports and is inflated in determining the direct medical education rate.

  • Project Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.2 of Exhibit B to the ITP.

  • MEDICAL STAFF LEADER means any Medical Staff Officer, department chair, section chief, and committee chair.

  • Clean coal technology demonstration project means a project using funds appropriated under the heading “Department of Energy—Clean Coal Technology,” up to a total amount of $2,500,000,000 for commercial demonstration of clean coal technology, or similar projects funded through appropriations for the Environmental Protection Agency. The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.

  • Non-Participating Clinical Professional Counselor means a Clinical Professional Counselor who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.