Medical Affairs Costs Sample Clauses

Medical Affairs 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. Medivation shall be responsible for fifty percent (50%) and Astellas shall be responsible for fifty percent (50%) of Joint Medical Affairs Costs; provided that the costs of Voluntary Phase 4 Clinical Trials shall be allocated in a manner consistent with the allocation of costs of Non-Clinical Studies and Clinical Trials under Section 3.3. Notwithstanding the amounts allocated to Medical Affairs Activities in the applicable Joint Medical Affairs Budget, for any calendar year, Astellas and Medivation shall each be permitted to recover Joint Medical Affairs Costs with respect to such Party’s Medical Affairs Activities for such year covered in the Joint Medical Affairs Budget in excess of the amount allocated therein (a) by up to [*] of the amount so allocated, but solely to the extent such overage was outside the reasonable control of the applicable Party and was not attributable to a failure by the applicable Party to use commercially reasonable efforts to adequately supervise any Third Party performing such activities or (b) with the unanimous approval of the JMAC, which approval may be granted either in advance of such costs being incurred or retroactively. 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. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the securities and exchange commission pursuant to rule 24b-2 of the securities exchange act of 1934, as amended.
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Medical Affairs Costs. 4.4.1 Profit-Share Territory. Subject to Section 9.4 (Sage Opt-Out), Xxxx will be responsible for fifty percent (50%) and Biogen will be responsible for fifty percent (50%) of all Joint Medical Affairs Costs in support of the Licensed Products for the Profit-Share Territory. 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.
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Medical Affairs Costs. Except as otherwise set forth in the Medical Affairs Strategy or unanimously agreed by the JMC, each Party shall solely bear all costs and expenses incurred by such Party in conducting Medical Affairs for Products.
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Medical Affairs Costs. (a) Medical Affairs Costs incurred during the Term by the Parties prior to obtaining Regulatory Approval for any given Licensed Product in any given country shall be borne [*], subject to clause 8.4.
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Medical Affairs Costs. Each Party shall be responsible for fifty percent (50%) of all Out-of-Pocket Costs and all Medical Affairs FTE Costs incurred by the Parties to conduct Medical Affairs Activities in accordance with the Medical Affairs Plan and the Medical Affairs Budget (the “Medical Affairs Costs”). Medical Affairs Costs shall initially be borne by the Party incurring the cost or expense, and thereafter shall be subject to reimbursement as provided in this Section 4.2.7. Each Party shall report to the JMAC, within [**] days after the end of each Calendar Quarter, an estimate of the Medical Affairs Costs incurred by such Party during such Calendar Quarter, with a final report submitted to the JMAC for such costs within [**] days after the end of each Calendar Quarter. Such report shall specify in reasonable detail all amounts incurred during such Calendar Quarter (broken down by activity).
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Medical Affairs Costs 
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Related to Medical Affairs Costs

  • Professional Development Reimbursement Management will provide reimbursement for approved professional development expenses for Lieutenants and Sergeants. Funds may be used for the purpose of improving job performance, maintaining and increasing proficiency, preparing Lieutenants and Sergeants for greater responsibility, or increasing promotional opportunities. Management must approve of the specific professional development request in advance. Denial will require written notification to the requesting Lieutenant or Sergeant.

  • Development Costs With respect to activities prior to the Amendment Effective Date, each Party was to pay [*] of the total Direct Development Costs of a Product incurred in accordance with the Development Budget (as defined in the Original Agreement). Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, with respect to activities on and after the Amendment Effective Date, subject to Sections 3.1.2, Alimera will be solely responsible for, and shall pay one hundred percent (100%) of, all development costs of a Product, including Direct Development Costs. Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, (i) all payments owing by CDS hereunder with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by CDS (or waived, to the extent such waiver may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original Agreement), further including any penalties and interest which might have accrued with respect thereto, and further including all CDS payments deferred pursuant to that February 11, 2008 letter agreement sent by CDS and executed by CDS and Alimera regarding deferral of payments under the Original Agreement as of such date; (ii) all payments owing by Alimera hereunder with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by Alimera (or waived, to the extent such waiver may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original Agreement), and further including any penalties and interest which might have accrued with respect thereto; and (iii) subject to Sections 3.1.1 and 3.1.2, from and after the Amendment Effective Date, CDS will have no liability whatsoever hereunder for any past, present or future development costs, including Direct Development Costs (which includes those incurred before, on and after the Amendment Effective Date), and instead Alimera shall have sole liability therefor.

  • Medical Expenses 1. Employees exposed to hazardous physical, biological, or chemical agents shall be provided, at no cost to the employee, with medical examinations or evaluations required by VOSHA regulations. If there are no specific VOSHA regulations or standards for the agent in question, recommendations of the National Institute of Occupational Safety and Health or other generally recognized expert organization shall be used, as determined by the Commissioner of Health.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • PROFESSIONAL DEVELOPMENT AND EDUCATIONAL IMPROVEMENT A. The Board agrees to implement the following:

  • Regulatory Affairs Development and production of medical products and processes fall under the purview of the Food and Drug Administration (FDA) and research on these products involving animal or human studies is regulated by other laws, directives, and regulations. Project Awards under this Agreement that involve work in support of or related to FDA regulatory approval will address contingencies for Government access to regulatory rights in the event of product development abandonment or failure. Efforts conducted under this OTA shall be done ethically and in accordance with all applicable laws, directives, and regulations. The Government shall ensure performance includes regulatory expertise and guidance for candidate medical countermeasure development efforts:

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Development Responsibilities Unless the Parties agree in writing upon an alternate allocation of responsibility, the Parties shall have the following rights and obligations with respect to operational responsibilities under each Development Plan:

  • Professional Development Program (a) The parties agree to continue a Professional Development Program for the maintenance and development of the faculty members' professional competence and effectiveness. It is agreed that maintenance of currency of subject knowledge, the improvement of performance of faculty duties, and the maintenance and improvement of professional competence, including instructional skills, are the primary professional development activities of faculty members.

  • Professional Development Plan Professional Development Plan (PDP) refers to plans developed by faculty members addressing the criteria contained in Article 22 and Appendix G.

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