Post-Approval Research and Regulatory Expenses definition

Post-Approval Research and Regulatory Expenses means those expenses incurred, on a Product by Product and country by country basis, by either Party directly attributable to (a) ongoing research and development of a Product after such Product has received Regulatory Approval in such country of the Copromotion Territory, including, without limitation, Phase IV clinical studies and clinical studies in support of additional indications within the Field or labeling changes for such Product in such country and/or (b) complying with its regulatory reporting obligations in the Copromotion Territory in accordance with Section 5.4.
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Post-Approval Research and Regulatory Expenses means, on a Co-Developed Product-by-Co-Developed Product basis, costs directly attributable to (a) research and development of a Co-Developed Product after it has received Commercialization Regulatory Approval (including, without limitation, Phase IV clinical studies and clinical studies in support of additional indications or labeling changes for such Co-Developed Product) and (b) complying with regulatory reporting obligations, including, without limitation, Personnel Costs for (a) and (b).
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Post-Approval Research and Regulatory Expenses means (deleted text — detailed listing of cost components)
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Examples of Post-Approval Research and Regulatory Expenses in a sentence

  • Staff members involved in the training included, Administration Secretary, Chief Executive Officer and Senior Administration Officer.

  • Subject to reconciliation as provided in Sections 6.1.6(d) and 6.1.6(e), as applicable, each Party shall be responsible and pay for the Sales and Marketing Expenses, Third Party License Fees, Assigned Sales Force Adjustment Payment, Distribution Expenses, Post-Approval Research and Regulatory Expenses and Working Capital Charges incurred by it in performing its activities in connection with the Commercialization of Products in the Territory.

  • The Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses charged by either Party to its Marketing Account in accordance with this Section 6.1.8, shall not be in amount in excess of ********************* of the amount included for such expenses in the then current Annual Commercialization Plan and Budget, unless the MSC approves such excess expenses.

  • The Sales and Marketing Expenses, Distribution Expenses, Post-Approval Research and Regulatory Expenses and Working Capital Charges charged by either Party to its Marketing Account in accordance with this Section 6.1.6, shall not be in an amount in excess of *** of the amount included for such expenses in the then current Annual Commercialization Plan, unless the JSC approves such excess expenses.


More Definitions of Post-Approval Research and Regulatory Expenses

Post-Approval Research and Regulatory Expenses means ("deleted text").
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Related to Post-Approval Research and Regulatory Expenses

  • 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 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.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

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

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

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

  • Marketing Expenses means the sum of Marketing Management Expenses, Advertising and Market Research Expenses and Education Expenses.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • medium term expenditure framework ’ means a budgeting framework applied by the National Treasury which—

  • Research Budget has the meaning set forth in Section 2.2.

  • 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.

  • Marketing Costs which means such reasonable charge for marketing of ores and concentrates sold or of concentrates tolled as is consistent with generally accepted industry marketing practices;

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • 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.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.