Phase 4 Development Costs definition

Phase 4 Development Costs means all costs incurred by or on behalf of a Party for the conduct of Phase 4 Clinical Trials of the Product for use in the Territory in accordance with the Development Plan and Development Budget. Phase 4 Development Costs include Development FTEs and out-of-pocket costs paid to Third Parties that are actually incurred by a Party to conduct Phase 4 Clinical Trials, including costs of Product or any comparator drug, costs relating to regulatory activities for such Phase 4 Clinical Trials including preparation, submission and review of Regulatory Materials with any Governmental Authority, and costs of CROs and other Third Parties engaged to conduct Phase 4 Clinical Trials, in each case as permitted under this Agreement.
Sample 1

Examples of Phase 4 Development Costs in a sentence

  • Within [*****] after each Calendar Quarter in which Anacor incurs Phase 4 Development Costs, Anacor shall provide to Sandoz an invoice for [*****] of all Phase 4 Development Costs incurred by Anacor in such Calendar Quarter, together with a detailed, activity-based statement thereof, to the extent that the aggregate Development Costs reimbursed by Sandoz for the Calendar Year containing such Calendar Quarter are less than or equal to [*****].

Related to Phase 4 Development Costs

  • 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 Cost means the total of all costs incurred in the completion of a Development excluding Developer Fee, operating deficit reserves, and total land cost as typically shown in the Development Cost line item on the development cost pro forma.

  • 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.

  • 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.

  • Total Development Cost means the total of all costs incurred in the completion of a Development, all of which shall be subject to the review and approval by the Credit Underwriter and the Corporation pursuant to this rule chapter, and as further described in Rule 67-48.0075, F.A.C.

  • Development Phase means the period before a vehicle type is type approved.

  • Development Project means a project for the development of land within a

  • Economic development project means land and existing or planned improvements suitable for use by an industrial or commercial enterprise, or housing development, or the protection of the environment, including, but not limited to, groundwater or surface water. Economic development project includes necessary buildings, improvements, or structures suitable for and intended for or incidental to use as an industrial or commercial enterprise or housing development; and includes industrial park or industrial site improvements and port improvements or housing development incidental to an industrial or commercial enterprise; and includes the machinery, furnishings, and equipment necessary, suitable, intended for, or incidental to a commercial, industrial, or residential use in connection with the buildings or structures.

  • Development Work means the work of development to be performed on or with respect to the Land (including, without limitation, the installation of utilities, roads and all related on-site and off-site improvements) in connection with the development of the Land for the subsequent construction thereon of Homes, all of which work and construction shall be completed by or on behalf of the Borrower in accordance with the Plans and Specifications, but shall not include the Construction Improvements.

  • Improvement Costs means any additional expenditure on a fixed asset that materially increases the capacity of the asset or materially improves its functioning or represents more than 10% of the initial depreciation base of the asset;

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • Development Budget means the cost categories listed on Pages 8 - 11 in Form 3 that are directly related to the proposed Project as submitted in the Application. Indirect or off-site costs not directly related to the development of the project are not valid or eligible costs.

  • Development Works means the external development works and internal development works on immovable property;

  • Annual Work Plan and Budget means the work plan and budget approved by the Bank and adopted by the Borrower in accordance with the provisions of Section I.C of Schedule 2 of this Agreement, as said work plan and budget may be modified from time to time with the written agreement of the Bank.

  • 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 Area means that area to which a development plan is applicable.

  • 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;

  • Manufacturing Costs means the costs of Processing that generate Manufacturing Proceeds received by Grantor.

  • 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.

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

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

  • 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;

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

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