Phase 4 Costs definition

Phase 4 Costs means those FTE Costs (charged in accordance with Section 6.9) (i) incurred and the direct out-of-pocket costs recorded as an expense in accordance with Accounting Standards by or on behalf of a Party or any of its Affiliates after the Effective Date, during the Term of and pursuant to this Agreement, and (ii) specifically identifiable or reasonably allocable to Phase 4 Studies, wherever Conducted, of a Co-Promotion Product in support of Commercialization of such Co-Promotion Product in the Co-Promotion Territory. Subject to the foregoing, Phase 4 Costs shall include (i) costs in connection with the preparation for, or Conduct of, Phase 4 Studies, data collection and analysis and report writing, and clinical laboratory work, (ii) related Regulatory Expenses, and (iii) related Manufacturing Costs; provided, that such Phase 4 Costs shall not be counted more than once as an Allowable Expense.
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Phase 4 Costs means all expenses incurred by either Party or for its account, and specifically attributable to: (a) direct support of the performance of a Phase 4 Trial for a Licensed Product; or (b) process development for a Licensed Product in a Phase 4 Trial. All Phase 4 Costs shall be treated as Post Launch R&D Expenses in accordance with Exhibit A.
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Phase 4 Costs means those FTE Costs and direct out-of-pocket costs recorded as an expense by or on behalf of a Party or any of its Affiliates or its (sub)licensees that are specifically identifiable or reasonably and directly allocable to Phase 4 Studies conducted in accordance with the applicable Registration Program Plan or Commercialization Plan, wherever conducted, of a Product. Phase 4 Costs that are shared by the Parties shall be limited to those activities that are specifically identified in the applicable Registration Program Plan or Commercialization Plan and subject to the applicable budget. Subject to the foregoing, Phase 4 Costs shall include (i) costs in connection with the preparation for, or conduct of, Phase 4 Studies, data collection and analysis and report writing, and clinical laboratory work, (ii) related Regulatory Expenses, and (iii) related Manufacturing Costs.
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Examples of Phase 4 Costs in a sentence

  • CENTRAL CRIMINAL COURT PLANT REPLACEMENT Appendix 1: Project Coversheet (Pages 229 – 232) Appendix 2: Risk Register (Pages 233 – 236) Appendix 3: Estimated Project Costs (Pages 237 – 238) Appendix 4: Detailed Breakdown of Phase 4 Costs (Pages 239 – 240) Appendix 5: Funding (Pages 241 – 242) Appendix 6: Chamberlain’s Financial Appraisal (Pages 243 – 244) Appendix 7: Tender Report (Pages 245 - 250) 30.

  • Phase 4- Costs should be estimated Even though cost estimation in information technology (IT) is intrinsically difficult, some effective methodologies are available to help quantify the total cost of ownership (TCO) and the strategic value of IT infrastructures.

Related to Phase 4 Costs

  • Cleanup costs means expenses (including but not limited to legal and professional fees) incurred in testing for, monitoring, cleaning up, removing, containing, treating, neutralizing, detoxifying or assessing the effects of Pollutants.

  • FTE Costs means the product of (a) the number of FTEs (proportionately, on a per-FTE basis) used by a Party or its Affiliates in directly performing activities assigned to such Party under and in accordance with the Global Development Plan, Commercialization Plan or Medical Affairs Plan, as applicable, and (b) the FTE Rate.

  • Start-Up Costs means all fees, costs, and expenses incurred in connection with establishing the State Mitigation Trust and the Indian Tribe Mitigation Trust and setting them up for operation. Start-up costs shall not include the cost of premiums for insurance policies.

  • 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.

  • Production Costs means those costs and expenditures incurred in carrying out Production Operations as classified and defined in Section 2 of the Accounting Procedure and allowed to be recovered in terms of Section 3 thereof.

  • 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:

  • Maintenance Costs means parts and materials, sublet and labour costs of a qualified licensed mechanic for the maintenance of the Revenue Service Vehicles, but shall not include costs associated with interior and exterior transit advertising signs and non-mechanical servicing of Revenue Service Vehicles such as fuelling, clearing fareboxes, cleaning and painting wheel rims, vehicle washing and other work performed by a serviceman; and,

  • Basic Costs means all direct and indirect costs and expenses incurred in connection with the Building as more fully defined in Exhibit C attached hereto.

  • 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;

  • Training costs means reasonable costs incurred to upgrade the technological skills of Full-Time Employees in Illinois and includes: curriculum development; training materials (including scrap product cost); trainee domestic travel expenses; instructor costs (including wages, fringe benefits, tuition and domestic travel expenses); rent, purchase or lease of training equipment; and other usual and customary training cots. “Training costs” do not include, except where the Company receives prior written approval of the Department, costs associated with travel outside the United States, wages and fringe benefits of employees during periods of training, administrative costs related to Full-Time Employees of the Taxpayer, or amounts paid to an affiliate of the Company.

  • 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:

  • Program Costs means all necessary and incidental costs of providing program services.

  • O&M Costs as defined in the Depositary Agreement.

  • Project Costs means all allowable costs, as set forth in the applicable Federal cost principles, incurred by a recipient and the value of the contribu- tions made by third parties in accom- plishing the objectives of the award during the project period.

  • Exploration Costs means costs incurred in identifying areas that may warrant examination and in examining specific areas that are considered to have prospects that may contain oil and gas reserves, including costs of drilling exploratory wells and exploratory type stratigraphic test wells. Exploration costs may be incurred both before acquiring the related property and after acquiring the property. Exploration costs, which include applicable operating costs of support equipment and facilities and other costs of exploration activities, are:

  • Soft Costs means the costs of professional work and fees, interim costs, financing fees and expenses, syndication costs, soft costs and Developer’s fees as shown in the Applicant’s properly completed UniApp, Section C - Uses of Funds. Soft Costs do not include operating or replacement reserves.

  • Overhead costs means the actual costs incurred or the estimated costs to be

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

  • Operating Costs means the incremental expenses incurred by the Recipient on account of Project implementation, management, and monitoring, including for office space rental, utilities, and supplies, bank charges, communications, vehicle operation, maintenance, and insurance, building and equipment maintenance, advertising expenses, travel and supervision, salaries of contractual and temporary staff, but excluding salaries, fees, honoraria, and bonuses of members of the Recipient’s civil service.

  • Development Charges or “DC” shall mean the amount charged by the Company from the Applicant(s) towards carrying out the developmental works inside or around the Project, including but not limited to the payment of the following:

  • Remediation Costs means the cost of any action taken to reduce the concentration of contaminants on, in or under the Eligible Property to permit a record of site condition to be filed in the Environmental Site Registry under section 168.4 of the Environmental Protection Act and the cost of complying with any certificate of property use issued under section 168.6 of the Environmental Protection Act, as further specified in the CIP.

  • Reimbursable Costs means expenses incurred by the employee in the course of engaging in the planned learning activity and include registration, tuition and examination fees as well as textbooks/discs and applicable taxes. They may also include reasonable, incremental meal, accommodation and travel expenses.

  • Direct Costs means the sum of the following:

  • Related Expenses means any and all costs, liabilities, and expenses (including, without limitation, losses, damages, penalties, claims, actions, reasonable attorney's fees, legal expenses, judgments, suits and disbursements) reasonably incurred by, or imposed upon, or asserted against, Lender in any attempt by Lender:

  • Operation and Maintenance Costs means the costs of:

  • Collection Costs means an amount that the Municipality can charge with regard to the enforcement of a consumer’s monetary obligations;