CMC Development Costs definition

CMC Development Costs means, with respect to the Product, the internal costs and direct out-of-pocket costs that are incurred by a Party or any of its Affiliates on or after the Effective Date that are directly attributable or reasonably allocable to CMC Development activities undertaken directly or indirectly by such Party or its Affiliates with respect to the Product, in each case, determined in accordance with the Collaboration Accounting Standards, including the costs incurred by a Party or its Affiliates directly attributable or reasonably allocable to the establishment (but not the on-going supply costs) of site(s) for the Manufacture of Product.
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CMC Development Costs has the meaning set forth in Schedule 1.8.
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CMC Development Costs means, with respect to any CMC Development activities that are not Phase 1A Activities or XXX-000 Xxxxx 0X Activities, the reasonable, attributable and required internal costs and reasonable, documented Third Party costs incurred by a Party or its Affiliates in performing such activities.
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Examples of CMC Development Costs in a sentence

  • BioNTech shall be solely responsible for, and shall bear, all CMC Development Costs incurred by or on behalf of BioNTech or Genentech in the performance of activities pursuant to a RNA Manufacturing Project.

  • Protagonist shall be responsible for twenty percent (20%) and Xxxxxxx shall be responsible for eighty percent (80%) of Phase 2 Development Costs and Phase 2 CMC Development Costs (with respect to a Party, such percentage is referred to as its [ * ] = 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 Act of 1934, as amended.

  • Costs related to Development (Development Costs as herein defined), to CMC Development (CMC Development Costs as herein defined), and other costs related to Manufacturing Improvements or to carrying out the Manufacturing Plan shall all be subject to verification according to the principles and practices described in this Section 8.10.

  • Document the specific authority and responsibility (e.g., to contractor, project technical lead, customer) for aspects of the products development, identified while defining the scope.

  • For clarity, and without limiting the treatment of CMC Development Costs as Development Costs, the portions of the existing Joint Development Plan and Joint Budget relating to Manufacturing or CMC Development will not become part of the Global Development Plan pursuant to this Section 2.3.2, and will instead become part of the Global Manufacturing Plan as addressed in Section 6.2.

  • Neither Shared Development Costs nor Shared CMC Development Costs will be included in Allowable Expenses for purposes of calculating U.S. Pre-Tax Profits and Losses, and any amounts included in Allowable Expenses will not be included in Shared Development Costs or Shared CMC Development Costs.

  • For clarity, all Phase 1 Development Costs and Phase 1 CMC Development Costs for any Xxxxxxx Xxxxx 0 Clinical Trial shall be borne solely by Xxxxxxx.

  • Protagonist shall be responsible for one hundred percent (100%) of the Phase 1 Development Costs and Phase 1 CMC Development Costs for the Initial Product.

  • For clarity, and without limiting the treatment of CMC Development Costs as Development Costs, the portions of the existing Joint Development Plan and Joint Budget relating to Manufacturing or CMC Development will not become part of the Global Development Plan pursuant to this Section ​ [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and is the type of information that we treat as private or confidential.

  • Protagonist shall be responsible for twenty percent (20%) and Xxxxxxx shall be responsible for eighty percent (80%) of Phase 2 Development Costs and Phase 2 CMC Development Costs for the Initial Product and for the first Phase 2 Clinical Trial to be conducted for each of the first two 2nd Generation Compounds (with respect to a Party, such percentage is referred to as its “Specified Phase 2 Percentage”).


More Definitions of CMC Development Costs

CMC Development Costs means Out-of-Pocket Costs incurred by a Party or its Affiliates or Subcontractors in connection with CMC Development, including all costs for materials (including vector and raw materials) acquired or used for any of the foregoing.
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CMC Development Costs means CMC Development FTE Costs and Out-of-Pocket Expenses incurred by each Party and its Affiliates in conducting activities under a CMC Development Plan. CMC Development Costs shall exclude
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CMC Development Costs means, with respect to any CMC Development activities that are not Phase 1A Activities or PTG-200 Phase 2A Activities, the reasonable, attributable and required internal costs and reasonable, documented Third Party costs incurred by a Party or its Affiliates in performing such activities.
Sample 1
CMC Development Costs means CMC Development FTE Costs and Out-of-Pocket Expenses incurred by each Party and its Affiliates in conducting activities under a CMC Development Plan. CMC Development Costs shall exclude (i) Shared Development Costs, (ii) Allowable Expenses, (iii) any payments made pursuant to the Profit Share Product Exhibit, (iv) capital expenditures for facility or equipment; provided, however, that Out-of-Pocket Expenses shall include capital expenditures for equipment used exclusively for the performance of activities under a CMC Development Plan and, then, only to the extent such capital expenditures are depreciable, and (v) costs attributable to general corporate activities, executive management, investor relations, treasury services, business development, corporate government relations, external financial reporting and other general and administrative overhead.
Sample 1
CMC Development Costs means, with respect to the Product, the [*] and [*] that are incurred by a Party or any of its Affiliates on or after the Effective Date that are directly [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and is the type of information that we treat as private or confidential. ​ attributable or reasonably allocable to CMC Development activities undertaken directly or indirectly by such Party or any of its Affiliates with respect to the Product anywhere in the Territory, in each case, determined in accordance with the Collaboration Accounting Standards; provided, that the costs incurred by a Party or any of its Affiliates directly attributable or reasonably allocable to the establishment (but not the ongoing supply costs) of site(s) for the Manufacture of Product shall [*]. ​
Sample 1

Related to CMC 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.

  • 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.

  • 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.

  • 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 Project means a project for the development of land within a project area.

  • 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;

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

  • Patent Costs means the reasonable fees and expenses paid to outside legal counsel, and filing, maintenance and other reasonable out-of-pocket expenses paid to Third Parties, incurred in connection with the Prosecution and Maintenance of Patent Rights.

  • 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;

  • Development Budget has the meaning set forth in Section 3.1.

  • 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.

  • 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.

  • Manufacturing Costs means, with respect to a given AquaBounty Product, the full-time equivalent costs (under a reasonable accounting mechanism to be agreed upon by the Parties) and out-of-pocket costs that AquaBounty or any of its Affiliates incurred in manufacturing such products, including costs and expenses incurred in connection with (a) the development or validation of any manufacturing process, formulations or delivery systems, or improvements to the foregoing; (b) manufacturing scale-up; (c) in-process testing, stability testing and release testing; (d) quality assurance/quality control development; (e) internal and Third Party costs and expenses incurred in connection with qualification and validation of Third Party contract manufacturers, including scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections; (f) packaging development and final packaging and labeling; (g) shipping configurations and shipping studies; and (h) overseeing the conduct of any of the foregoing. “Manufacturing Costs” shall further include: (i) to the extent that any such AquaBounty Product is manufactured by a Third Party manufacturer, the out-of-pocket costs incurred by AquaBounty or any of its Affiliates to the Third Party for the manufacture and supply (including packaging and labeling) thereof, and any reasonable out-of-pocket costs and direct labor costs incurred by AquaBounty or any of its Affiliates in managing or overseeing the Third Party relationship determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with US GAAP; and (ii) to the extent that any such AquaBounty Product is manufactured by AquaBounty or any of its Affiliates, direct material and direct labor costs attributable to such product, as well as reasonably allocable overhead expenses, determined in accordance with the books and records of AquaBounty or its Affiliates maintained in accordance with US GAAP.

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

  • Development Work means any work carried out in relation to the physical construction of a mine;

  • FTE means full-time equated.

  • FTE Costs means the FTE Rate multiplied by the applicable number of FTEs who perform a specified activity pursuant to this Agreement.

  • Public improvement costs means the costs of:

  • Economic Development Property means those items of real and tangible personal property of the Project which are eligible for inclusion as economic development property under the FILOT Act and this Fee Agreement, and selected and identified by the Company or any Sponsor Affiliate in its annual filing of a SCDOR PT-300S or comparable form with the Department (as such filing may be amended from time to time) for each year within the Investment Period.

  • Project Costs means the costs of the construction, acquisition or equipping of the Project, as further described in the Project Budget, and such other costs as may be approved in writing by the Department, provided such costs are permitted by the Act.

  • 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.

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

  • Routine Patient Costs means all health care services that are otherwise covered under the Group Contract for the treatment of cancer or other Life-threatening Condition that is typically covered for a patient who is not enrolled in an Approved Clinical Trial.

  • 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;