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CMC Costs definition

CMC Costs means external Costs and direct and indirect internal Costs associated with meeting the chemistry manufacturing and control requirements of the FDA and corresponding requirements in the EU and other countries of the world.
CMC Costs means all costs incurred by or on behalf of either Party that are reasonably and directly allocable to the conduct of the CMC activities described in the Manufacturing Plan including costs of producing the Compound or Product used in non clinical studies and in Clinical Trials for the Clinical Development Plan (i.e. excluding Product used in Clinical Trial for Territory Specific Work or for Unsponsored Work). CMC Costs shall include internal costs and reasonable out-of-pocket costs actually incurred by each Party. For clarity, equipment and facility depreciation and other allocations of fixed assets in use to support the development of Products are considered reasonably allocable costs and not corporate overhead to the extent and for so long as such equipment, facility and fixed assets are directly used for the development of the Products and set forth in the Manufacturing Plan.
CMC Costs means all Out-of-Pocket Cost incurred by Pieris for manufacturing the Lead Product pursuant to Section 2.4.2.(a) (or Collaboration Product as applicable) as well as reasonable FTE Costs for managing the CMOs (with no premium or markup) in accordance with the applicable Joint Development Plan or Collaboration Plan and Joint Development Budget or Collaboration Budget.

Examples of CMC Costs in a sentence

  • Until such time, the CMC Costs shall be included as part of Shared Costs and shall be split among the Parties in accordance with its Agreed Percentage.

  • The final audit report shall be shared with both Parties at the same time and shall specify (a) whether any royalties paid by the audited Party during the audited period were correct and, if incorrect, the amount of any underpayment or overpayment and (b) whether any Phase 2 Development Costs or Collaboration CMC Costs reported by the audited Party during the audited period were correct and, if incorrect, the difference between the reported amounts and the amounts actually incurred.

  • Protagonist shall be responsible for one hundred percent (100%) of the Collaboration CMC Costs for the Phase 1 Activities incurred by either Party or any of their Affiliates, and Xxxxxxx shall be responsible for one hundred percent (100%) of the Collaboration CMC Costs for any Phase 3 Clinical Trial(s) incurred by either Party or any of their Affiliates.

  • XOMA would be responsible for conducting CMC Activities and providing certain clinical trial materials as set forth in Sections 6.4 and 6.5 with respect to the Lead Cardiometabolic Indications, and Servier shall be responsible for all CMC Costs associated therewith, subject to repayment of a portion of such costs under Section 8.5 following XOMA’s exercise of the Cardiometabolic Indications Option.

  • Each Party shall report to the other Party, within […***…] ([…***…]) days after the end of each Calendar Quarter, Development Costs, CMC Costs and Galapagos IP Costs incurred by such Party during such Calendar Quarter.

  • In addition, following such exercise, the Parties will share the CMC Costs incurred following the date of such exercise, for such Development in the Lead Cardiometabolic Indications, in accordance with the Manufacturing Plan, with XOMA responsible for [*] percent ([*]%) of such costs and Servier responsible for [*] percent ([*]%) of such costs.

  • Such Reconciliation Report shall include for such calendar quarter the (i) total Development Costs and total CMC Costs incurred by each Party, and each Party’s respective share thereof, and (ii) the net payment due from one Party to the other Party in accordance with this Section 3.6(b).

  • AbbVie shall be responsible for and shall bear all CMC Costs incurred by the Parties from the Effective Date through the completion of the POC Development Plans in excess of the first […***…] Dollars ($[…***…]) of CMC Costs paid by Galapagos.

  • Inhibrx shall provide Elpiscience with a written invoice of CMC Costs, and Elpiscience shall pay such invoices within thirty (30) days of receipt.

  • In the event that BioMedicines wishes Schering to develop or implement a different or improved synthesis for the manufacture of the Licensed Product and Schering agrees, all activities related to the development, scale-up, and validation of an improved synthesis would be conducted at the expense of BioMedicines, and would constitute CMC Development and the costs would be included as a part of CMC Costs.


More Definitions of CMC Costs

CMC Costs means the (a) [**] and (b) [**], in each case ((a) and (b)), [**] in conducting the CMC Development activities allocated to it in a CMC Plan, but [**] under this Agreement.
CMC Costs means all costs incurred by or on behalf of either Party that are [*]. CMC Costs shall include [*]. For clarity, [*].
CMC Costs means the FTE Costs (charged in accordance with Section 6.7) incurred, and the direct out-of-pocket costs recorded as an expense by a Party or any of its Affiliates after the Effective Date, during the Term of and pursuant to this Agreement that are specifically identifiable to CMC Development activities (including CMC Development activities performed by the Step-In Party pursuant to Section 3.14); provided, that such costs shall be included in “CMC Costs” only (i) to the extent consistent with the applicable Development Plan, or (ii) as otherwise mutually agreed by the Parties.
CMC Costs means all internal and external costs incurred by a Party or any of its Affiliates after the Restatement Date, during the Term of and pursuant to this Agreement in connection with performing its obligations under the CMC Plan.
CMC Costs has the meaning set forth on Exhibit A. **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
CMC Costs means all costs incurred by or on behalf of either Party that are reasonably and directly allocable to the conduct of the CMC Activities pursuant to the Manufacturing Plan, including (a) Manufacturing Costs related to Product used in non-clinical and clinical studies and (b) FTE Costs and reasonable out-of-pocket costs actually incurred by each Party. For clarity, equipment and facility depreciation and other allocations of fixed assets in use to support the Development of Products are considered reasonably allocable costs and not corporate overhead to the extent and for so long as such equipment, facility and fixed assets are directly used for the Development of the Products and set forth in the Manufacturing Plan.

Related to CMC Costs

  • 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.

  • 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:

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

  • Direct Costs means the sum of the following:

  • 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, the Follow-On Research Plan, the Medical Affairs Plan, the Manufacturing Plan, the Quality Agreement, any Global Commercialization Plan or any Regional Commercialization Plan, as applicable, and (b) the FTE Rate.

  • 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.

  • Production Costs means the cost of the following:

  • 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.

  • 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.

  • Patent Expenses means all reasonable costs (including attorneys’ and application fees) incurred by University in accordance with this Agreement to apply for, prosecute and maintain Licensed Patents, including but not limited to the costs of interferences, oppositions, inter partes review and re-examinations. Patent Expenses include reimbursement for in-house costs provided they are for activities that would otherwise have been performed by outside counsel at an equal or greater expense.

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

  • 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.

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

  • Excess Costs means, in any Computation Period, the excess of Chargeable Costs associated with Assignee Minerals for that Computation Period over the amount determined by multiplying Assignor’s Net Share of Minerals produced during the Computation Period by the Sales Price for that Computation Period. Excess Costs shall bear interest at the Prime Interest Rate from the end of the Computation Period in which such costs were incurred to the date that Assignor recovers such amounts from Assignee Proceeds.

  • 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;

  • 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,

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

  • Project Expenses means usual and customary operating and financial costs. The term does not include extraordinary capital expenses, development fees and other non-operating expenses.

  • 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.

  • Sales Costs means costs associated with the sale including the cost of advertising, sale direct and indirect costs related to notification such as the cost of any reports required to determine the names of persons having an interest in the property or the status of the property, printing, postage, advertising, posting of the property, title insurance and staff salaries, benefits and overhead costs directly expended to complete the sale.

  • 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.

  • 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;

  • 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.

  • 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.

  • Prime costs and “Prime cost sum” means the amount actually paid by the contractor for any article, commodity or special work and shall include all proper charges for packing, carriage and delivery to site, after deduction of all trade documents, rebates and allowances and the discount obtainable for cash insofar as such discount for cash exceeds 2½%.

  • Initial Costs means all costs incurred by the Authority relating to the establishment and initial operation of the Authority, such as the hiring of a Chief Executive Officer and any administrative staff, any required accounting, administrative, technical and legal services in support of the Authority’s initial formation activities or in support of the negotiation, preparation and approval of power purchase agreements. The Board shall determine the termination date for Initial Costs.