Fully Allocated Manufacturing Costs definition

Fully Allocated Manufacturing Costs shall be as defined in Exhibit 1.22.
Fully Allocated Manufacturing Costs means
Fully Allocated Manufacturing Costs or “FAMC” for Generic Product shall have the meaning set forth in Exhibit E.

Examples of Fully Allocated Manufacturing Costs in a sentence

  • In order to determine the average, each Party shall provide to the other Party its Fully Allocated Manufacturing Costs on an annual basis which shall be subject to audit by the other Party in accordance with Section 6.12(f).

  • Each processor has an internal 32-bit counter that can be directly accessed by the ALU with specific instruction.

  • Duramed shall keep complete and accurate records, consistent with GAAP, of the Fully Allocated Manufacturing Costs and API Costs.

  • The related risk factors were observed to distribute significantly between ANC attendees and the GP of males showing both to have a high-risk profile.

  • The fee payable by Idenix to NPC for Packaging the Bulk Product and conducting its other activities in accordance with this Packaging Agreement shall be equivalent to the total of (i) Fully Allocated Manufacturing Costs, and (ii) and a xxxx-up of [**] percent ([**]%) of the Fully Allocated Manufacturing Costs (collectively, the "Fee").

  • The term Overheads shall be construed in accordance with meaning attributed to it under Appendix 5 — Fully Allocated Manufacturing Costs.

  • The fee payable by Idenix US to Novartis for Finishing the API into the LdT Finished Product shall be equivalent to the total of (i) Fully Allocated Manufacturing Costs, and (ii) a xxxx-up of [**] percent ([**]%) of the Fully Allocated Manufacturing Costs.


More Definitions of Fully Allocated Manufacturing Costs

Fully Allocated Manufacturing Costs or “FAMC” means:
Fully Allocated Manufacturing Costs means all of the direct and indirect costs of manufacturing a given Licensed Product (including rejected or failed batches), including but not limited to: (i) costs of direct materials (including raw materials, manufacturing materials, scrap, yield loss, materials usage and freight); (ii) direct production labor costs (including direct labor costs and related benefits) and salaries of administrators and managers overseeing the production of such Licensed Product (allocated on a systematic and rational basis); (iii) direct production costs (which could include among other costs: supplies, tooling, repairs and maintenance and depreciation); (iv) overhead costs associated with those activities that support production (including, but not limited to production supervision, indirect labor, purchasing, quality, engineering, facility, shipping & receiving) which are allocated based on a systematic and rational basis; (v) costs of handling, storing, analyzing, testing, formulating, finishing, packaging, inspecting labeling and preparing for shipment such Licensed Product; (vi) costs of depreciation of equipment used to produce, package, label or store such Licensed Product; (vii) costs of facilities (including portion of lease) systems and insurance which are allocated based on a systematic and rational basis; and (viii) quality control and quality assurance costs; provided, that such costs shall be computed by the manufacturer in a manner that is consistent with the then current methods and practices used by the manufacturer to determine the cost of other products manufactured by the manufacturer at its facilities, provided, further, that in any such case such methods are in accordance with U.S. GAAP consistently applied.
Fully Allocated Manufacturing Costs. Fully Allocated Manufacturing Costs shall mean with respect to the Finishing of the LdT Finished Product all direct and indirect costs and overhead allocable to the conduct of such activity in accordance with GAAP or IFRS, including but not limited to project and cost accounting consistently applied, such cost items to include, without limitation, costs of raw materials, supplies, other resources consumed in the conduct of such activity, rent, real estate depreciation, utilities, insurance, equipment lease payments, equipment depreciation and labor, plus general and administrative and similar expenses reasonably allocated to the conduct of such Finishing activities. For avoidance of doubt, it is expressly agreed that the API and costs and amounts detailed in Section 12.1 (a) below are specifically excluded from the items and costs which constitute a part of the Fully Allocated Manufacturing Costs.

Related to Fully Allocated Manufacturing Costs

  • Fully Burdened Manufacturing Cost means, with respect to any Licensed Product supplied by or on behalf of NVCR to Zai hereunder if such Licensed Product (or any precursor or intermediate thereof) is manufactured by a Third Party manufacturer [***].

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

  • Manufacturing Cost means ***

  • 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:

  • Combination Products means any product containing both a pharmaceutically active agent or ingredient which constitutes a Licensed Product and one or more other pharmaceutically active agents or ingredients which do not constitute Licensed Products.

  • Combination Product means any product that comprises a Licensed Compound or Licensed Product sold in conjunction with another active component so as to be a combination product (whether packaged together or in the same therapeutic formulation).

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • COGS means the cost of goods sold as determined in accordance with U.S.GAAP;

  • 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.

  • Developed exclusively at private expense means development was accomplished entirely with costs charged to indirect cost pools, costs not allocated to a government contract, or any combination thereof.

  • FTE Cost means, for any period, the FTE Rate multiplied by the number of FTEs in such period.

  • Annual Net Sales means, with respect to any Calendar Year, the aggregate amount of the Net Sales for such Calendar Year.

  • 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;

  • 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.

  • Reasonably Available Control Technology (RACT) means the lowest emission limit that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility. It may require technology that has been applied to similar, but not necessarily identical source categories.

  • Nondesignated country end product means any end product that is not a U.S.-made end product or a designated country end product.

  • Analytical x-ray equipment means equipment used for x-ray diffraction or fluorescence analysis.

  • FTE Costs means, for any period, the FTE Rate multiplied by the number of FTEs in such period.

  • Net Sales Price means the gross billing price of any PRODUCT received by Licensee or its SUBLICENSEE for the sale or distribution of any PRODUCT, less the following amounts actually paid by Licensee or SUBLICENSEE:

  • Net Sales Proceeds means, in the case of a transaction described in clause (i)(A) of the definition of Sale, the proceeds of any such transaction less the amount of selling expenses incurred by or on behalf of the Company, including all real estate commissions, closing costs and legal fees and expenses. In the case of a transaction described in clause (i)(B) of the definition of Sale, Net Sales Proceeds means the proceeds of any such transaction less the amount of selling expenses incurred by or on behalf of the Company, including any legal fees and expenses and other selling expenses incurred in connection with such transaction. In the case of a transaction described in clause (i)(C) of the definition of Sale, Net Sales Proceeds means the proceeds of any such transaction actually distributed to the Company or the Operating Partnership from the Joint Venture less the amount of any selling expenses, including legal fees and expenses incurred by or on behalf of the Company (other than those paid by the Joint Venture). In the case of a transaction or series of transactions described in clause (i)(D) of the definition of Sale, Net Sales Proceeds means the proceeds of any such transaction (including the aggregate of all payments under a Mortgage on or in satisfaction thereof other than regularly scheduled interest payments) less the amount of selling expenses incurred by or on behalf of the Company, including all commissions, closing costs and legal fees and expenses. In the case of a transaction described in clause (i)(E) of the definition of Sale, Net Sales Proceeds means the proceeds of any such transaction less the amount of selling expenses incurred by or on behalf of the Company, including any legal fees and expenses and other selling expenses incurred in connection with such transaction. In the case of a transaction described in clause (ii) of the definition of Sale, Net Sales Proceeds means the proceeds of such transaction or series of transactions less all amounts generated thereby which are reinvested in one (1) or more Assets within one hundred eighty (180) days thereafter and less the amount of any real estate commissions, closing costs, and legal fees and expenses and other selling expenses incurred by or allocated to the Company or the Operating Partnership in connection with such transaction or series of transactions. Net Sales Proceeds shall also include Refinancing Proceeds and any other amounts that the Company determines, in its discretion, to be economically equivalent to proceeds of a Sale. Net Sales Proceeds shall not include any reserves established by the Company, which shall be determined by the Board in its sole discretion.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • 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.

  • 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.

  • Least developed country end product means an article that—

  • Distillery manufacturing license means a license issued in accordance with