COSTS OF MANUFACTURING definition

COSTS OF MANUFACTURING means, with respect to each Product manufactured by a Party, the fully burdened and fairly allocable costs consistent with U.S. generally accepted accounting principles of the relevant Party and its Affiliates, on a consolidated basis, of manufacturing such Product, including: (a) depreciation or amortization of capital expenditures related thereto and a fair charge for direct costs (including, but not limited to, standard costs and variances from standard costs); (b) the reasonable cost of any excess or idle capacity not otherwise employed and incurred at a facility of such Party that is completed and licensed by the appropriate authorities for production of such Product to the extent that such capacity has been approved by the Parties pursuant to Section 9.4(e); (c) normal yield losses which arise under efficient and normal production operation conditions; (d) reasonable costs for process development and improvement following commercialization; (e) indirect costs (including, but not limited to, reasonable general and administrative costs associated with manufacturing, factory and facilities overhead, quality assurance and control, engineering, production administration and Allocable Overhead); (f) royalties to Third Parties for technology needed for the manufacture of such Product; and (g) costs of testing rejected or returned Products. Such costs shall be determined by the relevant Party in accordance with its internal accounting systems and methodologies and generally accepted accounting principles, as applied on a consistent basis.
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Examples of COSTS OF MANUFACTURING in a sentence

  • SUCH INVENTORIED COSTS INCLUDE DIRECT COSTS OF MANUFACTURING, ENGINEERING AND TOOLING, AND ALLOCABLE OVERHEAD COSTS INCLUDING GENERAL AND ADMINISTRATIVE EXPENSES ALLOWABLE IN ACCORDANCE WITH UNITED STATES GOVERNMENT CONTRACT COST PRINCIPLES.

Related to COSTS OF MANUFACTURING

  • Manufacturing Costs means [***].

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • 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.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • 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:

  • Manufacturing Process means any process for—

  • Date of manufacture means the date on which the food becomes the product as described;

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Manufacturing Cost means [***].

  • 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 [***].

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Finished Products means the fully assembled and shrink-wrapped Licensed Products, each including a Game Cartridge, Game Cartridge label and Printed Materials.

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Field means all fields of use.

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • 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.

  • Clinical Supply Agreement shall have the meaning set forth in Section 7.2.

  • 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: