Manufacturing Standard Cost definition

Manufacturing Standard Cost means the standard cost per Unit of Product, calculated annually. This includes the cost of raw materials, labor, and other direct and identifiable variable costs and appropriate costs for equipment pools, plant operations and plant support services. The costs for plant operations and support services would include utilities, maintenance, engineering, safety, human resources, finance, plant management and other similar activities, as well as, shipping costs to a finished goods warehouse. The plant operations and support services costs would be allocated to Product consistent with generally accepted accounting principles in the United States (“GAAP”), based on budgeted volumes. Costs which cannot be identified to a specific activity supporting Manufacturing, such as charges for corporate overhead which are not related to Manufacturing, would not be included in Manufacturing Standard Cost hereunder.
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Manufacturing Standard Cost means the standard cost per Unit of Product, calculated annually. This includes the cost of raw materials, labor, and other direct and identifiable variable costs and appropriate costs for equipment pools, plant operations and plant support services. The costs for plant operations and support services would include utilities, maintenance, engineering, safety, human resources, finance, plant management and other similar activities, as well as, shipping costs to a finished goods warehouse. The plant operations and support services costs would be allocated to the Product consistent with generally accepted accounting principles in the United States (“GAAP”), based on total budgeted volumes produced by or on behalf of Auxilium. Costs which cannot be identified to a specific activity supporting Manufacturing, such as charges for corporate overhead which are not related to Manufacturing, would not be included in Manufacturing Standard Cost hereunder.
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Manufacturing Standard Cost means, with respect to Licensed Bispecific, clinical standard cost for such Licensed Bispecific as of the time of manufacture as calculated in a manner consistent with Amgen’s other products. For clarity, [***].
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Examples of Manufacturing Standard Cost in a sentence

  • The Bulk Product supplied for Development Activities shall initially be invoiced at the lower of (i) Auxilium’s prevailing Manufacturing Standard Cost to Manufacture the Bulk Product at the time Pfizer issued the relevant Purchase Order or (ii) [***] Dollars ($[***]) per Unit of Product (the “Development Supply Price”).

  • Pfizer shall have the right to audit the calculation of Auxilium’s prevailing Manufacturing Standard Cost or Incremental Costs of Manufacture, as applicable, to manufacture the Bulk Product as provided in Section 7.7.1. Such audit shall be carried out in the same manner as the audit provisions of Section 8.11 which shall apply mutatis mutandis, to both Parties to facilitate such right of audit.

  • Manufacturing Standard Cost (in the case of Product manufactured in KKC’s (or its designee’s) clinical manufacturing facility) or Manufacturing Actual Costs (in the case of Product manufactured in KKC’s (or its designee’s) non clinical (i.e., commercial) manufacturing facility) for Product manufactured by KKUS or its Affiliates and used as part of Development will be included in KKUS’s Global Development Costs at the time of manufacture of such Product.

  • Asahi shall have the right to audit the calculation of Auxilium’s prevailing Manufacturing Standard Cost of the Bulk Product.

  • Actelion shall have the right to audit the calculation of Auxilium’s prevailing Manufacturing Standard Cost.

  • Sobi shall have the right to audit the calculation of Auxilium’s prevailing Manufacturing Standard Cost.

  • Units of Product (as well as any placebo requested by Actelion) supplied for Development Activities shall be invoiced at Auxilium’s prevailing Manufacturing Standard Cost (and placebo, if applicable) at the time Actelion issued the relevant Purchase Order (the “Development Supply Price”).


More Definitions of Manufacturing Standard Cost

Manufacturing Standard Cost means the standard cost per Unit of Bulk Product, calculated annually in accordance with GAAP. This includes the cost of raw materials, labor, and other direct and identifiable variable costs and appropriate costs for equipment pools, plant operations and plant support services. The costs for plant operations and support services would include utilities, maintenance, engineering, safety, human resources, finance, plant management and other similar activities, as well as shipping costs to a finished goods warehouse. The plant operations and support services costs would be allocated to the Product consistent with GAAP, based on budgeted volumes. Costs which cannot be identified to a specific activity supporting Manufacturing, such as charges for corporate overhead which are not related to Manufacturing, would not be included in Manufacturing Standard Cost hereunder.
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Related to Manufacturing Standard Cost

  • Manufacturing Cost means [***].

  • 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.

  • 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;

  • Manufacturing Costs means [***].

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

  • 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.

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

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

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

  • Product Specifications means those product, labeling and performance specifications for the Product filed with and approved by the relevant Regulatory Authority, including Product formulae, labeling, and materials required for the manufacture of the Product that is to be purchased and supplied under this Agreement, as such are set forth on Schedule 1.25, which specifications may be amended by the Parties from time to time in accordance with this Agreement.

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

  • 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.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Manufacturing Process means any process for—

  • 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 Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

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

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.