Product Manufacturing Cost definition

Product Manufacturing Cost means the fully allocated cost which is the sum total of all production related costs for the Product (direct labor, direct materials, facility overhead and expenses which can be allocated to the Product, QA/QC and analytical charges, packaging and regulatory compliance costs for the Product including, but not limited to, stability and FDA fees) accounted for in accordance with United States General Accepted Accounting Principles.
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Product Manufacturing Cost means, with respect to a particular Product sold by PENINSULA (or its Affiliate or sublicensee) hereunder, the sum of: (a) either (i) the actual purchase price of the Compound from TAKEDA, if the Compound in such Product was purchased from TAKEDA, or (ii) [***] the actual out-of-pocket costs incurred, paid or borne by PENINSULA in the manufacture and quality check of the Compound, if PENINSULA manufactures or has a third party manufacture on its behalf the Compound included in such Product; plus (b) [***] the actual out-of-pocket costs incurred, paid or borne by PENINSULA to process the Compound into and package the Product and quality check (or have a third party contractor perform such processing and packaging). “Product Manufacturing Cost” in subclause (b) above may include [***] the actual purchase price of any raw materials other than the Compound and insurance payments relating thereto, provided that any such consideration is commercially reasonable. It is understood that any payment to third party(ies) by PENINSULA to obtain a license under such third party’s patent or other intellectual property rights without which license the above mentioned manufacturing, processing or packaging would constitute an infringement of such patents or other intellectual property rights, which shall be treated pursuant to Section 3.4, if any, shall not be included in the Product Manufacturing Cost. For clarity, the term “Product Manufacturing Cost” shall not include any royalty paid by PENINSULA to TAKEDA under Section 3.3 or to any Third Party.
Sample 1
Product Manufacturing Cost in subclause (b) above may include [ * ]% of the actual purchase price of any raw materials other than the Compound and insurance payments relating thereto, provided that any such consideration is commercially reasonable. It is understood that any payment to third party(ies) by PENINSULA to obtain a license under such third party's patent or other intellectual property rights without which license the above mentioned manufacturing, processing or packaging would constitute an infringement of such patents or other intellectual property rights, which shall be treated pursuant to Section 3.4, if [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. any, shall not be included in the Product Manufacturing Cost. For clarity, the term "Product Manufacturing Cost" shall not include any royalty paid by PENINSULA to TAKEDA under Section 3.3 or to any Third Party.
Sample 1

Examples of Product Manufacturing Cost in a sentence

  • A Typical Manufacturing Cost Statement Product Product Manufacturing Cost Statements Production Volume A – Variable CostItemFactorsUsageCostUnit CostRaw Material Intermediates Additives Utilities Direct labor Packaging Wastewater Treatment Total Variable cost B – Fixed CostItem In this typical cost statement “labour” or “material” costs are influenced by the environmental objectives.

  • For the avoidance of doubt, in the event the Product is supplied by Elan to Xxxxxx in final market packaged form, Product Manufacturing Cost shall include the fully allocated costs of packaging the Product into final market packaged form.


More Definitions of Product Manufacturing Cost

Product Manufacturing Cost means, with respect to a particular Product sold by PENINSULA (or its Affiliate or sublicensee) hereunder, the sum of: (a) either (i) [*] purchase price of the Compound from TAKEDA, if the Compound in such Product was purchased from TAKEDA, or (ii) [*] percent ([*]%) of the actual out-of-pocket costs incurred, paid or borne by PENINSULA in the manufacture and quality check of the Compound, if [*] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Sample 1
Product Manufacturing Cost in subclause (b) above may include [*]% of the actual purchase price of any raw materials other than the Compound and insurance payments relating thereto, provided that any such consideration is commercially reasonable. It is understood that any payment to third party(ies) by PENINSULA to obtain a license under such third party's patent or other intellectual property rights without which license the above mentioned manufacturing, processing or packaging would constitute an infringement of such patents or other intellectual property rights, which shall be treated pursuant to Section 3.4, if any, shall not be included in the Product Manufacturing Cost. For clarity, the term "Product Manufacturing Cost" shall not include any royalty paid by PENINSULA to TAKEDA under Section 3.3 or to any Third Party.
Sample 1
Product Manufacturing Cost means the actual cost to Manufacture the Product by Manufacturer (including any subcontractor) during each calendar year during the Term, including the related quality assurance and quality control activities as required by Applicable Laws, which actual cost shall be determined in accordance with GAAP, and shall include direct labor, direct material (including raw material and components supplied by Manufacturer but not including the Ordered Components), direct overhead (e.g. depreciation of a packaging line solely dedicated to the Product) and the allocable portion of the indirect Manufacturing overhead directly attributable to the Manufacture of the Product. The allocable portion of the Manufacturing overhead of the Facility shall be equal to [**]. Product Manufacturing Cost shall exclude selling, general and administrative, research and development, interest expenses, any and all debt service payments of Manufacturer, and any other costs not directly associated with the Manufacture of the Product, other than direct and indirect manufacturing overhead. The Parties agree that in no event shall the Product Manufacturing Cost include capital expenditures and improvements to or for the Facility, except as directly or indirectly allocated through Manufacturing overhead.
Sample 1
Product Manufacturing Cost means the fully allocated cost which is the sum total of all production related costs, packaging and labeling for the Product (direct labor, direct materials, facility overhead, other overhead and expenses, including but not limited to manufacturing charges for material adjustments, handling losses, physical adjustments, salvage and start-up costs, QA/QC and analytical charges, packaging and regulatory compliance costs for the Product including, but not limited to, stability and FDA fees), together with insurance costs accounted for in accordance with United States Generally Accepted Accounting Principles and in manner consistent with expenses and overhead allocated to other products manufactured by Elan.
Sample 1
Product Manufacturing Cost means the costs to Emisphere directly related to the manufacture of any Product, calculated in accordance with the provisions of Schedule 1.
Sample 1

Related to Product Manufacturing Cost

  • Manufacturing Cost means [***].

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

  • 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 Site means a location where a manufacturing

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

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

  • 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 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.

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

  • 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.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • 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.

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • 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.

  • 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.

  • 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;

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • API means American Petroleum Institute.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

  • Manufacturing Process means any process for—

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

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