Actual Manufacturing Cost definition

Actual Manufacturing Cost means those costs actually incurred by Lilly for the acquisition of materials and their conversion into salable Devices. Such costs include: (i) the landed cost of purchased materials, including without limitation, invoice price, outside processing costs, freight, duties, and brokers fees (volume or trade discounts will be reflected in the calculation); (ii) conversion costs (including, without limitation, direct labor and direct overhead) directly associated with the manufacturing of a Device; (iii) replacement costs for Devices that are determined to be defective or recalled during the quality control process or for Devices that are returned to Lilly from Amylin or the customer; (iv) an appropriate allocation of service and administrative departments performing functions which support Manufacturing operations directly associated with the Manufacturing of Devices, including those items as set forth on Exhibit A ; (v) depreciation of Device specific capital investments; (vi) depreciation of an allocation of general manufacturing equipment and facilities directly associated with Manufacturing of Devices; (vii) Device breakage; (viii) obsolete Devices; and (ix) to the extent attributable to the Manufacture of Devices, any other costs considered inventory costs or Costs of Products Sold under Generally Accepted Accounting Principles. All of these costs, and the methodology to be used in allocating indirect or overhead costs among Manufacturing operations hereunder and other Lilly manufacturing operations, shall be determined in a manner consistent with the internal methods used by Lilly for other products and consistent with Generally Accepted Accounting Practices in the U.S. The foregoing definition of Actual Manufacturing Cost assumes that Lilly uses Dedicated Capacity for primary equipment for the Manufacture of Devices. In the event that Lilly does not use Dedicated Capacity for primary equipment for the Manufacture of Devices, the Parties shall agree in good faith upon an appropriate allocation of costs associated with the Manufacture of Devices based on relative usage.
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Actual Manufacturing Cost is defined as the cost of a Saleable Unit of a Product, packaged and delivered according to the specifications set forth in this Commercial Offer, and is composed of: (i) Cost of all raw materials; (ii) Direct labor cost; and
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Actual Manufacturing Cost has the meaning ascribed to that term in Section 4.2(a);
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Examples of Actual Manufacturing Cost in a sentence

  • Except as set forth in Section 5.7 below, the Actual Manufacturing Cost of the rejected Devices, the Actual Manufacturing Cost of the replacement Devices and Amylin’s costs of return or disposal of rejected, non-conforming Devices shall be included in Cost of Product Sold for purposes of Article 4 of the Collaboration Agreement, unless and to the extent that such costs are a result of Lilly’s gross negligence or willful misconduct, in which event Lilly shall pay or reimburse such costs to Amylin in full.

  • Each Party will have the right to audit the other Party’s financial books and records relating to this Agreement and the calculation of Actual Manufacturing Cost under the same terms and in the same manner as set forth in Section 4.9(e) of the Collaboration Agreement.

  • Calculation of the Actual Manufacturing Cost will be consistent with the usual methodology utilized by Lilly to calculate Lilly’s Cost of Products Sold.

  • She said TID #3 is a distressed TID and receives funding from TID #6 and the city refinanced the 2003 and 2007 General Obligation Refunding Bonds in 2018.

  • Each Party will have the right to audit the other Party’s financial books and records relating to this Agreement and the calculation of Device Development Costs and Actual Manufacturing Cost under the same terms and in the same manner as set forth in Section 4.9(e) of the Collaboration Agreement.

  • The Parties agree that all components of the Actual Manufacturing Cost will be established on a commercially sound manner, and will not exceed the market value at which they could be obtained from an unrelated third party.

  • For each Contract Year, the actual Supply Price of Compound shall be equal to the Actual Manufacturing Cost of Nycomed in Euro per kilogram in the preceding Contract Year plus a base profit margin of [**] percent ([**]%) of such Actual Manufacturing Costs (hereinafter referred to as the "Actual Supply Price of Compound").

  • NEC shall provide full disclosure to Stratus of the Actual Manufacturing Cost of each Product under the Cost Bucket profile.

  • Stratus shall pay Actual Manufacturing Cost up to 1.5 times the Committed Cost for the relevant Joint Product.

  • Amylin will provide to Lilly a report containing a good faith estimate of the Actual Manufacturing Cost, in a format similar to and with the similar detail as set forth in Exhibit D, within [***] prior to the end of each [***].


More Definitions of Actual Manufacturing Cost

Actual Manufacturing Cost means NEC’s actual direct and substantiated costs of manufacture or procurement, including (a) cost of components and other materials, (b) cost of direct or subcontracted labor (assembly and test), (c) manufacturing overhead (including but not limited to material loading, warranty, EDP system, inventory, management overhead, rent or depreciation, as applicable, and utilities), and (d) headquarters overhead (but excluding, development, sales and marketing activities).
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Related to Actual Manufacturing Cost

  • Manufacturing Cost means ***

  • Manufacturing Costs means, with respect to a given AquaBounty Product, the full-time equivalent costs (under a reasonable accounting mechanism to be agreed upon by the Parties) and out-of-pocket costs that AquaBounty or any of its Affiliates incurred in manufacturing such products, including costs and expenses incurred in connection with (a) the development or validation of any manufacturing process, formulations or delivery systems, or improvements to the foregoing; (b) manufacturing scale-up; (c) in-process testing, stability testing and release testing; (d) quality assurance/quality control development; (e) internal and Third Party costs and expenses incurred in connection with qualification and validation of Third Party contract manufacturers, including scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections; (f) packaging development and final packaging and labeling; (g) shipping configurations and shipping studies; and (h) overseeing the conduct of any of the foregoing. “Manufacturing Costs” shall further include: (i) to the extent that any such AquaBounty Product is manufactured by a Third Party manufacturer, the out-of-pocket costs incurred by AquaBounty or any of its Affiliates to the Third Party for the manufacture and supply (including packaging and labeling) thereof, and any reasonable out-of-pocket costs and direct labor costs incurred by AquaBounty or any of its Affiliates in managing or overseeing the Third Party relationship determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with US GAAP; and (ii) to the extent that any such AquaBounty Product is manufactured by AquaBounty or any of its Affiliates, direct material and direct labor costs attributable to such product, as well as reasonably allocable overhead expenses, determined in accordance with the books and records of AquaBounty or its Affiliates maintained in accordance with US GAAP.

  • 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 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 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.

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

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

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

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

  • Net Sales means [***].

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

  • 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;

  • 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.

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

  • 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.

  • 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.

  • 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.

  • Cost of materials means the cost of components, parts or materials which are intended for the production, manufacturing or assembling of the goods bid for and which are not produced, manufactured or assembled in the factory where the production, manufacture or assembly of such goods occurs, including freight, landing costs, port charges, import duties and other import costs of such components, parts or materials and all costs in connection with the handling and transport thereof prior to delivery at that factory;

  • Net Sales Revenue shall have the meaning as set out in Schedule "A"

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

  • 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:

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

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

  • API means the American Petroleum Institute.