Cost of Goods Manufactured definition

Cost of Goods Manufactured means one hundred percent (100%) of Obligor’s fully burdened Manufacturing cost of any Commercial Capsule incorporated into a Licensed Product, including but not limited to the cost of goods produced as determined by the Person performing (or contracting with a Third Party to perform) each stage of the Manufacturing process, including but not limited to facility costs, depreciation of capital expenditures, direct labor and equipment costs, material costs, product quality assurance/control costs (including testing), process improvements, manufacturing scale-up, manufacturing site qualification, manufacturing support costs conversion costs and overhead costs, all to the extent reasonably attributable to the Manufacture of such Commercial Capsules, as well as any other costs borne by the Manufacturing Person for transport, customs clearance and storage of Commercial Capsules, and inventory adjustments incurred in the normal course of business; provided, however, that “Cost of Goods Manufactured” shall not include the cost of any Protein and shall not exceed $[***] per Commercial Capsule. The Cost of Goods Manufactured shall exclude all costs of manufacturing any other components of Licensed Products other than the Commercial Capsule, such as but not limited to any Inhalers and kit components, and all final packaging for Commercial Capsules or Licensed Products. All components of Cost of Goods Manufactured shall be calculated in accordance with the applicable Person’s internal accounting policies and principles, which shall be in accordance with U.S. GAAP and applied consistently.
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Cost of Goods Manufactured means costs to produce Clinical Trial Materials and/or commercial supplies of Product to the extent that such costs would ordinarily be included as a Cost of Goods sold in accordance with U.S. generally accepted accounting principles, including: [***];
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Cost of Goods Manufactured means, with respect to a Product, [**].
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Examples of Cost of Goods Manufactured in a sentence

  • ZOGENIX shall be the exclusive supplier of all of DESITIN’s requirements for Clinical Trial Materials in the Territory at ZOGENIX’s Cost of Goods Manufactured.

  • Concepts of Asset, Cost, Expense, and Loss; Classification of Costs; Cost Centre and Cost Unit; Cost Object; Cost Accounting Cycle; Factory Cost Flow; Statement of Cost of Goods Manufactured and Sold; Income Statement.

  • From and after the Effective Date, principal and interest under the Note shall be paid by the Obligor to the Lender in quarterly installments on each Quarterly Due Date, commencing on the first Quarterly Due Date following the Effective Date, in an amount equal to the Cost of Goods Manufactured for Commercial Capsules sold during such Calendar Quarter as reported on the Quarterly Sales Report (each, a “Payment” and collectively, the “Payments”).

  • In addition during such [***] period, the Parties will amend this Agreement to add the “Cost of Goods Manufactured” definition set forth in the Security Agreement so as to provide for reporting of the number of units of Commercial Capsules sold and their Cost of Goods Manufactured pursuant to Section 5.4, and to provide for the audit of Cost of Goods Manufactured and payments made under the Security Agreement and Promissory Note pursuant to Section 8.1.

  • Learning Outcomes: • Classify costs as fixed, variable or mixed and prepare a Statement of Cost of Goods Manufactured.

  • From the Schedule of Cost of Goods Manufactured in Requirement 1.

  • The schedule in 2-34 can become a Schedule of Cost of Goods Manufactured and Sold simply by including the beginning and ending finished goods inventory figures in the supporting schedule, rather than directly in the body of the income statement.

  • Notwithstanding the foregoing, in the case of materials supplied to the Parties by either Party for use in clinical trials of R&D Candidates or Collaboration Products, the supplying Party shall charge to its R&D Account its Cost of Goods Manufactured for Clinical Supplies for such materials, as adjusted to account for customary and usual manufacturing cost variances allocable to such materials.

  • Costs included in Cost of Goods Manufactured For Sale are not subject to JSC approval as long as they are consistent with the definitions.

  • The costs to Beam for supply of such Terminated Reversion Product(s) from Verve shall be equal to Verve’s Cost of Goods Manufactured for such Terminated Reversion Product(s) [**].


More Definitions of Cost of Goods Manufactured

Cost of Goods Manufactured means costs to produce Clinical Trial Materials and/or commercial supplies of Product to the extent that such costs would ordinarily be included as a Cost of Goods sold in accordance with U.S. generally accepted accounting principles, including: (a) the amounts paid by ZOGENIX or its Affiliates for (i) manufacturing, filling and/or finishing Product, but excluding costs, charges and allocations related to or occasioned by unused manufacturing capacity, (ii) transporting, storing and insuring Product, and (iii) testing Product, including with respect to the foregoing subsections (i) – (iii), all taxes (other than income taxes) and customs duty charges imposed by governmental authorities with respect thereto; (b) to the extent not included in subsection (a), the direct costs and charges incurred by ZOGENIX or its Affiliates in connection with the manufacture, filling, finishing, testing, storing, insuring and transportation of the Product, including direct internal costs with respect thereto; (c) to the extent not included in subsection (a), ZOGENIX’s or its Affiliate’s intellectual property acquisition and licensing costs (including royalties) paid to Third Parties (i) directly allocable to the applicable Product to the extent that such intellectual property is required for the manufacture of such Product in the country of manufacture and (ii) actually incurred by ZOGENIX or its Affiliates and not otherwise reimbursed by or paid for by any Third Parties; and (d) to the extent not included in subsection (a), allocable depreciation, amortization and facilities costs (e.g., sewer, water, property taxes), with any such allocations made on the basis of theoretical full capacity operation of the relevant facility, adjusted for changeovers in production runs, and excluding costs and charges related to or occasioned by (i) unused manufacturing capacity not reserved for the production of Product; (ii) the manufacture of other products at the manufacturing party’s facilities, and (iii) allocation of general corporate overhead;
Sample 1
Cost of Goods Manufactured means the cost to produce a given quantity of Licensed Product by a Party or its Affiliate, as calculated in accordance with Schedule 1.39, including taking into account in such calculation any other capital expenditure, costs and expenses approved as Cost of Goods Manufactured under Section 3.4.2(o). 1.40 “Develop” means (a) to research, develop, analyze, test and conduct non-clinical, preclinical (including GLP Tox Studies), clinical and all other regulatory studies and trials for a Licensed Compound or the Licensed Product, as applicable, including new indications and new combinations, (b) all activities pertaining to CMC Development and formulation development (including new formulations), (c) all other activities related to securing and maintaining Marketing Authorization for a Licensed Compound or the Licensed Product, as applicable, and regulatory activities in connection therewith and (d) medical affairs activities for the Licensed Product. Development may also include the foregoing activities, if any, with respect to any Companion Diagnostic, which activities, if any, shall be set forth in the relevant Development Plan with respect to a Companion Diagnostic for a Licensed Compound or the Licensed Product, as applicable. “Developing” and “Development” shall have correlative meanings. 1.41 “Development Budget” means the budget for the Development of the Licensed Product for the Territory, as set forth in the applicable Development Plan, as the same may be amended from time to time in accordance with this Agreement. 1.42 “Development Costs” means the sum of (a) Development FTE Costs and Medical Affairs FTE Costs and (b) out-of-pocket costs and expenses, incurred by a Party or any of its Affiliates in connection with the Development of a Licensed Compound or the Licensed Product in the Territory, in each case, that are (i) incurred on or after the Effective Date, (ii) incurred as an expense in accordance with the applicable Party’s Accounting Standards of such Party and (iii) directly attributable or reasonably allocable to a Licensed Compound or the Licensed Product for the Territory, including, for clarity, those that are directly attributable or reasonably allocable to the Development of a Proprietary Combination pursuant to this Agreement and the Development Plan (and, for clarity, any such costs associated with the Development of a Proprietary Combination pursuant to this Agreement and the Development Plan shall be fully allocated to the Licensed...
Sample 1
Cost of Goods Manufactured means the fully allocated cost of manufacturing the Licensed Product or Licensed Compound, calculated in a manner that is consistent with the Lead Manufacturing Party’s standard practices for its products, consistently applied and in accordance with Accounting Standards, and consisting of the following components: [ * ] {2 pages omitted} [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED Schedule 1.133 SeaGen Existing CMO Agreements [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED Schedule 1.134 SeaGen Existing In-Licenses [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED Schedule 1.139 SeaGen Patents (see attached) [ * ] {30 pages omitted} [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED Schedule 1.152 SGN-LIV-1-A [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED Schedule 1.153 SGN-LIV-1-B [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED Schedule 1.154 SGN-LIV-1-C [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED Schedule 2.7 Permitted Distributor Countries [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED
Sample 1
Cost of Goods Manufactured means (i) For Clinical Collaboration Products and Clinical Contributed Products, the sum of (a) any royalties or other payments payable to a Third Party for the manufacturing of a Clinical Collaboration Product and Clinical Contributed Product and (b) the Process Development/Manufacturing Expenditures; and (ii) For Commercial Collaboration Products and Commercial Contributed Products, the sum of (a) any royalties or other payments payable to a Third Party for the manufacturing or sale of a Commercial Collaboration Product and Commercial Contributed Product and (b) Standard Costs; and (iii) In any event, excluding all Development Expenditures, Regulatory Expenditures, Commercial Expenditures and Other Allowed Expenditures; provided, that Cost of Goods Manufactured may be charged by the Party that incurred such costs [**] Expenses incurred for manufacture of Commercial Collaboration Products that are [**]. Expenses incurred for manufacture of Commercial Collaboration Products that are [**]. The per-unit cost of Commercial Collaboration Products will be calculated pursuant to the terms of this Exhibit B and Section 6.4(d) of the Agreement.
Sample 1
Cost of Goods Manufactured means, with respect to a Licensed Product, such Party’s Fully Absorbed Standard Cost to produce such Licensed Product. The Parties agree that the following costs (plus or minus, as the case may be) will not be included in the calculation of Cost of Goods Manufactured: (a) the Party’s costs for product inventory adjustments and losses and (b) any manufacturing cost variances allocable to such Licensed Products.
Sample 1

Related to Cost of Goods Manufactured

  • Cost of Goods means the fully burdened cost to manufacture Compound or Drug Product, as applicable, (the “Supplied Product”) which means: (a) [ * ]; and (b) in the case of [ * ]. Actual unit costs shall consist of [ * ].

  • Cost of Goods Sold means [ * ].

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

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Manufacturing Cost means ***

  • Tobacco products means cigars, cigarettes, cheroots, stogies, periques, granulated, plug cut, crimp cut, ready rubbed, and other smoking tobacco, snuff, snuff flour, moist snuff, cavendish, ping and twist tobacco, fine-cut and other chewing tobaccos, shorts, refuse scraps, clippings, cuttings and sweepings of tobacco, and other kinds and forms of tobacco, prepared in such manner as to be suitable for chewing or smoking in a pipe or otherwise, or both for chewing and smoking.

  • 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:

  • Supply of goods means the transfer of the right to dispose of tangible property as owner.

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

  • Hemp products means all products made from industrial hemp,

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

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

  • Finished Goods means units of a manufactured product awaiting sale.

  • 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:

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

  • 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 [***].

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

  • shipped includes removal from the work sites by ship or any other means;

  • API means the American Petroleum Institute.

  • Manufactured or “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 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.

  • Locally manufactured goods means goods whose value, either in whole or in part, is derived from growing, producing, processing, assembling, or manufacturing activities that occur within a city-based manufacturer's facility located within the city.

  • Manufactured good means a good brought to the construction site for incorporation into the building or work that has been--

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

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