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 means, with respect to Product:
Cost of Goods means, in respect of any PRODUCT, the amount paid by EAGLE to its contract manufacturer for the manufacturing and release of such finished PRODUCT including the cost of the active pharmaceutical ingredient, raw materials and packaging materials used in such finished PRODUCT.
Examples of Cost of Goods in a sentence
For clarity, access to such records also shall be provided to records related to Cost of Goods as described in Clause 15.
More Definitions of Cost of Goods
Cost of Goods means the total cost of Product in Final Packaging, including, but not limited to, the sum of the following actual costs: (i) manufacturing, shipping and storage of Enzyme; (ii) manufacturing, shipping and storage of Product, prior to sale to a Third Party; (iii) commercial packaging and labeling; (iv) routine quality compliance and quality assurance programs; and (v) customs or excise taxes, import duties, sales taxes and other taxes or duties (other than those taxes resulting from sales to a Third Party of Product in finished packaged and labeled form). In the event that BTC manufactures Enzyme or Products, Cost of Goods shall be calculated in accordance with Schedule 1.18.
Cost of Goods means, with respect to the supply of a Licensed Product: (a) where a Party or its Affiliates Manufacture such Licensed Product, the reasonable internal and external costs incurred by such Party and its Affiliates in Manufacturing such Licensed Product, including the fully allocated cost of Manufacture of such Licensed Product, consisting of direct material and direct labor costs (including direct material and labor costs incurred for facility start-up), plus overhead directly attributable to the Manufacture of such Licensed Product (including all [***], but in all cases excluding [***]), all calculated strictly in accordance with GAAP, and (b) where such Licensed Product is Manufactured by a Third Party manufacturer, the actual fees paid by a Party to the Third Party for the Manufacture and supply of such Licensed Product and vendor management costs.
Cost of Goods means the cost to ICN or Schering, as the case may be, of Products shipped in finished bulk capsules. As used herein, the cost of the Product means (i) in the case of products and services acquired from third parties, payments made to such third parties, and (ii) in the case of manufacturing services performed by the Parties, including manufacturing services in support of third party manufacturing, the actual unit costs of manufacture in bulk form or final manufacturing, as the case may be. Actual unit costs shall consist only of direct material and direct labor costs plus manufacturing overhead directly attributable to the Product at standard cost, all calculated in accordance with reasonable cost accounting methods, consistently applied, of the party performing the work, and as more fully set forth on Exhibit A hereto.
Cost of Goods means, with respect to API or Licensed Product, as the case may be, the aggregate of costs of TESARO or any of its Affiliates or Sublicensees to manufacture, package, label and release such API or Licensed Product, calculated as follows: (i) to the extent that the API or Licensed Product is manufactured, packaged, labeled or released by TESARO or any of its Affiliates or Sublicensees, their actual direct material costs and direct labor costs plus manufacturing overhead, directly and exclusively attributable to such API or Licensed Product (including the API incorporated into such Licensed Product), all calculated in accordance with GAAP; or (ii) to the extent that API or Licensed Product is manufactured, packaged, labeled or released by a Third Party, the actual amounts paid by TESARO or any of its Affiliates or Sublicensees to such Third Party for such activities performed on a specified quantity of such API or Licensed Product plus the costs of any materials (including API and raw materials) provided by TESARO or any of its Affiliates or Sublicensees to such Third Party for such activities, and any manufacturing overhead, quality control and distribution costs incurred by TESARO or any of its Affiliates or Sublicensees with respect to such materials provided or such Licensed Product, as calculated in accordance with clause (i) of this Section 1.11.
Cost of Goods means, with respect to the Licensed Products, the production cost of such Licensed Products (for the avoidance of doubt, including, without limitation, manufacturing oversight, freight, shipping, insurance and quality assurance) calculated in accordance with internal cost accounting methods consistently applied by Licensor for its other similar pharmaceutical products; provided, that such methods comply with IFRS or U.S. generally accepted accounting principles, as applicable. Cost of Goods shall include direct labor, direct materials (including taxes and duties), but exclude corporate administrative overhead, any costs associated with excess capacity, any royalties or license fees payable to Third Parties and any other indirect costs. Notwithstanding the foregoing, in the event a Licensed Product is manufactured by a Third Party supplier and procured by Licensor, the “Cost of Goods” shall include the costs charged for such Licensed Product by such Third Party supplier to Licensor.
Cost of Goods means (i) with respect to any unit of Product, Oculus’ direct out of pocket product production cost per unit of Product, including raw materials, packaging components (if any), and direct internal and outside labor allocable to such unit of Product in accordance with Oculus’s observed accounting procedures and using GAAP, consistently applied, for all products Manufactured in the facility where the Product is manufactured; and (ii) with respect to any unit of Manufacturing Equipment, Oculus’ direct out of pocket product acquisition cost per unit of Manufacturing Equipment, including raw materials, packaging, components, and direct outside labor for assembly allocable to such unit of Manufacturing Equipment in accordance with Oculus’s observed accounting procedures and using GAAP, consistently applied, for all Manufacturing Equipment manufactured in the facility where the Manufacturing Equipment is assembled.
Cost of Goods means in respect of any Products the fully allocated cost of manufacture as calculated in accordance with the accounting standard applicable to the selling party, consistently applied in accordance with Schedule 4 together with any and all royalties payable to any Third Party for technology directly related to the supply of the Products including without limitation any formulation technology and access to Materials owned by Third Parties;