Commercial Manufacturing Costs definition

Commercial Manufacturing Costs means the costs and expenses incurred [***].
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Commercial Manufacturing Costs means with respect to a CoDev Product Manufactured by or on behalf of a Party in accordance with the applicable CoDev Product Plan or the Global Commercialization Strategy and related budgets at any time following the first Regulatory Approval of the applicable CoDev Product, such Party’s actual costs (including labor and out-of-pocket costs) of Manufacturing such CoDev Product (for both clinical as well as commercial supply) without any xxxx-up, from the date of the first Regulatory Approval of the applicable CoDev Product until such CoDev Product is no longer Manufactured. Commercial Manufacturing Costs shall be calculated as further defined in Exhibit 1.189 (Profits and Losses).
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Commercial Manufacturing Costs means with respect to a CoDev Product Manufactured by or on behalf of a Party in accordance with the applicable CoDev Product Plan or the Global Commercialization Strategy and related budgets at any time following the first Regulatory Approval of the applicable CoDev Product, such Party’s actual costs (including labor and out-of-pocket costs) of Manufacturing such CoDev Product (for both clinical as well as commercial supply) without any xxxx-up, from the date PIRS receives the Option Notice until such CoDev Product is no longer Manufactured. Each Party’s Commercial Manufacturing Cost shall be calculated in accordance with the methodology consistently applied for such costs throughout the organization, and shall be the sum of the following components: (a) direct costs, including manufacturing labor and materials directly used in Manufacturing the CoDev Product by such Party or its Affiliates; (b) direct labor costs of non-manufacturing departments (such as quality) directly attributable or Reasonably Allocable to the CoDev Product; (c) toll process and other charges incurred by such Party for outsourcing the Manufacture of the CoDev Product and the cost of supervising and managing the Third Party manufacturers, and of receipt, incoming inspections, storage, packaging, handling quality control testing and release of the outsourced items, and (d) any other reasonable and customary out-of-pocket costs borne by such Party for the testing, transport, customs clearance, duty, insurance, storage or packaging of the CoDev Product. If a Party elects to Manufacture any such CoDev Product at a Manufacturing facility owned and operated by such Party, then the costs set forth in clauses (a) and (b) above shall be pro-rated based on capacity utilized by such Party in the Manufacture of the CoDev Product, as the case may be, or any intermediate thereof at such facility as compared to the capacity used to manufacture any other product or intermediate. The basis for all allocations under this Section shall be included in any invoice for Commercial Manufacturing Costs and all allocations under this Section shall be based on space occupied or head-count 154 Portions of the exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. CONFIDENTIAL TREATMENT REQUES...
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Examples of Commercial Manufacturing Costs in a sentence

  • Each Party shall keep complete, true and accurate books of account and records for the purpose of determining the amounts payable under this Agreement (including, for avoidance of doubt, Development Costs, Commercial Manufacturing Costs, Commercialization Expenses, Sublicensing Income, Third Party license payments, Shared Costs, and Profits and Losses).


More Definitions of Commercial Manufacturing Costs

Commercial Manufacturing Costs means [***].
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Commercial Manufacturing Costs has the meaning set forth on Exhibit A.
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Commercial Manufacturing Costs means, with regard to a particular Product: Roche’s fully burdened standard manufacturing costs of Product shipped for commercial use worldwide, determined in accordance with applicable Accounting Principles as consistently applied by Roche for all its products, as follows:
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Related to Commercial Manufacturing Costs

  • 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 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 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.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

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

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

  • Manufacturing Site means a location where a manufacturing

  • 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.

  • Manufacturing Process means any process for—

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • 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.

  • 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;

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

  • 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.