Manufacturing Actual Costs definition

Manufacturing Actual Costs means (i) [*]. Manufacturing Actual Costs will be calculated consistently with other products manufactured by the Manufacturing Lead and in accordance with GAAP or IFRS, as applicable. For clarity, in the event that the Manufacturing Lead uses a contract manufacturer to perform any manufacturing activities under this Agreement, Manufacturing Actual Costs for such activities will be the price the Manufacturing Lead pays such contract manufacturer for such activities, plus the Costs to manage and to process materials obtained from such contract manufacturer.
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Manufacturing Actual Costs means, with respect to a Product (i) the Costs (including Allocable Manufacturing Overhead) to Manufacture such Product including […***…] and (ii) […***…] under this Agreement. Manufacturing Actual Costs will be calculated consistently with other products manufactured by Amgen and in accordance with GAAP. For clarity, (a) in the event that Amgen uses a contract manufacturer to perform any manufacturing activities under this Agreement, Manufacturing Actual Costs for such activities will be the price Amgen pays such contract manufacturer for such activities, plus the Costs to manage and to process materials obtained from such contract manufacturer, (b) to the extent that any Manufacturing Actual Cost relates to a Product and any other product(s) of Amgen, the Manufacturing Actual Cost will be allocated by Amgen among such Product and other product(s)).
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Manufacturing Actual Costs means, with respect to a Product (i) the actual Costs (including, without limitation, Allocable Manufacturing Overhead and [***]) to Manufacture such Product including [***] and (ii) [***]. Manufacturing Actual Costs will be calculated consistently with other products manufactured by the applicable Party and in accordance with GAAP. For clarity, (a) in the event that a Party uses a contract manufacturer to perform any manufacturing activities under this Agreement, Manufacturing Actual Costs for such activities will be the price such Party pays such contract manufacturer for such activities (which price shall be on bona fide arm’s length terms and not, by way of example, transfer pricing for such Products), plus the Costs to manage and to process materials obtained from such contract manufacturer, (b) to the extent that any Manufacturing Actual Cost relates to a Product and any other product(s) of a Party, the Manufacturing Actual Cost will be properly allocated by Amgen among such Product and other product(s) in accordance with customary accounting principles consistent with the calculation of Allocable Manufacturing Overhead for such Product.
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Examples of Manufacturing Actual Costs in a sentence

  • After Technical Feasibility, Manufacturing Actual Costs for a Product manufactured in Amgen’s (or its designee’s) non-clinical (i.e., commercial) manufacturing facility and intended for use in a Clinical Study and calculated as part of Amgen Pipeline Product Global Development Costs, will be included in Amgen Pipeline Product Global Development Costs at the time such Product is shipped to a site for use of such Product in a Clinical Study.

  • Prior to Technical Feasibility, Manufacturing Actual Costs for a Product manufactured in Amgen’s (or its designee’s) non-clinical (i.e., commercial) manufacturing facility and intended for use in a Clinical Study, calculated as part of Amgen Pipeline Product Global Development Costs, will be included in Amgen Costs at the time of manufacture of such Product.

  • Prior to Technical Feasibility, Manufacturing Actual Costs for a Product intended for use in a clinical trial, calculated as part of Development Costs, will be included in Amgen Costs and Partner Costs, as applicable, at the time of manufacture of such Product.

  • By March 31 of each calendar year, the Manufacturing Lead will reconcile the estimated Manufacturing Actual Costs included in Development Costs and General Costs in the prior calendar year with the final Manufacturing Actual Costs for such Product and provide such reconciliation to the other Party.

  • The Manufacturing Actual Costs incurred with respect to the Early Access Product in connection with Hainan Bo Ao or Tianjin, as applicable, shall be deemed “Amgen Costs” for purposes of the calculations set forth under Section 7.2 (Profit Sharing).

  • Amgen will initially incur the Manufacturing Actual Costs and the portion of the Commercialization and Related Costs attributed to its activities hereunder.

  • The Manufacturing Actual Costs incurred with respect to the Bo Ao Product in connection with Hainan Bo Ao shall be deemed “Amgen Costs” for purposes of the calculations set forth under Section 7.2 (Profit Sharing).

  • In addition, due to the fact that Manufacturing Actual Costs may not be known at the time such costs are to be included within the Collaboration Profit (Loss), for the purposes of determining Development Costs or General Costs for a particular calendar quarter, the Manufacturing Lead will, to the extent any manufacturing costs are to be calculated using Manufacturing Actual Costs, use the then-current estimated Manufacturing Actual Costs for such calendar quarter.

  • By March 31 of each calendar year, Amgen will reconcile any estimated Manufacturing Actual Costs included in Amgen Pipeline Product Global Development Costs in the prior calendar year with the final Manufacturing Actual Costs for such Product and provide such reconciliation to BeiGene.

  • After Technical Feasibility, Manufacturing Actual Costs for a Product intended for use in a clinical trial, calculated as part of Development Costs, will be included in Amgen Costs and Partner Costs, as applicable, at the time such Product is shipped to a site for use of such Product in a clinical trial.

Related to Manufacturing Actual Costs

  • Manufacturing Costs means [***].

  • Actual Costs means any costs, direct losses and expenses (including any loss of revenue) reasonably incurred or reasonably expected to be incurred by the Train Operator including those attributable to limb (f) of a Category 3 Disruption and any increase in Variable Costs but net of:

  • Manufacturing Cost means [***].

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

  • Cost of Goods Sold means [***].

  • Actual consumption means the measured consumption by a customer of a municipal service;

  • Net Sales means [***].

  • 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 [***].

  • 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 [ * ].

  • 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 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.

  • Actual Cost means the cost of depleted supplies, records storage media costs, actual mailing and alternative delivery costs, or other transmitting costs, and any direct equipment operating and maintenance costs, including actual costs paid to private contractors for copying services.

  • Actual miles means the actual distance a vehicle has traveled while in operation.

  • 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.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • forecast prices and costs means future prices and costs that are:

  • Regulatory Costs means the out-of-pocket costs and expenses incurred by a Party or its Affiliates in connection with the preparation, obtaining or maintaining of Regulatory Documentation and Regulatory Approvals for the Product, including any filing fees that are consistent, if applicable, with the Development Plan.

  • Bondable stranded costs rate order means one or more

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

  • Actual emissions means the actual rate of emissions in tpy of any regulated pollutant (for fee calculation) emitted from a Part 71 source over the preceding calendar year. Actual emissions shall be calculated using each emissions unit’s actual operating hours, production rates, in-place control equipment, and types of materials processed, stored, or combusted during the preceding calendar year.

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

  • 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: