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.

  • 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.

  • 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).

  • 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.

  • 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.

  • In the case of unforeseen circumstances (for example the relevant leader being absent) Bunnings will respond to the Team Member’s request within 28 days.

  • 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.

  • 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).

  • 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, 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.

  • 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 ***

  • Baseline actual emissions means the rate of emissions, in tons per year, of a regulated NSR pollutant, as determined in accordance with paragraphs (i) through (iv) of this definition.

  • 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;

  • Projected actual emissions means the maximum annual rate, in tons per year, at which an existing emissions unit is projected to emit a regulated NSR pollutant in any one of the 5 years (12-month period) following the date the unit resumes regular operation after the project, or in any one of the 10 years following that date, if the project involves increasing the emissions unit’s design capacity or its potential to emit that regulated NSR pollutant, and full utilization of the unit would result in a significant emissions increase, or a significant net emissions increase at the major stationary source.

  • Net Sales means [***].

  • 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.

  • 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, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • 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 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.

  • 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, collectively, all future, supplemental, emergency or other changes in Reserve Percentages, assessment rates imposed by the FDIC, or similar requirements or costs imposed by any domestic or foreign governmental authority and related in any manner to the LIBO Rate, provided said amounts are actually paid by (or on behalf of) Lender.

  • 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 out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • own-source revenue means adjusted underlying revenue other than revenue that is not under the control of council (including government grants)