Manufacturing Cost. Means the fully-burdened manufacturing cost of Smart Cycler Instruments as determined using Cepheid's customary practices and procedures and, to the extent applicable, in accordance with Generally Accepted Accounting Principles in the United States ('GAAP'), including the following: direct material cost, material overhead cost, direct labor cost, fixed manufacturing overhead cost, variable manufacturing overhead cost, cost of quality control and product testing, manufacturing variance cost and... other costs that may be properly attributed and documented to inventory as manufacturing costs pursuant to GAAP, but excluding royalties or similar consideration paid to Third Parties for rights to Intellectual Property Rights, including up-front payments for such rights, even if any such royalties or other payments are included in fully burdened manufacturing cost in accordance with a Party's customary practices and procedures and, to the extent applicable, GAAP). In determining Manufacturing Cost, Cepheid shall take into account, in accordance with GAAP to the extent applicable and in accordance with Cepheid's normal and customary practices and procedures, including without limitation consideration of risks and uncertainties associated with projections related to the products in question, projections of sales of such products for at least a twelve month period made in good faith by Cepheid in accordance with its normal and customary procedures. Manufacturing Cost of Smart Cycler Instruments will be established and reestablished based upon projections for a period of not less than the next upcoming twelve month period, may be changed no more frequently than quarterly (and any new Manufacturing Cost will be effective only as of the first day of a quarter), and any new Manufacturing Cost of products will not be applied except upon a minimum of sixty (60) days prior notice from Cepheid to IDI.View More
Manufacturing Cost. The manufacturing cost of the BULK DRUG SUBSTANCE, which is manufactured by or on behalf of TANABE (or the PRODUCT manufactured and supplied by or on behalf of VIVUS under Section 8.5), and which includes the following: (a) Materials Cost, which means the price paid for raw material components and finished goods which are purchased from outside vendors as well as any freight and duty where applicable. (b) Direct Labor Costs, which means the employment costs attributable to manufacturing the... BULK DRUG SUBSTANCE including, without limitation, salary and employee benefits within the relevant manufacturing operating unit. (c) Overhead Costs, which means the cost of specific activities attributable to manufacturing the BULK DRUG SUBSTANCE that are provided by support functions and are performed at a frequency which is in correlation with the production. Overhead Costs includes, expenses associated with quality assurance testing, batch review, equipment maintenance costs, manufacturing utilities, waste removal, management and administrative expenses, general facilities costs, environmental engineering, property taxes and insurance. (d) Equipment Depreciation, which means the amortization of the costs of specific manufacturing facility, machinery or equipment dedicated either solely or partly (on a pro rata basis) to the production, calculated in accordance with the applicable generally accepted accounting practices. It is understood and agreed that the definition of MANUFACTURING COST shall be consistently applied during the term of the Agreement.View More
Manufacturing Cost. With respect to a finished Unit, Manufacturer's reasonable, documented, out-of-pocket costs to supply applicable Unit components, related inputs, and services (a) supplied by an unaffiliated third party or (b) manufactured directly by Manufacturer or its Affiliates; it being understood and agreed that (i) in the case of costs referred to in clause (a) of this sentence where an unaffiliated third party is the manufacturer, Manufacturing Costs will equal one hundred percent (100%) of the amounts... invoiced by (1) such unaffiliated third party and (2) any other unaffiliated third party engaged by Manufacturer or its Affiliates to provide product quality assurance/control services (e.g., release testing, stability testing) with respect to the applicable Unit or shipping of such components to the applicable assembly facility, and (ii) in the case of costs referred to in clause (b) of this sentence where Manufacturer or its Affiliates is the manufacturer, Manufacturing Costs will equal the Manufacturer's reasonable, documented, out-of-pocket costs of manufacturing the applicable Unit, which manufacturing costs: (x) will include the cost of raw materials actually purchased by Manufacturer or its Affiliates, direct and identifiable labor, product quality assurance/control costs and other direct and identifiable variable costs and appropriate direct and identifiable costs (or appropriate allocation thereof) for equipment pools, plant operations, yield losses (to the extent consistent with industry practice) and plant support services (including utilities, maintenance, engineering, safety, human resources, finance, plant management and other similar activities), and (y) will be calculated in accordance with GAAP and the Manufacturer's policies and procedures for its other products, in each case consistently applied (and such plant operations and support services costs will be allocated consistent with GAAP), and (z) notwithstanding anything to the contrary, will exclude all costs which cannot be linked to a specific manufacturing activity such as charges for corporate overheadView More
