definiens: means costs to supply applicable therapeutic ingredients, finished products, related inputs and services ( a ) supplied by an unaffiliated Third Party or ( b ) manufactured directly by either Party 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 such Party or its AfiIliates to provide product quality assurance / control services ( e.g., release testing, stability testing ) with respect to the applicable product, and ( ii ) in the case of costs referred to in clause ( b ) of this sentence where either Party or its AfiIliates is the manufacturer, Manufacturing Costs will equal the costs of manufacturing the applicable product, which manufacturing costs : ( x ) will include the cost of raw materials, 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 manufacturing party '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 the other manufacturing party 's products in that facility ), and ( z ) notwithstanding anything to the contrary, will exclude all costs which can not be linked to a specific manufacturing activity such as charges for corporate overhead which are not controllable by the manufacturing plant