definiens: means costs to supply Licensed Product ( a ) supplied by an unaffiliated Third Party or(b ) manufactured directly by a Party or an Affiliate of a Party . In the case of ( a ), Manufacturing Costs shall be a per unit ( calculated for each calendar year of the Term ), which standard cost shall include ( i ) theamount paid to such Third Party, plus ( ii ) direct and identifiable personnel compensation and benefits and direct andidentifiable Out - of - Pocket Costs incurred by the manufacturing Party ( i.e., the Party responsible for overseeing themanufacturing of the Third Party ) in connection with quality assurance, supply chain management and similaractivities comprising the manufacturing Party ’s oversight of the manufacturing process of the Third Party . In the caseof ( bi ), Manufacturing Costs shall be a per unit ( calculated annually and at a time to align with theParties ’ internal budget processes ), which standard cost shall include the cost of raw materials, direct and identifiablelabor, and other direct and identifiable variable costs and appropriate direct and identifiable costs ( or appropriateallocation thereof ) for equipment pools, plant operations and plant support services . The costs for plant operations andsupport services would include utilities, maintenance, engineering, safety, human resources, finance, plantmanagement and other similar activities . Standard costs shall be calculated in accordance with GAAP and Pfizer’spolicies and procedures for its other products, in each case consistently applied . The plant operations and supportservices costs shall be allocated consistent with GAAP and the other [COMPANY] products in that facility . Costs whichcannot be linked to a specific activity supporting 11Product manufacturing, such as charges for corporate overhead which are not controllable by the manufacturing plant, shall not be included in standard cost