definiens: means all costs actually incurred by [COMPANY] or its Affiliates in theManufacture of applicable therapeutic ingredients, finished products, related inputs, and services(a ) supplied by a Third Party or ( b ) Manufactured directly by [COMPANY] or its Affiliates ; it beingunderstood and agreed that ( i ) in the case of costs referred to in clause ( a ) of this sentence wherea Third Party is the Manufacturer, Fully Loaded Cost will equal [ * * * ] of the amounts invoiced by(1 ) such Third Party or ( 2 ) any other Third Party engaged by [COMPANY] to provide product qualityassurance / control services ( e.g., release testing, stability testing ) with respect to the applicableproduct, and ( ii ) in the case of costs referred to in clause ( b ) of this sentence where [COMPANY] or itsAffiliate is the Manufacturer, Fully Loaded Cost will equal [ * * * ], which Manufacturing costs : ( x)will include the cost of [ * * * ], and other direct and identifiable variable costs and appropriatedirect and identifiable costs ( or appropriate allocation thereof ) for [ * * * ] ( to the extent consistentwith industry practice ), and [ * * * ], including any reasonable overhead allocated thereto, and willinclude costs associated with the filing and maintaining of regulatory submissions for theLicensed Product [ * * * ] and ( y ) will be calculated in accordance with the accounting standardsand [COMPANY] ’s policies and procedures for its other products, in each case, consistently applied(and such [ * * * ] costs will be allocated consistent with the accounting standards and the otherCelgene products in that facility )