definiens: means that quantity of HPV Reagent Product(s ) necessary to generate I diagnostic n : sull for a single patient with respecllo one or more types of HPV, lIS described in the Specifications . Individual HPV Test Q\J(lI1lities, hall be individually provided 10 ROCHE by l.l [ ~Manufacturing Cost " shall mean ! he : fully - burdened CO$ ! 10 ROCHE ( exprased on a per unit basi, ) of manufacturing or having manufactured ! he : HPV ProdUdS, together wilh the packaging thereof, including the cost of mIIlerials, direct labor, quality control, and overhead ( including royalties paid 10 Third Parties ), all as detcnnined in accordance with ROCIIE ', standard accounting proclicc : s for other '' ' Confidential Treatment Requested 2 prodtK : ts manufactured . For the avoidance of doubt, Mallufacturing Cost maUMt include l1IIy cost compooeot allributable 10 excess or idle manufacturing capacity