definiens: willhave theemeaning ascribed thereto inthepreamble ; means theannual report totheFDA prepared byClient regarding theProductasdescribed inTitle 21oftheUnited States Code ofFederal Regulations, Section 314.81 ( b)(2 ) ; means theannual product review report prepared byPatheonasdescribed inTitle 21oftheUnited States Code ofFederal Regulations, Section 211.180(e ) ; means thevolume tiers ofProduct tobemanufactured inany Year ofthisAgreement assetforth inSchedule B ; means allLaws totheextent applicable tothesubject matter of, ortheperformance bytheparties oftheir respective obligations under, thisAgreement, including, butnotlimited to,(i)forPatheon, theActandanyother Laws ofalljurisdictions where theProductsaremanufactured ; and ( i1)forClient and theProducts, theLaws ofalljurisdictions where theProducts aredistributed, andmarketed asthese areagreed andunderstood bytheparties inthisAgreement ; means anygovemmental orregulatory authority, department, body oragency oranycourt, tribunal, bureau, commission orother simaar body, whether federal, slate, provincial, county ormunicipal, including, butnotlimited to, theFDA ; means theexpenses forallthird party supplier fees forthepurchase ofcolumns, standards, tooling, PAPR orPPE suits ( where applicable ), RFID tags and supportingequipment, and other items which arerequired solely fortheperformance oftheManufacturingServices forClient and which are notable tobeused byPatheon intheperformance ofmanufacturing services foranythird parties, ineach case necessary forPatheon toperform theManufacturing Services, andwhich arenotincluded asComponents ; means theproduct listed onSchedule A;-2- means adayother than aSaturday, Sunday oradaythat isastatutory holidayintheState ofOhio, theState ofCalifomia ortheProvince ofOntario, Canada, asapplicable ; willhave themeaning ascribed thereto inSection 2.2.4;·cGMPs " means current good manufacturing practices asdescribed inParts 210and211ofTitle21oftheUnited States ' Code ofFederal Regulations together with thelatest FDA guidancedocuments pertaining tomanufacturing andquality control practice, allasupdated, amended andrevised from time totime including, but notlimited to, the FDA 's guidance forIndustry, Manufacturing, Processing orHolding Active Pharrnaceuticallngredients ;