definiens: willhavetheemeaningsetforthintheFD&CAct;(b ) meansanycorporation orentitywhichisdirectlyorIndirectlycontrolled by, orcontrolsorisundercommon controlwith, anothercorporation orentity, prOVidedthatshallmeanownership astomorethan50%ofanothercorporation orentityorthepowertodirectdecisions ofanothercorporation orentity, including, withoutlimitation, thepowertodireptmanagement andpoliciesofanothercorporation orentity, whetherbyreasonofownership, bycontractorotherwise;(c ) andrelateddefinitions:(i ) or meansthispresentagreement andallschedules andwritteninstruments supplementaltooramending orconfirming itfromtimetotime;2of42(i1 ) meansthatcertainManufacture andSupplyAgreement enteredintobetween thePartiesasofJuly16,2003andwhichismorespecifically referredtoInparagraph 1,1hereto;(iii ) meansthatcertainManufacture andSupply Agreement entered intobetween thePartiescontemporaneously herewith andcovering Labopharm'srequirements oftheProductforsaleintheUSAthroughPurduePharmaInc,(d)meanstheactivepharmaceutical ingredient tramadol HCI;(e)meansanyandalllaws, rules, standards, guidelines, judgments, orders, decrees, statutes, ordinances, regUlations, andgovernment policiesrelatingtothemanufacture, packaging, use, transportation anddistribution of'theProducts inCanada, theU, S, A"Europe, LatinAmericaandallothercountries wheretheProducts aresold, includingwithoutlimitation allrelevantcGMPs;(f)meansaproduction batchofapproximately one(1)milliontabletsofeachProductofthe100mgand300mgdosagestrengths, andapproximately oneandahalf(1.5)milliontabletsofProductofthe200mgdosagestrength, tobemanufactured byConfabhereunder;(g ) meansanyandallInformation thatisconfidential innatureorthatistreatedasbeingconfidential byaPartyorbyanyofitsAffiliatesandthatisorhasalreadybeendisclosed byoronbehalfofsuchPartyorofanyofitsAffiliatestotheotherPartyortoanyoftheotherParty'sAffiliates pursuant tothisAgreement, whethersuchinformation isorhasbeenconveyed verballyorinwrittenorelectronic orothertangibieform, andwhethersuchinformation isacquired directlyorindirectly, Including, butnotlimitedtoalltechnology, data, know - how, tradesecrets, concepts, Ideas, alltechnical, financial orbusinessInformation, andallinternalreports, materials andotherdocumentscontaining orregarding anyoftheforegoing;(h)meansaperiodconsisting oftwelve(12)consecutivecalendarmonths, withthefirstContractYearcommencing onDecember13,2005andterminating onDecember 31Contramid ® POWder"meansLabopharm 's proprietary highamylosestarchmatrixusedintheFormulation(s ) oftheProduct(s ), inpowderform;0 ) or meansthepractices3of42setoutinthegUidelines pUblished asgoodmanufacturing practices fordrugmanufacturers by(i)theFood&DrugAdministration ofUSA,(ii)theTherapeutic ProductDirectorate ofHealthCanadaand(iii)theEuropeanAgencyofMedicinal Products, andassameareineffectfromtimetotimeduringtheTermofthisAgreement;(k)meansthedatefirstwrittenabove;(I)meansEuropean AgencyofMedicinal Products;(m)meanstheU.S.FoodandDrugAdministration, oranysuccessoragencywithresponsibilities comparable thereto;(n)meanstheU.S.FederalFood, DrugandCosmetic Act, asamended;(0 ) meansConfab 's manufacturing facilitylocatedat4355SirWilfridLaurierBlvd .,Saint - Hubert, Quebec, J3Y3X3;(p ) meanstheuniqueformulation(s ) forthemanufacturing oftheProducts andwhicharesuppliedbyLabopharm toConfab;(q)means, whetherornotreducedtowriting, allinventions, allrightstoInventions, patents, patentapplications andissuedpatents(andanycontinuations, divisions, patentsofaddition, applicationsforreissue, reissues, re - examinations orextensions ofanyoftheforegoing ), designs, designapplications anddesignregistrations, trademarks, trademarkapplications, trademarkregistrations, tradenames, logos(whether registered orunregistered ), copyright, copyrightapplications andregistrations, processes, licenses, knOW - how, technology, data, chemical structures, formulae, discoveries, tradesecrets, proprietaryinformation andallotherrightsandintellectual propertynoworhereafterdeveloped, whichrelatestotheProduct;(r ) shallhavethemeaning setoutintherelevantAppendix oftherelevantQualityAgreement, depending upontowhichofLabopharm 's designees thebulkProductistobeshippedforfinalpackaging;(s ) meansanyandallproprietary subjectmatter, tradesecrets, know - how, materials, information, data, methods, processes, derivatives, protocols, standard operating procedures, assays, knowledge, inventions, discoveries, improvements anddevelopments, whetherornotpatented orpatentable andwhetherornotreducedto40f42(t)(u)(v)(w)(x)(y)(z)(aa)writing, pertinent totheProducts ortothemanufacture, useorsaleoftheProducts ( including, withoutlimitation, thecontrolled deliverytechnologyknownas, theFormulation(s ) andtheProductSpecificationsandallimprovements, additions andmodifications thereto ) andallIntellectual Property Rightsrelatedthereto, noworhereafter ownedby, licensedto, inthepossession of, knownto, orcontrolled byLabopharm oritsAffiliates ; or meanstheRegUlatoryApproval(s ) requiredtobegrantedbytherelevantRegulatory Authoritiesinthevariouscountries wheretheProductissold ; willhavethemeaningsetforthintheFD&CAct;meanstheNewDrugApplication ( including allamendments andsupplements thereto)whichhasbeenfiledbyLabopharm withtheFDAinrespectoftheProducts andbearingnumber21 - 745;meanseitherLabopharm orConfab, individually ; meansLabopharm andConfab, collectively ; meanstheproducts referredtoinSection2.1above . ThePartiesmay, bymutualwrittenagreement, addnewProducts tothisAgreement atanytimethroughout theTermofthis Agreement ; meanstheconcentrations andcompositions ofeachconstituent ofeachoftheProducts andthemanufacturing process, validated analytical methods forqualityandreleasetesting, releaseprocedures andotherspecifications relatedtoeachoftheProducts . TheProductSpecifications areattached totheQualityAgreement(s ) asAppendices, andmayberevisedatanytimeinaccordance withtheprovisions setforthherein ; meansanorderforProduct(s ) fromLabopharm toConfab, inwriting, specifying atleasl : deliverydaterequired, quantities ofProduct(s ), andshipping destination ; meansthosePurchase Orders#25,26and27datedDecember 13,2005 ; meansaPurchase Orderthatisinexcessoftheapplicable bindingforecast ; meanstheagreements whichhavebeenorwillbeexecuted bythePartiesandpursuant towhichthePartiesagreeonthesharingoftheirrespective operational andtechnical responsibilities in50f42~_I#Iorderto.complywithcGMPsoftherelevantjurisdictions, namelyaQualityAgreement relatingtothejurisdictions ofCanada, USAandLatinAmerica, andaQualityAgreement relatingtothejurisdictions oftheEuropeancountries andwhereofcopies, asamended fromtimetotime, willbeattached asSchedules AandBhereto, andincorporated byreferenceherein;(bb ) meansallbUlkpharmaceutical ingredients ( activeandInactive ) andotherrelatedItemsnecessary orrequired forthemanufacture andsupplyoftheProductsinaccordance herewith;(cc ) meansfinalapproval oftheProduct bytheapplicable Regulatory Authorities tomanufacture anddistribute theProductInthejurisdiction(s } governed bysuchRegulatory Authorities;(dd ) meansagovernmental authority thathasjurisdiction overthemanufacture, use, storage, Import, export, clinicaltesting, transport, marketing, saleordistribution oftheProduct(s};(ee ) meanstheProductSpecifications, theRawMaterialsSpecifications, theAPISpecifications andContramid ® PowderSpecifications allasfurtherdefinedinAppendix Coftheapplicable QualityAgreement ; andContramid ® PowderSpecifications"meansthespecifications according towhichLabopharrn shallsupplyorcausetobesuppliedAPIandContramid ® PowdertoConfabpursuant toSection6.4,allasfurtherdefined Intherelevant Appendix oftheapplicable QualityAgreement;(ff)meanstheperiodsoftimereferredtoinSection13.1hereof