definiens: andwillhavetherespective meanings givensuchtermsinSection8.1 ; ofaPartywillmeananyinfonnation disclosedbyonePartyoritsAffiliates orrepresentatives toanother, whetherin60f69writing, orally, invideoorelectronic formorinthefonnofsamplesormaterials, ( i)whichisdesignated confidential atthetimeofdisclosure, whetherorallyorinwriting, or(ii)whichshouldbeconsideredconfidential byitsnatureandthecircumstances surrounding itsdisclosure, including withoutlimitation information concerning theotherParty'sbusiness, technology, products, proposed newproducts, productcosts, prod1lctprices, fmances, marketing plans, business opportunities, research,.development orknow - how whichisconfidential andproprietary totheotherPartyandisnotgenerally knowntothepublic, including anyinformation orreportsthereceiving partymaygenerate andthetermsofthisAgreement;(h)means·eachsuccessive twelvecalendar monthperiodduringthetermofthisAgreement . ThefirstContract YearwillbeginonthedateoftheLaunchoftheLicensed ProductintheTen'itory andendonDecember 31stofthatyear . ThelastContract YearwillendonthedaytheAgreement expiresoristenninated;(i ) meansLEL'sproprietary chemically modified high­amylose starchusedintheformulation oftheLicensed Product;(j)meanstheUnitedStatesDrugEnforcement Administration, oranysuccessor agencywithresponsibilities comparable tothoseoftheUnitedStatesDrugEnforcement Administration;(k ),, ~'DistributedDistributingEffective DateFDA"meanstheU.S.FoodandDrugAdministration, oranysuccessoragencywithresponsibilities comparable tothoseoftheU.S.FoodandDrugAdministration;(n)willmeantheguidelines ofgoodmanufacturing practicesdetermined bytheFDA, inthethencurrentversionandassetforthinTitle2lofthe C.F.R.,Parts210and·211, asamended fromtimetotime, andallotherApplicable Lawstothemanufacture oftheLicensed Productthatareineffectatthetimeandplaceofmanufacture oftheLicensed Product;(0)meanstheBart - Scott - Rodino Antitrust Improvements Actof1976,asamended;(P)NY2·429307.03 meansthelegaljurisdiction inwhichaPartyisincorporated orfOIDled;70f69(q)(r)(s)(t)(u)(v)(w)(x)(y)(z)(aa)NY2-'429.:307,03willmeanaproductwhichinfringestheLELIntellectual Propertyrights, PURDUE Intellectual Propertyrights;andiorLicensedProductPatents ; meanstheinitialLicensed Productlaunchquantities, setforthintheSupplyAgreement thatwillsatisfyPURDUE'sLicensedProductandsamplesrequirements fora6monthpm10dafterLaunchandenablePURDUE toadequ;>tely stocktheTradewiththe . LicensedProduct;willhavethemeaningsetforthinSection5.3 ; meansthefirstcommercial saleoftheLicensedProductintheTerritorybyPURD ~ JE oritsAffiliates ; willmeantheLELPatentstogetherwithauytradesecrets, know - how, data, rightsofreference, ConfidentialInformation, unpatented inventions, copyrights, trademarks orotherformsofindustrial oranyotherintellectual propertycoveringtheLicens«dProductownedorcontrolled byoronbehalfoforlicensedtoLELintheTerritory;willmeanthePatentssetforthinSchedule BasfinalizedpriortoClosing;willbeasdefinedinsection6;meanstheoncedailytramadolsolidoraldosageformulation inalldosagestrengths, including 100mg,200mg, and300mg, developed andownedbyLELanditsMfiliates, usingLEL'SContrarnid ® technology;willbethemethodology forthemanufacturing andproduction ofLicensedProductinaccordance withthetermsandconditions oftheQualityAgreement;willmeanthesubsetofLELPatentsandPurduePatentsrelatingonlytotheLicensedProduct, andnottorightswhichillllYbelicensedouttothirdpartiesforuse - inproductsotherthantheLicensedProduct ; willmeandetailedspecifications andstandards setforthemanufacture, production, packaging andreleaseoftheLicensedProductinaccordance withthetermsandconditions oftheQualityAgreement;80f69(bb)(cc).(dd)(ee)l\429307,03 meanstbetrademark(s ) underwhichtheLicensed Productisorwillbemarketed intheTerritory, whichwillbeappended heretoasSchedule Dattheappropriate timeaftertheEffectiveDate;meanstheNewDrugApplication ( including allamendnlents andsupplements totheapplication ) whichhasbeenorwillbefiledwiththeFDAinrespectoftheLicensed Product;''Marketing PlanAnnualMarketing PlanNetSales"willmeanthegrossamountbilledbyPURDUE oranAffiliateofPURDUE forsalesoftheLicensed Producttoanunrelated thirdpartyless:(a)normalandcustomary discounts, including(i)cashdiscounts,(ii)discounts tomanaged careorsimilarorganizations orgovernrnent organizations,(iii).rebatespaid, credited, accruedoractuallytaken, including government rebatessuchasMedicaid chargebacksorrebates,(iv)retroactive pricereductions, and(v)commercially reasonable andcustomary feespaidtodistributors ( otberthantoadistributor thatisanAffiliateofPURDUE),including wholesaler feesforvendormanaged inventory agreements orfeeforserviceagreements, pharmacy benefitmanagement feesforservices, orsimilaragreements,(b)Creditsorallowances actuallygranteduponclaims, rejectionsorreturnsofsuchsalesoftheLicensed Product, including recalls, regardless ofPURDUE requesting suchrecalls,(c)freight, postage, shipping andinsurance chargespaidfordeliveryofsuchLicensed Product, totheextentbilledseparately onthe'invoice, and(d)taxes(otherthantaxesbasedonnetincome ), dutiesorothergovelmnental chargesleviedonormeasured bythebillingamountwhenincluded inbilling, asadjustedforrebates, charge backsandrefundstotheextentactuallypaidorallowedbythesellingparty