definiens: meansthepublication entitled published bytheUnitedStatesDepartment ofHealthandHumanServices;(gg)meansLELorPURDUE and, whenusedintheplural, meansLELandPURDUE;(hh ) or willmeanissuedpatents, unpUblished patentapplications, published patentapplications, andcontinuation patentapplications intheTerritory, andanypatentissuingtherefrom, oranypatentsbased thereon, aswellasanycontinuing applications, continuations, continuations - in - patt, divisions, re - examinations, re - issues, substitutes, renewals orextensions ( including Supplementary ProtectionCertificates andpatenttermextensions ) ofanyoftheforegoing patentapplications orpatents, orrelatednewpatentapplications intheTerritory;(Ii)meansaprimarydetailwithproductpresentation;Cij)meanspostRegulatory Approval clinicalstudiesrelatedsolelytotheLicensed ProductintheTerritOlY;(kk ) meansanyaction, claim, suitorotherlegalproceeding;(11 ) meansPurduePatentstogetherwithanytradesecrets, know - how, data, Confidential Information, unpatentedinventions, copytights, trademarks, rightsofreference orotherformsofindustrial oranyotherintellectual propertycovering theLicensed Productovmedorcontrolled byoronbehalfoforlicensedtoPURDUE intheTerritory;(mm)meansthePatentslistedinSchedule Aheretoasfinalized priortoClosing;(un ) .. willmeantheagreement whichwillbeenteredintobythePatiiessubsequent totheexecution ofthisAgreement, governingthetechnical aspectsofthemanufacturing, packaging, production, qualitycomplaints, adversedrugexperience reports, andprofessional medicalserviceinquhiesoftheLicensed Product, whichwillbeappended heretoasSchedule Eattheappropriate timeaftertheEffective Date;100f69(00)Ny2·429307.03 meansalldocuments, sUPPoliingmaterials andothermaterials relatingtotheRegulatory Application, any.t!'-JI ~ fIJRegulatory Approval orothermatterrequiredtobesubmitted toanyRegulatory Authority inrelationtotheLicensedProduct, including anyIND, NDAanddocuments, supporting materials andothermaterialsrelatingtolabeling, anydrugmasterfile, investigators ' brochures, clinicalstudies(including anyPhaseIVorpost - approval clinicalstudies),safetydata, adverseeventreports, questionnaires, consultant reports, correspondence ( including correspondence withanyRegulatoryAuthority ), batchrepOl1s, protocols, specifications, qualityassurance, quality contro ~ customerqueriesand anyresponses thereto, andanycompilation orevaluations thereof, andquestionandanswerscripts;.(Pp)''Regulatory Application " meanstheapplications submitted ortobesubmitted byLELtotheFDAseekingapprovalforthedevelopment, manufacture, tcsting, storage, transport, marketing, advertisement, promotion, sale, use, Distribution orotherdisposaloftheLicensedProductXutheTerritory, including withoutlimitation theLicensedProductINDandNDA;(qq ) meansfinalapprovaloftheLicensedProductanditslabelingbytheapplicable Regulatory Authorities tomanufacture andmarkettheLicensedProductintheTerritory;(rr)''Regulatory Authority " meansagovernmental authoritythathastheauthority overthemanufacture, use, storage, inIport, export, clinicaltesting, transport, marketing, saleorDistribution oftheLicensedProductintheTerritory, including withoutlimitation theFDAandDBA;(ss)meansstandardoperating procedures;(tt ) meansnon - Affiliate thirdpartieswithwhomeitherPartymaycontracttoperformcertaininternalbusinessfunctionsofsuchPartyassetforthinthisAgreement;(uu ) willmean'theagreement whichwillbeenteredintobythePartiespriortotheClosingDate, goveming thesupplyarrangementbetweentheParties, providing intetaliaforforecasting, orderingandshippingmatters, whichwillbeappended heretoasScheduleFatClosing;(vv)hasthemeaningsetforthinSection19.1;(ww ) m ~ anstheUnited State ~ ofAmerica, itsterritories and'possessions .