definiens: meansfmalapprovaloftheLicensed Productanditslabelingbytheapplicable Regulatory Authorities tomanufacture andDistributetheLicensed ProductintheTerritory;"2.Section2.1.Thefollowing paragraphs ( c),(d)and(e)areherebyaddedattheendofSection2.1oftheAgreement, afterSection2.1(b):"(c)Notwithstanding Section2.1(b),inordertoaddresstheParties'concernthatRegulatory Approval oftheLicensed ProductmaybedelayedduetoBiovailCorporation 's ( together withanyAffiliate, ) once - daily extended - releaseformulation oftramadoIhavingreceived threeyearsofnon - patent exclusivity intheTerritory fromtheFDA(the ), thePartiesagreethatPurduewillhavetheright, tograntoneormoreadditional licensesofthePurdueIntellectual Property fortheBiovailProducttobemade, have made, packaged, imported, exported, used, Distributed andhaveDistributed intheTenitory . Itiscontemplated thatsuchadditionallicensesmaybegrantedto(i)Biovail,(ii)Johnson&Johnsonand / oritsAffiliatesNY3·396803.10(),and / or(iii)anythirdpartyinvolvedinthemanufacturing, packaging, importation, exportation, use, orDistribution oftheBiovailProduct, provided, that(A)inthecaseofalicensetoBiovail, Biovailagreestoexclusively waiveexclusivity ofits505(b)(2 ) application infavoroftheLicensedProductimmediately uponthegrantofsuchlicense(s ) andtheexecution ofanyagreement pertaining thereto, and / or(B)inthecaseofJNJorathirdparty, JNJorsuchthirdparty, asapplicable, hasthelegalauthorityto, andagreestoexclusively waiveexclusivity ofBiovail's505(b)(2 ) application infavoroftheLicensedProductimmediately uponthegrantofsuchlicense(s ) andtheexecutionofanyagrecment peltaining thereto, andinthecaseofJNJ, JNJalsoexclusively grantstoPurduefortheLicensedProduct rights ofreference totheUltramNDA, theUltracetNDA, and / orotherdatafrompreclinical andclinicaltrialsthatsupportthesafetyandefficacyoftramadol inordertofilea505(b)(I ) application withtheFDAfortheLicensedProduct