definiens: shall mean Tetrodotoxin, apoison extracted from the ﬁshor ﬁsh, excreted from theﬁsh ’s liver, ovaries andintestines andwhichenters intothecomposition oftheFinished Products;1.1.4 shall mean theanalytical certiﬁcate foreachbatch ofFinished Products tobedelivered pursuant toSection 7.2evidencing thattheFinished Products conform totheSpeciﬁcations;1.1.5 shall mean current Good Manufacturing Practices aspromulgated bytheHPFB, theFDAandtheEMEA ; acode ofregulationssetforth formethods tobeused inthemanufacture, processing, packing, orholding ofadrug toassure thatsuch drug meets therequirements astosafety, and has theidentity and strength and meets the quality andpurity characteristics thatitpurports to;1.1.6 shall have themeaning ascribed tothisterm inthefourthparagraph ofthePreamble;DM_M'TL/1184 - 00 - 000017829990.-4 EXT -Manufactltring andOption Agreement1.1.71.1.81.1.91.1.101.1.111.1.121.1.131.1.141.1.151.1.161.1.171.1.18DM_MTUl I8400 - 0000 If829990.11 - 3- shall have themeaning ascribed tothisterminSubsection 9.1.1 andasfurther deﬁned inSubsection 9.1.2 ; shallhave themeaning ascribed tothisterminSubsection 14.1.1 ; shall bethedateﬁrstwritten above ; shall mean theEuropean Agency fortheEvaluation ofMedicinalProducts, anyofitssuccessor agencies ordepartments, oranyotheragency serving thesame orsimilar function ; shall have themeaning ascribed tothisterm inSection 13.1 ; shall have themeaning setoutinthelncoterms of2000 publishedbytheInternational Chamber ofCommerce, asmodiﬁed from time totime ; shall mean shall mean theFood andDrug Administration ; theUnited States ofAmerica federal government agency thatregulates thequality, safety and effectiveness ofbiological and pharmaceuticalproducts intheUnited States ofAmerica, anyofitssuccessor agencies ordepartments, oranyother agency serving thesame orsimilar function ; shall mean theclinical lotsforthefollowing threeproducts currently being developed byWEX based onasodium channelblocking compound named Tetrodotoxin and itsderivatives, namelyTetrodinm, Tectinm and Tocudinm ; inﬁnished form and inanyformulation, asfurther described intheSpeciﬁcations ; shall have themeaning ascribed tothisterm inSubsection 9.1.1 ; shall mean theInitial Forecast andallForecast Updates ; shall have themeaning ascribed tothisterm inSection 5.2;"Governmentaf Body “ shall mean:1.1.18.1 anydomestic orforeign national, federal, provincial, state, municipal orother government orbody;1.1.18.2 anyinternational ormultilateral body;1.1.18.3 anysubdivision, ministry, department, secretariat, bureau, agency, commission, board orauthority ofany oftheforegoing governments orbodies;EXT -Manufactlnirlg andOption Agreement1.1.191.1.201.1.211.1.221.1.231.1.241.1.251.1.261.1.271.1.28 - 4 - 1.1.18.4 anyquasi - governmental orprivate body exercising anyregulatory, expropriation ortaxing authority under oronbehalfofanyoftheforegoing governments orbodies ; or1.1.18.5 any domestic, foreign, intemational, multilateral ormultinational judicial, quasi - judicial, arbitration oradministrative court, grand jury, tribunal, commission, boardorpanei shall mean theHealth Products andFood Branch, adivision ofHealth Canada, anyofitssuccessor agencies ordepartments, oranyother agency serving thesame orsimilar function ; shall have themeaning ascribed tothisterm inSection 5.1 ; means theskilloringenuity based upon thebody ofknowledge which comprises allofthemethods, processes, designs, information, formulas, manuals, guidelines andtrade secrets relating totheAPl 's, theFinished Products andtheir formulation, including, withoutlimitation, and allinformation necessary forobtaining theRegulatoryApprovals ; shall have themeaning ascribed tothisterm inSubsection5.3.1 ; shall have themeaning ascribed tothistenn inSubsection 9.1.1 ; shall have themeaning ascribed tothis term inSubsection 9.1.4 ; or shall mean allliability claims, demands, damages, actions, suits, andjudgments instituted bythird parties against either oftheparties hereunder attributable tobodily injury, sickness, disease, death, injury toproperty, infringement ofintellectual property rights orotherwise, including, without limitation, reasonable attomey 's fees andinvestigation andother costs ; or -anapplication totheFDA formarketing approval foranewtherapeutic agent made upon successfulcompletion ofclinical trials ; or -anapplication totheHPFB formarketing approval foranewtherapeutic agent made upon successfulcompletion ofclinical trials ; shall mean thecosts incurred bySabex inthemanufacturing oftheFinished Products pursuant totheterms andconditions ofthisAgreement, assuch costs aredeﬁned inSchedule attached hereto;DlNotice ofComplianceNOC " means anotice issued under sectionC.08.004 oftheFood andDrug Regulations enacted under theActtoallow thecommercialization ofanewpharmaceutical product;1.1.30 shall mean and include any individual, corporation, partnership, ﬁrm, joint venture, syndicate, association, trust, Governmental Body, andanyother formofentity ororganisation;1.1.31 shall have themeaning ascribed tothisterm inSubsection 5.3.1;1.1.32 or shall mean anyappropriate Governmental Body having jurisdiction over theapproval ofdrugs andphamraceutical products inanyjurisdiction oftheResearchArea;1.1.33 shallmean allthenecessary permits, licencesandapprovals from theappropriate Regulatory Agencies, tomarket, sellanddistribute theFinished Products intheResearch Area;1.1.34 shall have themeaning ascribed tothisterm inSection 4.3;1.1.35 shall mean thecountries ofCanada, theUnited StatesofAmerica andthemember states oftheEuropean Community;1.1.36 shall mean the Finished Products ‘ process andmanufacturing speciﬁcations and instructions, quality assurance andother applicable procedures, andproduct descriptions applicable totheFinished Products provided byWEX toSabex, assuch Speciﬁcations aresetforth inSchedule attached hereto;1.1.37 shall mean theperiod setforth under Section 4.1;1.1.38 shall mean thecountry ofCanada ; and1.1.39 shall have themeaning ascribed tothisterm inSubsection 9.2.5