ProprietaryDrugDevelopmentandMarketingAgreement专利药品研发及销售协议doc文档格式.docx
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ThisPROPRIETARYDRUGDEVELOPMENTANDMARKETINGAGREEMENT(Agreement),effectiveon_________,_________,_________(M,D,Y)(theEffectiveDate),ismadebyandbetweenAAA,Inc.,acorporationorganizedandexistingunderthelawsof_________andhavingitsprincipalofficesat_________(hereinafterAAA),andBBBCompany(hereinafterBBB),ageneralpartnershiporganizedandexistingunderthelawsoftheStateof_________andhavingitsprincipalofficesat_________.
WHEREAS,BBBisinthebusinessofdiscovering,developing,manufacturingandmarketingnewchemicalentitiesaspharmaceuticalproducts;
WHEREAS,AAAisinthebusinessofdeveloping,manufacturingandmarketinggenericandproprietarydrugs,andinparticularisdevelopingCyPat(TM),Seasonale(TM)and***asproprietarydrugs;
WHEREAS,thePartieshavedeterminedthatcertainproprietarydrugsunderdevelopmentatAAAmaybemoreefficientlyandeffectivelydevelopedandmarketedthroughabeneficialcollaboration,andinparticular,thatcollaborativedevelopmentandmarketingofCyPat(TM),Seasonale(TM)and***wouldbebeneficialtothePartiesandtheirpatients;
WHEREAS,BBBisnotinthepositiontodevelopCyPat(TM),Seasonale(TM)and***itselfandbelievesthatcollaborativedevelopmentCyPat(TM),Seasonale(TM)and***wouldbebeneficialtotheParties;
and
WHEREAS,thePartieswishtocreateanalliancethatpermitssuchefficientandeffectivedevelopmentandmarketing.
NOW,THEREFORE,inconsiderationofthemutualpromiseshereinaftersetforth,andintendingtobelegallyboundhereby,AAAandBBBherebyagreeasfollows:
1.Definitions.
EachofthecapitalizedtermsusedinthisAgreement(otherthantheheadingsoftheSections)shallhavethemeaningindicatedinthisAgreement.
1.1ThetermAffiliateorAffiliatedshallmean,withrespecttoaParty,anyotherbusinessentitywhichdirectlyorindirectlycontrols,iscontrolledby,orisundercommoncontrolwith,suchParty.AsusedinthisdefinitionofAffiliate,thetermcontrolshallmeandirectorindirectbeneficialownershipofmorethanfiftypercent(50%)ofthevotingorincomeinterestinsuchbusinessentity.
1.2ThetermAffiliatedCustomershallmean,withrespecttoaParty,anyAffiliate.
1.3ThetermAgencyasusedhereinmeansanygovernmentalregulatoryauthorityresponsibleforgrantinghealthorpricingapprovals,registrations,importpermits,andotherapprovalsrequiredbeforeaFundedProductmaybetestedormarketedinanycountry.ThetermAgencyincludestheFoodandDrugAdministration(FDA).
1.4ThetermAgencyApprovalshallmeanfinalauthorizationbyanAgencytomarketandselltheFundedProductsinacountryintheTerritory.
1.5ThetermCommerciallyReasonableEffortsasusedhereinshallmeanthoseeffortsconsistentwiththeexerciseofprudentscientificandbusinessjudgmentasappliedtootherresearch,developmentandcommercializationeffortsforproductsofsimilarscientificandcommercialpotentialwithintheresearchprogramsandrelevantproductlinesofsuchParty.
1.6ThetermCyPat(TM)asusedhereinmeanscyproteroneacetate,asyntheticoralhydroxyprogesteroneagentusedinthetreatmentofprostatecanceranditsassociatedsyndromes.
1.7ThetermDevelopmentCostsasusedhereinmeansExternalVerifiableDevelopmentExpenseandInternalVerifiableDevelopmentExpense.
1.8Theterm***asusedhereinmeans******.
1.9ThetermExternalVerifiableDevelopmentExpenseasusedhereinincludesthoseexternalcoststoacquire,developandsubmittheFundedProductstotheFDAforapprovalandreportedasresearchanddevelopmentexpenseonfinancialstatementstoshareholdersandconsistentwithFinancialAccountingStatementNo.2.Suchcostsinclude,butarenotlimitedto,theexpensesincludedinAttachmentAhereto.
1.10ThetermFirstCommercialSaleshallmean,withrespecttotheFundedProducts,thefirstsaleforuseorconsumptionbythepublicofsuchFundedProductsintheTerritoryafterallrequiredapprovals,includingmarketingapproval,havebeengrantedbytheFDA.
1.11ThetermFundedProductsasusedhereinmeansAAA’sproprietarydevelopmentcandidatesCyPat(TM),Seasonale(TM),***andanyproprietarydrugsubstitutedpursuanttoSection2.9hereof.ThetermFundedProductreferstoanyoneoftheprecedingdevelopmentcandidatesinthesingular.
1.12ThetermInternalVerifiableDevelopmentExpensesasusedhereinmeansthoseinternalcoststodevelopandsubmittheFundedProductstotheFDAforapprovalandreportedasresearchanddevelopmentexpenseonfinancialstatementstoshareholdersandconsistentwithFinancialAccountingStatementNo.2.Suchcostsinclude,butarenotlimitedto,thee