ProprietaryDrugDevelopmentandMarketingAgreement专利药品研发及销售协议doc文档格式.docx

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ProprietaryDrugDevelopmentandMarketingAgreement专利药品研发及销售协议doc文档格式.docx

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

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