2025年基因治療藥物質(zhì)量研究技術(shù)服務(wù)合同協(xié)議書草案大全PartiesThisServiceAgreement(the"Agreement")ismadeandenteredintoasof[InsertDate],byandbetween:[InsertFullLegalNameofClient],havingitsprincipalplaceofbusinessat[InsertClientAddress]("Client"),and[InsertFullLegalNameofServiceProvider],havingitsprincipalplaceofbusinessat[InsertServiceProviderAddress]("ServiceProvider").RecitalsWHEREAS,Clientisengagedintheresearch,development,andpotentialcommercializationofgenetherapymedicinalproductsanddesirestoengageServiceProvidertoperformqualityresearchandassuranceservices("Services")relatedthereto;andWHEREAS,ServiceProviderisexperiencedinprovidingqualityresearchandassuranceservicesforgenetherapymedicinalproductsandiswillingtoperformtheServicesforClientunderthetermsandconditionssetforthherein;NOW,THEREFORE,inconsiderationofthemutualcovenantsandagreementssetforthherein,thePartiesagreeasfollows:ScopeofWork1.1GeneralScope:ServiceProvidershallprovideServicestoClienttosupportthequalityresearchandassuranceofClient'sgenetherapymedicinalproduct(s)(the"Product"),asmoreparticularlydescribedinExhibitAattachedhereto(the"Exhibit"),whichExhibitformsanintegralpartofthisAgreement.TheServicesshallbeperformedinaccordancewithapplicableregulatoryguidelinesandstandards,primarilythoseissuedbytheU.S.FoodandDrugAdministration(FDA),theEuropeanMedicinesAgency(EMA),andtheChinaNationalMedicalProductsAdministration(NMPA),asineffectfromtimetotime.1.2SpecificServices:TheServicesshallinclude,butnotbelimitedto,thefollowing:a)Developmentandvalidationofanalyticalmethodsforthecharacterizationofthegenetherapyvectorandproduct,includingassessmentofidentity,purity,concentration/dotdensity,potency/infectivity/titer,hostcellDNA/RNA,endotoxins,mycoplasma,andotherrelevantqualityattributesasspecifiedintheExhibit.b)Developmentandqualification/validationofinvitroand/orinvivomethodstoassessvectordistribution,transductionefficiency,andbiologicalactivityrelevanttotheProduct'ssafetyandefficacyprofile,asspecifiedintheExhibit.c)Performanceofqualitycontroltestingonclinicaland/ornon-clinicalbatchesoftheProduct,insupportofprocessdevelopment,scale-up,andregulatorysubmissions,asrequestedbyClientanddetailedintheExhibit.d)Participationinprocessvalidationactivities,asneededandagreeduponinwritingbytheParties,tosupportthedemonstrationofconsistentproductquality.e)Provisionofstudyprotocols,finalreports,rawdatasummaries,methodvalidationreports,andotherdeliverablesasspecifiedinSection7ofthisAgreement.1.3RegulatoryCompliance:ServiceProvidershallperformtheServicesincompliancewithallapplicablelaws,regulations,andguidelines,includingbutnotlimitedtoGoodLaboratoryPractice(GLP),GoodManufacturingPractice(GMP),andGoodClinicalPractice(GCP)asmayberelevanttothespecificServices.TermandTermination2.1Term:ThisAgreementshallcommenceon[InsertStartDate]andshallcontinueuntilthecompletionofthefinaldeliverablesoutlinedintheExhibit,providedthateachdeliverableisacceptedbyClientwithinthirty(30)daysofsubmission,orsuchothertermasmaybemutuallyagreeduponinwritingbytheParties.UnlessterminatedearlierinaccordancewiththeprovisionsofthisAgreement,thisAgreementshallautomaticallyrenewfor[Number]twelve(12)-monthperiodsfollowingtheinitialterm,unlesseitherPartyprovideswrittennoticeofnon-renewalatleast[Number]monthspriortotheendofthethen-currentterm.2.2TerminationforConvenience:EitherPartymayterminatethisAgreementatanytimeupon[Number]days'writtennoticetotheotherParty.Intheeventofterminationforconvenience,ClientshallpayServiceProviderforallServicesperformedandcostsincurredpriortotheeffectivedateoftermination,asdeterminedbythePartiesinwriting.2.3TerminationforCause:ClientmayterminatethisAgreementimmediatelyuponwrittennoticetoServiceProviderifServiceProviderbreachesanymaterialtermorconditionofthisAgreementandfailstocuresuchbreachwithin[Number]daysofreceivingwrittennoticeofthebreachfromClient.ServiceProvidermayterminatethisAgreementimmediatelyuponwrittennoticetoClientifClientfailstomakeanypaymentdueunderthisAgreementwhendueforacontinuousperiodof[Number]days.Uponterminationforcause,ServiceProvidershallreturntoClientallnon-consumablepropertybelongingtoClient,andClientshallpayServiceProviderforallServicesperformedandcostsincurredpriortotheeffectivedateoftermination.2.4WarrantySurvival:NotwithstandingtheterminationorexpirationofthisAgreement,anyrepresentations,warranties,covenants,orobligationsoftheterminatingPartywithrespecttotheServicesperformedordeliverablesprovidedpriortoterminationshallsurviveandremaininfullforceandeffect.Deliverables3.1StudyProtocols:ServiceProvidershallprovideClientwithdraftstudyprotocolsforreviewandapprovalpriortocommencinganynon-exemptresearch.Clientshallprovidewrittenfeedbackonthedraftprotocolswithin[Number]daysofreceipt.ServiceProvidershallrevisetheprotocolsbasedonClient'sfeedbackandsubmitthefinalapprovedprotocolstoClient.3.2FinalReportsandOtherDocuments:ServiceProvidershallsubmitthefollowingdeliverablesuponcompletionoftheworkdescribedherein:a)FinalstudyreportsforallServicesperformed,intheformatandlanguagemutuallyagreeduponbytheParties.b)AllrawdatasummariesrequiredbyClientorapplicableregulations.c)Allmethodvalidationorqualificationreports.d)OtherdocumentsreasonablyrequiredbyClienttosupportregulatorysubmissions,asmutuallyagreedupon.3.3Timeliness:ServiceProvidershallendeavortosubmitdeliverableswithinthetimeframesspecifiedintheExhibit,orasotherwisemutuallyagreeduponinwriting.Client'sacceptanceofadeliverableshallbeconfirmedinwritingwithinthirty(30)daysofreceipt.PaymentTerms4.1PaymentSchedule:ThetotalfeefortheServicesshallbe[InsertTotalFeeAmountorBasisforCalculation](the"Fee").Paymentshallbemadeasfollows:a)Aninitialpaymentof[Percentage]%oftheFee,totaling[Amount],shallbeduewithin[Number]daysoftheeffectivedateofthisAgreement.b)Progresspaymentstotaling[Percentage]%oftheFee,basedoncompletionofthemilestonesspecifiedintheExhibit,shallbedueuponwrittencertificationfromServiceProviderandClient'sacceptanceofthecorrespondingdeliverableswithin[Number]daysofreceiptofsuchcertificationandacceptance.c)Afinalpaymentof[Percentage]%oftheFee,totaling[Amount],shallbeduewithin[Number]daysafterServiceProviderhasdeliveredallfinalreportsandotherdeliverablesandClienthasissuedwrittenacceptanceofsuchdeliverables.4.2PaymentMethods:Allpaymentsshallbemadewithoutdeduction,set-off,orcounterclaim,inUnitedStatesDollars(USD),bycheckpayabletotheorderof[InsertServiceProviderName]at[InsertServiceProviderBankNameandAddress],orbyelectronictransfertotheaccountnumberandbankinformationprovidedbyServiceProvider.ServiceProvidershallprovideadetailedinvoicewiththerelevantdeliverable(s)oruponrequest.4.3Interest:IfanypaymentdueunderthisAgreementisnotreceivedbyServiceProviderwithin[Number]daysafteritsduedate,interestshallaccrueontheoverdueamountatarateof[Percentage]%perannum,calculatedfromtheduedateuntilthedateofpayment.4.4Taxes:Allfeesspecifiedhereinareexclusiveoftaxes,duties,andsimilarcharges.ClientshallberesponsibleforanyandalltaxesandsimilarchargesincurredbyClientinconnectionwiththepaymentoffeesunderthisAgreement.Confidentiality5.1DefinitionofConfidentialInformation:"ConfidentialInformation"meansanyandallnon-publicinformation,whethertangibleorintangible,disclosedbyaPartytotheotherParty,includingbutnotlimitedtotechnicaldata,researchanddevelopmentinformation,manufacturingprocesses,formulas,designs,customerlists,businessplans,financialinformation,andanyinformationderivedfromorrelatedtotheotherParty'sbusiness,products,orservices,thatismarkedoridentifiedas"Confidential"or,ifnotsomarked,shouldbereasonablyunderstoodtobeconfidentialgiventhecontextofdisclosure.5.2ObligationsofConfidentiality:EachPartyshallholdtheConfidentialInformationoftheotherPartyinstrictconfidenceandshallusesuchConfidentialInformationsolelyforthepurposeoffulfillingitsobligationsunderthisAgreement.EachPartyshallnotdiscloseanyConfidentialInformationtoanythirdpartywithoutthepriorwrittenconsentofthedisclosingParty,exceptasrequiredbylaw,regulation,orcourtorder,inwhichcasethereceivingPartyshallprovidethedisclosingPartywithpromptwrittennoticeofsuchdisclosure.5.3Exclusions:Theobligationsofconfidentialityshallnotapplytoinformationthat:(a)wasalreadyknowntothereceivingPartypriortodisclosurebythedisclosingParty;(b)becomespubliclyknownthroughnobreachofthisAgreementbythereceivingParty;(c)isobtainedfromathirdpartywithoutbreachofsuchthirdparty'sobligationsofconfidentiality;or(d)isindependentlydevelopedbythereceivingPartywithoutuseoforreferencetothedisclosingParty'sConfidentialInformation.5.4ReturnofConfidentialInformation:UpontheterminationorexpirationofthisAgreement,orupontherequestofthedisclosingParty,thereceivingPartyshallreturnordestroyallcopiesoftheConfidentialInformation,andallobligationsofconfidentialityshallsurvivetheterminationorexpirationofthisAgreement.IntellectualPropertyRights6.1OwnershipofBackgroundIP:EachPartyretainsallownershipandrightsinandtoitsBackgroundIntellectualProperty(IP),asdefinedherein.BackgroundIPmeansallIPownedorcontrolledbyaPartypriortotheEffectiveDateofthisAgreement.6.2OwnershipofInventionsCreatedDuringtheTerm:SubjecttotheprovisionsofthisSection6andanyseparateIPAgreement,anyIP,includingbutnotlimitedtoinventions,discoveries,improvements,designs,know-how,data,andtechnicalinformation,developedsolelybyServiceProvider("ProviderDevelopedIP")duringthetermofthisAgreementshallbeownedbyServiceProvider.AnyIPdevelopedsolelybyClient("ClientDevelopedIP")shallbeownedbyClient.6.3IPDevelopedJointly:IfIPisdevelopedjointlybytheParties,titletosuchIPshallbeownedjointlybytheParties,unlessotherwiseagreedinwriting.ThePartiesshallhavetherighttolicensethejointlyownedIPtothirdpartiesonlywiththeconsentoftheotherParty.6.4UseofIP:ServiceProvidermayusetheClientDevelopedIPsolelyfortheperformanceofitsobligationsunderthisAgreement.ClientmayusetheProviderDevelopedIPsolelyforitsowninternalresearchanddevelopmentrelatedtotheProduct.6.5RegulatorySubmissionsandPatents:ServiceProvidershallhavetherighttoincludetheProviderDevelopedIPinregulatorysubmissionsmadetoauthorities,andtofilepatentapplicationsandenforcepatentsrelatedtosuchIP.ClientshallhavetherighttoincludetheClientDevelopedIPinregulatorysubmissionsmadetoauthorities,andtofilepatentapplicationsandenforcepatentsrelatedtosuchIP.ThePartiesshallcooperatereasonablytotheextentnecessarytosupporteachother'sregulatorysubmissionsandpatentfilingsrelatedtotheServicesprovidedunderthisAgreement.6.6NoLicenseGrant:NothinginthisAgreementshallbeconstruedasgrantingeitherPartyalicenseundertheotherParty'sBackgroundIPorIPdevelopedduringthetermofthisAgreement,exceptasexpresslyprovidedherein.Responsibility,Liability,andIndemnification7.1ServiceProvider'sWarranty:ServiceProviderrepresentsandwarrantsthatitshallusereasonableskill,care,anddiligenceinperformingtheServicesandthattheServicesandthedeliverablesshallbeconsistentwithapplicableregulatoryguidelinesandstandards.ServiceProvidershallalsowarrantthattheServicesanddeliverablesshallnotinfringeuponormisappropriateanythird-partyintellectualpropertyrights.7.2LimitationofLiability:Exceptasexpresslyprovidedherein,neitherPartyshallbeliabletotheotherPartyforanyindirect,incidental,consequential,special,orpunitivedamages,includinglossofprofits,data,orgoodwill,arisingoutoforinconnectionwiththisAgreement,regardlessofthecauseofaction.ThetotalliabilityofServiceProvidertoClientforallcausesofactionarisingoutoforinconnectionwiththisAgreementshallnotexceedtheFeepaidbyClientunderthisAgreement.Client'sliabilitytoServiceProvidershallbelimitedtotheamountofanypaymentsmadebyClienttoServiceProviderunderthisAgreement.7.3Indemnification:ClientshallindemnifyandholdharmlessServiceProviderfromandagainstanyandallclaims,losses,damages,liabilities,costs,andexpenses(includingreasonableattorneys'fees)incurredbyServiceProviderarisingoutoforresultingfrom:(a)Client'sbreachofthisAgreementoritsfailuretocomplywithapplicablelawsandregulations;(b)Client'suseoftheServicesorthedeliverablesinamannerthatisnotconsistentwithapplicableregulatoryguidelinesandstandards;or(c)anythird-partyclaimsrelatedtoClient'sproprietaryinformationorintellectualproperty.ServiceProvidershallindemnifyandholdharmlessClientfromandagainstanyandallclaims,losses,damages,liabilities,costs,andexpenses(includingreasonableattorneys'fees)incurredbyClientarisingoutoforresultingfrom:(a)ServiceProvider'sbreachofitswarrantiesunderSection7.1;or(b)ServiceProvider'suseofClient'sConfidentialInformationinamannerinconsistentwiththeobligationssetforthinSection5.EachPartyshallindemnifytheotherPartyforanyclaims,losses,damages,liabilities,costs,andexpensesincurredbysuchPartyarisingfromtheindemnifyingParty'sviolationofapplicablelawsandregulations,providedthattheindemnifyingPartyshallfirsthavehadtheopportunitytocuresuchviolationatitsownexpense.7.4AssumptionofLiability:NoindemnificationprovidedhereinshallbedeemedawaiverofanybreachbytheindemnifyingParty,norshallitconstituteanadmissionofliabilitybytheindemnifiedParty.Therightofindemnificationshallbeinadditionto,andnotinlimitationof,anyotherrightsorremediesavailabletotheindemnifiedParty.GoverningLawandDisputeResolution8.1GoverningLaw:ThisAgreementshallbegovernedbyandconstruedinaccordancewiththelawsoftheStateof[InsertState],withoutregardtoitsconflictoflawsprinciples.ThePartiesherebyirrevocablyattorntotheexclusivejurisdictionofthecourtslocatedin[InsertCounty/City],[InsertState],foranylegalactionarisingoutoforinconnectionwiththisAgreement.8.2DisputeResolution:Anydispute,controversy,orclaimarisingoutoforinconnectionwiththisAgreement,includinganyquestionregardingitsexistence,validity,ortermination,shallbesettledamicablythroughgoodfaithnegotiationsbetweentheParties.Ifthedisputecannotbesettledthroughnegotiationswithin[Number]daysfromthedateofthelatter'swrittenrequest,thedisputeshallbesubmittedto[InsertArbitrationInstitution,e.g.,theAmericanArbitrationAssociation]forarbitrationinaccordancewiththethen-currentrulesofthe[InsertArbitrationInstitution]applicablein[InsertJurisdiction],andthedecisionofthearbitrator(s)shallbefinalandbindingupontheParties.Thearbitrationshallbeheldin[InsertCity,State/Country].ThecostsofarbitrationshallbesharedequallybythePartiesunlessthearbitrator(s)determinesotherwise.Miscellaneous9.1EntireAgreement:ThisAgreement,includingtheExhibitattachedhereto,constitutestheentireagreementbetweenthePartieswithrespecttothesubjectmatterhereofandsupersedesallprioragreements,negotiations,andunderstandings,whetherwrittenororal,relatingtothesubjectmatterofthisAgreement.9.2Amendments:Noamendment,modification,orwaiverofanyprovisionofthisAgreementshallbeeffectiveunlessmadeinwritingandsignedbyauthorizedrepresentativesofbothParties.9.3Severability:IfanyprovisionofthisAgreementisheldbyacourtofcompetentjurisdictiontobeinvalid,illegal,orunenforceable,suchprovisionshallbeseveredfromthisAgreement,andtheremainingprovisionsshallcontinueinfullforceandeffect.9.4Waiver:NofailureordelaybyeitherPartyinexercisinganyrightorremedyunderthisAgreementshallconstituteawaiverofsuchrightorremedyorawaiverofanysubsequentfailureordelay.ContinuousorrepeatedfailureordelaybyaPartyinexercisinganyrightorremedyunderthisAgreementshallnotconstituteawaiverofsuchrightorremedy.9.5Notices:Allnotices,requests,demands,andothercommunicationsrequiredorpermittedunderthisAgreementshallbeinwritingandshallbedeemedgive