医院实施临床试验合约书(中英文)

HUMANCLINICALTRIALAGREEMENTWITHHOSPITALThisAgreementismadebetweenHospital(hereinafter

“PartyA”)andthetrialsponsor_____(hereinafter

“PartyB”).(PartyB

’sName______)hasanofficein____andisgovernedbythelawsoftheRepublicofChina.PartyAisamedicalinstitutionsituatedinTaipeiCity,Taiwan,theRepublicofChinaandisgovernedbythelawsoftheRepublicofChina.此合约是由台北市医院委托财团法人私立台北医学大学(以下简称“甲方”)，以及试验委托者(以下简称“乙方”)双方所签订。PartyAacceptsPartyB ’srequesttoimplementtheclinicaltrialprotocolnamed“ProtocolName”.(ProtocolNumber:____.PrincipleInvestigator:Dr.____.ExpectedCommencementandEndDatesoftheTrial:____).甲方接受乙方委托，实施临床试验 ____。（试验编号：____。试验主持人：____。试验预计起迄期间： ____）。ThePartiesagreetothefollowingtermsandconditions: 特立约遵照条款如下：1. Undertaking 声明PartyB(includingthedelegatedtrialinstitutionsub-delegatedbyPartyB)shallmakereasonableeffortstoprovideacompleteclinicaltrialprojectbasedonthedateandtitleoftheclinicaltrialprotocolandinaccordancewiththe“GoodClinicalPractice).AcopyoftheClinicalTrialProtocol(Attachment1)isattachedtothisAgreementforreference.Thecontentsoftheclinicaltrialshallbeguidedbythe[PrincipleInvestigator],whoshallbethe“PrincipleInvestigator”asagreedunderthisAgreement.IncaseofanydiscrepancybetweenthisAgreementandtheClinicalTrialProtocol,thisAgreementshallprevail.TheClinicalTrialProtocolcanonlybeamendedafterpriorwrittenagreementsbybothParties.乙方(及乙方复委托之受托研究机构 )应合理尽力的依照优良临床试验各项相关规范及准则于期间内执行并完成试验。试验内容应接受试验主持人 ____之指导，即本合约中所同意的“主要试验主持人。若在本合约及计划书中发生任何不一致时，以本合约内容为准。计划书只有在事先经由甲乙双方书面同意后才可进行更动。2. ImplementationPeriod 执行期间InaccordancewiththisAgreement,unlessthescopeofthisAgreementisextendedbyamendment,orthisAgreementisterminatedinaccordancewithArticle14,theimplementationperiodoftheclinicaltrialshallbefrom(CommencementDate)to(EndDate).ThisclinicaltrialshallonlybeimplementedaftertheapprovalfromPartyA’sInstitutionalReviewBoard(“IRB”)and/ortheapprovalfromtheDepartmentofHealthoftheExecutiveYuan.根据本合约，除非因本合约修正而扩大，或因第 14条而终止，本合约有效期间应为开始日期____至结束日期____。此试验将依据现行法规于收到甲方之人体试验委员会(“IRB”)同意及/或行政院卫生署通过后才开始执行。Fees费用PartyBshallpaytoPartyAthebudgedfeesunderAttachment2.BasedonbothParties’estimates,theamountofthebudgetwillbesufficientforthisclinicaltrial.However,PartyAmayreasonablyincurfeesexceedingthebudget,inwhichcasePartyAshallsubmitaMemorandumofUnderstandingforthepurposeofamendingandincreasingthebudget.UnlessotherwisestipulatedunderthisAgreement,PartyBshallnotbeobligedtopayanyfeeexceedingbudgetwhichhasnotbeenpreviouslyapprovedbyawrittenMemorandumofUnderstanding.乙方应根据附件二中列出的预算支付费用给甲方。由各方估算，预算规定的金额将足以支付此试验，但甲方可合理的预期超支的费用，则甲方需提交一份备忘录以要求修订增加的预算。除非本合约另有规定，否则乙方不必支付任何未经事先以书面备忘录核准的超支预算。Thetotalresearchbudgetis____NewTaiwanDollars(NT$____)includingtax.PartyBmaychoosetopaythefullamounttoPartyAuponsignatureofthisAgreement.FollowingnegotiationbybetweentheParties,PartyAmaydisposeofthisamountatitsowndiscretion.TheamountmaybeincreasedordecreasedbasedonactualneedsfollowingnegotiationsbetweentheParties.PartyBmayalsochoosetomakethepaymentsinaccordancewiththefollowingbasedonactualneeds.研究经费合计新台币 ____元整含税。乙方可选择于合约签订后全额汇款付予甲方，甲方可经由双方协商后全权支配此经费，并得视实际需求经双方议定后增减之。或乙方可视实际需求选择下列支付方式。WithinoneweekfromsigningthisAgreement,PartyBshallpaytoPartyAone-thirdofthetotalamountoftheExpense-BasedCostslistedinAttachment2 –ClinicalTrialBudgetTable –aswellastheMedicalManagementFees,totaling______NewTaiwanDollars(NT$____).UnlessstipulatedinthisAgreementwithregardtobudget,thefeesshallbepaidinfullwithinthirty(30)daysfromthedateofthisAgreement.乙方应根据附件二临床试验预算表中「消耗费用」总金额，于合约签订后一周内先拨三分之一经费，并同药品管理费，共计新台币 ____元整，付予甲方，且除本合约另有预算规定外，应于合约日期的三十 (30)天之内缴纳费用。Followingthecommencementofthetrial,variousExpense-BasedCostsincurred,theEmployeeSalaryExpensesandotherrelatedexpensesshallbecalculatedandpaidatonceonaquarterlybasisbasedonactualconsumptionandpaymentsituationsinaccordancewithAttachment2–ClinicalTrialBudgetTableandEmployeeSalaryExpensesSchedule.PartyBunderstandsandagreesthatthesubmissionfeebyPartyA ’sInstitutionalReviewBoardcannotbereimbursed,whetherithasbeenincludedinthebudgetornot.PartyBchoosestopaythefeesby:installmentpayment/fullpayment.试验开始后，所产生之各项消耗费用，研究护士工资及其它相关费用，将依据附件二临床试验预算表与研究护士工资付款期程表，依实际消耗支付状况，以每季结算一次方式给付之。无论是否被纳入预算，乙方都了解并同意支付甲方之人体试验委员会审查费用是不可退还的。乙方选择经费拨付方式为： ____。(全额汇款或分拨汇款 )FeestobepaidtoPartyAshallbewiredintothefollowingbankaccount:ChinaTrustCommercialBankTunNanBranch163538122106AccountName “TaipeiMedicalUniversity –MunicipalWanFangHospital ”Inordertoconfirmtheamountwired,eachpaymentshallbeaccompaniedbythenameofthepayinginstitutionandthenameofthemaininvestigatorofthetrial.应支付给甲方之费用，将汇入下列账户： ____为确认款项，每次的支付应注明签账单位名称以及主要试验主持人的姓名。4.Supply供应PartyBshallsupplyPartyA,freeofcharge,withsufficientvolumesofinvestigationalproducts(orequipment)inordertoimplementtheclinicaltrial.Itshallalsoprovideothercompoundsubstances,rawmaterials,instruments,equipmentandinformationthataredesignatedinotherprotocolsorthosedeemednecessarybyPartyB.Unlessotherwisestipulated,theownershipofallsuchinvestigationalproducts(orequipment),compoundedsubstances,rawmaterials,instrumentsandequipmentshallbelongtoPartyB.Suchinvestigationalproducts(orequipment)shallbelimitedtobeusedonsubjectsofthisClinicalTrialProtocolbyPartyA ’s(human)principleinvestigatorandshallnotbeusedforanyotherpurposes.乙方应免费提供甲方足够量的研究用产品、耗材、仪器设备以及信息以进行临床试验。除非另有规定，上述物品及信息之所有权仍归于乙方。本试验之研究用产品限于甲方之试验主持人使用于本试验之受试者，不得他用。5.PrincipleInvestigator ’sUndertaking 试验主持人的保证(a) PartyA’sprincipleinvestigatorguaranteestoundertakeallrelevantobligationsrequiredundertheprovisionsoftheClinicalTrialProject(Attachment1)andtocomplywithappropriategovernmentlawsandregulations.PartyBundertakestocomplywithandtoperformtherelevantrequirementsbytheinvestigatorandbytheDepartmentofHealthoftheExecutiveYuanundertheprovisionsoftheClinicalTrialProtocol(Attachment1).甲方之试验主持人承诺负担本试验计划书(附件一)条款中所要求的相应义务，并符合适当的政府法规。乙方承诺遵守并履行本试验计划书(附件一)条款中，试验主持人及行政院卫生署所要求的相关规定。6.Notice通知AnynoticeorrequestinrelationtothisAgreementshallbedoneinwritingandshallbemailedorfaxedtothefollowingaddressesbyexpresspre-paidcourier:任何与本合约有关的通知或要求，都应以书面、快递邮件、已付邮资的方式邮寄到：7.IndependentContractor 独立签约者PartyAisanindependentcontractorandisnotanagent,partner,orasponsor.该甲方是一个独立的签约者，而非乙方的代理人、合伙人或赞助者。8.IndependentClinicalTrial 独立临床试验Whethertheemployeesreceiveasalaryornot,thisAgreementmaynotbeconstruedtorestrictthefreedomoftheinvestigatorsandPartyA ’semployeestoengageinothersimilarcasesoutsidethisAgreementandforentitiesotherthanPartyB.无论人员受薪与否，本合约均不得被解释为可限制试验主持人及甲方中的雇员去从事非本合约、乙方以外之团体，所进行之其它类似案件之自由。9.Confidentiality 保密资料Allinformationwhichhasbeendesignatedasconfidentialshallbe,priortotheirpublicdivulgation,deemedasconfidentialinformationinthemannerofwrittenconfidentialityundertakings.TheconfidentialinformationmaynotbeusedbyanyotherentityforanypurposeotherthanthisAgreement.UponreceiptofconfidentialinformationprovidedbytheotherParties,eachPartyagreestohandlethemasiftheyareitsownconfidentialinformation,andshallnotdivulgesuchconfidentialinformationtoanythirdpartywithinthree(3)yearsunlesspriorwrittennotificationissenttotheotherParty.Theabovementionedconfidentialityobligationsshallnotapplytothefollowing:Informationofthepublicdomainatthetimeofdivulgation;Informationknowntootherspriortoitsdivulgation;Informationobtainedfromthirdpartywithoutconfidentialityobligations;orDivulgationrequiredbylaws.所有指定需保密的数据在其应被公开之时间以前，均应以书面保密协议之方式被视为机密数据，除了此合约所要达成的目的外，不得被其它团体任意使用。甲乙双方同意当收到由对方提供的机密数据时，将视同己方的机密数据一样妥善管理，并进一步同意若没有事先以书面方式通知对方，将于三(3)年内不向第三方揭露这些机密资料。前述的保密义务不适用于：揭露时属于公共领域；在揭露前已被他人得知；资料来自于对乙方没有保密义务的第三方；或被法律要求揭露。10.DataOwnershipandIntellectualPropertyRights 数据的所有权及智能财产权PartyBshallretainownershipoverthecasereportforms(CRF)andthedatageneratedastheresultofthepurposeoftheClinicalTrialProtocol.However,PartyAshallretainownershipoverthemedicalhistoryinformationandsourcedata(exceptthedailyrecordofthesubjects).However,PartyAanditsprincipleinvestigatorhavetherighttokeepaphotocopyoftheclinicaltrialdatageneratedastheresultoftheclinicaltrialforeducationaland/oracademicresearchpurposes,anditmaypublicizetheresultsoftheclinicaltrialinaccordancewithArticle11.乙方提供之个案报告表及由本试验计划书研究目的而产生的数据结果，其所有权归乙方所有。但病历数据及原始文件之所有权 (受试者日志除外 )归属甲方所有。但甲方及甲方之试验主持人有权保留此试验产生的数据结果复印件以作为教育及 /或学术探讨之用，并可如第十一 (11)条所述公开发表其临床试验结果。UnlessstipulatedinthisAgreement,theintellectualpropertyrightsoftheinventions,discovered,improvementofthetrialcoursesandresults,andthetrialresultsanditsproductsareownedbyPartyB.However,anyinnovativeoperations,therapiesandrelativetomedicaltechnologiesforthisClinicalTrialProtocolresearchedorinventedbyPartyAand/orPartyA ’sprincipleinvestigator,thepatentandintellectualpropertyrightsarebelongedtoPartyAanditsprincipleinvestigator.除本合约另有规定外，试验过程及结果之发明、发现、改良与研发成果与产品，其智能财产权均归属乙方所有。但甲方及其试验主持人，为本计划案所研发、创新之手术、治疗方式及相关医疗技术，其专利权及智慧财产权仍归甲方及其试验主持人所有。Excepttheabove-mentioned(a)and(b),intheeventthattheinvestigationalproducts(orequipment)usedbyPartyAinthetrialandthosepropertyrights/orintellectualpropertyrightsbelongtoPartyAoranythirdparty,PartyAshallnotifyPartyBinwritingpriorusingthem,butthosepropertyrightsand/orintellectualpropertyrightsstillbelongtooriginalowners.除前二项规定外，甲方于试验中如有使用原甲方所有或第三人所有之所有权及 /或智能财产权，应于使用前以书面通知乙方，惟其所有权及 /或智慧财产权仍归属各该原权利人所有。(d) SpecimenOwnership 检体的所有权Ifspecimenscollectedfortheclinicaltrialareusedbyothersubsequentadditionalexperiments,eachPartyagreesthefollowings:(a)AccordingtothestipulationprovidedbyDepartmentofHealth,ExecutiveYuan,R.O.C.,itshallbemadestatementintheInformedConsentFormthatspecimenssuppliedbythesubjectsofthisclinicaltrialwillbeusedbyothersubsequentadditionalexperimentsforotherpurposes.(b)complyingwithRegulationsforcollectingandusingofhumansforresearchthatprovidedbyDepartmentofHealth,ExecutiveYuan,R.O.C.(c)InformationofthesubjectsshallbekeptconfidentialandshallbeprotectedinaccordancewiththeprovisionsoftheInformedConsentFormandrelevantlaws.若试验所采集的检体样本会在后续进行其它附加研究，甲乙双方同意以下所有的事项：依据行政院卫生署相关规定于受试者同意书中说明此试验受试者提供之检体样本将会进行后续其它的目的。(2)遵守行政院卫生署「研究用人体检体采集及使用注意事项」之规定。(3)受试者的资料将保密并受到受试者同意书中的规定及相关法律所保护。11.Publication 公布出版PartyBunderstandsthatPartyAisfocusedontheexchangeofmedicalandacademicinformationandmaypublicizetheresultsofitsacademicactivities.Thus,PartyAhastherighttopublicizeinformationthatisrelatedtothisclinicaltrialverballyorinwriting.ForPartyA ’spublicationordisclosureoftheserelatedinformation,awrittenphotocopyshallbeprovidedbyPartyBthirty(30)dayspriortothepublicationordisclosure.Ifthepublicationordisclosureofinformationinvolvespatentsorotherconfidentialinformation,theconfidentialinformationshallbeprotected.DuringPartyB ’sreviewofwritteninformationwithinthethirty(30)dayperiod,PartyAmaydelayitspublicationordisclosureofrelatedinformationforamaximumofsixty(60)daysinorderforPartyBorPartyAtofileapatentapplication.乙方明了甲方乃致力于医疗学术交流并会公开传播其学术活动的成果。因此，甲方有权以口头或是书面方式发表与此试验相关的数据。甲方在出版或发表这些相关资料时，应于三十(30)天前提交一份书面的复印件给乙方。当这些资料被出版或发表时，若涉及专利或其它机密数据，则这些机密数据应被保护。甲方在乙方审查这些书面资料的三十(30)天期间，将最多可延迟六十(60)天来出版或发布相关资料，以使乙方或甲方能提出专利申请。Ifthisisamulti-agencyclinicaltrialproject,thenPartyAagreesnottopublicizeanyincompleteresultspriortothecompletionofthetrialorpriortoresultsofPartyB ’sanalysis.Afterpublicationofthemulti-agencytrialresults,oriftheresultsarenotpublicizedaftertwelve(12)monthsfollowingthefullcompletionofthemulti-agencytrial,PartyAhastherighttopublicizeitsindividualclinicaltrialresultsaftersendingtheinformationforPartyB ’sreviewandconfirmationthirty(30)dayspriortothepublication.However,iftheinvestigatordeemsthatthepublicationofthetrialresultsshouldnotbedelayedforpublichealth,safetyorbenefitreasons,thedelayedpublicationoftwelve(12)monthsshallbeexempt.如果这是一个多中心的临床试验计划，则甲方同意不会在试验结束前或乙方分析结果出来前发表任何不完整的成果。在多中心试验结果已被公开，或当多中心试验全部结束后十二(12)个月结果仍未被公开时，甲方有权在三十(30)天前将资料送交乙方审查无误后，发布个别的试验成果。然而，当试验主持人认为出于公共卫生、安全、或福利的原因，此试验成果的发布不应被延迟时，此十二(12)个月的发布延迟应被免除。12.SiteEntry 场所的进入InaccordancewiththelawsandregulationsoftheDepartmentofHealthoftheExecutiveYuan,whenPartyBortheDepartmentofHealthrequirescontactwiththeinvestigator,otherpersonnelorequipmentrelatedtothisclinicaltrial,medicalrecords,recordsofthesubjects,individualcasereporttablesandotherrecordswhicharedirectlyrelatedtothisclinicaltrialinaccordancewithrelevantlawsandregulations,itshalldosoduringnormalbusinesshourswithpriornotice.当乙方(及乙方复委托之受托研究机构 )或卫生主管机关需要与甲方之试验主持人及其它与此试验相关的人员接触以进行监测或稽核时，应在平常的上班时间内进行，并事先告知。13.Promotion 宣传Withoutpriorwrittenconsent,neitherPartymaypromoteoradvertisetheproductsrelatedtothisclinicaltrial.However,thisdoesnotincludepre-existingrequirementsincludedintheattachmenttothisAgreement(suchasrecruitmentadvertisingforsubjectsapprovedbytheIRB).如无事先的书面许可，任一方不得随意进行与此试验相关的产品推广及广告。但这其中不包括此合约附件中已存在的要求(例如经由甲方之人体试验委员会核准之受试者招募广告)。14.Termination

终止ThisAgreementmaybeterminatedbyeitherPartywithanyreason,withasimplethirty(30)daypriorwrittennoticetotheotherParty.IfbasedonPartyA

’sorPartyB’sevaluation,oriftheinvestigator,PartyA

’sIRBortheDepartmentofHealthoftheExecutiveYuanconsidersthatthisclinicaltrialisinappropriate,unrealisticorunsuitabletobecontinued,thisclinicaltrialmaybeterminatedbyPartyAorPartyBatanytimeforanyreason.UponterminationofthisAgreement,PartyAshallbecompensatedforreasonableexpensesincurredpriortotheterminationofthisAgreementandfeeswhichcannotbecanceledandwhichhavenotbeenpaid.此合约可能由任一方因任何理由提出终止，惟需于三十 (30)天前以书面方式告知另一方。当甲方或乙方在评估之后，或甲方之试验主持人、甲方之人体试验委员会、或卫生主管机关认为此试验不宜进行时，此试验可在任何时间及任何理由下由甲乙任一方径行终止。合约终止时，对于本合约终止之前已发生之合理支出及无法取消的一些未付清的费用，甲方应得到赔偿。UponterminationofthisAgreementorwhenPartyAreceivesthenoticefortheterminationofthisAgreement,PartyAshallreturntoPartyBallfeeswhichPartyBhasoverpaidpriortotheterminationofthisAgreement.Ifasubjectterminateshisorherparticipation,orifthetrialisdiscontinuedforanyreason,PartyAshallbeprotectedbytheprincipleofnolosses,andthereforePartyBshallpaytoPartyAexpensesrelatedtothesesubjectsbasedonareasonableproportion,orpayfeestoPartyAinaccordancewiththepaymenttimetablewhichwasalreadyagreedupon.WhenthisAgreementexpiresoristerminatedbyoneorbothPartiesinaccordancewiththisAgreement,bothPartiesshallstarttocomplywithrelevantprovisionswithregardtopost-terminationoftheAgreement.Suchprovisionsshallinclude(butarenotlimitedto)Articles3,5,6,9,10,11,12,15and17.当本合约终止或甲方收到决定终止的通知时，甲方应将合约终止之前乙方所给付的超额费用退还给乙方。若受试者中止其参与，或试验因任何原因不再继续时，甲方应受到无损失原则的保护，故乙方应按合理的支付甲方已发生之受试者费用及相关试验消费。当本合约期满或因第 14条规定而终止时，甲乙双方仍应遵循本合约包括限于)第3,5,6,9,10,11,12,15 及17条款等内容。

(但不仅15.Indemnification 赔偿PartyB(includingthedelegatedtrialinstitutionsub-delegatedbyPartyB)shallcompensate,holdharmlessandprotectPartyAanditsagents,representatives,contractors,officersandemployees(the“Indemnified”)fromanydamagesfromdemands,suits,claims,declarationsorreimbursements(includingreasonableattorneys’feesandotherfeesincurredforthedefense)forpersonalinjuries(includingbutnotlimitedtodeath)orpropertydamagesarisingoutoforrelatedtotheimplementationofthisclinicaltrial.PartyAagreestoreasonablyprovidePartyBwithnecessaryassistancetoproceedwithnegotiations,settlementsanddefenseswiththirdparties.PartyBunderstandsandagreesthatthesubjects(includingtheirlegalsuccessorsandotherlegalclaimants)haveadirectrightofclaimagainstPartyB(includingthedelegatedtrialinstitutionsub-delegatedbyPartyB).乙方(及乙方复委托之受托研究机构)应采取积极措施保护甲方及其参与试验人员免于遭受伤害(包括但不限于身体或财物)并赔偿所受之一切损害，包括遭提出之任何要求、诉讼、宣告、清偿及合理之律师费及其它因辩护产生的费用。甲方同意提供乙方合理之必要协助，与该第三人进行谈判、和解及提出抗辩等。PartyBisnotresponsibleforlossesordamagesincurredbyPartyAfor(1)failuretocomplywithrelevantprovisionsoftheClinicalTrialProtocoland(2)failuretocomplywithprovisionsrequiredbytheDepartmentofHealthoftheExecutiveYuanorothergovernmentagencies.乙方就下列事项，可不对甲方及其参与试验之人员负赔偿责任： (1)不遵循试验计划书中的相关规定，(2)不遵守行政院卫生署法规的行为。但乙方明了受试者(包括其法定继承人及其它法定请求权人)对乙方(及乙方复委托之受托研究机构)有直接请求权。Ifthesubjectsareinsufficientordysfunctionalduetothemanufacturingofthedrugsorequipment,orsideeffectsrelatedtothisclinicaltrial,orstepsrequiredunderthisclinicaltrial,including(1)PartyA’suseoftrialdrugsorequipmentinaccordancewiththeClinicalTrialProtocol,(2)medicalexpenseswhicharenotincludedinthesubjects’drugormedicalinsurancefees,and(3)damagesoradverseeffectwhicharenotcausedbyPartyA’snegligenceorimproperbehavior,PartyBshallcompensatePartyAofreasonableandnecessarylossofmedicalexpenses.乙方就下列事项，应对甲方、甲方参与试验之人员及

/或受试者负赔偿责任：

(1)甲方及其参与试验人员按照本试验计划书执行，造成受试者遭受伤害。

(2)不包含在受试者的医疗保险费而致使甲方、甲方之参与试验人员及

/或受试者所遭受到之损失。

(3)非由甲方疏忽或失当所引起而造成之受试者伤害。Forcasessub-delegatedbyPartyB,PartyBshallensurethatthedelegatedtrialinstitutionbearthefollowingresponsibilitiesandshallbearjointliabilitywiththedelegatedtrialinstitution:(1)alllossessufferedbythesubjectsandPartyAduetotheinsufficiencyofthetrialdrugsorequipmentshallbecompensatedbythemanufacturersofthetrialdrugsorequipment;(2)alllossessufferedbythesubjectsandPartyAcausedbycontractresearchorganizationsshallbecompensatedbythecontractresearchorganizations.BothPartiesshallmaketheirbestefforttonegotiateandresolveanyconflictorcompensationissues.乙方复委托案件予受托研究机构，乙方应使其受托研究机构承担以下责任，并与乙方连带负责：(1)负责赔偿研究用产品缺失所造成受试者及甲方之一切损害；(2)负责赔偿乙方之复委托之受托研究机构所造成受试者及甲方之一切损害。甲乙双方应尽最大努力彼此协商解决任何的冲突或索赔问题。16.Insurance. 保险PartyBshalltakeoutgeneralcommercialliabilityinsuranceorbeself-insuredfortheClinicalTrialProtocol.Thegeneralcommercialliabilityinsuranceorself-insuranceshouldcoverthelevelofcompensationthatPartyBshallbearunderitscontractualresponsibilities.Inaccordancewithneeds,PartyBshallprovidewrittenproofofsuchinsurancetoPartyApriortothecommencementoftheclinicaltrial.乙方或其受托研究机构应为其临床试验计划投保一般商业责任险、自身责任保险或临床试验保险。上述保险应可足以提供乙方在本合约责任中所需负担的赔偿。乙方应于试验开始前提供此类保险的书面证据给甲方。Incaseofcancellation,non-renewaloramendmentofsuchinsurance,PartyBshallinformPartyAinwritingatleastfifteen(15)dayspriortotheincident.IfPartyBdoesnotfindsimilarinsuranceforsubstitutionwithinaperiodoffifteen(15)days,PartyAhastherighttoterminatethisAgreementeffectivelywithoutanyfurtherwaitingtimeandwithoutanynotificationupontheexpiryofthefifteen(15)dayperiod.乙方应于上述保险取消、不续约或更改前至少十五 (15)天以书面方式告知甲方；乙方若于此十五(15)天的期间内没有找到其它同类的保险取代，则甲方有权在此十五 (15)天的期限到期时，不经任何的额外的等候时间且无需通知即有效的径行终止本合约。17.ProtectionofPrivacy 遵从隐私保护InaccordancewiththelawsandimplementationrulesoftheRepublicofChina,otherthanforthepurposeoftreatment,paymentormedicalcareprovision,PartyAmaynotuseordiscloseanyprotectedmedicalhistoryinformationwithoutauthorizationfromtheconcernedparties.PartyAshallcomplywiththeregulationsandshallobtainconsentsfromindividualsubjectswhoparticipateinthetrialandagreethatthesuchprotectedmedicalhistoryinformationshallbeusedanddisclosedbyPartyBforthepurposeofimplementingandmonitoringthetrial.PartyBagreesthatunlessauthorizedbylawsorbythesubjects,PartyBshallnotdisclosetheprotectedmedicallyhistoryinformationtoanypersonoranyentity.依据法律及其实施细则所规定，除治疗目的、支付、或为了医疗照护以外，甲方不得在未经当事人授权的情况下任意使用或透露被保护的医疗病历数据。甲方将遵循规定，取得个别进入试验的受试者同意，同意这些被保护的医疗病历数据将为了达到对此试验的进行及监测之目的而被乙方披露及使用。乙方同意除非法律及受试者授权允许，乙方不得对任何人或任何团体揭露被保护的医疗病历资料。18.Guarantee 担保PartyAdoesnotguaranteetheresultsofthisclinicaltrial,anddoesnotguaranteethemarketabilityandsuitabilityofitsownership.PartyBshallnotberesponsibleforanydirect,consequentialorotherdamagessufferedbyPartyBoranyotherpersonorentityduetotheresultsoftheclinicaltrial.甲方不担保有关本试验的结果，并且不保证其所有权具有可销售性、适用性等特定的效果。甲方不需为试验结果所引发对乙方或其它团体或个人所造成的任何直接、相应、或其它的损害负责。19. NoWaiver 非放弃追究WaiverofanybreachofcontractorfailuretoperformanyresponsibilityunderthecontractbytheotherPartyshallnotbedeemedtobeacontinuedwaiverofanysimilarrepeatedbreachesorotherbreachesorfailuretoperformresponsibilitiesunderthecontract.放弃追究另一方任何违约或不履行本合约的责任不应被视为继续放弃对任何此类重复的违约行为或其它违约或不履行合约责任的追究。20. Disputes 纠纷DisputesorviolationsorprovisionsarisingoutofthisAgreement,ifirreconcilablethroughnegotiations,thePartiesagreetoattempttomediatethedisputeongenuinelyfriendlybasisbeforereferringthemtoarbitrationandlitigationorseekotherdisputeresolutionprocedurestoresolvethem.ThePartiesagreethattheTaipeiDistrictCo