Accelerated Clinicaltrialagreement

Accelerated ClinicalTrialAgreement

- CRO Version

FORM: OGC-SC742

CTSA’s Accelerated Clinical Trial Agreement – CRO Version: 7.21.15

Form Date: 09.09.15

Revision Date: 09.09.15

ThisAcceleratedClinicalTrial(ACTA)Agreement(“Agreement”)ismadeasofthisdayof ,20 (the“EffectiveDate”)byandbetween theRegents of the University of Minnesota,anon-profit,educational,researchandhealthcare university(“University”)withanaddressat{UNIVERSITYADDRESS},and,acorporationhavingitsprincipalplaceofbusinessat(“CRO”).CROandUniversityarehereinreferredtocollectivelyas“Parties.”Individually,eachofCROandUniversityisa“Party.”

WHEREAS, CROhas been engagedby(the “Sponsor”) to arrange andadministeramulti-centerclinicaltrialfundedbySponsortodeterminethesafetyandefficacyofSponsor’sproduct;

WHEREAS,Sponsorisafor-profitorganizationthatintendstoconductasponsored multi-centerclinicaltrial,describedin1.1below,involvingtheuseofcertaindiagnostic(s),drug(s),devices(s),orbiologic(s)providedbySponsoranddesiresthatUniversityparticipateinsuchclinicaltrial;

WHEREAS,University,SponsorandCROhaveagreedto usetheACTA,toacceleratetheprocessoftranslatinglaboratorydiscoveriesintotreatmentsforpatients,toengagecommunitiesinclinicalresearchefforts,andtotrainanewgenerationofclinicalandtranslationalresearchers;

WHEREAS,theUniversityhasappropriatefacilitiesandpersonnelwiththequalification,training,knowledge,andexperiencenecessarytoconductsuchaclinicaltrial;and

WHEREAS,theStudycontemplatedbythisAgreementisofinterestandbenefittoUniversity,SponsorandCRO,andwillfurthertheinstructionalandresearchobjectivesofUniversityinamannerconsistentwithitsstatusasanonprofiteducational,researchandhealthcareUniversity;

NOW,THEREFORE,inconsiderationforthemutualpromisesmadeinthisAgreementandforvalidconsideration,thePartiesagreeasfollows:

1.Scopeof Agreement

1.1.Universitywillundertakeasponsoredmulti-centerclinicaltrial(“Study”)describedintheprotocolentitled, “”whichisincorporatedhereinasExhibitA(“Protocol”).UniversitywilluseitsreasonableeffortstoonlyrecruitsubjectsinaccordancewiththeProtocol.TheStudywillbeconductedattheUniversityunderthedirectionof,aofUniversity(“PrincipalInvestigator”).

1.2.Intheevent ofanyconflictbetweentheterms andconditions ofthisAgreementandtheProtocolorbetweenthisAgreementandanyofitsExhibits,thetermsandconditionsoftheProtocolshallcontrolwithrespecttomattersof theclinicalconductof theStudy,and thetermsof thisAgreementshall controlwithrespecttoallothermatters.

1.3.UnlessotherwiseagreedtobytheParties,Sponsorand/orCROwillprovidetoUniversityonatimelybasis,withoutcharge,therequiredquantitiesofproperly-labeledSponsordrug(s)orbiologics(s)(“StudyDrug”)and/ordevice(s)(“StudyDevice”)andothermaterials(e.g.,Investigator’sBrochure,handlingandstorageinstructions,and,ifapplicable,placebo)necessaryforUniversitytoconducttheStudyinaccordancewiththeProtocol.UnlessstatedotherwiseinwritingbySponsor,allsuchitemsareandwillremainthesolepropertyofSponsoruntiladministeredordispensedtoStudysubjectsduringthecourseoftheStudy.Receipt,storage,andhandlingofStudyDrugorStudyDevicewillbeincompliancewithallapplicablelawsandregulations,theProtocol,andCRO’sorSponsor’sinstructions.

1.4.CROandUniversityshallcomplywithandconductallaspectsoftheStudyin compliancewithallapplicablefederal,state,andlocallawsandregulations,includinggenerallyacceptedstandardsofgoodclinicalpracticeasadoptedbycurrentFDAregulationsandstatutesandregulationsoftheU.S.Governmentrelatingtoexportationoftechnicaldata,computersoftware,laboratoryprototypes,andothercommoditiesasapplicabletoacademicuniversities.UniversitywillonlyallowindividualswhoareappropriatelytrainedandqualifiedtoassistintheconductoftheStudy.

1.5.UniversityshallobtainIRBapprovalforthisStudyandproofthereofshallbeprovidedtoCRO.InitiationoftheProtocolandUniversity’sobligationtoconducttheStudyshallnotbeginuntil IRBapprovalisobtained.Universityshallobtainfromeachsubject,priortothesubject'sparticipationintheStudy,asignedinformedconsentandnecessaryauthorizationtodisclosehealthinformationtoCROand/orSponsorinaformapprovedinwritingbytheIRBorawaiverofconsentasdirectedbytheIRBandfurtherprovidedthattheinformedconsentisconsistentwithUniversity'spolicies.

1.6.UniversityshallpromptlyinformSponsorofanyurgentsafetymeasuresasinstructedintheProtocolorbreachesoftheProtocolofwhichUniversitybecomesaware.

1.7.University acknowledgesCRO’sright to assignortransfer, in whole orin part,withnotice toUniversity,anyofitsrightsorobligationsunderthisAgreementtotheSponsoror Sponsor’sdesignate.

2.Payments

Sponsor willprovidefinancial supportfortheStudyand willprovidesuchfundstoCROwhowillpayUniversityinaccordancewiththebudgetattachedasExhibitB(“Budget”)onaproratedbasis,accordingtotheactualworkcompletedandanynon-cancelableobligatedexpenses,forsubjectswhoareenrolledintotheStudy.ThePartiesacknowledgethat theBudgetamountsrepresentanequitableexchangefortheconductoftheStudyinlightoftheprofessionaltimeandexpensesrequiredfortheperformanceoftheStudy.

InadditiontoothernecessaryroutinginformationdetailedinExhibitB,eachpaymentshallclearlyreferencethe:StudyProtocolNumberandPIname.

Foradministrativeconvenience,variousStudycontactinformationmaybeattachedheretoandincorporatedbyreferenceasExhibitC,entitled,“AdministrativeStudyPointsofContact.”

TheUniversity’staxidentificationnumberis: .

3.Confidentiality

3.1.ItisanticipatedthatintheperformanceofthisAgreement,Sponsorand/orCROonbehalfofSponsormayneedtodisclosetoUniversityinformationwhichisconsideredconfidential.TherightsandobligationsofthePartieswithrespecttosuchinformationareasfollows:

“ConfidentialInformation”referstoinformationofanykindwhichisdisclosedtotheUniversitybySponsorand/or CROonbehalfofSponsorforpurposesofconductingtheStudyorData(asdefinedbelowinSection4)which:

a)byappropriatemarking,isidentifiedasconfidentialandproprietaryatthetimeofdisclosure;

b)ifdisclosedorally,isidentifiedinamarkedwritingwithinthirty(30)daysasbeingconfidential;or

c)isofsuchanaturethatareasonablepersonfamiliarwiththeStudywouldconsiderittobeconfidentialorproprietaryfromthecontextorcircumstancesofdisclosure.Notwithstandingtheforegoing,DataandresultsgeneratedinthecourseofconductingtheStudyarenotConfidentialInformationforpublishingpurposesinaccordancewithSection9ofthisAgreement.

Universityagrees,foraperiodoffive(5)yearsfollowingtheterminationorexpirationofthisAgreement,tousereasonableefforts,nolessthantheprotectiongiventheirownconfidentialinformation,touseConfidentialInformationreceivedfromSponsorand/orCROonbehalfofSponsorinaccordancewiththisSection.

UniversityagreestouseSponsor’sConfidentialInformationsolelyasallowedbythisAgreement,andforthepurposesofconductingtheStudy.UniversityagreestomakeSponsor’sConfidentialInformationavailableonlytothoseofits,oritsaffiliatedhospitals’employees,IRBmembers, personnel,agents,consultants,andvendors,andapprovedsubcontractors,asapplicable,whorequireaccesstoitintheperformanceofthisStudy,andaresubjecttosimilartermsofconfidentiality.

3.2.TheobligationofnondisclosuredoesnotapplywithrespecttoanyoftheConfidentialInformationthat:

a)isorbecomespublicknowledgethroughnobreachofthisAgreementbyUniversity;

b)isdisclosedtoUniversitybyathirdpartyentitledtodisclosesuchinformationwithoutknownobligationofconfidentiality;

c)isalreadyknownorisindependentlydevelopedbyUniversitywithoutuseofSponsor’sConfidentialInformationasshownbyUniversity’scontemporaneouswrittenrecords;

d)isnecessarytoobtainIRBapprovalofStudyorrequiredtobeincludedinthewritteninformationsummaryprovidedtoStudysubject(s)and/orinformedconsentform;

e)isreleasedwiththepriorwrittenconsentoftheSponsor;or

f)isrequiredtosupportthemedicalcareofa StudySubject.

3.3.UniversitymaydiscloseConfidentialInformationtotheextentthatitisrequiredtobeproducedpursuanttoarequirementofapplicablelaw, ,governmentagency,anorderofacourtofcompetentjurisdiction,orafaciallyvalidadministrative,Congressional,orothersubpoena,providedthatUniversity, subjecttotherequirement,order,orsubpoena,promptlynotifies Sponsor.Sponsormayseektolimit thescopeofsuchdisclosureand/orseektoobtainaprotectiveorder.UniversitywilldiscloseonlytheminimumamountofConfidentialInformationnecessarytocomplywithlaworcourtorderasadvisedbyUniversity’slegalcounsel.

3.4.Nolicenseorotherrightiscreatedorgrantedhereby,exceptthespecificrighttoconducttheStudyassetforthbyProtocolandundertermsofthisAgreement,norshallanylicenseorotherrightwith respecttothesubjectmatterhereofbecreatedorgrantedexceptbythepriorwrittenagreementofthePartiesdulysignedbytheirauthorizedrepresentatives.

3.5.UponSponsor’sand/orCRO'swrittenrequest,UniversityagreestoreturnallConfidentialInformationsuppliedtoitbySponsorand/orCRO onbehalfofSponsoratSponsor’sexpensepursuanttothisAgreementexceptthatUniversitymayretainone(1)copyofanysuchConfidentialInformationinasecurelocationforpurposesofidentifyingandsatisfyingitsobligationsandexercisingitsrightsunderthisAgreement.

3.6UniversitymaydisclosetheexistenceofthisAgreementandanyadditionalinformationnecessarytoensurecompliancewithapplicableFederal,StateandUniversitypolicies,regulations,andlaws.

4.DataUse/Ownership

“Data”shallmeanalldataandinformationgeneratedbyUniversityasa resultofconductingtheStudyinaccordancewiththeIRBapprovedProtocol.DatadoesnotincludeoriginalStudysubjectorpatientmedicalrecords,researchnotebooks,sourcedocuments,orotherroutineinternaldocumentskeptintheUniversity’sordinarycourseofbusinessoperations, whichshallremainthesoleandexclusivepropertyoftheUniversityormedicalprovider.SponsorownsandhastherighttousetheDatainaccordancewiththesignedinformedconsentandauthorizationform,applicablelaws,andthetermsofthisAgreement.

NotwithstandinganylicensesorotherrightsgrantedtoSponsorherein,butinaccordancewiththeconfidentialityandpublicationsectionsherein,UniversityshallretaintherighttousetheDataandresultsforitspublication,IRB,regulatory,legal,clinical,educational,andinternalresearchpurposes.

5.HIPAA/HIPAAPrivacy

5.1.Universityshallcomplywithapplicablelawsandregulations,asamendedfromtimetotime,includingwithoutlimitation,theHealthInsurancePortabilityandAccountabilityActof1996anditsimplementingregulations(HIPAA)withrespecttothecollection,use,storage,anddisclosureofProtectedHealthInformation(PHI)asdefinedinHIPAA.CROandSponsorthroughitsagreementwithCRO,shallcollect,use,store,access,anddisclosePHIcollectedfromStudysubjectsonlyaspermittedbytheIRBapprovedinformedconsentformorHIPAAauthorizationformobtainedfromaStudysubject.Sponsor willcollect, use,store,anddiscloseanySubjectMaterial,definedinSection15,itreceivesonlyinaccordancewiththeinformedconsentformand,inanyevent,willnotcollect,use,store,ordiscloseanyPHIattachedtoorcontainedwithintheSubjectMaterialinanymannerthatwouldviolatethisSectionoftheAgreement.

Universityacknowledgesthat,pursuanttoSection111oftheMedicare,Medicaid,andSCHIPExtensionActof2007("MMSEA"),SponsorhasanobligationtosubmitcertainreportstotheCentersforMedicare MedicaidServiceswithrespecttoMedicarebeneficiarieswhoparticipateintheStudyandexperiencearesearchinjuryforwhichdiagnosisortreatmentcostsareincurred.SponsorandCROrecognizethat eachpartyissubjecttolawsandregulationsprotectingtheconfidentialityofresearchsubjectinformation.Accordingly:(1)UniversityagreesuponpriorwrittenrequesttoprovidetoSponsor,orCROasdesignatedbySponsor,certainidentifiablepatientinformationrequiredbyMMSEAforStudysubjectswhoareMedicarebeneficiariesandincurmedicalcostsinassociationwitharesearchinjuryandwhosecostsarereimbursedbySponsorpursuanttothisAgreement;and(2) UniversityfurtheragreestootherwisecooperatewithSponsor(andCROasdesignatedbySponsor)totheextentnecessaryforSponsortomeetitsMMSEAreportingobligations.

5.2.CRO’sabilitytoreviewtheStudysubjects’Study-relatedinformationcontainedintheStudysubject’smedicalrecordshallbesubjecttoreasonablesafeguardsfortheprotectionofStudysubjectconfidentialityandtheStudysubjects’informedconsentformorHIPAAauthorizationform.

5.3.NeitherCRO,norSponsorthroughitsagreementwithCRO,shallattempttoidentify,orcontact,anyStudysubjectunlesspermittedbytheinformedconsentform.

6.RecordRetention

Asapplicablebylaw,UniversityshallretainandpreserveacopyoftheStudyrecordsforthelongerof:

a)two(2)yearsafteramarketingauthorizationforStudyDrug,orStudyDevicehasbeenapprovedfortheindicationforwhichitwasinvestigatedorSponsorhasdiscontinuedresearchontheStudyDrugorStudyDevice;

b)suchlongerperiodasrequiredbyfederalregulatoryrequirements;or

c)asrequestedbySponsoratSponsor’sreasonable storageexpense.

7.MonitoringandAuditing

7.1.SitevisitsbySponsor,CROand/oranotherauthorizeddesignee(e.g.,Studymonitor)willbescheduledinadvancefortimesmutuallyacceptabletothePartiesduringnormalbusinesshours.Sponsor’s, CRO’sand/orauthorizeddesignee’s accessissubjecttoreasonablesafeguardstoensureconfidentialityofmedicalrecordsandsystems.

7.2.UponbecomingawareofanauditorinvestigationbyaregulatoryagencywithjurisdictionovertheStudy,UniversityagreestoprovideSponsorwithpromptnoticeoftheauditorinvestigation.IflegallypermissibleorallowablebytheregulatoryagencyandpermissibleinaccordancewiththeUniversity’spolicy,Sponsormaybeavailableorrequesttobepresentwithapprovalfromauditorduringsuchaudit,butSponsorwillnotalterorinterferewithanydocumentationorpracticeofUniversity.UniversityshallbefreetorespondtoanyregulatoryagencyinquiriesandwillprovideSponsorwithacopyofanyformalresponseordocumentationtotheregulatoryagencyregardingtheStudy.

8.Inventions, DiscoveriesandPatents

8.1.Itisrecognizedandunderstoodthatcertainexistinginventionsandtechnologies,andthosearisingoutsideoftheresearchconductedunderthisAgreement,aretheseparatepropertyofSponsororUniversityandarenotaffectedbythisAgreement,andneitherSponsornorUniversityshallhaveanyclaimstoorrightsinsuchseparateinventionsandtechnologies.

8.2.Anynewpatentableinventions,developments,ordiscoveriesmadeduringandintheperformance oftheStudy(“Inventions”)shallbepromptlydisclosedtoSponsor.TitletoInventionsthatnecessarilyuseornecessarilyincorporateSponsor’sStudyDrugand/orStudyDeviceshallresidewithSponsor(“SponsorInventions”).UniversityshallassignallSponsorInventionstoSponsorinwriting.TitletoInventionsotherthanSponsorInventions(“OtherInventions”)shallresidewithSponsorifSponsorpersonnelarethesoleinventors,withUniversityifUniversitypersonnelarethesoleinventors,andshallbeheldjointlyifbothUniversityandSponsorpersonnelareinventors.

8.3.TotheextentthatUniversityownssoleorjointtitleinanysuchOtherInventions,Sponsorisherebygranted,withoutoptionfeeotherthanconsiderationoftheStudysponsoredhereinandthereimbursementtoUniversityforpatentexpensesincurredpriortoorduringtheoptionperiod,anoptiontoacquireanexclusive,worldwide,royalty-bearinglicensetoUniversity'srightstoanyOtherInvention,whichoptionshallextendfornomorethanninety(90)daysafterSponsor’sreceiptofanInventiondisclosurefromUniversity(“OptionPeriod”).SponsorandUniversity shallusetheirreasonableeffortstonegotiate,foraperiodnottoexceedninety(90)daysafterSponsor’sexerciseofsuchoption, alicenseagreementsatisfactorytobothparties(“NegotiationPeriod”).IntheeventSponsorfailstoexerciseitsoptionwithintheOptionPeriod,orSponsorandUniversityfailtoreachagreementonthetermsofsuchlicensewithintheNegotiationPeriod,UniversityshallhavenofurtherobligationtoSponsorunderthisAgreementwithregardtothespecificOtherInvention.

8.4.Universityshallretainaroyalty-free,irrevocablelicensetouseforitsowninternalnoncommercialresearch,educationalandpatientcarepurposes,allSponsorInventionsorOtherInventionslicensedorassignedtoSponsorhereunder.

8.5.NothingcontainedinthisAgreementshallbedeemedtogranteitherdirectlybyimplication,estoppel,orotherwiseanylicenseunderanypatents,patentapplications,orotherproprietaryinteresttoanyotherinventions,discoveryorimprovementofeitherSponsororUniversity.

8.6.CROandUniversityagreethattheprovisionsofthisAgreementareintendedtobeinterpretedandimplementedsoastocomplywithallapplicablefederallaws,rules,andregulations,includingwithoutlimitationtherequirementsofRev.Proc.2007-47;provided,however,ifitisdeterminedbytheInternalRevenueServiceoranyotherfederalagencyorinstrumentality(the"Government")thattheprovisionsofthisAgreementarenotinsuchcompliance,thenthosepartiesagreetomodifytheprovisionsandtheimplementationofthisAgreementsoastobeincompliancewithallapplicablefederallaws, rules,andregulationsasdeterminedbytheGovernment.

9.Publication

9.1.Universityshallbefreeto publish, present,oruseanyDataandresultsarisingoutofitsperformanceoftheProtocol(individually,a“Publication”).Atleastthirty(30)dayspriortosubmissionforPublication,UniversityshallsubmittoSponsorforreviewandcommentanyproposedoralorwrittenPublication("ReviewPeriod").UniversitywillconsideranysuchcommentsingoodfaithbutisundernoobligationtoincorporateSponsor’ssuggestions.TheReviewPeriodforabstractsorposterpresentationsshallbethirty(30)days.IfduringtheReviewPeriod,SponsornotifiesUniversityinwritingthat:(i)itdesirespatentapplicationstobefiledonanyinventionsdisclosedorcontainedinthedisclosures,UniversitywilldeferPublicationforaperiodnottoexceedsixty(60)days,topermitSponsortofileanydesiredpatentapplications;and(ii)ifthePublicationcontainsSponsor’sConfidentialInformationasdefinedinSection3andSponsorrequestsUniversityinwritingtodeletesuchSponsor’sConfidentialInformation,theUniversityagreestodeletesuchSponsor’sConfidentialInformationonlytotheextent suchdeletiondoesnot precludethecompleteandaccuratepresentationandinterpretationoftheStudyresults.

9.2.ThePartiesagreethatthisStudyisa multi-centerclinicaltrial.Therefore, UniversityagreesthatthefirstPublicationoftheresultsoftheStudyshallbemadeinconjunctionwiththepresentationofajointmulti-centerPublicationoftheStudyresultswiththePrincipalInvestigatorsfromallsites contributingData,analyses,andcomments.However,Universitymaypublishthe DataandStudyresultsindividuallyinaccordancewiththisSection9uponfirstoccurrenceofoneofthefollowing:(i)multi-centerPublicationispublished;(ii)nomulti-centerpublicationissubmittedwithineighteen(18)monthsafterconclusion,abandonment,orterminationoftheStudyatallsites;or(iii)Sponsorconfirmsinwritingtherewillbenomulti-centerPublication.

9.3.Ifnomulti-centerPublicationoccurswithineighteen(18)monthsofthecompletionoftheStudy atallsites,upon requestbyUniversity,SponsorwillprovidesuchUniversityaccesstotheaggregateDatafromallStudysites.

9.4.IftheUniversity,throughitsPrincipalInvestigator,isidentifiedtoparticipateinthemulti-centerPublication:(i)Universitywillhavetheopportunitytoreviewtheaggregatemulti-centerData,uponrequest;and(ii)consistentwiththeInternationalCommitteeofMedicalJournalEditors(ICMJE)regulations,UniversitywillhaveadequateopportunitytoreviewandprovideinputonanyabstractormanuscriptpriortoitssubmissionforPublication.Universityalsoretainstheright,onbehalfofitsPrincipalInvestigator,todeclinetobeanauthoronanyPublication.

10.Use of Name

10.1.NeitherUniversitynorCROmayusethename,trademark,logo,symbol,orotherimageortradenameofanyotherpartyortheiremployeesandagentsinanyadvertisement,promotion,orotherformofpublicityornewsreleaseorthatinanywayimpliesendorsementwithoutthepriorwrittenconsentofanauthorizedrepresentativeoftheotherpartywhosenameisbeingused.Suchapprovalwillnotbeunreasonablywithheld.

10.2.UniversityandSponsorunderstandthat theamountofanypaymentmadehereundermaybedisclosedandmadepublicbytheotherpartyasrequiredbylaworregulation,includingthePatientProtectionandAffordableCareActof2010,providedthatthedisclosureclearlydesignatesthepaymentashavingbeenmadetoUniversityforresearchandnottothephysician.

10.3.UniversitymayacknowledgetheSponsor’ssupport,includingbutnotlimitedtofinancialsupportasmayberequiredbyacademicjournals, professionalsocieties,fundingagencies,andapplicableregulations.NotwithstandinganythingtothecontraryinthisAgreement,UniversitymaypubliclypostinformationabouttheStudyonUniversity’sclinicaltrialsdirectory/website.Additionally,notwithstandinganythinghereintothecontrary,UniversityshallhavetherighttopostSponsor’sand/orCRO’snames, theStudytitle,andtheStudyperiod,andfundingamount,onUniversitypublicly accessiblelistsofresearchconductedbytheUniversity.

11.Indemnificationand LimitationofLiability

11.1Sponsor’sindemnificationobligationsare outlinedin a separateLetterofIndemnification,attachedheretoasExhibitD.

11.2.CROexpresslydisclaimsanyliabilityinconnectionwiththeStudyDrugorStudyDevice,includinganyliabilityforanyclaimarisingoutofaconditioncausedbyorallegedlycausedbyanyStudyproceduresassociatedwithsuchproductexcepttotheextentthatsuchliabilityiscausedbythenegligence,willfulmisconductorbreachofthis AgreementbyCRO.

11.3.UniversityshallhavenoobligationtoindemnifyCROandCROshallhavenoobligationtoindemnifyUniversity.

12.Subject Injury

Sponsor’ssubjectinjuryobligationsareoutlinedinExhibitD.

13.Insurance

13.1.Universityshall,at itssole costandexpensemaintainapolicyorprogramofinsuranceorself-insuranceatthelevelofatleast$1,000,000peroccurrence(orperclaim)and$3,000,000annualaggregatetosupportitsobligationsassumedinthisAgreement.However,ifUniversityisapublicentityentitledtogovernmentalimmunityprotectionsunderapplicablestatelaw,thenUniversity mayprovideliabilitycoverageinaccordancewithanylimitationsassociatedwiththeapplicablelaw. CROshallmaintainaninsurancepolicyoraprogramofself-insuranceatlevelssufficient tosupportitsobligationsassumedherein.

13.2.Uponwrittenrequest,eitherPartywillprovideevidenceofitsinsuranceorself-insuranceacceptabletotheotherParty.EitherPartywillprovidetheotherParty withwrittennoticeofmaterialchangeinitscoveragewhichwouldaffectsuchParty’sabilityto meetitsobligationsunderthisAgreement.AParty’sinabilitytomeetitsinsuranceobligationconstitutesmaterialbreachofthisAgreement.

14.TermandTermination

14.1.ThistermofthisAgreementshallcommenceupontheEffectiveDateandterminateuponthecompletionoftheParties’Study-relatedactivitiesundertheAgreement,unlessterminatedearlyasfurtherdescribedinthisSection.

14.2.CROhastherighttoterminatethisAgreementuponthirty(30)dayspriorwrittennoticetotheUniversity.ThisAgreementmaybeterminatedimmediatelyatanytimeforanyreasonbytheUniversityorCROwhen,intheirjudgmentorthatofthe PrincipalInvestigator,theUniversity’sIRB,ScientificReviewCommittee,ifapplicable,ortheFoodandDrugAdministration,itisdeterminedtobeinappropriate,impractical,orinadvisabletocontinue,inordertoprotecttheStudysubjects'rights,welfare,andsafety,ortheIRBotherwisedisapprovestheStudy.IfforanyreasonPrincipalInvestigatorbecomesunavailabletodirecttheperformanceoftheworkunderthisAgreement,UniversityshallpromptlynotifyCRO.IfthePartiesareunabletoidentifyamutuallyacceptablesuccessor,thisAgreementmaybeterminatedbyeitherPartyuponthirty(30)dayswrittennotice.

14.3.NotwithstandingtheaboveaPartymay,inadditiontoanyotheravailableremedies:

a)immediatelyterminatethisAgreementupontheotherParty’smaterialfailuretoadheretotheProtocol,exceptfordeviationrequiredtoprotecttherights,safety,andwelfareofStudysubjects;and/or

b)terminatethisAgreementupontheotherParty’smaterialdefaultorbreachofthisAgreement,providedthatthedefaulting/breachingPartyfailstoremedysuchmaterialdefault,breach,orfailuretoadheretotheProtocolwithinthirty(30)businessdaysafterwrittennoticethereof.

14.4.Inadditiontotheabove,thisAgreementmaybeterminatedbyUniversityintheeventofamaterialdefaultorbreachofthisAgreement byCRO, orbyCROintheeventofamaterial breachofthisAgreementbyUniversity,providedthatthedefaulting/breachingpartyfailstoremedysuchmaterialdefaultorbreachwithinthirty(30)businessdaysafterwrittennoticethereof.

14.5.IntheeventthatthisAgreementisterminatedpriortocompletionoftheStudy,foranyreason,Universityshall:

a)notifytheIRBthat theStudyhasbeenterminated;

b)ceaseenrollingsubjectsin theStudy;

c)ceasetreatingStudysubjectsundertheProtocolasdirectedbyCROtotheextentmedicallypermissibleandappropriate;

d)terminate,assoonaspracticable,allotherStudyactivities;and

e)furnishtoCROanyrequiredfinalreportfortheStudyintheformreasonablyacceptabletoCRO.

Promptlyfollowinganysuchtermination,UniversitywillprovidetoCROcopiesofDatacollectedpursuanttotheStudyProtocol.UponSponsor’sorCRO’swrittenrequest, Universityshall providetotherequestingpartyallSponsor’sConfidentialInformationprovidedunderthisAgreementprovided,however,thatUniversitymayretainone(1)copyofConfidentialInformationforrecordkeepingpurposes,monitoringitsobligations,andexercisingitsrightshereunder,subjecttoUniversity’songoingcompliancewiththeconfidentialityandnon-useobligationssetforthinthisAgreement.

14.6.IfthisStudyisterminatedearlybyeitherParty,theUniversityshallbereimbursedforallworkcompleted,onaproratabasis,andreasonablecostsofbringingtheStudytoterminationincurredthroughthedateoftermination,andfornon-cancelablecommitmentsproperlyincurredthroughthatdate.Uponreceiptofnoticeoftermination,Universitywillusereasonableeffortstoreduceor eliminatefurthercostsandexpensesandwillcooperatewithCROtoprovideforanorderlywind-downoftheStudy.

14.7.Subsections1.4,1.6,and14.6,andSections2,3,4, 5, 6, 7, 8, 9, 10,11(andtheattachedLetterofIndemnification),12,13,15,19and23,shallsurviveanyterminationorexpirationofthisAgreement,exceptthatSection3shallsurvivefortheperiodstatedinSection3.1.AnyprovisionofthisAgreementthatbyitsnatureandintentremainsvalidafterterminationwillsurvivetermination.

15.Subject Material

15.1.SubjectMaterialmeansanybiologicmaterialofhumanoriginincluding, withoutlimitation,tissues,blood,plasma,urine,spinalfluid,orotherfluidsderivedfromtheStudysubjectsinaccordance withandpursuanttotheProtocol(“SubjectMaterial”).

15.2.UniversityagreestomaketheSubjectMaterialavailabletotheSponsorinaccordancewiththeProtocolforthepurposesoftheStudy.TheSubjectMaterialmaybeusedbytheSponsor,centrallab,orothercontractedpartyonlyasallowedbytheStudysubject’sinformedconsentformorpertinentUniversityreviewboard(s).Sponsor’suseofSubjectMaterials,otherthanasallowedbythe Studysubject’sinformedconsentform,willrequireadditionalIRBreviewandapproval.

16.Subcontract

Ifapplicable,Universityhas therighttosubcontracttoothersites toconducttheStudyinaccordancewiththeProtocolwithtermsconsistentwiththisAgreementwithwrittenapprovaloftheSponsor,whichapprovalshallnotbeunreasonablywithheld.IfUniversitysubcontractsanyStudyrelatedduties,Universityshallcontractwithsuchsubcontractorsincorporatingtermssubstantiallysimilartothetermsherein.SuchsubcontractsmaybeprovidedtotheCROuponwrittenrequest.

ThePartiesacknowledgeandagreethattheSponsorandeachofitsaffiliatesisathirdpartybeneficiarytothisAgreement.

17.Notices

Anynotice,authorization,approval,consentorothercommunicationwillbeinwritinganddeemedgiven:

a)Upondeliveryinperson;

b)Upondeliverybycourier;

c)Upondeliverydatebyanationally-recognizedovernightdeliveryservicesuchasFedEx.

IftoCRO:

Attn:

Phone No.:

Facsimile No.:

E-Mail:

IftoSponsor:

Attn:

Phone No.:

Facsimile No.:

E-Mail:

IftoUniversity:

Regents of the University of Minnesota

Attn:

Phone No.:

Facsimile No.:

E-Mail:

WithacopytoPrincipalInvestigator:

Phone No.:

Facsimile No.:

E-Mail:

18.IndependentContractor

ItismutuallyunderstoodandagreedthattherelationshipbetweenUniversityandCROisthatofindependentcontractors.Nopartyshallrepresentitselfastheagent,employee,partner,jointventurer,orservantoftheother.Exceptasspecificallysetforthherein,nopartyshallhavenorexerciseanycontrolordirectionoverthemethodsbywhichtheotherpartyperformsworkorobligationsunderthisAgreement.Further,nothinginthisAgreementisintendedtocreateanypartnership,jointventures,lease,orequityrelationship,expresslyorbyimplication,amongthoseparties.

19.ClinicalTrial Registry

PriortoenrollmentofthefirstsubjectintheStudy,SponsorwillregistertheStudyon

20.Non-Referral/Anti-CorruptionLanguage

20.1.UniversityandCRO, onbehalfofSponsor,agreethat itisnot theirintentunderthisAgreementtoinduceorencouragetheunlawfulreferralofsubjectsorbusinessbetweentheParties,andthereshallnotbeanyrequirementunderthisAgreementthatthoseparties,theiremployeesoraffiliates,includingtheirmedicalstaff,engageinanyunlawfulreferralofsubjectsto,ororderorpurchaseproductsorservicesfrom,oneofthoseparties.

20.2.UniversityandCRO,onbehalfofSponsor,agree thattheiremployees,whoareinvolvedintheconductoftheStudy,willnotoffer,pay,requestoracceptanybribe,inducement,kickbackorfacilitationpayment,andshallnotmakeorcauseanothertomakeanyofferorpaymenttoanyindividualorentityforthepurposeofinfluencingadecisionforthebenefitofoneofthoseparties.

21.ForceMajeure

IfeitherPartyheretoshallbedelayedorhinderedin,orpreventedfrom,theperformanceofanyactrequiredhereunderforanyreasonbeyondsuchParty’sdirectcontrol, includingbutnotlimitedto,strike, lockouts,labortroubles,governmentalorjudicialactionsororders,riots,insurrections,war,actsofGod,inclementweather,orotherreasonbeyondtheParty’scontrol(a“Disability”)thensuchParty’sperformanceshallbeexcusedfortheperiodoftheDisability.AnyStudytimelinesaffectedbyaDisabilityshallbeextendedforaperiodequaltothedelayandanyaffectedBudgetshallbeadjustedtoaccountforcostincreasesordecreasesresultingfromtheDisability.ThePartyaffectedbytheDisabilityshallnotifytheotherPartyofsuchDisabilityasprovidedforherein.

22.Counterparts

ThisAgreementmaybe executedinanynumberofcounterparts,eachofwhichshallbean originalandallofwhichtogethershallconstituteoneandthesamedocument,andisbindingonallPartiesnotwithstandingthateachofthePartiesmayhavesigneddifferentcounterparts.Facsimilesorscannedcopiesofsignaturesorelectronicimagesofsignaturesshallbeconsideredoriginalsignatureunlessprohibitedbyapplicablelaw.

23.Debarment

TheUniversitycertifiesthattoitsknowledgeneitherit,noranyofitsemployees,agentsorotherpersonsperformingtheStudyunderitsdirection,iscurrentlydebarred,suspended,orexcludedunderthe FederalFood,DrugandCosmeticAct,asamended,ordisqualifiedundertheprovisionsof21CFR

§312.70.IntheeventthatthePrincipalInvestigatororanyStudypersonnelbecomesdebarredordisqualifiedduringthetermofthisAgreementorwithin1yearafterterminationoftheStudy,theUniversityagreestopromptlynotifyCROafterlearningofsuchevent.Universitycertifiesthatitisnotexcludedfromafederalhealthcareprogram,includingMedicareandMedicaid.IntheeventanUniversitybecomesexcludedduringthetermofthisAgreementorwithin1yearafterterminationofthe Study,theUniversityagreestopromptlynotifyCROafterlearningofsuchevent.

24.Choiceof Law–Intentionallyomitted

25.EntireAgreement

SectionandclauseheadingsareusedhereinsolelyforconvenienceofreferenceandarenotintendedassubstantivepartsoftheParties’agreement.ThisACTAincorporatestheExhibitsreferencedherein.ThiswrittenACTAconstitutestheentireagreementbetweenthePartiesconcerningthesubjectmatter,andsupersedesallotherorprioragreementsorunderstandings,whetherwrittenororal,withrespecttothatsubjectmatter.Anychangesmadetotheterms,conditionsoramountscitedinthisACTArequirethewrittenapprovalofeachParty'sauthorizedrepresentative.

TheauthorizedrepresentativesofthePartieshavesignedthisACTAassetforthbelow.

Regents of the University of Minnesota
By:
Name:
Title:
Dated: / By:
Name:
Title:
Dated:
READANDACKNOWLEDGED
By:
Name:
Title:Principal Investigator
Dated:

FORM: OGC-SC742

CTSA’s Accelerated Clinical Trial Agreement – CRO Version: 7.21.15

Form Date: 09.09.15

Revision Date: 09.09.15

EXHIBITA

PROTOCOL

FORM: OGC-SC742

CTSA’s Accelerated Clinical Trial Agreement – CRO Version: 7.21.15

Form Date: 09.09.15

Revision Date: 09.09.15

EXHIBITB

BUDGET

FORM: OGC-SC742

CTSA’s Accelerated Clinical Trial Agreement – CRO Version: 7.21.15

Form Date: 09.09.15

Revision Date: 09.09.15

EXHIBITC

ADMINISTRATIVEANDSTUDYPOINTSOFCONTACT

FORM: OGC-SC742

CTSA’s Accelerated Clinical Trial Agreement – CRO Version: 7.21.15

Form Date: 09.09.15

Revision Date: 09.09.15

EXHIBITD

LETTEROFINDEMNIFICATION(LOI)/SUBJECTINJURY

To: UNIVERSITY

TITLEOFCLINICALTRIAL:CRO:

STUDYNUMBER:

1)UniversityhasenteredintoanAcceleratedClinicalTrialAgreement(ACTA)withCROtoparticipateintheabovesponsoredStudy. CROhas been engagedby{SPONSOR NAME} [the “Sponsor”)toarrangeandadministerthis{SPONSORNAME}sponsoredmulti-centerclinicaltrial.

2)SponsorhasdelegatedtoCROresponsibilityforthemanagementandmonitoringofthisStudy.SponsorhasfurtherauthorizedCROtobindSponsorto itsobligationswithintheAcceleratedClinicalTrialAgreementforthisStudyexecutedbetweenCROandUniversity.Sponsoraccepts responsibilityforitsobligationscontainedinthatAcceleratedClinicalTrialAgreement.

3)UniversityagreestoparticipatebyallowingtheStudytobeundertakenutilizingsuchfacilities,personnelandequipmentasUniversitymayreasonablyneedforitsconductoftheStudy.

4)InconsiderationofsuchparticipationbyUniversity,andsubjecttoparagraph5below,theSponsorshalldefend,indemnify,andholdharmlesstheUniversityanditsmedicalaffiliatesandaffiliatedhospitals,andeachoftheirtrustees,officers,directors,governingbodies,subsidiaries,affiliates,investigators,employees,IRBmembers,agents,successors,heirsandassigns(collectivelyreferredtoas"University’sIndemnitees"),fromandagainstanythirdpartyclaims,loss,damage,costandexpenseofclaims(includingreasonableattorney’sfees)andsuitsallegedtobecausedbyorarisingfromtheconductoftheStudyoruseoftheStudyDrugorStudyDeviceunderthisAgreementorfromtheuseoftheStudyresults("Claims"),regardlessofthelegaltheoryasserted.

5)SponsorshallhavenoobligationtoprovidesuchindemnificationtotheextentthatsuchClaimissolelycausedbyUniversity’sIndemnitee(s)’:(1)failuretoadheretoandcomplywithallmaterialandsubstantivespecificationsanddirectionssetforthintheProtocol(excepttotheextentsuchdeviationisreasonabletoprotecttherights,safetyandwelfareoftheStudysubjects);(2)failuretocomplywithallapplicablelawsandregulationsintheperformanceoftheStudy;or(3)ifsuchclaimisdirectlycausedbythenegligentactsoromissionsofUniversity’sIndemnitees(s).

6)Subjecttothelimitsandwithoutwaivinganyimmunitiesprovidedunderapplicablelaw(includingconstitutionalprovisions,statutesandcaselaw)regardingthestatus,powersandauthorityoftheUniversityortheUniversity’sprincipal(s),Universityshallindemnify,holdharmlessanddefendSponsor,itsdirectors,officers,employeesandagents,(“Sponsor’sIndemnitees”)fromandagainstonlythosethirdpartyClaimstotheextentdirectlyattributabletoUniversity’snegligenceinitsconductoftheStudy.Notwithstandingtheabove,UniversityshallhavenoobligationtoindemnifySponsorforanyotherClaims(including,butnotlimitedto,infringementorproductliabilityClaims).

7)TheindemnifiedPartyshallgivenoticetotheindemnifyingPartypromptlyuponreceiptofwrittennoticeofaClaimforwhichindemnificationmaybesoughtunderthisAgreement, provided,however,thatfailuretoprovidesuchnoticeshallnotrelieveindemnifyingPartyofitsindemnificationobligationsexcepttotheextentthattheindemnifyingParty’sabilitytodefendsuch Claimismaterially,adverselyaffectedbysuchfailure.IndemnifyingPartyshallnotmake anysettlementadmittingfaultorincuranyliabilityonthepartoftheindemnifiedPartywithoutindemnifiedParty’spriorwrittenconsent,suchconsentnottobeunreasonablywithheldordelayed.TheindemnifiedPartyshallcooperatewithindemnifyingPartyinallreasonablerespectsregardingthedefenseofanysuchClaim,atindemnifyingParty’sexpense.TheindemnifiedPartyshallbeentitledtoretaincounselofitschoiceatitsown expense.IntheeventaClaimfallsunderthisindemnificationclause,innoeventshalltheindemnifiedPartycompromise,settleorotherwiseadmitanyliabilitywithrespecttoanyClaimwithoutthepriorwrittenconsentoftheindemnifyingParty,andsuchconsentnottobeunreasonablywithheldordelayed.

8)EXCEPTFORTHE PARTIES’ OBLIGATIONS TOINDEMNIFYEACHOTHERASSTATEDABOVE,NEITHERPARTYSHALLBELIABLETOTHEOTHERPARTYFORSPECIAL,CONSEQUENTIALORINCIDENTALDAMAGESARISINGOUTOFORINCONNECTIONWITHTHISAGREEMENT,EVENIFADVISEDOFTHEPOSSIBILITYOFTHESAME.

9)IfaStudysubjectsuffersanadversereaction,illness,orinjurywhich,inthereasonablejudgmentofUniversity,wasdirectlycausedbyaStudyDrugorStudyDeviceoranyproperlyperformedproceduresrequiredbytheProtocol,SponsorshallreimburseforthereasonableandnecessarycostsofdiagnosisandtreatmentofanyStudysubjectinjury,includinghospitalization,butonly totheextentsuchexpensesarenotattributableto:(i)University'snegligenceorwillfulmisconduct;or(ii)thenaturalprogressionofanunderlyingorpre-existingconditionorevents,unlessexacerbatedbyparticipatingintheStudy.

10)Sponsorshall,atitssolecostandexpense,procureandmaintaincommercialgeneralliabilityinsurance,clinicaltrialinsuranceandproductsliabilityinsuranceorequivalentself-insurance,unlessotherwiseindicatedinanattachedworkorder,inamountsnotlessthan$3,000,000peroccurrenceand$10,000,000annualaggregate.Suchcommercialgeneralliabilityinsurance,clinicaltrialinsuranceandproductsliabilityinsuranceorequivalentself-insuranceshallprovidecontractualliabilitycoverageforSponsor’sindemnificationobligationsherein.

11)Uponwrittenrequest,Sponsorwillprovideevidenceofitsinsurancepolicyoraprogramofself-insuranceandwillprovideUniversitywithwrittennoticeofanymaterialchangeinitscoveragewhichwouldaffectSponsor’sabilitytomeetitsobligationsunderthisAgreement.Sponsor’sinabilitytomeetitsinsuranceobligationconstitutesmaterialbreachofthisLOIandtheAcceleratedClinicalTrialAgreementexecutedwiththeCROforthisStudy.

12)DuringtheStudyandforatleasttwo(2)yearsfollowingthecompletionoftheStudyatallsites,SponsorshallpromptlyprovideUniversityandPrincipalInvestigatorwiththe writtenreportofanyfindings,includingStudyresultsandanyroutinemonitoringfindingsinsitemonitoringreports,anddatasafetymonitoringcommitteereportsincluding,butnotlimitedto,dataandsafetyanalyses, andanyStudyinformationthatmay(i)affectthesafetyandwelfareofcurrentorformerStudysubjects,or(ii)influencetheconductoftheStudy.Universityand/orPrincipalInvestigatorwillcommunicatefindingstotheIRBandStudysubjects,asappropriate.

13)ExceptaspermittedinArticle10.3intheACTA,neitherUniversitynorSponsormayusethename,trademark,logo,symbol,orotherimageortradenameofanyotherpartyortheiremployeesandagentsinanyadvertisement,promotion,orotherformofpublicityornewsreleaseorthatinanywayimpliesendorsementwithoutthepriorwrittenconsentofanauthorizedrepresentativeoftheotherpartywhosenameisbeingused.Suchapprovalwillnotbeunreasonablywithheld.

TheauthorizedrepresentativeshavesignedthisLetterofIndemnificationassetforthbelow.

Regents of the University of Minnesota
By:
Name:
Title:
Dated: / By:
Name:
Title:
Dated:
READANDACKNOWLEDGED
By:
Name:
Title:Principal Investigator
Dated:

FORM: OGC-SC742

CTSA’s Accelerated Clinical Trial Agreement – CRO Version: 7.21.15

Form Date: 09.09.15

Revision Date: 09.09.15