ACCELERATEDCONFIDENTIAL DISCLOSUREAGREEMENT

-CRO Version

FORM: OGC-SC743

CTSA’s Accelerated Confidential Disclosure Agreement – CRO Version: 07.21.15

Form Date: 09.09.15

Revision Date: 09.09.15

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ThisACCELERATEDCONFIDENTIALDISCLOSUREAGREEMENT(the“Agreement”)ismade byandbetween:

The Regents of the University of Minnesota,anon-profit,educational,researchandhealthcareuniversity(“University”)withanaddressof{UNIVERSITYADDRESS}

and

,acorporationhavingitsprincipalplaceofbusinessat(“CRO”).

CROandUniversity are hereinreferred to collectivelyas “Parties.”Individually, eachofCROandUniversity isa “Party.”

WHEREAS, CROhas been engagedby(the “Sponsor”) toarrangeandadministeramulti-centerclinicaltrialfundedbySponsortodeterminethesafetyandefficacyof Sponsor’sproduct;

WHEREAS,CRO,onbehalfofSponsor,isseekingtoidentifypotentialinvestigativesitesforastudyrelatingto{INSERTNAMEOFDISEASEORDRUG/DEVICEBEINGSTUDIED}pursuanttoProtocol{INSERTPROTOCOLTITLEAND/ORNUMBER}(the“Study”),andUniversitydesirestoreviewinformationabouttheStudyonbehalfof inordertodeterminewhetheritwouldbeinterestedinparticipatingintheStudy (“Purpose”);and

WHEREAS,inconsiderationfortheopportunitytobeconsideredasaninvestigativesite,UniversityiswillingtoreceivetheConfidentialInformationsubjecttothetermsandconditionssetforthbelow.

NOW,THEREFORE,inconsiderationofthebenefitssetforthherein,thePartiesherebyagreeasfollows:

1)“ConfidentialInformation”referstoinformationofanykindwhichisdisclosedtotheUniversitybySponsorand/orCROonbehalfofSponsortoevaluatethePurposewhich:

a)byappropriatemarking,isidentifiedasconfidentialandproprietaryatthetimeofdisclosure;or

b)ifdisclosedorally,isidentifiedinamarkedwritingwithinthirty(30)daysasbeingconfidential.

Sponsorand/orCROonbehalfofSponsorwillmakereasonableeffortstomark ConfidentialInformationasstatedin(a)and(b) above.However,totheextentsuchmarkingisnotpracticable,then intheabsenceofwrittenmarkings,informationdisclosed(writtenorverbal)that areasonablepersonfamiliarwiththeStudywouldconsiderittobeconfidentialorproprietaryfromthecontextorcircumstancesofdisclosureshallbe deemedassuch.

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

UniversityagreestouseConfidentialInformationsolelyasallowedbythisAgreement.UniversityagreestomakeConfidentialInformationavailableonlytothosepersonnelwhorequireaccesstoittoevaluatethePurposeandtoinformsuchpersonneloftheconfidentialnatureofsuchinformationandtheobligationofconfidentialitytowhichtheyarebound.

2)The obligationof nondisclosuredoesnotapplywith respecttoanyof theConfidentialInformationthat:

a)isorbecomespublicknowledgethroughnobreachofthisAgreementbyUniversity;

b)isdisclosedtoUniversitybyathirdpartyentitledtodisclosesuchinformationwithoutknownobligationofconfidentiality;

c)isalreadyknownorisindependentlydevelopedbyUniversitywithoutuseofConfidentialInformationasshownbyUniversity´scontemporaneouswrittenrecords;

d)isreleasedwiththepriorwrittenconsentoftheSponsor.

3)UniversitymaydiscloseConfidentialInformationtotheextentthatitisrequiredtobeproducedpursuanttoarequirementofapplicablelaw,IRB, governmentagency,an orderofacourtofcompetentjurisdiction,orafaciallyvalidadministrative,Congressional,orothersubpoena,providedthatUniversity,subjecttotherequirement,order,orsubpoena,promptlynotifiesSponsor.Totheextentallowedunderapplicablelaw,Sponsormayseektolimitthescopeofsuchdisclosureand/orseektoobtainaprotectiveorder.UniversitywilldiscloseonlytheminimumamountofConfidentialInformationnecessarytocomplywithlaw,orcourtorderasadvisedbyUniversity’slegalcounsel.

4)Nolicenseorotherrightiscreatedorgrantedhereby,exceptthespecificrightto usetheConfidentialInformationunderthetermsofthisAgreement,norshallanylicense orotherrightwithrespecttothesubjectmatterhereofbecreatedorgrantedexceptbythepriorwrittenagreementofthePartiesdulysignedbytheirauthorizedrepresentatives.

5)UponSponsor’sand/or CRO’swrittenrequest, Universityagrees toreturnallConfidentialInformationsuppliedtoitbySponsorand/orCROonbehalfofSponsorpursuanttothisAgreementexceptthatUniversity mayretainsuchConfidentialInformationinasecurelocationforpurposesofidentifyingandsatisfyingitsobligationsandexercisingitsrightsunderthisAgreement.

6)NeitherUniversity,CRO, norSponsormayusethename,trademark,logo,symbol,orotherimageortradenameoftheotherPartyoritsemployeesandagentsinanyadvertisement,promotion,orotherformofpublicityornewsreleaseorthatinanywayimpliesendorsementwithoutthepriorwrittenconsentofanauthorizedrepresentativeoftheotherpartywhosenameisbeingused.Suchapprovalwillnotbeunreasonablywithheld.

7)ThisAgreementmaybeexecutedinanynumberofcounterparts,eachofwhichshallbeanoriginalandallofwhichtogethershallconstituteoneandthesamedocument,andisbindingonallPartiesnotwithstandingthateachofthePartiesmayhavesigneddifferentcounterparts.Scannedcopiesofsignaturesorelectronicimagesofsignaturesshallbeconsideredoriginalsignatureunlessprohibitedbyapplicablelaw.

8)ThisAgreementshallexpireone(1)yearfromtheeffectivedate ofthis Agreement.

9)ThiswrittenAgreementconstitutestheentireagreementbetweenthePartiesconcerningthesubjectmatter,andsupersedesallotherorprioragreementsorunderstandings,whetherwrittenororal,withrespecttothatsubjectmatter.AnychangesmadetothetermsorconditionscitedinthisAgreementrequirethewrittenapprovalofeachParty'sauthorizedrepresentative.

TheauthorizedrepresentativesofthePartieshavesignedthisAgreementeffectiveasofthedatelastsignedbelow:

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

FORM: OGC-SC743

CTSA’s Accelerated Confidential Disclosure Agreement – CRO Version: 07.21.15

Form Date: 09.09.15

Revision Date: 09.09.15

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