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GetWithTheGuidelines®-StrokeHospitalParticipationAgreementfor

MildandRapidlyImprovingStrokeSymptoms(“MaRISS”)ResearchStudy

MaRISS Study ID No.______

ThisHospitalParticipation Agreement(“Agreement”)ismadeandenteredintoasof ,2017 (“EffectiveDate”) through September 30, 2019 (“End Date”)byandbetweentheAmericanHeartAssociation, Inc.(“AHA”),aNewYorknot-for-profitcorporationwithofficesat7272GreenvilleAvenue,Dallas,Texas75231and (enter hospital name here)(“ParticipatingSite”), a (enter hospital corporate entity type here) located at (enter hospital address here).

WHEREAS,AHAisanon-profithealthorganizationwithvolunteersthroughouttheUnitedStateswhoarededicatedtothegoalofbuildinghealthierlivesfreefromcardiovasculardiseaseandstroke,throughresearch,advocacyandthedevelopmentofprogramsthatimprovepatientaccesstohigh-qualityhealthcare;

WHEREAS,theAHAiscollaboratingwiththeUniversityofMiami(“UM”)toconducttheMildandRapidlyImprovingStrokeSymptomsResearchStudy(“Study”)andisrecruitinghospitalscurrentlyenrolledintheGetWiththeGuidelines®Stroke(“GWTG-S”)programtoparticipateintheStudy;

WHEREAS,theGWTG-Sprogramincludesthenationaldataregistry(“GWTG-SRegistry”)managedbyOutcomeSciences,Inc., a Quintiles company(“Quintiles”),AHA’sdatawarehouseandtechnologyvendor;

WHEREAS,ParticipatingSitehasenteredintoanagreementwithQuintilespursuanttowhichParticipatingSitehasenrolledinGWTG-SandutilizesthePatientManagementTool(“PMT”)tosubmitcertainpatientdataintotheGWTG-SRegistry;

WHEREAS,theAHAhasauthorizedQuintilestoprovideParticipatingSitewithaccesstothePMTforpurposesofsubmittingcertainStudydata;

WHEREAS,ParticipatingSitedesirestoparticipateintheStudy;

NOWTHEREFORE,inconsiderationofthemutualpromisessetforthherein,itisagreedbyandbetweenAHAandParticipatingSitethat:

TheAHAandParticipatingSiteenterintothisAgreementforpurposesofParticipatingSite’sparticipationintheStudyandagreetothetermsandconditionscontainedhereunder.

1.ParticipationintheStudy.ByexecutingthisAgreement,ParticipatingSiteagreestoparticipateinStudy,whichallowsParticipatingSitetosubmitcertainpatientdataintotheGWTG-SRegistry’sStudy-specificdatafieldsforpurposesofStudyanalysis.

2.Compliance.TheAHAandParticipatingSiteagreetocomplywiththeHealthInsurancePortabilityandAccountabilityActof1996,asamended,(“HIPAA”)andregulationspromulgatedthereunder,thePrivacyRuleandSecurityRuleasprovidedin45C.F.R.Parts160and164, including revisions and regulations promulgated under the HITECH Act;andallapplicablefederalandstatelawsandregulationsrelatingtotheconductoftheStudy,includingthoserelatedtotheconductofclinicalresearch,dataprivacy,safetyreporting,financialdisclosure,conflictofinterest,andpatientsafety.

3.TermandTermination.ThisAgreementwillbecomeeffectiveontheEffectiveDateandwillcontinue until the End Date. AHAmayterminatethisAgreementimmediatelyuponwrittennoticetoParticipatingSiteifAHAorUMcancelstheStudy. Either party mayterminatethisAgreementwithoutcauseuponthirty (30) calendar dayswrittennoticetothe other party. EitherpartymayterminatethisAgreementformaterialbreachuponthirty(30)calendar dayswrittennoticetotheotherparty.

4.StudyObjectives. TheoverallobjectiveoftheStudyistoclarifythelong-termoutcomesofStudypatients(“Subjects”)withmildorrapidlyimprovingstrokesymptomsandtoexaminetheassociationwithtPAtreatment. The StudywillfollowtheStudyProtocol, attached hereto as Exhibit E. The Study Protocol may be modified from time to time but will remain substantially similar to Exhibit E. The AHA will notify Participating Site of any modifications to the Study Protocol.

5.ParticipatingSiteResponsibilities.

a.InstitutionalReviewBoard(IRB)Approval.ParticipatingSiteshallobtainthenecessaryapprovalsfromtheapplicableIRB(s)beforestartingtheStudy,andwillprovideAHAwithcopiesofsuchapprovalswithinfive(5)businessdaysofreceivingconfirmationofIRBapproval.IfParticipatingSiteiswithoutaninternalIRB,ParticipatingSitewillsubmitarequesttoChesapeake or other AHA approvedIRBforstudyprotocolandinformedconsentreviewandapproval.ParticipatingSitewillsubmitannualcontinuingreportstotheIRBasrequiredbytheIRBandafinalreportonceallactivitiesarecomplete,inadditiontocomplyingwithanyotherconditionsrequiredbytheIRB.

b.InformedConsent.ParticipatingSiteshallobtainaninformedconsentform(“ICF”)fromeachSubjectpriortotheSubject’sparticipationintheStudy. ParticipatingSitewillensurethattheICFwasapprovedbytheAHAandIRBbeforeuse,andwillmaintainICFrecordsasneededforStudyrelatedauditing.ParticipatingSiteagreesthatitwillnotperformanystudy-specificprocedureorassessmentpriortoobtainingacompletedICFfromSubject.

c.Subject Data Recruitment. Within the first year of its staff completing the Training Module,ParticipatingSiteshallberesponsibleforrecruiting a minimum of six (6) patients, and shall continue to actively recruit patients throughout the term of this Agreement. Participating Site acknowledges and agrees that AHA shall not remit reimbursement of the Start-up costs and Training Module fees(as outlined in Exhibit A) until Participating Site successfully enrolls its first patient in the Study.

d.SubjectDataCollection.Participating Site shall ensure thatallSubjectdatacollectionmeetsapplicablepatientprivacyandsecuritystandardsandthedataprovidedfortheStudyisaccurateandcomplete.ParticipatingSitewillattendWeb-basedStudytrainingsessionsprovidedandscheduledbyAHA,whichwillincludeStudyProtocolspecifics(assessmentscales,datacollection,datatransmission)andclinicalresearchforms.

e.StatusReports.ParticipatingSitewillprovidetotheAHAregularupdatesandprojectstatusreportsontheday-to-dayprogressofParticipatingSite’sparticipation,includingSubjectenrollmentfortheStudy,oncepatientrecruitmentislaunchedandaccordingtoaschedulemutuallyagreedtobytheparties,butinanycasenolessfrequentlythanmonthly.Theseprogressreportswillinclude,butarenotlimitedto,thefollowinginformation:

  1. Statusofcompliance,includingIRBapprovaldocumentation;
  2. EvidenceofstaffandcliniciantrainingforallParticipatingSite’sStudyadministrators,includingCollaborativeInstitutionalTrainingInitiative(“CITI”)humansubjectstraining,ortheequivalent,andcompletionoftheAHAtrainingmoduleonStudyprotocol;
  3. NumberofSubjectsenrolledinthestudy;
  4. ConfirmationofICFreceivedfromallenrolledSubjects;
  5. Study-specificclinicalassessmentdata(AHAtodefine),tobecollectedviathePMT;
  6. ThreatstoStudyvalidityorchallengesthe ParticipatingSitemayfacewithadheringtoStudydesign;
  7. AnybreachesinconfidentialityordeviationsfromStudydesignonthepartofParticipatingSite; and
  8. AllSeriousAdverseEventsthatoccurredduringthereportingperiod.

f.ParticipatingSitewillidentifyanindividualprojectadministratororStudyadministratorwhowilloverseetheParticipatingSite’sparticipationintheStudyandwillbetheprimarycontactwiththeAHA.

g.Participating Site will make its project administrator or Study administrator and Study-related staff, as needed, available to AHA personnel responsible for on-site monitoring of the Study, and will cooperate with all such monitoring, training and reporting to AHA. Participating Site will provide necessary space for AHA on-site monitoring staff to perform their monitoring and review functions.

h.During on-site monitoring visits from AHA, Participating Site will allow AHA MaRISS staff access to the Study documents, including informed consent forms and source documents, pertinent hospital or medical records and patient charts. AHA MaRISS staff will not be allowed unsupervised access to electronic health records or other non-research records that contain protected health information.

i.ReportingSeriousAdverseEvents.IntheeventParticipatingSitebecomesawareofaSeriousAdverseEvent(SAE)thatisrelatedtoorassociatedwiththeuseoftPA,ParticipatingSitemustreporttoUMassetoutin Exhibit C Reporting Adverse Events and submit the SAEform attachedheretoasExhibit D.

6.AHAResponsibilities.

a.AHAwillprovidethefollowingStudyinformationtoParticipatingSite:

  1. AccesstotheGWTG-SPMTthroughQuintiles;
  2. GWTG-SPMTcodinginstructions;
  3. SupplementalSpecialInitiative(Study)researchtabwithinthePMT SupplementalStudydataelements;
  4. StudyTrainingModuleandSubsequentCertificationDocumentation:

a.AHAwillprovidescheduledandadhoctrainingregardingGWTG-SPMT,GWTG-Scodinginstructions,supplementalspecialinitiatives(Study)researchtab,supplementalcodinginstructions,andsupplementalstudydataelements.

  1. ContactinformationforAHAstaffresponsibleforMaRISS.

b. AHA will be responsible for the direct monitoring of the Participating Site through periodic scheduled site visits. All site visits shall be at mutually agreed upon times, except in circumstances where AHA reasonably believes that Participating Site is in material breach of the terms of this Agreement. Such site visits will include review of participant recruitment, flow of data, quality controls related to the data, including logging and maintaining required documents, Adverse Event reporting and Participating Site’s adherence to protocols.

c. Following on-site monitoring visits by AHA, AHA will provide Participating Site with a site monitoring report regarding any problems or issues that may have been noted during the visit. A follow-up timeline will be provided to ensure that any noted issues are resolved and corrections are implemented when needed.

7.Compensation.AHAwillreimburseParticipatingSiteforsatisfactorycompletionofallStudy-relatedobligationshereunder,includingSubjectenrollmentanddatacollection,assetoutinExhibitA. NocostsorexpensesrelatedtoanymedicaltreatmentofSubjectswillbepaid.ParticipatingSitewillnotpayanotherphysicianorfacilitytoreferSubjectstotheStudy.ParticipatingSitewillcomplywithallapplicabledisclosureobligationsrelatingtocompensationasmayberequiredbyanyIRBmedicalcommitteeorothermedicalorscientificorganizationaffiliatedwithParticipatingSite. AHA will reimburse the Participating Site an amount not to exceed $25,000.

8.Anti-Corruption/Anti-Fraud.ParticipatingSiteagreesthatthecompensationprovidedconstitutesthefairmarketvaluefortheservicesrenderedinlightofthedutiesrequiredtobeperformedhereunder;andwillnotaffectParticipatingSite’sjudgmentwithrespecttotheadviceandcareofeachSubject.

9.Debarment. ParticipatingSiterepresents thatneitheritnorits staffand personnel involvedin theStudyhaveeverbeendebarred,disqualifiedorsuspendedbytheU.S.FoodandDrugAdministration(FDA),theCentersforMedicareandMedicaidServices(CMS)orotherregulatorybody,norhavedebarment,disqualificationorsuspensionproceedingsbeencommenced.Duringtheterm ofthisAgreement,ParticipatingSitewillnotemployorotherwiseengageanyindividualtoperformStudyserviceswhohasbeendebarred,disqualifiedorsuspendedasdescribedinthisparagraph.ParticipatingSiterepresentsthatitisingoodstandingunderallapplicablelicensingbodies.IntheeventParticipatingSitereceivesnoticeofdebarment,suspension,sanction,exclusion,ineligibilityordisqualificationasnotedabove,ParticipatingSiteshallimmediatelynotifyAHAinwriting,andAHAshallhavetheright,butnottheobligation,toterminatethisAgreement,effective,atAHA’soption,immediatelyorataspecifiedfuturedate.

10.Inspections/AuditsofParticipatingSite.AHAanditsagentsoraffiliatesmayvisitParticipatingSiteduringnormalbusinesshourstomonitortheStudyandcompliancewiththisAgreement. ParticipatingSitewillbenotifiedpriortoanysuchvisitandwillprovideassistanceandcooperation. Theauditorwillmaintaintheconfidentialityofallrecordsviewed.ParticipatingSitealsowillcooperatewithallregulatoryauditsorinspectionsandwillnotifyAHApromptlyafterreceivinganyinquiries,correspondenceorcommunicationstoorfromanygovernmentalorregulatoryauthorityrelatingtotheStudy.

11.RepresentationsandWarrantiesofParticipatingSite. ParticipatingSiterepresentsandwarrantsthat:

a.ParticipatingSiteisdulyorganized,validlyexistingandingoodstandingunderthelawsofitsstatewhereitislicensedwithfullorganizationalpoweradequateforexecuting,delivering,andperformingitsobligationsunderthisAgreement;

b.ParticipatingSitewillcomplywithallapplicablefederalandstatelawsandregulationsrelatedtoParticipatingSite’sparticipationintheStudy;and

c.AtalltimesduringitsparticipationintheStudy,ParticipatingSitewillmaintaincommerciallyreasonabletypesandlevelsofinsurancecoverage,includingbutnotlimitedtoprofessionalliabilitycoverage,andprovideevidenceofsuchcoveragetoAHAuponrequest.

12.RepresentationsandWarrantiesofAHA.AHArepresentsandwarrantsthat:

a.AHAisanot-for-profitcorporationdulyorganized,validlyexisting, andingoodstandingunderthelawsoftheStateofNewYorkwithfullcorporatepoweradequateforexecuting,delivering,andperformingitsobligationsunderthisAgreement;

b.AHAwillcomplywithallapplicablefederalandstatelawsandregulationsrelatedtoStudy;and

c.AHAwillmaintaincommerciallyreasonabletypesandlevelsofinsurancecoverage.

13.Indemnity. Each party (the “Indemnifying Party”) agreestoindemnifyandholdharmlessthe other party,itsaffiliates,contractorsandlicensors,theirofficers,directors,employeesandagentsfromandagainstanyliabilityandcostsincurredinconnectionwithanyclaimarisingoutofanybreachbythe Indemnifying Partyofitrepresentations,warrantiesandagreementscontainedinthisAgreement.

14.IntellectualProperty.

a.Pre-existingIntellectualProperty.Ownershipoftrademarks,service-marks,inventions,discoveries,worksofauthorshipandotherdevelopmentsexistingasoftheEffectiveDatehereof,(collectively,Pre-existingIntellectualProperty),isnotaffectedbythisAgreement,andneitherAHAorParticipatingSiteshallhaveanyclaimstoorrightsinanyPre-existingIntellectualPropertyoftheotherexceptasmaybeotherwiseexpresslyprovidedinanyotherwrittenagreementbetweenthem.Forclarity,anyandallexistingdataresidinginorobtainedfromtheAHA’sGWTG-StrokeregistrydatabasemaintainedbyAHA,oritsvendor,willbethesoleandexclusivepropertyofAHAoritslicensors.ParticipatingSiteshallhavenorightstouseordisplayinanymannertheservicemarksownedbytheAHAwithouttheexpresswrittenpermissionoftheAHA.

b.StudyResults.AnyandallStudyresultsand/ordataanalysiscreatedbyUManddirectlyrelatingtotheStudy(“StudyDataAnalysis”)shallbethesoleandexclusivepropertyofUMorAHAasitslicensee.NorightswhatsoeverintheStudyDataAnalysisaregrantedhereundertoParticipatingSite.

c.MaRISS Publication Policy. The MaRISS limited dataset originates in the GWTG-Stroke registry and will be analyzed by UM. UM has first right to publish and present the data and Study Data Analysis at scientific meetings. If UM does not publish within 18 months of completion of the Study, the AHA has the right to publish the Study Data Analysis. All proposed publications and presentations need to be approved by the MaRISS Steering Committee. All publications are also subject to the written agreements between UM and the AHA, and UM and Genentech, and will comply with the AHA’s Get With The Guidelines Publication Policy. Sub-analyses not specified by the Study Protocol can be considered for review. A Participating Site may submit proposals to the MaRISS Steering Committee, which will evaluate the proposal for scientific merit and integrity, and potential conflict with other proposals or with the main Study objectives. These sub-analyses may be published after the main conclusions of the MaRISS Study have been published. The MaRISS Steering Committee makes the final determination on approval of these analyses.

15.DataOwnership.ParticipatingSiteauthorizesAHAandQuintilestoincludeitsParticipatingSiteDatainAHA’sGWTG-SRegistry.

a.SubjectData. AllinformationrelatingtoSubjectsandallParticipatingSitedatashallbetheexclusivepropertyofParticipatingSite,subjecttotherights,ifany,ofSubjectsinindividuallyidentifiedoridentifiableinformation,andsubjecttotherightsgrantedtoAHAinthisAgreement.Totheextentpermittedbylaw,alldatathatare:(1)generatedbyParticipatingSiteintheprocessingorreportingofSubjectencounters,and(2)containedinfilesofParticipatingSite,shallbeownedbyParticipatingSite.

b.Data Made Available to AHA. ParticipatingSiteauthorizesAHAtoreceiveandQuintilestodisclosetoAHA,atAHA’srequest,ParticipatingSite’sLimitedDataSetfortheStudy,totheextentpermittedbythePrivacyRuleandtheSecurityRuleandapplicablestate law and related agreements.Inaddition,ParticipatingSiteauthorizesQuintilestodisclosetoUMParticipatingSite’sSubjectDataenteredintothePMT,forpurposesoftheStudy. AHA also shall be allowed to access, use and disclose related protected health information of Study Subjects as necessary to carry out its duties under this Agreement.

16.Confidentiality.ForthepurposesofthisAgreement,“ConfidentialInformation”isdefinedasanyinformationincluding,butnotlimitedto,software,materials,dataorbusiness,financial,operational,customer,vendorandotherinformationdisclosedbyoneParty(“DisclosingParty”)toanotherParty(“ReceivingParty”),whichisnotgenerallyknownbyordisclosedtothepublicorknowntotheReceivingPartyexceptbyreasonofthenegotiationorperformanceofthisAgreement.ConfidentialInformationshallincludetheStudyProtocoldefinedasthedetaileddocumentmarked“Confidential”thatdescribestheobjectives,design,methodology,procedures,statisticalconsiderations,approachesandplanfortheStudywhetherdisclosedtoParticipatingSiteduringtheeffectiveperiodofthisAgreementordiscoveredbyParticipatingSiteasaresultoftheperformanceoftheStudy.Allmaterials,dataandreportsrelatingtotheStudy,aswellasintellectualpropertyofAHA,areConfidentialInformationandthepropertyofAHAoritslicensors.AllmedicalrecordsandothersourcedocumentsmaintainedbyParticipatingSiteshallremainthepropertyofParticipatingSite.ParticipatingSitewillkeeptheConfidentialInformationconfidentialanddiscloseitonlytoitsemployeesinvolvedinconductingthe Studyonaneed-to-knowbasis.Theseconfidentialityobligationswillcontinueuntilfive(5)yearsafter completionoftheStudy,butwillnotapplytoinformationtotheextentthatit:(i)isorbecomespubliclyavailablethroughnofaultofParticipatingSite;(ii)isdisclosedtoParticipatingSitebyathirdpartynotsubjecttoanyobligationofconfidentiality;(iii)mustbedisclosedtoIRBs;(iv)ispermittedtobedisclosedunderanICF;or(v)isrequiredtobedisclosedbyapplicablelaw,includingtoreportpublichealth/safetyinformation.ParticipatingSitewillnotifyAHAimmediatelyintheeventofadisclosureofConfidentialInformationnotpermittedbythissection.

17.LimitationofLiability;Remedies.

a.ParticipatingSiteagreesthattheuseofStudyProtocol,PMTorGWTG-SforanypurposerelatedtopatientcarecannotbecontrolledbytheAHAandmustnotbesubstitutedfortheprofessionalskillandjudgmentofalicensedhealthcareprovider.ParticipatingSiteacknowledgesthatAHAisinnowayresponsibleforanypharmacological,medical,legalorsimilarinformationcontainedin,enteredinto,orusedinconnectionwithStudy;

b.Studymaterialsareprovidedonan“ASIS,ASAVAILABLE” BASISANDTHEAHADISCLAIMSALLWARRANTIES,WHETHEREXPRESSORIMPLIED,INCLUDINGWARRANTIESOFMERCHANTABILITYANDFITNESSFORAPARTICULARPURPOSE.

c.ParticipatingSiteacknowledgesandagreesthattheAHAisnotresponsibleforanyerrorsinoromissionsfromtheStudy,including,withoutlimitation,anyinterpretationstherefrom,andparticipationisentirelyatParticipatingSite’ssolerisk;and,further,thatParticipatingSiteassumesanyandallclaims,damages,liabilities,suits,andexpensesarisingoutoforinconnectiontherewith;

d.Except for the indemnity provided in section 13 above, theentireliabilityoftheAHA,andParticipatingSite’sexclusiveremedyfordamagesfromanycauserelatedtoorarisingoutofthisAgreement,regardlessoftheformofaction,whetherincontractorintort,willnotexceedtheamountpaidbyAHAduringtheprevioustwelvemonthperiodtoParticipatingSite.INNOEVENTSHALLTHEAHABELIABLEFORANYINCIDENTAL,INDIRECT,SPECIALORCONSEQUENTIALDAMAGES,INCLUDINGBUTNOTLIMITEDTO,LOSSOFUSE,REVENUES,PROFITSORSAVINGS,EVENIFTHEAHAKNEWORSHOULDHAVEKNOWNOFTHEPOSSIBILITYOFSUCHDAMAGES,ORCLAIMS,DEMANDSORACTIONSAGAINSTPARTICIPANTBYANYPERSON; and

e.TheremediessetforththroughoutthisAgreementconstitutetheParticipatingSite’ssoleandexclusiveremediesandtheAHA’sentireliabilityintheeventofabreachoranyothercauseofactionarisingoutof,orinconnectionwith,thisAgreement.

18.IndependentContractors.ParticipatingSiteisanindependentcontractorandwillnotbeconsidered thepartner,agent,employeeorrepresentativeofAHAorUM,andneitherAHAnorUMwillberesponsibleforanyemployment-relatedtaxes,benefitsorinsurancerelatedtoParticipatingSite’sparticipationintheStudy.ParticipatingSitewillnothaveauthoritytomakeagreementswiththirdpartiesthatpurporttobindAHAorUM.

19.Miscellaneous.ThisAgreementconstitutesthecompleteagreementbetweenthepartiesandreplacesallotherwrittenandoralagreementsrelatingtotheStudy.NoamendmentsormodificationstothisAgreementwillbevalidunlessagreedtoinwritingbyallparties.FailuretoenforceanytermofthisAgreementwillnotconstituteawaiverofsuchterm.IfanypartofthisAgreementisfoundtobeunenforceable,itwillbereformedtotheextentpossible,andtherestofthisAgreementwillremainineffect.ThisAgreementwillbeinterpretedunderthelawsoftheStateofTexas.ThisAgreementwillbebindinguponthepartiesandtheirsuccessorsandassigns. ParticipatingSitewillnotassignortransferanyrightsorobligationsunderthisAgreementwithoutthewrittenconsentofAHA.Sections5through7,and10shallsurviveexpirationorterminationofthisAgreement.

INWITNESSWHEREOF,thepartieshaveexecutedthisAgreementbytheirdulyauthorizedrepresentativesasoftheEffectiveDate.

AmericanHeart Association,Inc.ParticipatingSite

By: ______By: ______

Print Name: Yosef Khan, MD, MPH, PhDPrint Name: enter name here

Title: Dir, Healthcare Quality Research Title: enter title here

and Bioinformatics

Date: ______Date: ______

EXHIBITA

Compensation Schedule

AHAshallcompensate the ParticipatingSite an amount not to exceed $25,000foritsparticipationintheStudyasfollows:

1.Funds to cover Start-up costs incurred by Participating Site ($500 for Year 1 only).

2.ReimbursementfordocumentedcostsincurredforIRBsubmission(maximum $2,500 for Year 1 and maximum $1,250 for Year 2).

3.CompletionofTrainingModule($500one-time fee paid to Participating Site upon completion of Training Module by all MaRISS staff). EligibleMDandRNtraineeswillreceiveone(1)hourofContinuingMedicalEducation(“CME”)credit.

4.Subjectenrollment$400perSubject, and an additional 22.7%FacilitiesandAdministrativecosts(formerlyindirectcosts), and detailed as follows:

  1. $270perSubjectforcompletingStudyassessmentsuptoday3(obtaininginformedconsent,patientenrollment,collectinginformationofalreadyperformedstandardofcareassessments,performingMaRISSNIHSS,TOAST,andcompletingMaRISSforms;
  2. $30perSubjectfora10minutephonecalltoperformmodifiedRankinScaleat30days;
  3. $100per Subjectforthe30minutephonecallat90days; and
  4. $90.80 per Subject for Facilities and Administrative costs (formerly indirect costs).
  5. $50.00 per Subject who completes the Patient Reported Outcome Tool questionnaire online,which is contained in the Study Protocol. This payment shall only be available until completion of 100 cumulatively accrued questionnairessubmitted by Subjects from across all MaRISS Participating Sites.

5.InternationalStrokeConference(ISC)attendance$500peryearforISCregistrationfor2years, which includes:

  1. ThiscoversoneattendeeperParticipatingSite; and
  2. ParticipatingSitetoinvoiceAHAafterattendeereturnsfromISC.
  3. In order to qualify for ISC reimbursement in the current year, Participating Sites that have been actively recruiting for the 6 months immediately preceding the ISC event must have enrolled at least 3 patients into the Study.

6.As provided for in Section 5(c), Participating Site understands that it is responsible for recruiting a minimum of six (6) patients within the first year of completing the Training Module. Upon successful enrollment of its first patient, AHA will reimburseParticipating Site Start-up costs and Training Module fees.

7.Participating Site to invoice AHA using the Invoice Template included herein as Exhibit B.

8.Participating Site to submit invoices to:

Yosef Khan, MD, MPH, PhD

Dir, Healthcare Quality Research & Bioinformatics

AmericanHeartAssociation/AmericanStrokeAssociation

7272GreenvilleAvenue

Dallas,Texas75231

Email:

EXHIBIT B

Participating Site Invoice

PARTICIPATING SITE: ______

INVOICE NUMBER: ______

INVOICE DATE: ______

Within 90 days of completion of each item listed below, please submit an invoice to AHA.

Item / Quantity / Unit Cost / Unit Rate / Previously Invoiced / Amount Due this Invoice
  1. Start-up Costs
/ $500 / Lump Sum
  1. IRBsubmission – Year 1
/ $2,500 / Each
  1. IRBsubmission – Year 2
/ $1,250 / Each
  1. Completion of Training Module
/ $500 / Lump Sum
  1. Subject Enrollment
/ $400 / Each
  1. 22.7% of $400 Facilities and Administrative costs (per patient)
/ $90.80 / Each Patient
  1. Subject questionnaire completion in Patient Reported Outcomes Tool
/ $50 / Each Patient
  1. ISC Attendance – Year 1
/ $500 / Each
  1. ISC Attendance – Year 2
/ $500 / Each
Total
Total Amount Previously Invoiced / Total Amount Due this Invoice

Form Rev 2017-02-14

1

EXHIBITC

Reporting Adverse Events

IntheeventParticipatingSitebecomesawareofaSeriousAdverseEvent(“SAE”)thatisrelatedtoorassociatedwiththeuseoftPA,ParticipatingSitemustreporttotheUMwithinone (1) businessdayofbecomingawareoftheSAE.

1.AdverseEvent(“AE”).AnyuntowardmedicaloccurrenceinaSubjectwhoisadministeredtPA,andwhichdoesnotnecessarilyhaveacausalrelationshipwith anytreatmentprovidedtoSubjectduringthetermoftheStudy,howeverinsignificantitmayappeartobe.ThisalsoincludesanSAEwithanassociatedproductqualityortechnicalcomplaintregardingtPA.

2.SeriousAdverseEvent(“SAE”). AnAEshouldbeclassifiedasanSAEifthefollowingcriteriaaremet:

  1. Itresultsindeath(i.e.,theAEactuallycausesorleadstodeath);
  2. Itislifethreatening(i.e.,theAE,intheviewofthe ParticipatingSite,placestheSubjectatimmediateriskofdeath.ItdoesnotincludeanAEthat,haditoccurredinamoresevereform,mighthavecauseddeath);
  3. ItrequiresorprolongsinpatienthospitalizationofSubject;
  4. Itresultsinpersistentorsignificantdisability/incapacity(i.e.,theAEresultsinsubstantialdisruptionoftheSubject’sabilitytoconductnormallifefunctions);
  5. Itresultsinacongenitalanomaly/birthdefectinaneonate/infantborntoamotherexposedtotPA; or
  6. ItisconsideredasignificantmedicaleventbytheParticipatingSitebasedonmedicaljudgment(e.g.,mayjeopardizetheSubjectormayrequiremedical/surgicalinterventiontopreventoneoftheoutcomeslistedabove).

3.AssessmentofAdverseEvents. AllSAEswhethervolunteeredbytheSubject,discoveredbyStudypersonnelduringquestioning,ordetectedthroughphysicalexamination,laboratorytest,orothermeanswillbereportedappropriately.EachreportedSAEwillbedescribedbyitsduration(i.e.,startandenddates),regulatoryseriousnesscriteriaifapplicable,suspectedrelationshiptothertPA(seefollowingguidance),andactionstaken.

  1. ReportingForm. ParticipatingSiteshallsubmitaseparateSeriousAdverseEventReportingForm(“SAEForm”)foreachEventwithinone(1)businessdayfollowingtheSAE. AnSAEForm isprovidedasExhibitD; and
  2. CompletedSAEFormsshallbesent via email and fax to:

i.IszetCampoBustillo,MPH

UniversityofMiami,NeurologyDepartment1120NW14thStreet,Suite1364

Miami,Florida33136

Email:

Fax: (305) 243-7081

Form Rev 2017-02-14