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FulgentTherapeuticsLLC-COVID-19DiagnosticTestingServices_D-20-280.pdf
July 31,AGREEMENTFORSERVICES2020,byandbetweenThisAgreementforServices,(the“Agreement”)iseffectiveasofFulgentTherapeuticsLLC(“LAB”),withabusinessaddressat4978SantaAnitaAve,TempleCity,CA91780andFresnoCounty(“CLIENT”)withabusinessaddressat1221FultonStreet,Fresno,CA93721.Whereas,LABhasthefacilitiesandexpertisetoprovideCOVID-19diagnostictestingtophysicians,hospitalsandotherlaboratories,andWhereas,CLIENTisapoliticalsubdivisionoftheStateofCaliforniathatdesirestopurchaseCOVID-19testingservicesfromtheLAB.Therefore,LABandCLIENTdoherebyagreeasfollows:ResponsibilitiesofthePartiesA.1.COVID-19TestingServices.LABagreestoprovidetoCLIENTthetestingservicesdescribedinAppendixAattachedhereto.2.Specimens.CLIENTwillprovideLABwithspecimensforCOVID-19testing.LABhasdevelopedspecificspecimenrequirements,whichareattachedheretoasAppendixA.CLIENTagreestofollowailinstructionsonAppendixAandunderstandsthatsuchinstructionsarecriticaltoLAB’sabilitytoperformthetestsdescribedherein.AllcostsassociatedwithCLIENT’SfailuretofollowtheinstructionsdescribedonAppendixAwillbeCLIENT’Sresponsibility.3.CLIENTRequirements.WhereCLIENTobtainsapatientsampleorsubmitsanorderforCOVID-19testingforapatient,CLIENTrepresentsandwarrantsthat(i)itisauthorizedinitsjurisdictiontoorderanytestsonbehalfofapatient;(ii)ithasadvisedthepatientofthebenefits,risks,capabilities,andlimitationsofthetest(s)andservices;(iii)CLIENTisfollowingalldataprivacyregulationsunderHIPAA,asamended,andunderanyotherapplicabledataprivacyrequirements;(iv)CLIENThasconfirmedthatitspatienthassignedorwillsignLAB’sinformedconsent,eitherinpaperform,oraspartofthetestrequisitionformprocess;and(v)CLIENTwillnotifyLABofanychangesinpatientinformationandconsentstatus.4.Transport.AllspecimensshouldbeshippedtothelabinthemannerspecifiedinAppendixA.5.Price.Fortheprovisionoftestingservices,CLIENTagreestopayLABattheratesetforthinExhibitAasthecurrentfeestobechargedtoCLIENTforservicesrenderedhereunder.Notestsorserviceswillbepricedbelowthefairmarketvalueasrequiredbylaw.AllquestionsregardinginvoicesshouldbedirectedtotheLAB’sInstitutionalBillingManagerat626-350-0537orbilling@fulgentgenetics.com,orsuchotherpersondesignatedinwritingbyLAB.5.Confidentiality.BothpartiesacknowledgeandagreethatthetermsofthisAgreementareconfidential.Bothpartiesagreethatneitherparty,itsagentsoremployeeswilldisclose,byanymeans,thetermsofthisAgreement,including,butnotlimitedto,thepricescheduleoranypartthereof,toanypartynotapartytothisAgreement.IntheeventCLIENTbreachesthisconfidentialityprovision,LABwillhavetheright,initssolediscretion,toincreasethepriceschargedfortheservicestobeperformedhereunderbyamendingAppendixA.6.HIPAARequirements.BothpartiesagreetocomplywiththeapplicableprovisionsoftheAdministrativeSimplificationsectionoftheHealthInsurancePortabilityandAccountabilityActof1996,ascodifiedat42U.S.C.§1320dthroughd-8,asamendedfromtimetotime(“HIPAA”),andtherequirementsofanyregulationspromulgatedthereunderincluding,withoutlimitation,thefederalprivacyregulationsascontainedin45CFRPart164(the“FederalPrivacyRegulations”)andthefederalsecuritystandardsascontainedin45CFRPart142(the“FederalSecurityRegulations”).Bothpartiesacknowledgethateachpartyconstitutesa“coveredentity,"asthattermPage1of7FULGENTTHERAPEUTICSLLC|AGREEMENTFORSERVICES isdefinedat45CFR§164.103,andbothpartiesareengagedin“coveredfunctions,”asthattermisdefinedat45CFR§164.501.Bothpartiesagreenottouseorfurtherdiscloseany“protectedhealthinformation,"asdefinedat45CFR§164.504,or"individuallyidentifiablehealthinformation,”asdefinedat42U.S.C.§1320d(collectively,the“ProtectedHealthInformation”),concerningapatientotherthanaspermittedbytheprovisionsofthisAgreementandtherequirementsofHIPAAandtheregulationspromulgatedpursuanttoHIPAA,includingwithoutlimitationtheFederalPrivacyRegulationsandtheFederalSecurityRegulations.BothpartiesmustimplementappropriatesafeguardstopreventtheuseordisclosureofprotectedhealthinformationotherthanasprovidedforbythisAgreement.EitherpartymustpromptlyreporttotheotherpartyanyuseordisclosureofprotectedhealthinformationnotinaccordancewiththisAgreementorinviolationofHIPAA,theFederalPrivacyRegulations,ortheFederalSecurityRegulationsofwhichthatpartybecomesaware.Intheeventeitherparty,withthepriorapprovaloftheotherpartyinwriting,contractswithanyotherpartiesoragentstowhomthepartyfurnishesprotectedhealthinformationreceivedfromtheparty,thatpartymustincludeprovisionsinsuchagreementswherebythatpartyandtheotherpartyoragentagreetothesamerestrictionsandconditionsthatapplytothatpartywithrespecttosuchprotectedhealthinformation.EitherpartymustreturntotheotherpartyorproperlydisposeofanyprotectedhealthinformationinaccordancewithfederalandstatelawandregulationsaftertheexpirationorterminationofthisAgreement.Eitherpartymustmakeitsinternalpractices,books,andrecordsrelatingtotheuseanddisclosureofprotectedhealthinformationavailabletotheSecretaryofHealthandHumanServicestotheextentrequiredfordeterminingcompliancewiththeFederalPrivacyRegulationsandtheFederalSecurityRegulations.Notwithstandingtheforegoing,noattorney-client,accountant-client,orotherlegalprivilegewillbedeemedwaivedbyeitherpartybyvirtueofthisparagraph.AnybreachofthisparagraphwillconstituteamaterialbreachuponwhichterminationofthisAgreementmaybebased.TheHIPAAPrivacyRulecreatesaspecialruleforasubsetofpublichealthactivitieswherebyHIPAAcannotpreemptstatelawif,“[t]heprovisionofstatelaw,includingstateproceduresestablishedundersuchlaw,asapplicable,providesforthereportingofdiseaseorinjury,childabuse,birth,ordeath,orfortheconductofpublichealthsurveillance,investigation,orintervention.”(45C.F.R.§160.203(c)[HITECHAct,§13421,sub.(a)].)Totheextentadisclosureoruseofdataunderthisagreementmayalsobeconsideredadisclosureoruseof“ProtectedHealthInformation”(PHI)ofanindividual,asthattermisdefinedinSection160.103ofTitle45,CodeofFederalRegulations,thefollowingPrivacyRuleprovisionsapplytopermitsuchdatadisclosureand/orusebytheparties,withouttheconsentorauthorizationoftheindividualwhoisthesubjectofthePHI:HIPAAcannotpreemptstatelawif,“[t]heprovisionofstatelaw,includingstateproceduresestablishedundersuchlaw,asapplicable,providesforthereportingofdiseaseorinjury,childabuse,birth,ordeath,orfortheconductofpublichealthsurveillance,investigation,orintervention.”(45C.F.R.§160.203(c)[HITECHAct,§13421,sub.(a)].)AcoveredentitymaydisclosePHItoa“publichealthauthority"carryingoutpublichealthactivitiesauthorizedbylaw;(45C.F.R.§164.512(b).)Acoveredentitymayuseordiscloseprotectedhealthinformationtotheextentthatsuchuseordisclosureisrequiredbylawandtheuseordisclosurecomplieswithandislimitedtotherelevantrequirementsofsuchlaw."(Title45C.F.R.§§164.502(a)(1)(vii),164.512(a))(1).)7.Insurance.CLIENTwill,atitssolecostandexpenseatalltimeduringthetermofthisAgreement,procureandmaintaincomprehensivegeneralandprofessionalliabilityinsuranceorself-insurance(includingpersonalinjury,propertydamage,productsliability,andcompletedoperationsliability),inaminimumamountofOneMillionDollars($1,000,000).CLIENTwillcausetobeissuedtoLABpropercertificatesofinsuranceorself-insuranceevidencingtheforegoingprovisionsofthisAgreementhavebeencompliedwithandsaidcertificateswillprovidethatpriorFULGENTTHERAPEUTICSLLC|AGREEMENTFORSERVICESPage2of7 toanycancellationorchangeintheunderlyinginsuranceduringthepolicyperiod,theinsurancecarrierwillfirstgivethirty(30)calendardayswrittennoticetoLAB.LABwill,atitssolecostandexpenseandatalltimesduringthetermoftheAgreement,procureandmaintaincommercialgeneralliabilityinsuranceandprofessionalliabilityself-insurance(includingpersonalinjury,propertydamage,productsliability)atthelevelsindictedbelow:•ComprehensiveAutomobileLiabilityInsurancewithlimitsofnotlessthanOneMillionDollars($1,000,000.00)peraccidentforbodilyinjuryandforpropertydamages.CoverageshouldincludeanyautousedinconnectionwiththisAgreement.•CommercialGeneralLiabilityInsurancewithlimitsofnotlessthanTwoMillionDollars($2,000,000.00)peroccurrenceandanannualaggregateofFourMillionDollars($4,000,000.00).Thispolicyshallbeissuedonaperoccurrencebasis.•ProfessionalLiability-IfLABemployslicensedprofessionalstaff,(e.g.,Ph.D.,R.N.,L.C.S.W.,M.F.C.C.)inprovidingservices,ProfessionalLiabilityInsurancewithlimitsofnotlessthanOneMillionDollars($1,000,000.00)peroccurrence,ThreeMillionDollars($3,000,000.00)annualaggregate.LABherebywaivesitsrighttorecoverfromCLIENT,itsofficers,agents,andemployeesanyamountspaidbythepolicyofworker'scompensationinsurancerequiredbythisAgreement.LABissolelyresponsibletoobtainanyendorsementtosuchpolicythatmaybenecessarytoaccomplishsuchwaiverofsubrogation,butLAB’swaiverofsubrogationunderthisparagraphiseffectivewhetherornotLABobtainssuchanendorsement.LABwillcausetobeissuedtoCLIENT,withinthirty(30)daysofsigningthisagreement,propercertificatesofself-insuranceevidencingtheforegoingprovisionsofthisAgreementhavebeencompliedwithandsaidcertificateswillprovidethatpriortoanycancellationorchangeintheunderlyinginsuranceduringthepolicyperiod,theinsurancecarrierwillfirstgivethirty(30)calendardayswrittennoticetoCLIENT.AllpoliciesshallbeissuedbyadmittedinsurerslicensedtodobusinessintheStateofCalifornia,andsuchinsuranceshallbepurchasedfromcompaniespossessingacurrentA.M.Best,Inc.ratingofAFSCVIIorbetter.B.GeneralProvisions1-Term.TheinitialtermofthisAgreementwillcommenceasofthedaterecitedaboveandcontinueforoneyear.Thereafter,thisAgreementwillautomaticallyrenewforadditionalone-yeartermsunlesseitherpartygiveswrittennoticeofterminationtotheotherparty.Suchterminationiseffective30daysafterreceiptofwrittennoticesentbytheterminatingparty.ThisAgreementmaybeterminatedwithoutcauseatanytimebeforeexpirationwiththirty(30)daysbywrittennoticefromeitherparty.2.Publicity.AnymentionoftheLabbytheCompanyforpublicitymustbepre-approvedbytheLabinwriting.3.Effectoftermination.Uponanytermination,LABmayatitssolediscretion,providetestingservicesforanyspecimensreceivedbutnotprocessedasofthedateoftermination,orreturnsuchspecimenstoCLIENT.LABmayconsiderbutnotbeobligatedtoprovidetestingservicesundersuchcircumstancesuponofferofprepaymentforthetestingservicesbyCLIENT.4.Assignment.ThisAgreementmaynotbeassignedbyeitherpartywithoutthepriorwrittenconsentoftheotherparty.ConsentmaybeconditioneduponwrittenacknowledgmentofobligationsunderthisAgreementbytheprospectiverecipientoftheassignment.FULGENTTHERAPEUTICSLLC|AGREEMENTFORSERVICESPage3of7 5.Amendments.ThisAgreementmaybemodifiedoramendedonlybyaninstrumentinwritingsignedbybothpartieshereto.6.ForceMaieure.Noliabilityhereunderwillresulttoapartybyreasonofdelayinperformancecausedbyforcemajeure,thatiscircumstancesbeyondthereasonablecontroloftheparty,including,withoutlimitation,actsofGod,fire,flood,war,terrorism,civilunrest,laborunrest,orshortageoforinabilitytoobtainmaterialorequipment.7.EntireAgreement.ThisAgreementconstitutestheentireagreementbetweenthepartiesandsupersedesanyandallpriornegotiations,correspondence,understandingsandagreementsbetweenCLIENTandLAB.8.IndependentContractors.LABandCLIENTareindependentcontractors,andnothinginthisAgreementwillbedeemedorconstruedtocreateanemploymentoragencyrelationshipbetweenLABandCLIENT.Inperformanceofthework,dutiesandobligationsassumedbyLABunderthisAgreement,itismutuallyunderstoodandagreedthatLAB,includinganyandalloftheLAB'Sofficers,agents,andemployeeswillatalltimesbeactingandperformingasanindependentcontractor,andshallactinanindependentcapacityandnotasanofficer,agent,servant,employee,jointventurer,partner,orassociateoftheCLIENT.Furthermore,CLIENTshallhavenorighttocontrolorsuperviseordirectthemannerormethodbywhichLABshallperformitsworkandfunction.However,CLIENTshallretaintherighttoadministerthisAgreementsoastoverifythatLABisperformingitsobligationsinaccordancewiththetermsandconditionsthereof.LABandCLIENTshallcomplywithallapplicableprovisionsoflawandtherulesandregulations,ifany,ofgovernmentalauthoritieshavingjurisdictionovermattersthesubjectthereof.Becauseofitsstatusasanindependentcontractor,LABshallhaveabsolutelynorighttoemploymentrightsandbenefitsavailabletoCLIENTemployees.LABshallbesolelyliableandresponsibleforprovidingto,oronbehalfof,itsemployeesalllegallyrequiredemployeebenefits.Inaddition,LABshallbesolelyresponsibleandsaveCLIENTharmlessfromallmattersrelatingtopaymentofLAB'Semployees,includingcompliancewithSocialSecuritywithholdingandallotherregulationsgoverningsuchmatters.ItisacknowledgedthatduringthetermofthisAgreement,LABmaybeprovidingservicestoothersunrelatedtotheCLIENTortothisAgreement.9.Non-Waiver.ThepartiescovenantandagreethatifapartyfailsorneglectsforanyreasontotakeadvantageofanyofthetermsprovidedfortheterminationofthisAgreementorifaparty,havingtherighttodeclarethisAgreementterminated,anysuchfailureorneglectbysuchpartywillnotbeawaiverorbedeemedorbeconstruedtobeawaiverofanycausefortheterminationofthisAgreementsubsequentlyarising,orasawaiverofanyoftheterms,covenantsorconditionsofthisAgreementoroftheperformancethereof.Noneoftheterms,covenantsandconditionsofthisAgreementmaybewaivedbyapartyexceptbyitswrittenconsent.10.Reformation.Thepartiesherebyagreethatneitherpartyintendstoviolateanypublicpolicy,statutoryorcommonlaw,rule,regulation,treatyordecisionofanygovernmentagencyorexecutivebodythereofofanycountryorcommunityorassociationofcountries,andthatifanyword,sentence,paragraphorclauseorcombinationthereofofthisAgreementisfound,byacourtorexecutivebodywithjudicialpowershavingjurisdictionoverthisAgreementoranyofthepartieshereto,inafinal,unappealableordertobeinviolationofanysuchprovisioninanycountryorcommunityorassociationofcountries,suchwords,sentences,paragraphsorclausesorcombinationwillbeinoperativeinsuchcountryorcommunityorassociationofcountries,andtheremainderofthisAgreementwillremainbindinguponthepartieshereto.Inlieuofsuchinoperativewords,sentences,paragraphsorclauses,orcombinationofclauses,therewillbeaddedautomaticallyaspartofthisAgreement,avalid,enforceableandoperativeprovisionasclosetotheoriginallanguageasmaybepossiblewhichpreservestheeconomicbenefitstotheparties.FULGENTTHERAPEUTICSLLC|AGREEMENTFORSERVICESPage4of7 InWitnessWhereof,thepartieshaveexecutedthisAgreementasofdateindicatedabove.FULGENTTHERAPEUTICSLLCSignatureJakubSramNameVPTitle7-30-20DateatureJeanM.RousseauNameCountyAdministrativeOfficerTitleTlDateFULGENTTHERAPEUTICSLLC|AGREEMENTFORSERVICESPage6of7 11.GoverningLaw.ThisAgreementwillbeconstrued,interpretedandgovernedbythelawsoftheStateofCalifornia.ThePartiessubmittojurisdictionandvenueintheStateofCaliforniainanylegalproceedingarisingregardingthisAgreement.12.Attorney’sFees.InanyactionbroughtunderthisAgreement,theprevailingPartywillbeentitledtorecoveritsactualcostsandattorney’sfeespursuanttoCaliforniaCivilCodeSection1717andallotherlitigationcosts,includingexpertwitnessfees,andallactualattorney’sfeesandlitigationcostsincurredinconnectionwiththeenforcementofajudgmentarisingfromsuchactionorproceeding.TheprovisionsoftheprecedingsentencewillbeseverablefromtheprovisionsofthisAgreementandwillsurvivetheentryofanysuchjudgment13.Indemnification.LABagreestoindemnify,save,holdharmless,andatCLIENT'Srequest,defendtheCLIENT,itsofficers,agents,andemployeesfromanyandallcostsandexpenses,damages,liabilities,claims,andlossesoccurringorresultingtoCLIENTinconnectionwiththeperformance,orfailuretoperform,byLAB,itsofficers,agents,oremployeesunderthisAgreement,andfromanyandallcostsandexpenses,damages,liabilities,claims,andlossesoccurringorresultingtoanyperson,firm,orcorporationwhomaybeinjuredordamagedbytheperformance,orfailuretoperform,ofLAB,itsofficers,agents,oremployeesunderthisAgreement.CLIENTagreestoindemnify,save,holdharmless,andatLAB'srequest,defendtheLAB,itsofficers,agents,andemployeesfromanyandallcostsandexpenses,damages,liabilities,claims,andlossesoccurringorresultingtoLABinconnectionwiththeperformance,orfailuretoperform,byCLIENT,itsofficers,agents,oremployeesunderthisAgreement,andfromanyandallcostsandexpenses,damages,liabilities,claims,andlossesoccurringorresultingtoanyperson,firm,orcorporationwhomaybeinjuredordamagedbytheperformance,orfailuretoperform,ofCLIENT,itsofficers,agents,oremployeesunderthisAgreement.14.Non-Solicitation.DuringthetermofthisAgreementandfortwelve(12)monthsafteranyterminationofthisAgreement,neitherPartywill,withoutthepriorwrittenconsentoftheotherParty,eitherdirectlyorindirectlysolicitorattempttosolicit,divertorhireawayanypersonfromeitherParty.15.Notices.Allnotices(exceptinvoiceswhichwillbesentperSectionA.5)underthisAgreementwillbeinwritinganddeliveredeitherbypersonaldeliveryormailedbyUnitedStatesmail,postageprepaid,oremailtothefollowingaddresses:IftoLAB:FulgentTherapeuticsLLC.4978SantaAnitaAve.TempleCity,CA91780Attn:JamesXiejxie@fulgentgenetics.comIftoCLIENT:CountyofFresnoDepartmentofPublicHealthAdministration1221FultonStreetFresno,CA93721Attn:DavidPomaville,Directordphcontracts@fresnocountyca.govFULGENTTHERAPEUTICSLLC|AGREEMENTFORSERVICESPage5of7 APPENDIXA.SERVICESANDPRICINGTheLABwillprovidetheCountywithCOVID-19testingbyRT-PCR.INSTITUTIONALPRICING•COVID-19RT-PCRTesting:$65pertest,includestestingandcollectionkit.•COVID-19RT-PCRTestingwithAt-homecollectionkitandtelehealthauthorization:$119.Thisincludesclinicalsupportforpatientswithpositiveresultsandshipping.ACCEPTABLESPECIMENTYPES•Mid-turbinateorAnteriorNaresNasalSwab•NasopharyngealSwab•OropharyngealSwab•ExtractedRNASHIPPING•LabwillprovidereturnshippingandshippingmaterialstoCounty•Countyagreestoshipspecimensinprovidedbulkpackagingwithintwenty-four(24)hoursofspecimencollection.TESTING•LABwillperformtestingassamplesarereturnedwithtestingcompletewithin24-48hoursandresultssentbacktotheCountywithin72hours.BILLING•InsuranceBilling.Fulgentwillbill3rdpartypayersforinsurance.TheCountyagreestopayforanydeniedclaims.•InstitutionalBilling.Foranytestsnotpayablebyinsurance,theLaboratorywillinvoicetheCounty.Countymustpaytheinvoicewithin30daysofinvoicedate.Paymentoptions:Mail-incheckFulgentTherapeuticsLLCAddress:POBox748677LosAngeles,CA90074USAPhonenumber:+1(626)350-0537BanktransferNameonAccount:Address:4978SantaAnitaAve,Ste205TempleCityCA91780USAPhonenumber:+1(626)350-0537BeneficiaryBank:Routing/Transit(ABA)Number:ABlNumber:--SWIFTNumber:CHIPAddress:BeneficiaryAccountNumber:RemittanceEmailAddress:billing@fulgentgenetics.comFULGENTTHERAPEUTICSLLC|AGREEMENTFORSERVICESPage7of7