Microsoft Word - IVD Test Kit Dev Agr

CONFIDENTIAL

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IVDTESTKITAGREEMENT–NOVASEQDX

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ThisIVDTestKitAgreement(this“Agreement”)iseffectiveasoftheEffectiveDateandismade

byandbetweenIllumina,Inc.(“Illumina”)and______________________(“Developer”).Illuminaand

Developermaybereferredtoeachindividuallyasa“Party”andcollectivelyasthe“Parties.”

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WHEREAS,DeveloperdesirestoDevelopandCommercializeuptothreeinvitrodiagnostictest

kitsforuseonIllumina’sexpectedNovaSeqDxsequencinginstrument.Thesetestkitswill:(a)include

targetenrichmentandlibrarypreparationcomponentsandoff‐instrumentsoftwareDevelopedby

Developer;and(b)usenucleicacidcoresequencingconsumablesandon‐instrumentsoftware

providedbyIllumina;and

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NOW,THEREFORE,inconsiderationofthemutualcovenantscontainedinthisAgreement,the

foregoingrecitals,andothergoodandvaluableconsideration,thereceiptandsufficiencyofwhichare

herebyacknowledged,thePartiesagreeasfollows:

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1. DEFINITIONS

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Thefollowingcapitalizedtermswillhavethefollowingmeanings:

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1.1 “AcceptancePeriod”isdefinedinSection2.4(a).

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1.2 “Advisors”means,withrespecttoaParty,itsanditsAffiliates’attorneys,accountants,

financialadvisors,andothersimilarprofessionaladvisors.

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1.3 “Affiliate”means,withrespecttoanyPerson,anyotherPersonthat,directlyorindirectly,

throughoneormoreintermediariescontrols,iscontrolledby,orisundercommoncontrolwith,such

firstPersonforsolongassuchotherPersoncontrols,iscontrolledby,orisundercommoncontrolwith

suchfirstPerson.Forpurposesofthisdefinition“control”meansthepossession,directorindirect,of

thepowertodirectorcausethedirectionofthemanagementofaPerson,whetherthroughownership

interests,bycontract,orotherwise.Withoutlimitingthegeneralityoftheforegoing,aPersonwillbe

deemedtocontrolanyotherPersoninwhichitowns,directlyorindirectly,morethan50%ofthe

outstandingshares,stock,securitiesorotherownershipinterestsofsuchPerson.

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1.4 “BusinessDay”meansalldaysotherthanSaturdays,Sundays,oranationalholiday

recognizedintheUnitedStates.

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1.5 “ChangePeriod”meanstheperiodoftimebeginningonthedatetheIVDHardwarereceives

RegulatoryApprovalintheUnitedStatesandendingonthedatetenyearsaftertheGRAILClosing

Date.IlluminawillensurethatallpartieswhohaveenteredintosimilaragreementswithIlluminato

developdistributableinvitrodiagnostictestkitsforusewiththeIVDHardwareintheFieldhavethe

sameChangePeriodfortheIVDHardware,includinganyextensionstotheChangePeriodIlluminamay

makefromtimetotime.

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1.6 “Claims”isdefinedinSection9.1.

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1.7 “Commercialization”(anditscorollaries)meansthoseactivitiesdirectedtotheselling,

marketing,andpromotionofaproduct,includingmanufacturing,marketing,promoting,transporting,

distributing,selling,andsupportingofsuchproduct.

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1.8 “Control”or“Controlled”means,withrespecttoanyIP,possessionoftheright,whether

directlyorindirectly,andwhetherbyownership,license,orotherwise,tograntaccess,alicenseor

sublicense,orotherrighttoorundersuchIPasprovidedforherein,withoutobtainingtheconsentof

anyThirdParty,violatingthetermsofanywrittenagreementwithanyThirdParty,orincurringany

financialorothermaterialobligationtoanyThirdParty.Notwithstandingtheforegoing,ifaPartyis

acquiredbyaThirdParty,whetherbymerger,acquisition,saleofassets,orotherwise,innoeventwill

anyIPrightsofsuchThirdPartyoritsAffiliatesbedeemedControlledbytheacquiredPartyor

otherwisebedeemedpartoftheacquiredParty’sBackgroundIP.

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1.9 “ConverterSoftware”meansBCLtoFASTQconversionsoftwareoranyfuturesimilar

softwaregenerallymadecommerciallyavailablebyIlluminathatconvertsIVDHardwaredataoutputto

adifferentformatforsubsequentanalysis.

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1.10 “ConfidentialInformation”meansallinformationandknow‐howandanytangible

embodimentsthereofprovidedbyoronbehalfoftheDisclosingPartyoritsAffiliatestotheReceiving

PartyoritsAffiliatesinthecourseofperformingunderthisAgreement,whetherdisclosedinwriting,

verbally,orotherwise,thatisidentifiedormarkedas“Confidential”(orwithsimilarlanguage)or

shouldreasonablybeascertainedtobeconfidential,eitherbecauseofthecircumstancesofdisclosure

orthenatureoftheinformationitself.ConfidentialInformationmayincludedata,knowledge,

practices,processes,ideas,researchplans,formulations,manufacturingtechniques,marketingand

businessplans,financialinformation,personnelinformation,andotherinformationrelatingtothe

DisclosingPartyoritsAffiliatesortoitsoritsAffiliates’presentorfutureproducts,sales,suppliers,

customers,employees,orbusiness;providedhoweverthatConfidentialInformationspecifically

excludesanyinformationthat:

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(a) atthetimeofdisclosureisgenerallyavailabletothepublic;

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(b) afterdisclosurebecomesgenerallyavailabletothepublicbypublicationorotherwise

throughnofaultoftheReceivingPartyoritsRepresentativesorAdvisors;

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RepresentativesbeforedisclosurebytheDisclosingPartyandwhichwasnotacquired,directlyor

indirectly,fromtheDisclosingPartyoritsRepresentatives,andwhichisheldbytheReceivingParty

freeofanyobligationofconfidencetoanyThirdParty;

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(d) theReceivingPartycandemonstratewasreceivedbyitafterthetimeofdisclosure

bytheDisclosingPartyfromaThirdPartywhohadalawfulrighttodiscloseittotheReceivingParty

andwhodidnotrequiretheReceivingPartytoholditinconfidence;or

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(e) theReceivingPartycandemonstratewasgeneratedbyorfortheReceivingPartyor

itsRepresentativeswithoutanyuseoforreferencetotheDisclosingParty’sConfidentialInformation

orviolationofthisAgreement,asevidencedbycontemporaneouswrittenrecords;

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ineachcase,evenifsuchinformationisspecificallydesignatedasConfidentialInformationinthis

Agreement.

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1.11 “Customer”meansanend‐userpurchaserofanIVDTestKit.

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1.12 “DeveloperAnalysisSoftware”meansoff‐instrumentanalysis,interpretation,andreporting

softwareDevelopedandCommercializedbyDeveloperoritsAffiliatesthatwillacceptstandard

sequencingoutputfilesgeneratedbytheIVDHardware(asconvertedbyConverterSoftwareif

specifiedintheIVDPlan).

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1.13 “DeveloperIndemnitees”isdefinedinSection9.2.

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1.14 “Development”(anditscorollaries)meansthoseactivitiesdirectedtothedevelopmentofa

product,includingresearch,development,verification,qualification,andvalidation.Withrespectto

anIVDTestKit,“Development”alsoincludesallactivitiesrelatingtoseeking,obtaining,and

maintainingRegulatoryApproval.

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1.15 “DisclosingParty”meansaPartywhodiscloses(orwhoseRepresentativeorAdvisor

discloses)itsConfidentialInformationtotheotherParty.

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1.16 “Dispute”isdefinedinSection13.1.

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1.17 “Distributor”meansaThirdPartyauthorizedbyDevelopertopurchaseIVDTestKitsfrom

DeveloperoritsAffiliateandre‐sellthoseIVDTestKitstoCustomers.

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1.18 “EffectiveDate”means(a)theGRAILClosingDateifthisAgreementissignedbeforethe

GRAILClosingDate,or(b)thedateoflastsignaturebelowifthisAgreementissignedaftertheGRAIL

ClosingDate.ThisAgreementwillnotbeeffectiveunlessanduntiltheGRAILTransactioncloses,

regardlessofthedateofsigning.

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1.19 “EMA”meanstheEuropeanMedicinesAgency,oranysuccessorthereto.

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1.20 “FDA”meanstheUnitedStatesFoodandDrugAdministration,oranysuccessorthereto.

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1.21 “Field”meansgenetictestingofhumansamplesinthefieldofoncology,includingrisk

assessment,predisposition,screening,diagnosis,staging,prognosis,prediction,monitoring,and

treatmentselection;provided,however,thattheFielddoesnotinclude:(a)WGSAssays;(b)forensic

testing;(c)non‐invasiveprenataltesting;(d)pre‐implantationgeneticscreeningofembryosorpre‐

implantationgeneticdiagnosisofembryos;or(e)humanleukocyteantigentestinginconnectionwith

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transplantation.Asusedabove,“forensictesting”specificallyincludeswithoutlimitationalltestingfor

(i)legalevidenceanalysis,(ii)massdisaster,missingpersonsandunidentifiedhumanremains

identifications,(iii)parentagedetermination,(iv)kinshipanalysis(includingfortwins),(v)forensic

phenotyping,(vi)generationofleadsinaninvestigation,includingintelligenceanddatacollection

regardingsuspectedpossession,transferanduseofbioweaponsinresponsetoaspecificbioterror

threatortip,(vii)bodyfluid,tissueidentification,andepigeneticanalysesforcrimecontext

information,and(viii)investigationofcriminalactsusingmicrobes,humanmetagenomicssignaturesat

crimescenes,includingactsofbioterrorandbiowarfare,tracesofhumanmovementvianonhuman

DNA,estimationofpostmorteminterval(PMI,necrobiome),molecularautopsy,orsuddendeath

investigation.Asusedabove,“non‐invasiveprenataltesting”specificallyincludeswithoutlimitationall

testingofnucleicacidsoffetalorplacentaloriginpresentinmaternaltissue(includingmaternalblood

andbloodcomponents).

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1.22 “ForceMajeure”meansanycausebeyondsuchParty’sreasonablecontrolandwithoutits

faultornegligence,whichforexamplemayincludefire,flood,tornado,earthquake,hurricane,

lightning,pandemic,actualorthreatenedactsofwar,terrorism,civildisturbanceorinsurrection,

sabotage,embargo,actsofgovernment(includinginjunctions),laborshortagesordisputes,materialor

equipmentshortages,transportationdifficulties,andinterruptionorfailureofanyutilityserviceor

equipment.

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1.23 “GAAP”meansgenerallyacceptedaccountingprinciplesintheUnitedStatesatthetimein

question.

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1.24 “GRAILClosingDate”meanstheclosingdateofIllumina’sproposedacquisitionofGRAIL,

Inc.pursuanttotheAgreementandPlanofMerger,datedSeptember20,2020(asamendedon

February4,2021bytheAmendmenttotheAgreementandPlanofMerger),amongIllumina,Grail,

SDGOps,Inc.,aDelawarecorporationanddirect,whollyownedsubsidiaryofIllumina,andSDGOps,

LLC,aDelawarelimitedliabilitycompanyanddirect,whollyownedsubsidiaryofIllumina(the“GRAIL

Transaction”).

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1.25 “IlluminaCoreIP”meanstheIPControlledbyIlluminaasofthedatetheIVDHardwareor

SequencingConsumableshipstoDeveloper,thatpertainstoorcoversaspectsorfeaturesoftheIVD

HardwareorSequencingConsumable(orusethereof)thatarecommontotheIVDHardwareor

SequencingConsumableinallapplicationsandallfieldsofuse,butdoesnotincludeIPthatpertainsto

orcoversaspectsorfeaturesoftheIVDHardwareorSequencingConsumable(orusethereof)only

withregardtospecificfield(s)orspecificapplication(s).

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1.26 “IlluminaIndemnitees”isdefinedinSection9.1.



1.27 “IP”meansallrightsinpatent,copyrights(includingrightsincomputersoftware),trade

secrets,know‐how,trademark,servicemarkandtradedressrightsandotherindustrialorintellectual

propertyrightsunderthelawsofanyjurisdiction,whetherregisteredornotandincludingall

applicationsthereforandregistrationsthereto.



CONFIDENTIAL



‐5‐



1.28 “IVDHardware”meansIllumina’sexpectedNovaSeqDxdiagnosticsequencinginstrument.



1.29 “IVDPlan”means,withrespecttoeachIVDTestKit,thewrittenplanagreeduponbythe

PartiesdescribingtheactivitiestobeundertakenbythePartiestoenableDevelopertoDevelopsuch

IVDTestKitinaccordancewiththisAgreement.EachIVDPlanwillincludeatleast:(a)thecomposition

andconfigurationofthesubjectIVDTestKitandtheSequencingConsumablesandIVDHardwaretobe

usedinthesubjectIVDSystem;(b)theplannedactivitiesandtimelinesfortheDevelopmentoftheIVD

TestKitandIVDSystem(includingtheLRMSoftwareModule)totheextentinvolvingorimpacting

Illumina;(c)theintendedusestatementfortheIVDTestKit;and(d)anyIlluminaconsultingactivities

orobligations.EachIVDTestKitwillbedescribedinanIVDPlan.Eachreferenceto“theIVDPlan”in

thisAgreementreferstotheapplicableIVDPlanrelatingtothesubjectIVDTestKit.



1.30 “IVDSystem”meansacompleteinvitrodiagnosticsystemconsistingof:(a)IVDHardware;

(b)SequencingConsumables;(c)theLRMSoftwareModule;(d)anIVDTestKit;and(e)anyOtherIVD

SystemComponentsasmaybespecifiedintheapplicableIVDPlan.EachIVDSystemwillbedescribed

inmoredetailintheapplicableIVDPlan.



1.31 “IVDTestKit”meansakittednucleicacidsequencingassayDevelopedbyDeveloperasthe

legalmanufacturerunderthisAgreementfor(andreceivingRegulatoryApprovalfor)invitrodiagnostic

usewithIVDHardware,SequencingConsumables,andanLRMSoftwareModuleinanIVDSystemin

theTerritoryintheField,consistinggenerallyofassay‐specifictargetenrichmentandlibrary

preparationcomponents(includingpanelspecificprimers),assay‐specificruncontrols,andDeveloper

AnalysisSoftware.EachIVDTestKitwillbedescribedintheapplicableIVDPlan.Ascontextrequires,

“IVDTestKits”or“anIVDTestKit”referstospecificunit(s)ofanIVDTestKit.Forclarity,(a)eachIVD

TestKitisspecifictoaparticularIVDHardware(andrelatedSequencingConsumables)andaparticular

LRMSoftwareModule;ifanassayisforusewithmorethanoneIVDHardware(andrelatedSequencing

Consumables)orLRMSoftwareModule,eachsuchversionisauniqueIVDTestKit;and(b)ifmultiple

versionsofanassayareorwouldbethesubjectofseparatePMAsor510(k)sunderU.S.law

(regardlessofthejurisdiction(s)whereRegulatoryApprovalsareactuallysought),theneachsuch

versionisauniqueIVDTestKit;and(c)subjectto(a),iftwoassaysareorwouldbethesubjectofthe

samePMAor510(k),suchthatthesecondassayonlyrequiresorwouldrequireasupplementalfiling

withtheFDA(regardlessofthejurisdiction(s)whereRegulatoryApprovalsareactuallysought),thetwo

assayswillbedeemedtobepartofthesameIVDTestKit.IfanymodificationtotheLRMSoftware

Moduleisrequired,DeveloperwillpayIlluminaonatime‐and‐materialsbasisforanynecessary

revisionstosuchLRMSoftwareModule.



1.32 “Law”means:(a)allstatutes,regulations,ordinances,anddirectivesandapplicablepolicies,

rules,orordersmadeorgivenbyagovernmentalauthorityorRegulatoryAuthoritythat,ineachcase,

arebindingonaPartyasamatteroflaw;(b)commonlawandthelawofequityasapplicabletoa

Party;(c)courtorders,judgments,ordecreesthatarebindinguponaParty;and(d)industrycodesof

practice,policies,orstandardsineachcasetotheextentenforceableagainstaPartybya

governmentalauthorityorRegulatoryAuthorityaslaw.



1.33 “Losses”isdefinedinSection9.1.

CONFIDENTIAL



‐6‐



1.34 “LRMSoftwareModule”meansatestexecutionsoftwaremodulethatenablesanIVDTest

KittobeexecutedontheIVDHardware,togetherwithConverterSoftwareifnecessaryandspecifiedin

theIVDPlan,whetherornottheConverterSoftwareispartoftheLRMSoftwareModuleorseparate.

ForIllumina’sexistingNextSeq550Dxdiagnosticsequencinginstrument,theLRMSoftwareModuleis,

asoftheEffectiveDate,anon‐IVDHardwarelocalrunmanagersoftwaremodule,buttheParties

acknowledgethattheNovaSeqDxmayusedifferentsoftwaretoaccomplishsimilarfunctionality,which

softwarewillconstitutetheLRMSoftwareModulefortheNovaSeqDx.



1.35 “MHRA”meanstheMedicinesandHealthcareProductsRegulatoryAgency,orany

successorthereto.



1.36 “MilestonePayments”isdefinedinSection5.1.



1.37 “NetSales”means,withrespecttoanIVDTestKit,thegrossamountcharged(inany

manner)byoronbehalfofDeveloperoritsAffiliatesforthearm’slengthsale,transfer,orother

dispositionofanIVDTestKittoaCustomerorDistributor(asfurtherspecifiedbelow)lessthe

followingitemstotheextentreasonableandactuallypaid,taken,orincurredwithrespecttosuchsale,

transfer,orotherdisposition,allinaccordancewithstandardallocationprocedures,allowance

methodologies,andaccountingmethodsconsistentlyapplied,inaccordancewithGAAP(exceptas

otherwiseprovidedbelow):



(a) creditsorallowancesforreturns,rejections,recalls,orbillingcorrections;



(b) separatelyitemizedfreight,postage,shipping,handling,andinsurance,andother

transportationandimportationcosts;



taxes(excludingincometaxes),tariffs,customsduties,surchargesandothergovernmentalcharges

leviedontheproduction,sale,transportation,deliveryoruseoftheIVDTestKitintheTerritorythat

areincurredattimeofsaleoraredirectlyrelatedtothesaleandareactuallypaid;and



(d) anyquantity,cash,orothertradediscounts,rebates,refunds,orchargebacks.

Nodeductionsmaybemadeforsalescommissions(orsimilarpayments)orcollectioncosts.



Developer’ssale,transfer,orotherdispositionofanIVDTestKittoanAffiliate,orthesale,transfer,or

otherdispositionbetweenAffiliates,willnotbeincludedinNetSalesunlesssuchsale,transfer,or

otherdispositionistoanAffiliateend‐userfortheperformanceofaSubjectTest(inwhichcaseNet

SalesforsuchSubjectTestwillbedeterminedasfollows).IfDeveloperoritsAffiliateusesanIVDTest

KittoperformaSubjectTest,suchusewillbedeemedasaleoftheIVDTestKitandNetSalesfrom

suchsalewillequaltheaverageNetSalesfromthearm’slengthsaleoftheIVDTestKitusedinthe

performanceofsuchSubjectTestinthecountryfromwhichthetestedsampleoriginatedduringthe

sameReportingPeriod,orifthereisnosuchaveragevalue,theaverageNetSalesfromthearm’s

lengthsaleoftheIVDTestKitinsimilarmarkets(oriftherearenosimilarmarkets,inallmarkets)

CONFIDENTIAL



‐7‐



duringthesameReportingPeriod.Fortheavoidanceofdoubt,thegrossamountchargedbyAffiliates

toCustomersorDistributorsforsale,transfer,orotherdispositionofanIVDTestKitisincludedinNet

Sales.



IfDeveloperoritsAffiliatedirectlyorindirectlychargesanyamounttoaDistributororCustomerfor

accesstoanLRMSoftwareModuleofanykind(inexcessofwhatischargedfortheIVDTestKitand

alreadyincludedinNetSales),suchamountwillbeincludedintheNetSalesfortherelatedIVDTest

Kit.

IntheeventthatanyIVDTestKitissold,transferred,orotherwisedisposedofincombinationwithone

ormoreproductswhicharethemselvesnotanIVDTestKit(orcomponentthereof)(“OtherProducts”),

forasingleprice(a“CombinationProduct”),theNetSalesforsuchIVDTestKitwillbecalculatedby

multiplyingthesalespriceofsuchCombinationProductbythefractionA/(A+B)whereAisthe

standardpublishedlistpriceoftheIVDTestKitandBisthestandardpublishedlistpriceoftheOther

Products,ineachcaseinthecountrywheretheCombinationProductwassold,transferred,or

otherwisedisposedof.IfastandardpublishedlistpriceforeithertheIVDTestKitortheOther

Productsisnotavailable,DeveloperwillnotifyIlluminaatleast60daysbeforethelaunchoftheIVD

TestKitintheapplicablecountryandthePartieswillingoodfaithnegotiateanappropriateand

reasonablefairmarketvaluetorepresentlistprice.

IfanIVDTestKitissold,transferred,orotherwisedisposedofinamannerthatisnotanarm’s‐length

transaction(includingwithoutlimitation,transactionswithrelatedparties,transactionsmadeunder

duressorthreatoflitigation,transactionsmadefornoconsideration,andtransactionsmadepursuant

toacollaboration,jointventure,orsimilarrelationship),orfornon‐monetaryconsideration,thenNet

SalesforsuchtransactionwillequaltheaverageNetSalesfromthearm’slengthsaleofsuchIVDTest

KitinthesamecountryduringthesameReportingPeriod.



If,inanycase,(x)thereisnotsufficientinformationavailabletoreasonablydetermineNetSales,(y)

DeveloperemploysamethodorstructureforCommercializingtheIVDTestKitsthatdoesnot

reasonablyfittheabovecalculationsordoesnotresultinareasonableNetSalescalculation,or(z)the

natureoftheapplicabletechnologyormarketsignificantlychangessuchthattheabovecalculationsdo

notresultinareasonableNetSalescalculation,IlluminaandDeveloperwillnegotiateingoodfaithan

appropriateandreasonableNetSalesvalue.



1.38 “NMPA”meanstheNationalMedicalProductsAdministration,oranysuccessorthereto.



1.39 “OtherIP”isdefinedinSection6.6(a).



1.40 “OtherIVDSystemComponents”meansinstruments,reagents,andothercomponents

otherthananIVDTestKit,IVDHardware,SequencingConsumables,andLRMSoftwareModule,that

arespecifiedintheIVDPlantobeDevelopedandCommercializedbyDeveloperaspartoftheIVD

System.



CONFIDENTIAL



‐8‐



1.41 “Person”meansanindividualorfirm,trust,corporation,partnership,jointventure

(whetherentity‐basedorbycontract),limitedliabilitycompany,association,unincorporated

organization,orotherlegalorgovernmentalentity.



1.42 “PMDA”meanstheJapanPharmaceuticalsandMedicalDevicesAgency,oranysuccessor

thereto.



1.43 “ReceivingParty”meansaPartywhoreceivesConfidentialInformationfromtheother

PartyoritsRepresentativesorAdvisors.



1.44 “RegulatoryApproval”meansallapprovals,licenses,consents,authorizations,clearances

andCE‐IVDmarking(includingself‐certificationwhenapplicable)fromapplicableRegulatory

AuthoritiesrequiredtoCommercializetheIVDTestKit(togetherwiththeLRMSoftwareModule),IVD

System,SequencingConsumables,orIVDHardware(asthecontextrequires)inagivenjurisdiction.



1.45 “RegulatoryAuthority”meansanynational,supranational,regional,stateorlocal

regulatoryagency,administration,department,bureau,commission,councilorothergovernmental

entityincludingtheFDA,theEMA,thePMDA,theNMPA,theMHRAandanynotifiedbodyorother

equivalententity,involvedinthegrantingorreceiptofRegulatoryApprovals.



1.46 “ReportingPeriod”isdefinedinSection5.3.



1.47 “Representatives”means,withrespecttoaParty,itsAffiliates,andsuchParty’sandits

Affiliates’respectivedirectors,officers,employees,contractors,consultants,Subcontractorsand

agents.



1.48 “RevenueShare”isdefinedinSection5.2.



1.49 “SequencingConsumables”meanstheIlluminadiagnosticcoresequencingconsumables

specifiedintheapplicableIVDPlanforeachIVDTestKit.



1.50 “Subcontractor”meansaThirdParty(includingaDistributor)towhichDeveloperhas

subcontractedanyofitsDevelopmentorCommercializationobligationsunderthisAgreementin

accordancewith,andtotheextentpermittedunder,thetermsandconditionsofthisAgreement.



1.51 “SubjectTest”meansagenetictestperformedbyoronbehalfofDeveloperoritsAffiliate

usinganIVDTestKittotestsamplesinexchangeforpayment.



1.52 “SupplyAgreement”meanstheSupplyAgreemententeredintobythePartieson

______________.



1.53 “Term”isdefinedinSection11.1.



CONFIDENTIAL



‐9‐



1.54 “Territory”means,foreachIVDTestKit,thejurisdiction(s)specifiedintheIVDPlaninwhich

DeveloperwillseekRegulatoryApprovalandCommercializetheIVDTestKit,whichjurisdiction(s)may

includeanyjurisdiction(s)worldwidewheretheIVDHardwarehastheappropriateRegulatory

Approval.



1.55 “ThirdParty”meansanypartyotherthan:(a)DeveloperoranyofitsAffiliates;or(b)

IlluminaoranyofitsAffiliates.



1.56 “ThirdPartyIP”meansanyIPownedorcontrolledbyaThirdParty.



1.57 “Withholding”isdefinedinSection5.6.



1.58 “WGSAssay”meansanassaythatsequencesallorsubstantiallyallofthegenometoa

depthgreaterthan10xandreportsinformationconcerningnucleotidebasecallsorvariantsin

nucleotidesequence,structure,orcopynumber;provided,however,thatWGSAssaydoesnotinclude

anysuchassaythatreportsonlygenome‐widesignalssuchas(a)DNAfragmentationpatternsor(b)

nucleotidebasemodificationsuchasmethylations.



2. DEVELOPMENTOFIVDTESTKITS



2.1 DevelopmentoftheIVDTestKits.



(a) FromtimetotimethroughouttheTerm,DeveloperwillsubmittoIlluminawritten

proposalsforIVDPlansconcerningIVDTestKitstobeDevelopedunderthisAgreementforIllumina’s

reviewandapproval.DevelopermayDevelopuptothreeIVDTestKitsunderthisAgreement.The

Partieswillingoodfaithnegotiatecommerciallyreasonableterms(e.g.withrespecttotimelines,

territory,regulatoryactivities,etc.)foreachproposedIVDPlan.Illuminamaynotunreasonablyreject

anyproposedIVDPlan.



(i) WithoutlimitingIllumina’srighttoreasonablyrejectanyproposedIVDPlan,

Illuminamayreject,initsdiscretion,anyproposedIVDPlanthat:(A)isreasonablylikelytocause

IlluminaoritsAffiliatenottocomplywithLaw,orresultinabreachofanyagreementorother

arrangementtowhichIlluminaoritsAffiliateisaparty,(B)wouldresultinanIVDTestKitthatis

reasonablylikelytobeusedinamannerthatiscontrarytoethicalguidelinespromulgatedby

establishednationalandinternationalethicalbodies;(C)isreasonablylikelytorequireIlluminato

engageinanyDevelopmentactivitiesafterexpirationoftheTerm;(D)isnottechnologicallyfeasible

orwouldrequireIVDHardwareorSequencingConsumablestobeusedinamanneroutsidestandard,

published,specificationsorIllumina’sstandardtermsandconditionsofsale;(E)isreasonablylikelyto

resultinanIVDTestKitthatviolatesorinfringesupontheIPofaThirdParty;or(F)requiresIllumina

toperformactivitiesnotcontemplatedbythisAgreement(specificallyincludinganymattersetforth

inSection2.3(e)or(f)).



(ii) UponagreementonthetermsofsuchIVDPlanandexecutionbythePartiesin

anamendmenttothisAgreementpursuanttoSection13.8,eachIVDPlanwillbeincorporatedinto

CONFIDENTIAL



‐10‐



thisAgreementinExhibitA.AnIVDPlanmayonlybeamendedbywrittenagreementpursuantto

Section13.8.IntheeventofanyconflictbetweenanIVDPlanandthisAgreement,thisAgreement

willgovernandcontrolunlesstheIVDPlanexpresslyprovidestothecontrary.



(b) DeveloperwillusecommerciallyreasonableeffortstoDevelop,atitssolecostand

expense,eachIVDTestKitinaccordancewiththeIVDPlanandwillprovidetoIlluminawrittenreports

reasonablysummarizingitsDevelopmenteffortsasreasonablyrequestedbyIlluminafromtimeto

time.



ConsumablesnecessaryforperformanceofeachIVDPlanpursuanttoSection2.2below.



(d) IlluminawilldevelopandverifytheLRMSoftwareModuleforeachIVDTestKit

pursuanttotheIVDPlanandSection2.4below.



(e) Illuminawill,subjecttoSection2.3,usecommerciallyreasonableeffortstomaintain

existingRegulatoryApprovals,andnewRegulatoryApprovalsonceobtained,foreachIVDHardware

andrelatedSequencingConsumablesintheTerritory,duringtheapplicableChangePeriodandforfive

yearsthereafter,inaccordancewiththeIVDPlanandthisAgreement.



(f) Developerwillusecommerciallyreasonableeffortstoseek,obtain,andmaintain

RegulatoryApprovalsforeachIVDTestKitandthecorrespondingLRMSoftwareModuleintheFieldin

theTerritory,inaccordancewiththeIVDPlanandthisAgreement.



(g) Illuminawill,subjecttoSection2.3,providereasonableconsultationwithrespectto

Developerseeking,obtaining,andmaintainingRegulatoryApprovalsforeachIVDTestKitandLRM

SoftwareModuleintheFieldintheTerritoryduringtheTerm,asrequestedbyDeveloper.



(h) Illuminawillprovidereasonableconsultationwithrespecttoperformance

optimizationofIVDTestKits,whichconsultationwillnotinvolvetechnicalDevelopmentortesting.



(i) Illumina’sDevelopmentobligationsunderthisAgreementwillbelimitedtothe

obligationsexpresslyspecifiedinSections2.1(a)‐(h)above.Fortheavoidanceofdoubt,and

notwithstandinganythinginthisAgreementtothecontrary,nothinginthisAgreementrequires,or

maybeconstruedtorequire,IlluminaoritsAffiliatesto(A)modifyIVDHardwareorSequencing

ConsumablesordevelopnewIVDHardwareorSequencingConsumables;or(B)engageinany

technicaldevelopmentorstudieswithrespecttoanIVDTestKitorIVDSystem,excepttotheextent

necessarytoDeveloptheLRMSoftwareModuleasdescribedinSection2.4.



(j) Forclarity,Developerwillbesolelyresponsible,atDeveloper’ssolecostandexpense,

for:(i)DevelopingeachIVDTestKit;(ii)testingandvalidatingeachIVDTestKitandrelatedLRM

SoftwareModule(includinganalyticalorpre‐clinicalstudies,validationstudies,stabilitystudies,and

clinicalstudies)inconnectionwiththeIVDSystem;and(iii)preparingandsubmittingregulatoryfilings

andobtainingRegulatoryApprovalsfortheIVDTestKitandrelatedLRMSoftwareModule.

CONFIDENTIAL



‐11‐



2.2 SupplyandPurchaseofIVDHardwareandSequencingConsumables.Developerwill

purchasetheIVDHardwareandSequencingConsumablesrequiredtoperformeachIVDPlanfrom

Illumina.AllIVDHardwareandSequencingConsumablespurchasedbyDeveloperforDevelopmentof

IVDTestKitsunderthisAgreementwillbepurchasedundertheSupplyAgreement.



2.3 RegulatoryMatters.



(a) FromtimetotimeuponDeveloper’srequest,IlluminawillprovideDeveloperwithan

updatedlistofallRegulatoryApprovalsobtainedfortheNovaSeqDx.Forclarity,Illuminamakesno

representation,warranty,orguaranteethatNovaSeqDxwillreceiveRegulatoryApprovalinany

jurisdiction.



(b) Developerwillownandretainallright,title,andinterestinandtoallRegulatory

Approvalsfor,andallregulatorydocumentationcovering,theIVDSystem,otherthantheIVD

HardwareandSequencingConsumables.Developerwillberesponsibleforallinteractionswith

RegulatoryAuthoritiesandwill(atitssolecostandexpense)prepareallregulatorydocumentationand

submitallregulatoryfilingstotherespectiveRegulatoryAuthoritiesintheTerritorywithregardtothe

IVDSystemotherthanIVDHardwareandSequencingConsumablesinaccordancewiththeIVDPlan.



materialregulatoryactivitiesrelatedtotheIVDTestKitsandrelatedLRMSoftwareModulestothe

extentthatsuchinformationisrelevanttoIllumina’sobligationsunderthisAgreement.



(d) Illuminawillownandretainallright,title,andinterestinandtoallRegulatory

ApprovalsandallregulatorydocumentationcoveringtheIVDHardwareandrelatedSequencing

Consumables.IlluminawillberesponsibleforallinteractionswithRegulatoryAuthoritieswithregard

totheIVDHardwareandrelatedSequencingConsumables.



(e) Notwithstandinganythingtothecontrary,Illuminawillnotberequiredunderthis

AgreementoranyIVDPlantoobtainanyRegulatoryApprovalortootherwiseexpandormodifyany

RegulatoryApprovalforSequencingConsumablesorIVDHardware(includinganyexpandedsample

typeclaimoradditionalRegulatoryApprovalinanyjurisdiction(s)).



(f) Notwithstandinganythingtothecontrary,Illuminawillnotberequiredunderthis

Agreementtoprovideanyregulatoryorothersupportfor:(i)site‐specificregulatorysubmissions,site‐

specificapplications,orsite‐specificregistrationsbeforetheFDA(oranysimilarsubmissions,

applications,orregistrationsbeforeanyotherRegulatoryAuthority);(ii)expansionsofindicationsor

intendedusesofanIVDTestKitinanyfieldotherthantheField;or(iii)Developmentor

CommercializationofanIVDTestKitoutsidetheFieldortheTerritory.



(g) ThePartieswillingoodfaithconsideranyguidanceandfeedbackobtainedfrom

RegulatoryAuthoritiesinresponsetoDeveloper’sattemptstoobtainRegulatoryApprovalforIVDTest

KitsandrelatedLRMSoftwareModules,includingguidanceandfeedbackobtainedduringpre‐

CONFIDENTIAL



‐12‐



submissionmeetings(orforeignequivalent),andifnecessarywillworktogetheringoodfaithto

negotiateacorrespondingamendmenttotheIVDPlan(e.g.,timelines,scope,orlimitstosupport)to

addressanysuchguidanceandfeedbackinamutuallyacceptablemannerasdeemedreasonably

necessarybythePartiestoaddresssuchfeedback,subjecttoSection2.3(e)and(f).



(h) DuringtheTerm,eachPartywillmaintainISO13485andMDSAPQualityManagement

CertificatesapplicabletoeachIVDSystemandwillcontinuetoretainaninternationallyrecognized

notifiedbodytoconductallISO13485andMDSAPaudits,andanyotherapplicableauditsforwhicha

notifiedbodyisrequired.



(i) Fortheavoidanceofdoubt,Illuminawillbethe“LegalManufacturer”oftheIVD

HardwareandSequencingConsumablesasthattermisdefinedintheMedicalDeviceRegulation(EU

2017/745)andtheInVitroDiagnosticRegulation(EU2017/746),andDeveloperwillbetheLegal

ManufactureroftheIVDTestKit,LRMSoftwareModule,andOtherIVDSystemComponents.



2.4 DevelopmentofLRMSoftwareModules.



(a) IlluminawilldevelopandverifyeachLRMSoftwareModulepursuanttotheIVDPlan

inaccordancewiththespecificationsagreeduponintheIVDPlan;provided,however,thatifanIVD

PlanspecifiesthatDeveloperwillprovideaccesstotheConverterSoftwareseparatelyfromtherestof

theLRMSoftwareModule,Developerwillbesolelyresponsibleforalltestingandverificationofthe

ConverterSoftware.PromptlyafterDeveloper’sreceiptofthedevelopmentversionoftheLRM

SoftwareModulefromIllumina,andwithintheperiodoftimespecifiedintheIVDPlan(the

“AcceptancePeriod”),DeveloperwillperformtestingoftheIVDTestKitwiththeLRMSoftware

ModuletoconfirmitmeetsthespecificationrequirementssetforthintheIVDPlan(the“Acceptance

Test”).



(b) IfanLRMSoftwareModulefailstheAcceptanceTest,Developerwillpromptlynotify

Illumina.IlluminawillusecommerciallyreasonableeffortstoremedytheissueandresubmittheLRM

SoftwareModuletoDeveloperforanewAcceptanceTest,tobecompletedinaccordancewithSection

2.4(a).ThisprocesswillcontinueuntiltheLRMSoftwareModulepassesorisdeemedtopassthe

AcceptanceTest.



SoftwareModulemeetsallofitsspecifiedrequirementsandprovideDeveloperwithasoftware

requirementdocument,softwareverificationprotocol,andverificationtestreport.Developermay

submitthesedocumentsinseekingRegulatoryApprovalfortheIVDTestKitandLRMSoftware

Module.



(d) DeveloperwillbesolelyresponsibleforvalidatingeachLRMSoftwareModuleandits

performancerelativetotheIVDTestKitandIVDSystem.IntheeventthatthevalidationoftheIVD

TestKitandIVDSystemfailsandrequireschangestotheLRMSoftwareModule,thePartieswill

negotiateingoodfaithsuchchangesforsuchLRMSoftwareModule,andtheacceptanceand

correctionprovisionsofSections2.4(a)and(b)willagainapply.

CONFIDENTIAL



‐13‐



(e) AsbetweentheParties,IlluminawillretainownershipoftheLRMSoftwareModules

andallIPembodiedthereinorrelatingthereto.FollowingRegulatoryApprovalofeachLRMSoftware

ModulepursuanttotheIVDPlan,orwhenotherwisespecifiedintheIVDPlan,Illuminawilldeliverto

DeveloperanexecutableversionoftheLRMSoftwareModulewrappedinaninstallerpackage,

includinginstructionsforinstallation.



(f) DeveloperwillnotreceivethesourcecodeforanyLRMSoftwareModule.Developer

maynot,directlyorindirectly,onitsownbehalforbyassistingorenablinganyAffiliateorThirdParty:

(i)modify,adapt,improve,translate,reverseengineer,decompile,disassemble,orcreatederivative

worksofanyLRMSoftwareModule;(ii)attempttodefeat,avoid,by‐pass,remove,deactivate,or

otherwisecircumventanysoftwareprotectionmechanismsinanyLRMSoftwareModule,including

withoutlimitation,anysuchmechanismusedtorestrictorcontrolthefunctionalityofanyLRM

SoftwareModule;or(iii)attempttoaccessorderivethesourcecodeortheunderlyingideas,

algorithms,structure,ororganizationformofanyLRMSoftwareModule.



2.5 ModificationandTerminationofIVDPlans.



(a) IfatanytimeIlluminacontendsitisnotreasonabletocontinueperformingunderan

IVDPlan(includingforthereasonssetforthinSection2.1(a)(i)above),orthatanIVDPlanoreither

Party’sperformancethereunderiscontrarytothetermsandconditionsofthisAgreement,theParties

willingoodfaithdiscussandnegotiatepotentialamendmentstotheIVDPlanormodificationstothe

Parties’activitiesundertheIVDPlaninordertoaddresssuchbelief.Notwithstandinganythingtothe

contrary,IlluminawillnotberequiredtoperformactivitieswithrespecttoanIVDPlandescribedin

Section2.1(a)(i).



(b) DevelopermayinitsdiscretionterminateanIVDPlanforanyornoreasonwithout

terminatingtherestofthisAgreementbyproviding30dayspriorwrittennoticetoIllumina.If

DeveloperterminatesanIVDPlan:(i)thePartieswillpromptlynegotiateingoodfaithaclose‐outplan;

and(ii)eachPartywillceaseperformingallworknotnecessaryfortheorderlyclose‐outoftheIVDPlan

orforthefulfillmentofanyregulatoryrequirementsrequiredbyapplicableLawtoterminatethe

Project.



3. COMMERCIALIZATIONOFIVDTESTKITS



3.1 CommercializationandSupport.



(a) DuringtheTerm,Developerwillusecommerciallyreasonableeffortsto:(i)

CommercializeeachIVDTestKitanddistributetheLRMSoftwareModuleforusewitheachIVDTest

KitintheTerritory;(ii)provideproductsupportandtechnicalsupportforeachIVDTestKitandLRM

SoftwareModuleinamannerconsistentwithindustrystandards;and(iii)promptlyrefertoIlluminaall

supportinquirieswhichDeveloperhasreasonablydeterminedtobecausedby,ordirectedto,theIVD

HardwareorSequencingConsumables.Forclarity,excepttotheextentexpresslyprovidedinthis

Agreement,Developerwillbesolelyresponsible,atDeveloper’ssolecostandexpense,for

CONFIDENTIAL



‐14‐



CommercializingtheIVDTestKitanddistributingtherelatedLRMSoftwareModuletoitsCustomers

forusewiththeIVDSystem.



(b) DuringtheTerm,Illuminawillusecommerciallyreasonableeffortsto:(i)provide

productsupportandtechnicalsupportfortheIVDHardwareandSequencingConsumablesinthe

Territory,includingprovidingsupporttoDeveloper’sCustomers,inaccordancewithitsstandard

warrantyandcustomerservicepractices;(ii)providesecond‐tierproductandtechnicalsupportforthe

LRMSoftwareModuletoDeveloper;and(iii)promptlyrefertoDeveloperallsupportinquirieswhich

Illuminahasreasonablydeterminedtobecausedby,ordirectedto,anIVDTestKitorLRMSoftware

Module.DeveloperwilladviseCustomersthattheymaypurchasetheIVDHardwareandSequencing

ConsumablesfromIllumina.DuringtheChangePeriod,IlluminawillsellIVDHardwareandSequencing

ConsumablestoCustomersintheTerritory(directlyorindirectlythroughitsAffiliatesandauthorized

distributors)inaccordancewithIllumina’sstandardsalespractices.Illuminawillusecommercially

reasonableeffortstocontinuesellingSequencingConsumablestoCustomersintheTerritory(directly

orindirectlythroughitsAffiliatesandauthorizeddistributors)inaccordancewithIllumina’sstandard

salespracticesforanadditionalfiveyearsaftertheChangePeriod.



Agreement,Developermay:(i)useSubcontractorstoDevelopIVDTestKitsonDeveloper’sbehalf;(ii)

useDistributorstopurchaseandresellIVDTestKitsonDeveloper’sbehalf;and(iii)useAffiliatesto

DevelopandCommercializeIVDTestKitsonDeveloper’sbehalf;ineachcase((i)‐(iii))intheordinary

courseofbusiness;providedthat:(iv)Developerwillberesponsibleforallactsandomissionsofsuch

SubcontractorsandAffiliates;(v)Developerwillbeliableforallactsandomissionsofsuch

SubcontractorsorAffiliatesthatconstituteabreachofthisAgreement,orthatwouldconstitutea

breachofthisAgreementifperformed(ornotperformed)byDeveloper,andsuchactsandomissions

willconstituteDeveloper’sbreachofthisAgreement;and(vi)withoutlimitingthegeneralityofthe

foregoing,foreachsuchsubcontract,DeveloperwillincludeinitssubcontractarightforIlluminato

auditthebooks,records,dataorotherinformationofsuchSubcontractortoconfirmcompliancewith

thetermsandconditionsofthisAgreement.



(d) DeveloperanditsAffiliatesmaysell,transfer,orotherwisedisposeofIVDTestKits

onlytoAffiliates,Distributors,andCustomers,andonlyintheordinarycourseofbusiness.Affiliates

andDistributorsmaysell,transfer,orotherwisedisposeofIVDTestKitsonlytoCustomers,andonlyin

theordinarycourseofbusiness.DeveloperanditsAffiliatesandDistributorsmaynotattemptto

circumventorreduceRevenueSharepayabletoIlluminabyenteringintoanyarrangementnotinthe

ordinarycourseofbusiness,includingshamarrangements,strawmanarrangements,orother

arrangementswiththeintentof,orhavingaprimarypurposeof,avoidingorreducingRevenueShare

payabletoIllumina.



(e) IVDTestKitsandLRMSoftwareModulesmaybeCommercializedonlyundera

Developer‐ownedbrandandnotasaprivatelabelor“whitelabel”foranyPersonotherthan

DeveloperoritsAffiliateorunderanyoriginalequipmentmanufacturer(OEM)arrangement.Without

limitingtheforegoing,DeveloperanditsAffiliatesmaynotDeveloporCommercializeanyIVDTestKit

ordistributeanyLRMSoftwareModuleonbehalfofanyotherPersonorotherwiseactinanymanner

CONFIDENTIAL



‐15‐



thatimpliesthesourceofanyIVDTestKitorLRMSoftwareModuleisPersonotherthanDeveloperor

itsAffiliate.



3.2 CommercializationofLRMSoftwareModules.



(a) DeveloperissolelyresponsiblefordistributingeachLRMSoftwareModuletoits

CustomerspursuanttotherightsgrantedinSection6.3.Withoutlimitingthegeneralityofthe

foregoing,Developerissolelyresponsiblefor:(i)providingeachLRMSoftwareModuletoits

Customers,bydistributingtheinstallerpackageorinstallingtheLRMSoftwareModule;and(ii)except

tothelimitedextentexpresslysetforthinSection3.2(b)below,supportingeachLRMSoftwareModule

anditsCustomers’useofeachLRMSoftwareModule.Developerwilluseanddistributetheinstaller

packagefortheLRMSoftwareModulesonlyforthepurposesexpresslyauthorizedunderthis

Agreement.Forclarity,DeveloperanditsDistributorsmayonlyinstall,orallowitsCustomersto

install,theLRMSoftwareModuleontheIVDHardwareforwhichitwasdesigned,andforusewiththe

IVDTestKitforwhichitwasdesigned,asspecifiedintheIVDPlan.



(b) FollowingthepassingoftheAcceptanceTestandverificationofeachLRMSoftware

ModulepursuanttotheIVDPlan:



(i) if,duringtheChangePeriod,eitherPartyidentifiesanymalfunctionintheLRM

SoftwareModulethatinterfereswiththefunctionalityoftheLRMSoftwareModuleandothersimilar

softwaremodulesdevelopedforDeveloperorIllumina’sotherThirdPartyinvitrodiagnostictestkit

developersforusewiththeIVDHardware,suchPartywillnotifytheother,andIlluminawill,at

Illumina’scost,usecommerciallyreasonableeffortstoremedysuchmalfunctionanddeliverto

DeveloperanewversionoftheLRMSoftwareModule(fordistributiontoitsCustomerspursuantto

thisSection3.2)withinacommerciallyreasonableperiodoftime,subjecttotheAcceptanceTest

processsetforthinSection2.4(a);



(ii) if,duringoraftertheChangePeriod,eitherPartyidentifiesanyother

malfunctionintheLRMSoftwareModule(nototherwisecoveredbySection3.2(b)(i))thatinterferes

withthefunctionalityoftheLRMSoftwareModule,thePartieswillnegotiateingoodfaiththeterms

underwhichIlluminamayremedysuchmalfunction;and



(iii) ifDeveloperdesiresthatIlluminaprovideanyfixes,enhancements,

modifications,orimprovementstotheLRMSoftwareModulenotaddressedbySection3.2(b)(i)or(ii)

thePartieswillnegotiateingoodfaiththetermsunderwhichIlluminamayperformsuchworkat

Illumina’sdiscretion.



fixes,orimprovementstoanyLRMSoftwareModuleexcepttothelimitedextentsetforthinSection

3.2(b)above.



(d) ForIllumina’sexistingNextSeq550Dxdiagnosticsequencinginstrument,theLRM

SoftwareModuleis,asoftheEffectiveDate,anon‐instrumentlocalrunmanagersoftwaremodule,but

CONFIDENTIAL



‐16‐



thePartiesacknowledgethattheNovaSeqDxmayusedifferentsoftwaretoaccomplishsimilar

functionality,whichsoftwarewillconstitutetheLRMSoftwareModulefortheNovaSeqDx.Ifthe

termsandconditionsofthisAgreementwithrespecttoLRMSoftwareModulesdonotreasonably

accommodatetheNovaSeqDxLRMSoftwareModules,oriftheapplicationofthosetermsand

conditionstotheNovaSeqDxLRMSoftwareModulesleadstoresultsthatmateriallydifferfromthe

intentandeffectofthetermsandconditionsofthisAgreementwithrespecttoLRMSoftware

Modules,thePartieswillingoodfaithnegotiatereplacementtermswithrespecttosuchNovaSeqDx

LRMSoftwareModulesthatmatchtheintentandeffectofthetermsandconditionsofthisagreement

withrespecttoLRMSoftwareModulesascloselyasisreasonablypossible.



3.3 Insurance.DuringtheTermandforfiveyearsthereafter,DeveloperandIlluminawilleach

self‐insureormaintain,atitssoleexpense,commercialandproductliabilityinsurancerelatingtoits

componentsoftheIVDSystemsthatiscomparableintypeandamounttotheinsurancecustomarily

maintainedbysuchPartywithrespecttosimilarproductsthatareCommercializedintheapplicable

Territory.



4. QUALITY



4.1 RoutineQualityAudits.DuringtheTerm,IlluminaagreestoallowDeveloper(atDeveloper’s

soleexpense)toauditIllumina’soperationsthatpertaintoSequencingConsumables,IVDHardware,

andLRMSoftwareModules,upon60days’priorwrittennotice,duringnormalbusinesshours,nomore

oftenthanoncepercalendaryearonlytotheextentnecessarytosatisfyDeveloper’sobligationsunder

applicableLawandregulatoryrequirements.Thelocations,times,dates,scope,andgoalsforsuch

auditsmustbereasonablyagreeduponinwritingbythePartiesbeforecommencementoftheaudit.



4.2 For‐CauseQualityAudits.DuringtheTerm,DeveloperwillhavetherighttoauditIllumina’s

facilitiesandrecordsthatpertaintoSequencingConsumables,IVDHardware,andLRMSoftware

Modulesupon30days’priorwrittennotice,duringnormalbusinesshours,relatedspecificallytoa

formalsuppliercorrectiveactionrequest(SCAR)previouslyissuedbyDeveloperassociatedwiththe

scopeandcorrectiveactionsassociatedwithsaidSCAR.



4.3 Process.DeveloperwillcomplywithallofIllumina’sreasonablesecurityandsafetypolicies

whenconductinganyauditpursuanttoSections4.1or4.2.AllinformationlearnedbyDeveloperinthe

courseofsuchauditisIlluminaConfidentialInformation.IfrequestedbyIllumina,Developerwill

ensurethatanypersonconductingtheauditsignIllumina’sconfidentialityagreementbefore

conductingsuchaudit;providedthatthetermsthereofaresubstantiallysimilartotheconfidentiality

obligationsinthisAgreement.DeveloperwillprovideIlluminawrittencopiesofallfindingsofanysuch

auditwithin30daysofcompletionoftheaudit.



4.4 ProductChangesandDiscontinuance.



(a) PlannedChanges.Illuminaacknowledgesthatplannedchangesto,ordiscontinuations

of,IVDHardware,SequencingConsumables,orLRMSoftwareModulesmayincurcostsandrisksfor

bothPartiesandwillonlybeconsideredduringtheChangePeriodwithacommerciallyreasonable

CONFIDENTIAL



‐17‐



rationaleandjustification.IlluminawillprovideDeveloperwithwrittennoticeofanymajorplanned

changesto,ordiscontinuationof,anyIVDHardware,SequencingConsumable,orLRMSoftware

ModulesduringtheChangePeriodatleastsixmonthsbeforemakingsuchachange,ortwelvemonths

beforeadiscontinuation,inordertoallowDevelopertoplanaccordingly.Asusedinthisparagraph

andin(b)below,a“major”changeisachangethatIlluminareasonablyexpectstorequireDeveloper

tomakeafilingorsubmissiontoanyRegulatoryAuthorityinconnectionwithobtainingormaintaining

RegulatoryApprovalfortheIVDTestKit.IfIlluminareasonablydeterminesthatsuchachangewould

requireDevelopertosubmitan“180DaySupplement”totheFDA(asdefinedin737(4)(c)ofthe

FederalFood,Drug,andCosmeticAct(21U.S.C.379i(4)(c)),orasimilarfilinginanyotherapplicable

jurisdiction,suchthatthesixortwelvemonthnoticeperioddescribedabovewouldnotallow

Developersufficienttimetogeneratedatarequiredforsuch180DaySupplement,Illuminawilluse

commerciallyreasonableeffortstoprovidenoticesufficientlyinadvanceofsuchchangetoenable

Developertogeneratesuchdata,andwillworkingoodfaithwithDevelopertoassistDeveloperto

timelysubmitthe180DaySupplement.



(b) UnplannedChanges.IlluminareservestherighttomakeunplannedchangestoIVD

Hardware,SequencingConsumables,andLRMSoftwareModulesduetosafety,applicableLaw,

regulatoryrequirements,failuretoconformtospecifications,orForceMajeure.Illuminawillnotify

Developerinwritingassoonasreasonablypracticableofanysuchunplannedmajorchangesduring

theTerm.



continuetosellandprovidesupportfortheIVDHardwareandSequencingConsumablesintheoriginal

formusedforDevelopmentandregulatorysubmissionforanIVDTestKitonthetermssetforthherein

intheTerritorythroughouttheChangePeriod,andwillusecommerciallyreasonableeffortsto

continuesellingSequencingConsumablesandprovidingsupportfortheIVDHardwareforfiveyears

aftertheChangePeriod.Illuminamakesnorepresentation,warranty,orcovenantthattheIVD

HardwareorSequencingConsumableswillbemanufacturedorsoldoutsidetheTerritoryorafterthe

ChangePeriod(exceptassetforthintheprecedingsentencewiththerespecttotheadditionalfive

yearperiod).Exceptassetforthin(a)and(b)andSection2.5above,Illuminaisundernoobligationto

notifyDeveloperofanychangesto,ordiscontinuationof,existingproductsorDevelopmentofnew

products.



(d) Transition.Followinganoticeunder(a)or(b)abovewithrespecttoSequencing

ConsumablesorLRMSoftwareModules(orsoftwarehavingsimilarfunctionality),uponDeveloper’s

reasonablerequest,IlluminawilldiscusswithDeveloperthestepsnecessarytotransitiontomodified

orsuccessorSequencingConsumablesorLRMSoftwareModules,ifany,andusecommercially

reasonableeffortstoassistDeveloperwithsuchtransitioninaccordancewiththisAgreement.



(e) IlluminaObligationstoCustomers.NothinginthisSection4.4isintendedtolimitany

contractualobligationsofIlluminatoCustomerspursuanttoanyseparateagreementsbetween

IlluminaandCustomerswithrespecttothesupplyofIVDHardwareorSequencingConsumables.



CONFIDENTIAL



‐18‐



5. FINANCIALCONSIDERATION



5.1 MilestonePayments.Developerwillpaythenon‐refundable,non‐creditable,milestone

paymentstoIlluminasetforthinExhibitBuponachievementofthemilestonessetforththerein(the

“MilestonePayments”).DeveloperwillpromptlynotifyIlluminainwritingofitsachievementofeach

milestoneinExhibitB(emailisacceptable),andIlluminawillpromptlyacknowledgesuchachievement

(emailisacceptable),and(unlessotherwisespecifiedinExhibitB)Developerwillmakethespecified

MilestonePaymentnolaterthan30daysaftersendingsuchnotice.



5.2 RevenueShare.AspartialconsiderationfortherighttoDevelopandCommercializetheIVD

TestKitsforusewithIVDHardwareandSequencingConsumables,andotheractivitiesand

considerationofIlluminacontemplatedbythisAgreement,DeveloperwillpayIlluminasixpercent(6%)

ofNetSales(suchamountreferredtoasthe“RevenueShare”).



5.3 Reporting.DeveloperwillfurnishtoIlluminaawrittenreportwithin30daysaftertheclose

ofeachcalendarquarter(March31,June30,September30,andDecember31)(each,a“Reporting

Period”)showingonaproduct‐by‐productandcountry‐by‐countrybasis:(a)thenumberofIVDTest

Kitssold,transferred,orotherwisedisposedof,andthenumberofIVDTestKitsusedbyDeveloperand

itsAffiliatesinperformingSubjectTests,duringtheReportingPeriod;(b)thegrossamountcharged

duringtheReportingPeriodforIVDTestKits;(c)adetailedexplanationofanyIVDTestKitssold,

transferred,orotherwisedisposedofduringtheReportingPeriodinanytransactionthatwasnotat

arm’slength;(d)areasonablydetailedcalculationofNetSalesduringtheReportingPeriod,includinga

separaterevenuecalculationforanySubjectTests;(e)theexchangeratesusedindeterminingthe

RevenueShare;and(f)theamountofRevenueSharepayabletoIllumina.Allcurrencyconversionswill

bemadeusingDeveloper’sstandardfinancialreportingprocedureswhichwillbeconsistentlyapplied

inaccordancewithGAAP.Developerwillprovidesuchadditionalinformationconcerningthe

calculationoftheRevenueShareasIlluminamayreasonablyrequestfromtimetotimetoenable

Illuminatoconfirmtheaccuracyofsuchcalculation.Allsuchreportswillbepreparedconsistentlyin

accordancewithGAAP,excepttotheextentotherwiseexpresslyrequiredbythisAgreement.Ifit

becomesnecessarytosatisfyIlluminaaccountingobligationsunderapplicableLaw,uponIllumina’s

requestDeveloperwillprovideagoodfaithestimateofRevenueSharepayabletoIlluminawithin10

BusinessDaysafterthecloseofeachquarter.



5.4 Payments.PaymentoftheRevenueShareearnedduringaReportingPeriodwillaccompany

eachreportdescribedinSection5.3.OtherthanpaymentforSequencingConsumablesandIVD

HardwarepurchasedbyDeveloper(whichwillbegovernedbytheSupplyAgreement),allpayments

requiredunderthisAgreementfromDeveloperwillbepaidintheUnitedStatesDollarsbywire

transferpursuanttothewireinstructionsasIlluminamayfromtimetotimeprovide.Developermay

notdeductorwithholdanywiretransferfees,bankcharges,oranyotherfeesorchargesincurredin

connectionwithmakingsuchpayment.IfDeveloperfailstomakeanypaymentonorbeforethedate

itisdue,interestwillaccrueonsuchpaymentonadailybasisfromthedatesuchpaymentwas

originallydueatarateequalto1.5%permonthcompoundedmonthly,orthemaximumamount

allowedbyLaw,iflower,untilpaid.Developer’sobligationstopayinterestonlatepaymentsmaynot

beconstruedtolimitorrestrictanyotherrightorremedywhichmaybeavailabletoIllumina.Inthe

CONFIDENTIAL



‐19‐



eventofadisputeregardinganypaymentsdueandowinghereunder,allundisputedamountswillbe

paidwhendue,andthebalance,ifany,willbepaidpromptlyaftersettlementofthedispute,including

anyaccruedinterestthereon.



5.5 Records.Developerwillmaintainwrittenrecordswithrespecttoitsactivitiesand

operationsunderthisAgreement,includingtheDevelopmentandCommercializationofIVDTestKits,

insufficientdetailtoenableIlluminaoritsdesignatedaccountantstoconfirmcompliancewiththe

termsofthisAgreementandtheaccuracyandcompletenessoftheamountsofNetSalesandRevenue

Sharereportedto,andallamountspaidorpayableto,Illumina.Suchrecordswillbecompleteand

accurateinallmaterialrespects.DeveloperwillmaintainsuchrecordsduringtheTermandforfive

yearsthereafter.DuringtheTermandforfiveyearsthereafter,DeveloperagreestoallowIllumina(at

Illumina’ssoleexpense,exceptasprovidedbelow)toauditsuchrecordsupon30days’priorwritten

notice,duringnormalbusinesshours,nomoreoftenthanoncepercalendaryearonlytotheextent

necessarytoconfirmcompliancewiththetermsofthisAgreementandtheaccuracyandcompleteness

ofthecalculationofNetSales,theamountsofRevenueShare,andanyotheramountspayableto

Illumina.TheexpenseofsuchauditwillbebornebytheIllumina;provided,however,that,ifan

underpaymentof5%ormoreforanyReportingPeriodisdiscovered,thensuchexpenseswillbepaid

byDeveloper.WithoutlimitingIllumina’srightsunderthisAgreement,ifanysuchauditdetermines

thatadditionalamountswereowedtoIlluminaduringanyperiod,Developerwillpaysuchamounts

(includinginterestthereonfromthedatesuchamountswereoriginallypayable)within30daysafter

thedateIlluminanotifiesDeveloperofsuchadditionalamounts.Thelocations,times,anddatesfor

suchauditsmustbereasonablyagreeduponinwritingbythePartiesbeforecommencementofthe

audit.IlluminawillcomplywithallofDeveloper’sreasonablesecurityandsafetypolicieswhen

conductinganyaudit.AllinformationlearnedbyIlluminainthecourseofsuchauditisDeveloper

ConfidentialInformation.IfrequestedbyDeveloper,Illuminawillensurethatanypersonconducting

theauditsignDeveloper’sconfidentialityagreementbeforeconductingsuchaudit;providedthatthe

termsthereofaresubstantiallysimilartotheconfidentialityobligationsinthisAgreement.



5.6 Taxes.AllamountspayabletoIlluminaunderthisAgreementareexclusiveofandare

payablewithoutwithholdingordeductionforgoodsandservicestaxes,valueaddedtaxes,othertaxes,

customsduties,tariffs,orotherchargesrequiredbyLawfromtimetotime.Withoutlimitingthe

foregoing,ifapplicableLawrequiresanyamounttobewithheld,charged,deducted,orassessed

againstanyamountowedbyDevelopertoIlluminaunderthisAgreement(each,a“Withholding”),

DeveloperwilltimelywithholdandpayallsuchWithholdings,andwillpromptlyfurnishIlluminawith

certificatesevidencingpaymentofallsuchWithholdings.IfapplicableLawrequiresIlluminatopay

suchWithholding,andwillnotpermitDevelopertopaysuchWithholding,thePartieswillingoodfaith

negotiateapaymentmechanismthatresultsinIlluminareceivingandretainingthefullamountsto

whichitisentitlednetoftheWithholding.



6. INTELLECTUALPROPERTY



6.1 DevelopmentRights.Subjectto,andcontingentuponcompliancewith,thetermsand

conditionsofthisAgreementandtheSupplyAgreement,Developer’soritsAffiliate’spurchaseof

SequencingConsumablesandIVDHardwarefromIlluminaanditsAffiliatesunderthisAgreementand

CONFIDENTIAL



‐20‐



theSupplyAgreementconfersuponDeveloper,itsAffiliate,orSubcontractor,byexhaustion,the

personal,limited,non‐exclusive,non‐transferable,rightunderIlluminaCoreIPtousethepurchased

SequencingConsumablesandIVDHardwaretoDeveloptheapplicableIVDTestKitduringtheTerm

solelyforuseintheTerritoryintheFieldwiththeIVDHardware,SequencingConsumablesandLRM

SoftwareModulestrictlyinaccordancewiththisAgreementandtheIVDPlanforsuchIVDTestKit.For

clarity,therightsgrantedinthisSection6.1expresslyexcludeanyandallrightsto,andDeveloperand

itsAffiliatesandSubcontractorsmaynot,make,havemade,sell,havesold,offerforsale,orhave

offeredforsaleSequencingConsumablesorIVDHardware.ThePartiesagreethatthisSection6.1is

intendedto,anddoes,altertheeffectoftheexhaustionofpatentrightsthatcouldotherwiseresultif

thesaleofSequencingConsumablesandIVDHardwarewasmadewithoutrestriction.



6.2 RightofReference.Subjectto,andcontingentuponcompliancewith,thetermsand

conditionsofthisAgreement,IlluminaherebygrantstoDevelopertherighttopermittheFDA(or

similarRegulatoryAuthorityinaTerritorydesignatedintheapplicableIVDPlan)torefertothedevice

listingfortheIVDHardwareandSequencingConsumablesinsupportofseekingRegulatoryApproval

fortheIVDTestKitandLRMSoftwareModuleintheTerritoryduringtheTerm,andtoincorporatethe

informationcontainedinsuchdevicelistingintothesubmission(s)fortheIVDTestKitandLRM

SoftwareModulebyreference,totheextentsetforthinandinaccordancewiththeapplicableIVD

PlanforsuchIVDTestKit.TotheextentrequiredbytheFDA(orsimilarRegulatoryAuthorityina

TerritorydesignatedintheapplicableIVDPlan)Illuminawillprepareandsubmitaletterof

authorizationdocumentingsuchrightofreference.



6.3 RighttoDistributeLRMSoftwareModules.Subjectto,andcontingentuponcompliance

with,thetermsandconditionsofthisAgreement,IlluminaherebygrantstoDeveloperthepersonal,

non‐transferable,non‐exclusive,rightduringtheTermto:(a)reproduceanddistributeeachLRM

SoftwareModuleinstallerpackagethathasbeendeliveredto,andacceptedby,Developerassetforth

inSection3.2(a),solelyinexecutableobjectcode,toitsCustomersintheTerritoryandauthorizesuch

CustomerstoinstallandusetheLRMSoftwareModuleontheIVDHardwareforwhichitwasdesigned

withtheIVDTestKitforwhichitwasdesigned;and(b)installeachsuchLRMSoftwareModuleonits

Customers’IVDHardwareintheTerritorybyrunningsuchinstallerpackageandauthorizesuch

CustomerstousetheLRMSoftwareModuleontheIVDHardwareforwhichitwasdesignedwiththe

IVDTestKitforwhichitwasdesigned.DevelopermaysublicensetheforegoingrightstoitsAffiliates

andDistributors.



6.4 RightsGrantedtoIllumina.Subjectto,andcontingentuponcompliancewith,thetermsand

conditionsofthisAgreement,DeveloperherebygrantstoIlluminaanditsAffiliatesalimited,

nonexclusive,non‐transferable,non‐sublicensablelicenseunderanyIPofDeveloperasnecessaryfor,

andforthesolepurposeofallowing,IlluminatoperformitsobligationsunderthisAgreement

(includingdevelopmentofLRMSoftwareModules)duringtheTerm.



6.5 AllRightsReserved.



(a) NoIPisassignedorotherwisetransferredunderthisAgreement.Withoutlimitingthe

generalityoftheforegoing,asbetweentheParties,eachPartyoritsAffiliatewillretainallIP:(i)thatis

CONFIDENTIAL



‐21‐



ControlledbythePartyoritsAffiliatebeforetheEffectiveDate;(ii)thatisdevelopedbythePartyorits

Affiliate,orwhichotherwisecomesundertheControlofthePartyoritsAffiliate,duringtheTerm

independentlyfromperformingunderthisAgreement;or(iii)thatisdeveloped,generated,conceived,

orreducedtopracticebyoronbehalfofthePartyoritsAffiliateinthecourseofperformingunderthis

Agreement.



(b) ExceptasexpresslystatedinthisSection6andintheSupplyAgreement,noright

underanyIlluminaIPisgrantedexpressly,byimplication,estoppel,orotherwise,underthis

Agreement.ExceptasexpresslystatedinthisSection6norightunderanyDeveloperIPisgranted,

expressly,byimplication,estoppel,orotherwise,underthisAgreement.



6.6 OtherIP.



(a) Developerissolelyresponsiblefordeterminingwhetherithas,andforobtaining,all

rightstoIPthatarenecessaryforDeveloper’sDevelopmentandCommercializationofIVDTestKits,

includinganyThirdPartyIPandanyadditionalrightsfromIlluminaorIllumina’sAffiliatesthatarenot

expresslygrantedinthisAgreementorintheSupplyAgreement(togetherwithThirdPartyIP,“Other

IP”).Illuminamakesnorepresentation,warranty,orguaranteethatDeveloper’sIVDTestKitswillnot

violateorinfringeOtherIP,andexpresslydisclaimsandexcludesanysuchrepresentation,warranty,or

guarantee,andanystatementorimplicationotherwise,tothemaximumextentpermittedbyLaw.

NotwithstandinganythinginthisAgreementtothecontrary,Developerassumesallrisksassociated

withnotobtaininganyrequiredrightstoOtherIP.



(b) IfanyIVDTestKitoranycomponentthereofviolatesorinfringesanyThirdPartyIP,

Developer,atitssolecostandexpense,willusecommerciallyreasonableeffortstoeither(i)obtaina

licenseunderIPorotherwiseprocuretherighttoCommercializesuchIVDTestKit,or(ii)replaceor

modifysuchIVDTestKitorcomponentthereofsothatitnolongerviolatesorinfringessuchIP.



grantingalicensetoDeveloperoritsAffiliateunderanyOtherIPControlledbyIlluminaoritsAffiliates

forthepurposeofDevelopingandCommercializingoneormoreIVDTestKits.Anysuchlicensewillbe

oncommerciallyreasonableterms.



6.7 RightsarePersonal.TherightsgrantedinthisSection6arepersonal,non‐sublicensable

(excepttothelimitedextentpermittedinSection6.3above),andnon‐transferable.Anypurported

transfer,grant,orotherconveyanceoftherightsgrantedinthisSection6(oranyportionofsuch

rights),excepttothelimitedextentpermittedinSection6.3above,willbenull,void,andofnoeffect.



7. CONFIDENTIALINFORMATION



7.1 DisclosureandUseRestriction.



CONFIDENTIAL



‐22‐



(a) ExcepttotheextentexpresslyauthorizedbythisAgreementorotherwiseagreedin

writingbytheParties,theReceivingPartywillkeepconfidentialandmaynotpublishorotherwise

discloseortransfertheDisclosingParty’sConfidentialInformationtoanyThirdParty.



(b) TheReceivingPartymaydisclosetheDisclosingParty’sConfidentialInformationonly

toitsAdvisorsandRepresentativeswhoareboundbyconfidentialityandnon‐userestrictionsatleast

asrestrictiveasthosesetforthinthisAgreementandwhohaveaspecificneedtoknowinorderfor

theReceivingPartytobeabletoperformitsobligationsandexerciseitsexpressrightsunderthis

Agreement,andonlytotheextentnecessaryforsuchpurposes.EachPartywillberesponsibleforany

conductbyitsrespectiveAdvisorsandRepresentativesthatconstitutesabreachofthisSection7or

thatwouldbeabreachofthisSection7bysuchPartyhadsuchPartyengagedinsuchconductitself.

SuchconductwillbedeemedandisabreachofthisAgreementbysuchParty.



proprietaryorconfidentialinformationofitsown(butinnoeventlessthanareasonablestandardof

care)toensurethatitanditsAdvisorsandRepresentativesdonotdiscloseormakeanyunauthorized

useoftheDisclosingParty’sConfidentialInformation.TheReceivingPartywillpromptlynotifythe

DisclosingPartyupondiscoveryofanyunauthorizeddisclosureoruseoftheDisclosingParty’s

ConfidentialInformation.



(d) Theconfidentialityandnon‐useobligationsinthisAgreementwillcontinue

throughouttheTermandforsevenyearsthereafter.



7.2 AuthorizedDisclosure.TheReceivingPartymaydisclosetheDisclosingParty’sConfidential

Informationtotheextentthatsuchdisclosureis:



(a) madeinresponsetoavalidorderofacourtofcompetentjurisdictionorother

governmentalauthority;provided,however,thattheReceivingPartywill,totheextentpermittedby

Law,givewrittennoticetotheDisclosingPartywithinfiveBusinessDaysofreceiptofsuchorderand

givetheDisclosingPartyareasonableopportunitytoquashorlimitthescopeofsuchorderandto

obtainaprotectiveorderrequiringthattheConfidentialInformationanddocumentsthatarethe

subjectofsuchorderbeheldinconfidencebysuchcourtorgovernmentalauthorityor,ifdisclosed,be

usedonlyforthepurposesforwhichtheorderwasissued;andprovided,further,thatifadisclosure

orderisnotquashedorlimitedinscope,oraprotectiveorderisnotobtained,theConfidential

Informationdisclosedinresponsetosuchcourtorgovernmentalauthoritywillbelimitedtothat

informationwhichislegallyrequiredtobedisclosedinresponsetosuchcourtorgovernmental

authority;



(b) otherwiserequiredbyLaw;provided,thattheReceivingParty:(i)promptlynotifies

theDisclosingPartyofthespecificsofsuchrequirement(providingacopyoftheConfidential

Informationtobedisclosed)atleast30daysbeforetheactualdisclosure(orassoonasreasonably

possiblebeforetheactualdisclosureifsuch30daypriornoticeisimpracticalunderthecircumstances)

orpromptlyafteractualdisclosureifpriordisclosureisimpracticalunderthecircumstances;(ii)

disclosesonlytheminimalinformationnecessarytosatisfysuchrequirement;(iii)reasonably

CONFIDENTIAL



‐23‐



cooperateswiththeDisclosingPartytopreventorlimitsuchdisclosure;and(iv)providestheDisclosing

PartywithacopyofConfidentialInformationactuallydisclosed;or



7.3 AuthorizedUse.TheReceivingPartymayusetheDisclosingParty’sConfidentialInformation

solelytotheextentnecessaryfortheReceivingPartytoperformitsobligationsandexerciseitsexpress

rightsunderthisAgreement,andsuchusewillbeotherwisesubjecttoallrestrictionsandlimitations

setforthinthisAgreement.



7.4 Agreement;Publicity.



(a) TheexistenceandtermsofthisAgreementarebothParties’ConfidentialInformation.

SubjecttoSection7.2above,eachPartymustobtainthepriorwrittenconsentoftheotherPartyonall

pressreleasesorotherpublicannouncementsrelatingtothisAgreement,providedthataPartyisnot

requiredtoobtainpriorwrittenconsentoftheotherPartyforpressreleasesorpublicdisclosuresthat

repeatinformationthathasbeenpreviouslypubliclydisclosedpursuanttothisSection7.4.



(b) NeitherPartymayuseanytrademarkoftheParty,oranyderivationthereof,without

theadvanceexpresswrittenconsentoftheotherParty,whichconsentmaybegrantedorwithheldin

theotherParty’ssolediscretion.



7.5 Post‐Termination.FollowingexpirationorterminationofthisAgreementforanyreason,

upontherequestoftheDisclosingParty,theReceivingPartywill,attheDisclosingParty’soption:(a)

returnallmaterialscontainingtheDisclosingParty’sConfidentialInformationtotheDisclosingParty;

or(b)destroyallmaterialscontainingtheDisclosingParty’sConfidentialInformationandcertifysuch

destructioninwritingtotheDisclosingParty;providedthattheReceivingPartywillbeauthorizedto

retainonecopyforthepurposeofdetermininganycontinuingobligationwithrespectthereto.

Notwithstandingtheforegoing,theReceivingPartywillnotberequiredtodestroyordeleteelectronic

copies(includingemails)thathavebecomeembeddedinitselectronicstoragesystemsthrough

routinebackupprocesses.AnyConfidentialInformationsoretainedwillcontinuetobeheldpursuant

toalloftheconfidentiality,non‐use,andothertermsofthisAgreement.



7.6 GRAILFirewall.IlluminashallestablishafirewalldesignedtopreventanyGRAILpersonnel

(andanyIlluminapersonnelcarryingoutactivitieswithrespecttotheGRAILbusinessorproducts)from

accessinganyConfidentialInformationobtainedbyormadeavailabletoIlluminarelatingtoDeveloper

oritsbusinessorproducts,whetherpursuanttothisAgreementorotherwise.



8. REPRESENTATIONSANDWARRANTIES



8.1 GeneralWarranties.EachPartyrepresentsandwarrantsthat:



CONFIDENTIAL



‐24‐



(a) SuchPartyisdulyorganized,validlyexisting,andingoodstandingunderthelawsof

jurisdictionofdomicile,andhasallrequisitepowerandauthoritytocarryonitsbusinessassuch

businessisnowbeingconducted;



(b) ThisAgreementhasbeendulyauthorized,executed,anddeliveredbysuchPartyand

constitutesthelegal,valid,andbindingobligationofsuchParty,enforceableagainstsuchPartyin

accordancewithitsterms,exceptasenforceabilitymaybelimitedbyLawrelatingtobankruptcy,

receivership,orsimilarlawsaffectingcreditors’rightsgenerallyorbyequitableprinciplesrelatingto

enforceability;



andtocarryoutitsobligationshereunder;



(d) TheexecutionanddeliveryofthisAgreementandtheperformanceofsuchParty’s

obligationshereunder(i)donotconflictwithorviolateanyrequirementofapplicableLaworany

provisionofthearticlesofincorporation,bylaws,limitedpartnershipagreementoranysimilar

instrumentofsuchParty,asapplicable,inanymaterialway,and(ii)donotconflictwith,violate,or

breachorconstituteadefaultorrequireanyconsentunder,anyapplicableLaworanycontractual

obligationbywhichsuchPartyisbound;and



(e) InperformingitsactivitiesrelatedtothisAgreement,itwillcomplywithallapplicable

Laws.



8.2 AdditionalRepresentations,WarrantiesandCovenantsofDeveloper.Developerhereby

represents,warrants,andcovenantstoIlluminathatanyandallIVDTestKitsCommercializedbyoron

behalfofDeveloperanditsAffiliatesunderthisAgreementwillbemanufacturedandtestedin

accordancewithapplicableLaws,includingcGMP,andwillnotbeadulteratedormisbrandedwithin

themeaningoftheUnitedStatesFood,DrugandCosmeticAct,21U.S.C.Section301et.seq.(“FDCA”)

orotherapplicableLaws.



8.3 AdditionalRepresentations,WarrantiesandCovenantsofIllumina.Illuminahereby

represents,warrants,andcovenantstoDeveloperthatanyandallIVDHardwareandSequencing

ConsumablesCommercializedbyoronbehalfofIlluminaanditsAffiliatesforusewithanIVDSystem

willbemanufacturedandtestedinaccordancewithapplicableLaws,includingcGMP,andwillnotbe

adulteratedormisbrandedwithinthemeaningoftheFDCAorotherapplicableLaws.



FORCLARITY,ANDNOTWITHSTANDINGANYTHINGTOTHECONTRARY:(A)ILLUMINA’SSOLE

REPRESENTATIONS,WARRANTIES,ANDINDEMNIFICATIONANDDEFENSEOBLIGATIONSWITHRESPECT

TOPRODUCTSPURCHASEDBYDEVELOPERANDITSAFFILIATESARECONTAINEDEXCLUSIVELYINTHE

SUPPLYAGREEMENT;AND(B)ILLUMINA’SSOLEREPRESENTATIONS,WARRANTIES,AND

INDEMNIFICATIONANDDEFENSEOBLIGATIONSWITHRESPECTTOPRODUCTSPURCHASEDBYANY

CUSTOMERWILLBECONTAINEDEXCLUSIVELYINANYAGREEMENT(S)BETWEENILLUMINAANDTHE

CUSTOMER.



CONFIDENTIAL



‐25‐



THEREPRESENTATIONSANDWARRANTIESEXPRESSLYSETFORTHINTHISAGREEMENTARETHE

PARTIES’EXCLUSIVEREPRESENTATIONSANDWARRANTIESWITHRESPECTTOTHISAGREEMENT,AND

ALLOTHEREXPRESSORIMPLIEDREPRESENTATIONSANDWARRANTIES(INCLUDINGTHEIMPLIED

WARRANTIESOFMERCHANTABILITY,NON‐INFRINGEMENTOFTHIRDPARTYRIGHTSANDFITNESSFOR

APARTICULARPURPOSE)AREEXPLICITLYDISCLAIMED.



9. ALLOCATIONOFRISKS



9.1 Developer’sIndemnificationObligations.Developerwilldefend,indemnify,andhold

harmlessIllumina,itsAffiliates,andtheirrespectiveofficers,directors,representatives,employees,

successors,andassigns(“IlluminaIndemnitees”),fromandagainstanyandallclaims,causesofaction,

andproceedingsbroughtorassertedbyaThirdParty(“Claims”),andallassociatedlosses,liabilities,

damages,fines,andpenaltiesofanyandeverykind,includinglegalexpensesandreasonable

attorneys’fees(“Losses”)totheextentresultingfrom,relatingto,orarisingoutof:



(a) anyDeveloperIndemnitee’sbreachofthisAgreement,includinganyobligation,

representation,warranty,orcovenanthereunder;



(b) anyDeveloperIndemnitee’sgrossnegligenceorintentionalmisconductinperforming

orfailingtoperformunderthisAgreement;



Agreement;or



(d) anyDeveloperIndemnitee’sDevelopmentorCommercializationofanIVDTestKit,

OtherIVDSystemComponent,orSubjectTest,includinganyviolationorinfringementofThirdPartyIP,

causedbyanIVDTestKit,OtherIVDSystemComponent,orSubjectTest;



ineachcaseexcepttotheextentresultingfrom,relatingto,orarisingoutofmattersforwhichIllumina

isobligatedtodefend,indemnify,andholdharmlessDeveloperIndemniteespursuanttoSection9.2.



ForpurposesofdeterminingwhetherornotanyviolationorinfringementofThirdPartyIPiscausedby

(a)anIVDTestKit,OtherIVDSystemComponent,orSubjectTestor(b)IVDHardwareorSequencing

Consumables,forpurposesofclause(d)aboveandSection9.2(d)below,theintentofthePartiesisto

determinewhetherandtowhatextenttheclaimsofsuchThirdPartyIPareprimarilydirectedto(a)

theIVDTestKit,OtherIVDSystemComponent,orSubjectTestor(b)IVDHardwareorSequencing

Consumables.



9.2 Illumina’sIndemnificationObligations.Illuminawilldefend,indemnify,andholdharmless

Developer,itsAffiliates,andtheirrespectiveofficers,directors,representatives,employees,

successors,andassigns(“DeveloperIndemnitees”),fromandagainstanyandallClaimsandLossesto

theextentresultingfrom,relatingto,orarisingoutof:



CONFIDENTIAL



‐26‐



(a) anyIlluminaIndemnitee’sbreachofthisAgreement,includinganyobligation,

representation,warranty,orcovenanthereunder;



(b) anyIlluminaIndemnitee’sgrossnegligenceorintentionalmisconductinperformingor

failingtoperformunderthisAgreement;



Agreement;or



(d) anyIlluminaIndemnitee’sDevelopmentorCommercializationofIVDHardwareor

SequencingConsumableswhenusedaspartofanIVDSystem,includinganyviolationorinfringement

ofThirdPartyIPcausedbyIVDHardwareorSequencingConsumableswhenusedaspartofanIVD

System;



ineachcaseexcepttotheextentresultingfrom,relatingto,orarisingoutofmattersforwhich

Developerisobligatedtodefend,indemnify,andholdharmlessIlluminaIndemniteespursuantto

Section9.1.



9.3 IndemnificationProcedures.EachParty’sobligationsunderSections9.1and9.2are

conditionedonthePartyseekingindemnification:(a)givingtheindemnifyingPartypromptwritten

noticeoftheClaim;provided,however,thatfailuretoprovidesuchnoticewillnotrelievethe

indemnifyingPartyfromitsliabilityorobligationhereunder,excepttotheextentofanymaterial

prejudiceasadirectresultofsuchfailure;(b)cooperatingwiththeindemnifyingParty,atthe

indemnifyingParty’sexpense,inconnectionwiththedefenseandsettlementoftheClaim,including

providingaccurateandcompleteinformationreasonablyrequestedbytheindemnifyingParty;and(c)

permittingtheindemnifyingPartytosolelycontrolthedefenseandsettlementoftheClaim;provided,

however,thattheindemnifyingPartymaynotsettletheClaim,enterintoorotherwiseconsenttoan

adversejudgmentororder,ormakeanyadmissionastoliabilityorfaultthatwouldadverselyaffect

theindemnifiedParty,withouttheindemnifiedParty’spriorwrittenconsent,whichwillnotbe

unreasonablywithheldordelayed.Further,theindemnifiedPartywillhavetherighttoparticipate

(butnotcontrol)andberepresentedinanysuitoractionbycounselofitsselectionatitsowncostand

expense.



9.4 Product‐relatedIndemnification.



(a) NotwithstandinganythinginthisAgreementtothecontrary,Illumina’sdefense,

indemnification,andholdharmlessobligationswithrespecttoSequencingConsumablesandIVD

HardwarepurchasedfromIlluminaoritsAffiliatesbyDeveloperoritsAffiliatesundertheSupply

AgreementarelimitedsolelytothoseobligationsexpresslyprovidedintheSupplyAgreementforsuch

products,andsuchtermswillsupersedeandcontroloveranyotherindemnificationobligationsof

IlluminaanditsAffiliatesprovidedinthisAgreement.Furthermore,neitherPartywillbeentitledto

anyduplicativerecoveryunderthisAgreementandtheSupplyAgreement.



(b) NotwithstandinganythinginthisAgreementtothecontrary,Illumina’sandits

CONFIDENTIAL



‐27‐



Affiliates’defense,indemnification,andholdharmlessobligationswithrespecttoSequencing

ConsumablesandIVDHardwarepurchasedbyaCustomerarelimitedsolelytothoseobligations

providedinanyagreement(s)betweenIlluminaoritsAffiliateandtheCustomer.



10. LIMITATIONSONLIABILITIES



10.1 EXCEPTASSTATEDINSECTION10.3,ANDEXCEPTWITHRESPECTTOLIABILITYARISING

FROMAPARTY’SDEFENSEANDINDEMNIFICATIONOBLIGATIONSUNDERSECTION9.1OR9.2(BUT

ONLYWITHRESPECTTODAMAGESACTUALLYPAIDORTOBEPAIDBYTHEINDEMNIFIEDPARTYTOTHE

THIRDPARTYCLAIMANT),BUTOTHERWISETOTHEFULLESTEXTENTPERMITTEDBYLAW,INNOEVENT

WILLILLUMINAORITSAFFILIATESBELIABLETODEVELOPERORITSAFFILIATES,NORWILLDEVELOPER

ORITSAFFILIATESBELIABLETOILLUMINAORITSAFFILIATES,FORCOSTSOFPROCUREMENTOF

SUBSTITUTEPRODUCTSORSERVICES,LOSTPROFITS,DATAORBUSINESS,ORFORANYINDIRECT,

SPECIAL,INCIDENTAL,EXEMPLARY,CONSEQUENTIAL,ORPUNITIVEDAMAGESOFANYKINDARISING

OUTOFORINCONNECTIONWITHTHISAGREEMENT,HOWEVERARISINGORCAUSEDANDONANY

THEORYOFLIABILITY(WHETHERINCONTRACT,TORT(INCLUDINGNEGLIGENCE),STRICTLIABILITY,

MISREPRESENTATION,BREACHOFSTATUTORYDUTY,OROTHERWISE).



10.2 EXCEPTASSTATEDINSECTION10.3BELOW,ANDEXCEPTTOTHEEXTENTARISINGFROM:(I)

DEVELOPER’SBINDINGCOMMITMENTTOPURCHASEPRODUCTPURSUANTTOONEORMOREISSUED

ANDACCEPTEDPURCHASEORDERS;(II)DEVELOPER’SREVENUESHAREOBLIGATIONS;OR(III)A

PARTY’SDEFENSEANDINDEMNIFICATIONOBLIGATIONSUNDERSECTION9;BUTOTHERWISETOTHE

FULLESTEXTENTPERMITTEDBYLAW,EACHPARTY’SCUMULATIVELIABILITYUNDERORARISINGOUT

OFTHISAGREEMENT,INCLUDINGANYCAUSEOFACTIONINCONTRACT,NEGLIGENCE,ORTORT

(INCLUDINGSTRICTLIABILITY),WILLNOTEXCEEDTHEGREATEROF(A)TWOTIMESTHEAGGREGATE

AMOUNTSPAIDBYDEVELOPERTOILLUMINAUNDERTHISAGREEMENTINTHEFIVEYEARPERIOD

PRIORTOTHEEVENTGIVINGRISETOSUCHDAMAGESAND(B)$15,000,000.



10.3 THELIMITATIONSOFLIABILITYINTHISSECTION10APPLYEVENIFAPARTYHASBEEN

ADVISEDOFTHEPOSSIBILITYOFSUCHLIABILITY,ANDNOTWITHSTANDINGANYFAILUREOFESSENTIAL

PURPOSEOFANYLIMITEDREMEDY.NOTWITHSTANDINGSECTION10.1AND10.2ANDANYTHINGTO

THECONTRARY,THISAGREEMENTDOESNOTLIMITLIABILITYOFEITHERPARTYFORANY

INFRINGEMENTOFTHEOTHERPARTY’SIP,SUCHPARTY’SWILLFULMISCONDUCT,ORFRAUD.



11. TERMANDTERMINATION



11.1 Term.ThetermofthisAgreementwillbeginontheEffectiveDateandcontinueuntilthe

date10yearsfromthelaterof(a)thedatetheNovaSeqDxreceivesRegulatoryApprovalintheUnited

Statesor(b)thedatetheGRAILTransactioncloses,unlessterminatedearlierinaccordancewiththis

Section11orextendedbyamendmentpursuanttoSection13.8(the“Term”).



11.2 EarlyTermination.Withoutlimitinganyotherrightsofterminationexpresslyprovidedin

thisAgreementorunderLaw,thisAgreementmaybeterminatedearlyasfollows:



CONFIDENTIAL



‐28‐



(a) BreachofProvision.IfaPartymateriallybreachesthisAgreementandfailstocure

suchbreachwithin60daysafterreceivingwrittennoticeofthebreachfromtheotherParty,thenthe

otherPartymayterminatethisAgreementwithimmediateeffectbyprovidingwrittennoticeof

terminationtothebreachingParty;provided,however,thatifsuchbreachiscurable,butnot

reasonablycurablewithinsuch60‐dayperiod,andthebreachingPartyisusingcommercially

reasonableeffortstocurethebreach,thensuchcureperiodwillbeextendedtonotlongerthan180

days.



(b) BankruptcyandInsolvency.APartymayterminatethisAgreement,effective

immediatelyuponwrittennotice,iftheotherPartybecomesthesubjectofavoluntaryorinvoluntary

petitioninbankruptcy,forwindingupofthatParty,oranyproceedingrelatingtoinsolvency,

receivership,administrativereceivership,administrativeliquidation,orvoluntaryarrangementor

schemeofarrangementwithitscreditorsthatisnotdismissedorsetasidewithin60days.



noticetoIllumina,terminatethisAgreementforanyornoreason.



11.3 EffectofExpirationorTermination.



(a) RightsTerminate.Ontheeffectivedateoftheexpiration(excepttotheextent

specifiedSection11.3(b))orterminationofthisAgreement,allrightsgrantedbyIlluminaunderthis

Agreementwillterminate,andDeveloperwill,andwillprocurethatitsAffiliatesandSubcontractors

will,assoonasisreasonablypracticable,ceasetheDevelopmentandCommercializationofallIVDTest

Kits.



(b) ContinuedCommercialization.AfterexpirationoftheTerm(butnotterminationof

thisAgreement),DevelopermaycontinueCommercializingIVDTestKitsthatwerelaunchedbefore

expirationoftheTermonanIVDTestKit‐by‐IVDTestKitandTerritory‐by‐Territorybasis;forsolongas

IlluminaisstillCommercializingtheSequencingConsumablesandservicingandsupportingtheIVD

HardwareintheapplicableTerritory.Developer’scontinuedCommercializationofIVDTestKitswould

besubjecttothetermsandconditionsofthisAgreement,includingtheRevenueShare.



expirationofthisAgreement:Sections1,2.3(b),2.3(d),2.3(i),2.4(f),3.3,5,6.5,6.7,7‐10(inclusive),

11.3,11.4,and13,andanyotherprovisionsorExhibitsnecessarytogiveeffecttothesurviving

provisions.TerminationorexpirationofthisAgreementwillnotrelievethePartiesofanyliabilityor

obligationthataccruedunderthisAgreementbeforetheeffectivedateofsuchterminationor

expiration,norprecludeeitherPartyfrompursuingallrightsandremediesitmayhaveunderthis

Agreement,atLaw,orinequitywithrespecttoanybreachofthisAgreement.



11.4 NoDamagesforTerminationorExpiration.NEITHERPARTYWILLBELIABLETOTHEOTHER

PARTYFORDAMAGESOFANYKIND(INCLUDINGWITHOUTLIMITATIONDAMAGESONACCOUNTOF

PRESENTORPROSPECTIVEPROFITS,ORONACCOUNTOFEXPENDITURES,INVESTMENTS,OR

COMMITMENTSMADEINCONNECTIONWITHTHISAGREEMENT,ORINCONNECTIONWITHTHE

CONFIDENTIAL



‐29‐



DEVELOPMENTORMAINTENANCEOFTHEBUSINESSORGOODWILLOFTHEOTHERPARTY)BYREASON

OFEXPIRATIONOFTHISAGREEMENTORPROPEREXERCISEOFITSRIGHTTOTERMINATETHIS

AGREEMENTINACCORDANCEWITHTHETERMSANDCONDITIONSSETFORTHINTHISAGREEMENT,

ANDEACHPARTYEXPRESSLYWAIVESANYRIGHTITMAYHAVETORECEIVEANYSUCHDAMAGES.



12. COMPLIANCE



12.1 GeneralCompliance.InperformingunderthisAgreement,eachPartywillatalltimes

complywithapplicableLaw.

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12.2 IVDTestKits.Specifically,andwithoutlimitingtheforegoing,Developer(a)willnot

CommercializeanyIVDTestKitorSubjectTestinanyjurisdictionwheresuchactivitiesareprohibited

byLaw,orinanymannerprohibitedbyLaw,and(b)willatalltimescomplywithgoodclinical

practices,goodlaboratorypractices,goodmanufacturingpractices(includingallqualitysystems

regulations),andtheIlluminaRegulatoryandSafetyComplianceRiderattachedtothisAgreementas

ExhibitC.

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12.3 SunshineAct.EachPartywillreasonablycooperatewiththeotherPartyinitsefforts

towardensuringthatallgovernmentpriceandgiftreporting,fraudandabuse,sales,marketing,and

promotionalpracticeswithrespecttotheIVDSystemmeetthestandardsrequiredbyapplicableLaw,

includingthePhysicianPaymentsSunshineActandsimilarstatelaws,aswellasapplicableguidelines

concerningtheadvertisingofinvitrodiagnosticsandmedicaldevices.

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12.4 CooperationinInvestigation.EachPartyagreestoreasonablycooperate,andtocauseits

Representativestoreasonablycooperate,ingoodfaithwiththeotherPartyandanyRegulatory

AuthorityattheotherParty’srequest:(a)toinvestigatetheextentofanypotentialviolationsof

applicableLawsinconnectionwiththisAgreement;and(b)toparticipateinanyinspectionorauditby

anyRegulatoryAuthority.

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12.5 RequestsforInformation.EachPartywillusereasonableeffortstocomplywithreasonable

requestsforinformation,includingansweringquestionnairesandnarrowlytailoredinquiries,toenable

theotherPartytocomplywithallapplicableLawsandrespondtorequestsforinformationfrom

RegulatoryAuthorities.

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13. GENERAL

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13.1 Arbitration.IfanydisputearisesfromorrelatestothisAgreement,(the“Dispute”),other

thanclaimsinvolvinginfringement,validity,orenforceabilityofIP(whetherIllumina’sorDeveloper’s),

oraboutthescopeofIPinthisAgreement,thePartiesshallsubmitthemattertoconfidentialbinding

arbitrationtodeterminefinaltermsandconditionsoftheagreement,ortosettlethedisputeastothe

termsoftheagreement.

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(a) Priortosubmittinganymattertoarbitration,IlluminaandDevelopershalleach

designateacontacthavingtheproperauthorizationtoresolvetheDisputeinafinalandbinding

CONFIDENTIAL

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‐30‐

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fashion,whoshallmeetinpersonorbytelephoneforaperiodofthirty(30)days(orsuchotherperiod

oftimeasIlluminaandtheDevelopershallmutuallyagree)inanattempttoresolvetheDisputein

goodfaith.

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(b) ThearbitrationproceedingshallbeconductedinaccordancewiththeCommercial

ArbitrationRulesoftheAAAandasotherwisedescribedinthisSection13.1.

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theeventthereisnoagreementastolocation,thearbitrationproceedingwilltakeplaceinNewYork

City,NY.

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(d) WithinfiveBusinessDaysofthecommencementofanarbitration,Developerand

Illuminaeachshallfurnishalegallybindingwritingtotheothercommittingtomaintainthe

confidentialityofthearbitrationandofanywrittenstatementanddiscoverymaterialsexchanged

duringthearbitration,andtolimittheuseofanysuchmaterialstothearbitration.

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(e) UponwrittenrequestbyeitherPartytotheotherParty,thePartiesshallpromptly

negotiateingoodfaithtoappointanappropriateArbitrator.IfthePartiesarenotabletoagreewithin

ten(10)daysafterthereceiptbyaPartyofthewrittenrequestintheimmediatelyprecedingsentence,

theAAAshallberesponsibleforselectinganArbitratorwithrelevantexperiencerelatedtothedispute

ofatleastten(10)yearsandtodosowithinfifteen(15)daysofbeingapproachedbyaParty.Thefees

andcostsoftheArbitratorandtheAAAshallbesharedequally(50%/50%)bytheParties.EachParty

tothearbitrationshallbearitsownlegalfeesandexpenses.

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(f) Withintwenty(20)daysafterthedesignationoftheArbitrator,thePartiesshalleach

simultaneouslysubmittotheArbitratorandoneanotherawrittenstatementoftheirrespective

positionsonsuchDispute.EachPartyshallhavefifteen(15)daysfromreceiptoftheotherParty’s

submissiontosubmitawrittenresponsethereto.TheArbitratorshallhavetherighttomeetwiththe

Parties,eitheraloneortogether,asnecessarytomakeadetermination.Further,theArbitratorshall

havetherighttorequestinformationandmaterialsandtorequireandfacilitatediscoveryasitshall

determineisappropriateinthecircumstances,takingintoaccounttheneedsofthePartiesandthe

desirabilityofmakingdiscoveryexpeditiousandcost‐effectivedeterminations.Inreachingadecision,

theArbitratormayconsideronlydocumentsexchangedindiscoverybetweentheParties,testimony

explainingthedocumentsandtheParties’writtenstatementsandothermaterialssubmittedand

argumentsmadebycounsel.

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(g) Nolaterthanthirty(30)daysafterthePartieseachsubmittheirwrittenstatementsto

theArbitrator,orasotherwiseagreedbytheParties,theArbitratorshallmakeadeterminationby

selectingtheresolutionproposedbyoneofthePartiesthatasawholeisthemostconsistentwiththis

AgreementandthemostfairandreasonabletothePartiesinlightofthetotalityofthecircumstances.

TheArbitratorshallprovidethePartieswithawrittenstatementsettingforththebasisofthe

determinationinconnectiontherewith,providedthat,theArbitratorshallnothavetheauthorityto

alteranyexplicitprovisionofthisAgreement.ThedecisionoftheArbitratorshallbefinal,bindingand

conclusive,absentmanifesterror;judgmentontheawardmaybeenteredinanycourthaving

CONFIDENTIAL

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‐31‐

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jurisdiction.NeitherPartymaydisclosetheexistence,content,orresultsofanyarbitrationwithoutthe

priorwrittenconsentofbothParties,unlessrequiredbylaw.

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(h) ThePartiesmay,byagreement,modifyanytimeperiodsspecifiedinthisSection13.1.

Atanytimeafterthecommencementofarbitration,thePartiesmayagreetosuspendthearbitration,

forperiodsnottoexceedfourteen(14)daysintheaggregate,toattempttoresolvetheirdispute

throughnegotiation.ThePartiesshalleffectuatesuchsuspensionthroughajointwritingfiledwiththe

AAA.EitherPartymayterminatethesuspensionatanytimebyfilingwiththeAAAawritingcallingfor

thearbitrationtoresume.

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13.2 ChoiceofLaw.ThisAgreementshallbegovernedby,andconstruedinaccordancewith,the

lawsoftheStateofNewYork,withoutgivingeffecttotheconflicts‐of‐lawprinciplesthereof.

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13.3 InjunctiveRelief;CumulativeRemedies.EachPartyacknowledgesthatitsbreachofSection

2.4(f),3.1(d),3.1(e),3.2(a),7,or13.5maycauseirreparableinjurytotheotherPartyforwhich

monetarydamageswouldnotbeanadequateremedy,andtheotherPartywillthereforebeentitledto

seekinjunctiverelief(includingspecificperformance)withrespecttoanysuchbreachorthreatened

breachwithoutpostingabondorothersecurityasaconditionforobtaininganysuchrelief.Therights

andremediesprovidedtoeachPartyinthisAgreementarecumulativeandinadditiontoanyother

rightsandremediesavailabletoeachPartyunderthisAgreement,atLaw,orinequity.

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13.4 Severability;NoWaiver.IfanytermorprovisionofthisAgreementisinvalid,illegal,or

unenforceableinanyjurisdiction,suchinvalidity,illegality,orunenforceabilitywillnotaffectanyother

termorprovisionofthisAgreementorinvalidateorrenderunenforceablesuchtermorprovisionin

anyotherjurisdiction,subjecttotheremainderofthisSection13.4.Uponadeterminationbyacourt

orarbitratorhavingjurisdictionthatanytermorprovisionofthisAgreementisinvalid,illegal,or

unenforceable,thePartieswillnegotiateingoodfaithtomodifythisAgreementtoeffecttheoriginal

intentofthePartiesascloselyaspossibleinorderthatthetransactionscontemplatedherebybe

consummatedasoriginallycontemplatedtothegreatestextentpossible.Thefailureordelayofeither

PartytoexerciseanyrightorremedyprovidedinthisAgreementortorequireanyperformanceofany

termofthisAgreementmaynotbeconstruedasawaiver,andnosingleorpartialexerciseofanyright

orremedyprovidedinthisAgreement,orthewaiverbyeitherPartyofanybreachofthisAgreement,

willpreventasubsequentexerciseorenforcementof,orbedeemedawaiverofanysubsequent

breachof,thesameoranyothertermofthisAgreement.Nowaiverofanyright,condition,orbreach

ofthisAgreementwillbeeffectiveunlessinwritingandsignedbybothParties.

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13.5 Assignment;IlluminaAffiliates;ThirdPartyBeneficiaries.



(a) DevelopermaynotassignortransferthisAgreement(includinganyassignmentor

transfer(includingvesting)byoperationoflaw,andspecificallyincludinganymergerorother

transactionwherebythesurvivingentityisanyentityotherthantheDeveloperentitythathas

executedthisAgreementasoftheEffectiveDate),ordelegate,sublicense,orsubcontractanyrightsor

obligationsunderthisAgreement,otherthandelegationtotheextentexpresslypermittedinthis

CONFIDENTIAL

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‐32‐

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Agreement,withoutthepriorwrittenconsentofIllumina,whichconsentmaybewithheldatIllumina’s

solediscretion.

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(b) IlluminamayassignortransferthisAgreement,andmaydelegate,sublicenseor

subcontractanyorallofitsrightsandobligationsunderthisAgreement,tooneormoreofits

Affiliates.IlluminainvoicesandotherdocumentationmaycomefromanIlluminaAffiliate,and

DeveloperwillhonorthosejustasiftheycamedirectlyfromIllumina.



Agreementmadeincontraventionofthetermshereofwillbenullandvoid.Subjecttotheforegoing,

thisAgreementwillbebindingonandinuretothebenefitoftheParties’respectivesuccessorsand

permittedassigns.TherearenoThirdPartybeneficiariestothisAgreementandnotermofthis

AgreementisenforceableundertheContracts(RightsofThirdParties)Act1999byapersonorentity

whoisnotaPartytothisAgreement.ThePartiesmayrescindorterminatethisAgreementorvaryany

ofitstermsinaccordancewiththeirrightsunderthisAgreementandbyLaw,withouttheconsentof

anyThirdParty.

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13.6 Notices.AllnoticesrequiredorpermittedunderthisAgreementwillbeinwriting,inEnglish,

andwillbedeemedreceivedonlywhen:(a)deliveredpersonally;or(b)onedayafterdepositwitha

commercialexpresscourierspecifyingnextdaydeliveryor,forinternationalcourierpackages,two

daysafterdepositwithacommercialexpresscourierspecifyingtwo‐daydelivery,withwritten

verificationofreceipt.Allnoticeswillbesenttothefollowingoranyotheraddressdesignatedbya

PartyusingtheproceduressetforthinthisSection:



IftoIllumina:



Illumina,Inc.

5200IlluminaWay

SanDiego,CA92122 

Attn:SVP,CorporateDevelopmentand

StrategicPlanning



Withacopyto:[email protected]



IftoDeveloper:



13.7 ForceMajeure.NeitherPartywillbeinbreachofthisAgreementnorliableforanyfailureto

performordelayintheperformanceofthisAgreementattributableinwholeorinparttoanyForce

Majeure;provided,however,thatineachsuchcasetheaffectedPartywillusereasonableeffortsto

avoidsuchoccurrenceandtoremedyitpromptly.TheaffectedPartywillgivepromptnoticeofany

suchcausetotheotherParty.TheaffectedPartywillbeexcusedfromsuchofitsobligationsasitis

disabledfromperformingduringtheperiodofForceMajeure;provided,however,thatsuchaffected

Partycommencesandcontinuestotakereasonableanddiligentactionstocuresuchcause.

PerformancehereunderwillbepromptlyresumedaftertheapplicableForceMajeureeventhasbeen

remedied.Developer’spaymentobligationsarenotaffectedbythisprovisionexcepttotheextentthe

CONFIDENTIAL



‐33‐



ForceMajeureaffectsfinancialinstitutionsand,asaresult,thefinancialinstitutionscannotcomplete

thetransactionnecessaryforDevelopertosatisfyitspaymentobligations.



13.8 EntireAgreement;Amendment.ThisAgreement,togetherwiththeSupplyAgreement,

representstheentireagreementbetweenthePartiesregardingthesubjectmatterhereofand

supersedesallpriordiscussions,communications,agreements,andunderstandingsofanykindand

naturebetweenthePartieswithrespecttotheDevelopmentandCommercializationoftheIVDTest

Kits.ThePartiesacknowledgeandagreethatbyenteringintothisAgreement,theydonotrelyonany

statement,representation,assurance,orwarrantyofanyPersonotherthanasexpresslysetoutinthis

Agreement.EachPartyagreesthatitwillhavenorightorremedy(otherthanforbreachofcontract)

inrespectofanystatement,representation,assurance,orwarranty(whethermadenegligentlyor

innocently)otherthanasexpresslysetforthinthisAgreement.NothinginthisSection13.8will

excludeorlimitliabilityforfraud.NoamendmenttothisAgreement(includingchangestoanyIVD

PlanoradditionofanyIVDPlan)willbeeffectiveunlessinwritingandsignedbybothParties.



13.9 RelationshipoftheParties.ThePartiesareindependentcontractorsunderthisAgreement

andnothinginthisAgreementmaybeconstruedascreatingapartnership,jointventure,oragency

relationshipbetweentheParties,orasgrantingeitherPartytheauthoritytobindorcontractany

obligationinthenameoftheotherPartyortomakeanystatements,representations,warranties,or

commitmentsonbehalfoftheotherParty.



13.10 Headings;Interpretation.Sections,titles,andheadingsinthisAgreementarefor

convenienceonlyandarenotintendedtoaffectthemeaningorinterpretationhereof.Whenever

requiredbythecontext,thesingulartermincludestheplural,thepluraltermincludesthesingular,and

thegenderofanypronounincludesallgenders.AsusedinthisAgreementexceptasthecontextmay

otherwiserequire,thewords“include,”“includes,”“including,”and“suchas”aredeemedtobe

followedby“withoutlimitation”or“butnotlimitedto,”whetherornottheyareinfactfollowedby

suchwordsorsimilarwords,and“will”and“shall”areusedsynonymously.Exceptasotherwise

expresslyprovided,“discretion”meanssoleandabsolutediscretion.Exceptasexpresslystated,any

referenceto“days”willbetocalendardays,anyreferenceto“calendarmonth”willbetothemonth

andnota30dayperiod,andanyreferenceto“calendarquarter”willmeanthefirstthreecalendar

monthsoftheyear,thefourththroughsixthcalendarmonthsoftheyear,thesevenththroughninth

calendarmonthsoftheyear,andthelastthreecalendarmonthsoftheyear.Wheneverthelastday

fortheexerciseofanyrightorthedischargeofanyobligationhereunderfallson,oranynoticeis

deemedtobegivenon,anon‐BusinessDay,thePartyhavingsuchrightorobligationwillhaveuntil

5:00pmPSTonthenextsucceedingBusinessDaytoexercisesuchrightortodischargesuchobligation

orthePartygivingnoticewillbedeemedtohavegivennoticeonthenextsucceedingBusinessDay.

Nousageoftrade,courseofperformance,orotherregularpracticebetweenthePartiesmaybeused

toalterthetermsandconditionsofthisAgreement.Unlessotherwiseexpresslyprovidedinthis

Agreement,anyagreement,instrument,orstatutedefinedorreferredtomeanssuchagreement,

instrument,orstatuteasfromtimetotimeamended,modified,orsupplemented,including(inthe

caseofagreementsorinstruments)bywaiverorconsentand(inthecaseofstatutes)bysuccessionof

comparablesuccessorstatutesandreferencestoallattachmentstheretoandinstruments

incorporatedtherein.ThePartieshaveparticipatedjointlyinthenegotiationanddraftingofthis

CONFIDENTIAL



‐34‐



Agreement.Ifanambiguityorquestionofintentorinterpretationarises,thisAgreementwillbe

construedasifdraftedjointlybythePartiesandnopresumptionorburdenofproofwillarisefavoring

ordisfavoringanyPartybecauseoftheauthorshipofanyprovisionofthisAgreement.



13.11 LegalCompliance.NothinginthisAgreementisintended,orshouldbeinterpreted,to

preventeitherPartyfromcomplyingwith,ortorequireaPartytoviolate,anyapplicableLaw.Should

eitherPartyreasonablyconcludethatanyportionofthisAgreementisormaybeinviolationofa

changeinaLawmadeaftertheEffectiveDate,orifanysuchchangeorproposedchangewould

materiallyaltertheamountormethodofcompensatingIlluminaforservicesperformedfor,or

RevenueShareowedby,Developer,orwouldmateriallyincreasethecostofIllumina’sperformance

hereunder,thePartiesagreetonegotiateingoodfaithwrittenmodificationstothisAgreementasmay

benecessarytoestablishcompliancewithsuchchanges,andtoreflectapplicablechangesin

compensationwarrantedbysuchlegalchanges,withanymutuallyagreeduponmodificationsaddedto

thisAgreementbywrittenamendmentinaccordancewithSection13.8ofthisAgreement.



13.12 CounterpartsandSignatures.ThisAgreementmaybeexecutedinoneormore

counterparts,eachofwhichwillbedeemedtobeanoriginal,andallofwhichwillconstituteoneand

thesameinstrument.DeliveryofanexecutedcounterpartofasignaturepageofthisAgreementby

PDForotherelectronictransmissionwillbeeffectiveasdeliveryofamanuallyexecutedoriginal

counterpartofthisAgreement.ThePartiesagreethattheexecutionofthisAgreementbyexchanging

pdfsignatures,and/orbyindustrystandardelectronicsignaturesoftware,willhavethesamelegal

forceandeffectastheexchangeoforiginalsignatures.



13.13 Costs.ExceptasexpresslyprovidedinthisAgreement,eachPartywillpayitsowncosts

incurredinconnectionwiththenegotiation,preparation,execution,andperformanceunderthis

Agreementandanydocumentsreferredtoinit.



13.14 Non‐ExclusiveRelationship.EachPartyacknowledgesandagreesthat,duringtheTermand

thereafter,nothinginthisAgreementwillcreateanyformofexclusiverelationshipbetweenthe

PartieswithrespecttothesubjectmatterofthisAgreement.



13.15 FurtherAssurances.EachPartywillexecuteanddeliversuchfurtherdocumentsandtake

suchfurtheractionsastheotherPartymayreasonablyrequesttoevidenceandimplementthe

provisionsandintentofthisAgreement.



[SIGNATURESONNEXTPAGE]

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CONFIDENTIAL



SIGNATUREPAGETO

IVDTESTKITAGREEMENT–NOVASEQDX



ILLUMINA



Illumina,Inc.



By:



Name:



Title:



Date:



Developer



____________________________________



By:



Name:



Title:



Date:





CONFIDENTIAL



EXHIBITA



IVDPLANS







CONFIDENTIAL



EXHIBITB



MILESTONEPAYMENTS



DeveloperwillpaytoIlluminathefollowingMilestonePaymentsuponachievementofthe

correspondingmilestones.



• TechAccessFee:$15,000,000,paidone‐timeonly,withinfiveBusinessDaysoftheEffectiveDate.

• DevelopmentMilestonePayments(perIVDTestKit):

$5,000,000totalperIVDTestKit

50%ofthetotalamountwillbedueuponDeveloper’sacceptanceoftheLRMSoftware

ModulefortheIVDTestKit(whichmaynotbeunreasonablywithheld,conditioned,or

delayed)andtheremaining50%willbedueuponthefirstRegulatoryApprovaloftheIVD

TestKit(inanyjurisdiction).



CONFIDENTIAL



EXHIBITC

ILLUMINAREGULATORYANDSAFETYCOMPLIANCERIDER

Inperformingundertheattachedagreement(the“Agreement”)withIllumina,Inc.and/oritsaffiliate

(referredtobelowas“Illumina”)thecontractingparty(referredtobelowas“Contractor”)willcomply

withthefollowingprovisions,totheextentapplicable.TotheextentContractorispermittedtoretain

subcontractorsintheperformanceoftheAgreementasapplicable,Contractorwillensurethatits

subcontractorscomplywiththefollowingprovisions,totheextentapplicable,andthebreachofany

provisionbelowbyasubcontractorwillconstituteabreachoftheAgreementbyContractor.



ExportCompliance.Contractorshallcomplywithallapplicableexportcontrollawswithrespecttothe

exportoforre‐exportoftechnicaldataandproductsthatarethesubjectoftheAgreement.Each

partyagreestodetermineandsecureinadvanceofanyexport,anyandalllicensesandpermitsasmay

berequiredorreasonablyrequiredinordertoexportorre‐exporttheproductsortechnicaldataused

inconnectiontherewith.ContractorshallnotifyIlluminainwritingifanyproductortechnicaldata

providedhereunderisorbecomessubjectofexportcontrollaws,includingthoseoftheUnitedStates,

suchthatitmayrequireanexportlicense.



IntegrityClause.Allcorruption,extortionandembezzlementareprohibited.Contractorshallnotpay

oracceptbribesorparticipateinotherillegalinducementsinbusinessorgovernmentrelationships.

Contractorshallconductitsbusinessconsistentwithfairandvigorouscompetitionandincompliance

withallantitrustlaws.Contractorshallemployfairbusinesspractices,includingaccurateandtruthful

advertising.Contractorrepresentsandwarrantsthatinconnectionwithitsperformanceunderthe

Agreementitcomplieswithallapplicablelawsandregulationsincludingthoserelatingtosustainable

developmentandsocialresponsibilitysuchasregulationsprohibitingchildlabor,bribes,thegrantingof

illegaladvantages,andfairemploymentpractices.Contractorshallneitheruseforced,bonded,

indenturedorvoluntaryprisonlabornorchildlabor.

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PersonalDataPrivacy.InthecourseofperformanceundertheAgreementContractormayreceive

personalinformationthatincludeswithoutlimitation,businesscontactinformation,ofcustomersand

employeesofIlluminaandIllumina’saffiliates(collectively“PersonalData”).IntheeventContractor

receivesanyPersonalDataundertheAgreement,ContractorshallprotectPersonalDatawhen

transferring,using,andprocessingPersonalDataasfollows:Contractorshall:(i)providenoticeabout

howContractorwillprotectandusePersonalDataandprovide,uponrequest,theaffectedindividuals

withappropriateoptionsonhowtoreceivesuchnotices;(ii)nottransferPersonalDatatoanythird

partywithoutIllumina’sexpresspriorwrittenconsent;(iii)provideindividualswithreasonableaccess

totheirPersonalDataasrequestedbyIllumina;(iv)takeallreasonablesecurityprecautionstoprotect

PersonalDatafromloss,misuseandunauthorizedaccess,disclosure,alterationanddestruction;and

(v)takeallreasonablestepstoensurePersonalDataisreliableforitsintendedusewhenContractor

willbeusingorprocessingPersonalDataortransferringtoathirdpartythatwillbeusingorprocessing

PersonalData.

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