Collaboration Agreement

Expiration Date11 February 2015
Date11 February 2012
PartiesBIOCEPT, INC. (“Biocept”), LIFE TECHNOLOGIES CORPORATION (“Life Technologies”)
StateCalifornia
SectionCommercial Contracts
Exhibit10.13
COLLABORATIONAGREEMENT
THISCOLLABORATIONAGREEMENT (the“Agreement”)isenteredintoasofNovember2,2012(the“EffectiveDate”)
byandbetweenBIOCEPT,INC.,aCaliforniacorporationhavinganaddressof5810NancyRidgeDrive,Suite150,SanDiego,
CA92121(“Biocept”),andLIFETECHNOLOGIESCORPORATION,aDelawarecorporationhavinganaddressof5791Van
AllenWay,Carlsbad,California92008(“LifeTechnologies”).
WHEREAS,LifeTechnologies,throughitsMedicalSciencesDivision,isengagedinthedevelopmentandcommercialization
ofdiagnosticsystems,testsandlaboratoryservices,includinginoncology;
WHEREAS,Biocepthasdevelopedexpertiseandproprietarytechnologyinenrichment,extractionandanalysisofcirculating
tumorcells(CTCs)foruseinlaboratorydevelopedtestsusedforthenon-invasiveandearlystagedetectionandcharacterization
ofprimary,metastaticorrecurrentcancers;and
WHEREAS,LifeTechnologiesandBioceptdesiretocollaboratesothatBioceptwilldevelopandcommercializeoneor
moreTests,asdefinedherein,forNon-SmallCellLungCancer(NSCLC),usingtheirrespectivetechnologiesandexpertise,on
thetermsandsubjecttotheconditionssetforthherein.LifeTechnologiesandBioceptwillbothpromotethetestandperform
differentcomponentsofthetest,andLifeTechnologieswillprovidetestresultsintheformofreportstophysicians.
NOW,THEREFORE,inconsiderationoftheforegoingpremisesandthemutualcovenantscontainedherein,andintendingto
belegallybound,thepartiesherebyagreeasfollows:
1. DEFINITIONS
1.1“Affiliate”shallmeananycompanyorentitycontrolledby,controlling,orundercommoncontrolwithapartyhereto
andshallincludeanycompanymorethan50%ofwhosevotingstockorparticipatingprofitinterestisownedorcontrolled,directly
orindirectly,byaparty,andanycompanywhichownsorcontrols,directlyorindirectly,morethan50%ofthevotingstockofa
party.
1.2Assay”shallmeanBiocept’sOncoCEE-LU™(andOncoCEE-LU™withMutationAnalysis)laboratorydeveloped
assayforcharacterizationandprofilingofCTCsfromNSCLCpatients,whichshallincorporate,asPhase1,CTCenumerationby
cytokeratinandCD45(andCEE-Enhanced™whenavailable),EML4/Alk1fusionsandEGFRamplificationbyfluorescencein
situhybridization(determinedbyBiocept);andasPhase2,theadditionaldetectionofmutationsforrelevantgenes,e.g.,K-RAS,
EGFRandB-RAF,asagreedbytheparties,oncapturedCTCsand/orcell-freecirculatingDNA,asagreedbytheparties,and
employingtechnologiesthatpotentiallymayincludeBiocept’sSelectortechnology,andanyimprovementsorenhancements
thereto,exclusiveofnewanalytes(whicharediscussedinSection3.5(f)underCollaborationAssays)orapplicationstoprimary
screening.
1.3“BioceptTrademarks”shallmeanBiocept,Inc.,“OncoCEE-LU ”,“OncoCEE™”,“CEE-Sure ”,CEE-
Enhanced™”,and/orsuchothertrademarksandtradenamesownedorlicensed,andused,byBioceptand/oritsAffiliatesinthe
TerritorytoidentifytheTests,ineachcase,whetherornotregistered.
1.4“LifeTechnologiesTrademarks,”shallmeanLifeTechnologies ,LifeTechnologiesMedicalSciencesand/orsuch
othertrademarksandtradenamesownedorlicensedandusedbyLifeTechnologiestoidentifytheTests,ineachcase,whetheror
notregistered.
1.5CLIA”shallmeantheClinicalLaboratoryImprovementAmendmentsof1988,asitmaybeamendedfromtimeto
time.
1.6Collaboration”shallhavethemeaningprovidedSection3.1.
1.7CollaborationAssay(s)”shallhavethemeaningprovidedinSection3.5(e).
1.8CPTCode”shallmeantheAmericanMedicalAssociation’s(“AMA”)“CurrentProceduralTerminology”aspublished
intheAMA’sCPTProcessManual,FourthEditionandanysuchfutureeditions,forproceduresusedinperformanceofthe
Assay,andamountsreimbursedbyMedicareforsuchproceduresforlocation99,asmodifiedannually.
1.9DesignatedExecutiveOfficer”shallmeantheexecutiveofficersofeachpartydesignatedinwritingbeeachpartyas
beingresponsibleforresolvingdisputesrelatedtotheCollaboration,whichshallinitiallybeDavidHaleonbehalfofBioceptand
RonnieAndrewsonbehalfofLifeTechnologies.
1.10FDA”shallmeantheUnitedStatesFoodandDrugAdministration,oranysuccessorfederalagencythereto.
1.11HIPAA”shallmean,collectively,theHealthInsurancePortabilityandAccountabilityActof1996,asamended,and
allregulationspromulgatedthereunderat45C.F.R.parts160through164,andtheHealthInformationTechnologyforEconomic
andClinicalHealthActof2009andrelatedregulationsandguidelines.
1.12IntellectualPropertyRights”meansallnoworhereafterexistingpatents,patentapplications,copyrights,
trademarks(includingservicemarks),tradesecrets,know-how,maskworkrightsanddesignrights,whetherregisteredor
unregistered,andallrightsorformsofprotectionofasimilarnaturehavingequivalentorsimilareffecttoanyoftheforegoing,
whichmaysubsistanywhereintheworld.
1.13Launch”shallmeanformalcommercialavailabilityandofferingtophysiciansofaTest,asmutuallyagreeduponby
theparties.
1.14Laws”shallmeanallfederal,stateandlocallawsandregulationsthatapplytothisAgreementincluding,without
limitation,(i)theBayh-DoleAct(ii)the
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