Collaboration Agreement
| Parties | F. Hoffmann-La Roche Ltd ("Roche Basel"), Hoffmann-La Roche Inc. (“Roche US”)(Roche Basel and Roche US together referred to as “Roche”), Foundation Medicine, Inc. ("FMI") |
| State | New York |
| Section | Commercial Contracts |
Exhibit10.2
EXECUTIONCOPY
***TextOmittedandFiledSeparatelywiththeSecuritiesandExchangeCommission
ConfidentialTreatmentRequestedUnder
17C.F.R.Sections200.80(b)(4)and240.24b-2
CollaborationAgreement
ThisAgreementisenteredintowitheffectasoftheEffectiveDate(asdefinedbelow)
byandbetween
F.Hoffmann-LaRocheLtd
withanofficeandplaceofbusinessatGrenzacherstrasse124,4070Basel,Switzerland(“RocheBasel”)
and
Hoffmann-LaRocheInc.
withanofficeandplaceofbusinessat150CloveRoad,Suite8,LittleFalls,NewJersey07424,U.S.A.(“RocheUS”;RocheBaselandRocheUS
togetherreferredtoas“Roche”)
ontheonehand
and
FoundationMedicine,Inc.
withanofficeandplaceofbusinessat150SecondStreet,Cambridge,Massachusetts02141(“FMI”)
ontheotherhand.
TableofContents
1. Definitions 7
1.1 Affiliate 7
1.2 Agreement 7
1.3 AgreementTerm 7
1.4 [...***...]ctDNA[...***...] 7
1.5 ApplicableLaw 7
1.6 ApprovedAssay 7
1.7 BackgroundIP 7
1.8 BusinessDay 8
1.9 CalendarHalf 8
1.10 CalendarQuarter 8
1.11 CalendarYear 8
1.12 CDx 8
1.13 CDxDevelopmentProgram 8
1.14 CLIA 8
1.15 ClinicalStudy 9
1.16 CommerciallyReasonableEfforts 9
1.17 ConfidentialInformation 9
1.18 Control 9
1.19 Cover 10
1.20 ctDNA 10
1.21 ctDNAAssay 10
1.22 ctDNAPlatform 10
1.23 ctDNAPlatformDevelopmentProgram 10
1.24 ctDNAWorkingGroup 10
1.25 DataSecurityBreach 10
1.26 EffectiveDate 10
1.27 ExceptedActivities 11
1.28 ExcludedPatentRights 11
1.29 FDA 11
1.30 FDCA 11
1.31 FMIBackgroundIPPatentRights 11
1.32 FMIDecisions 11
1.33 FMIDevelopmentCosts 11
1.34 FMIKnow-How 11
1.35 FMIForegroundPatentRights 12
1.36 FTE 12
1.37 FTERate 12
1.38 Handle 12
1.39 HSR 12
1.40 ImmunotherapyTestingPlatformDevelopmentProgram 12
1.41 Immuno-PlatformWorkingGroup 12
1.42 Initiation 12
1.43 InsolvencyEvent 12
1.44 Invention 13
1.45 IUO 13
1.46 JMC 13
1.47 JOC 13
1.48 JointKnow-How 13
1.49 JointPatentRights 13
***ConfidentialTreatmentRequested***
-2-
1.50 JOT 13
1.51 JRDC 13
1.52 Know-How 13
1.53 MolecularInformationPlatformProgram 13
1.54 MolecularInformationPlatformWorkingGroup 14
1.55 Party 14
1.56 PatentRights 14
1.57 PerformanceSpecifications 14
1.58 PersonalData 14
1.59 PhaseIStudy 14
1.60 PhaseIIStudy 14
1.61 PhaseIIIStudy 14
1.62 PMA 15
1.63 QualityStandards 15
1.64 R&DPlan 15
1.65 RegulatoryApproval 15
1.66 RegulatoryAuthority 15
1.67 RocheBackgroundIPPatentRights 15
1.68 RocheGroup 15
1.69 RocheKnow-How 15
1.70 RocheForegroundPatentRights 15
1.71 ROWTerritory 15
1.72 RUO 15
1.73 StudyData 16
1.74 Sublicensee 16
1.75 Territory 16
1.76 ThirdParty 16
1.77 US 16
1.78 US$ 16
1.79 WorkStream 16
1.80 AdditionalDefinitions 16
2. GrantofLicense 18
2.1 Licenses 18
2.2 Sublicense 20
2.3 RighttoSubcontract 20
3. ResearchandDevelopmentCollaboration 20
3.1 MolecularInformationPlatformProgram 20
3.2 ImmunotherapyTestingPlatformDevelopmentProgram 23
3.3 ctDNAPlatformDevelopmentProgram 25
3.4 CDxDevelopmentProgram 27
3.5 Samples,HandlingandDisposal 29
3.6 Records;Reports;Audits 30
4. Diligence 31
5. MostFavoredCustomer 31
6. Governance 31
6.1 JointManagementCommittee 31
6.2 JRDC 33
6.3 JOC 34
6.4 AllianceDirector 34
6.5 LimitationsofAuthority 34
6.6 Expenses 35
6.7 Lifetime 35
-3-
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