Exhibit 10.1

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

CONFIDENTIAL

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PHASE IB/II COMBINATION STUDY AGREEMENT

 

BETWEEN

 

GENENTECH, INC.

 

AND

 

CORVUS PHARMACEUTICALS, INC.

 

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TABLE OF CONTENTS

 

 

Page

 

 

Article 1 Definitions

1

 

 

1.1

“Adenosine A2A Competitive Program”

1

1.2

“Adenosine A2A Product”

1

1.3

“Affiliate”

2

1.4

“Agreement”

2

1.5

“Ancillary Agreements”

2

1.6

“Applicable Law”

2

1.7

“Budget”

2

1.8

“Business Day”

2

1.9

“Case Report Form”

3

1.10

“CFR”

3

1.11

“Change of Control”

3

1.12

“Collaboration IND”

3

1.13

“Collaboration Invention”

3

1.14

“Combination”

3

1.15

“Compound”

3

1.16

“Compound Supply Plan”

3

1.17

“Confidential Information”

3

1.18

“Continued Access”

3

1.19

“Control Arm Data”

3

1.20

“Corvus”

3

1.21

“Corvus Background IP”

3

1.22

“Corvus Compound”

4

1.23

“CRO”

4

1.24

“Database Lock”

4

1.25

“Data Review Committee”

4

1.26

“Delivery Locations”

4

1.27

“Effective Date”

4

1.28

“EMA”

4

1.29

“Exchange”

4

1.30

“FDA”

4

1.31

“Final Study Report”

4

1.32

“First Site Ready”

4

1.33

“GCP”

4

1.34

“GDP”

5

1.35

“Genentech”

5

1.36

“Genentech Compound”

5

1.37

“Genentech Protocol”

5

1.38

“GLP”

5

 

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1.39

“GMP”

5

1.40

“GMP Audit”

5

1.41

“HIPAA”

5

1.42

“IND”

5

1.43

“Inspection”

5

1.44

“Investigator”

5

1.45

“IRB”

6

1.46

“JDC Chair”

6

1.47

“JDC Co-Leader”

6

1.48

“Joint Development Committee”

6

1.49

“Joint Patent”

6

1.50

“Know-How”

6

1.51

“Letter of Cross-Reference”

6

1.52

“MAA”

6

1.53

“Manufacture and Supply”

6

1.54

“Manufacturing Facilities and Records”

6

1.55

“Material Regulatory Notice”

7

1.56

“Other Invention”

7

1.57

“Participating Site”

7

1.58

“Party” or “Parties”

7

1.59

“Patents”

7

1.60

“PD-L1/PD-1 Antagonist”

7

1.61

“PD-L1/PD-1 Competitive Program”

7

1.62

“Pharmacovigilance Agreement”

7

1.63

“Phase I/Ib Agreement”

7

1.64

“Project Participant Agreement”

7

1.65

“Project Participants”

7

1.66

“Prosecution and Maintenance”

7

1.67

“Publishing Party”

7

1.68

“Quality Agreement”

7

1.69

“Regulatory Authority”

7

1.70

“Regulatory Documentation”

7

1.71

“Reviewing Party”

8

1.72

“Roche Group”

8

1.73

“Rules”

8

1.74

“Sample Analyses”

8

1.75

“Sample Analyses Plan”

8

1.76

“Sample Data”

8

1.77

“Samples”

8

1.78

“Specifications”

8

1.79

“Sponsor”

8

1.80

“Study”

8

1.81

“Study Completion”

8

 

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1.82

“Study Data”

8

1.83

“Subinvestigator”

8

1.84

“Subject”

9

1.85

“Subject Injury Claim”

9

1.86

“Term”

9

1.87

“Third Party”

9

 

 

 

Article 2 Conduct of the Study

9

 

 

 

2.1

Overview

9

2.2

Genentech

9

2.3

Collaboration IND; Investigator’s Brochure

9

2.4

Genentech Protocol

9

2.5

Enrollment

10

2.6

Agreements With Project Participants

10

2.7

Regulatory Matters

11

2.8

Safety Reporting

12

2.9

Documentation, Updates and Final Study Report

12

2.10

Corvus Study Responsibilities

13

2.11

Costs

13

 

 

 

Article 3 Governance

14

 

 

 

3.1

Joint Development Committee

14

3.2

Data Review Committee

16

 

 

 

Article 4 Supply of Study Drugs

16

 

 

 

4.1

Genentech Compound

16

4.2

Corvus Compound

16

4.3

Insufficient Quantities

18

4.4

GMP Audit; Quality Agreement; Inspections

18

4.5

Mutual Obligations

19

 

 

 

Article 5 Study Data; Control Arm Data; Sample Analyses and Sample Data

19

 

 

 

5.1

Study Data

19

5.2

Sample Analyses and Sample Data

19

5.3

[Reserved.]

20

 

 

 

Article 6 Collaboration Inventions and Licenses

20

 

 

 

6.1

Collaboration Inventions

20

6.2

Use of Jointly Owned Inventions

21

6.3

Licenses

22

6.4

Patent Prosecution and Maintenance

22

6.5

Patent Enforcement and Defense

24

 

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Article 7 Confidentiality

25

 

 

 

7.1

Disclosure and Use of Confidential Information

25

7.2

Authorized Disclosures

25

7.3

Continuing Obligation

27

7.4

Prior Agreements

27

 

 

 

Article 8 Public Disclosures; Use of Names

27

 

 

 

8.1

Clinical Trials Registries

27

8.2

Publications and Presentations

27

8.3

Press Releases and Other Public Disclosures

28

8.4

Use of Names

29

 

 

 

Article 9 Human Subjects

29

 

 

 

9.1

Informed Consent

29

9.2

IRB Approval

29

9.3

Patient Privacy and Data Protection

29

 

 

 

Article 10 Subcontracting; Records

29

 

 

 

10.1

Subcontracting

29

10.2

Records

29

 

 

 

Article 11 Compliance With Laws

30

 

 

 

11.1

Compliance With Laws and Policies

30

11.2

Debarment

30

 

 

 

Article 12 Term; Termination

30

 

 

 

12.1

Term

30

12.2

Termination for Material Breach

30

12.3

Termination for Study-Related Reasons

31

12.4

Termination for Discontinued Development

31

12.5

Termination for Corvus’s Failure of GMP Audit

31

12.6

Effects of Termination or Expiration

32

 

 

 

Article 13 Representations and Warranties

33

 

 

 

13.1

Mutual Representations and Warranties

33

13.2

Disclaimers

33

 

 

 

Article 14 Indemnification; Subject Injury Claims; Limitation on Liability;
Insurance

33

 

 

 

14.1

Indemnification

33

14.2

Subject Injury Claims

35

14.3

Limitation on Liability

36

14.4

Insurance

36

 

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Article 15 Dispute Resolution

37

 

 

 

15.1

Internal Resolution

37

15.2

Arbitration

37

15.3

Subject Matter Exclusions

37

15.4

Continued Performance

38

 

 

 

Article 16 Miscellaneous

38

 

 

 

16.1

Prior Agreement

38

16.2

Notices

38

16.3

Governing Law

39

16.4

Actions of Affiliates

39

16.5

Assignment

39

16.6

Force Majeure

40

16.7

Relationship of the Parties

40

16.8

Amendment; Waiver

40

16.9

Construction; Captions

40

16.10

Severability

41

16.11

Entire Agreement

41

16.12

Counterparts; Facsimiles

41

 

Exhibits

 

 

 

 

 

Exhibit A

 

 

Sample Analyses Plan

 

 

B

 

 

Compound Supply Plan

 

 

C

 

 

Budget

 

 

 

 

 

 

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PHASE IB/II COMBINATION STUDY AGREEMENT

 

THIS PHASE IB/II COMBINATION STUDY AGREEMENT (“Agreement”) is made and entered
into, effective as of May 1, 2017 (“Effective Date”), by and between
Genentech, Inc., a Delaware corporation, having a principal place of business at
1 DNA Way, South San Francisco, California 94080 (“Genentech”) and Corvus
Pharmaceuticals, Inc., a Delaware corporation, having a principal place of
business at 863 Mitten Road, Suite 102, Burlingame, CA 94010 (“Corvus”). 
Genentech and Corvus are each referred to herein individually as a “Party” and
collectively as the “Parties.”

 

RECITALS

 

A.                                    Genentech is developing the Genentech
Compound (defined below) for the treatment of certain tumor types.

 

B.                                    Corvus is developing the Corvus Compound
(defined below) for the treatment of certain tumor types.

 

C.                                    Genentech wishes to conduct a Phase Ib/II
clinical study in evaluating the safety, tolerability and efficacy of the
Genentech Compound and the Corvus Compound, which will be dosed in combination,
in patients with locally advanced unresectable or metastatic non-small cell lung
cancer patients.

 

D.                                    Genentech and Corvus, consistent with the
terms of this Agreement, desire to collaborate as more fully described herein,
including by providing the Genentech Compound and the Corvus Compound for the
Study (defined below).

 

AGREEMENT

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency
of which is hereby acknowledged, Genentech and Corvus agree as follows:

 

Article 1
Definitions

 

Capitalized terms used in this Agreement shall have the meanings set forth
below, unless otherwise specifically indicated.

 

1.1                               “Adenosine A2A Competitive Program” means any
program to [***]

 

1.2                               “Adenosine A2A Product” means any product
containing a molecule that [***].

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

1

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1.3                               “Affiliate” of a Party means any corporation
or other business entity that, directly or indirectly, through one or more
intermediaries, controls, is controlled by, or is under common control with such
Party.  For purposes of this definition, the term “control” (including, the
correlative meanings, “controlled by” and “under common control with”) means
(a) the direct or indirect ownership of more than fifty percent (50%) of the
stock having the right to vote for directors thereof (or general partnership
interests) or (b) the ability to otherwise control the decisions of the board of
directors or equivalent governing body thereof.  Notwithstanding the foregoing,
for purposes of this Agreement, Chugai Pharmaceutical Co., Ltd (for purposes of
this definition, “Chugai”) and Foundation Medicine, Inc. (for purposes of this
definition, “FMI”), and all business entities controlled by Chugai or FMI, shall
not be considered Genentech’s Affiliates, unless and until Genentech elects to
include one or more of such business entities as its Affiliate, by providing
written notice to Corvus of such election.

 

1.4                               “Agreement” is defined in the recital.

 

1.5                               “Ancillary Agreements” means the Quality
Agreement and the Pharmacovigilance Agreement.

 

1.6                               “Applicable Law” means all (a) federal, state,
local, national and regional statutes, laws, rules, regulations and directives
applicable to a particular activity under this Agreement (including the
performance of clinical trials and medical treatment) that may be in effect from
time to time (including GCP, GDP, GLP, GMP and others promulgated by Regulatory
Authorities); (b) applicable data protection and patient privacy laws and
requirements in all countries in which information or data that is protected by
any applicable privacy laws is received, observed, collected or otherwise
possessed (including HIPAA (defined below) in the United States, the European
Union Privacy Directive (Directive 95/46/EC), the Personal Information
Protection and Electronic Documents Canada (PIPEDA) in Canada, and any related
regulations); (c) export control and economic sanctions regulations that
prohibit the shipment of United States-origin products and technology to certain
restricted countries, entities and individuals; (d) anti-bribery and
anti-corruption laws pertaining to interactions with government agents,
officials and representatives (including the United States Foreign Corrupt
Practices Act); (e) laws and regulations governing payments to healthcare
providers; (f) laws and requirements governing ineligibility to participate in
federal, state or other healthcare programs (including debarment under
21 USC § 335a, disqualification under 21 CFR §312.70 or § 812.119, sanctions by
a Federal Health Care Program (as defined in 42 USC § 1320a-7b(f)), including
the federal Medicare or a state Medicaid program); and (g) successor or
replacement statutes, laws, rules, regulations and directives relating to the
foregoing.

 

1.7                               “Budget” is defined in Section 2.11(b).

 

1.8                               “Business Day” means a day, other than a
Saturday, Sunday or day on which commercial banks located in San Francisco,
California, or Basel, Switzerland, or Welwyn, United Kingdom, are authorized or
required by law or regulation to close.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

2

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1.9                               “Case Report Form” means the form (whether
paper or electronic) for collecting certain data about each Subject, including
the data collected for such Subject.

 

1.10                        “CFR” means the United States Code of Federal
Regulations.

 

1.11                        “Change of Control” is defined in Section 16.5(a).

 

1.12                        “Collaboration IND” means, individually or
collectively (as applicable), any or all INDs that include the Genentech
Protocol, as further described in Section 2.3.

 

1.13                        “Collaboration Invention” is defined in
Section 6.1(a).

 

1.14                        “Combination” means the Genentech Compound and the
Corvus Compound used in combination, [***].

 

1.15                        “Compound” means the Genentech Compound and/or the
Corvus Compound, as applicable.

 

1.16                        “Compound Supply Plan” means the plan for supplying
the Corvus Compound for the Study, as set forth in Exhibit B hereto.

 

1.17                        “Confidential Information” means nonpublic
information (including Know-How) of a Party that is disclosed in connection with
this Agreement (whether orally, electronically, visually or in writing) by or on
behalf of such Party to the other Party or its designee.  Except as otherwise
expressly provided in this Agreement, Study Data, Sample Data, Control Arm Data,
Collaboration Inventions and other intellectual property shall be the
Confidential Information of the Party(ies) that own such Study Data, Sample
Data, Control Arm Data, Collaboration Inventions and other intellectual
property.  [***]  The terms and conditions of this Agreement and the Genentech
Protocol shall be the Confidential Information jointly of the Parties.

 

1.18                        “Continued Access” is defined in Section 4.2(b).

 

1.19                        “Control Arm Data” means the [***] from the [***]
collected from the  [***] following the [***] of the [***]

 

1.20                        “Corvus” is defined in the recital.

 

1.21                        “Corvus Background IP” means any Patents or Know-How
controlled by Corvus that claim or cover compositions of matter, or methods of
use, of Corvus Compound. For purposes of this Section 1.19, “controlled” means
the possession (whether by ownership or license) of the ability to grant a
license or sublicense or other right to exploit, as provided herein, without
violating the terms of any agreement or other arrangement with any Third Party.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

3

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1.22                        “Corvus Compound” means the investigational
medicinal product identified as CPI-444, an adenosine A2A receptor antagonist,
and any formulation thereof.

 

1.23                        “CRO” means a service provider (e.g., a person,
company or organization) that assumes one or more obligations of Genentech, in
accordance with Title 21 of the CFR, or the equivalent assumption of obligations
in a jurisdiction other than the United States.

 

1.24                        “Database Lock” means the locking of the Study
database maintained by Genentech that includes the data from the Case Report
Forms, after which no further changes to the database are allowed.

 

1.25                        “Data Review Committee” or “DRC” is defined in
Section 3.2(a).

 

1.26                        “Delivery Locations” is defined in Section 4.2(a).

 

1.27                        “Effective Date” is defined in the recital.

 

1.28                        “EMA” means, collectively, the European Medicines
Agency and the European Commission (with respect to its functions related to
marketing authorizations for medicinal products), or any successor entity
thereto performing similar functions.

 

1.29                        “Exchange” is defined in Section 8.3(c).

 

1.30                        “FDA” means the United States Food and Drug
Administration, or any successor entity thereto performing similar functions.

 

1.31                        “Final Study Report” means a formal clinical study
report documenting and summarizing the results and interpretation of the Study,
including the trial design, trial objectives, patient assessment, data analysis,
results, risk/benefit analysis, safety and effectiveness, in accordance with the
requirements of Regulatory Authorities on the structure and content of clinical 
study reports.

 

1.32                        “First Site Ready” means when the first
Participating Site has all deliverables and approvals in place to support
Subject enrollment in the Study.

 

1.33                        “GCP” means, as to the United States and the
European Union, applicable good clinical practices (for the design, conduct,
performance, monitoring, auditing, recording, analyses, and reporting of
clinical trials that provides assurance that the data and reported results are
credible and accurate, and that the rights, integrity, and confidentiality of
trial subjects are protected) in effect in the United States and the European
Union, respectively, during the Term and, with respect to any other
jurisdiction, clinical practices equivalent to good clinical practices then in
effect in the United States or the European Union.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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1.34                        “GDP” means, as to the United States and the
European Union, applicable good distribution practices in effect in the United
States and the European Union, respectively, during the Term and, with respect
to any other jurisdiction, distribution practices equivalent to good
distribution practices then in effect in the United States or the European
Union.

 

1.35                        “Genentech” is defined in the recital.

 

1.36                        “Genentech Compound” means atezolizumab, an
anti-PD-L1 (programmed death-ligand 1) monoclonal antibody, and any formulations
thereof.

 

1.37                        “Genentech Protocol” means the clinical trial
protocol for the Phase Ib/II study to evaluate the efficacy and safety of the
Corvus Compound and the Genentech Compound used in the Combination in patients
with non-small cell lung cancer, as agreed in writing by the Parties.

 

1.38                        “GLP” means, as to the United States and the
European Union, applicable good laboratory practices in effect in the United
States and the European Union, respectively, during the Term and, with respect
to any other jurisdiction, laboratory practices equivalent to good laboratory
practices then in effect in the United States or the European Union.

 

1.39                        “GMP” means, as to the United States and the
European Union, applicable good manufacturing practices in effect in the United
States and the European Union, respectively, during the Term and, with respect
to any other jurisdiction, manufacturing practices equivalent to good
manufacturing practices then in effect in the United States or the European
Union.

 

1.40                        “GMP Audit” is defined in Section 4.4(a).

 

1.41                        “HIPAA” means, collectively, the United States
Health Insurance Portability and Accountability Act of 1996 and the regulations
promulgated thereunder, as amended from time to time.

 

1.42                        “IND” means an investigational new drug application
filed or to be filed with the FDA as described in 21 CFR Part 312, or the
equivalent filing with the relevant Regulatory Authority in any jurisdiction
(including an investigational medicinal product dossier filed or to be filed
with the EMA or a clinical trial application filed or to be filed with Health
Canada), together with any amendments, supplements or other additions or
deletions thereto.

 

1.43                        “Inspection” is defined in Section 4.4(c).

 

1.44                        “Investigator” is defined in 21 CFR § 312.3(b) and,
under this Agreement, means an individual who conducts the Study at a
Participating Site in any jurisdiction.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

5

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1.45                        “IRB” means an institutional review board as
described in 45 CFR Part 46, or the equivalent entity (such as an independent
ethics committee) in any jurisdiction.

 

1.46                        “JDC Chair” is defined in Section 3.1(b).

 

1.47                        “JDC Co-Leader” is defined in Section 3.1(b).

 

1.48                        “Joint Development Committee” or “JDC” is defined in
Section 3.1(a).

 

1.49                        “Joint Patent” is defined in Section 6.4(c).

 

1.50                        “Know-How” means all information (including
scientific or other technical information), unpatented inventions (whether or
not patentable), improvements, practices, formula, trade secrets, techniques,
methods, procedures, knowledge, results, data (including pharmacological,
toxicological, pharmacokinetic and pre-clinical and clinical information and
test data, related reports, structure-activity relationship data and statistical
analysis), analytical and quality control data, protocols (including the
Genentech Protocol), processes, models, designs, and other information regarding
research, discovery, development, (including data, assays, techniques, models,
designs and databases).  Know-How shall not include any Patents, [***].

 

1.51                        “Letter of Cross-Reference” means a written and
signed statement by a Party to the applicable Regulatory Authority that
authorizes such Regulatory Authority to reference information submitted
previously by such Party to such Regulatory Authority, as described in
21 CFR § 312.23(b), or the equivalent authorization in a jurisdiction other than
the United States.

 

1.52                        “MAA” means an application for marketing
authorization, or extension of indication, filed or to be filed with the
relevant Regulatory Authority in any jurisdiction (including, e.g., a biologics
license application or new drug application filed or to be filed with the FDA or
a marketing authorization application filed or to be filed with the EMA or
Health Canada), together with any amendments, supplements or other additions or
deletions thereto.

 

1.53                        “Manufacture and Supply” or “Manufacturing and
Supplying” or the like, means all stages of the manufacture and supply of a
Compound, including planning, purchasing, manufacture, processing, compounding,
transportation, handling, storage, filling, packaging, disposal, labeling,
leafleting, testing, quality control, quality assurance, sample retention,
stability testing, release, instruction, training and dispatch, as applicable.

 

1.54                        “Manufacturing Facilities and Records” means, with
respect to a given Party, collectively, (a) the facilities at which any of the
stages of the Manufacture and Supply of such Party’s Compound to be used in the
Study are performed and (b) the records and other documentation relating to such
Manufacture and Supply, including batch records, deviations, investigations and
change control documents.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

6

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1.55                        “Material Regulatory Notice” is defined in
Section 2.7(b).

 

1.56                        “Other Invention” is defined in Section 6.1(a)(v).

 

1.57                        “Participating Site” means a hospital or other
institution participating in the Study.

 

1.58                        “Party” or “Parties”is defined in the recital.

 

1.59                        “Patents” means all patents and patent applications,
in any country, including any reissues, reexaminations, patents of addition,
extensions and supplementary protection certificates, registrations, divisions,
continuations, continuations-in-part, substitutions and renewals thereof.

 

1.60                        “PD-L1/PD-1 Antagonist” means any molecule that
[***]

 

1.61                        “PD-L1/PD-1 Competitive Program” means an active
program(s) to [***]

 

1.62                        “Pharmacovigilance Agreement” is defined in
Section 2.8.

 

1.63                        “Phase I/Ib Agreement” means that certain Phase I/Ib
Combination Study Agreement entered into between Corvus and Genentech dated
October 5, 2015, as may be amended from time to time.

 

1.64                        “Project Participant Agreement” is defined in
Section 2.6(a).

 

1.65                        “Project Participants” means Investigators,
Subinvestigators, Participating Sites, CROs, drug distributors, vendors and
subcontractors or agents of Genentech (or Genentech’s Affiliates), in all cases,
who conduct or assist in conducting the Study or provide related services.  For
clarity, Subjects are not within the definition of Project Participants.

 

1.66                        “Prosecution and Maintenance” or “Prosecute and
Maintain” is defined in Section 6.4(a).

 

1.67                        “Publishing Party” is defined in Section 8.2.

 

1.68                        “Quality Agreement” means a separate quality
agreement that will govern the Manufacture and Supply of the Corvus Compound
under this Agreement.

 

1.69                        “Regulatory Authority” means (a) the FDA; (b) the
EMA; or (c) any regulatory authority or body performing similar functions in any
jurisdiction anywhere in the world.

 

1.70                        “Regulatory Documentation” means any document
submitted to a Regulatory Authority, including all INDs, MAAs, drug master
files, correspondence with Regulatory

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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Authorities, periodic safety update reports, adverse event files, complaint
files, inspection reports and manufacturing records.

 

1.71                        “Reviewing Party” is defined in Section 8.2.

 

1.72                        “Roche Group” means Genentech and its Affiliates.

 

1.73                        “Rules” is defined in Section 15.2(a).

 

1.74                        “Sample Analyses” means the testing procedures and
analyses of the Samples to be performed under this Agreement in accordance with
the Sample Analyses Plan.

 

1.75                        “Sample Analyses Plan” means the plan that outlines
(a) the Sample Analyses to be performed; (b) the priority for using available
Samples; (c) which Party is responsible for performing particular Sample
Analyses; (d) the timing for sharing particular subsets of the Sample Data; and
(e) the ownership of particular subsets of the Sample Data, as set forth in
Exhibit A hereto.

 

1.76                        “Sample Data” means the data from the Sample
Analyses.  For clarity, Sample Data excludes Study Data.

 

1.77                        “Samples” means biological samples collected from
Subjects in accordance with the Genentech Protocol.

 

1.78                        “Specifications” means (a) with respect to the
Corvus Compound, the set of specifications set forth in the Quality Agreement
and (b) with respect to the Genentech Compound, the applicable set of
specifications for the Manufacture and Supply for use in the Study.

 

1.79                        “Sponsor” is defined in 21 CFR § 312.3(b) and, under
this Agreement, means the entity that takes responsibility for and initiates the
Study in any jurisdiction.

 

1.80                        “Study” means the Phase Ib/II clinical trial as set
forth in the Genentech Protocol to study the Combination.  For purposes of this
Agreement, [***].

 

1.81                        “Study Completion” means the last Subject visit
specified in the Genentech Protocol for primary endpoint evaluation.

 

1.82                        “Study Data” means the data from (a) Case Report
Forms, and (b) the Final Study Report. [***].

 

1.83                        “Subinvestigator” is defined in
21 CFR § 312.3(b) and, in the event the Study is conducted by a team at a
Participating Site, means an individual  l designated by the Investigator who is
the responsible leader of such team.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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1.84                        “Subject” is defined in 21 CFR § 312.3(b) and, under
this Agreement, means a human who participates in the Study in any jurisdiction.

 

1.85                        “Subject Injury Claim” is defined in
Section 14.1(a)(iv).

 

1.86                        “Term” means the term during which this Agreement is
in effect, in accordance with Section 12.1.

 

1.87                        “Third Party” means any person or entity other than
a Party or its Affiliates.

 

Article 2
Conduct of the Study

 

2.1                               Overview.  The Parties wish to collaborate
regarding the Study to be conducted under this Agreement.  Each Party shall use
commercially reasonable efforts to perform its obligations hereunder.

 

2.2                               Genentech.  Genentech shall be the Sponsor of
the Study.  Genentech shall conduct, and use commercially reasonable efforts to
cause all Project Participants to conduct and complete, the Study in accordance
with this Agreement, the Genentech Protocol and Applicable Law.  Genentech shall
be responsible for obtaining all approvals and clearances necessary to conduct
the Study, including approvals from Regulatory Authorities and IRBs and customs
clearances.  Genentech is solely responsible for the performance and conduct of
the Project Participants, including monitoring the conduct of the Study at the
Participating Sites.  In no event shall Corvus or any of its Affiliates be
deemed a Sponsor of the Study.

 

2.3                               Collaboration IND; Investigator’s Brochure. 
Genentech shall own and shall file the Collaboration IND.  For the avoidance of
doubt, the Collaboration IND will not be [***].  If a Regulatory Authority
requests [***] for the Study, the Parties shall meet and agree on an approach to
address such request.  Each Party shall be responsible for (a) drafting, and
updating as necessary for the Study, an investigator’s brochure for its Compound
and (b) filing, as applicable, all necessary Regulatory Documentation to its
existing IND for its Compound, including submitting to such IND any serious
adverse event and adverse drug reaction cases emerging from the Study.  Corvus
shall provide to Genentech its investigator’s brochure (and any updates) for the
Corvus Compound.  Further, if requested in writing by an IRB or an Investigator
for purposes of the Study, Corvus shall promptly provide to such requestor its
entire investigator’s brochure (and any updates) for the Corvus Compound and any
serious adverse event and adverse drug reaction cases regarding the Corvus
Compound emerging from the Study.

 

2.4                               Genentech Protocol.  Any proposed amendments
to the Genentech Protocol necessary to protect the safety of Subjects shall be
promptly reported to Corvus in writing. Notwithstanding anything to the contrary
in this Agreement, the prior written consent of Corvus is required for
amendments to the Genentech Protocol that are (a) material amendments ([***]),

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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including the maximum number of Subjects to be enrolled in the Study and
(b) amendments ([***]) relating specifically to the Corvus Compound.  Corvus
shall provide such consent, or a written explanation for why such consent is
being withheld, within [***] of receiving Genentech’s request therefor.  [***].

 

2.5                               Enrollment.  Genentech shall not begin
enrolling Subjects until after the full execution of the Pharmacovigilance
Agreement.  Genentech shall enroll Subjects in compliance with Applicable Law
and shall be responsible for tracking enrollment at Participating Sites.  The
total enrollment shall not exceed the maximum number of Subjects specified in
the Genentech Protocol, unless such number is increased by an amendment to the
Genentech Protocol.

 

2.6                               Agreements With Project Participants.

 

(a)                                 General.  [***] responsible for negotiating
and executing all agreements with Project Participants in connection with
conducting the Study (each such agreement, a “Project Participant Agreement”). 
In no event shall any Project Participant Agreement represent that Corvus or any
of its Affiliates is a Sponsor or is otherwise responsible for the Study.

 

(b)                                 Terms and Conditions.  Corvus acknowledges
that Genentech may have entered into Project Participant Agreements with certain
Project Participants prior to the Effective Date and that negotiations for new
Project Participant Agreements may require [***].  Genentech shall ensure that
each Project Participant is appropriately qualified and shall use [***] to
include in each Project Participant Agreement terms and conditions that are
consistent with the terms and conditions of this Agreement (including the
intellectual property provisions in Article 6 and the confidentiality provisions
in Article 7); provided, however, Genentech shall ensure, in all cases, that the
minimum requirements specified in Section 2.6(c) are satisfied.  Subject to
Section 2.6(c), the Parties agree that the rights and obligations of the Parties
under this Agreement shall be subject to, and limited by, the terms and
conditions of Project Participant Agreements.  To the extent Genentech obtains
the applicable rights under a Project Participant Agreement, Genentech shall
work with Corvus to exercise such rights with respect to Corvus in the same
manner as set forth in this Agreement.  By way of example, but not limitation,
with respect to the Prosecution and Maintenance of Joint Patents, to the extent
Genentech has the right to do so, Genentech shall work with Corvus to Prosecute
and Maintain any Joint Patents in the same manner as set forth in
Section 6.4(c).

 

(c)                                  Minimum Requirements.  Notwithstanding
anything to the contrary in Section 2.6(b), Genentech shall ensure that the
following terms and conditions are included in each Project Participant
Agreement:

 

(i)                                    Genentech is able to perform its
obligations under Section 11.2 of this Agreement;

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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(ii)           compensation paid to a Project Participant is paid at the fair
market value of the services to be provided;

 

(iii)         Genentech has [***] rights, under any Collaboration Inventions
intended to be solely owned by Genentech under Section 6.1(c), to grant the
license (with respect to such Collaboration Inventions that constitute Genentech
Owned Inventions) to Corvus under Section 6.3;

 

(iv)          Genentech has [***] rights, under any Collaboration Inventions
intended to be solely owned by Corvus under Section 6.1(c), to either assign or
grant a license to Corvus any such interest in the Collaboration Inventions
(with respect to such Collaboration Inventions that constitute Corvus Owned
Inventions);

 

(v)           Genentech has [***] rights, under any Collaboration Inventions
intended to be jointly owned by the Parties under Section 6.1(c), to grant
licenses to Corvus (with respect to such Collaboration Inventions that
constitute Jointly Owned Inventions) that are at least equivalent in scope to
the license granted to Corvus under Section 6.3(a) (with respect to Genentech
Owned Inventions),; and

 

(vi)          Corvus’s rights with respect to [***] relating to the [***] are
the same as Genentech’s rights with respect to [***] relating to [***].

 

2.7          Regulatory Matters.

 

(a)           General.  Genentech shall comply with all reasonable guidance and
direction provided by Regulatory Authorities and IRBs with jurisdiction over the
Study.  Genentech shall perform all regulatory obligations imposed on the
Sponsor (including preparing and submitting Regulatory Documentation for the
Study, in accordance with the Genentech Protocol and Applicable Law).

 

(b)           Interactions with Regulatory Authorities.  Genentech (or a Project
Participant) shall promptly provide Corvus with a copy or notice of any material
notice, inquiry or correspondence that it (or a Project Participant) receives
from a Regulatory Authority related to [***], within [***] (for purposes of this
Section, a “Material Regulatory Notice”), for reasons including any serious
safety matter or any inspection or investigation by a Regulatory Authority
related to [***].  Corvus shall have the right to provide comments to any
response to a Material Regulatory Notice and have the right for [***]
representative to be invited to any discussions with a Regulatory Authority
[***], to the extent permitted by such Regulatory Authority.  Without limiting
Corvus’s obligations under Section 2.10, Corvus shall promptly provide Genentech
with a copy of any [***].

 

(c)           Letter of Cross-Reference. Corvus shall, within [***] from the
Effective Date, provide Genentech a Letter of Cross-Reference authorizing
Genentech to reference certain information previously provided by Corvus in its
IND(s) for the Corvus Compound as support for the Collaboration IND.  Such
Letter of Cross-Reference shall remain in full force and effect

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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unless withdrawn by Corvus due to termination of this Agreement by a Party in
accordance with Section 12.6(c).

 

(d)           Notices of Debarment and Other Ineligibility.  If a Party receives
notice of debarment, suspension, sanction, exclusion, ineligibility or
disqualification under the statutes referenced in Section 13.1(c), such Party
shall promptly notify the other Party, and the Parties shall agree upon
appropriate action to address the matter.

 

2.8          Safety Reporting.

 

Genentech shall comply with Applicable Law for safety reporting requirements. 
Prior to the first dosing of the first Subject of the Study under this
Agreement, the Parties shall execute the Pharmacovigilance Agreement that
defines the Parties’ responsibilities and obligations with respect to the
procedures and timeframes for compliance with Applicable Law pertaining to
safety reporting for the Compounds used in each Study (“Pharmacovigilance
Agreement”).

 

2.9          Documentation, Updates and Final Study Report.

 

(a)           Documentation.  Genentech shall maintain reports and documentation
arising in connection with the Study in good scientific manner and in compliance
with Applicable Law.  Genentech shall provide Corvus all such reports and
documentation arising from the Study (including reports of interim analyses, if
applicable) reasonably requested to enable Corvus to comply with any of its
legal, regulatory and/or contractual obligations or to respond to any request by
a Regulatory Authority.

 

(b)           Updates.  Genentech shall provide written updates regarding the
status of the Study to Corvus on a quarterly basis within [***] after the end of
each calendar quarter.  Each quarterly report shall include information and data
regarding safety and efficacy and the Subjects, including, for [***],
information and data regarding the following:

 

(i)            [***];

 

(ii)           [***];

 

(iii)         [***], as described in [***]; and

 

(iv)          [***].

 

Genentech shall make its personnel reasonably available to answer Corvus
questions regarding the data and information provided to Corvus in each quarter
report.

 

(c)           Final Study Report.  Genentech shall summarize the findings of the
Study in the Final Study Report.  Genentech shall provide the Final Study Report
to Corvus within [***].

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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2.10        Corvus Study Responsibilities.

 

In addition to Corvus’s obligations under Section 2.7(c) and obligations to
supply the Corvus Compound under Section 4.2, Corvus shall provide and make
available to Genentech any information about the Corvus Compound necessary to
support Genentech in conducting the Study.  Further, Corvus shall provide
reasonable assistance to Genentech to support Genentech’s interactions with
Regulatory Authorities and IRBs in connection with the Study.

 

2.11        Costs.

 

Corvus will supply the Corvus Compound under Section 4.2 [***]. The Study will
be [***], as detailed in this Section, below.

 

(a)   Allocation.  Subject to Section 2.11, [***] incurred by the Parties in
accordance with the budget in conducting the Study and Sample Analyses Plan will
be [***] as set forth in this Section 2.11; except that each Party shall be
responsible for [***] pursuant to Article 4.

 

(b)   Budget.  The initial budget of the total estimated [***] to conduct the
Study and the corresponding Sample Analyses Plan (the “Budget”) has been agreed
to by the Parties and is attached hereto as Exhibit C hereto.  No later than
[***] prior to First Site Ready, Genentech shall provide Corvus with the final
estimated budget of the total estimated [***] to conduct the Study and the
corresponding Sample Analyses Plan (the “Final Budget”); provided, however, in
the event the Final Budget is greater than [***] of the Budget, Corvus shall
have [***]

 

(c)   Reimbursement.  Subject to Section 2.11(b), during the period [***],
Corvus shall reimburse Genentech [***] of the Final Budget equal to the total
budgeted [***] to conduct the Study and Sample Analyses Plan, as such amounts
are set forth in the Final Budget; [***].  Based on the Final Budget, Genentech
shall send [***] complete invoice to Corvus detailing [***] in accordance with
this Section 2.11(c).  Subject to Section 2.11(b), Corvus shall submit to
Genentech payment for [***], beginning the first day of the first calendar month
after [***] of its receipt of such invoice until [***].

 

(d)   Overestimation or Underestimation.  Subject to Section 2.11(b), the
Parties acknowledge and agree that the Final Budget shall reflect each Party’s
estimate of [***] costs and expenses to be incurred by each Party ([***]) and
that each Party’s actual costs and expenses incurred may be less or more than
the estimated costs and expenses.  In the event that such estimated costs and
expenses have been [***], subject to Section 2.11(b), each Party agrees that it
will [***].  If the final enrollment of the Study is [***], the JDC shall amend
the Final Budget pursuant to Section 3.1(c)(ii), and the Parties shall [***]. 
If, based on the [***].  In the event the Agreement terminates prior to Study
Completion, the Parties shall [***] in accordance with Section 12.6(d).

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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Article 3
Governance

 

3.1          Joint Development Committee.

 

(a)           Establishment of the JDC.  Within thirty (30) days after the
Effective Date, the Parties shall promptly establish a Joint Development
Committee (“Joint Development Committee” or “JDC”) to oversee the Study.  The
JDC shall be composed of at least [***] representatives designated by each Party
(and the Parties need not have the same number of representatives); provided,
however, the representatives of the JDC may be identical to the members of the
joint development committee established under the Phase I/Ib Agreement as of the
date hereof.  The representatives shall be appropriate (in terms of their
seniority, availability, function in their respective organizations, training
and experience) for the activities then being undertaken.  Each Party shall
designate one of its representatives as its primary JDC contact for JDC matters
(such Party’s “JDC Co-Leader”).  A Party may replace any or all of its
representatives (and designated JDC Co-Leader) at any time by informing the
other Party’s JDC Co-Leader in advance, in writing (which may be by email).  The
JDC shall exist during the Term, unless otherwise mutually agreed by the Parties
in writing.

 

(b)           Chair of JDC.  A Joint Development Committee representative from
Genentech shall chair the Joint Development Committee (“JDC Chair”).  The
JDC Chair shall be responsible for the following: (i) scheduling JDC meetings
and setting meeting agendas; (ii) calling emergency JDC meetings; and (iii) any
additional responsibilities specified in the Agreement.  Notwithstanding the
foregoing, Corvus’s JDC representatives have the right to schedule meetings,
raise matters for discussion and put matters to a vote.

 

(c)           Responsibilities of the JDC.  The Joint Development Committee
shall perform the following activities:

 

(i)            subject to Section 2.4, review and approve any amendments to the
Genentech Protocol;

 

(ii)           review and approve any amendments to the Budget and the Final
Budget, including changes to the cost overruns or overestimates;

 

(iii)         review the progress of the Study and make related decisions;

 

(iv)          evaluate and decide whether and how to address any safety matters
related to the Combination;

 

(v)           decide whether and how to address Data Review Committee’s
recommendations;

 

(vi)          address issues that arise if the available quantities of either
Compound are insufficient to reach Study Completion, including as described in
Section 4.3;

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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(vii)        review the progress of the Sample Analysis Plan and determine the
timing for Sample Analysis to be performed by a Party and the transfer of
results to the other Party;

 

(viii)       coordinate the transfer of materials and information between the
Parties, including Study Data, Control Arm Data, the Final Study Report, Samples
and Sample Data; and

 

(ix)          attempt to resolve disputes related to the Study and perform such
other functions as appropriate to further the purposes of the Study, or as
otherwise specified in this Agreement or agreed to by the Parties.

 

(d)           Decision Making Authority.  With respect to the responsibilities
of the Joint Development Committee, each Party shall have [***] in all
decisions, and the Parties shall attempt to make decisions by reaching
agreement.  If the JDC cannot reach agreement within [***] of a disputed matter
being brought to a vote, either Party may refer the dispute to the Parties’
executives for resolution in accordance with Section 15.1 and the other
provisions of Article 15.  The JDC has no authority to amend, or to waive
compliance with, any provisions of this Agreement.

 

(e)           Meetings; Attendees; Decisions.  Once established, the Joint
Development Committee shall meet as deemed appropriate by the JDC, but at least
once each calendar quarter.  The JDC may meet in person or via teleconference,
video conference or the like; provided that at least one (1) meeting per
calendar year shall  be held in person (unless otherwise agreed by the
Parties).  Between meetings of the JDC, Genentech will respond to reasonable
requests from Corvus for updates regarding the status of the Study.  Each Party
shall bear the expense of its respective representatives’ participation in JDC
meetings.  If a Party’s representative is unable to attend a given meeting, such
Party may designate a knowledgeable alternate to attend such meeting and perform
the functions of such representative.  Each Party may invite a reasonable number
of non-voting employees, consultants or scientific advisors to attend JDC
meetings, provided that such invitees are bound by appropriate confidentiality
obligations.  The JDC shall maintain written minutes of each JDC meeting,
including all decisions made, action items assigned or completed and other
appropriate matters.  The JDC Chair shall prepare the initial draft minutes and
provide them to the Corvus’s JDC Co-Leader within ten (10) Business Days of such
meeting, for review and approval.

 

(f)            Sub-Teams; Designees.  From time to time, the Joint Development
Committee may establish sub-teams to oversee particular projects or activities,
and such sub-teams will be constituted and operate as determined by the JDC. 
From time to time, the JDC may designate individuals (by name or function) to
oversee certain activities, and such designees will perform such activities as
determined by the JDC.  By way of example, but not limitation, the JDC may
establish sub-teams or designate individuals to oversee and coordinate
publications strategy or patent prosecution matters.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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3.2          Data Review Committee.

 

(a)           Establishment of the DRC; Meetings.  Under the direction of the
Joint Development Committee, the Parties may establish a Data Review Committee
(“Data Review Committee” or “DRC”) to monitor the safety of the Compounds and
the Combination being used in the Study.  The DRC shall be composed of
(i) [***]  The DRC clinicians shall be bound by appropriate confidentiality and
invention assignment obligations.  The DRC shall [***] during the conduct of the
Study, but no less frequently than every [***].

 

(b)           Responsibilities of the DRC.  The Data Review Committee shall
perform the following activities:

 

(i)            evaluate suspected dose-limiting toxicities (using criteria
defined in the Genentech Protocol, if applicable) and adjudicate treatment
related adverse events, based on clinical experience with the Compounds;

 

(ii)           make recommendations to the JDC to hold dosing or enrollment, if
safety data require further evaluation;

 

(iii)         make recommendations to the JDC to end dosing or enrollment; and

 

(iv)          perform such other functions as directed by the JDC.

 

(c)           Advisory Body.  The Data Review Committee shall be solely an
advisory body to the Joint Development Committee and shall not have any power to
make decisions that bind either Party.

 

Article 4
Supply of Study Drugs

 

4.1          Genentech Compound.

 

Genentech shall use commercially reasonable efforts to Manufacture and Supply,
[***], sufficient quantities of the Genentech Compound to conduct the Study and
related analyses as agreed by the Parties.  Genentech represents and warrants to
Corvus that the Genentech Compound used in the Study shall be Manufactured and
Supplied to the Participating Sites in compliance with the Specifications for
the Genentech Compound and Applicable Law.

 

4.2          Corvus Compound.

 

(a)           Manufacture and Supply.  Corvus shall use commercially reasonable
efforts to Manufacture and Supply, [***], the quantities of the Corvus Compound
that (i) are specified in the Compound Supply Plan and (ii) if applicable, are
needed for Continued Access, as described in Section 4.2(b).  Corvus represents
and warrants to Genentech that such Corvus

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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Compound shall be Manufactured and Supplied to Genentech, a Project Participant
designated by Genentech or other locations agreed to by the Joint Development
Committee (for purposes of Section 4.2, “Delivery Locations”) in compliance with
the Specifications for the Corvus Compound, Applicable Law and the Quality
Agreement.  Corvus shall ensure that any Corvus Compound Manufactured and
Supplied under this Agreement has, at the time of delivery, an adequate
remaining shelf life to meet anticipated Study and Continued Access
requirements; provided, however, in all cases, such remaining shelf life shall
be at least [***].

 

(b)           Continued Access.  In addition to the quantities specified in the
Compound Supply Plan, Corvus shall provide the quantities of the Corvus Compound
for Subjects to have continued access after Study Completion, if required,
solely based on Applicable Law (“Continued Access”).  While [***] may be able to
forecast before the Study commences whether or not Continued Access will likely
be applicable for the Study and, if so, to estimate the quantities of the Corvus
Compound for Continued Access, in most cases, [***] will only determine the
quantities of the Corvus Compound for Continued Access (if applicable) after the
Study results have been analyzed.  If applicable, the Joint Development
Committee shall designate individuals (by name or function) to oversee
activities related to Continued Access.

 

(c)           Delivery.  Corvus shall deliver the Corvus Compound to the
Delivery Locations in accordance with the Quality Agreement and the timelines
specified in the Compound Supply Plan or determined by the Joint Development
Committee.  Genentech shall require the Participating Sites to (i) maintain
accurate records of all Corvus Compound received and dispensed in the conduct of
the Study and (ii) properly store all Corvus Compound in accordance with all
written instructions from Corvus and Applicable Law, and in a secure and locked
location to prevent theft or misuse.

 

(d)           Remaining Compound.  Upon the later of (i) the completion or
termination of the Study or (ii) Continued Access (if applicable), Genentech
shall ensure that all unused quantities of the Corvus Compound, as well as all
used vials and bottles containing the Corvus Compound, are destroyed in
accordance with Corvus’s standard operating procedures and documented
accordingly (including certifying such destruction in writing to Corvus) .

 

(e)           Use of Compound.  Genentech has the right to use the Corvus
Compound only for the purposes of conducting the Study and for Continued Access
(if applicable), and Genentech shall not use the Corvus Compound for any other
purpose.  Genentech shall use, store, transport, handle and dispose of the
Corvus Compound in compliance with Applicable Law, the Quality Agreement and all
written instructions from Corvus.  Genentech shall not attempt to derive or
reverse engineer the composition or underlying information or structure of the
Corvus Compound, and in particular shall not analyze the Corvus Compound by
physical, chemical or biochemical means.  Corvus shall [***] this
Section 4.2(e); Genentech shall [***].  Genentech shall ensure that any party
performing Study-related activities on behalf of Genentech

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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is contractually bound in writing by obligations reasonably similar to those set
forth in this Section 4.2(e).

 

4.3          Insufficient Quantities.

 

If a Party determines that the quantities of the Corvus Compound or the
Genentech Compound are not sufficient to reach Study Completion and for
Continued Access (if applicable), such Party shall promptly notify the other
Party, including what quantities of its Compound, if any, are available for such
purpose.  The Parties will promptly discuss how to address the shortage and
allocate the available amounts of the Corvus Compound or the Genentech Compound,
as applicable.  [***].

 

4.4          GMP Audit; Quality Agreement; Inspections.

 

(a)           GMP Audit of Corvus by Genentech.  Genentech may request an audit
of Corvus’s Manufacturing Facilities and Records, no more than [***], through a
[***] prior written notice, to be conducted for the purpose of ascertaining that
the Corvus Compound to be used or being used in the Study is Manufactured and
Supplied in compliance with GMP and GDP (“GMP Audit”).  Upon such written notice
by Genentech to Corvus, Genentech (or its representatives) shall have the right
to perform the GMP Audit in accordance with an audit plan (including the dates
for such audit) proposed by Genentech and agreed to by the Parties.  Within
[***] of a GMP Audit, Genentech shall provide a copy of the audit report to
Corvus.  In the event it is determined that Corvus is not in compliance with
either GMP and/or GDP standards in a material respect, and Corvus does not cure
such non-compliance within [***] following receipt of the audit report from
Genentech, Genentech may elect to terminate the entire Agreement in accordance
with Section 12.5 [***]

 

(b)           Execution of Quality Agreement.  The Parties shall execute a
Quality Agreement within [***] of executing this Agreement.  In the event of a
conflict between the Quality Agreement and this Agreement, this Agreement shall
govern and control, other than solely with respect to the Parties’ roles and
responsibilities related to quality systems and quality requirements for the
Manufacture and Supply of the Corvus Compound.

 

(c)           Inspections by Regulatory Authorities.  As may be further
described in the Quality Agreement, Corvus shall cooperate with requests from
any Regulatory Authority to conduct inspections and audits of Corvus’s
Manufacturing Facilities and Records (each such inspection or audit, an
“Inspection”).  Also, as may be further described in the Quality Agreement,
Corvus shall (i) notify Genentech of any request from a Regulatory Authority for
an Inspection; (ii) inform Genentech of the results and conclusions of
Inspections; (iii) permit Genentech (or its representatives) to assist in the
preparation for, and be present at, to the extent practicable and permitted by
the Regulatory Authorities performing, Inspections; and (iv) provide Genentech
with copies of any written Inspection reports issued by a Regulatory Authority
and any related correspondence.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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(d)           Unilateral Provisions.  Corvus acknowledges that the FDA has
granted marketing authorization for the Genentech Compound and agrees that,
except as otherwise expressly provided in this Agreement, Corvus shall not have
the right to perform any audits or participate in inspections of Genentech’s
Manufacturing Facilities and Records.

 

4.5          Mutual Obligations.  Each Party shall obtain and maintain all
regulatory approvals (including facility licenses) required to Manufacture and
Supply its Compound to the other Party under this Agreement in compliance with
Applicable Law.  Each Party shall notify the other Party as promptly as possible
in the event any delay (or other event) is likely to adversely affect its
ability to fulfill its obligations to Manufacture and Supply its Compound under
this Agreement.  This Agreement does not create any obligation on the part of
either Party to provide its Compound for any purposes other than to conduct the
Study.

 

Article 5
Study Data; Control Arm Data; Sample Analyses and Sample Data

 

5.1          Study Data.

 

(a)           Maintenance of Database; Transfer of Study Data.  Genentech shall
maintain the data from Case Report Forms in its database, in accordance with
Applicable Law.  The Joint Development Committee shall determine, consistent
with the Genentech Protocol, the time points during the Study at which the Study
Data and Control Arm Data will be available to the Parties.  [***], Genentech
shall timely provide such available Study Data and/or Control Arm Data to
Corvus.  Without limiting the foregoing, promptly after Database Lock, Genentech
shall provide to Corvus a copy of all Study Data and Control Arm Data then
existing.  Genentech shall provide Study Data and Control Arm Data to Corvus via
electronic data transfer, in SAS format or as otherwise agreed by the Parties. 
Genentech shall provide the Final Study Report to Corvus in accordance with
Section 2.9(c).

 

(b)           Ownership and Use of Study Data and [***].  Corvus and Genentech
shall [***].  Subject to this Section 5.1(b), Genentech shall [***].  Genentech
hereby grants to Corvus a non-exclusive, worldwide, fully paid license under
Genentech’s right, title and interest in and to the [***] solely for the
purposes [***].  Further, each Party has the right to use Study Data for any
lawful purpose; provided, however, each Party’s use and disclosure of Study Data
is subject to other provisions of the Agreement, including Section 6.4(d),
provisions regarding the other Party’s Confidential Information in Article 7
(including authorized disclosures under Section 7.2) and Section 8.2.

 

5.2          Sample Analyses and Sample Data.

 

(a)   Performance of Sample Analyses; Transfer of Sample Data.  Genentech shall
provide to Corvus the Samples necessary for Corvus to perform the Sample
Analyses for which Corvus is responsible under the Sample Analyses Plan.  Each
Party, [***], shall perform

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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the Sample Analyses for which it is responsible in the Sample Analyses Plan
([***]).  Each Party is entitled to receive a copy of all of the Sample Data,
regardless of which Party owns the Sample Data.  Therefore, each Party shall
provide to the other Party the Sample Data for the Sample Analyses such Party
performed (regardless of which Party owns such Sample Data), via electronic data
transfer, in the format and using the media agreed to by the Parties, in
accordance with the timelines in the Sample Analyses Plan.  Neither Party shall
use the Samples for any purpose other than performing the Sample Analyses for
which it is responsible, without the prior written consent of the other Party.

 

(b)           Ownership and Use of Sample Data.  Each of Corvus and Genentech
shall ([***].  Each Party has the right to use the Sample Data that is solely
owned by the other Party for such Party’s internal research purposes.  Each
Party has the right to use the Sample Data that is solely or jointly owned by
such Party for any lawful purpose; provided, however, each Party’s use and
disclosure of the Sample Data is subject to other provisions of the Agreement,
including Section 6.4(d), provisions regarding the other Party’s Confidential
Information in Article 7 (including authorized disclosures under Section 7.2)
and Section 8.2.

 

5.3          [Reserved.]

 

Article 6
Collaboration Inventions and Licenses

 

6.1          Collaboration Inventions.

 

(a)           Definitions.  The definitions in this Section are for purposes of
Article 6 (and as referenced in Article 1).

 

(i)            “Collaboration Invention” means any invention, discovery or
creation (including materials and Know-How or other intellectual property),
whether or not patentable, that is first conceived, reduced to practice,
discovered or otherwise created, in each of the foregoing cases, by a Party
(directly or by another party on its behalf) (1) [***]; (2) [***]; or
(3) [***].  Collaboration Inventions may include new uses, compositions or
formulations [***].  Notwithstanding the foregoing definition, Collaboration
Inventions exclude [***].  The Parties acknowledge that the Final Study Report
may include certain Know-How that will be within the definition of Collaboration
Invention (e.g., information relating to data analysis, safety and
effectiveness), but agree that [***].

 

(ii)           “Corvus Owned Invention” means a Collaboration Invention that
[***].  For clarity, any Collaboration Invention that generically encompasses
within its scope the [***], is a Corvus Owned Invention.

 

(iii)         “Genentech Owned Invention” means a Collaboration Invention that
[***].  For clarity, any Collaboration Invention that generically encompasses
within its [***], is a Genentech Owned Invention.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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(iv)                             “Jointly Owned Invention” means a Collaboration
Invention that relates to [***].  For clarity, any Collaboration Invention that
generically encompasses within its scope [***], is a Jointly Owned Invention.

 

(v)                                 “Other Invention” means a Collaboration
Invention that is not a Genentech Invention, a Corvus Invention or a Jointly
Owned Invention.

 

(b)                                 Disclosure.  Each Party shall promptly
disclose to the other Party any Collaboration Inventions conceived, reduced to
practice, discovered or otherwise created by such Party (directly or by another
party on its behalf).

 

(c)                                  Ownership.  Subject to the licenses granted
by one Party to the other in Section 6.2, as between the Parties, (i) Genentech
and Corvus shall jointly own all right, title and interest in and to the Jointly
Owned Inventions; (ii) Genentech shall solely own all right, title and interest
in and to the Genentech Owned Inventions; (iii) Corvus shall solely own all
right, title and interest in and to the Corvus Owned Inventions; and (iv) which
Party(ies) shall solely (or jointly) own all right, title and interest in and to
a given Other Invention shall follow the inventorship of such Other Invention,
where inventorship is determined in accordance with United States patent law
(or, if applicable, other United States intellectual property laws regarding
discoveries and creations).

 

(d)                                 Assignments and Cooperation.  Each Party
shall assign and hereby assigns to the other Party a joint or sole right, title
and ownership interest in the Collaboration Inventions as necessary to
effectuate ownership of the Collaboration Inventions as set forth in
Section 6.1(c).  Each Party shall require its employees and other parties to
assign to such Party any Collaboration Inventions conceived, reduced to
practice, discovered or otherwise created by such employees or other parties,
and to cooperate with such Party in connection with obtaining patent protection
therefor.  The Parties agree to cooperate with each other to effectuate
ownership of the Collaboration Inventions as set forth in Section 6.1(c),
including by executing and recording documents.

 

6.2                               Use of Jointly Owned Inventions.

 

(a)                                 General.  Subject to other provisions of
Article 6 (including Section 6.2(b) and Section 6.4), each Party retains full
ownership right, title and interest (including as provided under 35 USC § 262)
in and to the Jointly Owned Inventions, [***]  For clarity, the foregoing rights
shall not give a Party any rights [***].

 

(b)                                 Limitations on Assignment and Licensing. 
Neither Party shall assign or license to any Third Party its rights under any
claim in a Joint Patent that [***].  Notwithstanding anything to the contrary in
the foregoing, [***].

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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6.3                               Licenses.

 

(a)                                 License to Corvus.  Genentech hereby grants
to Corvus a non-exclusive, worldwide, fully paid, irrevocable, perpetual,
sublicensable (as described in Section 6.3(c)(i)) license under Genentech’s
right, title and interest in and to the Genentech Owned Inventions solely for
the purpose of performing [***] for use in the Combination.

 

(b)                                 License to Genentech.

 

(i)                                    Corvus hereby grants to Genentech a
non-exclusive, worldwide, fully paid, irrevocable, perpetual, sublicensable (as
described in Section 6.3(c)) license under Corvus’s right, title and interest in
and to the Corvus Owned Inventions solely for the purpose of performing [***]
for use in the Combination.

 

(ii)                                Corvus hereby grants to Genentech a
non-exclusive, worldwide, fully paid, sublicensable (as described in
Section 6.3(c)) license, under Corvus’s right, title and interest in and to the
Corvus Background IP solely for the purpose of performing the Study pursuant to
the terms of this Agreement.

 

(c)                                  Sublicenses; Exercise of Licensed Rights by
Other Parties.  Each Party may sublicense the rights granted to such Party under
Section 6.2, and any rights under such sublicense may be further sublicensed
[***].  Further, the rights under such licenses may be exercised by another
party on behalf of such Party (or a sublicensee) without the grant of a
sublicense of such rights.

 

(d)                                 No Implied Licenses.  Except as otherwise
expressly provided in this Agreement, this Agreement does not grant any right or
license to either Party under any of the other Party’s intellectual property
rights (including pre-existing or independently developed intellectual property
rights), and no other right or license is to be implied or inferred from any
provision of this Agreement or by the conduct of the Parties.

 

6.4                               Patent Prosecution and Maintenance.

 

(a)                                 Definitions.  The definitions in this
Section are for purposes of Article 6 (and as referenced in Article 1):

 

(i)                                    “Outside Patent Counsel” means outside
patent counsel agreed to by Genentech and Corvus.

 

(ii)                                “Prosecution and Maintenance” or “Prosecute
and Maintain,” with regard to a given Patent, means the preparation, filing,
prosecution and maintenance of such Patent, as well as any ex parte and
inter partes proceedings, including reexaminations, reissues, applications for
patent term extensions, interferences, derivation proceedings, post-grant review
proceedings, oppositions, litigations, arbitrations and other similar
proceedings with respect to such Patent.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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(b)                                 Solely Owned Inventions.  Each Party, [***],
has the right (but not the obligation) to Prosecute and Maintain any Patents for
Collaboration Inventions that such Party solely owns, including the right to use
and disclose Study Data or Sample Data solely owned or jointly owned by such
Party in such Prosecution and Maintenance.

 

(c)                                  Jointly Owned Inventions.  The provisions
of this Section 6.4(c) apply to the Prosecution and Maintenance of any Patents
for Jointly Owned Inventions (each, a “Joint Patent”).

 

(i)                                    Prosecution and Maintenance.  The Parties
shall jointly decide on a strategy for the Prosecution and Maintenance of any
Joint Patent, including deciding on (A) the content of the application; (B) the
countries in which Prosecution and Maintenance should be conducted, subject to
Section 6.4(c)(v); and (C) whether to retain Outside Patent Counsel to conduct
all or particular Prosecution and Maintenance activities (e.g., to prosecute a
Patent application, but not to draft, file or maintain it).  Notwithstanding
anything to the contrary, in the event that, for all or particular activities,
one Party wants to retain Outside Patent Counsel and the other does not want to
retain Outside Patent Counsel, Outside Patent Counsel shall be retained for such
activities; provided, however, any disagreement about which Outside Patent
Counsel to retain shall be resolved under Article 15.

 

(ii)                                Cooperation.  Each Party shall cooperate
with and assist the other Party in the Prosecution and Maintenance of any Joint
Patent, including (A) consulting with the other Party after receiving any
substantial action or development in the Prosecution and Maintenance of such
Patent and (B) making its relevant scientists and scientific records reasonably
available.  In addition, each Party shall sign and deliver, or use commercially
reasonable efforts to have signed and delivered, at no charge to the other
Party, all documents necessary in connection with such Prosecution and
Maintenance.

 

(iii)                            Instructions to Outside Patent Counsel.  With
respect to any Joint Patent, the Outside Patent Counsel (if any) shall be
instructed to (A) keep the Parties informed regarding the Prosecution and
Maintenance thereof; (B) promptly furnish to each Party a copy of such Patent
and copies of documents relevant to such Prosecution and Maintenance, including
copies of correspondence with any patent office, foreign associates and outside
counsel; and (C) act on the Parties’ instructions relating to such Prosecution
and Maintenance.

 

(iv)                             Costs.  Except as provided in
Section 6.4(c)(v), the Parties shall [***].

 

(v)                                 [***].  In the event that one Party (for
purposes of this Section, the “Filing Party”) wishes to file a patent
application for a given Jointly Owned Invention and the other Party (for
purposes of this Section, the “Non-Filing Party”) does not wish to file such
patent application in any countries or in particular countries, the Non-Filing
Party shall [***], [***], as may be reasonably necessary to [***] to the [***]
in [***], in a [***], to [***],

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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[***].  Likewise, if a Party (for purposes of this Section, the “Opting-Out
Party”) wishes to discontinue the Prosecution and Maintenance of a patent
application for a given Jointly Owned Invention in any countries or in
particular countries, the other Party, [***] (for purposes of this Section, the
“Continuing Party”), may continue such Prosecution and Maintenance.  In such
event, the Opting-Out Party shall [***], [***], as may be reasonably necessary
to [***] to the [***] in [***], in a [***], to [***], [***].  The Non-Filing
Party or the Opting-Out Party (as applicable) shall be entitled to receive
copies of all patent applications filed and all related Prosecution and
Maintenance documents.  [***].

 

(d)                                 Limitations on Patent Prosecution. 
Notwithstanding anything to the contrary in Section 5.1(b), and Section 5.2(b),
and except as expressly provided in Section 6.4(b) and Section 6.4(c), without
the prior written consent of the other Party:

 

(i)                                    neither Genentech nor Corvus shall file
or prosecute any patent application covering the subject matter of a Jointly
Owned Invention;

 

(ii)                                Genentech shall not file or prosecute any
patent application covering the subject matter of a Corvus Owned Invention;

 

(iii)                            Corvus shall not file or prosecute any patent
application covering the subject matter of a Genentech Owned Invention; and

 

(iv)                             neither Genentech nor Corvus shall (A) provide
assistance to any Third Party for any patent application covering subject matter
that such Party is restricted from filing or prosecuting under
clauses (i)-(iii) of Section 6.4(d) or (B) use or disclose (or grant the right
to another party to use or disclose) Study Data or the other Party’s solely
owned Sample Data in the filing or prosecution of any patent application, unless
such Study Data or Sample Data is, at the time of such filing or prosecution, no
longer the Confidential Information of such other Party; [***].

 

6.5                               Patent Enforcement and Defense.  The rights
and obligations of each Party with respect to the enforcement and defense of a
given Patent for a Collaboration Invention (including settling related claims,
suits or actions) shall be the same as the rights and obligations of such Party
with respect to the Prosecution and Maintenance of such Patent under Section 6.4
mutatis mutandis.  In the event that a Party takes action to enforce or defend a
given Patent for a Collaboration Invention, the other Party, [***], shall
provide all reasonable assistance and cooperation, including, by way of example,
being joined as a party to the action, providing any necessary powers of
attorney and executing any other required documents or instruments for such
purposes.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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Article 7
Confidentiality

 

7.1                               Disclosure and Use of Confidential
Information.

 

(a)                                 Rights and Obligations.  Except to the
extent expressly authorized by this Agreement, each Party (for purposes of
Article 7, the “Receiving Party”) in possession of the Confidential Information
of the other Party (for purposes of Article 7, the “Disclosing Party”) agrees
to: (i) hold in confidence and not disclose the Disclosing Party’s Confidential
Information to any Third Party and (ii) only use (or permit the use of) the
Disclosing Party’s Confidential Information in connection with activities
contemplated by this Agreement (including exercising rights granted hereunder). 
Except as otherwise expressly provided in this Agreement: (i) each Party has the
right to use and disclose Confidential Information that is the Confidential
Information solely of such Party for any purpose and (ii) each Party shall treat
Confidential Information that is the Confidential Information jointly of Parties
as it treats Confidential Information that is Confidential Information solely of
the other Party.

 

(b)                                 Exceptions.  The obligations of the
Receiving Party set forth in Section 7.1(a) shall not apply to the Disclosing
Party’s Confidential Information to the extent that the Receiving Party
establishes by written evidence that such Confidential Information:

 

(i)                                    was already known to the Receiving Party,
other than under an obligation of confidentiality, at the time of its disclosure
by the Disclosing Party;

 

(ii)                                was generally available to the public or
otherwise part of the public domain at the time of its disclosure by the
Disclosing Party;

 

(iii)                            became generally available to the public or
otherwise part of the public domain, other than through any act or omission of
the Receiving Party in breach of this Agreement, after its disclosure by the
Disclosing Party;

 

(iv)                             was disclosed to the Receiving Party, other
than under an obligation of confidentiality, by a another party who had no
obligation to the Disclosing Party not to disclose such information to others;

 

(v)                                 was subsequently developed by or on behalf
of the Receiving Party without use of the Disclosing Party’s Confidential
Information; or

 

(vi)                             is no longer subject to the provisions of
Section 7.1(a) by the prior written consent of the Disclosing Party.

 

7.2                               Authorized Disclosures.

 

(a)                                 Legal Compliance.  A Party may disclose the
other Party’s Confidential Information or Joint Confidential Information, as the
case may be, if such disclosure is required by law, rule or regulation
(including to comply with the order of a court or governmental

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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regulations , and any disclosure requirements of the Securities and Exchange
Commission or the securities exchange or other stock market on which such
Party’s securities are traded), but only to the extent such disclosure is
reasonably necessary for such compliance; provided, however, except for
disclosures otherwise permitted under Section 7.2, or as otherwise required or
necessitated by law, such Party shall where practicable provide prompt notice of
such disclosure requirement to the other Party and provide reasonable assistance
to enable such other Party to seek a protective order or otherwise prevent such
disclosure (in each case, to the extent it is legally permitted to do so).

 

(b)                                 Regulatory Authorities.  A Party may
disclose the other Party’s Confidential Information or Joint Confidential
Information, as the case may be, to Regulatory Authorities to the extent such
disclosure is required to comply with applicable governmental regulations or is
in connection with such Party’s filings, submissions and communications with
Regulatory Authorities regarding such Party’s Compound.

 

(c)                                  Patent Prosecution.  The prosecution of
patent applications for Collaboration Inventions, which are the sole or joint
Confidential Information of a Party or the Parties, is governed by Section 6.4.

 

(d)                                 Publications and Presentations.  The
publication and presentation of Study Data and Sample Data, including provisions
regarding the Confidential Information of a Party contained in such a
disclosure, is governed by Section 8.2.

 

(e)                                  Subcontractors.  A Party may disclose the
other Party’s Confidential Information to subcontractors to the extent such
disclosure is required to conduct the Study or to otherwise fulfill its
obligations under this Agreement; provided, however, any such subcontractors
must be contractually bound in writing by obligations no less stringent than
those set forth in Section 7.1 and Section 7.3.  By way of example, but not
limitation, Genentech may, subject to the foregoing, disclose Corvus’s
Confidential Information and the Genentech Protocol to CROs, prospective and
actual Participating Sites, IRBs, Investigators, the Data Review Committee and
any advisory boards related to the Study.

 

(f)           Affiliates; Professional Advisors; Other Third Parties.  A Party
may disclose the terms of this Agreement (or a summary thereof) or the other
Party’s Confidential Information or Joint Confidential Information, as the case
may be, on a confidential basis and to the extent reasonably necessary, to its
Affiliates, board members, accountants, attorneys, auditors or other
professional advisors; provided that any such board members, accountants,
attorneys, auditors or other professional advisors are contractually bound in
writing by obligations reasonably similar to those set forth in Section 7.1. 
[***]  Notwithstanding the foregoing, [***], to a potential or actual licensee
or corporate partner, provided that (i) such disclosure is [***]; (ii) such
[***]; (iii) any such disclosure is not [***]; and (iv) Corvus provides written
notice to Genentech prior to [***]

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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7.3                               Continuing Obligation.  Article 7 shall
survive the expiration or termination of this Agreement for a period of [***].

 

7.4                               Prior Agreements.  Corvus and
Hoffman-La Roche Inc. (covering the Roche Group, including Genentech) are
parties to that certain Non-Disclosure Agreement, effective [***] (for purposes
of this Section, “CDA”).  As of the Effective Date (of this Agreement), all
“Information” (as defined in the CDA) that the Parties (to this Agreement)
exchanged under the CDA shall be deemed Confidential Information under this
Agreement and shall no longer be governed by the CDA. Furthermore, nothing in
this Agreement supersedes any obligations of confidentiality under the Phase
I/Ib Agreement.

 

Article 8
Public Disclosures; Use of Names

 

8.1                               Clinical Trials Registries.  Genentech agrees
that it is the “responsible party” as that term is used in
Title VIII Section 801 of the Food Drug Administration Amendments Act 2007
(known as FDAAA 801) and, as such, agrees to timely post the required Study
information on ClinicalTrials.gov, and on other clinical trials registries as
required by Applicable Law.

 

8.2                               Publications and Presentations.  Genentech may
publish or present the final results of the Study (in accordance with this
Section 8.2), whether such results are positive or negative in any respect, such
as with respect to the Combination or either Compound; provided that Genentech
gives Corvus an opportunity to review and provide comments.  Authorship of
publications or presentations of any Study Data or Sample Data shall be
determined in accordance with appropriate scientific and academic standards and
customs.  In the event that either Party (for purposes of this Section, the
“Publishing Party”) wishes to publish or present any Study Data or Sample Data,
the Publishing Party shall submit to the other Party (for purposes of this
Section, the “Reviewing Party”) all materials related to the proposed
publication or presentation (including posters, abstracts, manuscripts and
written descriptions of oral presentations) at least [***] (or [***], in the
case of abstracts) prior to the date of submission for publication or the date
of presentation, whichever is earlier, of any of such submitted materials.  The
Reviewing Party shall review such submitted materials and respond to the
Publishing Party as soon as reasonably possible, but in any case within [***]
(or [***], in the case of abstracts) of receipt thereof.  The Publishing Party
will be permitted to publish or present such Study Data or Sample Data, but
shall give reasonable consideration to any request by the Reviewing Party;
provided, however, at the request of the Reviewing Party, the Publishing Party
shall (i) delete from such proposed publication or presentation Confidential
Information of the Reviewing Party (including Sample Data owned solely or
jointly by the Reviewing Party), provided that the Publishing Party shall have
no obligation to delete any Study Data; and/or (ii) if such proposed publication
or presentation contains patentable subject matter owned solely or jointly by
the Reviewing Party, delay such proposed publication or presentation, for [***],
to

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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permit the Reviewing Party to prepare and file a patent application.  The
Publishing Party shall comply with all applicable requirements regarding
disclosure of industry support (financial or otherwise) in connection with any
publications and presentations.  For clarity, the provisions of this Section 8.2
only apply to publications or presentations of Study Data or Sample Data and do
not apply to any other publications or presentations by a Party, including with
respect to results from such Party’s development activities outside of the
Study.

 

8.3                               Press Releases and Other Public Disclosures.

 

(a)                                 General.  For purposes of Section 8.3, a
“Disclosure” means a press release or other public disclosure concerning this
Agreement or the subject matter hereof, including the terms and conditions of
this Agreement and the Genentech Protocol.  The provisions of Section 8.3 are in
addition to the provisions of Article 7.

 

(b)                                 Review and Approval.  Each Party agrees that
the other Party shall have no less than [***] (before the date of a proposed
Disclosure) to review and provide comments regarding any proposed Disclosure
(subject to Section 8.3(c)), unless a shorter review time is agreed to by both
Parties.  Except for Disclosures covered by other provisions of Section 8.3, if
a Party desires to make a Disclosure, it shall obtain the other Party’s prior
written approval for the proposed Disclosure.  Disclosures include public
communications that contain previously disclosed information; provided, however,
neither Party shall be required to obtain the other Party’s approval to repeat
any information regarding the terms of this Agreement that has already been
publicly disclosed by such Party, or by the other Party, in accordance with
Section 8.3, provided such information remains accurate at such time.

 

(c)          Disclosure Required by Law.  In the event that one Party reasonably
concludes, based on the opinion of legal counsel, that a Disclosure is required
by Applicable Law or the disclosure requirements of the securities exchanges or
other stock markets on which such Party’s securities are traded (for purposes of
Section 8.3, collectively, an “Exchange”), such Party shall provide the other
Party with such advance notice of this Disclosure as it reasonably can, but
shall not be required to obtain approval therefor. Each Party agrees that it
shall obtain its own legal advice with regard to its compliance with Applicable
Law and applicable Exchange requirements, and will not rely on any statements
made by the other Party relating to such matters.

 

(d)                                 Filing of Agreement.  The Parties
acknowledge that either or both Parties may be obligated under the disclosure
requirements of an Exchange to file a copy of this Agreement with such
Exchange.  Each Party shall be entitled to make such a required filing, provided
that it uses commercially reasonable efforts to request confidential treatment
of the commercial terms and sensitive technical terms of this Agreement, to the
extent such confidential treatment is reasonably available to such Party.  The
filing Party shall provide to the other Party a copy of this Agreement marked to
show the provisions for which the filing Party intends to seek

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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confidential treatment no less than [***] before the date of the proposed
filing, for such other Party’s review and comment, [***].

 

8.4                               Use of Names.  Each Party agrees to identify
the other Party and acknowledge its support in any press release and any
publication or presentation of any Study Data or Sample Data (which shall be in
accordance with other provisions of this Agreement, including Section 8.2). 
Except as otherwise expressly provided in this Agreement, no right, express or
implied, is granted by the Agreement to use in any manner the name of “Corvus,”
“Genentech,” “Roche” or any other trade name or trademark of the other Party (of
its Affiliates) in any public statement or for commercial, marketing or other
promotional purpose, without the other Party’s prior written consent.

 

Article 9
Human Subjects

 

9.1                               Informed Consent.  Genentech shall obtain the
informed written consent of all Subjects, in accordance with Applicable Law. 
[***].  Genentech shall provide copies of such informed written consents upon
Corvus’s request.  Genentech further represents and warrants that the Samples
may be used as contemplated in this Agreement [***]

 

9.2                               IRB Approval.  Genentech shall obtain IRB
review and approval of the Genentech Protocol and the informed consent form to
be used in the Study in accordance with Applicable Law.

 

9.3                               Patient Privacy and Data Protection.  Each
Party shall comply with Applicable Law relating to patient privacy and data
protection.  Such compliance includes [***] for the purposes of [***]  Each
Party agrees that [***]

 

Article 10
Subcontracting; Records

 

10.1                        Subcontracting.  In addition to the right to perform
its obligations through its Affiliates (as set forth in Section 16.4), each
Party shall have the right to delegate any portion of its obligations under this
Agreement to a subcontractor, provided that such Party shall remain solely and
fully liable for the performance of such subcontractors.  Each Party shall
ensure that each of its subcontractors performs its obligations pursuant to the
terms of this Agreement, including the Exhibits.  Each Party shall [***] to
obtain and maintain copies of documents relating to the obligations performed by
such subcontractors that are held by or under the control of such subcontractors
and that are required to be provided to the other Party under this Agreement.

 

10.2                        Records.  In addition to providing Study Data to
Corvus under Section 5.1(a), [***].  Genentech (or its designee) shall maintain
such records for at least the period of time

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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required by Applicable Law, but for no less than [***] following the completion
or termination of the Study.

 

Article 11
Compliance With Laws

 

11.1                        Compliance With Laws and Policies.  Each Party shall
perform activities under this Agreement in compliance with Applicable Law and in
accordance with good business ethics and the ethics and other corporate policies
applicable to such Party.  Specifically, each Party covenants that it, its
directors, employees, officers, and anyone acting on its behalf, shall not, in
connection with the performance of this Agreement, directly or indirectly, make,
promise, authorize, ratify or offer to make, or take any act in furtherance of
any payment or transfer of anything of value for the purpose of influencing,
inducing or rewarding any act, omission or decision to secure an improper
advantage; or improperly assisting it in obtaining or retaining business for it
or the other Party, or in any way with the purpose or effect of public or
commercial bribery.  Other provisions of the Agreement require compliance with
specified areas of Applicable Law and such other provisions do not limit the
scope of compliance required of the Parties under this Section.

 

11.2                        Debarment.  Genentech shall require each Project
Participant to (a) represent and warrant or (b) represent and certify, in either
case (as applicable), that neither such Project Participant nor anyone employed
by such Project Participant has been debarred under 21 USC § 335a, disqualified
under 21 CFR § 312.70 or § 812.119, sanctioned by a Federal Health Care Program
(as defined in 42 USC § 1320a-7b(f)), including the federal Medicare or a state
Medicaid program, or debarred, suspended, excluded or otherwise declared
ineligible from any other similar regional, national, federal or state agency or
program.  If a Project Participant receives notice of debarment, suspension,
sanction, exclusion, ineligibility or disqualification under the
foregoing-referenced statutes, Genentech shall promptly notify Corvus, and the
Parties shall agree upon appropriate action to address the matter.

 

Article 12
Term; Termination

 

12.1                        Term.  This Agreement shall be effective as of the
Effective Date.  Unless sooner terminated as provided in Article 12, this
Agreement shall expire on the earlier of (i) ten (10) years from the Effective
Date or (ii) the day after all of the following obligations are fulfilled (or
are no longer applicable, e.g., because the Study terminated prior to
completion) for the Study: (a) Genentech provides the Final Study Report to
Corvus in accordance with Section 2.9(c) and (b) each Party provides to the
other Party the Sample Data in accordance with Section 5.2(a).

 

12.2                        Termination for Material Breach.  Either Party may
terminate this Agreement, by notice to the other Party, for any material breach
of this Agreement by the other Party

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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(including a breach of the representation and warranty under Section 13.1(c)),
if such breach is not cured within [***] after the breaching Party receives
notice of such breach from the non-breaching Party; provided, however, if such
breach is not capable of being cured within such [***] period, the cure period
shall be extended for such amount of time that the Parties agree to in writing
is reasonably necessary to cure such breach, so long as the breaching Party is
using diligent efforts to do so.

 

12.3        Termination for Study-Related Reasons.

 

(a)           General.  Either Party may, subject to Section 12.3(b), upon
thirty (30) days’ notice to the other Party terminate the Study, if:

 

(i)            based on a review of Study Data or other Study-related
information, such Party determines that the Study may unreasonably affect
Subject safety;

 

(ii)           any Regulatory Authority withdraws the authorization and/or
approval to conduct the Study; or

 

(iii)         any Regulatory Authority takes any action, or raises any
objection, that prevents such Party from supplying its Compound for purposes of
the Study.

 

(b)           Limitations.  Prior to terminating the Study under Section 12.3,
the Joint Development Committee shall meet and seek to resolve the situation
(other than by termination) to the reasonable satisfaction of the terminating
Party.  In addition, clauses (ii) and (iii) of Section 12.3(a) will only apply
to suspending the Study at Participating Sites under the jurisdiction of the
applicable Regulatory Authority or IRB, and will not be cause for terminating
the Study, unless such or similar actions are taken by the FDA, EMA or
substantially all applicable Regulatory Authorities or IRBs (in which cases, the
Study may be terminated).

 

12.4        Termination for Discontinued Development.  Either Party may
terminate this Agreement, upon [***] notice to the other Party, if such Party
determines, in its sole discretion, to discontinue development of its Compound
for indications contemplated by this Agreement (i.e., locally advanced
unresectable or metastatic non-small cell lung cancer), for medical, scientific,
business or legal reasons; provided, however, if Corvus is the terminating Party
under this Section 12.4, it shall use commercially reasonable efforts to fulfill
its supply obligations, to the extent supply of Corvus Compound is available,
under Section 4.2 after such termination.

 

12.5        Termination for Corvus’s Failure of GMP Audit.  If, following the
GMP Audit under Section 4.4(a), Genentech elects to terminate the entire
Agreement, Genentech may do so upon [***] written notice to Corvus of such
election and the Parties’ rights and obligations with respect to the Study shall
terminate.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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12.6        Effects of Termination or Expiration.

 

(a)           Study Wind-Down.  Following termination of this Agreement, the
Parties shall cooperate to ensure the orderly wind-down of applicable Study
activities, taking into consideration the safety and welfare of the Subjects.

 

(b)           Accrued Rights and Obligations.  Except as otherwise expressly
provided in this Agreement, termination of this Agreement, or of the Study,
shall not affect the rights and obligations of the Parties that accrued prior to
the effective date of such termination.  Any right that a Party has to terminate
this Agreement, and any rights that such Party has under Article 12, shall be in
addition to and not in lieu of all other rights or remedies that such Party may
have at law or in equity or otherwise.

 

(c)           Withdrawal of Letter of Cross-Reference.  Following termination
(but not expiration) of this Agreement under Article 12, any and all rights
granted by Corvus to Genentech under Section 2.7(c) (Letter of Cross-Reference)
shall terminate and Corvus may withdraw any Letter of Cross-Reference by sending
a written notice to Genentech, such withdrawal to be effective immediately upon
receipt.

 

(d)           Final Reconciliation.  In the event the Agreement terminates prior
to Study Completion, if Corvus has made an overpayment to Genentech due to early
termination of the Study, Genentech shall promptly reimburse such amount that
Corvus has overpaid to Genentech.  Subject to Section 2.11(b), if Corvus has
made an underpayment to Genentech of its pro-rata share of the Final Budget as
of the effective date of termination of this Agreement, Corvus shall promptly
reimburse such amount that Corvus has underpaid to Genentech.

 

(e)           Survival.  Except as otherwise expressly provided in this
Agreement, the following shall survive this Agreement’s expiration or
termination for any reason:  Article 1 (Definitions), Section 2.7 (Regulatory
Matters)(except Section 2.7(c) in the event of termination),
Section 2.9(a) (Documentation), Section 4.2(b) (Continued Access)(subject to
Applicable Law), Section 4.2(d) (Remaining Compound), Section 4.2(e) (Use of
Compound), Article 5 (Study Data; Sample Analyses and Sample Data),
Article 6 (Collaboration Inventions and Licenses), Article 7 (Confidentiality),
Article 8 (Public Disclosures; Use of Names), Section 9.3 (Patient Privacy and
Data Protection), Section 10.2 (Records), Section 12.6 (Effects of Termination),
Article 13 (Representations and Warranties) and any representations and
warranties in other Sections of the Agreement, Article 14 (Indemnification;
Subject Injury Claims; Limitation on Liability; Insurance), Article 15 (Dispute
Resolution) and Article 16 (Miscellaneous).  To the extent applicable to a
Section or Article that survives the expiration or termination of this
Agreement, any other Sections and Articles that are (directly or indirectly)
referenced in, or refer to, such surviving Section or Article shall survive.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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Article 13
Representations and Warranties

 

13.1        Mutual Representations and Warranties.  Each Party represents and
warrants to the other Party the following:

 

(a)           Such Party has the full right, power and authority, and has
obtained all approvals, permits or consents necessary, to enter into this
Agreement, to perform all of its obligations hereunder.

 

(b)           Subject to Section 2.6, such Party has not prior to the Effective
Date entered into, and shall not following the Effective Date enter into, any
agreement that conflicts with this Agreement or such Party’s obligations
hereunder.

 

(c)           Neither such Party nor anyone employed by it has been debarred
under 21 USC § 335a, disqualified under 21 USC § 312.70 or § 812.119, sanctioned
by a Federal Health Care Program (as defined in 42 USC § 1320a-7b(f)), including
the federal Medicare or a state Medicaid program, or debarred, suspended,
excluded or otherwise declared ineligible from any other similar regional,
national, federal or state agency or program.

 

13.2        Disclaimers.  NEITHER GENENTECH NOR CORVUS REPRESENTS OR WARRANTS
THAT THE STUDY WILL BE SUCCESSFUL OR LEAD TO ANY PARTICULAR RESULT.  EXCEPT AS
OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, (A) NEITHER PARTY MAKES ANY
REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO ITS RESPECTIVE COMPOUND,
MATERIALS OR INFORMATION SUPPLIED BY IT TO THE OTHER PARTY HEREUNDER AND
(B) EACH PARTY EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND
NON-INFRINGEMENT.

 

Article 14
Indemnification; Subject Injury Claims; Limitation on Liability; Insurance

 

14.1        Indemnification.

 

(a)           Definitions.  The definitions in this Section are for purposes of
Article 14 (and as referenced in Article 1):

 

(i)            “Claims” means claims, suits, actions, demands or other
proceedings commenced or threatened against a Party by a Third Party arising out
of this Agreement or the Study, including Subject Injury Claims.

 

(ii)           “Indemnitee” means, as applicable, a Corvus Indemnitee (as
defined in Section 14.1(b)(i)) or a Genentech Indemnitee (as defined in
Section 14.1(c)(i)).

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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(iii)         “Losses” means any and all liabilities, damages, settlements,
penalties, fines, costs or expenses (including, reasonable attorneys’ fees and
other expenses of litigation and reasonable costs of treatment of any adverse
reaction or other physical injury).

 

(iv)          “Subject Injury Claim” means any request for compensation by a
Project Participant or Subject for reasonable costs of treatment of any
(A) adverse reaction by a Subject to a Compound or the Combination or (B) other
physical injury to a Subject (i.e., other than such an adverse reaction), in all
cases, as a result of participating in the Study.

 

(b)           Indemnification by Genentech.

 

(i)            Indemnification Scope.  Genentech hereby agrees to indemnify,
defend (if requested by Corvus) and hold harmless each of Corvus, its Affiliates
and its and their officers, directors, employees, subcontractors and agents (for
purposes of Section 14.1, each, a “Corvus Indemnitee”) from and against Losses
incurred by such Corvus Indemnitee in connection with Claims made against such
Corvus Indemnitee, to the extent such Losses arise out of (A) the negligence or
willful misconduct of any Genentech Indemnitee; (B) a breach by Genentech of any
of its representations, warranties, covenants or obligations under this
Agreement or any Ancillary Agreement; (C) a breach by any Genentech Indemnitee
of any Applicable Law pertaining to activities it performs under this Agreement
or a subcontract under this Agreement; or (D) Genentech’s use of Study Data or
Sample Data.  Genentech’s obligations under this Section 14.1(b)(i) shall not
apply to the extent such Losses (A) arise out of the scope of Corvus’s
indemnification obligations under Section 14.1(c)(i) or (B) are reimbursed by
Genentech to Corvus for a Subject Injury Claim under Section 14.2.

 

(ii)           Procedures.  Subject to Section 14.2, Corvus shall (A) notify
Genentech of any Claim for which it seeks to exercise its rights under
Section 14.1(b)(i) as soon as reasonably possible after it receives notice of
such Claim, (B) permit Genentech to assume the sole control of the defense
thereof, including the right to investigate, prepare for, settle or conclude
such defense.  In the event that Corvus requests that Genentech assume such
control, Corvus shall (A) cooperate and assist as reasonably requested (at the
expense of Genentech) in the defense of such Claim, including investigation and
preparation for such defense and (B) not settle such Claim without the express,
prior written consent of Genentech.  Genentech’s obligations under
Section 14.1(b)(i) shall not apply to amounts paid in settlement of any Claims
if such settlement is effected without Genentech’s consent, not to be
unreasonably withheld.

 

(c)           Indemnification by Corvus.

 

(i)            Indemnification Scope.  Corvus hereby agrees to indemnify, defend
(if requested by Genentech) and hold harmless each of Genentech, its Affiliates
and its and their officers, directors, employees, subcontractors and agents (for
purposes of Section 14.1, each, a “Genentech Indemnitee”) from and against
Losses incurred by such Genentech Indemnitee in connection with Claims made
against such Genentech Indemnitee, to

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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the extent such Losses arise out of (A) the negligence or willful misconduct of
any Corvus Indemnitee; (B) a breach by Corvus of any of its representations,
warranties, covenants or obligations under this Agreement or any Ancillary
Agreement; (C) a breach by any Corvus Indemnitee of any Applicable Law
pertaining to activities it performs under this Agreement or a subcontract under
this Agreement; or (D) Corvus’s use of Study Data or Sample Data.  Corvus’s
obligations under this Section 14.1(c)(i) shall not apply to the extent such
Losses (A) arise out of the scope of Genentech’s indemnification obligations
under Section 14.1(b)(i) or (B) are reimbursed by Corvus to Genentech for a
Subject Injury Claim under Section 14.2.

 

(ii)           Procedures.  Subject to Section 14.2, Genentech shall notify
Corvus of any Claim for which it seeks to exercise its rights under
Section 14.1(c)(i) as soon as reasonably possible after it receives notice of
such Claim.  If requested by Genentech, Corvus shall assume control of the
defense thereof, with counsel mutually satisfactory to the Parties, including
the right to investigate, prepare for, settle or conclude such defense.  In the
event that Genentech requests that Corvus assume such control, Genentech shall
(A) cooperate and assist as reasonably requested (at the expense of Corvus) in
the defense of such Claim, including investigation and preparation for such
defense and (B) not settle such Claim without the express, prior written consent
of Corvus.  Corvus’s obligations under Section 14.1(c)(i) shall not apply to
amounts paid in settlement of any Claims if such settlement is effected without
Corvus’s consent, not to be unreasonably withheld.

 

(d)           Limitations.  The failure of an Indemnitee to deliver notice to
the other Party (for purposes of this Section, the “Indemnitor”) within a
reasonable time after the commencement of any Claim for which such Indemnitee
seeks to exercise its rights under Section 14.1, to the extent prejudicial to
the Indemnitor’s ability to defend such Claim, shall relieve the Indemnitor of
its obligation to the Indemnitees under Section 14.1.  The Parties agree that
only Corvus or Genentech may seek to exercise the rights under Section 14.1 (on
its own behalf or on behalf of its Indemnitees), and other Indemnitees may not
directly seek to exercise such rights.

 

14.2        Subject Injury Claims.

 

(a)           General.  Notwithstanding anything to the contrary in
Section 14.1, the Parties agree that all Subject Injury Claims shall be handled
in accordance with Section 14.2, regardless of which Party receives notice of a
Subject Injury Claim or if such Party has the right to indemnification for such
Subject Injury Claim.  For clarity, nothing in Section 14.2 precludes a Party
from exercising its right to indemnification under Section 14.1, if applicable. 
[***].

 

(b)           Procedures.  Each Party shall notify the other Party as soon as
reasonably possible after it receives notice of a Subject Injury Claim.  Corvus
shall permit Genentech to [***], and Corvus [***] shall [***] to resolve such
Subject Injury Claim in a timely manner.

 

(c)           Allocation of Compensation.  Corvus shall reimburse Genentech for
compensation paid by Genentech for a Subject Injury Claim as follows: [***]. 
Corvus’s

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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obligation under this Section 14.2 to reimburse Genentech for amounts paid to
resolve a given Subject Injury Claim shall [***].  In resolving a Subject Injury
Claim, Genentech shall not admit fault on behalf of Corvus or impose injunctive
relief on Corvus.

 

14.3        Limitation on Liability.  IN NO EVENT SHALL EITHER PARTY BE LIABLE
FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL, PUNITIVE OR EXEMPLARY DAMAGES,
HOWEVER CAUSED; PROVIDED HOWEVER, NOTHING IN THIS SECTION 14.3 IS INTENDED TO
LIMIT THE RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER
SECTION 14.1(INDEMNIFICATION), SECTION 14.2 (SUBJECT INJURY CLAIMS) OR FOR
DAMAGES ARISING OUT OF A BREACH OF ARTICLE 7 (CONFIDENTIALITY).

 

14.4        Insurance.

 

(a)           General.  Each Party shall maintain, at its own expense, insurance
to cover such Party’s obligations under this Agreement; provided, however,
Genentech has the right, in its sole discretion, to self-insure, in part or in
whole, for any such coverage.  Each Party shall, at a minimum, maintain the
insurance coverage specified in Section 14.4, in accordance with the following
provisions.  The limits of any required insurance coverage shall not limit the
Parties’ liability under the indemnification provisions of this Agreement.

 

(i)            The insurance policies may be under a claims-made form and each
Party shall maintain the insurance coverage for a minimum of [***] for products
liability insurance and [***] for clinical trial liability insurance, in all
cases, after the last Subject receives treatment in connection with the Study,
including any treatment received after Study Completion, but not for less than
the statute of limitations in the state or location where the Study is being
conducted.

 

(ii)           Insurance coverage shall be maintained with an insurance company
or companies having an A.M. Best’s rating (or its equivalent) of A-VII or
better.  Upon written request, each Party shall provide to the other Party
certificates of insurance evidencing the insurance coverage required under
Section 14.4.  Each Party shall provide to the other Party notice of any
cancellation or non-renewal in any of the required insurance coverages promptly
after such Party learns of such event.

 

(b)           Each Party’s Coverage.  Each Party shall maintain (i) commercial
general liability (including contractual liability) insurance covering bodily
injury and property damage arising out of such Party’s obligations under this
Agreement, for limits no less than [***] per occurrence and [***] in the
aggregate; (ii) product liability insurance relating to the Compound provided by
such Party under this Agreement, for limits no less [***] per occurrence; and
(iii) if applicable, automobile liability insurance, for limits of not less than
[***] each accident, and the policy definition of automobile shall include hired
autos and non-owned autos.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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(c)           Genentech’s Coverage.  In addition to the coverages under
Section 14.4(b), Genentech shall maintain clinical trial liability insurance for
limits of no less than [***] per occurrence.  Prior to enrolling any Subjects,
Genentech shall ensure that the insurance policies required by this
Section cover injuries that may arise in connection with the Study.

 

Article 15
Dispute Resolution

 

15.1        Internal Resolution.   Except as otherwise expressly provided in
this Agreement, any disputes shall be first referred to [***] and [***] for
resolution, prior to proceeding under the other provisions of Article 15.  A
dispute shall be referred to such executives upon one Party providing the other
Party with notice that such dispute exists, and such executives (or their
designees) shall attempt to resolve such dispute through good faith
discussions.  In the event that such dispute is not resolved within [***] of
such other Party’s receipt of such notice, [***]; and (d) either Party may
initiate dispute resolution under Section 15.2 with respect to any other
unresolved disputes, including [***], publications strategy and patent
prosecution.

 

15.2        Arbitration.

 

(a)           General.  Except as otherwise expressly provided in this
Agreement, the Parties agree that any dispute not resolved internally by the
Parties pursuant to Section 15.1 shall be resolved through binding arbitration
administered by the American Arbitration Association in accordance with its
Commercial Arbitration Rules (for purposes of Article 15, the “Rules”), except
as modified in this Agreement, applying the substantive law specified in
Section 16.3.

 

(b)           Arbitrators.  Each Party shall select one (1) arbitrator, and the
two (2) arbitrators so selected shall choose a third arbitrator.  All
three (3) arbitrators shall serve as neutrals and have at least ten (10) years
of (i) dispute resolution experience (which may include judicial experience) or
(ii) legal or business experience in the biotechnology or pharmaceutical
industry.  In any event, at least one (1) arbitrator shall satisfy the foregoing
experience requirement under clause (ii).  If a Party fails to nominate its
arbitrator, or if the Parties’ arbitrators cannot agree on the third arbitrator,
the necessary appointments shall be made in accordance with the Rules.  The
arbitration proceeding shall be conducted in [***].

 

15.3        Subject Matter Exclusions.  Notwithstanding the provisions of
Section 15.2, any dispute not resolved internally by the Parties pursuant to
Section 15.1 that involves the validity, infringement or enforceability of any
Patent that may arise under this Agreement and/or be included in a license
granted in this Agreement (a) that is issued in the United States shall be
subject to actions before the United States Patent and Trademark Office and/or
submitted exclusively to the federal court located in the jurisdiction of the
district where any of the defendants reside and (b) that is issued in any other
country (or region) shall be brought before

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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an appropriate regulatory or administrative body or court in that country (or
region), and in all cases, the Parties hereby consent to the jurisdiction and
venue of such courts and bodies.

 

15.4        Continued Performance.  Provided that this Agreement has not
terminated, the Parties agree to continue performing under this Agreement in
accordance with its provisions, pending the final resolution of any Dispute.

 

Article 16
Miscellaneous

 

16.1        Prior Agreement.  For clarity, nothing in this Agreement supersedes
Section 2.11 (Additional Studies) and Section 2.12 (Right of First Negotiation)
under the Phase I/Ib Agreement.

 

16.2        Notices.  Except as otherwise expressly provided in this Agreement,
any notice required under this Agreement shall be in writing, shall specifically
refer to this Agreement and shall be sent in accordance with the provisions of
this Section 16.2.  Notices shall be sent via one of the following means and
will be effective (a) on the date of delivery, if delivered in person; (b) on
the date of receipt, if sent by a facsimile (including a PDF image delivered via
email); or (c) on the date of receipt, if sent by private express courier or by
first class certified mail, return receipt requested (or its equivalent).  Any
notice sent via facsimile shall be followed by a copy of such notice by private
express courier or by first class mail.  Notices shall be sent to the other
Party at the addresses set forth below.  Either Party may change its addresses
for purposes of this Section 16.1 by sending written notice to the other Party.

 

If to Corvus:

 

Corvus Pharmaceuticals, Inc.

863 Mitten Road

Suite 102

Burlingame, CA 94010

Attn:  Richard Miller, M.D.

Telephone: (650) 900-4520

Facsimile:  N/A

 

with a required copy to:

 

Latham & Watkins

140 Scott Drive

Menlo Park, CA 94025

Attn: Alan C. Mendelson, Esq.

Telephone:  (650) 328-4600

Facsimile:  (650) 463-3000

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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If to Genentech:

 

Genentech, Inc.

1 DNA Way

South San Francisco, CA 94080

Attn:  Corporate Secretary

Telephone:  (650) 225-1000

Facsimile:  (650) 467-9146

 

with a required copy to:

 

F Hoffmann-La Roche Ltd

Grenzacherstrasse 124

CH-4070 Basel

Switzerland

Attn:  Head of Oncology, Business Development, Roche Partnering

Telephone:  +41 61 688 06 29

 

16.3        Governing Law.  This Agreement shall be governed by and construed
under the laws of the State of Delaware, without regard to conflict of laws
principles.  The Parties hereby exclude from this Agreement the application of
the United Nations Convention on Contracts for the International Sale of Goods.

 

16.4        Actions of Affiliates.  Each Party may exercise its rights or
perform its obligations under this Agreement personally or through one or more
Affiliates, provided that such Party shall nonetheless be primarily liable for
the performance of its Affiliates and for any failure by its Affiliates to
comply with the restrictions, limitations and obligations set forth in this
Agreement.

 

16.5        Assignment.

 

(a)           General.  Except as otherwise expressly provided in this
Agreement, neither Party may assign any of its rights or delegate any of its
obligations under this Agreement without the prior written consent of the other
Party, such consent not to be unreasonably withheld.  Subject to the other
provisions of Section 16.5, either Party may assign this Agreement, in its
entirety, to (i) an Affiliate; (ii) an acquirer of all its capital stock (by
reverse triangular merger or otherwise) or all or substantially all its assets;
[***] (any of the foregoing, a “Change of Control”), provided that in the event
of any Change of Control, the party to which this Agreement is assigned
expressly agrees in writing to assume and be bound by the obligations of the
assigning Party under this Agreement.  A copy of such writing shall be provided
to the non-assigning Party within [***] of the assignment.  Subject to the
foregoing and other applicable provisions of Section 16.5, this Agreement will
inure to the benefit of and bind

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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the Parties’ successors and assigns.  Any assignment or delegation in
contravention of any such applicable provisions shall be null and void. 
Notwithstanding any other provision of Section 16.5, this Agreement may only be
assigned together with the Ancillary Agreements.

 

(b)           Assignment by Corvus; Acquisitions.  In the case of a Change of
Control of Corvus, Corvus shall notify Genentech promptly upon completing such
Change of Control if the acquiring party [***] or is (ii) [***] (directly or
indirectly) or the like.  Corvus, including its acquiring party, shall [***] and
(ii) [***]  The foregoing obligations shall also apply if Corvus or a Corvus
Affiliate [***].

 

(c)           Assignment by Genentech; Acquisitions.  In the case of a Change of
Control of Genentech, Genentech shall notify Corvus promptly upon completing
such Change of Control if the acquiring party [***] or is (ii) [***] (directly
or indirectly) or the like.  Genentech, including its acquiring party, shall
[***].  The foregoing obligations shall also apply if Genentech or a Genentech
Affiliate [***].

 

16.6        Force Majeure.  Neither Party shall be deemed to have breached this
Agreement for failure to perform its obligations under this Agreement to the
extent such failure results from causes beyond the reasonable control of the
affected Party, such causes including acts of God, earthquakes, fires, floods,
embargoes, wars, acts of terrorism, insurrections, riots, civil commotions,
omissions or delays in action by any governmental authority, acts of a
government or agency thereof and judicial orders or decrees.  If a force majeure
event occurs, the Party unable to perform shall promptly notify the other Party
of the occurrence of such event, and the Parties shall meet (in person or
telephonically) promptly thereafter to discuss the circumstances relating
thereto.  The Party unable to perform shall (a) provide reasonable status
updates to the other Party from time to time; (b) use commercially reasonable
efforts to mitigate any adverse consequences arising out of its failure to
perform; and (c) resume performance as promptly as possible.

 

16.7        Relationship of the Parties.  The Parties to this Agreement are
independent contractors, and nothing contained in this Agreement shall be deemed
or construed to create a partnership, joint venture, employment, franchise,
agency or fiduciary relationship between the Parties.

 

16.8        Amendment; Waiver.  Except as otherwise expressly provided in this
Agreement, no amendment to this Agreement shall be effective unless made in
writing and executed by an authorized representative of each Party.  A Party’s
failure to exercise, or delay in exercising, any right, power, privilege or
remedy under this Agreement shall not (a) operate as a waiver thereof or
(b) operate as a waiver of any other right, power, privilege or remedy.  A
waiver will be effective only upon the written consent of the Party granting
such waiver.

 

16.9        Construction; Captions.  Each Party acknowledges that it
participated in the negotiation and preparation of this Agreement and that it
had the opportunity to consult with an

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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attorney of its choice in connection therewith.  Ambiguities, if any, in this
Agreement shall not be construed against either Party, irrespective of which
Party may be deemed to have drafted the Agreement or authorized the ambiguous
provision.  Capitalized terms defined in the singular shall include the plural
and vice versa.  The terms “includes” and “including” mean “includes, without
limitation,” and “including, without limitation,” respectively.  Titles,
headings and other captions are for convenience only and shall not affect the
meaning or interpretation of this Agreement.

 

16.10                 Severability.  If any of the provisions of this Agreement
are held to be illegal, invalid or unenforceable, such illegal, invalid or
unenforceable provisions shall be replaced by legal, valid and enforceable
provisions that will achieve to the maximum extent possible the intent of the
Parties, and the other provisions of this Agreement shall remain in full force
and effect.

 

16.11                 Entire Agreement.  This Agreement, together with the
Ancillary Agreements, and the exhibits hereto contain the entire understanding
between the Parties with respect to the subject matter hereof and thereof and
supersede and terminate all prior agreements, understandings and arrangements
between the Parties with respect to such subject matter, whether written or
oral.

 

16.12                 Counterparts; Facsimiles.  This Agreement may be executed
in two (2) or more counterparts, each of which will be deemed an original, but
all of which together will constitute one and the same instrument.  A facsimile
(including a PDF image delivered via email) of this Agreement, including the
signature pages hereto, will be deemed to be an original.  Notwithstanding the
foregoing, the Parties shall deliver original execution copies of this Agreement
to one another as soon as practicable following execution thereof.

 

[Signature page follows]

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their respective duly authorized representatives as set forth below.

 

CORVUS PHARMACEUTICALS, INC.

GENENTECH, INC.

 

 

Signed:

/s/ Richard A. Miller

 

Signed:

/s/ Eric Hoefer

Name:

Richard A. Miller

 

Name:

Eric Hoefer

Title:

CEO

 

Title:

LifeCycle Leader

 

Signature page to Master Phase Ib/II Combination Study Agreement

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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EXHIBIT A

 

SAMPLE ANALYSES PLAN

 

[***]

 

Corvus/Genentech may elect to perform additional assays retrospectively by
mutual agreement.

 

·                  [***]

 

·                  To the extent not expressly provided herein, the Parties
agree to share such Data and other information as necessary for Regulatory
Submission ([***]).

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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EXHIBIT B

 

COMPOUND SUPPLY PLAN

 

CPI-444 SUPPLY PLAN

 

[***]

 

[***] for the supply of CPI-444 [***] for the Study.  The supply chain teams
from Corvus and Genentech will meet regularly to review demand and supply
requirements and adjust the delivery schedule to ensure continuous supply for
the Study.  [***]

 

The delivery dates below are based on the current expectation that [***]

 

Estimated Delivery Date

 

Estimated Quantity of labeled product

[***]

 

[***]

Total

 

[***]

 

Other working assumptions

 

Supply plan accounts for [***]

 

[***]

 

Study enrolls [***]

 

Updated supply plan would be provided [***]

 

Product Information

 

[***]

 

[***]

[***]

 

[***]

[***]

 

[***]

[***]

 

[***]

[***]

 

[***]

[***]

 

[***]

[***]

 

[***]

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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EXHIBIT C

 

BUDGET

 

[***]

 

Costs

 

Estimate
[***]

 

Key assumptions

[***]

 

[***]

 

[***]

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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