Document:

Exhibit 10.15

 

Execution Copy

 

[***] 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.

 

 

PHASE I/IB COMBINATION STUDY AGREEMENT

 

BY AND BETWEEN

 

GENENTECH, INC.

 

AND

 

CORVUS PHARMACEUTICALS, INC.

 

 

TABLE OF CONTENTS

 

	
 
    	
 
    	
Page
    
	
 
    	
 
    	
 
    
	
ARTICLE 1 DEFINITIONS
    	
1
    
	
 
    	
 
    
	
1.1
    	
“Affiliate”
    	
1
    
	
1.2
    	
“Ancillary Agreements”
    	
2
    
	
1.3
    	
“Applicable Law”
    	
2
    
	
1.4
    	
“Business Day”
    	
2
    
	
1.5
    	
“Case Report Form”
    	
2
    
	
1.6
    	
“CFR”
    	
2
    
	
1.7
    	
“Collaboration IND”
    	
2
    
	
1.8
    	
“Collaboration   Invention”
    	
2
    
	
1.9
    	
“Combination”
    	
3
    
	
1.10
    	
Competitive Product”
    	
3
    
	
1.11
    	
“Confidential   Information”
    	
3
    
	
1.12
    	
“Corvus Molecule”
    	
3
    
	
1.13
    	
“CRO”
    	
3
    
	
1.14
    	
“Database Lock”
    	
3
    
	
1.15
    	
“Data Review Committee”
    	
3
    
	
1.16
    	
“EMA”
    	
3
    
	
1.17
    	
“FDA”
    	
3
    
	
1.18
    	
“Final Study Report”
    	
3
    
	
1.19
    	
“GCP”
    	
3
    
	
1.20
    	
“Genentech Molecule”
    	
4
    
	
1.21
    	
“GLP”
    	
4
    
	
1.22
    	
“GMP”
    	
4
    
	
1.23
    	
“HIPAA”
    	
4
    
	
1.24
    	
“IND”
    	
4
    
	
1.25
    	
“Investigator”
    	
4
    
	
1.26
    	
“IRB”
    	
4
    
	
1.27
    	
“JDC Chair”
    	
4
    
	
1.28
    	
“JDC Co-Leader”
    	
4
    
	
1.29
    	
“Joint Development   Committee”
    	
4
    
	
1.30
    	
“Joint Patent”
    	
4
    
	
1.31
    	
“Know-How”
    	
4
    
	
1.32
    	
“Molecules”
    	
5
    
	
1.33
    	
“Molecule Supply Plan”
    	
5
    
	
1.34
    	
“NDA”
    	
5
    
	
1.35
    	
“Participating Site”
    	
5
    
	
1.36
    	
“Patents”
    	
5
    
	
1.37
    	
“PD-1 Antagonist”
    	
5
    
	
1.38
    	
“PD-L1 Antagonist”
    	
5
    
	
1.39
    	
“Project Participants”
    	
5
    
	
1.40
    	
“Prosecution and   Maintenance”
    	
5
    

 

[***] 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.

 

i

 

	
1.41
    	
“Protocol”
    	
5
    
	
1.42
    	
“PV Agreement”
    	
5
    
	
1.43
    	
“Quality Agreement”
    	
5
    
	
1.44
    	
“Regulatory Authority”
    	
6
    
	
1.45
    	
“Regulatory   Documentation”
    	
6
    
	
1.46
    	
“Roche Group”
    	
6
    
	
1.47
    	
“Sample Analyses”
    	
6
    
	
1.48
    	
“Sample Analysis Plan”
    	
6
    
	
1.49
    	
“Sample Data”
    	
6
    
	
1.50
    	
“Samples”
    	
6
    
	
1.51
    	
“Specifications”
    	
6
    
	
1.52
    	
“Sponsor”
    	
6
    
	
1.53
    	
“Study”
    	
6
    
	
1.54
    	
“Study Completion”
    	
6
    
	
1.55
    	
“Study Data”
    	
6
    
	
1.56
    	
“Subinvestigator”
    	
6
    
	
1.57
    	
“Subject”
    	
6
    
	
1.58
    	
“Third Party”
    	
7
    
	
 
    	
 
    
	
ARTICLE 2 CONDUCT OF THE STUDY; REGULATORY   MATTERS
    	
7
    
	
 
    	
 
    
	
2.1
    	
Overview
    	
7
    
	
2.2
    	
Sponsor
    	
7
    
	
2.3
    	
Collaboration IND;   Protocol
    	
7
    
	
2.4
    	
Enrollment
    	
7
    
	
2.5
    	
Project Participants
    	
7
    
	
2.6
    	
Regulatory Matters
    	
8
    
	
2.7
    	
Adverse Experience   Reporting
    	
8
    
	
2.8
    	
Documentation, Updates   and Final Study Report
    	
9
    
	
2.9
    	
Genentech Study   Responsibilities
    	
9
    
	
2.10
    	
Costs
    	
9
    
	
2.11
    	
Additional Studies
    	
10
    
	
2.12
    	
Right of First Negotiation
    	
10
    
	
 
    	
 
    
	
ARTICLE 3 GOVERNANCE
    	
11
    
	
 
    	
 
    
	
3.1
    	
Joint Development   Committee
    	
11
    
	
3.2
    	
Data Review Committee
    	
12
    
	
 
    	
 
    
	
ARTICLE 4 SUPPLY OF STUDY DRUGS
    	
13
    
	
 
    	
 
    
	
4.1
    	
Corvus Molecule
    	
13
    
	
4.2
    	
Genentech Molecule
    	
13
    
	
4.3
    	
Insufficient Quantities
    	
14
    
	
4.4
    	
Quality Agreement
    	
14
    
	
4.5
    	
Mutual Obligations
    	
14
    
	
 
    	
 
    
	
ARTICLE 5 STUDY DATA; SAMPLE ANALYSES AND   SAMPLE DATA
    	
15
    
	
 
    	
 
    
	
5.1
    	
Study Data
    	
15
    

 

[***] 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.

 

ii

 

	
5.2
    	
Samples and Sample   Analyses
    	
15
    
	
5.3
    	
Sample Data
    	
15
    
	
 
    	
 
    
	
ARTICLE 6 INTELLECTUAL PROPERTY
    	
16
    
	
 
    	
 
    
	
6.1
    	
Inventorship; Ownership   and Use; Definitions
    	
16
    
	
6.2
    	
Licenses
    	
17
    
	
6.3
    	
Patent Prosecution and   Maintenance of Solely Owned Inventions
    	
18
    
	
6.4
    	
Patent Prosecution and   Maintenance of Jointly Owned Inventions
    	
18
    
	
6.5
    	
Third Party   Infringement, Third Party Challenges and Third Party Allegations of   Infringement
    	
19
    
	
 
    	
 
    
	
ARTICLE 7 CONFIDENTIALITY
    	
20
    
	
 
    	
 
    
	
7.1
    	
Disclosure and Use of   Confidential Information
    	
20
    
	
7.2
    	
Authorized Disclosures
    	
21
    
	
7.3
    	
Continuing Obligation
    	
22
    
	
7.4
    	
Termination of Prior   Agreements
    	
22
    
	
 
    	
 
    
	
ARTICLE 8 PUBLIC DISCLOSURES; USE OF NAMES
    	
23
    
	
 
    	
 
    
	
8.1
    	
Clinical Trials   Registries
    	
23
    
	
8.2
    	
Publications and   Presentations
    	
23
    
	
8.3
    	
Press Releases and   Other Public Disclosures
    	
23
    
	
8.4
    	
Use of Names
    	
24
    
	
 
    	
 
    
	
ARTICLE 9 HUMAN SUBJECTS
    	
24
    
	
 
    	
 
    
	
9.1
    	
Informed Consent
    	
24
    
	
9.2
    	
IRB Approval
    	
25
    
	
9.3
    	
Patient Privacy and   Data Protection
    	
25
    
	
 
    	
 
    
	
ARTICLE 10 SUBCONTRACTING; RECORDS
    	
25
    
	
 
    	
 
    
	
10.1
    	
Subcontracting
    	
25
    
	
10.2
    	
Records
    	
25
    
	
 
    	
 
    
	
ARTICLE 11 COMPLIANCE WITH LAWS
    	
26
    
	
 
    	
 
    
	
11.1
    	
Compliance with Laws   and Policies
    	
26
    
	
11.2
    	
Debarment
    	
26
    
	
 
    	
 
    
	
ARTICLE 12 TERM; TERMINATION
    	
26
    
	
 
    	
 
    
	
12.1
    	
Term
    	
26
    
	
12.2
    	
Termination for   Material Breach
    	
26
    
	
12.3
    	
Termination for Other   Reasons
    	
27
    
	
12.4
    	
Effects of Termination   or Expiration
    	
27
    
	
 
    	
 
    
	
ARTICLE 13 REPRESENTATIONS AND WARRANTIES
    	
28
    
	
 
    	
 
    
	
13.1
    	
Mutual Representations   and Warranties
    	
28
    
	
13.2
    	
Disclaimers
    	
28
    

 

[***] 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.

 

iii

 

	
ARTICLE 14 INDEMNIFICATION; LIMITATION ON   LIABILITY; INSURANCE
    	
28
    
	
 
    	
 
    
	
14.1
    	
Indemnification
    	
28
    
	
14.2
    	
Limitation on Liability
    	
30
    
	
14.3
    	
Insurance
    	
30
    
	
 
    	
 
    
	
ARTICLE 15 DISPUTE RESOLUTION
    	
31
    
	
 
    	
 
    
	
15.1
    	
Internal Resolution
    	
31
    
	
15.2
    	
Arbitration
    	
31
    
	
15.3
    	
Subject Matter   Exclusions
    	
32
    
	
15.4
    	
Continued Performance
    	
32
    
	
 
    	
 
    
	
ARTICLE 16 MISCELLANEOUS
    	
33
    
	
 
    	
 
    
	
16.1
    	
Notices
    	
33
    
	
16.2
    	
Governing Law
    	
34
    
	
16.3
    	
Assignment
    	
34
    
	
16.4
    	
Force Majeure
    	
35
    
	
16.5
    	
Relationship of the   Parties
    	
35
    
	
16.6
    	
Amendment; Waiver
    	
35
    
	
16.7
    	
Construction; Captions
    	
35
    
	
16.8
    	
Severability
    	
35
    
	
16.9
    	
Entire Agreement
    	
35
    
	
16.10
    	
Counterparts;   Facsimiles
    	
36
    

 

	
Exhibits
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Exhibit A
    	
Protocol
    	
 
    
	
 
    	
 
    	
 
    
	
Exhibit B
    	
Sample Analysis Plan
    	
 
    
	
 
    	
 
    	
 
    
	
Exhibit C
    	
Molecule Supply Plan
    	
 
    

 

[***] 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.

 

iv

 

PHASE I/IB COMBINATION STUDY AGREEMENT

 

THIS PHASE I/IB COMBINATION STUDY AGREEMENT (“Agreement”) is made and entered into, effective as of October 5, 2015 (“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 Molecule (defined below) for the treatment of certain tumor types;

 

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

 

C.                                    Corvus wishes to conduct a Phase I/Ib clinical study evaluating the safety and tolerability of the Corvus Molecule, in patients with selected incurable cancers, as a single agent and in combination with the Genentech Molecule.

 

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

 

E.                                     Corvus is willing to provide to Genentech the Study Data, Samples and Final Study Report (each, 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                               “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

 

[***] 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

 

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 FMI 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.

 

1.2                               “Ancillary Agreements” means the Quality Agreement and the PV Agreement.

 

1.3                               “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, GLP, GMP and other laws promulgated by Regulatory Authorities); (b) applicable data protection and patient privacy laws and requirements (including those specified in the EU Data Protection Directive and the regulations issued under HIPAA); (c) export control and economic sanctions regulations that prohibit the shipment of United States-originated 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.

 

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

 

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

 

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

 

1.7                               “Collaboration IND” means the IND that includes the Protocol.

 

1.8                               “Collaboration Invention” means any invention, discovery or creation (including materials and Know-How but excluding Study Data and Sample Data) that is first conceived or reduced to practice by a Party (directly or by a Third Party on its behalf) or jointly by the Parties, in each case, (1) [***]; (2)[***]; or (3) [***].  Collaboration Inventions may include new uses, compositions or formulations [***]

 

[***] 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

 

[***].

 

1.9                               “Combination” means the Genentech Molecule and the Corvus Molecule used in combination, but not co-formulated together.

 

1.10                        “Competitive Product” means any compound or molecule that is [***].

 

1.11                        “Confidential Information” means nonpublic information (including Know-How) (i) that is disclosed by or on behalf of one Party to the other or its designee in connection with this Agreement (whether orally, electronically, visually or in writing) and/or (ii) Joint Confidential Information.

 

1.12                        “Corvus Molecule” means the investigational medicinal product identified as CPI-444 in final form for administration to Subjects in the Study.  CPI-444 is an investigational adenosine-2A (A2A) receptor antagonist that has the following chemical formula: [***].

 

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

 

1.14                        “Database Lock” means the database lock of the Study Data after Study Completion.

 

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

 

1.16                        “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.

 

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

 

1.18                        “Final Study Report” is defined in Section 1.1(c).

 

1.19                        “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 of the Agreement 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.

 

3

 

1.20                        “Genentech Molecule” means atezolizumab in final form for administration to Subjects in the Study.  Atezolizumab is an investigational monoclonal antibody that targets PD-L1 (programmed death-ligand 1) and is also identified as an anti-PD-L1 antibody (MPDL3280A and RG7446).

 

1.21                        “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 of the Agreement 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.

 

1.22                        “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 of the Agreement 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.

 

1.23                        “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.

 

1.24                        “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 a 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.

 

1.25                        “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.

 

1.26                        “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.

 

1.27                        “JDC Chair” is defined in Section 3.1(a).

 

1.28                        “JDC Co-Leader” is defined in Section 3.1(a).

 

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

 

1.30                        “Joint Patent” is defined in Section 6.4(a).

 

1.31                        “Know-How” means all information, unpatented inventions (whether or not patentable), improvements, practices, formula, trade secrets, techniques, methods, procedures, knowledge, results, test 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, processes, models, designs,

 

[***] 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.

 

4

 

and other information regarding research, discovery, development, marketing, pricing, distribution, cost, sales and manufacturing.  Know-How shall not include any Patents.

 

1.32                        “Molecules” means the Genentech Molecule and the Corvus Molecule.  A “Molecule” means either the Genentech Molecule or the Corvus Molecule, as applicable.

 

1.33                        “Molecule Supply Plan” means the plan for supplying the Genentech Molecule for the Study attached hereto as Exhibit C.

 

1.34                         “NDA” means a new drug application filed or to be filed with the FDA as described in 21 CFR Part 314, or the equivalent filing with a relevant Regulatory Authority in any jurisdiction (including 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.

 

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

 

1.36                        “Patents” means all patents and patent applications and any patents issuing therefrom or claiming priority to, in any country, including any reissues, extensions, supplementary protection certificates, registrations, divisions, continuations, continuations-in-part, reexaminations, substitutions or renewals thereof.

 

1.37                        “PD-1 Antagonist” means any molecule that [***].

 

1.38                        “PD-L1 Antagonist” means any molecule that [***].

 

1.39                         “Project Participants” means Investigators, Subinvestigators, Participating Sites, CROs, drug distributors, vendors and subcontractors or agents of Corvus (or its Affiliates), who conduct or assist in conducting the Study or provide related services.

 

1.40                        “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 and other similar administrative proceedings with respect to such Patent.

 

1.41                        “Protocol” means the mutually agreed protocol by the Parties attached hereto as Exhibit A, titled “A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose Selection Study of CPI-444 as Single Agent and in Combination with Atezolizumab in Patients with Selected Incurable Cancers,” which may be amended by the JDC in accordance with this Agreement.

 

1.42                        “PV Agreement” is defined in Section 2.7(a).

 

1.43                        “Quality Agreement” is defined 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.

 

5

 

1.44                        “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.

 

1.45                        “Regulatory Documentation” means any document submitted to a Regulatory Authority, including all INDs, NDAs, drug master files, correspondence with Regulatory Authorities, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records.

 

1.46                        “Roche Group” means Genentech and its Affiliates.

 

1.47                        “Sample Analyses” is defined in Section 5.2.

 

1.48                        “Sample Analysis Plan” means the plan, attached as Exhibit B, that outlines the Sample Analyses to be performed by Corvus or Genentech and the priority for performing such Sample Analysis.

 

1.49                        “Sample Data” is defined in Section 5.3(a).

 

1.50                        “Samples” is defined in Section 5.2(a).

 

1.51                        “Specifications” means, with respect to a Molecule, the set of requirements for such Molecule set forth in the Quality Agreement.

 

1.52                        “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.

 

1.53                        “Study” means the Phase I/Ib clinical study to be sponsored and conducted by Corvus as set forth in the Protocol.  The principal purpose of the Study is a preliminary determination of the safety of Corvus Molecule as a single agent and in combination with Genentech Molecule, consistent with the requirements further described in 21 CFR § 312.21(a) (as may be amended) or foreign counterpart thereto, or a similar clinical study in a country other than the United States. [***].

 

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

 

1.55                        “Study Data” means all data (including raw data), Case Report Forms, findings, conclusions and other results, in all cases, from the single agent arm and Combination arm of the Study and the Final Study Report, including investigator reports (both preliminary and final), statistical analyses and expert opinions and reports.  Study Data excludes Sample Data.

 

1.56                        “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 designated by the Investigator to be the responsible leader of such team.

 

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

 

6

 

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

 

ARTICLE 2
 CONDUCT OF THE STUDY; REGULATORY MATTERS

 

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                               Sponsor.  Corvus shall be the Sponsor of the Study.  Corvus shall conduct, and use commercially reasonable efforts to cause all Project Participants to conduct, the Study in accordance with this Agreement, the Protocol and Applicable Law.  Corvus shall be responsible for obtaining all approvals and clearances necessary to conduct the Study, including approvals from Regulatory Authorities and IRBs and customs clearances.  In no event shall Genentech or any member of the Roche Group be deemed a Sponsor of the Study.

 

2.3       Collaboration IND; Protocol.  

 

(a)         Collaboration IND.  Corvus shall prepare and file IND #126559 for the Study (“Collaboration IND”).  Subject to the ownership provisions of Sections 5.1, 5.3 and 6.1, Corvus shall own all right, title and interest in and to the Collaboration IND and related Regulatory Documentation.

 

(b)         Protocol.  The Protocol for such Collaboration IND is set forth in Exhibit A. Any amendments to the Protocol shall be reviewed and approved by Genentech in accordance with Section 3.1.  Subject to the terms of this Agreement, Corvus shall be responsible for preparing and filing all necessary Regulatory Documentation for the Collaboration IND and the Study.

 

(c)          Investigator’s Brochure for the Combination.  Corvus shall prepare an investigator’s brochure for the Combination.  Genentech shall provide to Corvus those portions of the investigator’s brochure (and any updates) for the Genentech Molecule that pertain to safety matters and other information that may be required by Corvus to prepare the investigator’s brochure for the Combination.  Corvus shall provide a draft of the Combination investigator’s brochure to Genentech and shall duly consider Genentech’s comments.

 

2.4       Enrollment.  Commencing on or after the date the PV Agreement is executed by the Parties, Corvus may begin enrolling Subjects in the Study in compliance with Applicable Law.  Corvus shall be responsible for tracking enrollment at Participating Sites which shall not exceed the maximum number of Subjects specified in the Protocol, unless such number is increased by an amendment to the Protocol.

 

2.5       Project Participants.  Corvus shall be solely responsible for the performance and conduct of the Project Participants, including monitoring the conduct of the Study at the Participating Sites.  Corvus shall be solely responsible for negotiating and executing the necessary agreements with all Project Participants.  Corvus shall ensure that (a) all such

 

[***] 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.

 

7

 

agreements include terms and conditions that are necessary for Corvus to comply with the terms and conditions of this Agreement (including the confidentiality provisions in Article 7); (b) all Project Participants are appropriately qualified and satisfy the requirements of Section Article 1; and (c) the compensation being paid to a Project Participant under its agreement with Corvus for the Study constitutes the fair market value of the services to be provided.  In no event shall any agreement with a Project Participant represent that any member of the Roche Group is a Sponsor or is otherwise responsible for the Study.

 

2.6       Regulatory Matters. 

 

(a)         Generally.  Corvus shall comply with all guidance and direction provided by Regulatory Authorities and IRBs with jurisdiction over the Study.  Corvus shall perform all regulatory obligations related to the Study, including preparation and submission of Regulatory Documentation for the Study, in accordance with the Protocol and Applicable Law.

 

(b)         Interactions with Regulatory Authorities.  Corvus shall promptly provide Genentech with a copy of any material notice, inquiry or correspondence that Corvus (or a Project Participant) receives from a Regulatory Authority regarding the Study (“Material Regulatory Notice”), including any serious safety matter related to a Party’s Molecule or the Combination and any inspection or investigation by a Regulatory Authority.  Genentech shall have the right (but not the obligation) to provide comments to any response to such Material Regulatory Notice and to participate in any discussions with a Regulatory Authority to the extent permitted by such Regulatory Authority. Without limiting Genentech’s obligations under Section 2.9, Genentech shall promptly provide Corvus with a copy of any [***].

 

(c)          Letter of Cross-Reference.  Promptly, but no later than [***], after the Effective Date, Genentech shall provide to Corvus a letter of cross-reference authorizing Corvus to reference certain information previously provided by Genentech in its INDs for the Genentech Molecule as support for the Combination portion of the Study in accordance with 21 CFR § 312.23(b).  Such letter of cross-reference shall remain in full force and effect unless it is withdrawn by Genentech due to termination of this Agreement by a Party.

 

2.7                               Adverse Experience Reporting.

 

(a)         Prior to enrollment of Subjects in the Study, the Parties shall enter into a pharmacovigilance agreement setting forth the Parties’ responsibilities and obligations with respect to the procedures and timeframes for compliance with Applicable Law pertaining to safety reporting of the respective Molecules and the Combination (“PV Agreement”).

 

(b)         The Parties shall cooperate in determining how to respond to adverse experience reports under the Study.  For adverse experience reports solely related to the Corvus Molecule, Corvus shall have final decision making authority.  For adverse experience reports solely related to the Genentech Molecule, Genentech shall have final decision making authority.  For adverse experience reports solely related to the Combination, [***]

 

[***] 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.

 

8

 

[***].  Notwithstanding the foregoing, Corvus may submit a response to Regulatory Authorities if required by a regulatory deadline.

 

(c)          Corvus shall be responsible for reporting adverse events from the Study to Regulatory Authorities in accordance with Applicable Law, including 21 CFR § 312.32.

 

2.8       Documentation, Updates and Final Study Report.

 

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

 

(b)         Updates.  Corvus shall provide written updates regarding the status of the Study (including enrollment status, project timelines, Genentech Molecule inventory and Genentech Molecule forecasting) to Genentech on a quarterly basis within [***] of the end of each calendar quarter or such other time as reasonably requested by Genentech.  Following receipt of such written update, Genentech may request that Corvus make available personnel and/or Project Participants (if requested by Genentech) responsible for the Study on a reasonable basis to address Genentech’s questions regarding such written update, either in person or by telephone.  Genentech shall provide a list of questions and/or topics for discussion in advance of such meeting.

 

(c)          Final Study Report.  Corvus shall complete the Study as outlined in the Protocol.  Corvus shall summarize the findings of the Study in a Final Study Report.  Corvus shall provide the Final Study Report to Genentech within [***] after Database Lock.  “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 then-existing Regulatory Authority rules, regulations and guidance on the structure and content of clinical study reports.

 

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

 

2.10                                                Costs.  [***].

 

[***] 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.

 

9

 

2.11                                                Additional Studies.  During the Term and continuing [***], Corvus agrees to negotiate exclusively with Genentech for a period of [***] prior to entering into any clinical study or clinical development agreement with a Third Party involving the combination of Corvus Molecule and any PD-L1 Antagonist or PD-1 Antagonist.  During such [***], the Parties shall discuss in good faith the terms and conditions for collaborating with each other to conduct further clinical studies of the Combination, including terms [***].

 

2.12                                                Right of First Negotiation.  During the Term and continuing through [***] (“RFN Period”), Corvus shall negotiate exclusively with Genentech for a period of up to [***] prior to entering into any agreement with a Third Party for a license relating to the development and commercialization of the Corvus Molecule (a “Corvus License”).  Notwithstanding the foregoing, if Genentech enters into a license with or acquires a Third Party with a Competitive Product during the RFN Period, Genentech will notify Corvus and all of Corvus’ obligations under this Section 2.12(a) will expire on the effective date of such transaction.  Further, Genentech will thereafter adopt reasonable procedures to prevent any disclosure and/or use of Confidential Information of Corvus or Joint Confidential Information, as the case may be, to such Third Party and provide notice to Corvus describing such procedures as soon as practicable.  For clarity, the obligations and covenants set forth in this Section 2.12(a) expressly exclude and shall not limit the separate activities of Genentech’s Affiliates, including the Roche pRED (Research and Early Development) organization.

 

(b)         If Corvus is interested in negotiating with Genentech and/or a Third Party the terms of a Corvus License during the RFN Period, it shall so notify Genentech in writing.  Thereafter, the Parties shall negotiate, on an exclusive basis, the terms and conditions of a potential Corvus License for a period of [***] after Genentech receives such notice from Corvus, or such longer time period as the Parties may mutually agree in writing (the “Exclusive Negotiation Term”). If Corvus and Genentech do not reach mutually agreeable terms and conditions of a Corvus License during the Exclusive Negotiation Term, then Corvus shall be free to negotiate and enter into a Corvus License with a Third Party; provided that Corvus shall not, during the [***] period following the end of the Exclusive Negotiation Term, enter into any Corvus License with a Third Party on terms more favorable to such Third Party than those last proposed by Genentech.  If Corvus enters into a Corvus License with a Third Party during the [***] following the end of the Exclusive Negotiation Term, Corvus shall so notify Genentech.  Genentech shall have the right, within [***] days after Corvus enters into such Corvus License, [***].

 

[***] 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.

 

10

 

ARTICLE 3
 GOVERNANCE

 

3.1       Joint Development Committee.

 

(a)         Establishment of the JDC.  Within thirty (30) days after the Effective Date, the Parties shall establish a Joint Development Committee (“Joint Development Committee” or “JDC”) to oversee the Study.  The JDC shall be composed of [***] representatives designated by each Party (and the Parties need not have the same number of representatives).  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 (each, a Party’s “JDC Co-Leader”).  Corvus’ JDC Co-Leader shall chair the Joint Development Committee (“JDC Chair”), including scheduling JDC meetings (at the request of either Party) and setting meeting agendas.  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)         Responsibilities of the JDC.  The Joint Development Committee shall be responsible for the following activities:

 

(i)                                    reviewing and approving amendments to the Protocol;

 

(ii)                                approving Participating Sites and Investigators;

 

(iii)                            reviewing the progress of the Study and making necessary joint decisions;

 

(iv)                             establishing the Data Review Committee (as described in Section Article 2) and deciding whether and how address its recommendations;

 

(v)                                 evaluating and determining how to address any safety matters related to the Combination;

 

(vi)                             reviewing the progress of the Sample Analysis Plan and making necessary joint decisions, including subsequent amendments to the Sample Analysis Plan and determining the timing for Sample Analysis to be performed by a Party and the transfer of results to the other Party;

 

(vii)                         coordinating the transfer of materials and information between the Parties, including the Study Data, the Final Study Report, the Samples and the Sample Data;

 

(viii)                     addressing any issues that may arise in the event of a shortage of supply of Corvus Molecule or Genentech Molecule for the Study, subject to Section 4.3;

 

(ix)                             attempting to resolve any Disputes related to the Study; and

 

(x)                                 performing such other functions as appropriate to further the purposes of the Study, or as otherwise specified in this Agreement.

 

(c)                                  Unanimous Decisions.  Actions and decisions to be taken by the JDC shall be made only following a unanimous vote, with each Party’s representatives on the JDC

 

[***] 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. 

 

11

 

having collectively one (1) vote.  If the JDC cannot reach unanimous agreement within [***] of a 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.

 

(d)         Meetings; Attendees; Decisions.  Once established, the Joint Development Committee shall meet at least once each calendar quarter and at such other times as deemed appropriate by the JDC.  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).  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 the Genentech Co-Leader with ten (10) business days for Genentech to review and approve such minutes.

 

(e)          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 activities, and such designees will perform such activities as determined by the JDC.

 

3.2       Data Review Committee.

 

(a)         Establishment of the DRC; Meetings.  Under the direction of the Joint Development Committee, the Parties shall establish a Data Review Committee (“Data Review Committee” or “DRC”) to monitor the safety of the Molecules being used in the Study.  The DRC shall be composed of [***].  The DRC shall [***] during the Study.

 

(b)         Responsibilities of the DRC.  The Data Review Committee shall be responsible for performing the following functions:

 

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

 

[***] 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.

 

12

 

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

 

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

 

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

 

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

 

ARTICLE 4
 SUPPLY OF STUDY DRUGS

 

4.1       Corvus Molecule.  Corvus shall use commercially reasonable efforts to supply for use in the Study, at its expense, sufficient quantities of the Corvus Molecule to conduct the Study.  Corvus represents and warrants to Genentech that the Corvus Molecule used in the Study shall be manufactured in compliance with the Specifications for the Corvus Molecule and Applicable Law.

 

4.2       Genentech Molecule.

 

(a)         Manufacture and Supply.  Genentech shall use commercially reasonable efforts to supply for use in the, at its expense, the quantities of the Genentech Molecule specified in the Molecule Supply Plan attached hereto as Exhibit C.  Genentech represents and warrants to Corvus that such Genentech Molecule shall be manufactured in compliance with: the Specifications for the Genentech Molecule, Applicable Law and the Quality Agreement.  Genentech or its designee will deliver Genentech Molecule to (i) Corvus or (ii) a Project Participant as designated by Corvus or the Joint Development Committee (for purposes of Section 4.2, “Delivery Locations”).

 

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

 

(c)          Remaining Molecule.  Upon completion or termination of the Study, Corvus shall ensure that all unused quantities of Genentech Molecule, as well as all used vials and bottles containing the Genentech Molecule, are destroyed in accordance with Corvus’ standard operating procedures and documented accordingly (including certifying such destruction in writing to Genentech), or returned to Genentech or its designated agent if requested by 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.

 

13

 

(d)         Use of Genentech Molecule.  From the Effective Date until the first to occur of Study Completion or any earlier termination of the Study, Corvus (i) has the right to use the Genentech Molecule for the purpose of conducting the Study and shall use the Genentech Molecule solely for such purpose.  Corvus shall use, store, transport, handle and dispose of the Genentech Molecule in compliance with Applicable Law, the Quality Agreement and all instructions from Genentech.  Corvus shall not use the Genentech Molecule for any research, development or commercial purpose; Corvus shall not attempt to derive or reverse engineer the composition or underlying information or structure of the Genentech Molecule, and in particular shall not analyze the Genentech Molecule by physical, chemical or biochemical means, except as necessary to perform its obligations under the Quality Agreement.  [***].  The provisions of this Section 4.2(d) shall apply to any Third Party performing Study-related activities on behalf of Corvus mutatis mutandis.

 

4.3       Insufficient Quantities.  In the event that a Party determines that there are insufficient quantities of the Corvus Molecule or the Genentech Molecule to reach Study Completion, such Party shall promptly provide written notice to the other Party, including what quantities of its Molecule, if any, are available for the Study.  The JDC will promptly discuss how to address the shortage and allocate the available amounts of Corvus Molecule or Genentech Molecule, as applicable.  Notwithstanding the foregoing, [***].

 

4.4       Quality Agreement.  Within [***] of executing this Agreement, the Parties shall enter into a quality agreement establishing the quality requirements for Genentech Molecule (“Quality Agreement”).  In the event of a conflict between the Quality Agreement and this Agreement, this Agreement shall govern and control, unless otherwise expressly provided in the Quality Agreement.

 

4.5       Mutual Obligations.  Each Party shall obtain and maintain all regulatory approvals (including facility licenses) required to manufacture its respective Molecule in compliance with Applicable Law.

 

(b)         Each Party shall notify the other Party as promptly as possible in the event any manufacturing delay (or other event) is likely to adversely affect its ability to fulfill its obligations to supply its Molecule under this Agreement.

 

(c)          Each Party hereby agrees that it shall not disclose to the other Party information related to the identity (including chemical identity), chemical structure, or sequence (amino acid or nucleic acid) of its proprietary Molecule.  [***]

 

[***] 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.

 

14

 

[***].

 

(d)         For clarity, this Agreement does not create any obligation on the part of either Party to provide its Molecule for any activities or purposes other than to conduct the Study.

 

ARTICLE 5
 STUDY DATA; SAMPLE ANALYSES AND SAMPLE DATA

 

5.1       Study Data.

 

(a)         Database.  Corvus shall maintain all Study Data in its database in accordance with Applicable Law.  [***], Corvus shall timely provide such Study Data to Genentech via electronic data transfer, in SAS format or as otherwise agreed by the Parties.

 

(b)         Ownership of Study Data.  Corvus shall own all right, title and interest in and to Study Data from the single agent arm of the Study and such Study Data shall be deemed Corvus Confidential Information.  Corvus and Genentech shall [***].  Genentech has the right to [***].

 

5.2       Samples and Sample Analyses.

 

(a)         Samples.  During the Study, Corvus will direct the collection of certain biologic samples from Subjects in both the single agent arm and Combination arm (“Samples”), as set forth in the Protocol.

 

(b)         Sample Analysis.  Each Party, [***], shall perform (directly or through an Affiliate or Third Party acting on its behalf) the testing procedures and analyses of the Samples (together “Sample Analysis”) pursuant to the sample analysis plan attached hereto as Exhibit B (“Sample Analysis Plan”).  The Sample Analysis shall be performed by a Party within [***] of receipt of the Samples or such other timeline as determined by the JDC.  Neither Party shall use the Samples for any purpose other than to perform the Sample Analyses for which it is responsible, without the prior written consent of the other Party.  Corvus shall provide to Genentech the Samples necessary for Genentech to perform the Sample Analyses.

 

5.3       Sample Data.

 

(a)         Corvus and Genentech will each generate data [***].  Each Party shall

 

[***] 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.

 

15

 

provide to the other Party the results and/or analysis generated in the course of performing Sample Analyses for both the single agent arm and the Combination arm via electronic data transfer or other format/media determined by the JDC.  Such results and/or analysis shall be provided to the other Party within [***] of completion of the assay or as otherwise agreed by the JDC.

 

(b)         Corvus shall own all right, title and interest in and to [***] shall be deemed Corvus Confidential Information.

 

(c)          Corvus and Genentech shall [***] (collectively “[***] Sample Data”).  [***] Sample Data shall be deemed Joint Confidential Information.

 

ARTICLE 6
 INTELLECTUAL PROPERTY

 

6.1       Inventorship; Ownership and Use; Definitions.

 

(a)         Inventorship.  The inventorship of any Collaboration Invention shall be determined in accordance with United States patent laws.

 

(b)         Sole Ownership and Use of Molecule-Specific Inventions

 

(i)                                    Corvus shall solely own all right, title and interest in and to any Collaboration Invention that [***] (“Corvus Owned Invention”).  For the avoidance of doubt, any Collaboration Invention generically encompassing [***], is a Corvus Owned Invention.  Corvus shall have the right to use and exploit any Corvus Owned Invention for any and all purposes.  Further, Corvus shall be obligated to disclose any such Corvus Owned Invention [***].

 

(ii)                                Genentech shall solely own all right, title and interest in and to any Collaboration Invention that [***] (“Genentech Owned Invention”).  For the avoidance of doubt, any Collaboration Invention generically encompassing [***], is a Genentech Owned Collaboration Invention.  Genentech shall have the right to use and exploit any Genentech Owned Invention for any and all purposes.  Further, Genentech shall be obligated to disclose any such 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.

 

16

 

(c)          Joint Ownership and Use of Jointly Owned Inventions.  Genentech and Corvus shall jointly own all right, title and interest in and to the any Collaboration Invention that relates to [***] (in both cases, a “Jointly Owned Invention”) and any Patent that claims or covers a Jointly Owned Invention (each, a “Joint Patent”).  Each Party shall promptly disclose to the other Party any Jointly Owned Invention.  During and after the Term, Genentech and Corvus shall use Joint Confidential Information solely in connection with [***].  After the Term, with respect to Joint Patents only, Genentech and Corvus shall [***].

 

(d)         Assignments and Cooperation.  Each Party hereby assigns to the other Party any joint or sole ownership interest in the Collaboration Inventions as necessary to effectuate ownership of the Collaboration Inventions as set forth in this Section 6.1.  Each Party shall require its employees and Third Parties acting on a Party’s behalf to assign to such Party any Collaboration Inventions conceived, reduced to practice or otherwise created by such employees or Third 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, including by executing and recording documents.

 

6.2       Licenses.

 

(a)         License to Corvus.  Genentech hereby grants to Corvus a non-exclusive, [***], sublicensable (as described in Section 6.2(c)) license, under Genentech’s right, title and interest in and to [***], solely for the purpose of performing [***] for use in the Combination.

 

(b)         License to Genentech.  Corvus hereby grants to Genentech a non-exclusive, [***], sublicensable (as described in Section 6.2(c)) license, under Corvus’ right, title and interest in and to [***], solely for the purpose of performing [***] for use in the Combination.

 

(c)          Sublicenses; Exercise of Licensed Rights by Third Parties.  Each Party may sublicense the rights granted to such Party under this Section 6.2, [***].

 

(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

 

[***] 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.

 

17

 

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.

 

6.3       Patent Prosecution and Maintenance of 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 Study Data and Sample Data in such Prosecution and Maintenance.

 

6.4       Patent Prosecution and Maintenance of Jointly Owned Inventions.

 

(a)         Prosecution and Maintenance of Joint Patents.  At [***] sole cost and expense, [***] shall be responsible for the Prosecution and Maintenance of any Joint Patent through mutually agreed outside counsel (“Outside Patent Counsel”); provided that [***] consults with [***] on the Prosecution and Maintenance of any such Joint Patents as set forth in this Section 6.4.  [***] shall instruct Outside Patent Counsel to provide each of Genentech and Corvus with copies of any and all papers associated with such Prosecution and Maintenance, including all filings, submissions and correspondence to and from a patent office pertaining to such Prosecution and Maintenance so as to give [***] reasonable opportunities to provide comments in connection with such Prosecution and Maintenance.  Genentech and Corvus shall consult with each other after receiving any substantive action or after any material development in such Prosecution and Maintenance (including issues regarding the scope of, the allowance of or the rejection of any claims and any proposed or actual response to any correspondence from a patent office in connection with any such patent applications or patents).  [***] shall consider and incorporate [***] reasonable comments with respect to such Prosecution and Maintenance.

 

(b)         Selection of Outside Patent Counsel.  Outside Patent Counsel shall be selected by [***], following consultation with [***], within [***] of the Effective Date or such other date as mutually agreed by the Parties.  During the Term, [***] may, in its sole discretion, change the selected outside counsel to new patent counsel, provided that [***] consults with [***] prior to make such change.  Following any such change of patent counsel in accordance with this Section 6.4, the new patent counsel shall be deemed “Outside Patent Counsel” for purposes of this Section 6.4.

 

(c)          Step-in Rights.  In the event that [***] declines to Prosecute and Maintain a Patent for a Jointly Owned Invention or wishes to discontinue the Prosecution and Maintenance of a Joint Patent in any countries or in particular countries, [***], at its sole option, may continue such Prosecution and Maintenance, [***].

 

(d)         Limitations on Filing of Joint Patents.  Each Party [***].  In the event [***].

 

[***] 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.

 

18

 

(e)          Joint Research Agreement.  This Agreement shall be deemed a joint research agreement under 35 U.S.C. §102(c) and any foreign counterparts entered into for the purpose of developing the combination of Corvus Molecule and Genentech Molecule.

 

(f)                                   European Patent Court. At any time prior to the end of the “transitional period” as such term is used in Article 83 of the Agreement on a Unified Patent Court between the participating Member States of the European Union, for a given relevant EU Patent, [***].  [***] as a result of taking the requested action.

 

6.5       Third Party Infringement, Third Party Challenges and Third Party Allegations of Infringement.

 

(a)         Notice.  Each Party shall promptly provide the other Party with written notice reasonably detailing any known or alleged infringement by a Third Party of any Joint Patent, including Third Party submissions and post-grant reviews, unenforceability, or non-infringement of any such Joint Patent (collectively “Third-Party Infringement”).  Within [***] after receipt of such notice, the Parties shall consult with each other to determine the response to any Third Party Infringement.

 

(b)         Enforcement or Defense.

 

(i)                                    Subject to consultation with [***] as set forth in Section 6.4(a), [***] will have the initial right to determine and control a course of action designed to curtail or address such Third Party Infringement, [***], in connection with such Third Party Infringement, against such Third Party which is infringing the Joint Patent or challenging the validity, patentability, or enforceability of the Joint Patent, at its own expense, as it reasonably determines appropriate.

 

(ii)                                [***] shall keep [***] reasonably informed as to any legal or other courses of action it pursues pursuant to this subsection (i).  [***] shall provide reasonable assistance to [***] in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action.

 

(iii)                            In connection with any such proceeding, [***] shall not enter into any settlement admitting the invalidity of, or otherwise impairing the Joint Patent without the prior written consent of [***], such consent not to be unreasonably withheld.  Any recoveries received from such an action arising from Third Party Infringement shall be applied as follows:

 

(A)                               First, [***]; and

 

[***] 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.

 

19

 

(B)                               Second, any remainder shall be paid [***] to Genentech and [***] to Corvus.

 

(iv)                             If, within [***] after [***] receipt of a notice of a Third Party Infringement, [***] does not take or decides not to take any action as described in subsection (i) against a Third Party (who is infringing such Joint Patent or is challenging the validity, patentability, or enforceability of any Joint Patent), [***] may, subject to the following sentence, in its sole discretion, bring and control any legal action in connection therewith at its sole expense.  If [***] intends to bring any such legal action, it shall first notify [***] in writing of such intent and the reasons therefor and provide [***] with an opportunity to indicate to [***] its reasons for not bringing such legal action.  If [***] provides either [***].  [***] shall keep [***] reasonably informed as to any legal or commercial courses of action it pursues pursuant to this subsection (ii).  At the request [***] of [***], [***] shall provide reasonable assistance to [***] in connection therewith, including by executing reasonably appropriate documents, and cooperating in discovery; provided, however, that nothing herein shall require [***] to join as a party or otherwise participate in such legal action unless required by law or regulation, if in [***] reasonable opinion such participation will [***]. [***] may choose, at its own expense, to be represented in any such action by counsel of its own choice; provided, however, that if [***] is required as a necessary party to such action, [***]. In connection with any such proceeding, [***] shall not enter into any settlement admitting the invalidity of or otherwise impairing any Joint Patent without the prior written consent of [***], which consent shall not be unreasonably withheld.  [***].

 

ARTICLE 7
 CONFIDENTIALITY

 

7.1       Disclosure and Use of Confidential Information.  Corvus Confidential Information and Genentech Confidential Information.  Except to the extent expressly authorized by this Agreement or otherwise agreed to in writing, each Party (the “Receiving Party”) in possession of the Confidential Information of the other Party (the “Disclosing Party”) shall: (i) hold in confidence and not disclose the Disclosing Party’s Confidential Information to any Third Party, (ii) take all reasonable precautions to protect the Confidential Information of the other Party (including all precautions a Party employs with respect to its own confidential information of a similar nature and taking reasonable precautions to assure that no unauthorized use or disclosure is made by others to whom access to the Confidential Information of the Party is granted) and (iii) only use the Disclosing Party’s Confidential Information in connection with activities contemplated by, the exercise of rights permitted by or in order to further the purposes of this Agreement.  The foregoing obligations of the Receiving Party shall

 

[***] 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.

 

20

 

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 Third 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 Joint Confidential Information, as the case may be; or

 

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

 

(b)         Joint Confidential Information.  Except to the extent expressly authorized by this Agreement (including Section 6.1(c)) or otherwise agreed to in writing, each Party shall, with regard to Joint Confidential Information, (i) hold in confidence and not disclose Joint Confidential Information to any Third Party, (ii) take all reasonable precautions to protect Joint Confidential Information (including all precautions a Party employs with respect to its own confidential information of a similar nature and taking reasonable precautions to assure that no unauthorized use or disclosure is made by others to whom access to the Confidential Information of the Party is granted) and (iii) subject to Section 6.1(c), only use Joint Confidential Information in connection with activities contemplated by, the exercise of rights permitted by or in order to further the purposes of this Agreement.

 

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 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 Article 3, 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).

 

[***] 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.

 

21

 

(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 Molecule.

 

(c)          Subcontractors.  A Party may disclose the other Party’s Confidential Information or Joint Confidential Information, as the case may be, to subcontractors to the extent such disclosure is required to conduct the Study or perform the Sample Analysis; provided that any such subcontractors are contractually bound in writing by obligations reasonably similar to those set forth in Section 7.1.

 

(d)         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 [***].

 

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

 

7.4       Termination of Prior Agreements.  As of the Effective Date, this Agreement supersedes the Non-Disclosure Agreement between Corvus and Hoffman-La Roche Inc. (covering the Roche Group, including Genentech) effective as of [***].  All “Information” (as defined in such non-disclosure agreement) exchanged between the Parties thereunder shall be deemed Confidential Information of the Disclosing Party hereunder and shall be subject to the provisions of Article 7.

 

[***] 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.

 

22

 

ARTICLE 8
 PUBLIC DISCLOSURES; USE OF NAMES

 

8.1       Clinical Trials Registries.  Corvus 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.

 

(a)         Corvus may publish or present the final results of the Study (in accordance with this Section 8.2); provided that Corvus gives Genentech an opportunity to review and provide comments in accordance with subsection (b).

 

(b)         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 [***] days (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), 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 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.

 

(c)          Authorship of publications or presentations of final results of the Study and/or any Study Data or Sample Data shall be determined in accordance with appropriate scientific and academic standards and customs.

 

8.3       Press Releases and Other Public Disclosures.

 

(a)         Generally.  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 Protocol.  The provisions of Section 8.3 are in addition to the provisions of Article 7.

 

[***] 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.

 

23

 

(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(d)), 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 law, rule or regulation (including the disclosure requirements of the Securities and Exchange Commission or the securities exchange or other stock market 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 securities laws, rules and regulations, and will not rely on any statements made by the other Party relating to such securities laws, rules and regulations.

 

(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 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 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 the 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 (or 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.  Corvus shall obtain the informed written consent of all Subjects participating in the Study, in accordance with Applicable Law.  [***]

 

[***] 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.

 

24

 

[***].  Corvus shall provide copies of such informed written consents upon Genentech’s request.  Corvus further represents and warrants that the Samples may be used as contemplated in this Agreement [***].

 

9.2       IRB Approval.  Corvus shall obtain IRB review and approval of the 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.  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 use reasonable efforts 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.

 

(a)         In addition to providing Study Data to Genentech under Section 5.1(a), [***]

 

[***] 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.

 

25

 

[***].

 

(b)         Corvus (or its designee) shall maintain such records for at least the period of time 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.  Corvus shall require each Project Participant to represent and warrant that neither the 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, Corvus shall promptly notify Genentech, and the Parties shall agree upon appropriate action to address the matter.

 

ARTICLE 12
 TERM; TERMINATION

 

12.1                                                Term.  Unless sooner terminated as provided in Article 12, this Agreement shall expire on the one year anniversary of the date that Corvus provides the Final Study Report to Genentech or termination of the Study (in either case, “Term”).

 

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, if such breach is not cured within [***] after the allegedly 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

 

[***] 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.

 

26

 

of time that the Parties agree to in writing is reasonably necessary to cure such breach, so long as the allegedly breaching Party is using diligent efforts to do so.

 

12.3                                                Termination for Other Reasons.  Either Party may terminate this Agreement immediately, by notice to the other Party, if: (a) based on a review of Study Data or other Study-related information, such Party determines that the Study may unreasonably affect patient safety; (b) any Regulatory Authority or IRB withdraws the authorization and/or approval to conduct the Study; (c) any Regulatory Authority takes any action, or raises any objection, that prevents such Party from supplying its Molecule for purposes of the Study; (d) the other Party breaches the representation and warranty under Section 13.1(c); or (e) such Party determines, in its sole discretion, to discontinue all development of its Molecule, for medical, scientific, business or legal reasons, [***].

 

12.4                                                Effects of Termination or Expiration.

 

(a)         Study Wind-Down.  Following termination of this Agreement under Section 12.2 or Section 12.3, the Parties shall cooperate to ensure the orderly wind-down of Study activities, taking into consideration the safety and welfare of Subjects.

 

(b)         Accrued Rights and Obligations.  Except as otherwise expressly provided in this Agreement, termination of this Agreement 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)          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 2.6 (Regulatory Matters), Section 1.1(a) (Documentation), Section 2.11 (Additional Studies), Section 2.12 (Right of First Negotiation), Section 5.1(b) (Ownership of Study Data), Sections 5.3(b) and (c) (Sample Data), Article 6 (Intellectual Property and Licenses), Article 7 (Confidentiality), Article 8 (Public Disclosures; Use of Names), Section 9.3 (Patient Privacy and Data Protection), Section 10.2(a) (Records), Section 12.4 (Effects of Termination), Section 13.2 (Disclaimers), Section 14.1 (Indemnification), Section 14.2 (Limitation on Liability), 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.

 

27

 

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)         Such Party has not entered into prior to the Effective Date, and shall not enter into during the Term, any agreement that conflicts with a Party’s obligations hereunder.

 

(c)          Neither 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.  If such Party receives notice of debarment, suspension, sanction, exclusion, ineligibility or disqualification under the foregoing-referenced statutes, such Party shall promptly notify the other Party, and the Parties shall agree upon appropriate action to address the matter.

 

13.2                                                Disclaimers.  NEITHER PARTY REPRESENTS OR WARRANTS THAT THE STUDY WILL BE SUCCESSFUL OR LEAD TO ANY PARTICULAR RESULT.  EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO ITS RESPECTIVE MOLECULE, MATERIALS OR INFORMATION SUPPLIED BY IT TO THE OTHER PARTY HEREUNDER, AND EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.

 

ARTICLE 14
 INDEMNIFICATION; LIMITATION ON LIABILITY; INSURANCE

 

14.1                                                Indemnification.

 

(a)         Definitions.  The following definitions are for purposes of Section 14.1:

 

(i)                                    “Claims” means claims, suits, actions, demands or other proceedings by any Third Party arising out of this Agreement or the Study, including product liability 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)).

 

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

 

[***] 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.

 

28

 

(b)         Indemnification by Genentech.

 

(i)                                    Indemnification Scope.  Genentech hereby agrees to indemnify, defend 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 in connection with Claims, to the extent such Losses (A) arise out of or in connection with (1) the negligence or willful misconduct of any Genentech Indemnitees; (2) Genentech’s breach of any of its representations, warranties, covenants or obligations under this Agreement; or (3) Genentech’s breach of any Applicable Law pertaining to activities it performs under this Agreement or (B) are directly caused by the Genentech Molecule.

 

(ii)                                Procedures.  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 settle or conclude such defense; (C) cooperate as reasonably requested (at the expense of Genentech) in the defense of such Claim; and (D) not settle such Claim without the express, prior written consent of Genentech.  Genentech’s obligations under Section 14.1(b)(i) shall not apply (A) to amounts paid in settlement of any Claims if such settlement is effected without Genentech’s consent or (B) to the extent any Losses arise out of or in connection with (1) the negligence or willful misconduct of any Corvus Indemnitees; (2) Corvus’ breach of any of its representations, warranties, covenants or obligations under this Agreement; or (3) Corvus’ breach of any Applicable Law pertaining to activities it performs under this Agreement.

 

(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 in connection with Claims, to the extent such Losses (A) arise out of or in connection with (1) the negligence or willful misconduct of any Corvus Indemnitees; (2) Corvus’ breach of any of its representations, warranties, covenants or obligations under this Agreement; or (3) Corvus’ breach of any Applicable Law pertaining to activities it performs under this Agreement or (B) are directly caused by the Corvus Molecule.

 

(ii)                                Procedures.  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 settle or conclude such defense.  In the event that Genentech requests that Corvus assume such control, Genentech shall (A) cooperate as reasonably requested (at the expense of Corvus) in the defense of such Claim and (B) not settle such Claim without the express, prior written consent of Corvus.  Corvus’ obligations under Section 14.1(c)(i) shall not apply (A) to amounts paid in settlement of any Claims if such settlement is effected without Corvus’ consent or (B) to the extent any Losses arise out of or in connection with (1) the negligence or willful misconduct of any Genentech Indemnitees; (2) Genentech’s breach of any of its representations, warranties, covenants or

 

[***] 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.

 

29

 

obligations under this Agreement; or (3) Genentech’s breach of any Applicable Law pertaining to activities it performs under this Agreement.

 

(d)         Limitations.  The failure of an Indemnitee to deliver notice to the other Party (for purposes of this Section 14.1(d), 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.

 

(e)                                  Study Subjects.  [***]

 

14.2                                                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 14.2 IS INTENDED TO LIMIT THE RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER SECTION 14.1.

 

14.3                                                Insurance.

 

(a)         General.  Each Party shall maintain insurance coverage as set forth in Section 14.3; provided, however, Genentech has the right, in its sole discretion, to self-insure, in part or in whole, for any such coverage.  Insurance coverage shall be primary insurance with respect to each Party’s own participation under this Agreement and shall be maintained with an insurance company or companies having an A.M. Best’s rating (or its equivalent) of A-VII or better.  On request, each Party shall provide to the other Party certificates of insurance evidencing the insurance coverage required under Section 14.3.  Each Party shall provide to the other Party at least [***] notice of any cancellation, nonrenewal or material change in any of the required insurance coverages.  The limits of any required insurance coverage shall not limit the Parties’ liability under the indemnification provisions of this Agreement.

 

(b)         Genentech Coverage.  Genentech shall maintain product liability insurance relating to the Genentech Molecule provided by Genentech under this Agreement, for limits no less than [***] per occurrence and [***] in the aggregate.

 

(c)          Corvus Coverage.  Corvus shall maintain in full force and effect through the term of this Agreement, sufficient insurance, including (i) commercial general liability (including contractual liability) insurance covering bodily injury and property damage arising out of Corvus’ obligations under this Agreement, for limits no less than [***] per occurrence and [***] in the aggregate and (ii) product liability insurance relating to the Corvus Molecule provided by Corvus under this Agreement, for limits of no less than [***] per occurrence and [***] in the aggregate.  For claims-made type coverage, product liability

 

[***] 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.

 

30

 

insurance shall be maintained for a minimum of [***] after the last Subject receives treatment in connection with the Study (which may be achieved, without limitation, by way of an extended reporting period endorsement), including any treatment received after Study Completion, but not less than the statute of limitations in the state or location where the Study is being conducted.  Corvus shall ensure prior to the enrollment of any Subjects 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.  Corvus and Genentech recognize that a dispute, controversy or claim of any nature whatsoever arising out of or relating to this Agreement (each, a “Dispute”) may from time to time arise during the Term.  In the event of the occurrence of such a Dispute, the Parties shall first refer such Dispute to the JDC pursuant to Section 3.1(c).  If the JDC cannot resolve such Dispute, the Party bringing the Dispute shall provide written notice, including a description of the Dispute and the steps taken to resolve such Dispute, to the other Party.  Upon receipt of such notice, the Dispute shall be referred to [***] and [***] for resolution, prior to proceeding under the other provisions of Article 15.  In the event that such Dispute is not resolved within [***] of such other Party’s receipt of such notice, [***].  For all other Disputes not subject to final decision making authority of a Party, either Party may commence an arbitration to resolve such Dispute in accordance with Section 15.2.

 

15.2                                                Arbitration.  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 conducted by the American Arbitration Association in accordance with the then prevailing Commercial Arbitration Rules of the American Arbitration Association (for purposes of Article 15, the “Rules”), except as modified in this Agreement, applying the substantive law specified in Section 16.2.

 

(a)         Arbitrators; Location.  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 both (i) dispute resolution experience (which may include judicial experience) and (ii) legal or business experience in the biotech or pharmaceutical industry.  If a Party fails to nominate its arbitrator, or if the Parties’ arbitrators cannot agree on

 

[***] 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.

 

31

 

the third arbitrator, the necessary appointments shall be made in accordance with the Rules.  Once appointed by a Party, such Party shall have no ex parte communication with its appointed arbitrator.  The arbitration proceedings shall be conducted in [***].

 

(b)         Procedures; Awards.  Each Party agrees to use reasonable efforts to make all of its then current employees available, if reasonably needed, and agrees that the arbitrators may deem any employee or person as necessary to the arbitration.  The arbitrators shall be instructed and required to render a written, binding, non-appealable resolution and award on each issue that clearly states the basis upon which such resolution and award is made.  The written resolution and award shall be delivered to the Parties as expeditiously as possible, but in no event more than ninety (90) days after conclusion of the hearing, unless otherwise agreed by the Parties.  Judgment upon such award may be entered in any competent court or application may be made to any competent court for judicial acceptance of such an award and order for enforcement.  Each Party agrees that, notwithstanding any provision of applicable law or of this Agreement, it will not request, and the arbitrators shall have no authority to award punitive or exemplary damages against any Party.

 

(c)          Interim Equitable Relief.  Notwithstanding anything to the contrary in Article 15, in the event that a Party reasonably requires relief on a more expedited basis than would be possible pursuant to the procedure set forth in Article 15, such Party may seek a temporary injunction or other interim equitable relief in a court of competent jurisdiction pending the opportunity of the arbitrators to review the decision under Article 15.  Such court shall have no jurisdiction or ability to resolve disputes beyond the specific issue of temporary injunction or other interim equitable relief.

 

(d)         Protective Orders; Arbitrability.  At the request of either Party, the arbitrators shall enter an appropriate protective order to maintain the confidentiality of information produced or exchanged in the course of the arbitration proceedings.  The arbitrators shall have the power to decide all questions of arbitrability.

 

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 scope, enforceability, validity or infringement of any Corvus Patent, Genentech Patent or Joint Patent (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 resides; and (b) that is issued in any other country shall be brought before an appropriate regulatory or administrative body or court in that country, and 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.

 

[***] 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.

 

32

 

ARTICLE 16
 MISCELLANEOUS

 

16.1                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 16.1.  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 (with delivery confirmed); 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

 

If to Genentech:

 

Genentech, Inc.

1 DNA Way

South San Francisco, CA 94080

Attn:  Corporate Secretary

Telephone:  (650) 225-1000

Facsimile:  (650) 467-9146

 

[***] 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.

 

33

 

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

 

16.2                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.

 

16.3                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 16.3, either Party may assign this Agreement, in part or in its entirety, to (a) an Affiliate; (b) an acquirer of all its capital stock (by reverse triangular merger or otherwise) or all or substantially all its assets; or [***] (for purposes of Section 16.3, any of the foregoing, a “Change of Control”), provided that in the event of any Change of Control, the Third 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 thirty (30) days of the assignment.  Subject to the foregoing and other applicable provisions of Section 16.3, this Agreement will inure to the benefit of and bind 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 16.3, 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 (i) [***] or (ii) [***] (directly or indirectly) or the like.  Corvus, including its acquiring party, shall (i) [***] and (ii) provide [***].  The foregoing obligations shall also apply if Corvus or a Corvus Affiliate [***].

 

[***] 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.

 

34

 

16.4                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.

 

16.5                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.

 

16.6                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.

 

16.7                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 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.

 

16.8                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.

 

16.9                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.

 

[***] 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.

 

35

 

16.10              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.

 

36

 

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 Miller 
    	
 
    	
Signed:
    	
/s/   Mark Davis
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Richard   A. Miller 
    	
 
    	
Name:
    	
Mark   Davis 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
CEO
    	
 
    	
Title:
    	
Lifecycle   Leader
    

 

[Signature page to PhI/Ib 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.

 

 

CONFIDENTIAL

 

EXHIBIT A

 

 

PROTOCOL FOR THE STUDY

 

[see separate attachment]

 

[***] 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.

 

Exhibit A-1

 

CONFIDENTIAL

 

EXHIBIT B

 

SAMPLE ANALYSIS PLAN

 

[***]

 

[***] 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.

 

Exhibit B-1

 

CONFIDENTIAL

 

EXHIBIT C

 

GENENTECH MOLECULE SUPPLY PLAN

 

Schedule of Deliveries for the Genentech Molecule

 

Genentech will supply the quantities of Genentech Molecule set forth below. [***].

 

The delivery dates below are based on the [***].

 

[***]

 

Genentech Molecule 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.

 

Exhibit C-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.

 

Exhibit C-2

 

CONFIDENTIAL

 

CLINICAL STUDY PROTOCOL

 

Adenosine-2A Receptor Antagonist CPI-444

 

 

863 Mitten Road, Suite 102

Burlingame, CA 94010-1311

Telephone: +1 (650) 900-4520

email: Admin@CorvusPharma.com

 

	
Study Title
    	
A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection   Study of CPI-444 as Single Agent and in Combination with Atezolizumab in   Patients with Selected Incurable Cancers
    
	
 
    	
 
    
	
Protocol Number
    	
CPI-444-001
    
	
 
    	
 
    
	
Development Phase
    	
Phase 1
    
	
 
    	
 
    
	
IND Number
    	
126,559
    
	
 
    	
 
    
	
Drug Substance
    	
Adenosine-2A (A2A) Receptor Antagonist CPI-444

 

[***]
    
	
 
    	
 
    
	
Indication
    	
Treatment of patients with selected incurable cancers
    
	
 
    	
 
    
	
Medical Monitor
    	
[***]
   Vice President of Clinical Development
   Corvus Pharmaceuticals, Inc.
   Phone: [***]
   Email:   [***]
    
	
 
    	
 
    
	
Sponsor
    	
Corvus Pharmaceuticals, Inc.
   863 Mitten Road, Suite 102
   Burlingame, CA 94010
    
	
 
    	
 
    
	
Protocol Version: Date
    	
Original: September 24, 2015
    

 

The information contained in this document, particularly unpublished data, is the property or under control of Corvus Pharmaceuticals, Inc. (Corvus) and is provided to you in confidence as an investigator, potential investigator, or consultant, for review by you, your staff, and an applicable Institutional Review Board or Independent Ethics Committee. The information is only to be used by you in connection with authorized clinical studies of the investigational drug described in the protocol. Your acceptance and use of this document is subject to the condition that no information contained herein will be published or disclosed without first obtaining written approval from Corvus Pharmaceuticals, Inc., except to the extent necessary to obtain informed consent from those persons to whom the drug may be administered. If you do not agree to this condition, please return the document to Corvus at the above address.

 

[***] 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

24   September 2015

Phase   1/1b Clinical Study Protocol
    	
Corvus Pharmaceuticals, Inc.

CPI-444

IND 126,559
    

 

[***]

 

[***] 105 Pages of Exhibit A constituting the Relevant Clinical Study Protocol have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted pages.

 

2exhibit_10-1.htm

Exhibit 10.1

 

AGREEMENT FOR THE PROVISION OF A LOAN FACILITY

OF UP TO US$ 20,000,000

 

Dated December 30, 2015

Between

KREOS CAPITAL V (EXPERT FUND) L.P. a company incorporated in Jersey whose registered office is at 47 Esplanade, St Helier, Jersey (the “Lender”, which expression shall include its successors and assigns);

and

REWALK ROBOTICS LTD., a company incorporated in Israel under registered number 513121376 whose registered office is at Three Hatnufa Street, 6th Floor, P.O. Box 161, Yokneam 2069203, Israel (the “Borrower”).

WHEREAS:

	
1.

	
The Borrower wishes to borrow up to the Total Loan Facility (as defined below) and the Lender wishes to make the Total Loan Facility available to the Borrower on the terms of this agreement (the “Loan Agreement”); and

	
2.

	
The Borrower hereby confirms that on or about the date hereof it shall enter into the Initial Security Documents as security for monies borrowed by the Borrower hereunder under which it shall grant to the Lender, as security for monies borrowed by the Borrower hereunder, (A) a first priority fixed charge over the Equipment and the Intellectual Property of the Borrower as well as all shares held by the Borrower in ReWalk Robotics Inc. and Argo Medical Technologies GmbH (the “Fixed Charge”), and (B) a first priority floating charge over all the assets of the Borrower as of the date hereof or hereafter acquired (the “Floating Charge”).

LOAN FACILITY TERMS:

	
Total Loan Facility

	
Up to US$20,000,000 to be drawn down as follows:

 

US$12,000,000 (“Amount A”); and

 

Up to US$8,000,000 (“Amount B”), subject to the conditions set forth in Section ‎3.5.1‎(ix) herein.

 

	
Drawdown Date/Period

	
With respect to Amount A – January 4, 2016;

 

With respect to Amount B – from January 4, 2016 until the Expiry Date of Amount B (“Drawdown Period”);

 

	
Expiry Date

	
With respect to Amount B only - December 31, 2016.

(subject to Clause ‎3.4 below).

 

	
 

Advance Payment

	
 

Last month deposit for each Tranche (as defined below).

 

	
 

Repayment Term

	
 

Thirty six (36) months (in respect of each Tranche) as follows: Twelve (12) monthly repayments of interest only followed by twenty-four (24) or thirty six (36) monthly repayments of principal and interest accrued thereon, all as set forth in Clause ‎3.4 below.

	
 

Transaction Fee

	
 

1.00% of the Total Loan Facility (Amount A and Amount B), payable upon execution of this Loan Agreement.

 

	
 

End of Loan Payment

	
 

1.00% of each Tranche (as defined below) upon the termination of such Tranche.

 

	
Minimum Drawdown Amount

 

	
With respect to Amount B- US$ 2,000,000 (subject to Clause ‎3.4 below).

 

 

  

  

  

 

	
1

	
DEFINITIONS

In this Loan Agreement, including the recitals set out above, unless otherwise defined:

	
1.1

	
“Accounts” means the audited annual consolidated profit and loss account and balance sheet of the Borrower.

 

	
1.2

	
“Advance Payment” has the meaning given in Clause ‎5.1 and is in the amount set forth above in the Loan Facility Terms;

 

	
1.3

	
“Affiliate” means, in relation to any person, a subsidiary of that person or a holding company of that person or any other subsidiary of that holding company;

 

	
1.4

	
“Applicable Interest Rate” has the meaning given in Clause ‎6.1;

 

	
1.5

	
“Assignee” has the meaning given in Clause ‎16.4;

 

	
1.6

	
“Business Day” means any day on which banks are generally open for business in London and Tel Aviv other than a Friday, Saturday or Sunday;

	
1.7

	
“Charged Assets” means the assets and undertaking charged or to be charged to the Lender from time to time pursuant to the Security Documents;

 

	
1.8

	
“Companies Registrar” means the Registrar of Companies in Israel;

 

	
1.9

	
“Contractual Currency” has the meaning given to it in Clause ‎5.2.6;

 

	
1.10

	
“Debentures” Means the Debenture – First Ranking Fixed Charge and the Debenture – First Ranking Floating Charge signed between the Borrower and the Lender on December 28, 2015.

 

	
1.11

	
“Drawdown” means the drawdown of a Tranche under the Loan Facility;

 

	
1.12

	
“Drawdown Date” means, unless otherwise provided herein, the date on which any Tranche is actually advanced to the Borrower by the Lender;

 

	
1.13

	
“Drawdown Notice” means a drawdown notice served in accordance with Clause ‎3.2 in the form attached hereto as Schedule A (as may be amended with the prior written consent of the Lender);

 

  

2

  

 

	
1.14

	
“End of Loan Payment” means the End of Loan Payment set forth above under the Loan Facility Terms;

 

	
1.15

	
"Equipment" means all the equipment of the Borrower as listed in Schedule B.

 

	
1.16

	
“Event of Default” means any of the events or circumstances described in Clause ‎9;

 

	
1.17

	
“Expiry Date” means the date set forth above under the heading Loan Facility Terms;

 

	
1.18

	
“Financial Indebtedness” means (i) monies borrowed, (ii) finance or capital leases, (iii) receivables sold or discounted (other than on a non-recourse basis), (iv) other transactions having the commercial effect of borrowing, (v) the market to market value of derivative transactions entered into in connection with protection against or benefit from fluctuation in any rate or price, (vi) counter-indemnity obligations in respect of guarantees or other instruments issued by a bank or financial institution, (vii) any other transaction or arrangement having the commercial effect of a borrowing, and (viii) liabilities under guarantees or indemnities for any of the obligations referred to in items (i) to (vii);

 

	
1.19

	
“Group” means (i) the Borrower and its subsidiaries, (ii) any holding company of the Borrower, and (iii) any subsidiaries of such holding companies from time to time and “Group Company” means any member of the Group;

 

	
1.20

	
“Intellectual Property” means copyrights and related rights (including, without limitation, rights in computer software), patents, supplementary protection certificates, utility models, trademarks, trade names, service marks, domain name registrations, registered and unregistered rights in designs, database rights, semi-conductor topography rights, plant variety rights, rights in undisclosed or confidential information (such as know-how, trade secrets and inventions (whether patentable or not)), and other similar intellectual property rights (whether registered or not) and applications for such rights as may exist anywhere in the world;

 

	
1.21

	
“Initial Security Documents” means the documents listed in Schedule C and dated on or about the date of this Loan Agreement;

 

	
1.22

	
Reserved.

 

	
1.23

	
“Loan” means the loan to be made in accordance with the terms of this Loan Agreement;

 

	
1.24

	
“Loan Facility” means the loan facility set out in this Loan Agreement;

 

	
1.25

	
“Loan Term” means with respect to each Tranche, the period commencing on the Drawdown Date and expiring  thirty six (36) Monthly Repayment Date thereafter; In the event the Borrower raises, in a new equity financing round (including, for the avoidance of doubt, loans and/or securities convertible into shares, provided that, such loans and/or securities shall be conditioned to the following (the “Conditions to Future Convertible Loans”): (i) be subordinated to the Lender’s Loan; (ii) be repaid only after the Borrower’s full repayment of the last Tranche including any fees and/or End of Loan Payments to the Lender under the provisions of this Agreement; (iii) not create any Security Interest except any Permitted Security Interest; and (iv) the provider of such loans and/or securities shall sign a subordination agreement in the form approved by the Lender), an aggregate amount of at least US$20,000,000, the Loan Term shall mean with respect to each Tranche, the period commencing on the Drawdown Date and expiring forty eight (48) Monthly Repayment Date thereafter;

 

  

3

  

 

	
1.26

	
“Material Adverse Change” is (a) a material adverse change in the operations, or condition (financial or otherwise) of the Borrower, provided, however, that a "Material Adverse Change" shall not include (a) changes in the management of the Borrower; (b) the Borrower's product not being approved by the US Food and Drug Administration; (c) any declaration or acts of war, hostilities or terrorism or any escalation or worsening of any acts of war, armed hostilities or terrorism in any country or region in which the Borrower or any of its subsidiaries or a material portion of their business is situated, or in which major customer(s) or sources of supply are situated; or (d) changes in general economic conditions or changes affecting the industry generally in which Borrower or any of its subsidiaries operate.

 

	
1.27

	
“Minimum Drawdown Amount” means the minimum amount permitted to be drawn down in each Tranche as set forth above under the heading Loan Facility Terms;

 

	
1.28

	
“Monthly Repayment Date” means the first Business Day of a calendar month, and “First Monthly Repayment Date” shall mean the first Monthly Repayment Date following the Drawdown Date;

 

	
1.29

	
“Permitted Indebtedness” means (a) bank credit not to exceed US$400,000; (b) indebtedness for current taxes or other governmental or regulatory assessments which are not delinquent, or which are contested in good faith by the appropriate procedures and for which appropriate reserves are maintained; (c) indebtedness in favor of the Lender; (d) indebtedness incurred for the acquisition of supplies or inventory on normal trade credit as provided in the budget as approved by the Borrower's board of directors from time to time (with a deviation of not more than 10%); (e) indebtedness in favor of customs and revenue authorities arising as a matter of law to secure payments of customs duties in connection with the importation of goods; (f) any indebtedness in favor of the Office of Chief Scientist; and (g)   indebtedness which have been approved by Lender, at its reasonable discretion, provided that such debt is subordinated to the Lender.

 

	
1.30

	
“Permitted Security Interests” means: (a) security interests on any property held or acquired in the ordinary course of business securing the purchase price of such property or indebtedness incurred or assumed solely for the purpose of financing all or any part of the cost of acquiring such property; (b) security interests in an account number 12600/93 (or any account replacing such account) created on April 4, 2015, in the amount of NIS 1,200,000 in favor of Bank Leumi Le'Israel B.M. for the purpose of the Company’s obligations to lease the premises, as registered with the Israeli Registrar of Companies; (c) debt approved by Lender with a subordination agreement approved by the Lender; (d) bankers’ indebtedness, rights of setoff and similar indebtedness incurred on deposits made in the ordinary course of business; and (e) materialmen’s, mechanics’, repairmen’s, employees’ or other like indebtedness arising in the ordinary course of business.

 

  

4

  

 

	
1.31

	
“Related Fund” in relation to a fund (the “First Fund”), means a fund which is managed or advised by the same investment manager or investment adviser as the First Fund or, if it is managed by a different investment manager or investment adviser, a fund whose investment manager or investment adviser is an Affiliate of the investment manager or investment adviser of the First Fund;

 

	
1.32

	
“Repayment Schedule” has the meaning given in Clause ‎5.2.1;

 

	
1.33

	
“Security Documents” means the Initial Security Documents, and any other applicable document evidencing the security over assets of the Borrower (or any Group Company), or (for the avoidance of doubt) any document creating a Security Interest in favor of the Lender;

 

	
1.34

	
“Security Interest” means any mortgage, charge (whether fixed or floating, legal or equitable), pledge, lien, hypothecation, assignment by way of security or otherwise, trust arrangement, title retention or encumbrance or enforceable right of a third party, any other type of Security Interest or preferential arrangement having a similar effect to any of the foregoing or in the nature of security of any kind whatsoever and in any jurisdiction;

 

	
1.35

	
“Security Period” means the period commencing on the first Drawdown Date and ending on the date on which all amounts due and payable by the Borrower under this Loan Agreement and the Security Documents have been repaid in full, including the End of Loan Repayment of the last Tranche;

 

	
1.36

	
“Taxes” means all present and future income, value added and other taxes, levies, imposts, deductions, charges and withholdings in the nature of taxes (other than taxes on the profits and overall income of the Lender) whatsoever together with interest thereon and penalties with respect thereto made on or in respect thereof;

 

	
1.37

	
“Total Loan Facility” means the amount set forth above under the heading Loan Facility Terms;

 

	
1.38

	
“Tranche” an amount drawn down pursuant to this Loan Agreement as set forth above under the heading Loan Facility Terms;

 

	
1.39

	
“Transaction Fee” has the meaning given in Clause ‎10.1 and is the amount set forth above in the Loan Facility Terms;

 

	
1.40

	
“Warrant Instrument” means a warrant instrument in agreed form to be issued by the Borrower to the Lender on the date of this Loan Agreement.

 

	
2

	
INTERPRETATION

In this Loan Agreement (unless the context requires otherwise) any reference to:

	
2.1

	
any law or legislative provision includes a reference to any subordinate legislation made under that law or legislative provision before the date of this Loan Agreement, to any modification, re-enactment or extension of that law or legislative provision made before that date and to any former law or legislative provision which it consolidated or re-enacted before that date;

 

  

5

  

 

	
2.2

	
any gender includes a reference to other genders and the singular includes a reference to the plural and vice versa;

 

	
2.3

	
a Clause or Schedule is to a Clause or Schedule (as the case may be) of or to this Loan Agreement;

 

	
2.4

	
a “person” shall be construed as including a reference to an individual, firm, company, corporation, unincorporated body of persons or any country (or state thereof or any agency thereof);

 

	
2.5

	
an “amendment” includes a supplement, novation or re-enactment executed by both Lender and Borrower in writing and “amended” is to be construed accordingly;

 

	
2.6

	
“assets” includes present and future properties, undertakings, revenues, rights and benefits of every description;

 

	
2.7

	
an “authorization” includes an authorization, consent, approval, resolution, license, exemption, filing, registration and notarization;

 

	
2.8

	
a “regulation” includes any regulation, rule, official directive, request or guideline (whether or not having the force of law) of any governmental, inter-governmental or supranational body, agency, department or regulatory, self-regulatory or other authority or organization;

 

	
2.9

	
“other” and “otherwise” are not to be construed ejusdem generis with any foregoing words where a wider construction is possible and “including” and “in particular” are to be construed as being by way of illustration or emphasis only and are not to be construed as, nor shall they take effect as, limiting the generality of any foregoing words;

 

	
2.10

	
a document being in “agreed form” is a document which is previously agreed in writing by or on behalf of the Lender and the Borrower;

 

	
2.11

	
any reference to an Event of Default being continuing is a reference to an Event of Default that has not been remedied to the reasonable satisfaction of the Lender; and

 

	
2.12

	
the headings in this Loan Agreement are inserted for convenience only and do not form part of this Loan Agreement and do not affect its interpretation.

 

	
3

	
LOAN FACILITY

 

	
3.1

	
Lender’s Commitment

	
3.1.1

	
Subject to Clause ‎3.5 below, the Lender shall and agrees hereby to make available to the Borrower a loan facility of up to the Total Loan Facility under the terms of this Loan Agreement, to be drawn down as set out in the Loan Facility Terms and in accordance with Clause ‎3.2 before the Expiry Date of the Loan Facility.

 

The Borrower shall not be under any commitment or obligation to draw down or borrow any amount out of Amount B under this Loan Agreement.

 

	
3.1.2

	
The Lender shall not be under any commitment to advance any Tranche or any part thereof after the Expiry Date or upon the earlier termination of the Loan Facility in accordance with Clause ‎3.4.

 

	
3.1.3

	
The unutilized portion (if any) of Amount B shall be cancelled after the Expiry Date, whereupon the Total Loan Facility available for Drawdown shall be reduced accordingly.

 

  

6

  

 

	
3.1.4

	
In granting the Loan Facility the Lender is relying on the representations and warranties contained in Clause ‎7.

 

	
3.1.5

	
Each Drawdown made under the Loan Facility shall be secured by the Security Documents.

 

	
3.2

	
Date of Advance(s) of the Loan

	
3.2.1

	
Subject to Clause ‎3.1.2, (and subject to the satisfaction of the relevant conditions set forth in Clause ‎3.5), Amount A shall be advanced and made available to the Borrower on January 4, 2016 and together with the execution of this Agreement, the Borrower shall execute a Drawdown Notice as to Amount A and Amount A shall be advanced and made available to the Borrower within ten (10) Business Days from receipt by the Lender of an executed Drawdown Notice.

 

	
3.2.2

	
With respect to Amount B only, subject to Clause ‎3.1.2, (and subject to the satisfaction of the relevant conditions set forth in Clause ‎3.5), each Tranche shall be advanced and made available to the Borrower within ten (10) Business Days from receipt by the Lender of an executed Drawdown Notice. Each Drawdown Notice shall constitute a separate and independent obligation of the Borrower incorporating the terms of this Loan Agreement.  No more than one Drawdown Notice may be served in respect of each Tranche. Each Tranche requested to be advanced out of Amount B pursuant to a Drawdown Notice shall be in an amount equal to or greater than the Minimum Drawdown Amount except for the last Tranche in the amount of the remaining Total Loan Facility which can be made in a lower amount.

 

	
3.3

	
Method of Disbursement

The payment by the Lender to the account specified in the Drawdown Notice shall constitute the making of the Loan (or the relevant part thereof) and the Borrower shall thereupon become indebted, as principal and direct obligor, to the Lender in an amount equal to the Loan (or the relevant part thereof).

 

	
3.4

	
Termination or Modification of Funding Commitment

The Lender’s commitment to advance each Tranche of the Loan in accordance with the terms of this Loan Agreement is limited in aggregate to the amount of the Total Loan Facility; provided, however, that the Lender, acting in its sole discretion, may terminate or modify its funding commitment pursuant to this Loan Agreement at any time if, in the opinion of the Lender:

	
3.4.1

	
there is any Material Adverse Change  in the general affairs, business, management, results of operations, or financial condition  of the Group whether or not arising from transactions in the ordinary course of business;

 

	
3.4.2

	
there is any material deviation by the Borrower from its business plan (as it may have been supplemented in writing with the prior consent of the Lender) presented to the Lender prior to the date of this Loan Agreement, provided however that such deviation results in Material Adverse Change;

 

	
3.4.3

	
on either the date of the Drawdown Notice or at the Drawdown Date:

 

	
  

	
(i)

	
an Event of Default has occurred and is continuing or would result from the borrowing to be made pursuant to the Drawdown Notice; or

 

	
  

	
(ii)

	
the Borrower’s representations and warranties in Clause ‎7.1 or those which are set out in any Security Document would not be true in all material respects if repeated on each of those dates with respect to the circumstances then existing taking into account the time that has lapsed since the representations and warranties were made;

 

  

7

  

 

	
3.5

	
Conditions Precedent requirements relative to the Advance of the Loan

 

	
3.5.1

	
The Lender’s obligation to provide the Loan (or any part thereof) is subject to the satisfaction by the Borrower of the following conditions:

 

	
  

	
(i)

	
the provision of a duly executed copy of the resolution of the Borrower’s board of directors authorizing the transactions contemplated by this Loan Agreement and the execution and delivery to the Lender of this Loan Agreement and associated documents, including but not limited to, the Security Documents;

 

	
  

	
(ii)

	
certified copies of the Certificate of Incorporation and the Articles of Association of the Borrower;

 

	
  

	
(iii)

	
all necessary consents of any third parties (including landlords, to the extent required) with respect to the entering into of this Loan Agreement and the execution of associated documents, including but not limited to, any Security Documents, have been obtained;

 

	
  

	
(iv)

	
submission of the Security Documents to the Companies Registrar or any equivalent in any relevant foreign jurisdiction and registration of the Security therein and the approval thereof, subject to compliance with all applicable laws in respect of such registration within the time frame provided for under applicable law.

 

	
  

	
(v)

	
the Borrower’s compliance with Clause ‎10.1 and evidence of the Borrower’s compliance with Clause ‎12.2.3 below.

 

	
  

	
(vi)

	
delivery of a copy of the financial model and forecasts for the Group as reasonably requested by the Lender;

 

	
  

	
(vii)

	
the most recent reports to the Board of the Borrower;

 

	
  

	
(viii)

	
certified copies of any policies of insurance maintained by the Borrower or any other Group Company in respect of the Charged Assets including such insurances as are required pursuant to and complying in all material respects with the requirements of Clause ‎12 shall be provided to the Lender;

 

	
  

	
(ix)

	
Subject to the Permitted Security Interests, the Charged Assets being free and clear of all Security Interests of third parties whatsoever (including, for the avoidance of doubt, Kreos IV (Expert Fund) Limited;

 

	
  

	
(x)

	
the legal opinion of counsels for the Borrower - Goldfarb Seligman & Co., Law Offices, in form and substance satisfactory to the Lender; and

 

	
  

	
(xi)

	
With respect to Amount B, only, the Borrower shall have raised an aggregate amount of at least US$10,000,000 in consideration for the issuance of shares (including, for the avoidance of doubt, loans and/or securities convertible into shares, provided that, such loans and/or securities shall be conditioned to the following the Conditions to Future Convertible Loans).

 

  

8

  

	
3.5.2

	
Each copy document delivered under this Clause ‎3.5 shall be either in its original form or certified as a true and up to date copy by a director or the company secretary of the Borrower.

	
3.5.3

	
This Agreement, the Security Documents and the Warrant Instrument shall be delivered to the Borrower in original form.

 

	
3.5.4

	
The Borrower on the date of this Loan Agreement shall deliver to the Lender an original of the Warrant Instrument.

 

	
3.6

	
Waiver Possibility

If the Lender advances all or any part of the Loan to the Borrower prior to the satisfaction of all or any of the conditions referred to in Clause ‎3.5 (which the Lender has no obligation to do) the Borrower shall satisfy or procure the satisfaction of such condition or conditions which have not been satisfied within fourteen (14) Business Days of the Drawdown Date (or within such longer period as the Lender may agree or specify in writing), provided, that the Lender at its sole discretion may waive the satisfaction of any condition.

 

	
3.7

	
Equipment

 

	
  

	
The existing Equipment of the Borrower as listed in Schedule B (as may be amended from time to time with the consent of the Borrower and the Lender) shall be part of the Security Interest of the Lender and be included in the Fixed Charge. Future purchases of any Equipment purchased until (and including) the last day of the Security Period ("New Equipment") shall, in addition  be made subject to the provisions of this Loan Agreement and form part of the Security and shall be charged by way of either listing such New Equipment to the relevant schedule in the Debenture - Fixed Charge, to be amended accordingly, or, at the Lender's election, as a separate supplemental Fixed Charge (which shall be part of the Security Documents hereunder), and submitted to and registered with the Companies Registrar (at the Lender’s request, Schedule B hereto shall be replaced or supplemented from time to time to reflect any addition of such New Equipment as aforesaid); it being agreed that, at any time until the end of the Security Period, the Borrower shall be obliged to register any additional Fixed Charge and/or US Security Interest in favor of the Lender only at such time as the aggregate value of the New Equipment exceeds US$ 50,000, provided that in any event, upon Lender's request, the Borrower shall register a Fixed Charge and/or US Security Interest on any New Equipment in favor of the Lender within seven (7) days following the last Business Day of each calendar year during the Security Period, regardless of the value of such New Equipment. For the avoidance of doubt, in addition, the Equipment is subject to the Floating Charge and any New Equipment shall become subject to the Floating Charge as soon as an interest therein is acquired by Borrower (without any further action being required to effect the same).

 

  

9

  

 

	
3.8

	
Intellectual Property

 

	
  

	
The registered Intellectual Property of the Borrower as of the date hereof is listed in Schedule D (as may be amended from time to time with the consent of the Borrower and the Lender) and is covered by the Fixed Charge.

 

Future applications for registration of Intellectual Property of the Borrower shall, in addition, be made subject to the provisions of this Loan Agreement and form part of the Security Interest of the Lender and be charged by way of either listing such new Intellectual Property on the relevant schedule in the Fixed Charge and/or US Security Interest, as applicable, to be amended accordingly, or, at the Lender's election, as a separate supplemental Fixed Charge and/or US Security Interest (and, at the Lender’s request, Schedule D hereto shall be replaced or supplemented from time to time to reflect any addition of such new Intellectual Property as aforesaid), and, in either case, submitted to and registered with the Companies Registrar, and with respect to applications for registration of Intellectual Property submitted to the Companies Registrar, submitted to the Israeli Patent Office or to the United States Patent and Trademark Office until (and including) the last day of the Security Period ("New Registered Intellectual Property") shall, in addition, be submitted to and registered with the Israeli Patent Office and/or the United States Patent and Trademark Office, as applicable; it being agreed that, at any time until the end of the Security Period, the Borrower shall be obliged to create and register any such additional Fixed Charge in favor of the Lender, as follows:

 

	
  

	
(i)

	
with respect to New Registered Intellectual Property, the Borrower shall be obliged to notify the Lender within five (5) Business Days of the day of filing of each New Registered Intellectual Property, and upon Lender's request, within seven (7) Business Days from registration of such New Registered Intellectual Property by the Borrower and if such registration is not possible under the rules governing such New Registered Intellectual Property, then, no later than seven (7) days from the date on which the charge of such New Registered Intellectual Property becomes registrable;

 

	
  

	
(ii)

	
with respect to other new unregistered Intellectual Property, if any, at the request of the Lender and in any event within seven (7) days following the last Business Day of each calendar year and if such registration is not possible under the rules governing such new registered Intellectual Property, then, no later than seven (7) days from the date on which the charge of such new registered Intellectual Property becomes registrable; and

 

  

10

  

 

	
  

	
(iii)

	
with respect to any future applications for registration of Intellectual Property submitted by the Borrower in countries other than Israel and the United States, , the Borrower shall be obliged to notify the Lender within five (5) Business Days of the day of filing of each such application, and upon Lender's request,  the Borrower will be obliged to create and register an additional Fixed Charge (as aforesaid) in favor of the Lender within seven (7) Business Days from request of the Lender and if such registration is not possible under the rules governing such Intellectual Property, then, no later than seven (7) Business Days from the date on which the charge of such Intellectual Property becomes registrable.

 

For the avoidance of doubt, in addition, the Intellectual Property of the Borrower is subject to the Floating Charge and any New Intellectual Property of the Borrower shall become subject to the Floating Charge as soon as an interest therein is acquired by Borrower (without any further action being required to effect the same).

 

	
3.9

	
Charged Assets

	
3.9.1

	
Unless the Lender shall otherwise agree in writing, the Borrower shall use the Loan solely for the purpose of general working capital. The Lender shall not be under any obligation to concern itself with the application of the Loan.

 

	
3.9.2

	
The Charged Assets charged to the Lender pursuant to the Security Documents shall form security for the monies borrowed by the Borrower.

	
3.10

	
Condition Precedent: OCS Approval.

	
3.10.1

	
This Loan Agreement, all Security Documents and Debentures are subject to the prior written approval of the Office of the Chief Scientist in the Ministry of Economy of the State of Israel (the "OCS").

	
3.10.2

	
Notwithstanding anything to the contrary in this Loan Agreement, including without limitation the Security Documents and Debentures, the exercise of the Fixed Charge, Floating Charge and any Security Interest and/or other Lender's interest in the Charged Assets, shall be subject to OCS approval and any applicable payments required by the Law for the Encouragement of Industrial Research and Development, 5756-1996 (the "R&D Law").

 

	
4

	
TERM

 

	
4.1

	
This Loan Agreement is effective upon execution by the Lender and the Borrower and shall continue until the later of (i) the Expiry Date (subject to Section 3.1.2) and (ii) the date upon which the Borrower shall have performed all its obligations hereunder.

 

	
4.2

	
If the conditions set out in Clause ‎3.5 have not been satisfied within forty-five (45) days of the execution of this Loan Agreement (except to the extent waived in writing by the Lender), the Lender shall in its sole discretion have the option to either terminate this Loan Agreement or extend the period in which such conditions must be satisfied.

 

  

11

  

 

	
4.3

	
For as long as no amount was actually withdrawn by the Borrower under this Loan Agreement, or if the Borrower elects to prepay the Loan in whole, subject to the conditions set forth in Section 5.4 below, then, upon such payment, Borrower shall have the right to terminate this Loan Agreement, provided, however, that there are no further outstanding obligations of the Borrower under this Loan Agreement.

 

	
5

	
REPAYMENT AND PREPAYMENT

 

	
5.1

	
Advance Payment

	
  

	
On delivery of each Drawdown Notice with respect to a Tranche, the Borrower shall pay to the Lender (by way of deduction by Lender from the amount of the Tranche actually advanced to the Borrower) the advance payment specified above in the Loan Facility Terms with respect to the applicable Tranche (the “Advance Payment”) which shall be held by the Lender and applied in or towards payment of the last repayment in respect of that particular Tranche.

 

	
5.2

	
Repayments

 

	
5.2.1

	
The Borrower shall pay all unpaid and accrued interest in respect of each Tranche (principal and interest accrued thereon) separately by way of standing order ("Hora'at Keva"), by way of thirty-six (36) monthly payments as follows: twelve (12) equal monthly payments, each such payment of interest only, based on an annual rate of 10.75%  and principal and interest accrued thereon in twenty-four (24) equal monthly payments, each such payment in an amount equal to 4.6079% of the amount of such Tranche.

 

	
5.2.2

	
Notwithstanding the above, in the event the Borrower raises an aggregate amount of at least US$20,000,000 in consideration for the issuance of shares (including, for the avoidance of doubt, loans and/or securities convertible into shares, provided that, such loans and/or securities shall be conditioned to the following the Conditions to Future Convertible Loans) then the Repayment Term for each Tranche shall be amended retroactively to forty eight (48) months (in respect of each Tranche) as follows: Twelve (12) monthly repayments of interest only followed by thirty six (36) monthly repayments of principal and interest accrued thereon, each such payment in an amount equal to 3.2331% of the amount of such Tranche. In such event, the Repayment Schedule (as defined in Section ‎‎5.2.1) shall be amended and replaced accordingly.

 

	
5.2.3

	
Each monthly payment shall be paid to the Lender on the first Business Day of each calendar month or, if such day is not a Business Day, the first Business Day thereafter, commencing on (and including) the first calendar month following the Drawdown Date of such Tranche, all as specified in a fully-amortizing repayment schedule issued by the Lender prior to the Drawdown Date (the “Repayment Schedule”).

 

Subject to Clause ‎5.2.4, each payment received by the Lender in respect of any Tranche shall be applied as follows:

 

	
5.2.3.1

	
firstly, to discharge all outstanding fees, costs and expenses of or due to the Lender in respect of such Tranche;

 

  

12

  

 

	
5.2.3.2

	
secondly, to discharge all accrued interest in respect of such Tranche; and

 

	
5.2.3.3

	
thirdly, to reduce the outstanding principal balance of such Tranche.

 

	
5.2.4

	
For the avoidance of doubt, the Lender may in its discretion apply any payment received or recovered from the Borrower to discharge any unpaid amount in respect of any Tranche.

 

	
5.2.5

	
Any amount repaid or prepaid may not be redrawn.

 

	
5.2.6

	
If the Drawdown Date is not a Monthly Repayment Date, the Borrower shall pay to the Lender on the Drawdown Date (by way of deduction by the Lender of the amount of the Tranche actually advanced to the Borrower) the Interim Repayment which shall discharge interest accrued on the Tranche for the period from the Drawdown Date to First Monthly Repayment Date. For the purpose of this Clause ‎5.2.6 “Interim Repayment” shall mean the payment in respect of interest accruing during the period from each Drawdown Date to the first Monthly Repayment Date being the amount of interest accruing at the Applicable Interest Rate on the amount drawn down for the period from and including the Drawdown Date to First Monthly Repayment Date.

 

	
5.3

	
Currency of Payments

Repayment of the Loan and payment of all other amounts owed to the Lender will be paid in US Dollars (the “Contractual Currency”), unless otherwise agreed by the parties in writing. The Borrower shall bear the costs in the event of and in respect of any conversion of a currency to the Contractual Currency. The exchange rate will be defined at the time of each Drawdown.

 

	
5.4

	
Prepayments

The Borrower shall be entitled to prepay the Loan, in whole but not in part, subject to the following conditions:

 

	
5.4.1

	
The Borrower shall submit to the Lender an irrevocable written notice for prepayment of the applicable Tranche, at least thirty (30) days in advance, indicating the amount to be prepaid (the "Prepayment Sum") and the date of prepayment, provided that such prepayment shall be made on the last day of a calendar month;

 

	
5.4.2

	
In the event that the Borrower prepays the Loan in accordance with this Section ‎5.4, the Prepayment Sum shall be the outstanding principal of the Loan (without any interest) plus  (i) in case prepayment is made within twelve (12) months of the principal repayments of the Tranche, an amount of 5% of the outstanding principal of the Loan Facility Amount at the time; or (ii) in case prepayment is made between month twelve (12) and twenty-four (24) of the principal repayment, an amount equal to 3% of the outstanding principal of the Loan at that time; or (iii) in case prepayment is made after month twenty-four (24) of the principal repayment, an amount equal to 1% of the outstanding principal of the Loan at that time.

 

	
5.4.3

	
The Borrower shall also pay the Lender:

 

	
5.4.3.1

	
the End of Loan Payment;

 

	
5.4.3.2

	
all unpaid Transaction Fee (if any); and

 

	
5.4.3.3

	
all other sums payable by the Borrower to the Lender hereunder (including without limitations the fees and payment to be made according to the provisions of Section ‎10 and Section ‎11 herein below);

 

  

13

  

 

	
6

	
INTEREST

	
6.1

	
Interest on the principal amount of each Tranche from time to time shall accrue from day to day until repayment of the applicable Tranche at a rate of 10.75% per annum, from the Drawdown Date until the repayment in full of such Tranche (the “Applicable Interest Rate”). Interest on each Tranche and each part thereof shall be calculated and paid in the Contractual Currency.

	
6.2

	
Time of payment of any sum due from the Borrower is of the essence under this Loan Agreement. If the Borrower fails to pay any sum to the Lender on its due date for payment and during five (5) Business Days thereafter, the Borrower shall pay to the Lender forthwith on demand interest on such sum from the original due date to the date of actual payment (as well after as before judgment) at a rate equal to the Applicable Interest Rate plus 5% per annum.

	
6.3

	
Unless otherwise instructed in writing by the Lender, immediately upon each due date for effecting any interest payment under or pursuant to this Loan Agreement and the Security Documents to which the Borrower is or is to be party, or upon actually paying any interest in advance of the due date for any reason, the Borrower shall report such payment to the relevant Israeli tax authorities, on behalf of the Lender, pay in full (or offset based on self-invoicing) the value added tax liability arising in accordance with Section 6D of the Israeli Value Added Tax Regulations 5736-1976 and the Israeli Value Added Tax Law 5735-1975, and shall provide the Lender with documentation evidencing such payment (or offset based on self-invoicing), provided, however, that commencing upon Lender's request and continuing afterward until otherwise notified by Lender, the Borrower shall pay in full any applicable value added tax directly to Lender (or such agent of the Lender as the Lender may direct in written) against delivery of an Israeli VAT invoice which is valid under the Israel Value Added Tax Law 5735-1975 and its regulations  (i.e., Lender will have an Israeli VAT file)..

 

	
7

	
REPRESENTATIONS AND WARRANTIES OF THE BORROWER

	
7.1

	
The Borrower warrants and represents the following as of the date hereof:

	
7.1.1

	
ReWalk Robotics Ltd. is a public company whose ordinary shares are listed for trading on Nasdaq, duly organized and validly existing under the laws of Israel.

 

	
7.1.2

	
The Borrower has the corporate capacity, and has taken all corporate action and obtained all consents, including third party consents, necessary for it:

	
  

	
(i)

	
to execute this Loan Agreement and the Security Documents to which the Borrower is or is to be party;

 

	
  

	
(ii)

	
to borrow under this Loan Agreement and to make all the payments contemplated by, and to comply with all its other obligations under this Loan Agreement and the Security Documents to which the Borrower is or is to be party; and

 

  

14

  

 

	
  

	
(iii)

	
to grant the Lender first priority Security Interest in respect of the Charged Assets (subject to the OCS rules and regulations as set forth in the Debentures)     pursuant to the Security Documents to which the Borrower is or is to be party;

	
7.1.3

	
this Loan Agreement and the Security Documents will, upon execution and delivery (and, where applicable, registration as provided for in this Loan Agreement and the Security Documents):

	
  

	
(i)

	
constitute the Borrower’s legal, valid and binding obligations enforceable against the Borrower in accordance with their respective terms; and

 

	
  

	
(ii)

	
create legal, valid and binding Security Interests enforceable in accordance with their respective terms (subject to the OCS rules and regulations as set forth in the Debentures), subject to any relevant insolvency laws affecting creditors’ rights generally;

	
7.1.4

	
the execution and (where applicable) registration by the Borrower of this Loan Agreement and each Security Document to which it is or is to be party, and the borrowing by the Borrower of the Loan and its compliance with this Loan Agreement and each Security Document to which it is or is to be party, will not involve or lead to a contravention of:

	
  

	
(i)

	
any applicable law or other legal requirement; or

 

	
  

	
(ii)

	
the constitutional documents of the Borrower; or

 

	
  

	
(iii)

	
any contractual or other obligation or restriction which is binding on the Borrower or any of its assets;

	
7.1.5

	
all consents, licenses, approvals and authorizations required by the Borrower in connection with the entry into, performance, validity and enforceability of this Loan Agreement and the Security Documents to which it is or is to be party have been or (upon execution thereof) shall have been obtained by the Drawdown Date and are (or upon execution thereof shall be) in full force and effect during the life of this Loan Agreement;

 

	
7.1.6

	
all financial and other information furnished by or on behalf of the Borrower in connection with the negotiation of this Loan Agreement and the Security Documents pursuant to this Loan Agreement or the Security Documents was true and accurate in all material respects when given, there are no other facts or matters the omission of which would have made any statement or information contained therein misleading in any material respect and all projections and statements of belief and opinion given to the Lender were made in good faith after due and careful enquiry;

 

	
7.1.7

	
all payments made or to be made by the Borrower under or pursuant to this Loan Agreement and the Security Documents to which the Borrower is or is to be party shall be made following deduction or withholding for, or on account of, any taxes for which withholding is required pursuant to applicable law and/or tax ruling of the applicable tax authorities.

 

  

15

  

 

	
7.1.8

	
the Accounts were prepared in accordance with accounting principles and practices generally accepted in Israel or the US, and consistently applied and fairly represent (in conjunction with the notes thereto) the financial condition of the Borrower as at the date to which they were drawn up and the results of the Borrower’s operations during the financial year then ended;

 

	
7.1.9

	
since execution of the Accounts, there has been no Material Adverse Change in the business or financial condition of the Borrower and/or any of its subsidiaries;

 

	
7.1.10

	
there is no action, proceeding or claim pending or, so far as the Borrower is aware or ought reasonably to be aware, threatened against any Group Company before any court or administrative agency which might have a material adverse effect on the business, condition of operations of the Borrower or any subsidiary;

 

	
7.1.11

	
subject to the Permitted Security Interests, the Borrower owns good and marketable title in all the Charged Assets, free from all Security Interests and other interests and rights of every kind, and all the Charged Assets are in good operating condition and repair, and are adequate for the uses to which they are being put, and none of such Charged Assets are in need of maintenance or repairs except for ordinary, routine maintenance and repairs that are not material in nature or cost. It is clarified that part of the Charged Assets are subject to restrictions set forth in the R&D Law and the regulation promulgated thereunder; and

 

	
7.1.12

	
the Borrower’s representations and warranties set out in this Clause ‎7 shall survive the execution of this Loan Agreement until the end of the Security Period and shall be deemed to be repeated on each Drawdown Date and each date of repayment with respect to the facts and circumstances then existing, as if made at such time.

 

	
7.1.13

	
The Borrower's representations and warranties set out in this Clause ‎7 are subject to the applicable OCS approvals set out in Clause 3.10 above.

 

	
7.2

	
REPRESENTATIONS AND WARRANTIES OF THE LENDER

 

	
7.2.1

	
It is duly organized and validly existing under the laws of its jurisdiction of incorporation, and has the full power and authority to consummate the transactions contemplated hereunder. The consummation of the transactions contemplated hereunder and the performance of this Agreement by it do not violate the provisions of its corporate documents, or any applicable law, and will not result in any breach of, or constitute a default under, any agreement or instrument to which it is a party or under which it is bound.

 

	
7.2.2

	
The execution and performance of this Agreement by it have been duly authorized by all necessary actions, and this Agreement has been duly executed and delivered by it. This Agreement is valid and binding upon it and enforceable in accordance with its terms.

 

	
8

	
UNDERTAKINGS

 

The Borrower undertakes to the Lender to comply with the following provisions of this Clause ‎8 at all times during the Security Period, except as the Lender may otherwise permit:

 

	
8.1.1

	
the Borrower will (and will procure that each Group Company will) obtain, effect and keep effective all permissions, licenses, consents and permits which may from time to time be required (i) in connection with the Charged Assets and (ii) to conduct its business;

 

  

16

  

 

	
8.1.2

	
With the exception of the Permitted Security Interest, the Borrower will (and to the extent any Group Company has charged its assets pursuant to a Security Document, the Borrower shall procure that this Group Company shall) own only for its own account the Charged Assets free from all Security Interests, except for those created by the Security Documents, and shall not (and shall ensure that no other Group Company will) create or permit to subsist any security over any of its assets;

 

	
8.1.3

	
the Borrower will not (and shall procure that each Group Company will not) sell, assign, transfer or otherwise dispose of any of the Charged Assets (except for the Charged Assets charged under the Floating Charge (as set forth in the Debentures), which may be sold, assigned, transferred or otherwise disposed in the ordinary course of business), without the Lender's prior written consent, and shall give immediate notice to the Lender of any judicial process or encumbrance affecting the Charged Assets;

 

	
8.1.4

	
Reserved;

 

	
8.1.5

	
the Borrower will provide the Lender (and will procure that each Group Company will provide the Lender) with:

 

 (i) for as long as the Borrower is a public company, annual audited, and quarterly reviewed but unaudited,  consolidated financial statements of the Borrower.  In the event the Borrower becomes a private company, the Borrower then shall provide monthly, and quarterly reviewed but unaudited, consolidated financial statements of the respective Group Company;

 

(ii) such other information (financial or otherwise) as the Lender may reasonably request from time to time concerning any of the Group Company and its affairs (including, without limitation, information concerning the Charged Assets, its assets from time to time and any request for amplification or explanation of any item in the financial statements, budgets or other material provided by the Borrower under this Loan Agreement).

 

	
8.1.6

	
the Borrower will provide to the Lender all documents, confirmations and evidence required by the Lender to satisfy its “know your customer” requirements or similar identification checks in order to meet its obligations from time to time under applicable money laundering, or similar, laws and regulations;

 

	
8.1.7

	
the Borrower will provide the Lender with annual audited consolidated financial statements for each Group Company within one hundred and fifty (150) days of the end of fiscal year of the respective Group Company;

 

	
8.1.8

	
the Borrower will (and will procure that each Group Company will) within ten (10) days from the board of directors' approval, provide a budget showing a projected consolidated balance sheet as of the end of each financial year, a projected profit and loss account, and a cash flow forecast for the forthcoming financial year;

 

  

17

  

 

	
8.1.9

	
the Borrower will deliver (and shall procure that each Group Company will deliver) to the Lender copies of all notices, minutes, consents and other materials formally sent to the board of directors at the same time they are delivered to the directors. Upon the occurrence of an Event of Default and for as long as the Borrower shall be in default, the Lender shall be entitled to have a representative to attend all meetings of the Borrower’s (and each Group Company’s) board of directors in a non-voting observer capacity, provided that such representative shall have executed a confidentiality undertaking in a form satisfactory to both the Lender and the Borrower. The Lender's observer may be excluded from participation in certain meeting(s) of the board of directors (or any part thereof), if based on the legal advice of the legal counsel of the Company such observer may have a personal or conflict of interest in the subject matter thereof. The Borrower agrees (and shall procure that each Group Company agrees) to give notice of all board meetings to the Lender at the same time as to its directors.

 

	
8.1.10

	
the Borrower will (and will procure that each Group Company will) maintain in force and promptly obtain or renew, and will promptly send certified copies to the Lender of, all consents to the extent required:

	
  

	
(i)

	
for the Borrower and each Group Company to perform its obligations under this Loan Agreement and each Security Document, as relevant;

 

	
  

	
(ii)

	
for the validity or enforceability of this Loan Agreement and any Security Document; and

 

	
  

	
(iii)

	
for the Borrower and each Group Company to continue to own the Charged Assets,

and the Borrower will, and will procure that each Group Company will, comply with the terms of all such consents;

	
8.1.11

	
the Borrower will notify the Lender as soon as it becomes aware of:

	
  

	
(i)

	
the occurrence of an Event of Default; or

 

	
  

	
(ii)

	
any matter which indicates that an Event of Default has occurred or, may have occurred,

	
  

	
and will thereafter keep the Lender fully up to date with all developments;

	
8.1.12

	
the Borrower will (and shall ensure that each Group Company will) maintain adequate risk protection through insurances on and in relation to its business and assets to the extent reasonably required on the basis of good business practice taking into account, inter alia, its (and any Group Company’s) financial position and nature of operations. All insurances must be with reputable independent insurance companies or underwriters;

 

	
8.1.13

	
the Borrower shall not (and shall ensure that no Group Company will) incur or allow to remain outstanding any Financial Indebtedness, except:

	
  

	
(i)

	
Any Permitted Indebtedness or any other indebtedness under this Loan Agreement;

 

  

18

  

 

	
  

	
(ii)

	
where a Group Company is lending to or borrowing from the Borrower or another Group Company;

 

	
  

	
(iii)

	
non-speculative hedging transactions entered into in the ordinary course of business in connection with protection against interest rate or currency fluctuations; or

 

	
  

	
(iv)

	
arising in the ordinary course of business with suppliers of goods with a maximum duration of 90 days;

 

	
8.2

	
The Borrower shall, to the extent reasonably possible, affix to the Equipment (as listed in Schedule B attached hereto and as to be amended from time to time with the consent of the Borrower and the Lender) permanent indications of Lender's interest in the Equipment, and shall not remove or hide them and shall comply with Lender's request in assisting Lender with all perfection requirements under the laws of the State of Israel and pursuant to and in accordance with the provisions of the Security Documents;

 

	
8.2.1

	
With the exception of the Permitted Indebtedness, the Borrower shall not (and shall ensure that no Group Company will) incur or allow to remain outstanding any Financial Indebtedness, unless such Financial Indebtedness is on terms (including interest, repayment and subordination) satisfactory to the Lender at its sole discretion;

 

	
8.2.2

	
With the exception of the Permitted Security Interest, the Borrower shall not (and shall ensure that no other Group Company will) create or permit to subsist any Security Interest over any of its assets;

 

	
8.2.3

	
the Borrower shall not (and shall ensure that no other Group Company will):

	
  

	
(i)

	
sell, transfer or otherwise dispose of any of its assets on terms whereby they are leased to or intended to be re-acquired by any Group Company; or

	
  

	
(ii)

	
sell, transfer or otherwise dispose of any of its receivables on recourse terms;

	
  

	
(iii)

	
enter into any arrangement under which money or the benefit of a bank or other account may be applied, set-off or made subject to a combination of accounts; or

	
  

	
(iv)

	
enter into any other preferential arrangement having a similar effect in circumstances where the arrangement or transaction is entered into primarily as a method of raising Financial Indebtedness or of financing the acquisition of an asset.

 

	
8.2.4

	
the Borrower will not (and shall ensure that no other Group Company will) make any distribution by way of dividend or otherwise without the prior written consent of the Lender;

 

	
8.2.5

	
the Borrower shall be responsible for all costs associated with the Charged Assets including all tax assessments, insurance premiums, operating costs and repair and maintenance costs as well as any fees associated with registering of any security granted in connection with this Loan; and

 

	
8.2.6

	
the Borrower shall at the request of the Lender from time to time (and shall procure that each Group Company) execute and deliver such further documents creating Security Interests in favor of the Lender over such Charged Assets and in such form as the Lender may reasonably require in its discretion from time to time to: (i) secure all monies, obligations and liabilities of the Borrower and/or any Group Company to the Lender or (ii) facilitate the realization of the Charged Assets or (iii) exercise the powers conferred on the Lender or a receiver appointed under any Security Document, from time to time.

 

  

19

  

 

	
8.2.7

	
During the Loan Term the Borrower shall provide the Lender with a first offer for additional debt or loan financing fifteen (15) Business Days prior to the time that such requests are provided to other financing sources (the "Notice of First Offer"). Should the Lender and the Borrower fail to agree on the terms and conditions of such financing within five (5) Business Days from the date of receipt of the Notice of First Offer by the Lender, then the Borrower may accept a funding source other than the Lender.

 

	
9

	
EVENTS OF DEFAULT

 

	
9.1

	
An Event of Default occurs if:

 

	
9.1.1

	
the conditions set out in Clause ‎3.5  (except to the extent waived in writing by Lender) are not satisfactorily accomplished within forty five (45) days of signature of this Loan Agreement unless the period for satisfactory accomplishment is extended in accordance with Clause ‎4.2; or

 

	
9.1.2

	
any Group Company fails to pay when due and payable or (if so payable) on demand any sum payable under this Loan Agreement or the Security Documents or under any document relating to the Security Documents; or

 

	
9.1.3

	
any other breach by any Group Company (as relevant) of any material provision of this Loan Agreement or any Security Document occurs, or if the Borrower or any Group Company does not comply with, perform or observe any other material obligation accepted or material undertaking given by it to the Lender, unless the Lender (at its sole discretion) notifies the Borrower in writing that it is satisfied that the breach has not put any of the security for the Loan immediately at risk and that it considers that the breach is capable of remedy, and within ten (10) Business Days after the Lender serves on the Borrower a notice of default under this Loan Agreement, or such longer period as the Lender may specify in such notice, the Borrower remedy the breach to the satisfaction of the Lender; or

 

	
9.1.4

	
any representation, warranty or statement made by the Borrower, or by an officer of, any Group Company in this Loan Agreement or the Security Documents or in the Drawdown Notice or any other notice or document relating to this Loan Agreement or any other Security Document is incorrect, untrue or misleading in any material respect when it is made or deemed repeated; or

 

	
9.1.5

	
Financial Indebtedness of any Group Company in an amount which the Lender considers to be material (which shall not be below US$ $400,000) is not paid when due or any Security Interests over any of the assets of any Group Company is lawfully enforced; or

 

	
9.1.6

	
any order shall be made by any competent court, a petition presented or any resolution shall be passed by any Group Company for the appointment of a liquidator, administrator or receiver of, or for the winding up of, any Group Company or a moratorium is imposed or declared over any or all of the assets and business of any Group Company and, in any such case, such order, resolution or declaration is not set aside, cancelled or revoked within thirty (30) days after being made or passed provided that (i) the Borrower has informed the Lender in writing shortly after first notification that it intends to contest such enforcement order and (ii) the Borrower has actively contested such enforcement order within 10 days after being made or passed; or

 

  

20

  

 

	
9.1.7

	
an encumbrancer takes possession of or a receiver, liquidator, supervisor, compulsory manager, trustee, administrator or similar official is appointed over the whole or, in the opinion of the Lender, any material part of, the assets of any Group Company or a distress, execution or other process is levied or enforced upon or sued out against the whole or, in the opinion of the Lender, a material part of the assets of any Group Company, and, in any such case, either such procedure is not terminated within thirty (30) days after commencement provided that (i) the Borrower has informed the Lender in writing shortly after first notification that it intends to contest such enforcement order and (ii) the Borrower has actively contested such enforcement within 10 days after commencement of such enforcement order; or

 

	
9.1.8

	
any judgment made against any Group Company is not paid, stayed or discharged within 14 days; or

 

	
9.1.9

	
any Group Company shall stop payment or shall be unable to, or shall admit inability to, pay its debts as they fall due, or shall be adjudicated or declared bankrupt or insolvent, or shall enter into any composition or other arrangement with its creditors generally; or

 

	
9.1.10

	
any event shall occur which under the law of any jurisdiction to which any Group Company is subject has an effect equivalent or similar to any of the events referred to in Clause ‎9.1.6, ‎9.1.7 or ‎9.1.9; or

 

	
9.1.11

	
any Group Company ceases, threatens to cease, or suspends carrying on its business or a part of its business which is material in the context of this Loan Agreement and the Security Documents; or

 

	
9.1.12

	
it becomes unlawful or impossible (i) for the Borrower and/or each Group Company (as relevant) to discharge any liability under this Loan Agreement or to comply with any other obligation which the Lender considers material under this Loan Agreement or the Security Documents, or (ii) for the Lender to exercise or enforce any right under, or to enforce any Security Interest created by, this Loan Agreement or the Security Documents; or

 

	
9.1.13

	
any provision of this Loan Agreement or the Security Documents proves to have been or becomes invalid or unenforceable, or a security interest created by the Security Documents proves to have been or becomes invalid or unenforceable or such a security interest proves to have ranked after, or loses its priority to, another security interest or any other third party claim or interest, provided however that if the Borrower and/or any Group Company proposes replacement security which the Lender accepts, and such replacement security is constituted in a manner acceptable to the Lender within such period of time as the Lender may require, such event shall cease to constitute an Event of Default; or

 

  

21

  

 

	
9.1.14

	
the security constituted by the Security Documents is in any way materially imperiled or in jeopardy (including by way of depreciation in value beyond a normal depreciation), provided however that if the Borrower and/or any Group Company proposes replacement security which the Lender accepts, and such replacement security is constituted in a manner acceptable to the Lender within such period of time as the Lender may require, such event shall cease to constitute an Event of Default; or

 

	
9.1.15

	
any other event (whether related or not) occurs in the business affairs, operations, assets or condition (financial or otherwise) of the Group, the effect of which is, in the reasonable opinion of the Lender, to materially imperil, delay or prevent the due fulfillment by the Borrower and each Group Company of any of its obligations or undertakings under this Loan Agreement or the Security Documents; or

 

	
9.1.16

	
any event of default (howsoever described) specified in the Security Documents shall occur.

 

	
9.2

	
Lender’s Rights

On or at any time following the occurrence of any Event of Default the Lender may:

 

	
9.2.1

	
serve on the Borrower a notice stating that all obligations of the Lender to the Borrower under this Loan Agreement including (without limitation) the obligation to advance the Loan (or any part thereof) are terminated; and/or

 

	
9.2.2

	
serve on the Borrower a notice stating that the Loan, all accrued interest and all other amounts accrued or owing under this Loan Agreement and the Security Documents are immediately due and payable; and/or

 

	
9.2.3

	
Subject to applicable OCS approvals set forth in Clause ‎3.10 above, take any other action which, as a result of the Event of Default or any notice served under Clauses ‎9.2.1 or ‎9.2.2 above, the Lender is entitled to take under the Security Documents or any applicable law.

 

	
9.3

	
End of Lender’s Obligations

On the service of a notice under Clause ‎9.2.1 and/or Clause ‎9.2.2, all the obligations of the Lender to the Borrower under this Loan Agreement shall terminate

 

	
9.4

	
Acceleration

	
  

	
On the service of a notice under Clause ‎9.2.2, the following sums shall become immediately due and payable:

	
9.4.1.1

	
the outstanding principal amount of the Loan;

 

	
9.4.1.2

	
all accrued and unpaid interest;

 

	
9.4.1.3

	
in respect of each Tranche, the aggregate of the monthly interest payments scheduled to be paid by the Borrower on each Monthly Repayment Date (as is set out in the most recent Repayment Schedule issued by the Lender) for the period from the date of prepayment to the expiry of the Loan Term, in each case discounted from the applicable Monthly Repayment Date to the date of prepayment at the rate of 2% per annum;

 

	
9.4.1.4

	
the End of Loan Payment;

 

  

22

  

 

	
9.4.1.5

	
all unpaid fees, costs and expenses; and

 

	
9.4.1.6

	
all other sums payable by the Borrower to the Lender under this Loan Agreement and the Security Documents.

 

	
9.5

	
Waiver of Event of Default

The Lender, at its sole and absolute discretion, may waive any Event of Default hereunder, prior to or after the event or events giving rise thereto, provided that such waiver may be effected only by written notice provided by the Lender to the Borrower to that effect (and subject further to Clause ‎16.3 below); it being understood and acknowledged, that if and so long as no notice of waiver of an Event of Default was so provided, such Event of Default shall be deemed as having occurred and in effect for all purposes hereunder.

	
9.6

	
Change of Control

 

	
9.6.1

	
All the obligations of the Lender to the Borrower under this Loan Agreement shall terminate if there is a Change of Control (as defined below) in the Borrower. In such event, unless the Lender agrees otherwise by written notice to the Borrower, immediately and simultaneously with the closing of the transaction that constitutes a Change of Control the Borrower shall prepay the outstanding Loan in accordance with Clause ‎5.4 above.

 

	
9.6.2

	
For purposes of this Clause ‎9.6, a “Change of Control” shall mean any of the following events (whether in one or in a series of related transactions): (a) merger, consolidation, or reorganization of the Borrower with or into another entity after which the shareholders who held the majority of the voting power in the Borrower prior to such transaction do not retain a majority of the voting power in the Borrower after the transaction, or (b) the sale of all or substantially all the assets of the Borrower (on a consolidated basis with its Subsidiaries), or (c) the sale of shares of the Borrower (whether by the Borrower or by shareholders of the Borrower) after which the shareholders who held the majority of the voting power in the Borrower prior to such transaction do not retain a majority of the voting power in the Borrower after the transaction, excluding sale of shares in equity financing, sale of shares in a public market or sale of shares to employees, or (d) the exclusive license of all or a material portion of the Borrower's Intellectual Property, to, any other entity or person, other than a wholly-owned subsidiary of the Borrower.

 

Notwithstanding anything to the contrary in this Section 9.6 or otherwise in this Agreement, it is agreed that in the event that a Change of Control occurs before any amount was withdrawn by the Borrower under this Agreement, then the Borrower shall be entitled to terminate this Agreement and the Security Documents with no liability whatsoever towards the Lender provided that the Transaction Fee, the End of Loan Payment Fee and other fees and expenses incurred by the Lender in connection to this Loan Agreement and any of the Security Documents have been already paid.

 

	
10

	
FEES, EXPENSES AND TAXES

 

	
10.1

	
Transaction Fee

The Parties hereby agree and acknowledge that the Transaction Fee and other expenses shall be paid by the Borrower to the Lender as follows:

 

(i) upon the execution of this Loan Agreement, a one-time transaction fee in an amount of US$200,000; and (ii) all expenses related to registration of the Security; and (iii) all expenses of Lender in connection with the negotiation and execution of this Loan Agreement, including, without limitation, costs of due diligence and reasonable fees of attorneys, appraisers, examiners and consultants up to U.S. $20,000 plus applicable VAT.

 

  

23

  

 

	
10.2

	
Documentary Costs

The Borrower shall promptly pay to the Lender on the Lender’s demand, the reasonable legal expenses and disbursements incurred by the Lender in connection with the following, plus VAT, to the extent applicable:

 

	
10.2.1

	
any amendment or supplement to this Loan Agreement or the Security Documents or any proposal for such amendment to be made that was initiated by the Borrower; and

 

	
10.2.2

	
any consent or waiver by the Lender concerned under or in connection with this Loan Agreement or the Security Documents or any request for such a consent or waiver; and

 

	
10.2.3

	
any step taken by the Lender with a view to the protection, exercise or enforcement of any right or security interest created by this Loan Agreement or the Security Documents or for any similar purpose.

 

	
10.3

	
Certain taxes and duties

	
  

	
The Borrower shall promptly pay any documentary, stamp or other equivalent tax or duty payable on or by reference to this Loan Agreement or the Security Documents, and shall, on the Lender’s demand, fully indemnify the Lender against any costs, losses, liabilities and expenses resulting from any failure or delay by the Borrower to pay such a tax.

 

	
10.4

	
Recovery of Overdue Fees

Without prejudice to any other provisions of this Loan Agreement, the Lender shall be entitled (and the Borrower hereby irrevocably authorizes the Lender), at any time and from time to time, to apply any credit balance to which the Borrower are then entitled on any account with the Lender in satisfaction of the sum or sums from time to time owing by the Borrower to the Lender under and/or pursuant to this Clause ‎10.4 The Lender shall give notice to the Borrower of any such application promptly thereafter.

 

	
10.5

	
Liability for Taxes

 

	
10.5.1

	
The Borrower shall make all payments to be made by it without any Tax deduction, unless a Tax deduction is required by law. The Borrower shall promptly upon becoming aware that it must make a Tax deduction (or that there is any change in the rate or the basis of a Tax deduction) notify the Lender.

 

	
10.5.2

	
If the Borrower is required to make a Tax deduction, the Borrower shall make that Tax deduction and any payment required in connection with that Tax deduction within the time allowed and in the minimum amount required by law.

 

	
10.5.3

	
Within thirty (30) days of making either a Tax deduction or any payment required in connection with that Tax deduction, the Borrower shall deliver to the Lender evidence reasonably satisfactory to it that the Tax deduction has been made or (as applicable) any appropriate payment paid to the relevant taxing authority.

 

  

24

  

 

	
10.6

	
Illegality and Increased Costs

	
10.6.1

	
If it is or becomes contrary to any law or regulation for the Lender to make available the Loan Facility or to maintain its obligations to do so or fund the Loan, the Lender shall promptly notify the Borrower whereupon (a) the Lender’s obligations to make the Loan Facility available shall be terminated and (b) the Borrower shall be obliged to prepay the Loan either (i) forthwith or (ii) on a future specified date on or before the latest date permitted by the relevant law or regulation.

 

	
10.6.2

	
If the result of any change in (or in the interpretation, administration or application of), or to the generally accepted interpretation or application of, or the introduction of, any law or regulation is to subject the Lender to Taxes or change the basis of the payment of Taxes by the Lender with respect to any payment under this Loan Agreement (other than Taxes on the overall net income, profits or gains of the Lender), then (i) the Lender shall notify the Borrower in writing of such event promptly upon its becoming aware of the same; and (ii) the Borrower shall on demand, made at any time whether or not the Loan has been repaid, pay to the Lender the amount of the increased costs which the Lender has suffered as a result.

 

	
11

	
INDEMNITIES

 

	
11.1

	
Indemnity for Non-Scheduled Payments

	
  

	
Without derogating from Clause ‎9 above, the Borrower shall indemnify the Lender fully on its demand in respect of all expenses, liabilities and losses which are suffered or incurred by the Lender, as a result of or in connection with:

 

	
11.1.1

	
any Tranche not being borrowed on the date specified in the Drawdown Notice for any reason other than a default by the Lender;

 

	
11.1.2

	
any failure (for whatever reason) by the Borrower to make payment of any amount due under this Loan Agreement or the Security Documents on the due date or, if so payable, on demand; or

 

	
11.1.3

	
the occurrence and/or continuance of an Event of Default and/or the acceleration of repayment of the Loan under Clause ‎9.4, and in respect of any Taxes for which the Lender is liable or held liable in connection with any amount paid or payable to the Lender (whether for its own account or otherwise) under this Loan Agreement or the Security Documents.

 

	
11.2

	
Third Party Claims Indemnity

	
  

	
The Borrower shall indemnify the Lender fully on its demand in respect of claims, demands, proceedings, liabilities, taxes, losses and expenses of every kind, including without limitation legal fees and expenses which were brought against, or incurred by, the Lender, in any country, in relation to:

 

	
11.2.1

	
any action lawfully taken, or omitted or neglected to be taken, under or in connection with this Loan Agreement or the Security Documents by the Lender or by any receiver appointed under the Security Documents after the occurrence of any Event of Default; and

 

	
11.2.2

	
any breach or inaccuracy of any of the representations and/or warranties contained in Clause ‎7 hereof or in the Security Documents or any breach of any covenant, commitment or agreement by the Borrower contained in Clause ‎8 hereof or elsewhere in this Loan Agreement or in the Security Documents.

 

  

25

  

 

	
12

	
RISK AND INSURANCE

 

	
12.1

	
All risk of loss, theft and damage of and to the Charged Assets from any cause whatsoever shall be the risk of the Borrower, and no such event shall relieve the Borrower of any obligation under a Drawdown Notice.

	
12.2

	
The Borrower shall:

	
12.2.1

	
bear all risk of loss of or damage to the Charged Assets whether insured against or not;

 

	
12.2.2

	
maintain with an insurance company approved by the Lender, in accordance with good and prudent practices of owners of such Charged Assets, fully comprehensive insurance under a standard form of “new for old” all risks policy including terrorism, third party, and business interruption for a 6 month period covering (i) loss of or damage to, the Charged Assets and against such other risks as assets of the same type as the Charged Assets are normally (or when used in the manner or for the purposes for which the Charged Assets are to be used) insured, and the new replacement value of the Charged Assets; and (ii) all liability whatsoever (including liability of the Lender) to any third party whomsoever including any employee, agent or sub-contractor of the Lender or the Borrower who may suffer damage to or loss of property or death or personal injury, whether arising directly or indirectly from the Charged Assets or their use;

 

	
12.2.3

	
procure that the Lender and, if the Lender so requests, any affiliates of the Lender is an additional insured and that the interest of the Lender is noted under the policy and that the Lender is loss payee;

 

	
12.2.4

	
upon request produce to the Lender the policy and all premium receipts;

 

	
12.2.5

	
promptly notify the Lender of any event which may give rise to a claim under the policy and upon request irrevocably appoint the Lender to be its sole agent to negotiate agree or compromise such claim; and

 

	
12.2.6

	
upon request assign by way of security, or following the occurrence of an Event of Default, a complete assignment to the Lender, the Borrower’s rights under such policy and irrevocably appoint the Lender to institute any necessary proceedings.

 

	
13

	
END OF LOAN PAYMENT

 

Upon the final repayment of each Tranche, the Borrower shall pay the Lender the End of Loan Payment. Upon payment of the End of Loan Payment for the last Tranche, subject to the terms of this Loan Agreement and the Security Documents (including the making of all payments hereunder and thereunder), the Lender shall take appropriate action to release the security over the Charged Assets.  Failure to pay the End of Loan Payment for any Tranche shall constitute a breach of this Loan Agreement.

 

	
14

	
POWER OF ATTORNEY

 

	
14.1

	
The Borrower by way of security hereby irrevocably appoints the Lender and separately any receiver appointed under any Security Document severally to be its attorney in its name and to act on its behalf and to execute and complete any deeds or documents which the Lender may require for perfecting its title to or for vesting the Charged Assets both present and future in the Lender or its respective nominees or in any purchaser and otherwise generally to sign seal and deliver and otherwise perfect any such legal or other Security Interest referred to in Clause ‎1.34 and all such deeds and documents and to do all such acts and things as may be required for the full exercise of the powers conferred hereunder or under any Security Document including any sale, lease, disposition, realization or getting in and this appointment shall operate as a general power of attorney made under applicable law. The Borrower hereby covenants with the Lender and separately with any such receiver to ratify and confirm any deed, document, act and thing and all transactions which any such attorney may lawfully execute or do.

 

  

26

  

 

	
15

	
NOTICES

 

	
15.1

	
Any notice, demand or other communication (“Notice”) to be given by any party under, or in connection with, this Loan Agreement shall be in writing and signed by or on behalf of the party giving it. Any Notice shall be served by sending it by fax to the number set out in Clause ‎15.2, or delivering it by hand to the address set out in Clause ‎15.2 and in each case marked for the attention of the relevant party set out in Clause ‎15.2 (or as otherwise notified from time to time in accordance with the provisions of this Clause ‎15).  Any Notice so served by fax or hand shall be deemed to have been duly given or made as follows:

	
15.1.1

	
if sent by fax, at the time of transmission; or

	
15.1.2

	
in the case of delivery by hand, when delivered,

provided that in each case where delivery by fax or by hand occurs after 5pm on a Business Day (local time in the place of receipt) or on a day which is not a Business Day, service shall be deemed to occur at 9am on the next following Business Day (local time in the place of receipt).

References to time in this Clause ‎15 are to local time in the country of the addressee.

 

	
15.2

	
The addresses and fax number of the parties for the purpose of this Clause ‎15 are as follows:

 

	
15.2.1

	
Lender:

 

Address:  47 esplanade Saint Helier, Jersey

with a copy to:

Kadouch & Co., Law Offices,

8b Abba Eban

46733 Herzliya

Israel

For the attention of Emmanuel Kadouch, Adv.

Fax: +972-9-9525450

Email: emmanuel@kadouchlaw.com

 

Borrower:

 

               Address:

Three Hatnufa Street, 6th Floor P.O. Box 161, Yokneam 2069203, Israel

Fax: +972 4 959 0123/0125; and

and

c/o ReWalk Robotics, Inc.

33 Locke Drive

Marlborough, MA 01752

For the attention of: Kevin Hershberger

with a copy (which shall not constitute notice) to:

Goldfarb Seligman & Co., Law Offices

Ampa Tower

98 Yigal Alon Street, Tel Aviv, Israel

Fax: +972 3- 6089909

For the attention of:

Aaron M. Lampert, Adv.

Email: aaron.lampert@goldfarb.com

 

  

27

  

 

	
15.3

	
A party may notify the other party to this Loan Agreement of a change to its name, relevant addressee, address or fax number for the purposes of this Clause ‎15, provided that such notice shall only be effective on:

	
15.3.1

	
the date specified in the notification as the date on which the change is to take place; or

 

	
15.3.2

	
if no date is specified or the date specified is less than five Business Days after the date on which notice is given, the date following five Business Days after notice of any change has been given.

 

	
15.4

	
In proving service it shall be sufficient to prove that the envelope containing such notice was properly addressed and delivered to the address shown thereon or that the facsimile transmission was made and a facsimile confirmation report was received, as the case may be.

 

	
16

	
GENERAL

	
16.1

	
All agreements, covenants, representations and warranties of each of the Borrower contained in this Loan Agreement or in the Drawdown Notices or other documents delivered pursuant hereto or in connection herewith and continuing, shall survive and remain binding the execution and delivery, and the expiration, cancellation or other termination of this Loan Agreement and/or the Drawdown Notice.

	
16.2

	
If the Borrower shall fail to perform any of its obligations under any Drawdown Notice duly and promptly, the Lender may, at its option and at any time, perform the same without waiving any default on the part of the Borrower, or any of the Lender’s rights.  The Borrower shall reimburse the Lender, within five (5) Business Days after notice thereof is given to the Borrower, for all expenses and liabilities incurred by the Lender in the performance of the Borrower’s obligations.

	
16.3

	
No failure to exercise, nor any delay in exercising, on the part of the Lender, any right or remedy hereunder shall operate as a waiver, nor shall any single or partial exercise of any right or remedy prevent any further or other exercise or the exercise of any other right or remedy.  The rights and remedies provided in this Loan Agreement are cumulative and not exclusive of any rights or remedies provided by law or in equity.  Waiver by the Lender of any default shall not constitute waiver of any other default.

	
16.4

	
The Borrower may not assign or transfer its rights, benefits and obligations under this Loan Agreement. The Lender shall have the right, in its sole discretion, to assign, sell, pledge, grant a security interest in or otherwise encumber its rights under this Loan Agreement and/or one or more Drawdown Notices to any reputable financing institutions (an “Assignee”), or may be acting as an agent for any Assignee in entering into any Drawdown Notice.  The Borrower hereby irrevocably consents to any assignment, sale, pledge, grant of a security interest or any other disposal to an Assignee.  The Borrower agrees that if it receives notice from the Lender that it is to make payments under this Loan Agreement and/or any Drawdown Notice to such Assignee rather than to the Lender, or that any of its other obligations under the relevant Drawdown Notice are to be owed to the named Assignee, the Borrower shall comply with any such notice.  Subject to the foregoing, this Loan Agreement and each Drawdown Notice inures to the benefit of, and is binding upon, the successors and assigns of the Lender.

 

  

28

  

 

	
16.5

	
The Borrower consents to the disclosure of information by the Lender to its Affiliates, Related Funds and to other parties to the Security Documents and potential Assignees.

	
16.6

	
Clause titles are solely for convenience and are not an aid in the interpretation of this Loan Agreement.

	
16.7

	
If, at any time, any provision herein is or becomes illegal, invalid or unenforceable in any respect under any law of any jurisdiction, neither the legality, validity or enforceability of the remaining provisions nor the legality, validity or enforceability of such provision under the law of any other jurisdiction will in any way be affected or impaired.

	
16.8

	
A person who is not a party to this Loan Agreement has no right to enforce or enjoy the benefits of this Loan Agreement.

	
16.9

	
This Loan Agreement, together with the Security Documents, constitutes the entire agreement between the parties with respect to the subject matter hereof. This Loan Agreement may not be modified except in writing executed by the Lender and the Borrower.  No supplier or agent of the Lender is authorized to bind the Lender or to waive or modify any term of this Loan Agreement.

	
16.10

	
This Loan Agreement may be executed in counterparts (including facsimile copies), each of which shall be an original, but all such counterparts shall together constitute one and the same instrument.

	
16.11

	
This Loan Agreement and any obligations arising out of or in connection with it are governed by the laws of the State of Israel without regard to the conflict of laws provisions thereof. The courts of Tel Aviv - Jaffa have exclusive jurisdiction to settle any dispute arising out of or in connection with this Loan Agreement (including a dispute relating to the existence, validity or termination of this Loan Agreement or any obligation arising out of or in connection with this Loan Agreement (a “Dispute”). The parties to this Loan Agreement agree that the courts of Israel are the most appropriate and convenient courts to settle Disputes and accordingly no party to this Loan Agreement will argue to the contrary. Notwithstanding the above, the Lender may be entitled to initiate proceedings against the Parent in any applicable jurisdiction.

	
16.12

	
Lender, or an agent appointed by it, in either case acting solely for this purpose as an agent of the Borrower, shall maintain a register (the “Register”) for the recordation of (i) the name and address of the Lender, and the commitments of, and principal amounts (and stated interest) of the Loan owing to, the Lender pursuant to the terms thereof from time to time and (ii) any transfers.  The entries in the Register shall be conclusive absent manifest error.  The Register shall be available for inspection by the Borrower and/or any subsidiary and the Lender at any reasonable time and from time to time upon reasonable prior notice.  The obligations of the Borrower and/or any subsidiary under the Loan Documents are registered obligations and the right, title and interest of the Lender and its assignees in and to such obligations shall be transferable only upon notation of such transfer in the Register.  This Section 16.12 shall be construed so that such obligations are at all times maintained in “registered form” within the meaning of Sections 163(f), 871(h)(2) and 881(c)(2) of the Internal Revenue Code of 1986, as amended (the “Code”) and any related regulations (and any other relevant or successor provisions of the Code or such regulations).

  

29

  

 

SCHEDULE A

FORM OF DRAWDOWN NOTICE

DRAWDOWN NOTICE

 

Drawdown

No. [   ]

dated

between

	
KREOS CAPITAL V (EXPERT FUND) L.P.

 

	
REWALK ROBOTICS LTD.

	
the (“Lender”)

	
the (“Borrower”)

This Drawdown Notice forms a Schedule to a Loan Agreement between the Lender and the Borrower dated [                                  ] 2016 (the “Loan Agreement”)

 

The Lender has granted the Borrower a loan facility pursuant to the terms and conditions set out in the Loan Agreement and attached Schedules.

 

Words and expressions in this Drawdown Notice shall have the same meanings as in the Loan Agreement.

 

  

30

  

 

PART 1

Loan Details

 

	
Total Loan Facility

	  	
up to US$ 20,000,000

 

	
Amount of Loan Facility to be drawn down pursuant to this Drawdown Notice

 

	  	
[                      ]

	
Loan Term

 

	  	
[                      ]

	
Bank Account Details for remittance of funds

	  	
[                      ]

 

We confirm that:

	
(a)

	
the representations and warranties made by us in the Loan Agreement are true and accurate on the date of this Drawdown Notice as if made on such date; and

	
(b)

	
no Event of Default has occurred and is continuing or would result from the delivery of this Drawdown Notice.

for and on behalf of

[                                ]

Authorized Signatory..................

Name ........................................

Dated [                     ] 201[ ]

 

  

31

  

SCHEDULE B

LIST OF EQUIPMENT

 

  

32

  

 

SCHEDULE C

INITIAL SECURITY DOCUMENTS

Debenture Fixed Charge.

 

Debenture Floating Charge.

 

US IP Security Agreement

 

Security Agreement

 

Guaranty from ReWalk Robotics Inc.

 

Guaranty from Argo Medical Technologies GmbH.

 

  

33

  

  

SCHEDULE D

REGISTERED INTELLECTUAL PROPERTY

 

  

34

  

 

Duly executed by the parties on the date first set out on the first page of this Loan Agreement.

BORROWER

REWALK ROBOTICS LTD.

 

By: /s/ Jeff Dykan

Its: Chairman of the Board

Date: December 30, 2015

 

	
LENDER

For and on behalf of

 

KREOS CAPITAL V (EXPERT FUND) L.P.

 

By: /s/ Raoul Stein

Its: General Partner

Date: December 30, 2015

 

35

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