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.  

 

(a)                                 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 the activities contemplated by, the exercise of rights permitted by or in order to further the purposes of this Agreement as more specifically set forth in Section 7.1(b), unless otherwise agreed in writing by the Parties.  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, worldwide, fully paid, perpetual, sublicensable (as described in Section 6.2(c)) license, under Genentech’s right, title and interest in and to the Genentech Owned Inventions, solely for the purpose of performing [***] for use in the Combination.

 

(b)                                 License to Genentech.  Corvus hereby grants to Genentech a non-exclusive, worldwide, fully paid, perpetual, sublicensable (as described in Section 6.2(c)) license, under Corvus’ right, title and interest in and to the Corvus Owned Inventions, 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,  and any rights under such sublicense may be further sublicensed [***].  Further, the rights under such licenses may be exercised by an Affiliate or Third Party on behalf of such Party (or a sublicensee) without the grant of a sublicense of such rights.

 

(d)                                 No Implied Licenses.  Except as otherwise expressly provided in this Agreement, this Agreement does not grant any right or license to either Party under any of the

 

[***] 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 Genentech’s sole cost and expense, Genentech shall be responsible for the Prosecution and Maintenance of any Joint Patent through mutually agreed outside counsel (“Outside Patent Counsel”); provided that Genentech consults with Corvus on the Prosecution and Maintenance of any such Joint Patents as set forth in this Section 6.4.  Genentech 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 Corvus 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).  Genentech shall consider and incorporate Corvus’ reasonable comments with respect to such Prosecution and Maintenance.

 

(b)                                 Selection of Outside Patent Counsel.  Outside Patent Counsel shall be selected by Genentech, following consultation with Corvus, within sixty (60) days of the Effective Date or such other date as mutually agreed by the Parties.  During the Term, Genentech may, in its sole discretion, change the selected outside counsel to new patent counsel, provided that Genentech consults with Corvus 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 Genentech 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, Corvus, at its sole option, may continue such Prosecution and Maintenance, at Corvus’ sole cost and expense.

 

(d)                                 Limitations on Filing of Joint Patents.  Each Party covenants and agrees that it will not, directly or indirectly, without the prior written consent of the other Party, file any Patent covering a Jointly Owned Invention.  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, Genentech may request in writing that Corvus, with respect to Patents claiming a Jointly Owned Invention, either (i) opt out from the exclusive competence of the Unified Patent Court or (ii) if applicable, withdraw a previously-registered opt-out, and Corvus shall notify the Registry [***] and take such other action as may be necessary to effect the opt-out or opt-out withdrawal (“Register”).  Corvus shall Register [***] 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 fifteen (15) days 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 Corvus as set forth in Section 6.4(a), Genentech will have the initial right to determine and control a course of action designed to curtail or address such Third Party Infringement, whether legal or commercial, 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)                                Genentech shall keep Corvus reasonably informed as to any legal or other courses of action it pursues pursuant to this subsection (i).  Corvus shall provide reasonable assistance to Genentech 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, Genentech shall not enter into any settlement admitting the invalidity of, or otherwise impairing the Joint Patent without the prior written consent of Corvus, 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, to reimburse each Party for all Out-of-Pocket Costs in connection with such proceeding (on a pro rata basis, based on each Party’s respective litigation costs, to the extent the recovery was less than all such litigation costs); 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 sixty (60) days after Genentech’s receipt of a notice of a Third Party Infringement, Genentech 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), Corvus may, subject to the following sentence, in its sole discretion, bring and control any legal action in connection therewith at its sole expense.  If Corvus intends to bring any such legal action, it shall first notify Genentech in writing of such intent and the reasons therefor and provide Genentech with an opportunity to indicate to Corvus its reasons for not bringing such legal action.  If Genentech provides either [***].  Corvus shall keep Genentech reasonably informed as to any legal or commercial courses of action it pursues pursuant to this subsection (ii).  At the request and expense of Corvus, Genentech shall provide reasonable assistance to Corvus in connection therewith, including by executing reasonably appropriate documents, and cooperating in discovery; provided, however, that nothing herein shall require Genentech to join as a party or otherwise participate in such legal action unless required by law or regulation, if in Genentech’s reasonable opinion such participation will [***]. Genentech may choose, at its own expense, to be represented in any such action by counsel of its own choice; provided, however, that if Genentech is required as a necessary party to such action, [***]. In connection with any such proceeding, Corvus shall not enter into any settlement admitting the invalidity of or otherwise impairing any Joint Patent without the prior written consent of Genentech, 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
    	
Corvus   Pharmaceuticals, Inc.
    
	
24 September 2015
    	
CPI-444
    
	
Phase 1/1b Clinical Study   Protocol
    	
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. 

 

28K - Hulk Exh 101 Asset Purchase Agmt  2-8-16

		

			Exhibit 10.1

		

		
			 
		

		
			 
		

		
			 
		

		
			 
		

		
			ASSET PURCHASE AGREEMENT
		

		
			by and between
		

		
			MERIT MEDICAL SYSTEMS, INC.
		

		
			and CRYOLIFE, INC.
		

		
			 
		

		
			February 3, 2016
		

		
			 
		

		
			 
		

		

		

		 

		

			7897718_2.docx

		

 

		

			 

		

		TABLE OF CONTENTS
		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

					
					
						Page

				
	1 
					
					
						Definitions

					
					
						 

					1 
				
	2 
					
					
						Basic Transactions

					
					
						 

					7 
				
	
					
						 

					
					
						(a)  Transactions

					
					
						 

					7 
				
	
					
						 

					
					
						(b) Assumption/Exclusion of Liabilities

					
					
						 

					7 
				
	
					
						 

					
					
						(c) Consideration Provided by Buyer for the Acquired Assets

					8 
				
	
					
						 

					
					
						(d) Allocation of Purchase Price

					
					
						 

					8 
				
	
					
						 

					
					
						(e) The Closing

					
					
						 

					8 
				
	
					
						 

					
					
						(f) Deliveries at the Closing

					
					
						 

					8 
				
	3 
					
					
						Representations and Warranties of Seller

					9 
				
	
					
						 

					
					
						(a) Organization of Seller

					
					
						 

					9 
				
	
					
						 

					
					
						(b) Authorization of Transaction

					
					
						 

					9 
				
	
					
						 

					
					
						(c) Non-contravention

					
					
						 

					9 
				
	
					
						 

					
					
						(d) Title to Assets; Sufficiency of Assets

					
					
						 

					9 
				
	
					
						 

					
					
						(e) No Adverse Change

					
					
						 

					10 
				
	
					
						 

					
					
						(f) Legal Compliance

					
					
						 

					10 
				
	
					
						 

					
					
						(g) Intellectual Property

					
					
						 

					10 
				
	
					
						 

					
					
						(h) Environmental, Health, and Safety Matters

					12 
				
	
					
						 

					
					
						(i) Contracts

					
					
						 

					12 
				
	
					
						 

					
					
						(j) Litigation

					
					
						 

					12 
				
	
					
						 

					
					
						(k) Product Warranty

					
					
						 

					13 
				
	
					
						 

					
					
						(l) Product Liability

					
					
						 

					13 
				
	
					
						 

					
					
						(m) Customers and Suppliers

					
					
						 

					13 
				
	
					
						 

					
					
						(n) [Intentionally omitted]

					
					
						 

					14 
				
	
					
						 

					
					
						(o) Financial Statements

					
					
						 

					14 
				
	
					
						 

					
					
						(p) Taxes

					
					
						 

					14 
				
	
					
						 

					
					
						(q) Bankruptcy

					
					
						 

					14 
				
	
					
						 

					
					
						(r) FDA and Regulatory Matters

					
					
						 

					15 
				
	
					
						 

					
					
						(s) Broker Fees

					
					
						 

					15 
				
	4 
					
					
						Representations and Warranties of Buyer

					15 
				
	
					
						 

					
					
						(a) Organization of Buyer

					
					
						 

					15 
				
	
					
						 

					
					
						(b) Authorization of Transaction

					
					
						 

					15 
				
	
					
						 

					
					
						(c) Non-contravention

					
					
						 

					15 
				
	
					
						 

					
					
						(d) Brokers’ Fees

					
					
						 

					15 
				
	
					
						 

					
					
						(e) Sophisticated Buyer

					
					
						 

					15 
				
	5 
					
					
						[Intentionally Omitted]

					
					
						 

					16 
				

		 

		

			-1-

		

 

		

			 

		

			6 
					
					
						[Intentionally Omitted]

					
					
						 

					16 
				
	7 
					
					
						Post-Closing Covenants

					
					
						 

					16 
				
	
					
						 

					
					
						(a) General

					
					
						 

					16 
				
	
					
						 

					
					
						(b) Reimbursement Obligation

					
					
						 

					16 
				
	
					
						 

					
					
						(c) Non-Competition

					
					
						 

					16 
				
	
					
						 

					
					
						(d) Transfer of Assets

					
					
						 

					17 
				
	
					
						 

					
					
						(e) Tax Periods

					
					
						 

					19 
				
	
					
						 

					
					
						(f) Supply

					
					
						 

					19 
				
	
					
						 

					
					
						(g) Records

					
					
						 

					19 
				
	8 
					
					
						Remedies for Breaches of this Agreement

					19 
				
	
					
						 

					
					
						(a) Survival of Representations and Warranties

					19 
				
	
					
						 

					
					
						(b) Indemnification Provisions for Benefit of Buyer and Seller

					20 
				
	
					
						 

					
					
						(c) Matters Involving Third Parties

					
					
						 

					21 
				
	
					
						 

					
					
						(d) Characterization of Payments

					
					
						 

					22 
				
	
					
						 

					
					
						(e) Limitations

					
					
						 

					22 
				
	
					
						 

					
					
						(f) Escrow Agreement

					
					
						 

					23 
				
	
					
						 

					
					
						(g) Exclusive

					
					
						 

					23 
				
	9 
					
					
						[Intentionally Omitted]

					
					
						 

					23 
				
	10 
					
					
						Miscellaneous

					
					
						 

					24 
				
	
					
						 

					
					
						(a) Press Releases and Public Announcements

					24 
				
	
					
						 

					
					
						(b) No Third-Party Beneficiaries

					
					
						 

					24 
				
	
					
						 

					
					
						(c) Entire Agreement

					
					
						 

					24 
				
	
					
						 

					
					
						(d) Succession and Assignment

					
					
						 

					24 
				
	
					
						 

					
					
						(e) Counterparts

					
					
						 

					24 
				
	
					
						 

					
					
						(f) Headings

					
					
						 

					24 
				
	
					
						 

					
					
						(g) Notices

					
					
						 

					24 
				
	
					
						 

					
					
						(h) Governing Law; Jurisdiction

					
					
						 

					26 
				
	
					
						 

					
					
						(i) Amendments and Waivers

					
					
						 

					26 
				
	
					
						 

					
					
						(j) Severability

					
					
						 

					26 
				
	
					
						 

					
					
						(k) Expenses

					
					
						 

					26 
				
	
					
						 

					
					
						(l) Construction

					
					
						 

					26 
				
	
					
						 

					
					
						(m) Incorporation of Exhibits and Schedules

					26 
				
	
					
						 

					
					
						(n) Specific Performance

					
					
						 

					27 
				
	
					
						 

					
					
						(o) Waiver of Trial By Jury

					
					
						 

					27 
				
	
					
						 

					
					
						(p) Transfer Taxes

					
					
						 

					27 
				

		
			 
		

		

		

		 

		

			-2-

		

 

		

			 

		

		
		

		
			 
		

		
			Exhibit ADescription of the Device
		

		
			Exhibit BEscrow Agreement
		

		
			Exhibit CBill of Sale
		

		
			Exhibit DAssignment and Assumption of Acquired Contracts
		

		
			Exhibit EIntellectual Property Transfer Documents
		

		
			Exhibit FTransition Supply Agreement
		

		
			 
		

		
			Schedule AAcquired Assets
		

		
			Schedule BExcluded Assets
		

		
			Schedule CAssumed Liabilities
		

		
			 
		

		

		

		 

		

			-3-

		

 

		

			 

		

		ASSET PURCHASE AGREEMENT
		

		
			THIS ASSET PURCHASE AGREEMENT (this “Agreement”) is entered into as of February 3, 2016, by and between MERIT MEDICAL SYSTEMS, INC., a Utah corporation (“Buyer”), and CRYOLIFE,  INC., a Florida corporation (“Seller”).  Buyer and Seller are referred to collectively herein as the “Parties” and individually as a “Party.”
		

		
			RECITALS
		

		
			A.Seller owns the intellectual property and other assets related to the “Device” as defined below.
		

		
			B.Seller desires to sell to Buyer Seller’s right, title and interest in the assets used by Seller exclusively in Seller’s Device business (the “Business”) and certain other assets of Seller identified in this Agreement, which assets are collectively defined below as the Acquired Assets, and Buyer desires to purchase from Seller all the Acquired Assets in exchange for the consideration set forth herein, all upon the terms and subject to the conditions of this Agreement.
		

		
			C.Seller and Buyer are willing to make certain representations, warranties, covenants and agreements in connection with such sale and purchase.
		

		
			AGREEMENT
		

		
			NOW, THEREFORE, in consideration of the premises and the mutual promises herein made, and in consideration of the representations, warranties, and covenants herein contained, the Parties agree as follows:
		

		
			1.Definitions.  For purposes of this Agreement, the following terms have the meanings set forth below:
		

		
			“Acquired Assets” means all of the assets of Seller used by Seller exclusively in the Business and certain other assets of Seller identified in Schedule A  to this Agreement, including each of the following: (a) all Acquired Intellectual Property; (b)  the Manufacturing Equipment (including Inventory); (c) all of Seller’s plans, drawings and specifications, and all of Seller’s books, records and files, in each case, (i) to the extent related to the Device,  (ii) which Seller either owns or possesses the right to assign to Buyer and (iii) which is used by Seller to operate the Business prior to the Closing Date; (d) Seller’s vendor and supplier lists to the extent related to the Device or the manufacture of the Device; (e) all goodwill of Seller in the Acquired Intellectual Property and the Device to the extent related to the Business; (f) the Acquired Contracts; and (g) all Seller’s enhancements, improvements, developments, extensions, modifications and subsequent versions of any of the foregoing through the Closing; provided, however, that the term “Acquired Assets” shall not include any of the Excluded Assets.
		

		

		

		 

		

			 

		

 

		

			 

		

		“Acquired Contracts” means the contracts, leases, licenses and other agreements or arrangements of Seller which are listed on Section 3(i) of the Disclosure Letter.
		

		
			“Acquired Intellectual Property” means all of Seller’s right, title and interest in the following Intellectual Property:
		

		
			(a)all inventions (whether patentable or unpatentable, whether or not reduced to practice, and whether or not the subject of any patent applications) and any additions and improvements thereto, in each case if such invention, addition or improvement (i) is owned by Seller or Seller possesses the right to assign such invention, addition or improvement to Buyer and (ii) is an Acquired Asset, is used by Seller exclusively in the Business or is held by Seller exclusively for use in the Business;
		

		
			(b)all patents, patent rights, patent disclosures, utility models, certificates of invention, statutory invention registrations, and applications for any of the foregoing, together with any reissuances, continuations, continuations in part, revisions, extensions, divisions, renewals, or reexaminations of any of the foregoing, in each case which are listed on Section 3(g)(iii) of the Disclosure Letter (each a “Patent”);
		

		
			(c)all trademarks, service marks, trade dress, logos, trade names and any applications, registrations, and renewals in connection therewith), in each case which are listed on Section 3(g)(iii) of the Disclosure Letter and all goodwill associated therewith (each a “Trademark”);
		

		
			(d)all works of authorship which Seller either owns or has the right to assign to Buyer  in whatever form or medium, any copyrights therein (whether registered or unregistered), and any applications, registrations, and renewals relating thereto, in each case which are listed on Section 3(g)(iii) of the Disclosure Letter (each a “Copyright”);
		

		
			(e)all trade secrets (including but not limited to ideas, research and development, know-how, formulas, tutorials, training materials, processes, protocol, compositions, manufacturing and production processes and techniques, procedures, devices, technical data, designs, drawings, specifications and supplier lists) if such trade secret (i) is owned by Seller or Seller possesses the right to assign such trade secret to Buyer and (ii) is an Acquired Asset, is used by Seller exclusively in the Business or is held by Seller exclusively for use in the Business;
		

		
			(f)all other proprietary rights in information and technology if such proprietary right (i) is owned by Seller or Seller possesses the right to assign such proprietary right to Buyer and (ii) is an Acquired Asset, is used by Seller exclusively in the Business or is held by Seller exclusively for use in the Business;
		

		
			(g)except with respect to rights of Seller under this Agreement or as a result of the Transactions, all of Seller’s legal and equitable remedies for past, present, and future infringements, misappropriations, misuses, dilutions, and other violations by third persons of any of the foregoing Acquired Intellectual Property; and
		

		

		

		 

		

			-2-

		

 

		

			 

		

		(h)except with respect to rights of Seller under this Agreement or as a result of the Transactions, all of Seller’s rights, title, and interests in and to any of the foregoing Acquired Intellectual Property provided by any treaty, statute, convention, common law, regulation, or any other Law
		

		
			“Acquisition Proposal” shall mean any proposal or offer made by any Person other than the Buyer or any Affiliate thereof to acquire, license, commercialize, distribute, market, manufacture, lease or transfer all or any part of, the Device or any of the Acquired Assets (or any of Seller’s interest in the Device or any of the Acquired Assets), but excluding proposals and offers, in each case to the extent occurring in the Ordinary Course of Business and excluding proposals and offers contemplating the acquisition of control of Seller.
		

		
			“Adverse Consequences” means all damages, dues, penalties, fines, costs, reasonable amounts paid in settlement, obligations, taxes, Encumbrances, losses or fees, together with all reasonable expenses and fees, including court costs and attorneys’ fees and expenses, including those arising out of any actions, suits, proceedings, hearings, official inquiries, investigations, charges, complaints, claims, demands, injunctions, judgments, orders, decrees or rulings, in each case if and to the extent arising out of, resulting from or caused by a breach by a Party of a representation, warranty or covenant of this Agreement giving rise to indemnification pursuant to Section 8 of this Agreement.
		

		
			“Affiliate” has the meaning set forth in Rule 12b-2 of Regulation 12B promulgated under the Securities Exchange Act.
		

		
			“Assignment of Contracts” has the meaning set forth in Section 5(a)(ix)(C) below. 
		

		
			“Assumed Liabilities” has the meaning set forth in Section 2(b)(i) below.
		

		
			“Bill of Sale” has the meaning set forth in Section 5(a)(ix)(B) below.
		

		
			“Buyer Indemnitees” has the meaning set forth in Section 8(b)(i) below.
		

		
			“Closing” has the meaning set forth in Section 2(e) below.
		

		
			“Closing Date” has the meaning set forth in Section 2(e) below.
		

		
			“Commercially Reasonable Efforts” the efforts required to be taken by a Party for such Party’s efforts to be considered commercially reasonable when evaluated in light of the applicable circumstances.
		

		
			“Device” means the HeRO® Graft and related products, as described in greater detail on Exhibit A attached hereto.
		

		
			“Device Confidential Information” has the meaning set forth in Section 7(c) below.
		

		
			“Disclosure Letter” has the meaning set forth in Section 3 below.
		

		

		

		 

		

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		“Encumbrance” shall mean any mortgage, pledge, assessment, security interest, deed of trust, lease, lien, adverse claim, levy, charge or other encumbrance of any kind, or any conditional sale or title retention agreement or other agreement to give any of the foregoing in the future, excluding in each case Permitted Liens.
		

		
			“Escrow Agent” has the meaning set forth in Section 2(c)(i) below.
		

		
			“Escrow Agreement” has the meaning set forth in Section 2(c)(i) below.
		

		
			“Escrow Amount” has the meaning set forth in Section 2(c)(i) below.
		

		
			“Escrow Funds” has the meaning set forth in Section 2(c)(ii) below.
		

		
			“Excluded Assets” has the meaning set forth in Section 2(a) below.
		

		
			“Excluded Liabilities” has the meaning set forth in Section 2(b)(ii) below.
		

		
			“FDA” shall mean the United States Food and Drug Administration and any successor entity.
		

		
			“FDCA” shall mean the Food, Drug, and Cosmetic Act, as amended, including the rules and regulations promulgated thereunder, and the FDA’s published policies and guidelines related thereto.
		

		
			“Financial Statements” has the meaning set forth in Section 3(o) below.
		

		
			“GAAP” means generally accepted accounting principles in the United States of America, as in effect from time to time, consistently applied.
		

		
			“Governmental Authority” means any government, state, commonwealth or any subdivision thereof, whether domestic, foreign or multinational, or any agency, authority, bureau, commission, department or similar body or instrumentality thereof, or any governmental court or tribunal.
		

		
			“Governmental Order” shall mean any consents, approvals, authorizations, qualifications order, writ, judgment, injunction, decree, stipulation, determination or award entered by or with any Governmental Authority.
		

		
			“Indemnified Party” has the meaning set forth in Section 8(c) below.
		

		
			“Indemnifying Party” has the meaning set forth in Section 8(c) below.
		

		
			“Intellectual Property” means (a) inventions (whether patentable or unpatentable, whether or not reduced to practice, and whether or not the subject of any patent applications) and any additions and improvements thereto; (b) patents, patent disclosures, utility models, certificates of invention, statutory invention registrations, and applications for any of the foregoing, together with any reissuances, continuations, continuations in part, revisions, extensions, divisions, renewals, or reexaminations of any of the foregoing, (c) trademarks, service marks, trade dress, logos, trade 
		

		 

		

			-4-

		

 

		

			 

		

		names, Internet domain names and URLs, and corporate names, together with any translations, adaptations, derivations, and combinations thereof, and any applications, registrations, and renewals in connection therewith; (d) works of authorship (including tutorials, programs, brochures, posters and documentations) in whatever form or medium, any copyrights therein (whether registered or unregistered), and any applications, registrations, and renewals relating thereto; (e) trade secrets and confidential information, including ideas, research and development, know-how, formulas, processes, protocol, compositions, manufacturing and production processes and techniques, sterilization processes and validation information, procedures, devices, technical data, designs, drawings, specifications, customer and supplier lists, pricing and cost information, and business and marketing plans and proposals; and (f) mask works.
		

		
			“Intellectual Property Rights” means all rights in and to Intellectual Property.
		

		
			“Inventory” means all inventory of the Device, including raw materials held by or on behalf of Seller for manufacturing the Device.
		

		
			“Laws” means all federal, state, municipal, foreign, and international laws, rules, regulations, codes, statutes, constitutions, ordinances, directives, treaties, proclamations, conventions, and orders, and all judicial, quasi-judicial and administrative and other official interpretations of any of the foregoing.
		

		
			“Liability” means any liability, obligation, debt, demand, claim, expense or commitment (whether known or unknown, whether asserted or unasserted, whether absolute or contingent, whether accrued or unaccrued, whether liquidated or unliquidated, and whether due or to become due).
		

		
			“Manufacturing Equipment” means all equipment, machinery, tools and dies that are used by Seller exclusively in the Business,  including those assets as described in Schedule A, but excluding the items set forth on Schedule B attached hereto.
		

		
			 “Material Adverse Effect” means an effect or effects which, individually or in the aggregate, (i) with respect to Seller, materially affects the Seller’s ability to consummate the Transactions, or could reasonably have a material adverse economic effect on the Acquired Assets or Device, or (ii) with respect to Buyer, an effect or effects which, individually or in the aggregate, materially adversely affects Buyer’s ability to consummate the Transactions.
		

		
			“Most Recent Balance Sheet” has the meaning set forth in Section 3(o) below.
		

		
			“Ordinary Course of Business” means the ordinary course of business consistent with past custom and practice (including with respect to quantity, frequency and price).
		

		
			“Permitted Lien” means Encumbrances (i) for Taxes that are not delinquent, (ii) for Taxes being contested in good faith by appropriate proceedings, (iii) that are statutory or common law Encumbrances to secure landlords, lessors or renters under leases or rental agreements for amounts not yet due or payable, and (iv) in connection with Seller’s secured credit facility as disclosed in 
		

		 

		

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		Seller’s Form 8-K filed with the Securities and Exchange Commission on January 25, 2016, which in the case of (iv) will be released on the Closing Date.
		

		
			“Person” means an individual, a partnership, a limited liability company, limited partnership, a limited liability partnership, a corporation, an association, a joint stock company, a trust, a joint venture, an unincorporated organization, or a Governmental Authority.
		

		
			“Post-Closing Liabilities” has the meaning set forth in Section 2(b)(i) below.
		

		
			“Purchase Price” has the meaning set forth in Section 2(c) below.
		

		
			“Restricted Period” has the meaning set forth in Section 7(d)(ii) below.
		

		
			“Securities Exchange Act” means the Securities Exchange Act of 1934, as amended.
		

		
			“Seller Indemnitees” has the meaning set forth in Section 8(b)(ii) below.
		

		
			“Seller’s Knowledge” is applicable to certain of those warranties and representations set forth in Section 3 of this Agreement or other provisions elsewhere in this Agreement, which are subject to the qualification “to Seller’s knowledge” or “to the knowledge of Seller,” or otherwise limited to matters “known” to Seller.  Seller will be deemed to have “knowledge” of a matter relating to Seller, the Device or the Acquired Assets if an executive officer (as defined in Rule 16a-1(f) promulgated under the Securities Exchange Act of 1934, as amended) of Seller had knowledge of such matter or would have acquired such actual knowledge had he or she inquired at or prior to that time as to such subject matter to (i) those of Seller’s employees that would be expected to have knowledge of such subject matter in the course of performing their duties for Seller and (ii) with respect to Section 3(g)((iii)(D) only, Kevin King, Seller’s outside patent legal counsel based on the information of which he is aware as a result of serving as Seller’s outside patent legal counsel with respect to the Acquired Intellectual Property and the information in the Seller’s files and records maintained by him.
		

		
			“Tax” means any federal, state, local or foreign income, gross receipts, license, payroll, employment, excise, severance, stamp, occupation, premium, environmental, customs duties, franchise, profits, withholding, social security (or similar), unemployment, disability, real property, personal property, sales, use, transfer, registration, value added, estimated or other tax, including any interest, penalty or addition thereto, whether disputed or not.
		

		
			“Tax Returns” means any return (including any information return), report, statement, declaration, schedule, notice, notification, form, certificate or other document or information filed with or submitted to, or required to be filed with or submitted to, any Governmental Authority in connection with the determination, assessment, collection or payment of any Tax or in connection with the administration, implementation or enforcement of or compliance with any Legal Requirement relating to any Tax.
		

		
			“Third Party Claim” has the meaning set forth in Section 8(c)(i) below.
		

		

		

		 

		

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		“Transaction Documents” means this Agreement and the documents attached hereto as an exhibit or required to be executed and delivered pursuant to this Agreement.
		

		
			“Transactions” means the transactions provided for or contemplated by this Agreement and the other Transaction Documents.
		

		
			“Transition Supply Agreement” means the Transition Supply Agreement to be entered into on the Closing Date by and between the Seller and the Buyer, as set forth in Exhibit F to this Agreement.
		

		
			2.Basic Transactions.  
		

		
			(a)Transactions.  On and subject to the terms and conditions of this Agreement, at the Closing, Buyer agrees to purchase from Seller, and Seller agrees to sell, transfer, convey, assign and deliver to Buyer, all of Seller’s right, title and interest in, all of the Acquired Assets at the Closing, for the consideration specified below in this Section 2.  Title to the Acquired Assets owned by Seller, shall pass to Buyer at the Closing, and risk of loss shall pass to Buyer upon the Closing.  The Parties intend for all of the Acquired Assets owned by Seller or an Affiliate of Seller to be transferred to Buyer, and Seller agrees to cause all of the Acquired Assets to be sold, transferred, conveyed, assigned and delivered to Buyer in accordance with the terms of this Agreement.  The parties acknowledge and agree that the Acquired Assets do not include the assets, rights, or property that is not an Acquired Asset, including, for clarity, the assets identified on Schedule B attached hereto (the “Excluded Assets”).
		

		
			(b)Assumption/Exclusion of Liabilities.  
		

		
			(i)Assumed Liabilities.  Subject to the conditions specified in this Agreement, on the Closing Date, Buyer shall assume and shall pay, defend, discharge and perform as and when due only the liabilities identified in Schedule C, including those liabilities and obligations under the Acquired Contracts first arising or accruing after the Closing Date, but, in the case of each Acquired Contract, only to the extent that Seller’s rights and benefits under such Acquired Contract are validly assigned to Buyer pursuant to this Agreement (collectively, such assumed liabilities and obligations pursuant to this Section 2(b)(i) are referred to herein as the “Assumed Liabilities”).  Buyer shall also be solely responsible for, and shall pay, defend, discharge and perform, all obligations and liabilities resulting from or arising out of the ownership or use of the Acquired Assets, or the operation of the Business, in each case solely at or after the Closing collectively, the (“Post-Closing Liabilities”).    As between Seller and Buyer, Buyer assumes sole liability for all Assumed Liabilities and all Post-Closing Liabilities.
		

		
			(ii)Excluded Liabilities.  Other than the Assumed Liabilities and the obligations of Buyer under this Agreement or in connection with the Transactions, Buyer will not assume or be liable for, and will have no responsibility for any Liabilities of Seller of any kind or nature (all such Liabilities other than the Assumed Liabilities collectively, the “Excluded Liabilities”).  As between Seller and Buyer, Seller retains sole liability for all Excluded Liabilities.  
		

		
			
		

		 

		

			-7-

		

 

		

			 

		

		(c)Consideration Provided by Buyer for the Acquired Assets.  Subject to the terms and conditions of this Agreement, including the provisions of Section 2(d) below, as total consideration for the Acquired Assets, Buyer shall pay Seller an aggregate of Eighteen Million Five Hundred Thousand Dollars ($18,500,000) (the “Purchase Price”), as follows:
		

		
			(i)Buyer shall deliver to Seller at the Closing, by wire transfer in accordance with Seller’s wiring instructions, Eighteen Million Five Hundred Thousand Dollars ($18,500,000) less $740,000 (such amount, the “Escrow Amount”) held pursuant to the “Escrow Agreement” substantially in the form of Exhibit B attached hereto, among Buyer, Seller and Zions First National Bank, as escrow agent (“Escrow Agent”); and
		

		
			(ii)Buyer shall deliver to the Escrow Agent the Escrow Amount.  The Escrow Amount plus all earnings thereon (the “Escrow Funds”) will be available to satisfy indemnification obligations of Seller as set forth in Section 8.
		

		
			(d)Allocation of Purchase Price.  The Purchase Price (and all Assumed Liabilities and other capitalized costs treated for income Tax purposes as paid for the Acquired Assets) shall be allocated among the Acquired Assets in a reasonable manner in accordance with Section 1060 of the Internal Revenue Code of 1986, as amended, and the regulations thereunder, based on the relative fair market values of the Acquired Assets. Buyer shall complete and deliver a schedule setting forth the proposed allocation of the Purchase Price among the Acquired Assets to Seller on or before March 31, 2016.  Unless Seller notifies Buyer of any objection to the Buyer-prepared allocation schedule within 30 days after Seller’s receipt of such allocation schedule, such schedule shall be deemed to be mutually agreed upon by the Parties. In the event that Seller timely and reasonably disagrees with the proposed allocation schedule, the Parties will work and negotiate in good faith to resolve any disputes and finalize such allocation schedule as soon as possible thereafter.  If Buyer and Seller fail to agree on a resolution of Seller’s objections to the allocation schedule within 30 days after Seller notifies Buyer of Seller’s objections, any disputed elements of the allocation schedule shall be promptly referred to the accounting firm of KPMG, LLP for final resolution, with each party bearing 50% of the fees and other costs associated with resolution of the disagreement by the accounting firm. Buyer and Seller will file all of their tax returns consistent with the foregoing allocation schedule as agreed upon or otherwise finally determined by the accounting firm and will not take any position inconsistent with such allocation on any tax return or in any tax audit or tax-related proceeding, unless otherwise required by a Governmental Authority.  If a Party receives a request from a Governmental Authority to alter the allocation schedule, such Party will notify the other Party of such request.
		

		
			(e)The Closing.  The closing of the Transactions (the “Closing”) shall take place at the offices of Buyer, effective as of 11:59:59 p.m. Eastern Time on the date of this Agreement (the “Closing Date”).
		

		
			(f)Deliveries at the Closing.  At the Closing, (i) Seller will deliver to Buyer the various certificates, instruments, and documents referred to in Section 5(a) below; (ii) Buyer will deliver to Seller the various certificates, instruments, and documents referred to in Section 5(b) below; and (iii) Buyer will deliver to Seller the consideration specified in Section 2(c)(i) above.  
		

		
			
		

		 

		

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		3.Representations and Warranties of Seller.  Except as otherwise set forth in the disclosure letter delivered by Seller to Buyer on the date hereof (the “Disclosure Letter”), corresponding to the relevant Sections below, Seller represents and warrants to Buyer as follows:
		

		
			(a)Organization of Seller.  Seller is a corporation duly incorporated, validly existing and in good standing under the laws of Florida.  Seller has full power and authority to carry on the business in which it is engaged, and to own and use the properties owned and used by it.
		

		
			(b)Authorization of Transaction.  Seller has full corporate power and authority to execute and deliver this Agreement and the Transaction Documents to which it is a party and to perform its obligations hereunder and thereunder.  The execution, delivery and performance of this Agreement and the Transaction Documents by Seller and the consummation of the Transactions have been duly and validly authorized by all necessary action on the part of Seller and no other corporate proceedings on the part of Seller are necessary to authorize this Agreement or any of the Transaction Documents or to consummate any of the Transactions.  This Agreement and the other Transaction Documents to which Seller is a party, assuming the due authorization, execution and delivery hereof and thereof by Buyer hereto and thereto, constitute the valid and legally binding obligations of Seller, as applicable, enforceable against Seller in accordance with their terms and conditions, except as enforceability may be limited by applicable bankruptcy, insolvency or similar laws affecting or relating to the enforcement of creditors’ rights generally or by equitable principles relating to enforceability.
		

		
			(c)Non-contravention.  Neither the execution and delivery of this Agreement nor any of the other Transaction Documents to which Seller is a party, nor the consummation of the Transactions, will (i) result in a violation by Seller of any Law or other restriction of any Governmental Authority to which Seller is subject or any provision of the certificate of incorporation or bylaws (or any other governance document) of Seller or (ii) conflict with, result in a breach of, constitute a default under, result in the acceleration of, create in any party the right to accelerate, terminate, modify, or cancel, or require any notice under any agreement, contract, lease, license, instrument, or other arrangement to which Seller is a party or by which it is bound or to which any of the Acquired Assets is subject (or result in the imposition of any Encumbrance upon any of the Acquired Assets), or (iii) require Seller to obtain or make any waiver, consent, action, approval or authorization of, or registration, declaration, notice or filing with, any Governmental Authority or private non-governmental third-party.  Section 3(c) of the Disclosure Letter sets forth each consent required from a third party, in each case, which would reasonably be expected to have a Material Adverse Effect (including any Governmental Authority) in order for Seller to consummate the Transactions (including to sell and assign the Acquired Assets to Buyer free and clear of any Encumbrance) or where such consent is required by the terms of an Assumed Contract or other Acquired Assets.
		

		
			(d)Title to Assets; Sufficiency of Assets.  Schedule A contains an accurate and complete listing of all of the Acquired Assets.  All of the tangible Acquired Assets are in material compliance with all requirements of all governing laws and regulations, and in good working order and repair, except for ordinary wear and tear.  Seller owns, and has good and valid title to, all of the 
		

		 

		

			-9-

		

 

		

			 

		

		Acquired Assets, free and clear of any Encumbrance or other restriction on transfer, other than the Assumed Liabilities.  At the Closing, Seller will convey to Buyer good and valid title to all of the tangible Acquired Assets, free and clear of any Encumbrance or other restriction on transfer.  The Acquired Assets include Seller’s assets necessary for Buyer to operate the Business in substantially the same manner immediately following the Closing as Seller has been operating the Business in the Ordinary Course of Business.  Other than certain infrastructure and office equipment described in Schedule B,  Seller does not use assets owned by another Person in the operation of the Business.   For purposes of clarity, this Section 3(d) is not a representation or warranty with respect to non-infringement of the Acquired Intellectual Property, which is addressed exclusively in Section 3(g).
		

		
			(e)No Adverse Change.  Except as set forth on Section 3(e) of the Disclosure Letter, since December 31, 2015, there has not been any Material Adverse Effect with respect to Seller.  Without limiting the generality of the foregoing, since that date, other than in the Ordinary Course of Business and other than with respect to Permitted Liens, except as set forth on Section 3(e) of the Disclosure Letter:
		

		
			(i)Seller has not sold, leased, transferred, or assigned any of the Acquired Assets;
		

		
			(ii)Seller has not granted any license or sublicense or any Intellectual Property Rights under or with respect to any Acquired Intellectual Property;
		

		
			(iii)Seller has not committed to any of the foregoing set forth in subparagraphs (e)(i) and (e)(ii); and
		

		
			(iv)Seller has not experienced any damage, destruction, or loss (whether or not covered by insurance) to any tangible Acquired Assets.
		

		
			(f)Legal Compliance.  The Seller conducts the Business in compliance in all material respects with all applicable Laws and Governmental Orders.  Seller has in effect all approvals, clearances, authorizations, certificates, filings, franchises, licenses, notices, permits, clearances, exemptions and registrations of, with or from all Governmental Authorities  that are required for Seller’s operation of the Business (collectively, “Permits”).  Section 3(f) of the Disclosure Letter contains a complete listing of all Permits required for the conduct of Seller’s Business as currently conducted.  No violation, loss or expiration of any of such Permits is pending or, to Seller’s Knowledge, threatened other than expiration in accordance with the terms thereof.  No notice, citation, summons or order has been issued to Seller, no complaint has been filed with Seller, no penalty has been assessed against Seller and no investigation or review is pending or, to Seller’s Knowledge, threatened, by any Governmental Authority, in each case with respect to any alleged failure by Seller to have any such Permit.
		

		
			(g)Intellectual Property.  
		

		
			(i)Seller owns all Acquired Intellectual Property.  
		

		

		

		 

		

			-10-

		

 

		

			 

		

		(ii)To Seller’s Knowledge, the Device, as it is intended to be manufactured and sold, does not infringe upon, misappropriate, or violate any Intellectual Property Rights of any third Person; and none of the officers or directors (or employees with responsibility for Intellectual Property matters) of Seller has ever received, or has knowledge of, any charge, complaint, claim, allegation, demand, or notice, in each case with respect to Intellectual Property rights in the Device, whether directed to Seller or an Affiliate of Seller or any subcontractor, sublicensee, subdistributor, or retailer, alleging any such infringement, misappropriation, or  violation of any third-party Person’s Intellectual Property.  To Seller’s Knowledge, no Person is infringing upon, misappropriating or violating any Acquired Intellectual Property.  
		

		
			(iii)Section 3(g)(iii) of the Disclosure Letter identifies each Patent, Copyright registration, and Trademark registration that has been issued to Seller or any Subsidiary of Seller included in the Acquired Intellectual Property and identifies each pending application for a Patent, Copyright registration and Trademark registration  that Seller or Subsidiary has made with respect to any of the Acquired Intellectual Property. Section 3(g)(iii) of the Disclosure Letter also includes any actions that must be taken within 90 days of the Closing Date to maintain the registrations and applications identified in Section 3(g)(iii) of the Disclosure Letter.  With respect to each item of Intellectual Property required to be identified in Section 3(g)(iii) of the Disclosure Letter:
		

		
			(A) Seller solely owns the item, free and clear of any Encumbrance or license (provided that this subsection (A) does not constitute a representation or warranty regarding infringement upon, misappropriation of, or violation of any Intellectual Property Rights of any third Person), except for such licenses, agreements, and other permissions that Seller has granted to any Person with respect to such item and that also are identified in Section 3(g)(iii) of the Disclosure Letter;
		

		
			(B) the item is not subject to any binding outstanding injunction, judgment, order, decree, or other ruling of any Governmental Authority of competent jurisdiction; 
		

		
			(C) to Seller’s Knowledge, the item if a Patent, registered Trademark or registered Copyright remains valid, enforceable, and subsisting; and
		

		
			(D) To Seller’s Knowledge, Seller’s executive officers have not evaluated any prior art with respect to such item, which is reasonably likely to render such item invalid or unenforceable.
		

		
			(iv)Section 3(g)(iv) of the Disclosure Letter identifies each item of Acquired Intellectual Property that Seller uses pursuant to license, sublicense, agreement, or permission (other than generally, commercially available or off-the-shelf software with a purchase or license price of less than $5,000). 
		

		
			(v)All of the employees of Seller and all independent contractors and consultants of Seller, in each case, who participated in the conception, creation, reduction to practice, or other development of any Acquired Intellectual Property, have entered into invention 
		

		 

		

			-11-

		

 

		

			 

		

		assignment and confidentiality agreements under which such contractors and consultants have assigned to Seller all of their right, title and interest in and to the Acquired Intellectual Property and have agreed not to use or disclose, other than for the benefit of Seller or its successors or assigns, any confidential information of Seller that is included in the Acquired Intellectual Property.  To Seller’s Knowledge, no such employee, independent contractor or consultant has breached any of the provisions of any such agreement.
		

		
			(vi)The docket report set forth in Section 3(g)(iii) of the Disclosure Letter is accurate.
		

		
			(h)Environmental, Health, and Safety Matters.  Seller and its predecessors and Affiliates have complied in all material respects with all applicable environmental, health, and safety Laws the failure of which to comply with would have a Material Adverse Effect with respect to Seller or which would be reasonably expected to create any Encumbrance on the Acquired Assets.  Without limiting the generality of the foregoing, Seller and its predecessors and Affiliates have obtained and complied with all permits, certificates, licenses, filings, approvals and other authorizations of any Governmental Authority that are required pursuant to any applicable environmental, health, and safety Laws for Seller’s independent manufacture, packaging, validation, production and sale of the Device.
		

		
			(i)Contracts.  
		

		
			(i)Section 3(i) of the Disclosure Letter lists the contracts and other agreements related to the Acquired Assets to which Seller is a party and which are being assigned to Buyer as part of the Transactions, other than purchase orders entered into in the Ordinary Course of Business (the “Acquired Contracts”). 
		

		
			(ii)Seller has delivered to Buyer a correct and complete copy of each written agreement listed in Section 3(i) of the Disclosure Letter (as amended to date), except as redacted to reflect pricing and other information for Seller’s products that are not Acquired Assets.  Except as described in Section 3(i) of the Disclosure Letter, with respect to each such agreement: (A) the agreement is legal, valid, binding, enforceable, and in full force and effect; (B) the agreement will continue to be legal, valid, binding, enforceable, and in full force and effect on identical terms (other than the assignment of Seller’s rights and obligations to the Buyer) following the consummation of the Transactions; and (C) none of Seller nor, to Seller’s Knowledge, the other party or parties to the agreement are in breach or default, no event has occurred which with notice or lapse of time would constitute a breach or default, or permit termination, modification, or acceleration, under the agreement and Seller does not have the present expectation or intention of not fully performing all its respective obligations under each such agreement prior to Closing.  Where consent is required to the assignment of such contract to Buyer, Seller has obtained such consent in writing and will deliver a copy of such consent to Buyer prior to Closing as further provided in Section 5(a)(iv) herein.  
		

		
			(j)Litigation.  Except as set forth in Section 3(j) of the Disclosure Letter, there is no litigation or governmental proceeding or investigation pending or, to Seller’s Knowledge, 
		

		 

		

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		threatened against or affecting the Device or any of the Acquired Assets, nor to Seller’s Knowledge has there occurred any event or does there exist any condition on the basis of which any such litigation, proceeding or investigation might properly be instituted against Seller or any Affiliate of Seller, related to the Device or any of the Acquired Assets.  Neither Seller nor any Affiliate of Seller is in default with respect to any order, writ, injunction, decree, ruling or decision of any court, commission, board or other Governmental Authority related to the Acquired Assets.  There are no actions, suits, claims, investigations or proceedings pending or, to Seller’s Knowledge, threatened, against Seller or any Affiliate of Seller related to the Acquired Assets that would reasonably be expected to result, either in any individual case or in the aggregate, in a Material Adverse Effect or affect the rights of Buyer in the Acquired Assets or the ability of Buyer to manufacture, distribute, sell or otherwise dispose of the Device.  The foregoing sentences include, without limiting their generality, actions pending or, to Seller’s Knowledge, threatened against Seller involving the employment (prior or present) of any of Seller’s officers’ or employees’ use of any information or techniques related to the Acquired Assets allegedly proprietary to such officer or employee.
		

		
			(k)Product Warranty.  
		

		
			(i)All units of the Device have been manufactured, sold and delivered in conformity with all applicable Laws of all Governmental Authorities applicable to the Business or with respect to jurisdictions in which the Device is manufactured, marketed or sold.  Except as set forth in Section 3(k) of the Disclosure Letter, Seller has no knowledge of any product failure, recall, or injury-causing event relating to the Device, whether related to Seller or any of its Affiliates.
		

		
			(ii)Seller has furnished or made available to Buyer complete and correct copies of the terms and conditions of sale for the Device (containing applicable guaranty, warranty and indemnity provisions).  
		

		
			(l)Product Liability.  Except as described in Section 3(l) of the Disclosure Letter, to Seller’s Knowledge, Seller does not have any Liability arising out of any injury to individuals as a result of such individuals’ use of any Device as manufactured, sold or delivered, in each case, by Seller prior to the date hereof.
		

		
			(m)Customers and Suppliers.  Section 3(m) of the Disclosure Letter sets forth (a) the name and net sales of each of the twenty (20) most significant customers (by revenue) (“Material Customers”) and (b) the name of the twelve  (12) largest suppliers (by purchases) (“Material Suppliers”) of the Seller and/or its Affiliates with respect to the Device as of twelve (12)-month period ending December 31, 2015.  To the Sellers’ knowledge, no Material Customer intends, anticipates or otherwise expects to stop, materially decrease the volume of, or change, adjust, alter or otherwise modify in any material manner any of the terms (whether related to payment, price or otherwise) with respect to purchasing the Device (whether as a result of the consummation of the Transactions).  To the Seller’s Knowledge, no Material Supplier is considering or intends, anticipates or otherwise expects to stop, materially decrease the volume of, or change, adjust, alter or otherwise modify in any material manner any of the terms (whether related to payment, price or otherwise) with respect to supplying materials, products or services to the Seller (whether as a result of the consummation of the Transactions).
		

		
			
		

		 

		

			-13-

		

 

		

			 

		

		(n)[Intentionally omitted]
		

		
			(o)Financial Statements.  Seller has delivered to Buyer: unaudited financial information related to the Business for the period ending November 30, 2015 (the “Financial Information”).  The Financial Information fairly presents the financial condition of the Business as of the date thereof and for the periods referred to in such Financial Information.
		

		
			(p)Taxes.  To the extent that failure to do so would have a Material Adverse Effect with respect to Seller, Seller has filed or caused to be filed on a timely basis all Tax Returns that are or were required to be filed by or with respect to Seller, pursuant to the Laws of each Governmental Authority with taxing power over it or its assets, except such Taxes, if any, as are set forth in the Financial Statements and are being contested in good faith and as to which adequate reserves (determined in accordance with GAAP) have been provided in the most recent balance sheet included in the Financial Statements.  There has been no audit, the resolution of which has had or will have, a Material Adverse Effect with respect to Seller, by the Internal Revenue Service or relevant state tax authorities of the United States federal or state income, or state franchise or sales, Tax Returns of Seller.  Seller has not given or been requested to give waivers or extensions (or is or would be subject to a waiver or extension given by any other entity) of any statute of limitations relating to the payment of Taxes of Seller or for which Seller may be liable, to the extent that the failure to pay such Taxes would have a Material Adverse Effect with respect to Seller.  The charges, accruals and reserves with respect to Taxes, including deferred Taxes, on the respective books of Seller are adequate (determined in accordance with GAAP) and are at least equal to Seller’s Liability for Taxes, to the extent that the failure to pay such Taxes would have a Material Adverse Effect with respect to Seller.  There exists no material proposed tax assessment against Seller except as disclosed in the Financial Statements.  To the extent that failure to do so would have a Material Adverse Effect with respect to Seller, all Taxes that Seller is or was required by law to withhold or collect have been duly withheld or collected and, to the extent required, have been paid to the proper Governmental Authority or other Person.  All Tax Returns filed by or on behalf of Seller are true, correct and complete, to the extent that failure to do so would have a Material Adverse Effect with respect to Seller.  Seller has no, and will not have any, Liability for Taxes of any nature relating to periods prior to the Closing Date, to the extent that failure to pay such Taxes would have a Material Adverse Effect with respect to Seller, except as will be reflected in the Financial Statements, and all such Liability for Taxes reflected in the Financial Statements shall remain the sole obligation of Seller, except as set forth in Section 7(e) or 10(p) of this Agreement. 
		

		
			(q)Bankruptcy.  Neither Seller nor any member of Seller have made any assignment for the benefit of creditors, filed any petition in bankruptcy, been adjudicated insolvent or bankrupt, petitioned or applied to any tribunal for any receiver, conservator or trustee of any of them or any of their property or assets, or commenced any action or proceeding under any reorganization arrangement, readjustment of debt, conservation, dissolution or liquidation law or statute or any jurisdiction; and no such action or proceeding has been commenced or threatened against Seller by any creditor, claimant, Governmental Authority or any other Person.
		

		
			
		

		 

		

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		(r)FDA and Regulatory Matters.  Except as set forth in Section 3(r) of the Disclosure Letter, Seller has obtained, or has permitted a designated third party to obtain, all material applicable approvals, licenses/registrations or clearances required by a Governmental Authority  (collectively, the “Seller Approvals”) necessary for the marketing and sale of the Device in the countries in which Seller sells the Device immediately prior to the Closing Date and all such Seller Approvals are set forth on Section 3(c) of the Disclosure Letter; (ii) Seller is in compliance in all material respects with the applicable terms and conditions of each Seller Approval and with all applicable Laws, including applicable requirements under the FDCA, as they apply to the Device; and (iii) Seller is in compliance in all material respects with all applicable Laws regarding registration, license, and certification for each Seller controlled site at which the Device is manufactured.
		

		
			(s)Broker Fees.  Seller does not have any Liability or obligation to pay any fees or commissions to any broker, finder, agent or investment banker with respect to the Transactions.
		

		
			4.Representations and Warranties of Buyer.  Buyer represents and warrants to Seller as follows:
		

		
			(a)Organization of Buyer.  Buyer is a corporation duly organized, validly existing, and in good standing under the laws of the State of Utah.
		

		
			(b)Authorization of Transaction.  Buyer has full corporate power and authority to execute and deliver this Agreement and the other Transaction Documents to which it is a party and to perform its obligations hereunder and thereunder.  This Agreement and the other Transaction Documents to which Buyer is a party, assuming the due authorization, execution and delivery hereof and thereof by Seller and any other parties hereto and thereto, constitute the valid and legally binding obligation of Buyer, enforceable against Buyer in accordance with their terms and conditions, except as enforceability may be limited by applicable bankruptcy, insolvency or similar laws affecting or relating to the enforcement of creditors’ rights generally or by equitable principles relating to enforceability.
		

		
			(c)Non-contravention.  Neither the execution and the delivery of this Agreement or the other Transaction Documents to which Buyer is a party, nor the consummation of the Transactions, will (i) violate any Law or other restriction of any Governmental Authority to which Buyer is subject or any provision of its charter or bylaws (or any other governance document) or (ii) conflict with, result in a breach of, constitute a default under, result in the acceleration of, create in any party the right to accelerate, terminate, modify, or cancel, or require any notice under any agreement, contract, lease, license, instrument, or other arrangement to which Buyer is a party or by which it is bound or to which any of its assets is subject.
		

		
			(d)Brokers’ Fees.  Buyer has no Liability or obligation to pay any fees or commissions to any broker, finder, agent or investment banker with respect to the Transactions.
		

		
			(e)Sophisticated Buyer.  Buyer is an informed and sophisticated buyer and possesses such knowledge and experience in financial and business matters that it is capable of 
		

		 

		

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		evaluating the merits and risks of the acquisition of the Acquired Assets and the Device and the assumption of the Assumed Liabilities.  Buyer has undertaken such investigation as it deems necessary or appropriate to enable it to make an informed and intelligent decision with regard to this Agreement and the Transactions including a complete review of the Acquired Contracts.
		

		
			5.[Intentionally Omitted].  
		

		
			6.[Intentionally Omitted].  
		

		
			7.Post-Closing Covenants.  The Parties agree as follows with respect to the period following the Closing, effective upon the Closing:
		

		
			(a)General.  In case within three (3) years after the Closing any further action is necessary or desirable to carry out the purposes of the Agreement, each of the Parties will take such further action (including the execution and delivery of such further instruments and documents) as the other Party reasonably may request, all at the sole cost and expense of the requesting Party.
		

		
			(b)Reimbursement Obligation.  Buyer will reimburse Seller for reasonable attorneys’ fees and expenses incurred by Seller to complete the patent prosecution and maintenance requests described in Schedule 7(b).
		

		
			(c)Non-Competition.  
		

		
			(i)Seller agrees and acknowledges that it is familiar with the trade secrets and other information of a confidential or proprietary nature related to the Acquired Assets.  Seller also agrees and acknowledges that Buyer would be irreparably damaged if Seller or any of its subsidiaries were to provide services or operations in competition with the Device or the Business of Buyer with respect to the sale, distribution or manufacture of a product which is competitive with the Device and that any such competition would result in a significant loss of goodwill by Buyer.  Seller further agrees and acknowledges that (A) the covenants and agreements set forth in this Section 7(c) were a material inducement to Buyer to enter into this Agreement and to perform its obligations hereunder, and that Buyer would not obtain the benefit of the bargain set forth in this Agreement as specifically negotiated by the parties hereto if Seller breached any of the provisions of this Section 7(c), and (B) in order to assure Buyer that the Device will retain its value, it is necessary that Seller and its subsidiaries undertake not to utilize their special knowledge of the sale, distribution or manufacture of the Device, or their relationship with clients or customers to compete with Buyer with respect to the Device, in each case during the Restricted Period.
		

		
			(ii)Therefore, in further consideration of the amounts to be paid hereunder in exchange for the Acquired Assets, Seller agrees that from and after the date of this Agreement and continuing for five (5) years from such date (the “Restricted Period”), it will not, and will cause each of its subsidiaries not to, directly or indirectly, either for itself or through any other Person, compete anywhere within the entire world in any business directly competitive with the Device.
		

		

		

		 

		

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		(iii)Without limiting the generality of the provisions of Section 7(c)(ii), Seller hereby agrees that during the Restricted Period, Seller will not, directly or indirectly, without Buyer’s prior written consent, (A) solicit or otherwise deal with any clients, purchasers or suppliers of Buyer, in each case, in any manner designed to  take business away from Buyer with respect to the Device.
		

		
			(iv)Seller acknowledges and agrees that during the Restricted Period the territorial, time and scope limitations set forth in this Section 7(c) are reasonable and are properly required to protect Buyer’s substantial investment hereunder and for the protection of Buyer’s legitimate interest in client relationships, goodwill and trade secrets related to the Device, and that such limitations would not impose any undue burden upon Seller.  In the event that any such territorial, time or scope limitation is deemed to be invalid, prohibited or unenforceable by a court of competent jurisdiction, Seller agrees, and Seller submits, to the reduction of any or all of said territorial, time or scope limitations to such an area, period or scope as said court will deem reasonable or enforceable under the circumstances.  If such partial enforcement is not possible in such jurisdiction, the provision will be deemed severed as to such jurisdiction, and the remaining provisions of this Agreement will remain in full force and effect.
		

		
			(v)Seller acknowledges and agrees that in the event of Seller’s or any of its subsidiaries’ actual or threatened breach of any of the provisions contained in this Section 7(c), Buyer will have no adequate remedy at law.  Seller accordingly agrees that in the event of any actual or threatened breach of any of the provisions contained in this Section 7(c), Buyer will be entitled to the following rights and remedies, without the need of posting bond or proving actual damages, each of which rights and remedies will be independent of the others and severally enforceable: (A) such injunctive and other equitable relief as may be deemed necessary or appropriate by a court of competent jurisdiction; and (B) the right and remedy to require Seller to account for and pay over to Buyer any profits, monies, accruals, increments or other benefits derived or received by such Seller as the result of any transactions or conduct constituting a breach of any of the provisions contained in this Section 7(c).  Nothing contained herein will be construed as prohibiting Buyer from pursuing any other remedies available to it for such breach or threatened breach, including the recovery of any damages that it is able to prove.
		

		
			(vi)Notwithstanding anything in this Section 7(c) to the contrary, nothing in this Agreement shall impose any obligation on a Person who acquires control of Seller, unless such acquisition is consummated primarily for the purpose of avoiding the obligations under this Section 7(c).
		

		
			(d)Transfer of Assets.  The Parties agree to the following with respect to the delivery to Buyer of the Acquired Assets:
		

		
			(i)Delivery of Items; Training.  Commencing as soon after the execution of this Agreement as reasonable practicable and continuing until the expiration of the term of the Transition Supply Agreement (the “Transfer of Assets Support Period”), Seller shall provide to Buyer the following Transfer of Assets Support:
		

		

		

		 

		

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		(A)Manufacturing Operator Training: Training at Seller’s facilities in Georgia for up to four (4) Buyer manufacturing operators and one (1) Supervisor/Lead (“Buyer manufacturing trainees”) per month. To the extent reasonably required and requested in writing by Buyer with seven (7) calendar days advance notice, Seller shall also provide up to forty (40) hours of manufacturing operator training at Buyer’s facilities.  
		

		
			(B)Quality and Inspection Training: Training at Seller’s facilities in Georgia for up to two (2) Buyer quality and inspection personnel (“Buyer quality and inspection trainees”) per month. To the extent reasonably required and requested in writing by Buyer with seven (7) calendar days advance notice, Seller shall also provide up to forty (40) hours of quality and inspection training at Buyer’s facilities.  
		

		
			(C)Engineering:  Up to eighty (80) hours of engineering, one hundred (100) hours of research and development (inclusive of validation support), sixty (60) hours Purchasing, sixty (60) hours of operations and sixty (60) hours of Quality Control and forty (40) hours of Quality Assurance and Regulatory Systems support by Seller’s employees at Buyer’s facilities located in South Jordan, Utah or at such other location as mutually acceptable to Buyer and Seller to assist the Buyer in establishing its own manufacturing operations, research and development capabilities and quality systems and regulatory assurance program for the Device. In connection with the foregoing, Sellers agrees to use commercially reasonable efforts, as reasonably requested by Buyer, to train Buyer’s personnel on manufacturing, component or raw materials acquisition, manufacturing product, WIP Inspection, sterilizing, and inspecting the Device, as well as on current research and development activities and the establishment of an effective quality systems and regulatory assurance program to support the Device.
		

		
			(D)Sales and Marketing Support: Up to forty (40) hours of sales and marketing support by Seller’s employees at or from Seller’s facilities in Georgia, to assist Buyer in developing its own marketing program and materials for the Device and to assist Buyer in the transition of Device customers from Seller to Buyer, as well as to train Buyer’s employees on the sale of the Device.  Upon mutual agreement of the Parties, Seller’s employees may travel to locations other than Seller’s Georgia facilities to provide Buyer with such sales and marketing support.
		

		
			(E)Other Training or Support:  Upon seven (7) calendar days advance written request from Buyer, Seller agrees to make its then current personnel that are experienced and knowledgeable about the Device reasonably available at Seller’s facilities in Georgia to Buyer to provide such other training or support to Buyer as Buyer may reasonably request, up to, inclusive of the training or support provided under other paragraphs of this Article 7(d), a maximum of five hundred (500) hours of Transfer of Asset Support by Seller.
		

		
			(ii)Reimbursement of Seller’s Costs and Expenses:   To the extent Seller provides training or support to Buyer’s employees at Seller’s facilities in Georgia, Buyer shall bear any travel, hotel and other expenses for Buyer’s employees, as well as any out-of-pocket expenses incurred by Seller associated with such training or support. To the extent Seller’s employees provide training or support to Buyer at locations other than Seller’s facilities, including at Buyer’s main 
		

		 

		

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		headquarters at South Jordan, Utah, Buyer agrees to reimburse Seller for all travel, hotel and other expenses for such Seller’s employees to provide associated with providing such training or support.
		

		
			(iii)Transfer of Acquired Assets:   Except as otherwise provided in this Agreement, immediately following the Closing (and subsequently to the extent Acquired Assets have not been physically transferred to Buyer), Buyer and Seller shall use commercially reasonable efforts to physically transfer the Acquired Assets from Seller to Buyer, on reasonable timing considerations for both Parties, and subject to Buyer’s reasonable discretion as to when such transfer shall occur. 
		

		
			(e)Tax Periods.  Subject to Section 10(p): (i) Seller shall bear and pay when due, or otherwise indemnify and reimburse Buyer for, all Taxes related to the Acquired Assets or Business that are allocable to taxable years or other periods ending on or prior to the Closing Date (and in the case of any taxable year beginning before but ending after the Closing Date, Taxes that are allocable to the portion of such taxable year or period ending on the Closing Date), including income and excise Taxes on Seller resulting from the sale of the Acquired Assets; and (ii) Buyer shall bear and pay when due, or otherwise indemnify and reimburse Seller for, for all Taxes related to the Acquired Assets or Business that are allocable to taxable years or other periods beginning after the Closing Date (and in the case of any taxable year beginning before but ending after the Closing Date, Taxes that are allocable to the portion of such taxable year or period beginning after the Closing Date). With respect to any taxable period that begins before but ends after the Closing Date, Taxes for such straddle period shall be allocated between the portion of the period ending on the Closing Date and the portion of period beginning after the Closing Date based on an interim closing of the books as of the of the Closing Date. 
		

		
			(f)Supply.  Through December 31, 2016, Buyer shall continue to supply Devices to distributors and customers of Seller in compliance in all material respects with the terms and conditions Seller, immediately prior to the Closing, supplied such Devices to such distributors and customers of Seller; provided that Seller has provided to Buyer a copy of such terms and conditions. 
		

		
			(g)Records.  Upon Buyer’s reasonable request, Seller shall deliver accurate copies of records in Seller’s possession or control maintained by Seller with respect to Seller’s operation of the Business prior to the Closing Date if and to the extent Seller created or used such records exclusively with respect to the Device prior to the Closing Date. 
		

		
			8.Remedies for Breaches of this Agreement.  
		

		
			(a)Survival of Representations and Warranties.  All of Seller’s representations and warranties contained in Section 3 of this Agreement shall survive the Closing (even if Buyer knew or had reason to know of any misrepresentation or breach of warranty at the time of Closing) and continue in full force and effect for a period of one year thereafter, except that Seller’s representations and warranties contained in Sections 3(a),  3(b),  3(d),  3(g) and 3(p) of this Agreement (collectively, the “Fundamental Representations”) shall survive the Closing and continue in full force and effect until the expiration of the applicable statutes of limitations periods;  provided,  however, that the representations and warranties contained in Section 3(g) shall continue in full force 
		

		 

		

			-19-

		

 

		

			 

		

		and effect for a period of four years after the Closing.   The Seller’s representations and warranties shall terminate upon the expiration of the applicable survival period described in this Section 8(a).  All of Buyer’s representations and warranties contained in Section 4 of this Agreement shall survive the Closing (even if Seller knew or had reason to know of any misrepresentation or breach of warranty at the time of Closing) and continue in full force and effect for a period of one year thereafter, at which point such representations and warranties shall terminate.  The Parties’ covenants shall survive the Closing, except to the extent specified otherwise in this Agreement.
		

		
			(b)Indemnification Provisions for Benefit of Buyer and Seller.  
		

		
			(i)In the event that Seller has breached  any of its representations and warranties contained in Section 3 of this Agreement or any of its covenants or agreements contained in this Agreement (including the post-closing covenants set forth in Section 7), and, provided that Buyer makes a written claim for indemnification against Seller pursuant to Section 8(c) below within such survival period, then Seller agrees to indemnify Buyer and its Affiliates and their respective officers, directors, employees and agents (collectively, the “Buyer Indemnitees”) from and against the entirety of any Adverse Consequences the Buyer Indemnitees may suffer through and after the date of the claim for indemnification (including, with respect to Indemnification Claims asserted pursuant to Section 8 prior to the end of the applicable survival period, any Adverse Consequences Buyer Indemnitees may suffer after the end of any applicable survival period), in each case resulting from, arising out of, or caused by, such breach.
		

		
			(ii)From and after the Closing, and without giving effect to any limitations set forth in Section 8(e) hereof (except with respect to Section 8(b)(ii)(B), which shall be subject to such limitations), Seller agrees to indemnify Buyer Indemnities from and against the entirety of any and all damages, dues, penalties, fines, costs, reasonable amounts paid in settlement, obligations, taxes, Encumbrances, losses or fees, together with all reasonable expenses and fees, including court costs and attorneys’ fees and expenses, including those arising out of any actions, suits, proceedings, hearings, official inquiries, investigations, charges, complaints, claims, demands, injunctions, judgments, orders, decrees or rulings, in each case arising out of, resulting from, or caused by:
		

		
			(A)Any amounts owing pursuant to the payment obligations set forth in the Agreement and Plan of Merger, dated as of May 14, 2012 by and among Seller, CL Crown, Inc., Hemosphere, Inc. and Mitchell Dann.
		

		
			(B)a personal injury to the extent such personal injury is caused solely by a manufacturing defect in or a design defect in a Device manufactured by Seller prior to the Closing Date or is caused solely by a failure to warn in the printed Instructions for Use (“IFU”) included by Seller on, or in, the package containing, a Device manufactured by Seller prior to the Closing Date.
		

		
			(iii)In the event that Buyer has breached any of its representations or warranties contained in Section 4 of this Agreement or any of its covenants or agreements contained in this Agreement, and provided that Seller makes a written claim for indemnification pursuant to 
		

		 

		

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		Section 8(c) below within such survival period, then Buyer agrees to indemnify Seller and its Affiliates, managers, members, employees and agents (collectively, the “Seller Indemnitees”) from and against the entirety of any Adverse Consequences Seller Indemnitees may suffer through and after the date of the claim for indemnification (including, with respect to Indemnification Claims asserted pursuant to Section 8 prior to the end of the applicable survival period, any Adverse Consequences Seller Indemnitees may suffer after the end of any applicable survival period) , in each case arising out of, resulting from, or caused by, such breach. 
		

		
			(iv)From and after the Closing, and subject to the limitations set forth in Section 8(e) hereof, Buyer agrees to indemnify Seller Indemnities from and against the entirety of any and all damages, dues, penalties, fines, costs, reasonable amounts paid in settlement, obligations, taxes, Encumbrances, losses or fees, together with all reasonable expenses and fees, including court costs and attorneys’ fees and expenses, including those arising out of any actions, suits, proceedings, hearings, official inquiries, investigations, charges, complaints, claims, demands, injunctions, judgments, orders, decrees or rulings, in each case arising out of, resulting from, or caused by a personal injury to the extent such personal injury is caused solely by a manufacturing defect in or design defect in a Device manufactured by Buyer after the Closing Date or is caused solely by a failure to warn in the IFU included by Buyer on, or in, the package containing, a Device manufactured by Buyer after the Closing Date.
		

		
			(v)If both Seller and Buyer breach a covenant, representation or warranty in connection with a single claim for indemnification by a Third Party, then the obligations of (i) and (iii) will apply, but the Adverse Consequences of indemnifying the other Party pursuant to this Section 8 will be offset against the Adverse Consequences of such breach for each Party.
		

		
			(c)Matters Involving Third Parties.  
		

		
			(i)If any third party shall notify any Party (the “Indemnified Party”) with respect to any matter (a “Third Party Claim”) which gives rise to a claim for indemnification against any other Party (the “Indemnifying Party”) under this Section 8, then the Indemnified Party shall promptly notify the Indemnifying Party thereof in writing; provided, however, that as long as the notice of such indemnification claim to the Indemnifying Party is made prior to the expiration of the survival period pursuant to Section 8(a), no delay on the part of the Indemnified Party in notifying the Indemnifying Party shall relieve the Indemnifying Party from any obligation hereunder unless (and then solely to the extent) the Indemnifying Party thereby is actually prejudiced.
		

		
			(ii)Any Indemnifying Party will have the right to defend the Indemnified Party against the Third Party Claim with counsel of its choice reasonably satisfactory to the Indemnified Party so long as (A) the Indemnifying Party notifies the Indemnified Party in writing within 15 business days after the Indemnified Party has given notice of the Third Party Claim of its intention to contest the Third Party Claim (it being understood that the Indemnifying Party may reserve its rights as to whether or not it in fact is liable to indemnify the Indemnified Party), (B) the Indemnifying Party provides the Indemnified Party with evidence reasonably acceptable to the Indemnified Party that the Indemnifying Party will have the financial resources to defend against the Third Party Claim and fulfill its indemnification obligations hereunder (including the payment in 
		

		 

		

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		cash of all fees and costs associated with such defense), (C) the Third Party Claim involves only money damages and does not seek an injunction or other equitable relief, (D) settlement of, or an adverse judgment with respect to, the Third Party Claim is not, in the good faith judgment of the Indemnified Party, likely to establish a precedential custom or practice materially adverse to the continuing business interests of the Indemnified Party, and (E) the Indemnifying Party conducts the defense of the Third Party Claim actively and diligently.  If a Third Party Claim involves entitles both Parties or their indemnitees to indemnification, then the Party reasonably likely to have the more costly indemnification obligation pursuant to Section 8 shall be deemed to be the Indemnifying Party for purposes of the defense of such Third Party Claim.
		

		
			(iii)So long as the Indemnifying Party is conducting the defense of the Third Party Claim in accordance with Section 8(c)(ii) above, (A) the Indemnified Party may retain separate co-counsel at its sole cost and expense and participate in the defense of the Third Party Claim, (B) the Indemnified Party will not consent to the entry of any judgment or enter into any settlement with respect to the Third Party Claim without the prior written consent of the Indemnifying Party (not to be withheld unreasonably), and (C) the Indemnifying Party will not consent to the entry of any judgment or enter into any settlement with respect to the Third Party Claim without the prior written consent of the Indemnified Party (not to be withheld unreasonably), unless the following shall apply (in which case the Indemnifying Party may settle and compromise such Third Party Claim without the prior written consent of the Indemnified Party): (x) there is no finding or admission of any violation of Law or any violation of the rights of any person and no effect on any other claims that may be made against the Indemnified Party; and (y) the sole relief provided is monetary damages that are paid in full in cash by the Indemnifying Party.  If the Indemnified Party fails to consent to any settlement or compromise offer, the Indemnifying Party may continue to contest such Third Party Claim and, in such event, (subject always to Section 8(b)(i)) the maximum liability of the Indemnifying Party for such Third Party Claim shall not exceed such settlement or compromise offer.
		

		
			(iv)In the event any of the conditions in Section 8(c)(ii) above is or becomes unsatisfied, however, (A) the Indemnified Party may defend against, and consent to the entry of any judgment or enter into any settlement with respect to, the Third Party Claim in any manner it reasonably may deem appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party in connection therewith), (B) the Indemnifying Party will reimburse the Indemnified Party (with cash) promptly and periodically for its reasonable costs of defending against the Third Party Claim (including reasonable attorneys’ fees and expenses), and (C) the Indemnifying Party will remain responsible for any Adverse Consequences the Indemnified Party may suffer resulting from, arising out of, relating to, or caused by the Third Party Claim to the fullest extent provided in this Section 8.
		

		
			(d)Characterization of Payments.  All indemnification payments under this Section 8 shall be deemed adjustments to the Purchase Price.
		

		
			(e)Limitations.  Notwithstanding anything contained herein to the contrary, no party to this Agreement shall be liable to any other party for consequential, special, exemplary, or 
		

		 

		

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		punitive damages; provided,  however, that an Indemnifying Party under this Agreement shall be liable to an Indemnified Party under this Agreement for all Third Party Claim amounts that include any of the foregoing types of damages.  All indemnification payments payable hereunder shall be reduced by the amount of insurance proceeds received by the Indemnified Party as a result of the Adverse Consequences for which the Indemnified Party is seeking indemnification.  Each party agrees to use reasonable commercial efforts to realize such insurance benefits.  The maximum aggregate indemnification obligation of any Party with respect to any and all claims under this Agreement or pursuant to the Transactions shall be capped at and shall not exceed $18,500,000 (taking into account all indemnification payments previously made by such Party), except that indemnification obligations solely pursuant to Section 8(b)(ii)(A) shall not be limited by this provision.  Unless total Adverse Consequences for which a Party is entitled to indemnification pursuant to Section 8 exceed $185,000, such Party shall not be entitled to indemnification for such Adverse Consequences, except that indemnification obligations solely pursuant to Section 8(b)(ii)(B) shall not be limited by this provision.  Each Party’s indemnification obligation with respect to a representation and warranty shall terminate upon the expiration and termination of the representation and warranty pursuant to Section 8(a); provided, however, that if a Party asserts a claim for indemnification pursuant to Section 8(c) based on a breach of a representation and warranty in this Agreement prior to the expiration and termination of such representation or warranty, then with respect to the representation and warranty upon which such indemnification is based, the survival period of such representation and warranty shall be extended and shall not terminate with respect to such indemnification claim only until such claim is resolved.  The indemnification obligations in Section 8(b)(ii)(B) and (iv) shall terminate upon the fourth anniversary of the Closing Date; provided, however, that if a Party asserts a claim for indemnification pursuant to Section 8(c) based on Section 8(b)(ii)(B) or (iv), as applicable, prior to the fourth anniversary of the Closing Date, then with such indemnification claim, the survival period of such representation and warranty shall be extended and shall not terminate with respect to such indemnification claim only until such claim is resolved.
		

		
			(f)Escrow Agreement.  During the term of the Escrow Agreement (i.e. the first anniversary of the Closing unless extended with respect to then pending claims), the indemnification obligations of Seller pursuant to Section 8 shall be first satisfied from the Escrow Fund.  Except with respect to (i) a breach by Seller of any of the Fundamental Representations prior to the expiration of the survival period with respect to such Fundamental Representation,  Seller’s fraud and indemnification under Section 8(b)(ii) the Escrow Fund shall be Buyer’s exclusive remedy for indemnification pursuant to this Agreement.
		

		
			(g)Exclusive.  The provisions of this Article 8 hereof set forth the exclusive rights and remedies of Buyer and Seller with respect to matters arising under or in connection with this Agreement and the Transactions, and such indemnification remedies are in lieu of all other remedies based upon any other theory, except with respect to fraud by a Party.
		

		
			9.[Intentionally Omitted].  
		

		
			
		

		 

		

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		10.Miscellaneous.  
		

		
			(a)Press Releases and Public Announcements.  Notwithstanding anything to the contrary in the Mutual Non-Disclosure Agreement between the Parties, Seller may issue a press release or make any public announcement or comment relating to the fact of or the subject matter of this Agreement, including filing or furnishing such information to the Securities and Exchange Commission, NYSE or any other regulatory body, in each case, without prior written consent of Buyer.
		

		
			(b)No Third-Party Beneficiaries.  This Agreement shall not confer any rights or remedies upon any Person other than the Parties and their respective successors and permitted assigns with respect to all rights and obligations of such Parties hereunder.
		

		
			(c)Entire Agreement.  Except with respect to the Mutual Non-Disclosure Agreement, this Agreement and the Transaction Documents (including the Disclosure Letter) constitutes the entire agreement between the Parties and supersedes any prior understandings, agreements, or representations by or between the Parties, written or oral, to the extent they address the subject matter hereof.
		

		
			(d)Succession and Assignment.  This Agreement shall be binding upon and inure to the benefit of the Parties named herein and their respective successors and permitted assigns.  No Party may assign either this Agreement or any of its rights, interests, or obligations, in each case, hereunder without the prior written approval of the other Party.
		

		
			(e)Counterparts.  This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together will constitute one and the same instrument.  A facsimile copy of this Agreement or any counterpart hereto shall be valid as an original.
		

		
			(f)Headings.  The section headings contained in this Agreement are inserted for convenience only and shall not affect in any way the meaning or interpretation of this Agreement.
		

		
			(g)Notices.  All notices, demands or other communications to be given or delivered under or by reason of the provisions of this Agreement shall be in writing and shall be deemed to have been given when delivered personally to the recipient or when sent by facsimile followed by delivery by reputable overnight courier service (charges prepaid), one day after being sent to the recipient by reputable overnight courier service (charges prepaid) or five (5) days after being mailed to the recipient by certified or registered mail, return receipt requested and postage prepaid.  Any notice, demand or other communication hereunder may be given by any other means (including telecopy or electronic mail), but shall not be deemed to have been duly given unless and until it is actually received by the intended recipient.  Such notices, demands and other communications shall be sent to the addresses indicated below:
		

		

		

		 

		

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		If to Seller:
		

		
			CryoLife, Inc.
		

		
			1655 Roberts Blvd., NW
		

		
			Kennesaw, Georgia 30144 
		

		
			Facsimile: (770) 426-0031
		

		
			Attention: Jean F. Holloway, General Counsel
		

		
			With a copy to:
		

		
			Wilson Sonsini Goodrich & Rosati,
		

		
			Professional Corporation
		

		
			900 S. Capital of Texas Hwy.
		

		
			Las Cimas IV, Fifth Floor
		

		
			Austin, Texas 78746
		

		
			Facsimile: (512) 338-5499
		

		
			Attention: Paul Tobias
		

		
			If to Buyer:
		

		
			Merit Medical Systems, Inc. 
		

		
			1600 West Merit Parkway 
		

		
			South Jordan, Utah 84095
		

		
			Facsimile: (801) 253-1600
		

		
			Attention: Fred P. Lampropoulos, Chairman and CEO
		

		
			and 
		

		
			Merit Medical Systems, Inc. 
		

		
			1600 West Merit Parkway 
		

		
			South Jordan, Utah 84095
		

		
			Facsimile: (801) 208-4302
		

		
			Attention: Delos Larson 
		

		
			With a copy to:
		

		
			Parr Brown Gee & Loveless 
		

		
			185 S.  State St., Suite 800 
		

		
			Salt Lake City, Utah 84111 
		

		
			Facsimile: (801) 532-7750
		

		
			Attention: Brian G.  Lloyd, Esq.
		

		
			or to such other address, to the attention of such other Person and/or with such other copy or copies as the recipient Party has specified, by prior written notice to the sending Party.  If any time period for giving notice or taking action expires on a day which is a Saturday, Sunday or legal holiday in 
		

		 

		

			-25-

		

 

		

			 

		

		the State of Utah or the State of Georgia (any other day being a “business day”), such time period shall automatically be extended to the next business day immediately following such Saturday, Sunday or legal holiday.
		

		
			(h)Governing Law; Jurisdiction.  This Agreement shall be governed by and construed in accordance with the domestic laws of the State of Delaware without giving effect to any choice or conflict of law provision or rule (whether of the State of Delaware or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of Delaware.
		

		
			(i)Amendments and Waivers.  Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively), in each case, only by the mutual written consent of Buyer and Seller.  No waiver by any Party of any default, misrepresentation, or breach of warranty or covenant hereunder, whether intentional or not, shall be valid unless the same shall be in writing and signed by the non-breaching Party, nor shall any such waiver be deemed to extend to any prior or subsequent default, misrepresentation, or breach of warranty or covenant hereunder or affect in any way any rights arising by virtue of any prior or subsequent such occurrence.
		

		
			(j)Severability.  Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction.
		

		
			(k)Expenses.  Except as provided in this Agreement, Buyer and Seller will each bear its own costs and expenses (including legal fees and expenses) incurred in connection with this Agreement, the other Transaction Documents and the Transactions.
		

		
			(l)Construction.  The Parties have participated jointly in the negotiation and drafting of this Agreement.  In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any of the provisions of this Agreement.  Any reference to any federal, state, local, or foreign statute or law shall be deemed also to refer to all rules and regulations promulgated thereunder, unless the context requires otherwise.  The word “including” shall mean “including without limitation.” The Parties intend that each representation, warranty, and covenant contained herein shall have independent significance.  If any Party has breached any representation, warranty, or covenant contained herein in any respect, the fact that there exists another representation, warranty, or covenant relating to the same subject matter (regardless of the relative levels of specificity) which the Party has not breached shall not detract from or mitigate the fact that the Party is in breach of the first representation, warranty, or covenant.  
		

		
			(m)Incorporation of Exhibits and Schedules.  The Exhibits and Schedules identified in this Agreement are incorporated herein by reference and made a part hereof.
		

		
			
		

		 

		

			-26-

		

 

		

			 

		

		(n)Specific Performance.  Each of the Parties acknowledges and agrees that the other Party would be damaged irreparably in the event any of the provisions of this Agreement are not performed in accordance with their specific terms or otherwise are breached.  Accordingly, each of the Parties agrees that the other Parties shall be entitled to seek an injunction or injunctions to prevent breaches of such provisions and to enforce specifically this Agreement and the terms and provisions hereof in any action instituted in any court of the United States or any state thereof having jurisdiction over the Parties and the matter (subject to the provisions set forth in Section 10(o) below), in addition to the right to indemnification pursuant to Section 8 and any remedy to which it may be entitled, at law or in equity, with respect to fraud by the other Party.
		

		
			(o)Waiver of Trial By Jury.  EACH PARTY HEREBY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, TRIAL BY JURY IN ANY LITIGATION IN ANY COURT WITH RESPECT TO, IN CONNECTION WITH, OR ARISING OUT OF THIS AGREEMENT OR ANY OF THE OTHER TRANSACTION DOCUMENTS OR THE VALIDITY, PROTECTION, INTERPRETATION, COLLECTION OR ENFORCEMENT HEREOF OR THEREOF.  EACH PARTY AGREES THAT THIS SECTION 10(o) IS A SPECIFIC AND MATERIAL ASPECT OF THIS AGREEMENT AND EACH OF THE OTHER TRANSACTION DOCUMENTS AND ACKNOWLEDGES THAT THE OTHER PARTY WOULD NOT HAVE ENTERED INTO THIS AGREEMENT AND CONSUMMATED THE TRANSACTIONS IF THIS SECTION 10(o) WERE NOT PART OF THIS AGREEMENT AND THE OTHER TRANSACTION DOCUMENTS.
		

		
			(p)Transfer Taxes.  All transfer, documentary, sales, use, value-added, goods and service, stamp, registration and other such Taxes and fees (including penalties and interest) incurred in connection with this Agreement or the Transactions shall be paid by the Party against whom the relevant taxing authority assesses such Tax.  Each of Seller and Buyer, as appropriate, shall, at its expense, file all necessary tax returns and other documentation with respect to all such Taxes.
		

		
			[remainder of page intentionally left blank; signature page follows]
		

		
			 
		

		

		

		 

		

			-27-

		

 

		

			 

		

		IN WITNESS WHEREOF, the Parties hereto have executed this Asset Purchase Agreement on as of the date first above written.
		

		
			 
		

		
			Buyer:
		

		
			MERIT MEDICAL SYSTEMS, INC.
		

		
			 
		

		
			By:  /s/ Fred P. Lampropoulos
		

		
			Name: Fred P. Lampropoulos
		

		
			Title: Chairman and CEO
		

		
			 
		

		
			Seller: 
		

		
			 
		

		
			CRYOLIFE, INC.
		

		
			 
		

		
			By:  /s/ J. Patrick Mackin
		

		
			Name: J. Patrick Mackin
		

		
			Title: President & Chief Executive Officer
		

		
			 
		

		
			 
		

		
			 
		

		 

		

			-1-

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