Exhibit 10.2

 

 

 

 

 

 

CLINICAL COLLABORATION AGREEMENT

BY AND BETWEEN

HUMANIGEN, INC.

AND

KITE PHARMA, INC.

 

 

 

 

 

   

 

 

Table of Contents

 

Page

 

ARTICLE 1 DEFINITIONS 1 ARTICLE 2 CONDUCT OF THE STUDY; REGULATORY MATTERS 6 2.1
Overview 6 2.2 Sponsor 6 2.3 Collaboration IND; Protocol. 6 2.4 Enrollment 6 2.5
Project Participants 6 2.6 Regulatory Matters. 7 2.7 Adverse Experience
Reporting. 7 2.8 Documentation, Updates and Final Study Report. 8 2.9 Costs 8
2.10 Additional Studies. 9 ARTICLE 3 GOVERNANCE 9 3.1 Joint Development
Committee. 9 3.2 Data Review Committee. 11 3.3 Data Monitoring Committee 11
ARTICLE 4 SUPPLY OF STUDY DRUGS 11 4.1 Humanigen Investigational Product. 11 4.2
Insufficient Quantities 12 4.3 Quality Agreement 12 4.4 Mutual Obligations. 12
ARTICLE 5 STUDY DATA; SAMPLE ANALYSES AND SAMPLE DATA 13 5.1 Study Data 13 5.2
Samples and Sample Analyses. 13 5.3 Sample Data. 13 ARTICLE 6 INTELLECTUAL
PROPERTY 14 6.1 Ownership and Use; Definitions. 14 6.2 Mutual Freedom to Operate
. 15 6.3 Patent Prosecution and Maintenance of Collaboration Inventions 16 6.4
Third Party Infringement and Patent Enforcement or Defense. 17 ARTICLE 7
CONFIDENTIALITY 17 7.1 Ownership of Confidential Information. 17 7.2 Disclosure
and Use of Confidential Information. 18 7.3 Authorized Disclosures 19

 

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Table of Contents
(continued)

 

Page

 

7.4 Termination of Prior Agreement 19 ARTICLE 8 PUBLIC DISCLOSURES; USE OF NAMES
20 8.1 CLINICAL TRIALS REGISTRIES 20 8.2 Publications and Presentations. 20 8.3
Press Releases and Other Public Disclosures. 20 8.4 Use of Names 21 ARTICLE 9
HUMAN SUBJECTS 21 9.1 Informed Consent 21 9.2 IRB Approval 22 9.3 Patient
Privacy and Data Protection 22 9.4 Financial Disclosures 22 9.5 Transparency 22
ARTICLE 10 SUBCONTRACTING; RECORDS 22 10.1 Subcontracting 22 10.2 Records. 23
ARTICLE 11 COMPLIANCE WITH LAWS 23 11.1 Compliance with Laws and Policies 23
11.2 Debarment 23 ARTICLE 12 TERM; TERMINATION 23 12.1 Term 23 12.2 Termination
for Material Breach 23 12.3 Termination for Other Reasons 24 12.4 Effects of
Termination or Expiration. 24 ARTICLE 13 REPRESENTATIONS AND WARRANTIES 24 13.1
Mutual Representations and Warranties 24 13.2 Disclaimers 25 ARTICLE 14
INDEMNIFICATION; LIMITATION ON LIABILITY; INSURANCE 25 14.1 Indemnification. 25
14.2 Limitation on Liability 26 14.3 Insurance. 26 ARTICLE 15 DISPUTE RESOLUTION
27 15.1 Internal Resolution 27 15.2 Dispute Resolution and Jurisdiction 27
ARTICLE 16 MISCELLANEOUS 27

 

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Table of Contents
(continued)

 

Page

 

16.1 Notices 27 16.2 Assignment. 28 16.3 Force Majeure 28 16.4 Relationship of
the Parties 28 16.5 Amendment; Waiver 28 16.6 Construction; Captions 28 16.7
Severability 29 16.8 Entire Agreement 29 16.9 Counterparts; Facsimiles 29

 

  -iii- 

 

 

CLINICAL COLLABORATION AGREEMENT

 

 

This Clinical Collaboration Agreement (“Agreement”) is made and entered into,
effective as of May 30, 2019 (“Effective Date”), by and between Humanigen, Inc.,
a Delaware corporation, having a principal place of business at 533 Airport
Boulevard, Suite 400, Burlingame, CA 94010 (“Humanigen”) and Kite Pharma, Inc.,
a Delaware corporation, having a place of business at 2400 Broadway, Santa
Monica, CA 90404 (“Kite”). Humanigen and Kite are each referred to herein
individually as a “Party” and collectively as the “Parties.”

 

Recitals

 

A.       Humanigen is developing the anti-GMCSF antibody Humanigen
Investigational Product (defined below) for the prevention of neurotoxicity and
cytokine release syndrome related to CAR-T and potentially other therapies;

 

B.       Kite is developing the Kite Investigational Product (defined below) for
the treatment of certain blood cancers;

 

C.       Based on a hypothesis that certain CAR-related neurologic events may be
reduced after treatment of Kite Investigational Product and sequential
prophylaxis with an anti-GMCSF antibody, Kite wishes to conduct a Phase I/II
clinical study evaluating the incidence of neurologic events when Kite
Investigational Product is used with Humanigen Investigational Product in
patients with relapsed/refractory large B cell lymphoma; and

 

D.       Humanigen and Kite, consistent with the terms of this Agreement, desire
to collaborate as more fully described herein, including by providing the
Humanigen Investigational Product to Kite for the conduct of the Study described
herein.

 

Agreement

 

Now, Therefore, for good and valuable consideration, the receipt and sufficiency
of which is hereby acknowledged, Humanigen and Kite 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
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.

 

1.2       “Ancillary Agreements” means the Supply Agreement, Quality Agreement,
PV Agreement, and other operational agreements to be entered into by the Parties
after the Effective Date, including without limitation, an agreement to track
financial disclosures pursuant to Section 9.4

 

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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 General Data Protection Regulation 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       “Background IP” is defined in Section 6.2(d).

 

1.5       “Biologics License Application” or “BLA” means a biologics license
application filed or to be filed with the FDA as described in 21 CFR Part 601,
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.

 

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

 

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

 

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

 

1.9       “Collaboration IND” means the IND that includes the Protocol covering
the Study.

 

1.10       “Collaboration Invention” is defined in Section 6.1(c).

 

1.11       “Combination” means the Humanigen Investigational Product and the
Kite Investigational Product used in the combination or sequence as set forth in
the Protocol, but not co-formulated, together.

 

1.12        “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 as defined in
Section 7.1(c).

 

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).

 

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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 2.8(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.

 

1.20       “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.

 

1.21       “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.

 

1.22       “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.

 

1.23       “Humanigen Investigational Product” means lenzilumab in final form
for administration to Subjects in the Study.

 

1.24       “Humanigen Owned Invention” is defined in Section 6.1(b)(ii).

 

1.25        “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.

 

1.26       “Invention” means any invention, discovery or creation (including
materials and Know-How but excluding Study Data and Sample Data) that is first
conceived, reduced to practice, discovered or otherwise created by a Party
(directly or by a Third Party on its behalf) or jointly by the Parties, in each
case, (i) in the course of, or as a result of, conducting and providing support
for the Study; (ii) through use of the Study Data or the Sample Data; or (iii)
through use of the Samples.

 

1.27       “Investigational Products” means the Humanigen Investigational
Product and the Kite Investigational Product. An “Investigational Product” means
either the Humanigen Investigational Product or the Kite Investigational
Product, as applicable.

 

1.28        “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.

 

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1.29       “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.

 

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

 

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

 

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

 

1.33       “Joint Patent” is defined in Section 6.3(a).

 

1.34       “Kite Investigational Product” means axicabtagene ciloleucel
(“axi-cel”) in final form for administration to Subjects in the Study.

 

1.35       “Kite Owned Invention” is defined in Section 6.1(b)(i).

 

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

 

1.37       “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.

 

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

 

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

 

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

 

1.41       “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.

 

1.42       “Protocol” means the protocol to be based on the Kite protocol
synopsis attached hereto as Exhibit A, titled “A Phase1/2 Open-Label,
Multicenter Study Evaluating the Incidence of Neurologic Events after
Axicabtagene Ciloleucel as a Combination Therapy with Lenzilumab in Subjects
with Refractory Large B-Cell Lymphoma” which shall be approved and may be
amended by the JDC in accordance with this Agreement. The Kite protocol synopsis
(Exhibit A), Protocol and Study design is Kite Confidential Information.

 

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

 

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1.44       “Quality Agreement” is defined in Section 4.3.

 

1.45       “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.

 

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

 

1.47       “Sample Analyses” is defined in Section 5.2(b).

 

1.48       “Sample Analysis Plan” means the plan, attached as Exhibit C, that
outlines the Sample Analyses to be performed by Kite or Humanigen and the
priority for performing such Sample Analysis. The Sample Analysis Plan (Exhibit
C) is Kite Confidential Information.

 

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 an Investigational Product,
the set of requirements for such Investigational Product 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/II clinical study to be sponsored and
conducted by Kite as set forth in the Protocol. The principal purpose of the
Study is to evaluate the incidence of neurologic events after treatment of Kite
Investigational Product in Combination with Humanigen Investigational Product,
consistent with the requirements further described in 21 CFR § 312.21(a) & (b)
(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 from 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.

 

1.58       “Supply Agreement” is defined in Section 4.1.

 

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

 

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Article 2

CONDUCT OF THE STUDY; REGULATORY MATTERS

 

2.1       Overview. Kite has the hypothesis that there may potentially be a
reduction in the incidence of CAR-related inflammatory events, such as
neurologic events, after treatment with axicabtagene ciloleucel (Kite
Investigational Product) and sequenced prophylaxis with an anti-GMCSF antibody
in subjects with relapsed/ refractory large B-cell lymphoma. Kite now wishes to
evaluate the hypothesis by conducting the Study under this Agreement, with
support from Humanigen as described herein.

 

2.2       Sponsor. Kite shall be the Sponsor of the Study. Kite shall use
commercially reasonable efforts to 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. Kite shall be responsible
for obtaining all approvals and clearances necessary to conduct the Study,
including approvals from Regulatory Authorities, IRBs and customs clearances. In
no event shall Humanigen be deemed a Sponsor of the Study.

 

2.3       Collaboration IND; Protocol.

 

(a)       Collaboration IND. Kite shall maintain the Collaboration IND and will
likewise maintain, or prepare and file (as applicable) any investigational
medicinal product dossier(s), clinical trial application(s), or similar
applications, necessary for the approval of the Study outside the United States,
subject to co-ownership rights to jointly owned Study Data, jointly owned Sample
Data, and jointly owned Collaboration Inventions. Subject to the ownership
provisions of Sections 2.6(c), 5.1, 5.3, and 6.1(c), Kite shall own all right,
title and interest in and to the Collaboration IND, investigational medicinal
product dossier(s) or clinical trial application(s) (as the case may be), and
related Regulatory Documentation.

 

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

 

(c)       Investigator’s Brochure. Kite shall prepare an investigator’s brochure
for the Kite Investigational Product. Humanigen shall provide to Kite an
investigator’s brochure(s) (and shall immediately provide any updates) for the
Humanigen Investigational Product that pertain to safety matters and other
information that may be required to keep the investigator’s brochure(s) for the
Humanigen Investigational Product up to date.

 

2.4       Enrollment. Commencing on or after the date the PV Agreement is
executed by the Parties, Kite may begin enrolling Subjects in the Study in
compliance with Applicable Law. Kite 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. Kite shall be solely responsible for the
performance and conduct of the Project Participants, including monitoring the
conduct of the Study at the Participating Sites. Kite shall be solely
responsible for negotiating and executing the necessary agreements with all
Project Participants. Kite shall reasonably determine that the compensation
being paid to a Project Participant under its agreement with Kite 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 Humanigen is a
Sponsor of the Study.

 

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2.6       Regulatory Matters.

 

(a)       Generally. Kite shall comply with all lawful direction provided by
Regulatory Authorities and IRBs with jurisdiction over the Study. Kite 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. Kite shall promptly provide
Humanigen with a copy of any material notice, inquiry or correspondence that
Kite receives from a Regulatory Authority regarding the Study (“Material
Regulatory Notice”), including any serious safety matter related to a Party’s
Investigational Product or the Combination and any inspection or investigation
by a Regulatory Authority. Humanigen shall have the right (but not the
obligation) to provide comments to any response to such Material Regulatory
Notice, to the extent such Material Regulatory Notice is related to either the
Combination or the Humanigen Investigational Product, and to participate in any
discussions with a Regulatory Authority relating to such Material Regulatory
Notice, to the extent permitted by such Regulatory Authority. Notwithstanding
the aforementioned, if a Material Regulatory Notice is directed at the Humanigen
Investigational Product, then Humanigen will immediately review and respond to
Kite with all necessary information to address the Material Regulatory Notice.
Furthermore, without limiting Humanigen’s obligations under Section 2.6(c),
Humanigen shall promptly provide Kite with a copy of any material notice,
inquiry or correspondence that Humanigen or its Affiliate receives from a
Regulatory Authority regarding the Humanigen Investigational Product that would
reasonably have an impact on the conduct of the Study, including without
limitation, any serious safety matter related to the Humanigen Investigational
Product. In addition to Material Regulatory Notices, Kite may conduct other
meetings with Regulatory Authorities relating to the Study, and at the JDC’s
discretion, invite Humanigen to observe and/or contribute to Kite’s interactions
with Regulatory Authorities. The Parties shall keep confidential the nature and
substance of such Kite’s discussions with Regulatory Authorities, and any
Confidential Information or Joint Confidential Information exchanged in such
discussions shall at all times be subject to the terms of this Agreement.

 

(c)       Letter of Cross-Reference. Promptly, but no later than ten (10)
business days, after the Effective Date, Humanigen shall provide to Kite a
letter of cross-reference authorizing Kite to reference Humanigen INDs for the
Humanigen Investigational Product as reasonably necessary to support the Study
under the existing Collaboration IND maintained by Kite. Such letter of
cross-reference shall remain in full force and effect until the end of the Term.
In addition to Humanigen’s obligations to supply the Humanigen Investigational
Product under Section 4.1, Humanigen shall, promptly following Kite’s request,
provide and make available to Kite any necessary information about the Humanigen
Investigational Product, including without limitation, any Humanigen
Confidential Information, to support Kite in obtaining approval to conduct the
Study from Regulatory Authorities and IRBs and in conducting the Study. Further,
Humanigen shall provide reasonable assistance to Kite to support Kite’s
interactions with Regulatory Authorities and IRBs in connection with the Study.
Neither Party shall have any rights to use the other Party’s solely owned
Confidential Information or Joint Confidential Information, except as otherwise
expressly provided in this Agreement, including this Section 2.6(c), Section
5.1(b), Section 5.3(b), Article 7, and Article 8, and such permitted uses do not
grant any right or license or transfer ownership to either Party under any of
the other Party’s information (including without limitation Confidential
Information). Notwithstanding the foregoing, while a Party may have rights to
use solely owned Confidential Information or Joint Confidential Information as
expressly set forth in this Agreement, in no event shall any Party disclose,
disseminate or otherwise share the other Party’s solely owned Confidential
Information or Joint Confidential Information with any Third Party except as
expressly authorized in Articles 7 or 8, without the express written consent of
such other Party.

 

2.7       Adverse Experience Reporting.

 

(a)       Within ninety (90) days of executing this Agreement, and in any event
prior to the in the initiation of any clinical Study activities, including
enrollment of the first Study subject, 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 Investigational
Products and the Combination (“PV Agreement”). Such PV Agreement will ensure
that adverse event and other safety information is exchanged according to a
schedule that will permit each Party to comply with Applicable Laws, including
any local regulatory requirements. Kite will be responsible for fulfilling all
regulatory reporting obligations with regard to the Study and the Collaboration
IND and such requirements will be documented in the PV Agreement.

 

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(b)       Kite 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 a 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. Kite shall provide written updates regarding the status of
the Study (including enrollment status, project timelines, Humanigen
Investigational Product inventory and Humanigen Investigational Product
forecasting) to Humanigen on a quarterly basis within forty-five (45) days of
the end of each calendar quarter. Following receipt of such written update,
Humanigen may request that Kite make available Kite personnel responsible for
the Study on a reasonable basis to address Humanigen’s questions regarding such
written update, either in person or by telephone; provided, however, that Kite
shall have no obligation to conduct any unplanned Study Data cuts to address any
such Humanigen questions unless necessary and required to address a material
safety concern. Humanigen shall provide a list of questions and/or topics for
discussion in advance of such meeting.

 

(c)       Final Study Report. Kite shall complete the Study as outlined in the
Protocol. Kite shall summarize the findings of the Study in a Final Study
Report. Kite shall provide the Final Study Report to Humanigen within six (6)
months after Database Lock, subject to complete payment of all Kite invoices by
Humanigen. “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       Costs. Each Party shall share equally (fifty percent (50%) each) in
all out-of-pocket expenses actually incurred in conducting the Study, including
but not limited to expenses for CROs, Third Party testing and analysis service
providers and central labs, Sample Analysis, Participating Sites, patient
screening, imaging and care, clinical data management, statistical analysis,
data safety monitoring and advisory boards, investigator meetings, and shipping
of patient materials to and from a manufacturing site, in accordance with the
mutually agreed budget as set forth in Exhibit B attached hereto, as may be
amended from time to time by the unanimous agreement of the JDC (as defined
below). For clarity, such expenses shall not include any expenses incurred for
the raw materials of an Investigational Product and for the manufacturing and
processing of an Investigational Product by a Party or any of its contractors.
Each Party shall perform its obligations under this Agreement and will be
responsible for all other indirect costs at its own cost and expense, including
internal FTE and overhead costs. Thirty (30) days prior to the initiation of the
Study (with such date to be determined by the JDC), Humanigen shall pay to Kite
an amount equal to Two Million Dollars (US$2,000,000), which is approximately
equal to fifty percent (50%) of the out-of-pocket costs to be incurred in the
conduct of the Study for eighteen (18) Subjects to be dosed. In the event the
Study is terminated prior to 18 Subjects being dosed, Kite agrees to reconcile
the funds received from Humanigen against the out-of-pocket costs and
non-cancellable expenses actually incurred up to the date of Study termination,
and refund Humanigen that amount. Once 18 Subjects have been dosed, within
thirty (30) days prior to the first day of each subsequent calendar quarter
thereafter until Study Completion, Kite shall invoice Humanigen an amount equal
to fifty percent (50%) of the anticipated out-of-pocket costs to be incurred in
conducting the Study for the upcoming calendar quarter, as reasonably forecasted
by Kite, and Humanigen shall pay all such invoices within thirty (30) days of
receipt of such invoice from Kite. Any excess amounts paid by Humanigen to Kite
hereunder will be refunded to Humanigen within sixty (60) days of Study
Completion.

 

  8 

 

 

2.10       Additional Studies.

 

(a)       Using Combination. After completing the Study, if one Party
(“Proposing Party”) wishes to conduct one or more additional studies that
include the other Party’s Investigational Product (“Additional Study(ies)”), the
Proposing Party will provide the other Party with a protocol summarizing the
Additional Study(ies) (“Additional Study Plan(s)”), and the opportunity to
participate, at least six (6) months prior to initiating any Additional Studies.
If the other Party decides to not participate in the Additional Study(ies), the
Proposing Party may proceed alone on the Additional Study Plan(s) at its own
expense, provided the Additional Studies are approved by regulatory authorities,
and provided further that the non-Proposing Party will be under no obligation to
provide any support, Investigational Products or materials to the Proposing
Party for such Additional Study(ies). The Parties shall discuss providing supply
of its respective Investigational Product for an Additional Study, provided that
neither Party shall be obligated to supply its Investigational Product for any
Additional Study.

 

(b)       Other Studies. Nothing in this Agreement shall (a) prohibit either
Party from performing any additional studies relating to its own Investigational
Product, either individually or in combination with any other compound or
product, in any therapeutic area or (b) create an exclusive relationship between
the Parties with respect to either Investigational Product.

 

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 at least two (2), but no more than three (3) 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”). Kite’s JDC Co-Leader shall chair the Joint Development
Committee (“JDC Chair”), including scheduling JDC meetings 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 the Protocol and any subsequent amendments to
the Protocol;

 

(ii)       reviewing and amending the budget as may be reasonably necessary to
reflect changes in the Study;

 

(iii)       approving Participating Sites and Investigators;

 

  9 

 

 

(iv)       reviewing the progress of the Study;

 

(v)       establishing the Data Review Committee (as described in Section 3.2)
and deciding whether and how to address its recommendations;

 

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

 

(vii)       reviewing the progress of the Sample Analysis Plan, including
determining the timing for Sample Analysis to be performed by a Party and the
transfer of results to the other Party;

 

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

 

(ix)       addressing any issues that may arise in the event of a shortage of
supply of Humanigen Investigational Product for the Study, subject to Section
4.1;

 

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

 

(xi)       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 having collectively one (1) vote, provided that, Kite’s JDC
representatives shall have the final decision making authority with respect to
(i) operational matters in conducting the Study, including selecting
Participating Sites, Investigators and CROs, and (ii) amendments to the Protocol
that do not directly relate to the Humanigen Investigational Product or the part
of the Combination that consists of the Humanigen Investigational Product, in
each case that does not result in an increase in the mutually agreed upon budget
by fifteen percent (15%). For clarity, Kite’s JDC representatives shall not have
final decision making authority with respect to matters directly related to the
Humanigen Investigational Product or the part of the Combination that consists
of the Humanigen Investigational Product, and Humanigen’s JDC representatives
shall not have final decision making authority with respect to matters directly
related to the Kite Investigational Product or the part of the Combination that
consists of the Kite Investigational Product. If the JDC cannot reach unanimous
agreement within fifteen (15) Business Days of a matter being brought to a vote
not otherwise addressed by this Section 3.1(c), either Party may refer the
dispute to the Parties’ executives for resolution in accordance with Section
15.1. 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. 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 Humanigen
Co-Leader with ten (10) business days for Humanigen to review and approve such
minutes.

 

  10 

 

 

(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. The JDC also reserves the right to discontinue sub-teams.

 

3.2       Data Review Committee.

 

(a)       Establishment of the DRC; Meetings. Under the direction of the Joint
Development Committee, the Parties may establish a Data Review Committee (“Data
Review Committee” or “DRC”) to monitor the safety of the Investigational
Products being used in the Study. The DRC shall be composed of (i) at least one
clinician designated by Humanigen familiar with the therapeutic profile of the
Humanigen Investigational Product; (ii) at least one clinician designated by
Kite familiar with the therapeutic profile of the Kite Investigational Product;
and (iii) if the Parties agree to include one or more Third Party clinicians,
such individuals shall be acceptable to both Parties, and shall be bound by
appropriate confidentiality and invention assignment obligations. The DRC shall
meet at least once each calendar quarter or at such other times as deemed
appropriate by the Parties and on an ad hoc basis as necessary 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 Investigational Products;

 

(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.

 

3.3       Data Monitoring Committee. The Parties may establish a data monitoring
committee, of independent clinician(s) agreed to by the Parties, to make safety
recommendations about the safety of the Study to the JDC.

 

Article 4

SUPPLY OF STUDY DRUGS

 

4.1       Humanigen Investigational Product.

 

(a)       Manufacture and Supply. Promptly following the Effective Date, but in
no event later than sixty (60) days following the Effective Date, Humanigen and
Kite will enter into a supply agreement (the “Supply Agreement”) which will set
out the quantities of the Humanigen Investigational Product that Humanigen will
supply, or cause to be supplied (including setting aside a reserve of Humanigen
Investigational Product in case of unanticipated or unforeseen shortages, or in
the event of dissolution or insolvency), and the timelines for such supply, in
each case, for use in the Study, including any extensions thereto. Humanigen
shall supply Humanigen Investigational Product for use in the Study, at its
expense, and in the quantities specified in the Supply Agreement. Humanigen
represents and warrants to Kite that: (i) Humanigen shall supply Humanigen
Investigational Product to reach Study Completion; (ii) such Humanigen
Investigational Product shall be manufactured in compliance with: the
Specifications for the Humanigen Investigational Product, Applicable Law and the
Quality Agreement. Humanigen or its designee will deliver Humanigen
Investigational Product to (i) Kite or (ii) a Project Participant as designated
by Kite or the Joint Development Committee (for purposes of Section 4.1(b),
“Delivery Locations”).

 

  11 

 

 

(b)       Delivery. Humanigen shall deliver the Humanigen Investigational
Product to the Delivery Locations in accordance with the Quality Agreement and
the timelines specified in the Supply Agreement or determined by the Joint
Development Committee.

 

(c)       Remaining Investigational Product. Upon completion or termination of
the Study, Kite shall use commercially reasonable efforts to have all unused
quantities of Humanigen Investigational Product, as well as all used vials and
bottles containing the Humanigen Investigational Product, returned to Humanigen
or destroyed (as directed by Humanigen, and at Humanigen’s cost) and documented
accordingly.

 

(d)       Use of Humanigen Investigational Product. From the Effective Date
until the first to occur of Study Completion or any earlier termination of the
Study, Kite has the right to use the Humanigen Investigational Product for the
purpose of conducting the Study, including without limitation, to perform any
analytical methods validation transfer, if required, and shall use the Humanigen
Investigational Product solely for such purpose. Kite shall use, store,
transport, handle and dispose of the Humanigen Investigational Product in
compliance with Applicable Law, the Quality Agreement and all reasonable
instructions from Humanigen. Kite shall not use the Humanigen Investigational
Product for any research, development or commercial purpose, other than for the
Study; Kite shall not attempt to derive or reverse engineer the composition or
underlying information or structure of the Humanigen Investigational Product,
and in particular shall not analyze the Humanigen Investigational Product by
physical, biological, chemical or biochemical means, except as necessary to
perform its obligations under the Quality Agreement.

 

4.2       Insufficient Quantities. In the event that Humanigen determines that
there are insufficient quantities of the Humanigen Investigational Product to
reach Study Completion, Humanigen shall promptly provide written notice to Kite,
including what quantities or manufacturing capacity of its Humanigen
Investigational Product, if any, are available for the Study. The JDC will
promptly discuss how to address the shortage and allocate the available amounts
of Humanigen Investigational Product manufacturing capacity.

 

4.3       Quality Agreement. Within sixty (60) days of executing this Agreement,
the Parties shall enter into a quality agreement establishing the quality
requirements for Humanigen Investigational Product (“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.

 

4.4       Mutual Obligations.

 

(a)       Each Party shall (directly or through its subcontractor, subject to
Section 10.1) obtain and maintain all regulatory approvals (including facility
licenses) required to manufacture its respective Investigational Product 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 Investigational Product under
this Agreement.

 

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

 

  12 

 

 

Article 5

STUDY DATA; SAMPLE ANALYSES AND SAMPLE DATA

 

5.1       Study Data.

 

(a)       Database; Analysis. Kite shall maintain all Study Data in its database
in accordance with Applicable Law. Prior to Study Completion, Kite shall provide
Study Data summaries and interim clinical study reports to Humanigen in
accordance with the timelines to be determined by the JDC. Following Study
Completion, Kite shall lead and coordinate the analysis of Study Data, with
Humanigen support and involvement. Kite shall provide such Study Data to
Humanigen via electronic data transfer, in SAS format or as otherwise agreed by
the Parties, in conjunction with the Final Study Report.

 

(b)       Ownership and Use of Study Data. Kite shall solely own all Study Data
that relate solely to the Kite Investigational Product. Humanigen shall solely
own all Study Data that relate solely to the Humanigen Investigational Product.
Except to the extent otherwise agreed in writing by an authorized representative
of each Party, each Party shall use the other Party’s Study Data only for the
purposes of: (i) seeking regulatory approval for the use of its Investigational
Product in the Combination, and (ii) filing and Prosecuting Patent applications
for Collaboration Inventions and enforcing any resulting Patents in accordance
with Article 6. The Parties shall jointly own Study Data that relate solely to
the Combination, and not solely to an Investigational Product. Such jointly
owned Study Data shall be deemed Joint Confidential Information. Each Party has
the right to use the jointly owned Study Data for any lawful purpose; provided,
however, each Party’s use of the jointly owned Study Data is subject to: (i)
Section 6.3(e), (ii) the limitations on disclosure of the other Party’s
Confidential Information in Section 2.6(c) and Article 7, (iii) the limitations
on disclosure of Joint Confidential Information in Section 2.6(c) and Article 7;
(iv) Article 8; and (v) providing written notice to the other Party of such
Party’s anticipated use of the jointly owned Study Data in a timely manner prior
to such anticipated use.

 

5.2       Samples and Sample Analyses.

 

(a)       Samples. During the Study, Kite will direct the collection of certain
biologic samples from Subjects (“Samples”), as set forth in the Protocol.

 

(b)       Sample Analysis. Kite shall provide to Humanigen the Samples necessary
for Humanigen to perform the Sample Analysis for which Humanigen is responsible,
pursuant to the Sample Analysis Plan. Each Party, at its own expense, 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/es”) pursuant to the sample analysis plan attached hereto as Exhibit C
(“Sample Analysis Plan”), which shall be set forth in the Protocol. The Sample
Analyses shall be performed by a Party in accordance with the timeline set forth
in the Sample Analysis Plan or otherwise determined by the JDC.

 

(c)       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. Humanigen shall not reverse engineer,
reverse compile, disassemble or otherwise attempt to derive the composition or
underlying information, structure or ideas of the Kite Investigational Product,
and in particular, shall not analyze the Kite Investigational Product by
physical, chemical or biochemical means.

 

5.3       Sample Data.

 

(a)       Each Party will be responsible for conducting the Sample Analysis for
its own Investigational Product; the Party responsible for conducting Sample
Analysis for the Combination will be set forth in the Sample Analysis Plan. Kite
and Humanigen will each generate data (including raw data), findings,
conclusions and other results in conducting such Sample Analyses for Samples
obtained from the Study (“Sample Data”). Each Party shall provide to the other
Party the results and/or analysis generated in the course of performing Sample
Analyses for the Study via electronic data transfer or other format/media
determined by the JDC. Such results shall be provided to the other Party within
thirty (30) days of completion of the analysis or as otherwise set forth in the
Sample Analysis Plan or otherwise agreed by the JDC.

 

  13 

 

 

(b)       Kite shall solely own all Sample Data that relate solely to the Kite
Investigational Product. Humanigen shall solely own all Sample Data that relate
solely to the Humanigen Investigational Product. Except to the extent otherwise
agreed in writing by an authorized representative of each Party, each Party
shall use the other Party’s Sample Data only for the purposes of (i) seeking
regulatory approval for the use of its Investigational Product in the
Combination, and (ii) filing and Prosecuting Patent applications for
Collaboration Inventions and enforcing any resulting Patents in accordance with
Article 6. Further, Kite shall have the right to access and use Humanigen Sample
Data for the purpose of performing correlative analysis(es) with the Kite Sample
Data. The Parties shall jointly own Sample Data that relate solely to the
Combination, and not solely to an Investigational Product. Such jointly owned
Sample Data shall be deemed Joint Confidential Information. For clarity, and by
way of example, the results of the correlative analysis(es) to be performed by
Kite with use of the Humanigen Sample Data and Kite Sample Data relates solely
to the Combination, shall be jointly owned by the Parties, and shall be deemed
jointly owned Sample Data and Joint Confidential Information. Each Party has the
right to use the jointly owned Sample Data for any lawful purpose; provided,
however, each Party’s use of the jointly owned Sample Data is subject to: (i)
Section 6.3(e); (ii) the limitations on disclosure of the other Party’s
Confidential Information in Section 2.6(c) and Article 7; (iii) the limitations
on disclosure of Joint Confidential Information in Section 2.6(c) and Article 7;
(iv) Article 8; and (v) providing written notice to the other Party of such
Party’s anticipated use of the jointly owned Sample Data in a timely manner
prior to such anticipated use.

 

Article 6

INTELLECTUAL PROPERTY

 

6.1       Ownership and Use; Definitions.

 

(a)       Ownership of other Inventions. Ownership of any Invention that is not
a Kite Owned Invention, Humanigen Owned Invention, or Collaboration Invention
will be determined in accordance with U.S. patent law.

 

(b)       Sole Ownership and Use of Investigational Product-Specific Inventions

 

(i)       All Inventions that relate solely to (A) the Kite Investigational
Product and uses thereof, methods of making, and modifications thereof,
including improvements thereto, or (B) the Study Data and Sample Data that is
solely owned by Kite (collectively, a “Kite Owned Invention”), and all right,
title and interest therein, shall be the sole and exclusive property of Kite.
For the avoidance of doubt, any Collaboration Invention that generically
encompasses the Kite Investigational Product (and not the Humanigen
Investigational Product) within its scope, even where the Kite Investigational
Product is not disclosed per se, is a Kite Owned Invention. Kite shall solely
own all right, title and interest in and to any Kite Owned Invention. Kite shall
have the sole right (but not the obligation), at its sole expense, to file,
Prosecute, Maintain, and enforce Patents on the Kite Owned Inventions, including
the right to use Study Data and Sample Data in such Prosecution and Maintenance
subject to the obligations in Articles 5, 6 and 7.

 

(ii)       All Inventions that relate solely to (A) the Humanigen
Investigational Product and uses thereof, methods of making, and modifications
thereof, including any improvements thereto, or (B) the Study Data and Sample
Data that is solely owned by Humanigen (“collectively, “Humanigen Owned
Inventions””), and all right, title and interest therein, shall be the sole and
exclusive property of Humanigen. For the avoidance of doubt, any Collaboration
Invention that generically encompasses the Humanigen Investigational Product
(and not the Kite Investigational Product) within its scope, even where the
Humanigen Investigational Product is not disclosed per se, is a Humanigen Owned
Invention. Humanigen shall solely own all right, title and interest in and to
any Humanigen Owned Invention. Humanigen shall have the sole right (but not the
obligation), at its sole expense, to file, Prosecute, Maintain, and enforce
Patents on the Humanigen Owned Inventions, including the right to use Study Data
and Sample Data in such Prosecution and Maintenance subject to the obligations
in Articles 5, 6 and 7.

 

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(c)       Joint Ownership of Collaboration Inventions. All rights to all
Inventions relating to, or covering the Combination that are not Kite Owned
Inventions or Humanigen Owned Inventions (“Collaboration Inventions”), and all
right, title and interest thereto, shall be jointly owned by Kite and Humanigen.
Each Party shall promptly disclose to the other Party any Invention they
reasonably believe to be a Collaboration Invention. For those countries where a
specific license is required for a joint owner of a Collaboration Invention to
practice such Collaboration Invention in such countries, (i) Humanigen hereby
grants to Kite a perpetual, irrevocable, non-exclusive, worldwide, royalty-free,
fully paid-up license, transferable and sublicensable, under Humanigen’s right,
title and interest in and to all Collaboration Inventions to use such Inventions
for any use, and (ii) Kite hereby grants to Humanigen a perpetual, irrevocable,
non-exclusive, worldwide, royalty-free, fully paid-up license, transferable and
sublicensable, under Kite’s right, title and interest in and to all
Collaboration Inventions to use such Inventions for any use, in each case
subject to the obligations in Articles 5, 6 and 7. For clarity, the terms of
this Agreement do not provide either Party with any rights, title or interest or
any license to the other Party’s intellectual property except as necessary to
conduct the Study, and as expressly provided under this Agreement, including as
set forth in Section 6.3(e), below.

 

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

 

6.2       Mutual Freedom to Operate for Collaboration Inventions.

 

(a)       License to Kite. Humanigen hereby grants to Kite a non-exclusive,
worldwide, fully paid, perpetual, sublicensable (as described in Section 6.2(c))
license, under Humanigen’s right, title and interest in and to the Humanigen
Owned Inventions, solely for the purpose of performing of the Study with the
Kite Investigational Product for use in the Combination.

 

(b)       License to Humanigen. Kite hereby grants to Humanigen a non-exclusive,
worldwide, fully paid, perpetual, sublicensable (as described in Section 6.2(c))
license, under Kite’s right, title and interest in and to the Kite Owned
Inventions, solely for the purpose of performing the Study with the Humanigen
Investigational Product 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 to multiple tiers of
sublicensees. 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; Background IP. Except as otherwise expressly
provided in this Agreement, this Agreement does not grant any right or license
to either Party under any of the other Party’s intellectual property rights
(including pre-existing intellectual property rights owned or controlled by
either Party prior to the Effective Date or intellectual property rights
developed by such Party independently from the activities contemplated under
this Agreement (“Background IP”)), 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, provided, however, that (i) Humanigen hereby covenants and agrees
not to assert that the use of any Collaboration Invention, or the Study Data, or
the Sample Data by Kite or its Affiliates has infringed any Background IP of
Humanigen and (ii) Kite hereby covenants and agrees not to assert that the use
of any Collaboration Invention, or the Study Data, or the Sample Data by
Humanigen or its Affiliates has infringed any Background IP of Kite. For
clarity, the terms of this Agreement do not provide Kite or Humanigen any rights
to use or commercialize the other Party’s Investigational Products, alone or in
combination with that Party’s Investigational Products.

 

  15 

 

 

(e)       Termination. Any and all licenses granted under this Section 6.2 shall
terminate upon the latest of (i) termination of this Agreement, and (ii) Study
Completion.

 

6.3       Patent Prosecution and Maintenance of Collaboration Inventions.

 

(a)       Prosecution and Maintenance of Joint Patents. Kite will control the
Prosecution and Maintenance of any Patent covering the Collaboration Invention
(“Joint Patent”), including deciding on (i) the content of the application; (ii)
the countries in which Prosecution and Maintenance should be conducted, subject
to Section 6.3(d); and (iii) the timing for filing of any provisional or regular
Patent application. Kite will consult Humanigen in a timely manner and consider
Humanigen’s comments in good faith. In the event of conflicting comments to
Prosecution and Maintenance, Kite will make the final decision. Kite will
provide copies of all Joint Patent applications filed and all related
Prosecution and Maintenance documents to Humanigen.

 

(b)       Cooperation. Humanigen shall cooperate with and assist Kite in the
Prosecution and Maintenance of any Joint Patent, including (i) consulting with
Kite after receiving any substantial action or development in the Prosecution
and Maintenance of such Patent and (i) making its relevant scientists and
scientific records reasonably available.

 

(c)       Costs. Except as provided in Sections 6.3(a) and 6.3(d), the Parties
shall equally share the out-of-pocket costs for all Joint Patents, with each
Party contributing up to US$250,000 per annum unless jointly agreed in writing
by the Parties.

 

(d)       Assignment to One Party. In the event that one Party (for purposes of
this Section, the “Filing Party”) wishes to file a Patent application for a
given Collaboration Invention and the other Party (for purposes of this Section,
the “Non-Filing Party”) does not wish to file such Patent application in any
countries or in particular countries, the Non-Filing Party shall execute such
documents and perform such acts, at the Filing Party’s expense, as may be
reasonably necessary to effect an assignment of such Collaboration Invention
(including applicable Patent applications) to the Filing Party in all applicable
countries, in a timely manner, to allow the Filing Party to Prosecute and
Maintain such Patent applications, at the Filing Party’s expense. Likewise, if a
Party (for purposes of this Section, the “Opting-Out Party”) wishes to
discontinue the Prosecution and Maintenance of a Patent application for a given
Collaboration Invention in any countries or in particular countries, the other
Party, at its sole option (for purposes of this Section, the “Continuing
Party”), may continue such Prosecution and Maintenance. In such event, the
Opting-Out Party shall execute such documents and perform such acts, at the
Continuing Party’s expense, as may be reasonably necessary to effect an
assignment of such Collaboration Invention (including applicable Patent
applications) to the Continuing Party in all applicable countries, in a timely
manner, to allow the Continuing Party to Prosecute and Maintain such Patent
applications, at the Continuing Party’s expense. The Non-Filing Party and the
Opting-Out Party (as applicable) shall be entitled to receive copies of all
Patent applications filed and all related Prosecution and Maintenance documents.
Any Collaboration Invention (including applicable Patent applications) so
assigned shall thereafter be owned solely by the Filing Party or Continuing
Party (as applicable), provided however, that the Non-Filing Party or Opting-out
Party as applicable (including its successors and assigns) shall retain a
perpetual, irrevocable, non-exclusive, worldwide, royalty-free, sublicensable,
transferable, and fully paid-up license for all purposes under any Patent claims
arising from such Collaboration Invention or Joint Patent in any applicable
countries with respect to a product discovered, developed, or commercialized by
the Non-Filing Party or Opting-out Party.

 

  16 

 

 

(e)       Limitations on Patent Prosecution. Notwithstanding anything to the
contrary in Section 5.1(b) and Section 5.3(b), and except as expressly provided
in Section 6.1(d) and Section 6.3(a), without the prior written consent of the
other Party:

 

(i)       neither Humanigen nor Kite shall file or Prosecute any Patent
application covering the subject matter of a Collaboration Invention or
otherwise disclosing the other Party’s Confidential Information or, the
Protocol, any jointly owned or solely owned Study Data or Sample Data, either
relating to the Combination of the Kite Investigational Product and the
Humanigen Investigational Product or any relating to the other Party’s
Investigational Product, to the extent such information has not been previously
published;

 

(ii)       Humanigen shall not file or Prosecute any Patent application covering
the subject matter of a Kite Owned Invention;

 

(iii)       Kite shall not file or Prosecute any Patent application covering the
subject matter of a Humanigen Owned Invention; and

 

(iv)       neither Humanigen nor Kite shall (A) provide assistance to any Third
Party for any patent application covering subject matter that such Party is
restricted from filing or prosecuting under clauses 6.3(e)(i) – 6.3(e)(iii) or
(B) grant the right to any Third Party to disclose the Study Data or the Sample
Data in the filing or prosecution of any patent application, regardless of which
Party(ies) own such data, except in the case of clause (B), if such Third Party
is an Affiliate of such Party.

 

(f)       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 Kite Investigational
Product and Humanigen Investigational Product.

 

6.4       Third Party Infringement and Patent Enforcement or Defense.

 

(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. Kite will have the sole right, at its sole
discretion and expense, for enforcing and defending any Patents on Kite Owned
Inventions and any Joint Patents assigned to Kite under Section 6.3(d).
Humanigen will have the sole right, at its sole discretion and expense, for
enforcing and defending any Patents on Humanigen Owned Inventions and any Joint
Patents assigned to Humanigen under Section 6.3(d). The Parties shall jointly
decide on a strategy for the enforcement and defense of any Joint Patent that is
jointly owned and on each Party’s rights and obligations in connection
therewith.

 

Article 7

CONFIDENTIALITY

 

7.1       Ownership of Confidential Information.

 

(a)       Except as otherwise expressly provided in the Agreement, Study Data,
Sample Data, Inventions and other intellectual property, shall be the
Confidential Information of the Party(ies) that own such Study Data, Sample
Data, Inventions and other intellectual property.

 

  17 

 

 

(b)       Data and other information (including Study Data, Sample Data and
Inventions) specifically and solely related to the Kite Investigational Product
or to the Humanigen Investigational Product shall be the Confidential
Information solely of Kite or solely of Humanigen, respectively. Such
information includes protocol synopses, investigators’ brochures (and portions
thereof), biomarker data, pharmacokinetic and pharmacodynamic data and product
storage, handling, expiry, administration and in use handling information.

 

(c)       Data and other information (including Study Data, Sample Data and
Collaboration Inventions) generated in conduct of the Study and not solely
related to only one of the Investigational Products, shall be Confidential
Information of both Kite and Humanigen (“Joint Confidential Information”).

 

7.2       Disclosure and Use of Confidential Information.

 

(a)       Kite Confidential Information and Humanigen 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 (including without limitation, any future or
potential Third Party collaborators), (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.

 

(b)       Exceptions. The foregoing obligations under Section 7.2(a) of the
Receiving Party shall not apply to the Disclosing Party’s Confidential
Information, to the extent that the Receiving Party establishes by written
evidence that such Confidential Information:

 

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

 

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

 

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

 

(iv)       was disclosed to the Receiving Party, other than under an obligation
of confidentiality, by a 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 7.2 by the prior
written consent of the Disclosing Party.

 

(c)       Joint Confidential Information. Except to the extent expressly
authorized by this Agreement or otherwise agreed to in writing, or to the extent
Study results have been published in accordance with Section 8.2 , each Party
shall, with regard to Joint Confidential Information, (i) hold in confidence and
not disclose Joint Confidential Information to any Third Party (including
without limitation, any future or potential Third Party collaborators), (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) 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.

 

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7.3       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, disclosure by sponsor on any
clinical trial registries, if applicable, 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; and further provided,
that such Party shall where practicable provide prompt notice of such disclosure
requirement to the other Party and provide reasonable assistance to enable such
other Party to seek a protective order or otherwise prevent such disclosure (in
each case, to the extent it is legally permitted to do so).

 

(b)       Regulatory Authorities. A Party may disclose Joint Confidential
Information 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 Investigational Product; provided, however, such Party
shall provide written notice to the other Party of such Party’s anticipated use
of the Joint Confidential Information in a timely manner prior to such
anticipated use.

 

(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 7.2.

 

(d)       Affiliates; Professional Advisors; Other Third Parties. Except for
Exhibit A (Kite protocol synopsis) and Exhibit C (Sample Analysis Plan), which
is Kite Confidential Information, for the purposes of this Section 7.3(d) , the
terms of this Agreement shall be deemed to be Joint Confidential Information. 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 legally bound by
obligations reasonably similar to those set forth in Section 7.2. A Party may
disclose the terms of this Agreement (or a summary thereof) or any Joint
Confidential Information, to the extent reasonably necessary, to any bona fide
(as evidenced by a written offer or term sheet) potential or actual investors,
acquirers or merger partners for the sole purpose of evaluating an actual or
potential investment, acquisition or merger; provided, however any such
permitted disclosees must be contractually bound in writing by obligations
reasonably similar to those set forth in Section 7.2.

 

7.4       Termination of Prior Agreements. As of the Effective Date, this
Agreement supersedes the Non-Disclosure Agreement between Kite and Humanigen,
Inc. effective as of June 4, 2018. 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.

 

Article 8

PUBLIC DISCLOSURES; USE OF NAMES

 

8.1       Clinical Trials Registries. Kite 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.

 

  19 

 

 

8.2       Publications and Presentations.

 

(a)       Kite is committed to timely publication of the final results following
Study Completion, after taking appropriate action to secure intellectual
property rights (if any) arising from the Study. Kite shall have the right to
first publish or present any interim results and the final results of the Study
(in accordance with this Section 8.2); provided that Kite gives Humanigen an
opportunity to review and provide comments in accordance with subsection (b),
with such comments to be included at Kite’s sole discretion. Humanigen agrees
not to publish any results of the Study or Sample Data (including any interim
Study results or Sample Data) prior to the timely publication of such Study
results by Kite.

 

(b)       Each Party shall use reasonable efforts to publish or present
scientific papers dealing with the Study in accordance with accepted scientific
practice. The Parties agree that prior to submission of the Study results for
publication or presentation or any other dissemination of results, including
oral presentations, the publishing Party shall invite the other to comment on
the content of the material to be published or presented according to the
following procedure:

 

(i)       At least forty-five (45) days prior to submission for publication of
any paper, letter or any other publication, or thirty (30) days prior to
submission for presentation of any abstract, poster, talk or any other
presentation, the publishing Party shall provide to the other Party the full
details of the proposed publication or presentation in an electronic version.
Upon written request from the other Party, the publishing Party agrees not to
submit data for publication/presentation for an additional ninety (90) days in
order to allow for actions to be taken to preserve rights for patent protection.

 

(ii)       The publishing Party shall give reasonable consideration to any
request by the other Party made within the periods set forth in subsection (i)
above to modify the publication and the Parties shall work in good faith and in
a timely manner to resolve any issue regarding the content for publication.

 

(iii)       The publishing Party shall remove all Confidential Information of
the other Party as requested by such other Party before finalizing the
publication.

 

(iv)       Acknowledgements. Each Party agrees to identify and acknowledge the
other Party’s support in any press release and any other publication or
presentation of the results of the Study.

 

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 (including without limitation, investor
calls) 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.

 

(b)       Review and Approval. Each Party agrees that the other Party shall have
no less than five (5) Business Days (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;
provided that if such proposed Disclosure contains patentable subject matter
owned solely or jointly by the reviewing party, the disclosing party will delay
such proposed Disclosure, for ninety (90) days, to permit the reviewing party to
prepare and file a patent application. 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.

 

  20 

 

 

(c)       Joint Press Release by Kite. Promptly after the Effective Date, the
Parties shall issue the joint press release in the form set forth in Exhibit D.

 

(d)       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.

 

(e)       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 five (5) Business Days
before the date of the proposed filing, for such other Party’s review and
comment, and shall thereafter provide reasonable advance notice and opportunity
for comment on any subsequent changes to the proposed redactions.

 

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 “Kite,” “Gilead,” “Humanigen”
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.

 

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Article 9

HUMAN SUBJECTS

 

9.1       Informed Consent. Kite shall prepare the patient informed consent form
for the Study (which shall include any required consent for the Sample Analysis)
in consultation with Humanigen (it being understood and agreed that the portion
of the informed consent form relating to the Humanigen Investigational Product
will be provided to Kite by Humanigen and shall include risks and discomforts
associated with the Humanigen Investigational Product substantially similar to
those identified in the safety information made available to Kite by Humanigen).
Any changes to such form that relate to the Humanigen Investigational Product
shall be subject to Humanigen’s review and prior written consent. Kite shall
obtain the informed written consent of all Subjects participating in the Study,
in accordance with Applicable Law. The informed consent form: (a) shall not
represent that Humanigen is a Sponsor; (b) shall not represent that Humanigen
agrees to compensate Subjects for Study-related injuries; and (c) shall not
represent that Humanigen shall provide the Humanigen Investigational Product to
Subjects after Study Completion or early termination of the Study. Kite shall
provide copies of the forms of informed written consents upon Humanigen’s
request. To the extent consents are validly obtained, and in a form approved by
Kite, Kite further represents and warrants that the Samples may be used as
contemplated in this Agreement without any obligation to the Subjects or Project
Participants, including any obligations of compensation to such Subjects or
Project Participants or any other Third Party for the intellectual property
associated with such Samples or Sample Data.

 

9.2       IRB Approval. Kite 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. Each Party
agrees that it shall not disclose in any publication, information that would
reveal the identity of a Subject (such as name, social security number,
telephone number or address), without the written consent of such Subject.

 

9.4       Financial Disclosures. Within a reasonable time after the Effective
Date, the Parties shall enter into an agreement related to the collection of
financial disclosure information from “clinical investigators” involved in the
Study and the certification and/or disclosure of the same in accordance with all
Applicable Law, including, but not limited to, Part 54 of Title 21 of the United
States Code of Federal Regulations (Financial Disclosure by Clinical
Investigators) and related FDA Guidance Documents. Among other things, such
agreement will provide (a) for Kite to track and collect from all “clinical
investigators” involved in the Study either separate certification and/or
disclosure forms for each of Kite and Humanigen or one (1) “combined”
certification and/or disclosure form for both Kite and Humanigen and (b) that
Kite will be responsible for preparing and submitting the Financial Disclosure
Module 1.3.4 components to the FDA for any Regulatory Documentation in
connection with the Study. For purposes of this Section 9.4, the term “clinical
investigators” shall have the meaning set forth in Part 54.2(d) of Title 21 of
the United States Code of Federal Regulations.

 

9.5       Transparency. To the extent required by Applicable Law, Kite will be
responsible for reporting payments and other transfers of value made to health
care professionals (e.g. investigators, steering committee members, data
monitoring committee members, consultants, etc.) in connection with the Study in
accordance with reporting requirements under Applicable Law (including the
Physician Payment Sunshine Act and state gift laws, and the European Federation
of Pharmaceutical Industries and Associations Disclosure Code) and Kite
policies. Humanigen shall provide all information required for such reporting
regarding the value of the Humanigen Investigational Product provided for use in
the Study. Such information shall be provided to the point of contact within
Kite’s Global Clinical Supplies group who is identified to Humanigen in writing
upon the execution of the Agreement and thereafter promptly following any change
to such point of contact. Humanigen shall provide the necessary information
regarding the value of the Humanigen Investigational Product within fifteen (15)
business days following the execution of this Agreement. In the event that, at
any time during the term of this Agreement, the value of the Humanigen
Investigational Product provided under this Agreement changes, Humanigen shall
notify Kite of such revised value, and the effective date of such revised value,
within fifteen (15) business days following such change in value.

 

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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)       Each Party shall maintain complete and accurate records of its
activities under this Agreement, including without limitation, records relating
to its Sample Analysis, and the manufacture and supply of the Investigational
Product in accordance with Applicable Law, including GCP, GLP, and GMP.
Humanigen shall make its manufacturing and supply records with respect to the
Humanigen Investigational Product available to review, audit and inspect by Kite
in accordance with the Quality Agreement and PV Agreements, as applicable, or
upon request by Kite at reasonable times during normal business hours. Kite
shall make such records which are related to use of funds by Kite to conduct the
Study, for review, audit and inspection by Humanigen, once a year, with at least
fifteen (15) days advance notice by Humanigen, and such audit and inspection
will occur during normal business hours.

 

(b)       Each Party shall maintain such records for at least the period of time
required by Applicable Law, but for no less than ten (10) years 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 scientific and 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. Kite 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, Kite shall promptly notify Humanigen, and the
Parties shall agree upon appropriate action to address the matter.

 

  23 

 

 

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 Kite
provides the Final Study Report to Humanigen 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 thirty (30)
days 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 thirty (30) day period, the cure period shall be extended for
such amount of time that the Parties agree to in writing is reasonably necessary
to cure such breach, so long as the allegedly breaching Party is using diligent
efforts to do so.

 

12.3       Termination for Other Reasons. Kite may immediately suspend or
terminate the Study by notice to Humanigen. 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 Investigational Product for purposes of the Study;
or (d) the other Party breaches the representation and warranty under Section
13.1(c). Either Party may terminate this Agreement with thirty (30) days’ notice
to the other Party, if such Party determines, in its sole discretion, to
discontinue all development of its Investigational Product, for medical,
scientific, business or legal reasons; provided, however that if Humanigen is
the terminating Party pursuant to this provision, it shall fulfill its supply
obligations under Section 4.1 after such termination.

 

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
2.8(a) (Documentation), Section 2.10 (Additional Studies), Section 5.1(b)
(Ownership of Study Data), Section 5.3(b) (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 (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.

 

  24 

 

 

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 INVESTIGATIONAL PRODUCT, 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 Kite Indemnitee (as defined in
Section 14.1(b)) or a Humanigen Indemnitee (as defined in Section 14.1(c)).

 

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

 

(b)       Indemnification by Humanigen. Humanigen hereby agrees to indemnify,
defend (if requested by Kite) and hold harmless each of Kite, its Affiliates and
its and their officers, directors, employees, subcontractors and agents (for
purposes of Section 14.1, each, a “Kite 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 Humanigen
Indemnitees; (2) Humanigen’s breach of any of its representations, warranties,
covenants or obligations under this Agreement; or (3) Humanigen’s breach of any
Applicable Law pertaining to activities it performs under this Agreement; or (B)
are directly caused by the Humanigen Investigational Product, except to the
extent to Losses arise out of or in connection with (1) the negligence or
willful misconduct of any Kite Indemnitees; (2) Kite’s breach of any of its
representations, warranties, covenants or obligations under this Agreement; or
(3) Kite’s breach of any Applicable Law pertaining to activities it performs
under this Agreement.

 

  25 

 

 

(c)       Indemnification by Kite. Kite hereby agrees to indemnify, defend (if
requested by Humanigen) and hold harmless each of Humanigen, its Affiliates and
its and their officers, directors, employees, subcontractors and agents (for
purposes of Section 14.1, each, a “Humanigen 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
Kite Indemnitees; (2) Kite’s breach of any of its representations, warranties,
covenants or obligations under this Agreement; or (3) Kite’s breach of any
Applicable Law pertaining to activities it performs under this Agreement; or (B)
are directly caused by the Kite Investigational Product, except to the extent
any Losses arise out of or in connection with (1) the negligence or willful
misconduct of any Humanigen Indemnitees; (2) Humanigen’s breach of any of its
representations, warranties, covenants or obligations under this Agreement; or
(3) Humanigen’s breach of any Applicable Law pertaining to activities it
performs under this Agreement.

 

(d)       Each Party’s respective obligations under Section 14.1(b) and 14.1(c)
are conditioned upon the Party seeking indemnification (the “Indemnitee”)
delivering written notice to the other Party (the “Indemnitor”) of any potential
Losses subject to indemnification hereunder promptly after the Indemnitee
becomes aware of such potential Losses. The Indemnitor will have no
indemnification obligations hereunder to the extent materially prejudiced by any
delay by the Indemnitee in providing such notice. The Indemnitor will have the
sole right to defend or settle (subject to the remainder of the paragraph) any
Claim (using counsel reasonably satisfactory to the Indemnitee). The Indemnitee
will cooperate fully with Indemnitor in connection therewith, at the
Indemnitor’s expense. The Indemnitee may participate in (but not control) the
defense thereof at its sole cost and expense. The Indemnitor shall keep the
Indemnitee advised of the status of such action, suit, proceeding or claim and
the defense thereof and shall reasonably consider recommendations made by the
Indemnitee with respect thereto. The Indemnitee shall not agree to any
settlement of such action, suit, proceeding or claim without the prior written
consent of the Indemnitor, which shall not be unreasonably withheld, delayed or
conditioned. The Indemnitor shall not agree to any settlement of such action,
suit, proceeding or claim or consent to any judgment in respect thereof that
does not include a complete and unconditional release of the Indemnitee from all
liability with respect thereto or that imposes any liability or obligation on
the Indemnitee without the prior written consent of the Indemnitee, which shall
not be unreasonably withheld, delayed or conditioned.

 

(e)       Study Subjects. Kite shall not offer compensation on behalf of
Humanigen to any Subject or bind Humanigen to any indemnification obligations in
favor of any Subject. The Parties shall share equally all Losses arising out of
any Claims, other than those described in paragraphs 14.1(b) or 14.1(c) above,
to the extent such Losses arise out of the Study after both Parties’ respective
Investigational Products have been administered (i.e., such Losses would not
have occurred but for the Combination).

 

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 OR FOR DAMAGES ARISING
OUT OF A BREACH OF ARTICLES 6 OR 7.

 

14.3       Insurance.

 

(a)       General. Each Party shall maintain insurance coverage as set forth in
Section 14.3(b); provided, however, that both Parties have the right, in their
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 written notice of any cancellation,
nonrenewal or adverse material change in any of the required insurance coverages
in accordance with policy provisions. The limits of any required insurance
coverage shall not limit the Parties’ liability under the indemnification
provisions of this Agreement.

 

  26 

 

 

(b)       Coverage. Each Party 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 such Party’s obligations under this
Agreement, for limits no less than one million dollars ($1,000,000) per
occurrence and two million dollars ($2,000,000) in the aggregate; (ii) clinical
trial liability insurance with limits not less than $10,000,000 per occurrence;
and (iii) product liability insurance relating to such Party’s Investigational
Product, for limits of no less than one million dollars ($1,000,000) per
occurrence and two million dollars ($2,000,000) in the aggregate. For
claims-made type coverage, product liability insurance and clinical trial
liability insurance shall be maintained for a minimum of three (3) years 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 any state or location where the Study is
being conducted. Each Party 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. Kite and Humanigen 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 Humanigen’s Chief Executive Officer and Kite’s Vice President,
Clinical Development, for resolution, prior to proceeding under the other
provisions of Article 15.

 

15.2       Dispute Resolution and Jurisdiction. The Parties shall attempt in
good faith to settle all Disputes in an amicable manner. Any Dispute arising out
of or relating to this Agreement, including the breach, termination or validity
hereof or thereof, shall be governed by and construed in accordance with the
substantive laws of the State of California, without giving effect to its choice
of law principles that would direct the application of the substantive law of
any other jurisdiction. The Parties hereby exclude from this Agreement the
application of the United Nations Convention on Contracts for the International
Sale of Goods. Nothing contained in this Agreement shall deny either Party the
right to seek injunctive or other equitable relief from a court of competent
jurisdiction in the context of a bona fide emergency or prospective irreparable
harm, and such an action may be filed or maintained notwithstanding any ongoing
discussions between the Parties.

 

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 or email (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 or email 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.

 

  27 

 

 

  If to Kite:  

Kite Pharma, Inc.

2225 Colorado Avenue

Santa Monica, CA 90404

Attn: Corporate Counsel

Telephone: 310-824-9999

Email: legal@kitepharma.com

          If to Humanigen:   Humanigen, Inc.

533 Airport Blvd, Suite 400

Burlingame, CA 94010

Attn: Cameron Durrant

Email: cdurrant@humanigen.com

  

16.2       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 16.2, 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 (c) an acquirer (whether by license or acquisition) of all of the assigning
Party’s rights with respect to its Investigational Product, including rights to
research, develop, manufacture and commercialize the Investigational Product
(for purposes of Section 16.2, 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 16.2 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 16.2, this Agreement may only be assigned together with the
Ancillary Agreements.

 

(b)       Acquisitions. If Humanigen or its Affiliates acquires, or is acquired
by, a Third Party that has an active program researching, developing or
commercializing a chimeric antigen receptor designed to target the antigen CD19
(any or all of which such programs are a “Kite Competitive Program”), Humanigen
shall (i) adopt reasonable procedures to prevent any disclosure and/or use of
Confidential Information of Kite or Joint Confidential Information, as the case
may be, in any Kite Competitive Program, and (ii) provide notice to Kite
describing such procedures as soon as practicable.

 

16.3       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.

 

  28 

 

 

16.4       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.

 

16.5       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.

 

16.6       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.

 

16.7       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.

 

16.8       Entire Agreement. This Agreement, together with the Ancillary
Agreements and the Exhibits hereto, contains the entire understanding between
the Parties with respect to the subject matter hereof and thereof and supersedes
and terminates all prior agreements, understandings and arrangements between the
Parties with respect to such subject matter, whether written or oral.

 

16.9       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]

 

  29 

 

 

In Witness Whereof, the Parties have caused this Agreement to be executed by
their respective duly authorized representatives as set forth below.

 

 

 

Kite Pharma, Inc.  

 

 

 

Humanigen, Inc.

 

 

/s/ J.G. McHutchison   /s/ Cameron Durrant Signature   Signature       Name:
J.G. McHutchison

Title: CSO

Date: May 30, 2019   Name: Cameron Durrant

Title: CEO

Date: May 30, 2019

  

  30 

 

  

Exhibit A

 

Kite Protocol Synopsis 

 

  31 

 

 

Exhibit B

 

Study Budget 

 

  32 

 

  

Exhibit C

 

Sample Analysis Plan

 

  33 

 

 

Exhibit D

 

Press Release

 

This press release was filed as Exhibit 99.1 to the Current Report on Form 8-K
of Humanigen, Inc. with the Securities and Exchange Commission on May 31, 2019.