Exhibit 10.1

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS EXHIBIT, MARKED BY [*], HAS
BEEN OMITTED BECAUSE Agenus INC., HAS DETERMINED such INFORMATION (I) IS NOT
MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO AGENUS INC., IF
PUBLICLY DISCLOSED.

LICENSE AND COLLABORATION AGREEMENT

 

This LICENSE AND COLLABORATION AGREEMENT (this “Agreement”) is made as of June
20, 2020 (the “Effective Date”) by and between Agenus Inc., a Delaware
corporation with offices at 3 Forbes Road, Lexington, Massachusetts 02421, USA
(“Agenus”), and Betta Pharmaceuticals Co., Ltd., having an address at No. 355
Xingzhong Road, Yuhang Economic and Technological Development Area, Hangzhou,
China (“Betta”). Agenus and Betta may each be referred to herein individually as
a “Party” or, collectively, as the “Parties”.

WHEREAS, Agenus owns or controls certain intellectual property rights with
respect to its proprietary molecules known as Balstilimab and Zalifrelimab (each
as defined below);

WHEREAS, Betta is a pharmaceutical company focused on the development and
commercialization of innovative drug candidates and desires to obtain from
Agenus certain license rights to develop and commercialize Balstilimab and
Zalifrelimab into commercial products in the Field and in the Territory (each as
defined below); and

WHEREAS, simultaneously with entering into this Agreement, Agenus, Betta and an
Affiliate of Betta are entering into a stock purchase agreement, pursuant to
which Agenus will issue, and such Affiliate of Betta will purchase, shares of
capital stock of Agenus on the terms and conditions set forth therein.

NOW, THEREFORE, in consideration of the premises and of the mutual covenants set
forth herein, the Parties, intending to be legally bound, hereby agree as
follows:

ARTICLE 1.

DEFINITIONS

Capitalized terms used but not otherwise defined in the body of this Agreement
will have the meanings set forth in this ARTICLE 1.

1.1

“Accounting Standards” means, as applicable (a) U.S. generally accepted
accounting principles, consistently applied, (b) the PRC generally accepted
accounting principles, consistently applied, or (c) International Financial
Reporting Standards as issued by the International Accounting Standards Board,
consistently applied.

1.2

“Affiliate” means, as to a Person, any Person which, directly or indirectly,
controls, is controlled by, or is under common control with such Person. For the
purposes of this definition, “control” refers to any of the following: (a)
direct or indirect ownership of fifty percent (50%) or more of the voting
securities entitled to vote for the election of directors in the case of a
corporation, or of fifty percent (50%) or more of the equity interest with the
power to direct management in the case of any other type of legal entity; (b)
status as a general partner in any partnership; or (c) any other arrangement
where an entity possesses, directly or indirectly, the power to direct the
management or policies of another entity, whether through ownership of voting
securities, by contract or otherwise.

1.3

“Agenus Manufacturing Technology” means the Manufacturing Materials and the
Manufacturing Process for each Licensed Antibody.

--------------------------------------------------------------------------------

1.4

“Agenus Other Component” means any [*].

1.5

[*]

1.6

“Amendment to Inter-Company Agreements” means that certain Fourth Amendment to
Amended and Restated Research and Development Cost Sharing Agreement by and
between Agenus and its wholly-owned subsidiary, Agenus Switzerland Inc., to be
executed immediately prior to the execution of this Agreement.

1.7

“Antibody” means one (1) or more molecules, or one (1) or more genes encoding
such molecule(s), which comprises or consists [*].

1.8

“Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act, as amended,
the UK Bribery Act 2010, as amended, the PRC Anti-Unfair Competition Law and the
PRC Criminal Law, as amended, and any other applicable anti-corruption laws and
laws for the prevention of fraud, racketeering, money laundering or terrorism,
as amended.

1.9

“Applicable Law” means all applicable statutes, ordinances, codes, executive or
governmental orders, laws, rules and regulations, including (a) GCP, GDP, GLP
and GMP, (b) any and all Anti-Corruption Laws, (c) any and all Data Privacy
Laws, and (d) any rules, regulations, guidelines or other requirements of
Regulatory Authorities, that may be in effect from time to time.

1.10

“Balstilimab” means the Antibody targeting PD-1 identified by Chemical Abstract
Service Registry Number 2148321-77-9 and internally referenced by Agenus as
“AGEN2034.”

1.11

“Betta IP” means (a) Betta Improvements and Betta Improvement Patent Rights and
(b) Know-How and Patent Rights [*] related to the Licensed Antibody or Licensed
Products [*] for the exercise of the Retained Rights.

1.12

“Betta Other Component” means any Other Component that is Controlled by Betta or
any of its Affiliates as of the Effective Date or during the Term.

1.13

“Betta Parties” means Betta, its Affiliates and/or each of the Sublicensees.

1.14

“Biologics License Application” or “BLA” means a Biologics License Application
(as more fully described in U.S. 21 C.F.R. Part 601.20 or its successor
regulation) and all amendments and supplements thereto submitted to the FDA, or
any equivalent filing in a country or regulatory jurisdiction other than the
U.S. with the applicable Regulatory Authority, or any similar application or
submission for Regulatory Approval filed with a Regulatory Authority to obtain
Regulatory Approval for a biologic product in a region or country or in a group
of countries.

1.15

“Bi-specific Licensed Products” means any Licensed Product that contains two (2)
or more antigen-recognition sequences where [*] one is a Licensed Antibody [*].

1.16

“BLA Submission Summaries” means the Regulatory Submission section containing
manufacturing, nonclinical, and clinical summaries, equivalent to Module 2 of
the U.S. FDA BLA Regulatory Submission.

1.17

“Business Day” means a day other than a Saturday or Sunday or a federal holiday
in New York, New York, USA, or a public holiday in Hong Kong, or a national
holiday in the People’s Republic of China.

2

--------------------------------------------------------------------------------

1.18

“Change in Control” means, with respect to a Party: (a) any transaction or
series of related transactions pursuant to which a Third Party that does not,
itself or together with its Affiliates, prior thereto beneficially own more than
fifty percent (50%) of the voting power of the outstanding securities of such
Party acquires or otherwise becomes the beneficial owner of securities of such
Party representing more than fifty percent (50%) of the voting power of the then
outstanding securities of such Party with respect to the election of directors;
or (b) a merger (including a reverse triangular merger), reorganization,
consolidation, share exchange, or similar transaction involving such Party in
which the holders of voting securities of such Party outstanding immediately
prior thereto and their Affiliates cease to hold voting securities that
represent at least fifty percent (50%) of the combined voting power of the
surviving entity immediately after such merger, reorganization, consolidation,
share exchange, or similar transaction; or (c) such Party sells all or
substantially all of its assets to a Third Party.

1.19

“Clinical Trial” means any human clinical trial of a Licensed Product in the
Field.

1.20

“Combination Product” means any pharmaceutical or biopharmaceutical product
containing both (a) one or more Licensed Product(s)/Licensed Antibody(ies) [*]
and (b) one or more [*] that is not a Licensed Antibody (such other ingredient,
an “Other Product”) [*].

1.21

“Commercialization” or “Commercialize” means any and all activities directed to
new product planning activities, obtaining pricing and/or reimbursement
approvals, marketing, promoting, distributing, importing, offering to sell,
and/or selling a product (including establishing the price for such product),
whether or not the applicable Regulatory Approval(s) for such product has been
obtained. When used as a verb, “Commercialize” means to engage in
Commercialization. Commercialization expressly excludes (a) Development and (b)
Manufacture.

1.22

“Commercially Reasonable Efforts” of a Party means [*].

1.23

“Confidential Information” means, subject to Section 9.1(b), any technical,
scientific or business information furnished by or on behalf of one Party and/or
its Affiliates to the other Party and/or its Affiliates in connection with this
Agreement or the activities contemplated hereunder, regardless of whether such
information is specifically designated as confidential and regardless of whether
such information is in oral, written, electronic or other form. Confidential
Information may also include information of a Third Party that is disclosed by a
Party to the other Party. The existence of this Agreement and its terms will be
deemed to be the Confidential Information of each of the Parties.

1.24

“Control” or “Controlled” means, with respect to any (a) material, document,
item of information, method, data or other Know-How or (b) Patent Rights or
other intellectual property rights, the possession by a Party or, subject to
Section 14.3(b)(ii), any of its Affiliates (whether by ownership or license
(other than by a license granted under this Agreement)) of the ability to grant
to the other Party access, a license and/or a sublicense as provided herein [*]
in each case as of the Effective Date, or if any of the same are acquired or
created after the Effective Date, at the date it is acquired or created by the
relevant Party or its Affiliate; provided, however, that if any of the same are
acquired or created after the Effective Date, at the date it is acquired or
created, [*] further provided, [*] Control will be deemed to exist thereafter.

1.25

“Cover”, “Covering” or “Covered” with respect [*], the Development, Manufacture,
and/or Commercialization of [*].

1.26

“Data Privacy Laws” means the U.S. Health Insurance Portability and
Accountability Act of 1996 Privacy and Security Rules, 45 C.F.R. Parts 160-164,
and the Health Information Technology for

3

--------------------------------------------------------------------------------

Economic and Clinical Health Act, P.L. No. 111-005, Part I, Title XIII, Subpart
D, 13401-13409, and state privacy laws, the EU General Data Protection
Regulation, Cybersecurity Law of the People’s Republic of China, and any other
applicable data privacy and protection laws.

1.27

“Development” or “Develop” means, together with all correlative meanings,
pre-clinical and clinical drug development activities, conducted before or after
obtaining Regulatory Approval that are [*] related to or leading to the
development, preparation, and submission of data and information to a Regulatory
Authority for the purpose of obtaining, supporting or expanding Regulatory
Approval, including, all activities related to preclinical testing, assay
development and validation, in vivo testing, biomarker development and
validation, toxicology, pharmacokinetic profiling, optimizing, design and
conduct of Clinical Trials and any other clinical trials or studies, regulatory
affairs, statistical analysis, report preparation and filing, regulatory filing
creation and submission (including the services of outside advisors and
consultants in connection therewith), development activities conducted after
receipt of Regulatory Approval that are required or requested in writing by a
Regulatory Authority as a condition of, or in connection with, obtaining or
maintaining a Regulatory Approval, and pharmacoeconomic studies relating to the
indication for which the applicable Licensed Product is being developed; in each
case above, including investigator- or institution-sponsored studies for which a
Party is providing material or assistance or otherwise has written obligations
to such investigator or institution; and all regulatory activities related to
any of the foregoing. Development expressly excludes (a) Commercialization and
(b) Manufacture.

1.28

“Efficacy Trial” means any Clinical Trial of a Licensed Product [*].

1.29

“Exploit” or “Exploitation” means to Develop, Manufacture, have Manufactured,
Commercialize, or otherwise use, offer for sale, sell, import, or otherwise
exploit a product or process.

1.30

“FDA” means the U.S. Food and Drug Administration.

1.31

“Field” means all uses (excluding intravesical delivery), including all oncology
and non-oncology indications, of a Licensed Antibody and/or Licensed Product as
a monotherapy or combination therapy with each other or with Other Components
(excluding any Agenus Other Components), for the program(s) Developed by Betta
Parties or a Third Party.

1.32

“First Commercial Sale” means, with respect to a Licensed Product, the first
sale or other disposition for Value by a Betta Party to a Third Party in a
region in the Field and in the Territory after the applicable Regulatory
Approval of such Licensed Product has been obtained in the PRC, or such
marketing and sale is otherwise permitted, by the Regulatory Authority of such
region. [*].

1.33

“FTE” means the equivalent of the work of a full-time individual for a twelve
(12) month period.

1.34

“Fully Burdened Manufacturing Costs” means the cost of Manufacturing the
Licensed Product. [*].

1.35

“GCP” or “Good Clinical Practices” means all applicable current good clinical
practices for Clinical Trials for pharmaceuticals, including, as applicable the
United States Code of Federal Regulations, the PRC Good Clinical Practices for
Pharmaceuticals Products, as released by the NMPA in 2020, or its subsequent
versions, ICH guidelines and applicable regulations, laws or rules as
promulgated thereunder, as amended from time to time, and such standards of good
clinical practice as are required by other organizations and governmental
agencies in the Territory; provided that to the extent any requirement of the
foregoing is less stringent than the requirement under ICH guidelines, the
requirement under ICH guidelines will apply.

4

--------------------------------------------------------------------------------

1.36

“GDP” or “Good Distribution Practices” means all applicable current good
distribution practices for the distribution or supply or pharmaceuticals,
including, as applicable, European Directive 2001/83/EC and the EU Guidelines on
Good Distribution Practice of Medicinal Products (2013/C 68/01) and the PRC Good
Supply Practices of Pharmaceutical Products as released by the NMPA in 2000, or
its subsequent versions.

1.37

“GLP” or “Good Laboratory Practices” means all applicable current good
laboratory practices, including, as applicable, the regulations set forth in 21
C.F.R. Part 58, and the requirements thereunder imposed by the FDA, and the
equivalent thereof in any jurisdiction.

1.38

“GMP” or “Good Manufacturing Practices” means all applicable current good
manufacturing practices, including, as applicable, the applicable regulations
set forth in 21 C.F.R. Parts 210–211, and 600, the requirements thereunder
imposed by the NMPA, and the equivalent thereof in any jurisdiction, and the
laws, regulations, guidelines, guidance, pharmaceutical industry standards and
requirements in force from time to time that apply to the Manufacture of each
Licensed Antibodies and/or Licensed Product in any jurisdiction.

1.39

“Government Official” means any Person employed by or acting on behalf of a
Governmental Body, government-controlled entity or public international
organization.

1.40

“Governmental Body” means any: (a) nation, state, commonwealth, province,
territory, county, municipality, district or other jurisdiction of any nature;
(b) federal, state, local, municipal, foreign or other government; (c)
governmental or quasi-governmental authority of any nature (including any
governmental division, department, agency, commission, instrumentality,
official, ministry, fund, foundation, center, organization, unit, body or entity
and any court or other tribunal); or (d) self-regulatory organization (including
the NASDAQ Global Market, the NASDAQ Global Select Market or its respective
counterparts in the Territory).

1.41

“Hong Kong” mean the Hong Kong Special Administrative Region.

1.42

“HGRAC Approval” means any and all necessary record filings with, and approvals,
licenses, and/or permits issued by, the Human Genetics Resources Administration
of the PRC or any other Governmental Bodies in the PRC required for any
activities, including Development activities and data sharing, under this
Agreement.

1.43

“IND” means an investigational new drug application filed with the NMPA, or the
equivalent in other jurisdictions in the Territory, for the authorization to
commence Clinical Trials.

1.44

“Inventions” means all inventions, discoveries, improvements, data, Know-How and
other technology (whether or not patentable), and any intellectual property
rights therein, that are discovered, made or conceived during the Term and in
connection with the Development, Manufacture and/or Commercialization of
Licensed Antibodies and/or Licensed Products in the course of the performance of
this Agreement.

1.45

“Know-How” means any and all information (including scientific, technical or
regulatory information), pre-clinical and clinical data (including laboratory
notes and notebooks), discoveries, materials, results, inventions, improvements,
protocols, formulas, processes, methods, compositions, articles of manufacture,
formulations, discoveries, findings, know-how and trade secrets of any kind,
including scientific, preclinical, clinical, regulatory, manufacturing,
marketing, financial and commercial information or data, sequence information,
[*], in each case whether or not confidential, proprietary, patented or
patentable, or in written, electronic or any other form now known or hereafter
developed.

5

--------------------------------------------------------------------------------

1.46

“Licensed Antibody” means each of Balstilimab and Zalifrelimab, [*].

1.47

“Licensed Know-How” means, subject to Section 14.3(b)(ii), all Know-How that (a)
are Controlled by Agenus or any of its Affiliates, as of the Effective Date or
during the Term; and (b) [*] Develop, Manufacture or Commercialize any Licensed
Antibody or Licensed Product in the Field in the Territory.

1.48

“Licensed Patent Rights” means, subject to Section 14.3(b)(ii), all Patent
Rights that (a) are Controlled by Agenus or any of its Affiliates, as of the
Effective Date or during the Term; and (b) [*] Develop, Manufacture or
Commercialize a Licensed Antibody or Licensed Product in the Field in the
Territory. Schedule 1.48 includes the Licensed Patent Rights as of the Effective
Date.

1.49

“Licensed Product” means [*] containing a Licensed Antibody or both Licensed
Antibodies [*].

1.50

“Licensed IP” means Licensed Know-How and Licensed Patent Rights.

1.51

“Manufacture” or “Manufacturing” means, as applicable, all activities and
operations associated with the production, manufacture, supply, receipt,
processing, filling, finishing, inspections, testing, packaging, labeling,
shipping, warehousing, storage and handling of a Licensed Product (including the
Licensed Antibody component thereof), including: [*]; process and formulation
development; process validation; stability and release testing; manufacturing
scale-up; pre-clinical, clinical and commercial manufacture and supply;
qualification and validation of Third Party contract manufacturers, scale up,
process and equipment validation, and initial manufacturing licenses, approvals
and inspections; analytical development and product characterization; quality
assurance and quality control development; testing and release; packaging
development and final packaging and labeling; shipping configurations and
shipping studies; and overseeing the conduct of any of the foregoing. When used
as a verb, “Manufacture” means to engage in Manufacturing. Manufacture expressly
excludes (a) Development and (b) Commercialization.

1.52

“Manufacturing Materials” means the [*] for the Manufacture of each Licensed
Antibody.

1.53

“Manufacturing Process” means, subject to Section 14.3(b)(ii), the
documentation, materials and other [*] that is for the Manufacture of the
Licensed Antibodies, as such process may be revised, changed or modified from
time to time at the sole discretion of Agenus. As of the Effective Date, the
Manufacturing Process for each of the Licensed Antibodies is known as “Process
2.1.”

1.54

“Net Sales” means, [*].

1.55

“NMPA” mean the National Medical Product Administrations of the PRC, or its
successor entity(ies) or authority thereto having substantially the same
function.

1.56

“OFAC” means the Office of Foreign Assets Control of the U.S. Department of
Treasury.

1.57

“Other Component” means, with respect to [*].

1.58

“Patent Rights” means all the rights and interests in and to all patents and
patent applications in any jurisdiction in the applicable Territory, including
certificates of invention, applications for certificates of invention and
priority rights, provisional patent applications, divisionals, continuations,
substitutions, continuations-in-part, and all patents granted thereon; and all
re-examinations, re-issues, additions, renewals, extensions, confirmations or
registrations based on any such patent or patent application; and any extensions
or restorations by existing or future

6

--------------------------------------------------------------------------------

extension or restoration mechanisms, including patent term extensions and
supplementary protection certificates.

1.59

“Person” means any individual, partnership, limited liability company, firm,
corporation, association, trust, unincorporated organization or other entity.

1.60

“PRC” means the People’s Republic of China, which for purposes of this Agreement
only, excludes Hong Kong, Macau and Taiwan.

1.61

“Prosecution” or “Prosecute” means, with respect to a particular Patent Right,
all activities associated with the prosecution and maintenance of such Patent
Right (and patent application(s) derived from such Patent Right), as well as
re-examinations, reissues, applications for patent term adjustments and
extensions, supplementary protection certificates and the like with respect to
that Patent Right, [*], with respect to that Patent Right. For clarity,
“Prosecution” will not include the preparation and filing of patent
applications.

1.62

“Province” means each of the provinces, autonomous regions, and municipalities
of the PRC.

1.63

“Quality Agreement” means the quality agreement to be executed by the Parties
after the Effective Date with respect to cGMP Manufacturing of the Licensed
Antibody, in substantially the form attached hereto as Schedule 1.63, as may be
revised by the Parties from time to time.

1.64

“Regulatory Approval” means, with respect to a Licensed Product in a country or
region, all approvals that are necessary for the commercial sale of such
Licensed Product for use in the Field in such country or region, excluding any
pricing and reimbursement approvals, except to the extent required by Applicable
Law to sell the Licensed Product in such country or region.

1.65

“Regulatory Authority” means any court or Governmental Body, including any
department, commission, council, board, bureau, agency, or other regulatory or
administrative governmental authority or instrumentality, any quasi-governmental
Person or entity exercising the functions of any of these, which will for
clarity include the NMPA and other government entities regulating or otherwise
exercising authority with respect to the Exploitation of the Licensed Antibodies
and/or Licensed Products pursuant to the terms and conditions of this Agreement,
including any such entity involved in the granting of Regulatory Approval for
pharmaceutical products.

1.66

“Regulatory Exclusivity Period” means any period of data, market or other
regulatory exclusivity (as distinct from and excluding any exclusivity arising
under Patent Rights) for a Licensed Product in a country or region in the
Territory under applicable laws, rules and regulations in such country or region
which prevents any unlicensed Third Party from marketing, promoting or selling a
product that is biosimilar to or interchangeable with such Licensed Product in
such country or region.

1.67

“Regulatory Submissions” means any filing, application or submission with any
Regulatory Authority, including authorizations, approvals or clearances arising
from the foregoing, including Regulatory Approvals and any pricing or
reimbursement approvals, as applicable, and in each case any and all supporting
documents (including documents arising in the course of Clinical Trials), and
all correspondence or communication with or from the relevant Regulatory
Authority, as well as minutes of any meetings, telephone conferences or
discussions with the relevant Regulatory Authority, in each case, with respect
to a Licensed Antibody and/or a Licensed Product.

1.68

“Representatives” means a Party, its Affiliates, and their respective
sublicensees, employees, officers, contractors, consultants or agents.

7

--------------------------------------------------------------------------------

1.69

“Results” means all data (including all raw data), results, final clinical study
reports and documentation [*].

1.70

“Restricted Party” means a party that is: (a) listed on a Restricted Party List,
(b) resident in, located in, or organized under the laws of a country or
territory that is the subject of country- or territory-wide economic sanctions
administered by OFAC; (c) subject to end-use or end-user restrictions imposed by
the U.S. Department of Commerce’s Bureau of Industry and Security; or (d)
majority-owned or controlled by any of the foregoing.

1.71

“Restricted Party List” means the list of sanctioned entities maintained by the
United Nations; the Specially Designated Nationals and Blocked Persons List, the
Foreign Sanctions Evaders List and the Sectoral Sanctions Identifications List,
all administered by OFAC; the U.S. Denied Persons List, the U.S. Entity List,
and the U.S. Unverified List, all administered by the U.S. Department of
Commerce; and the consolidated list of Persons subject to E.U. Financial
Sanctions, as implemented by the E.U. common Foreign & Security Policy.

1.72

“sBLA Approval” means the Regulatory Approval of the Licensed Product in the PRC
as a domestically manufactured product manufactured in the PRC, which if the
Licensed Product was previously approved under a Biologics License Application
(BLA) as an imported product manufactured outside the PRC, is a supplemental
approval to such approved Biologics License Application (BLA). For clarity, the
sBLA Approval of a Licensed Product in this Agreement means that the Licensed
Product Manufactured in the PRC using the Territory Manufacturing Process has
received Regulatory Approval from the Regulatory Authority in the PRC.

1.73

“Territory” means the PRC, Hong Kong, Macau and Taiwan, each of which will be
considered a region under this Agreement.

1.74

“Third Party” means any Person other than a Party or an Affiliate of such Party.

1.75

“Two-Invoice Policy” means the policy described in the Opinion on the
Implementation of the “Two-Invoices” System in the Procurement of Pharmaceutical
Products by Public Medical Institutions (trial) (Guoyigaibanfa [2016] No. 4),
officially released on January 9, 2017 and in any other Applicable Law that
mandates public hospitals or any other purchaser of drugs in the PRC to purchase
drugs from the distributor that purchases the drugs directly from the drug
manufacturer, limiting the total number of invoices to two.

1.76

“Valid Claim” means, with respect to any jurisdiction, (a) a claim of an issued
and unexpired patent included within any of the Licensed Patent Rights that has
not been revoked, held unpatentable, invalid or unenforceable by a patent
office, court or other governmental agency of competent jurisdiction in a final
and non-appealable judgment (or judgment from which no appeal was taken within
the allowable time period) and which claim has not been disclaimed, denied or
admitted to be invalid or unenforceable through reissue, re-examination or
disclaimer or otherwise; or (b) a claim of a pending patent application within
the Licensed Patent Rights that [*].

1.77

“Value” means cash or cash equivalents invoiced or received, or in the event
that in-kind, equity interests or other non-cash consideration is promised or
received, the fair market value thereof.

1.78

“Zalifrelimab” means the Antibody targeting CTLA-4 identified by Chemical
Abstract Service Registry Number 2148321-69-9 and internally referenced by
Agenus as “AGEN1884.”

1.79

Additional Definitions. The following table identifies the location of
definitions set forth in various sections of this Agreement:

8

--------------------------------------------------------------------------------

Definition

Section

Abandoned Commercialization

4.10

Abandoned Development

4.10

Annual Net Sales

7.3(b)

[*]

[*]

Agenus

Preamble

Agenus Indemnitees

13.1

Agenus Improvements

8.1(a)

Agenus Improvement Patent Rights

8.1(a)

Agenus Product Mark

6.2(b)(i)

Agreement

Preamble

Betta

Preamble

[*]

[*]

Betta Indemnitees

13.2

Betta Improvements

8.1(b)

Betta Improvements Patent Rights

8.1(b)

Betta Product Mark

6.2(b)(i)

Chinese Trademarks

6.2(b)(i)

CMO

1.34

Commercial Milestone

7.3(b)

Commercial Milestones Notice

7.3(b)

Cure Period

10.2(c)

Disclosing Party

9.1(a)

Effective Date

Preamble

Executive Officers

3.3(a)

Force Majeure Event

14.6

General Distributor

6.3(b)

Global Branding Strategy

6.2(a)

Initial Payment

7.1

Insolvency Event

10.2(d)

Joint Improvements

8.1(a)

Joint Improvement Patent Rights

8.1(a)

JSC

3.1(a)

Liabilities

13.1

License

2.1

Licensed Patent Right Challenge

8.6

[*]

[*]

[*]

[*]

Manager

3.1(b)

9

--------------------------------------------------------------------------------

Manufacturing Standards

5.2(e)

Manufacturing Technology Transfer Completion

5.2(b)

Milestone Payment

7.3

[*]

[*]

New Trademark

6.2(b)(i)

Other Product

1.20

Party(ies)

Preamble

Permissible Deviation

6.2(a)

Price Difference

6.3(b)(ii)

Prior Agreements

14.4

Product Invention

8.1(a)

Product Invention Patent Rights

8.1(a)

Product Marks

6.2(b)(i)

Product Trademarks

6.2(b)(i)

Promotional Materials

6.2(c)

Public Official

11.6(b)(vi)

Recipient

9.1(a)

Records

5.2(d)

Remaining Inventory

10.3(c)

Retained Rights

2.3

Right of Reference

4.7(g)

Royalty Payment Statement

7.5(b)

Royalty Term

7.4(a)

SDEA

4.6

SEC

9.2(b)

[*]

[*]

[*]

[*]

Specifications

5.2(c)

Sublicensee

2.5(a)

Sublicensee Breach

2.5(c)

Sublicensee Obligation

2.5(c)

Supply Agreement

5.1

Tech Transfer Agreement

5.2(b)

Tech Transfer Fee

7.2

Tech Transfer Notice

5.2(b)

Tech Transfer Plan

5.2(b)

Territory Development Plan

4.1

Term

10.1

Termination Date

10.3(b)

10

--------------------------------------------------------------------------------

Territory Commercialization Plan

6.1

Territory Development Plan

4.1

Territory Manufacturing Process

5.2 (c)

Territory Specifications

5.2 (c)

[*]

[*]

Third Party Manufacturer

5.2(b)

Transaction Agreements

11.7

Upstream License Agreement

2.6

Upstream Licensor

2.6

 

ARTICLE 2.

LICENSES

2.1

License Grant. Subject to the terms of this Agreement, [*], Agenus hereby grants
Betta a royalty-bearing, non-transferable (except in accordance with Section
14.3), sublicenseable (subject to Section 2.5) license or sublicense, as
applicable, under the Licensed IP solely to Develop, Manufacture and
Commercialize Licensed Products in the Field and in the Territory (the
“License”). Subject to Section 2.2 and Section 2.3, the License will be (a)
exclusive (even as to Agenus and its Affiliates) with respect to the Licensed
Patent Rights and the Licensed Know-How that are exclusively licensed to Agenus
or owned by Agenus, and (b) non-exclusive with respect to the Licensed Patent
Rights and Licensed Know-How that are non-exclusively licensed to Agenus.

2.2

Exclusion. Notwithstanding anything to the contrary in this Agreement, Betta is
not granted a license under the Licensed IP or any other intellectual property
rights Controlled by Agenus to Exploit any [*].

2.3

Retained Rights. Agenus retains all rights to use the Licensed IP except those
expressly granted to Betta under the terms of this Agreement. Without limiting
the foregoing, the Parties agree that Agenus and its Affiliates will retain the
rights under the Licensed IP for Agenus and its Affiliates to (a) Exploit the
Licensed Antibodies and/or Licensed Products [*] in all fields outside the
Territory and outside the Field in the Territory, (b) Develop and Manufacture
the Licensed Antibodies and/or Licensed Products [*] in the Territory solely for
the Exploitation outside the Territory of such Licensed Antibodies and/or
Licensed Products, but in no event for the Commercialization of such Licensed
Antibodies and/or Licensed Products in the Field and in the Territory, and (c)
research the Licensed Antibodies and/or Licensed Products [*] in or outside the
Territory (collectively, the “Retained Rights”).

2.4

License to Agenus. Betta hereby grants to Agenus a perpetual, irrevocable,
non-exclusive, fully paid, royalty free, sublicenseable (through multiple
tiers), non-transferrable (except in accordance with Section 14.3) license under
the Betta IP to (a) exercise the Retained Rights with respect to Licensed
Antibodies and Licensed Products as a monotherapy or combination [*] (b) to
perform its obligations under this Agreement.

2.5

Sublicense Rights.

 

(a)

Sublicense Grant. Subject to the terms and conditions of this Agreement, Agenus
hereby grants to Betta the right to sublicense its rights under the License to
one or more Affiliates without the right to further sublicense [*] (each such
sublicensee, a “Betta Sublicensee”) or to Third Parties without the right to
further sublicense subject to Agenus’ prior written

11

--------------------------------------------------------------------------------

 

approval, [*] (each such approved sublicensee, a “Third Party Sublicensee”; each
Third Party Sublicensee or each Betta Sublicensee, a “Sublicensee”). For
clarity, Betta shall notify Agenus [*] in advance of execution of any potential
sublicense agreement and may not grant a Sublicensee with a right to further
sublicense, and no Sublicensee may grant further sublicense(s), without Agenus’
prior written approval.

 

(b)

Scope of Sublicense. No sublicense may exceed the scope of rights granted to
Betta hereunder. Betta will require all sublicenses to be in writing and to: (i)
include an agreement by the Sublicensee to be bound by the terms and conditions
of this Agreement to the same extent as such terms and conditions apply to
Betta, including an audit right by Agenus of the same scope as provided in
Section 4.7(h), 5.2(e), 7.5(e), and 11.6(b); (ii) agree to and acknowledge
Agenus’ right to enforce its rights in the Licensed IP as set forth herein;
(iii) provide for conversion into a direct license at the election of Agenus in
accordance with Section 10.4; and (iv) provide that the term of the sublicense
thereunder may not extend beyond the Term. Betta will enforce all sublicenses at
its cost and will be responsible for the acts and omissions of its Sublicensees.

 

(c)

Betta Liability. Notwithstanding any sublicense agreement, Betta will remain
primarily liable to Agenus for all of Betta’s duties and obligations contained
in this Agreement, including the payment of all royalties due pursuant to
Section 7.4. Any act or omission of a Sublicensee that would be a breach of this
Agreement and is not timely cured (to the extent curable) will be a breach by
Betta of this Agreement. Performance or satisfaction of any of the obligations
of Betta under this Agreement by any of its Sublicensees shall be deemed
performance or satisfaction of such obligations by Betta. Each sublicense
agreement must contain a right of termination by Betta for the Sublicensee’s:
(i) breach of any payment or reporting obligations affecting Agenus; (ii)
participation in a Licensed Patent Right Challenge; (iii) violation of any US
export control laws in connection with the sale or distribution of any Licensed
Product; (iv) violation of any Anti-Corruption Laws in connection with any
activity related to the Licensed Product; or (v) breach of any other terms or
conditions of the sublicense agreement which breach would constitute a breach of
this Agreement if Betta failed to comply therewith (each, a “Sublicensee
Obligation”). In the event that a Sublicensee breaches any Sublicensee
Obligation (each, a “Sublicensee Breach”), (A) if such Sublicensee Breach is
curable, and after a [*] cure period provided in the sublicense agreement, not
to exceed [*] without Agenus’ written consent, the Sublicensee or Betta fails to
cure the Sublicensee Breach; or (B) if such Sublicensee Breach is otherwise not
capable of being cured, then, in the case of (A) or (B), Betta will terminate
the sublicense agreement by written notice to the Sublicensee [*] thereafter and
concurrently provide a copy of such notice to Agenus. In the event any
Sublicensee Breach does not cause Agenus to be in breach of any of its
obligations under any Upstream License Agreement, then termination of the
corresponding sublicense agreement by Betta will be deemed to have cured any
breach by Betta of this Agreement to the extent caused by such Sublicensee
Breach. In the event any such Sublicensee Breach causes Agenus to be in breach
of any of its obligations under any Upstream License Agreement, termination of
the corresponding sublicense agreement by Betta will only be deemed to have
cured any breach by Betta of this Agreement to the extent caused by such
Sublicensee Breach if (1) the Sublicensee Breach is capable of being cured and
(2) termination of the corresponding sublicense agreement also cures all
corresponding breaches by Agenus of its obligations under any Upstream License
Agreement.

 

(d)

Copy of Sublicense Agreement. Betta will deliver to Agenus a true, complete and
correct copy of each sublicense agreement (i) with respect to Betta Sublicensee,
in the form entered

12

--------------------------------------------------------------------------------

 

into by Betta, and any modification or termination thereof, [*] following the
applicable execution, modification, or termination of the sublicense agreement;
(ii) with respect to Third Party Sublicensee, (A) in the form intended to be
entered into by Betta, and any modification thereof, in order for Agenus to
consider as part of deciding whether to provide its prior written approval for
the applicable sublicense, prior to execution; and (B) in the form entered into
by Betta, and any modification or termination thereof, [*] following the
applicable execution, modification, or termination of the sublicense agreement;
[*].

2.6

Upstream Licenses. Betta acknowledges that Agenus has licensed certain of the
Licensed IP from [*] (each, an “Upstream License Agreement” and each of [*], an
“Upstream Licensor”). Betta acknowledges and agrees that (i) the License
constitutes, in part, a sublicense under each applicable Upstream License
Agreement; (ii) the License is subject to the terms and conditions of the
applicable Upstream License Agreement; and (iii) that prior to the Effective
Date, Agenus has provided Betta with a copy of each Upstream License Agreement,
which copy may be redacted to remove any provisions or terms not necessary to
determine Betta’s rights under the License. Betta further acknowledges and
agrees that it will (and Betta will require all Betta Parties to) comply with
the provisions set forth in Schedule 2.6. Nothing in this Agreement will be
deemed to grant to Betta any rights under any of the Upstream License Agreements
beyond those that Agenus has the right to sublicense to Betta pursuant to such
Upstream License Agreement.

2.7

Limitations. Except as expressly set forth in this ARTICLE 2, nothing in this
Agreement will be deemed to grant to Betta any ownership or other rights in or
to any products or technologies owned or Controlled or developed or otherwise
obtained by or on behalf of Agenus as of the Effective Date or thereafter, nor
to any intellectual property or other proprietary rights therein, all of which
will remain solely and exclusively owned by Agenus. For clarity, and without
limiting the foregoing, the License does not include a right under the Licensed
IP to Develop, Manufacture or Commercialize any product containing [*].

2.8

Non-Compete.

 

(a)

By Betta. During the Term, except for the Licensed Antibodies and Licensed
Products as expressly contemplated under this Agreement, Betta will not, and
Betta will cause Betta Parties to not, [*].

 

(b)

By Agenus. During the Term, except as required to perform the obligations
provided in this Agreement and performance of this Agreement, Agenus will not,
and Agenus will cause its Affiliates to not, [*].

ARTICLE 3.

GOVERNANCE

3.1

Joint Steering Committee.

 

(a)

Establishment. [*] after the Effective Date, the Parties will establish a joint
steering committee (the “JSC”), responsible for the overall coordination and
oversight of activities contemplated under this Agreement.

 

(b)

Representation. JSC shall be comprised of an equal number of members appointed
by Betta and Agenus, provided that each Party will initially have the right to
appoint three (3) representatives to the JSC who have requisite knowledge and
experience in (i) regulatory and clinical Development of antibody-based
immuno-therapeutics, (ii) antibody supply chain and Manufacturing, and (iii)
product Commercialization. Agenus’ initial JSC representatives will be
[redacted], and Betta’s initial JSC representatives will be

13

--------------------------------------------------------------------------------

 

[redacted]. In addition to the JSC members, each Party will appoint one (1)
non-member or member representative to coordinate JSC activities and act as a
collaboration manager (the “Manager”). The Managers will attend each JSC meeting
and other non-member attendance will be as agreed by the Parties on a
case-by-case basis. Each Party’s representatives and any substitute for a
representative will be bound by the obligations of confidentiality set forth in
ARTICLE 9. A representative from [*] will act as the chairperson of the JSC. The
chairperson will not have any greater authority than any other representative on
the JSC, but will be responsible for the following activities: (A) calling
meetings of the JSC (in accordance with Section 3.2); (B) preparing and issuing
minutes of each such meeting [*] thereafter; and (C) preparing and circulating
an agenda for the upcoming meeting; provided that the chairperson will include
any agenda items proposed by the other Party. Each Party will be free to change
its representatives on written notice to the other Party or to send a substitute
representative to any JSC meeting; provided, however, that each Party will
ensure that at all times during the existence of the JSC, its representatives on
the JSC are appropriate, in the appointing Party’s reasonable discretion, in
terms of expertise and seniority for the then-current stage of Development,
Manufacturing and/or Commercialization of the Licensed Antibodies and/or
Licensed Products.

 

(c)

Responsibilities. The JSC will have responsibility for: (i) overseeing the
Development, Manufacturing, and Commercialization of the Licensed Antibodies and
the Licensed Products in the Field and in the Territory; (ii) reviewing and
approving the Territory Development Plans, including any updates or amendments
thereto; (iii) reviewing and providing comments to the Territory
Commercialization Plans, including Commercialization activities of the Licensed
Antibodies and the Licensed Products in the Field and in the Territory; (iv)
exchanging information on communications with Regulatory Authorities in the
Territory regarding the Licensed Antibodies and/or the Licensed Products; (v)
reviewing scientific publications proposed by Betta in relation to Licensed
Antibodies and/or the Licensed Products; (vi) serving as a forum to coordinate
with respect to implementation of the Global Branding Strategy, review of
Promotional Materials, sales, pricing, reimbursement and other items relevant to
the Commercialization of Licensed Products in the Territory; (vii) serving as a
forum to coordinate with respect to the Manufacture of the Licensed Antibodies
and Licensed Products in the Territory, including the selection of Third Party
Manufacturers and oversight of the Tech Transfer Plan; (viii) coordinating the
supply of the Licensed Antibodies from Agenus to Betta as contemplated under
Section 5.1, the Supply Agreement, and the supply of the Licensed Antibodies or
Licensed Products from Betta to Agenus as contemplated under Section 5.2; and
(ix) performing such other functions as expressly set forth in this Agreement or
appropriate to further the purposes of this Agreement, as mutually agreed upon
by the Parties in writing.

 

(d)

Subcommittees. The JSC may establish and disband subcommittees as deemed
necessary by the JSC in order to coordinate and expedite the Development,
Manufacture or Commercialization of the Licensed Antibodies and the Licensed
Products in the Field in the Territory. The Parties will have the right to
appoint equal numbers of representatives to each subcommittee. No subcommittee
established by the JSC will have the authority to bind the Parties hereunder and
any such subcommittee will report to, and any decisions will be made by, the
JSC.

3.2

JSC Meetings. The JSC will hold at least one (1) meeting per calendar quarter.
In advance of each JSC meeting, Betta will circulate to JSC members a written
report regarding its (or its Affiliates’, Sublicensees’ or Third Party
contractors’) Development, Manufacture and Commercialization

14

--------------------------------------------------------------------------------

activities in respect of Licensed Antibodies and Licensed Products, including
(a) progress against the most recent Territory Development Plans, (b) Net Sales
of Licensed Product on a Licensed Product-by-Licensed Product and
region-by-region basis, and (c) information relating to Betta’s partnering or
sublicensing efforts. [*]. The JSC may meet either (i) in person at either
Party’s facilities or at such locations as the Parties may otherwise agree or
(ii) by audio or video teleconference. Additional meetings of the JSC may also
be held with the consent of each Party, and neither Party will unreasonably
withhold, delay or condition its consent to hold such additional meetings. Each
Party will be responsible for all of its own expenses incurred in connection
with participating in all such meetings.

3.3

Decisions.

 

(a)

General. Subject to the provisions of this Section 3.3, actions to be taken by
the JSC within the scope of its authority will be taken only following [*]. If
the JSC fails to reach [*] agreement on a matter properly set forth before it
(in accordance with this Section 3.3) for a period in excess of [*], such matter
will be referred to the Chief Executive Officer of Agenus (or an executive
officer of Agenus designated by the Chief Executive Officer of Agenus who has
the power and authority to resolve such matter) and the Chief Executive Officer
of Betta (or an executive officer of Betta designated by the Chief Executive
Officer of Betta who has the power and authority to resolve such matter)
(collectively, the “Executive Officers”) for resolution. If the Executive
Officers cannot resolve such matter [*] after such matter has been referred to
them, then:

 

(i)

Subject to Section 3.3(a)(ii) below, Betta will have the final decision-making
authority over [*]; and

 

(ii)

Agenus will have the final decision-making authority over the matter if [*].

 

(b)

Exceptions. Notwithstanding the foregoing, neither Party may exercise its right
to finally resolve a dispute: (i) in a manner that expands such Party’s rights
or excuses such Party from any of its obligations under this Agreement; or (ii)
in a manner that would require the other Party to perform any act that it
[*]believes to be inconsistent with any Applicable Law or any approval, order,
policy or guidelines of a Regulatory Authority in its Territory.

ARTICLE 4.

DEVELOPMENT

4.1

Development Plans. [*], Betta will provide a development plan for the Territory
in reasonable details including the clinical trials to be conducted for each
Licensed Antibody, and a timeline for such Development (“Initial Territory
Development Plan”) to the JSC for discussion and approval. A more comprehensive
development plan describing in reasonable detail the proposed overall program of
Development for the Licensed Product(s) containing such Licensed Antibodies in
each region in the Territory, including preclinical and non-clinical studies,
toxicology, formulation, plans for preparation and filing of INDs, indications
for each Licensed Antibody to be Developed by Betta, Clinical Trials and
regulatory plans and other key elements necessary to obtain Regulatory Approvals
for such Licensed Product(s) (each, together with the Initial Territory
Development Plan, a “Territory Development Plan”) will be provided by Betta to
the JSC for discussion and approval [*]. Each Territory Development Plan will be
updated at least annually by Betta, and submitted to the JSC for review and
approval not later than June 30 of each calendar year during the Term. Each new
or updated Territory Development Plan will include, with respect to each
Licensed Product, an outline of an overall plan for such Licensed Product that
sets forth all major Development tasks remaining to be accomplished prior to
submission of INDs and, once Clinical Trials in the Territory have commenced,
filings for Regulatory Approvals to the extent

15

--------------------------------------------------------------------------------

such tasks are known or can reasonably be ascertained. Betta will Develop each
Licensed Antibody and Licensed Product in the Field and in the Territory in
accordance with the applicable Territory Development Plan. Betta will be solely
responsible for all costs and expenses in connection with the Development of
Licensed Antibodies and Licensed Products in the Field and in the Territory.

4.2

Execution and Performance. Betta will [*] carry out its responsibilities under
this Agreement in accordance with the Territory Development Plans. Without
limiting the foregoing, Betta will [*] Develop and obtain Regulatory Approvals
for [*] in the Field and in the Territory. Betta may, subject to Section 2.5 for
any subcontract that constitutes a sublicense of the License, subcontract
portions of the activities described in a Territory Development Plan to a Third
Party subcontractor or a Sublicensee in the Territory; provided that (a) Betta
will be responsible and liable for the performance of its subcontractors and
Sublicensees; (b) Betta will ensure that all Inventions discovered, made or
conceived by each subcontractor or Sublicensee in the course of the performance
of such activities are assigned to Betta in a manner consistent with Section 8.1
below; provided that, in the event any such assignment is prohibited by
Applicable Law, Betta will ensure that such Inventions are otherwise Controlled
by Betta; and (c) Betta will require and [*] ensure that its subcontractors and
Sublicensees comply with all Applicable Laws, including all GCP, GLP,
Anti-Corruption Laws and Data Privacy Laws.

4.3

Document Transfer. Promptly following the Effective Date, Agenus will deliver
and/or make available to Betta the documents listed on Schedule 4.3. During the
Term, Agenus will provide Betta with all additional documents reasonably
requested that are not already in Betta’s possession.

4.4

Assistance. Agenus will [*] provide [*] assistance to Betta (a) in connection
with the transfer of documentation under Section 4.3, (b) to support its
Development, including clinical and regulatory activities under Section 4.7, and
Commercialization of the Licensed Antibodies and Licensed Products in the Field
in the Territory, and (c) to facilitate the manufacturing technology transfer
under Section 5.2(b), in each case, in accordance with this Section 4.4. The
first [*] hours of any such assistance during the Term will be at no additional
cost to Betta; provided that Betta will reimburse all out of pocket travel and
accommodation costs incurred by Agenus at Betta’s request. In the event Betta
reasonably requests any assistance from Agenus that would require Agenus to
provide assistance in excess of the amounts described in the preceding sentence,
the Parties shall negotiate [*] and agree upon all such assistance and
appropriate compensation, which shall be documented in a separate written
agreement. Notwithstanding the foregoing, Agenus will not be required to provide
any assistance to the extent Agenus determines it would unreasonably interfere
with Agenus’ own business. [*].

4.5

Data Sharing.

 

(a)

To the extent permitted by Applicable Laws (including the requirements of
applicable Regulatory Authorities), Betta will provide written updates on a
quarterly basis prior to each JSC meeting in English to Agenus summarizing
Betta’s clinical progress and key data during the activities performed under the
Territory Development Plan. Betta will maintain all Results in validated
computer systems that are compliant with 21 C.F.R. §11. Betta will provide all
Results (including final clinical study reports and all raw data) in its
original format and language [*] after generation of such data or information.
In addition, at Agenus’ written request, Betta will provide all final clinical
study reports and all raw data translated and provided in English within a
reasonable time as mutually agreed by the Parties. [*]. To the extent permitted
by law (including the requirements of applicable Regulatory Authorities), Betta
will provide access to all other data related to any Clinical Trial in
accordance with procedures set forth in this Section 4.5, including case report

16

--------------------------------------------------------------------------------

 

forms, investigator reports, raw data and any analyses thereof. To the extent
permitted by Applicable Laws (including the requirements of applicable
Regulatory Authorities), Betta will [*] ensure that any agreement any Betta
Party enters into with any Person regarding the Licensed Product will include
data sharing obligations for such Persons consistent with this Section 4.5(a).
[*].

 

(b)

To the extent permitted by Applicable Laws (including the requirements of
applicable Regulatory Authorities), Agenus shall provide Betta with copies of
all clinical data, final clinical study reports and other data and information
reasonably required in Betta’s filings for Regulatory Approvals in the Territory
or as requested by the Regulatory Authorities in the Territory relating to the
Licensed Antibodies and/or Licensed Products generated by Agenus or its
Affiliates [*] after generation of such data and information, in all cases,
solely to the extent specifically relating to a Licensed Antibody in a
monotherapy setting or in combination with the other Licensed Antibody, but
excluding combinations of either or both Licensed Antibodies with any Other
Component. Betta shall have the right to share any and all such data and other
regulatory materials received from Agenus with Betta’s Affiliates and
Sublicensees in the Territory. Providing such information or data shall be
performed free of charge.

 

(c)

All data and information disclosed by one Party to the other under this
Agreement shall be deemed Confidential Information of the disclosing Party.

4.6

Adverse Events Reporting. Betta will be responsible for reporting all safety
related events for the Licensed Antibodies and Licensed Products to appropriate
Regulatory Authorities in the Territory according to the Applicable Law and
provide all necessary safety reporting information to ensure Agenus meets all
applicable regulatory reporting obligations. Agenus will be responsible for
reporting all safety related events, including annual reporting obligations, for
the Licensed Antibodies and Licensed Product to the appropriate Regulatory
Authorities outside the Territory according to Applicable Law. Betta and Agenus
will keep each other informed of any serious adverse reactions, or other
significant, unusual or unexpected safety findings related to either Licensed
Antibody in English [*]; provided that Agenus will only be required to inform
Betta of any serious adverse reactions, or other significant, unusual or
unexpected safety findings related to a Licensed Antibody in a monotherapy
setting or in combination with one another but excluding combinations of either
or both Licensed Antibodies with any Other Component. In addition, Betta will
provide summary safety reports in English to Agenus [*] or more frequently as
required to meet regulatory requests. The Parties will coordinate adverse event
reporting in accordance with a Safety Data Exchange Agreement (the “SDEA”) to be
entered into by the Parties [*] after the Effective Date, which will be
consistent with this Section 4.6 and in substantially the form attached as
Schedule 4.6. The Parties may, if agreed under such SDEA, coordinate such
activities through the JSC or the JSC may designate an appropriate person(s) to
oversee pharmacovigilance matters.

4.7

Regulatory Matters.

 

(a)

Holder of Regulatory Approvals and Regulatory Submissions. Betta will hold
Regulatory Approvals and Regulatory Submissions for Licensed Products in the
Field in the Territory, including any pricing or reimbursement approvals, to the
extent permitted by Applicable Law and in accordance therewith. Agenus will [*]
cooperate with Betta, at Betta’s expense, to enable Betta to hold any or all
such Regulatory Approvals and Regulatory Submissions; provided, however, that if
Applicable Laws in the Territory do not allow Betta to hold Regulatory Approvals
or Regulatory Submissions for Licensed Product in the Field in the Territory,
then during the Term Agenus (i) will hold such

17

--------------------------------------------------------------------------------

 

Regulatory Approval for Betta’s benefit, (ii) will appoint Betta as its
exclusive agent to handle all regulatory activities for the Licensed Product in
the Field in the Territory, and (iii) will promptly transfer such Regulatory
Approval to Betta or its designee when allowed by Applicable Laws; further
provided that in the event and during any period that Agenus holds such
Regulatory Approval for Betta’s benefit, (A) Agenus will not be obligated to
perform any activities, bear any obligations, or bear any costs, in each case,
in addition to the activities set forth in this Agreement due to Agenus or its
Affiliate holding such Regulatory Approval; (B) Agenus will not assume any
liability in connection with Agenus holding such Regulatory Approval; (C) should
Agenus incur any costs or expenses related to holding or transferring any such
Regulatory Approval, Betta will reimburse Agenus or its Affiliates for any and
all costs and expenses incurred by Agenus in holding or transferring such
Regulatory Approval; and (D) Betta will indemnify and hold Agenus Indemnitees
from and against any and all Liabilities to the extent arising from Agenus
holding such Regulatory Approval in the Field in the Territory as set forth in
ARTICLE 13.

 

(b)

Betta’s Responsibilities. Betta will be responsible, at its sole cost and
expense, for all regulatory activities leading up to and including the obtaining
of Regulatory Approvals and any pricing or reimbursement approvals, as
applicable, for the Licensed Products from Regulatory Authorities in the Field
and in the Territory. Betta will keep Agenus informed of regulatory developments
related to Licensed Products in the Field and in the Territory and will promptly
notify Agenus in writing of any decision by any Regulatory Authority in the
Field and in the Territory regarding any Licensed Product. All regulatory
activities conducted, and Regulatory Submissions prepared, by or on behalf of
Betta with respect to the Licensed Product in the Territory will be conducted
and prepared in compliance with Applicable Laws.

 

(c)

Agenus’ Responsibilities. Agenus will [*] cooperate with Betta in obtaining any
Regulatory Approvals and any pricing or reimbursement approvals, as applicable,
for a Licensed Product in the Field and in the Territory including by providing
reasonable access to clinical data, and other data, information, and
documentation for Licensed Products in the Field that is included in the
Licensed Know-How, including any Regulatory Approvals or Regulatory Submissions
for the Licensed Products in the Field in the Territory and, as applicable, and
subject to any Third Party obligations, outside the Territory.

 

(d)

Communications with Regulators. Betta will notify the JSC in writing of all
material oral or written communications to and from Regulatory Authorities
relating to Licensed Products in the Territory, provide a copy of any such
material written communications in its original format and language, and provide
an English language summary of such communications and description of the
principal issues raised, in each case, within [*] after the occurrence of such
material oral or written communications. If any such material written
communications are not in English, upon Agenus’ request, Betta will provide the
JSC with an English translation of such written communications within [*] of
Agenus’ request. [*]. Betta will provide the JSC complete copies of all written
communications (including communications relating to meetings with Regulatory
Authorities) in their original format and language within [*] after its receipt
or submission of such written communications. Betta will not have the right to
communicate with Regulatory Authorities outside the Territory in connection with
the Licensed Antibodies and/or the Licensed Products without Agenus’s prior
consent.

18

--------------------------------------------------------------------------------

 

(e)

Meetings. Betta will provide Agenus with [*] advance notice (to the extent Betta
has reasonable advanced noticed thereof) of all material or substantive meetings
(including telephone conference calls) with Regulatory Authorities in the
Territory pertaining to any Licensed Antibodies and/or Licensed Products, or
with as much advance notice as practicable. Betta will consider [*] Agenus’
reasonable suggestions and comments with respect to such meetings or conference
calls and will keep Agenus [*] informed of all significant issues arising from
such meetings.

 

(f)

Submissions.

 

(i)

Agenus will have the right to comment and consult with Betta on any
communications or Regulatory Submissions made by Betta Parties to Regulatory
Authorities in the Territory in connection with the Licensed Antibodies and/or
Licensed Products. Betta will provide Agenus with copies of (i) in the original
language in its entirety and an English translation [*] prior to the estimated
date of submission thereof, all draft Regulatory Submissions (including BLAs,
INDs, orphan drug applications and designations) and any referenced Results
regarding any Licensed Product for Agenus’ review and comment, and Betta will
[*] in preparing the final versions thereof; (ii) in the original language in
its entirety promptly after submission and an English translation [*] after
submission, all Regulatory Submissions actually submitted; and (iii) in the
original language and an English translation [*] after receipt or denial
thereof, all Regulatory Approvals received or denied; provided, however, that in
all circumstances, Betta will inform Agenus of such event prior to its public
disclosure of such event. [*].

 

(ii)

Agenus will provide Betta with copies in the original language of sections
relating to clinical results, efficacy, safety, dosage, and any other sections
reasonably requested by Betta of (A) all Regulatory Submissions actually
submitted (including in the original language thereof) in the United States; and
(B) all Regulatory Approvals obtained or denied in the United States, in each
case of (A) and (B), to the extent solely related to a Licensed Antibody in a
monotherapy setting or in combination with the other Licensed Antibody, but
excluding combinations of either or both Licensed Antibodies with any Other
Component.

 

(g)

Right of Reference. Each Party will have access and a “Right of Reference,” as
that term is defined in 21 C.F.R. §314.3(b) (or any successor rule or analogous
law recognized outside of the United States) to all data contained or referenced
in any Regulatory Submission and Regulatory Approvals Controlled by the other
Party or its Affiliates necessary or reasonably useful for (i) Betta to exercise
the License; and (ii) Agenus to exercise its Retained Rights. Each Party will
have the right to sublicense its Right of Reference together with a sublicense
of the licenses granted to such Party under Section 2.1 or Section 2.4, as
applicable. Each Party will bear its own costs and expenses associated with
providing the other Party with the Right of Reference and sharing of data and
information pursuant to this Section 4.7(g).

 

(h)

Audits. No more than [*] period, or more frequently as reasonably required to
address any quality issues or to allow any Regulatory Authority to inspect any
Clinical Trial sites, and upon not less than [*] prior written notice, Betta
will permit Agenus or any Regulatory Authority, and will require its Affiliates
and Sublicensees engaged to perform work on any such Clinical Trial to permit
Agenus or any Regulatory Authority, to audit any such study sites and to audit
the study records of such Persons to determine compliance with Section

19

--------------------------------------------------------------------------------

 

4.2, and to audit the study records of such Persons for data-sharing purposes as
set forth in Section 4.5. Such audits will take place during normal business
hours [*], unless significant non-compliance identified warrants further
assessment or any Regulatory Authority reasonably requires additional time. Such
audits will be conducted in a manner that minimizes interruption of Betta’s or
the study site’s operations and will be at Agenus’ sole cost and expense.
Persons auditing the facilities, books or records will be required to enter into
separate confidentiality agreements, if not expressly covered by this Agreement,
and will abide by the safety protocols and standard operating procedures of the
audited facility while on site.

4.8

Scientific Records. Betta will maintain scientific records, in sufficient detail
and in good scientific manner appropriate for patent and regulatory purposes,
which will fully and properly reflect all material work done and results
achieved in the performance by Betta Parties of Development and/or Manufacturing
activities with respect to Licensed Antibodies and Licensed Products.

4.9

Betta Personnel. Betta represents and warrants that, to the extent permissible
under Applicable Laws, each employee and contractor of Betta performing
obligations under this Agreement will, prior to conducting any such obligations
hereunder, be obligated by written contract to (a) promptly disclose to Betta
all Inventions and other Know-How conceived or reduced to practice by such
employee or contractor during any performance under this Agreement, (b)
automatically assign to Betta all right, title and interest in and to all such
Inventions and other Know-How and all intellectual property rights therein, and
(c) adhere to similar obligations of confidentiality as are set forth in this
Agreement.

4.10

Abandoned Development. Betta will, through itself and the Betta Parties, [*]
Develop, Manufacture and Commercialize Licensed Products in the Territory in the
Field in accordance with the Territory Development Plan. If, at any point in
time prior to the First Commercial Sale of the first Licensed Product containing
a Licensed Antibody to obtain Regulatory Approval, (a) the Betta Parties have
substantially ceased to conduct Development of such Licensed Antibody [*], (b)
such inactivity was not imposed by a Regulatory Authority, a result of a change
in Applicable Laws, and was not due to a Force Majeure Event, and (c) Agenus has
complied with its obligations under this Agreement during such period, then
Betta will be deemed to have abandoned Development of such Licensed Antibody
(“Abandoned Development”). If, at any point in time following the First
Commercial Sale of the first Licensed Product containing a Licensed Antibody to
obtain Regulatory Approval, (i) [*], (ii) such inactivity was not imposed by a
Regulatory Authority, a result of a change in Applicable Laws, and was not due
to a Force Majeure Event, and (iii) Agenus has complied with its obligations
under this Agreement during such period, then Betta will be deemed to have
abandoned Commercialization of such Licensed Antibody (“Abandoned
Commercialization”). If Agenus [*] concludes that Betta has Abandoned
Development or Abandoned Commercialization of either Licensed Antibody, as
applicable, then Agenus may deliver written notice to Betta setting out the
basis for Agenus’ conclusion. [*].

ARTICLE 5.

MANUFACTURING AND SUPPLY

5.1

Supply Agreement. Unless the Parties agree otherwise, [*] following the
Effective Date, the Parties will negotiate in good faith and enter into a supply
agreement (the “Supply Agreement”) consistent with the supply terms and
conditions in this Section 5.1 for the supply of the Licensed Antibodies in a
[*] drug product format in final form by Agenus to Betta for Development and
Commercialization in the Field in the Territory.

 

(a)

The Parties agree that the Supply Agreement should be consistent with the
following principle: prior to the Manufacturing Technology Transfer Completion
pursuant to Section

20

--------------------------------------------------------------------------------

 

5.2(b), Agenus will [*] supply the Licensed Antibodies in a [*] drug product
format in final form to Betta for the Field in the Territory at [*] of Agenus’
Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of
its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all
logistics, shipping, and any VAT or other applicable transfer taxes, subject to
(i) reasonable forecasting and other typical supply terms and (ii) Betta’s
procurement of all import permits and other approvals needed for such
Development and Commercialization in the Field in the Territory where such
supply is intended for use.

 

(b)

As long as Agenus supplies the Licensed Antibodies to Betta for
Commercialization in the Field in the Territory, no more than once per [*] or
more frequently as reasonably required to address any quality issues, and upon
not less than [*] prior written notice, Agenus will (i) [*] accommodate Betta’s
reasonable request to audit Agenus’ third party manufacturer facilities where
the Licensed Antibodies supplied hereunder are Manufactured in order to assess
compliance with GMP, (ii) accommodate Betta’s reasonable request to audit the
parts of Agenus’ facilities that oversee the Manufacture of the Licensed
Antibodies by Agenus’ third party manufacturer of the Licensed Antibodies in
order to assess compliance with GMP, and (iii) accommodate Betta’s reasonable
request to audit Agenus’ books and records directly related to the Manufacture
of such Licensed Antibodies, including such records provided to Agenus by
Agenus’ third party manufacturer of the Licensed Antibodies. Betta will [*]
complete such audits within [*], during business hours, without unreasonable
disruption to the audited party’s normal business operations and in accordance
with such party’s security, safety and other rules and requirements. Persons
auditing the facilities, books or records shall be required to enter into
separate confidentiality agreements, if not expressly covered by this Agreement
and shall abide by the safety protocols and standard operating procedures of the
audited facility while on site. Any authorized audits of third party facilities
shall be on the terms and subject to the requirements and approval of any such
third party. For the avoidance of doubt, Agenus will have satisfied its
obligation in Section 5.1(b)(i) above to [*] by asking its third party
manufacturer to accommodate an audit by Betta, and in no event will Agenus be
required to exercise its own audit right in its agreement with any such third
party manufacturer to accommodate an audit request by Betta.

5.2

Supply by Betta.

 

(a)

Manufacturing by Betta. At Betta’s request, and subject to the License and the
terms of this Section 5.2, Betta will have the right to Manufacture the Licensed
Antibodies and Licensed Products in the Territory for (i) Development use in the
Field in the Territory under the Territory Development Plans and (ii)
Commercialization use in the Field in the Territory, in each case at Betta’s
cost and expense, only after Betta’s completion of any studies or testing
required by and receipt of any qualifications and Regulatory Approvals from any
Regulatory Authorities or other Governmental Bodies necessary to Manufacture
such Licensed Antibodies and Licensed Products in the Territory.

 

(b)

Manufacturing Technology Transfer. Subject to its compliance with Applicable
Laws and this Agreement, Betta will commence manufacturing technology transfer
as contemplated under this Section 5.2 by written notice to Agenus (the “Tech
Transfer Notice”) no later than [*] from the Effective Date. [*] of the Tech
Transfer Notice, the Parties will enter into a technology transfer agreement
(the “Tech Transfer Agreement”) detailing a technology transfer plan (the “Tech
Transfer Plan”) for the transfer of Agenus Manufacturing Technology for both
Licensed Antibodies; provided that, notwithstanding

21

--------------------------------------------------------------------------------

 

the Tech Transfer Agreement and Tech Transfer Plan, any assistance provided by
Agenus in connection with the Tech Transfer Plan and Tech Transfer Agreement
will be subject to the provisions contained in Section 4.4. [*] following the
execution of the Tech Transfer Agreement, the Parties will begin the transfer of
the Agenus Manufacturing Technology for both Licensed Antibodies from Agenus to
Betta, its Affiliate or a permitted Third Party manufacturer engaged by Betta
(which will be approved by Agenus, [*] (the “Third Party Manufacturer”), in
accordance with the Tech Transfer Plan at Betta’s sole cost and expense, subject
to Section 4.4. Among other things, the Tech Transfer Plan will provide that
Agenus will [*] (i) provide reasonable assistance to Betta in accordance with
Section 4.4 and (ii) make available reasonably sufficient quantities of the
Manufacturing Materials for the Licensed Antibodies to support the ongoing
production of such Licensed Antibodies for commercial manufacturing purposes,
together with appropriate documentation regarding the history, validation,
stability and propagation of such Manufacturing Materials and such other
documentation and information as Betta, its Affiliate or the Third Party
Manufacturer, as applicable, may reasonably request. Subject to Section 4.4,
Betta will reimburse all out of pocket travel and accommodation costs incurred
by Agenus and Affiliates in the course of the performance of the Tech Transfer
Plan. Any and all Know-How transferred under the Agenus Manufacturing Technology
may only be used by Betta, its Affiliate, or the Third Party Manufacturer, as
applicable, to Manufacture the Licensed Antibodies and/or the Licensed Products
in the Territory, in the Field, during the Term, and not for any other purpose.
Upon [*], the transfer of Agenus Manufacturing Technology contemplated under
this Section 5.2(b) will be deemed completed (the “Manufacturing Technology
Transfer Completion”), and Betta will provide Agenus with written confirmation
of the Manufacturing Technology Transfer Completion [*] of the occurrence
thereof, and pay Agenus the Tech Transfer Fee in accordance with Section 7.2.
Notwithstanding anything to the contrary, Betta will [*] ensure the
Manufacturing Technology Transfer Completion will occur within [*] following the
effective date of the Tech Transfer Agreement.

 

(c)

Compliance with Manufacturing Process. Upon Manufacturing Technology Transfer
Completion, Betta Party and Third Party Manufacturers will, Manufacture each
Licensed Antibody in compliance with the existing Manufacturing Process
delivered by Agenus for each Licensed Antibody and/or Licensed Product. Betta
Party and Third Party Manufacturers can further modify the Manufacturing Process
to ensure that the Licensed Antibody and/or Licensed Product obtains necessary
Regulatory Approvals in the Territory (the “Territory Manufacturing Process”);
provided that, before making any modification, Betta will provide Agenus a
Manufacturing Process change plan in reasonable details for discussion and
written approval by Agenus, which will not be unreasonably withheld. The
Territory Manufacturing Process will be established in accordance with product
specifications for such Licensed Antibody and/or Licensed Product for
Exploitation in the Territory to meet regulatory requirements in the Territory
(the “Territory Specifications”). Any modification to the Territory
Manufacturing Process and/or the Territory Specifications shall also be reviewed
and approved by Agenus by written consent, which will not be unreasonably
withheld. [*]. Betta will, if requested in writing by Agenus, annually send
samples of each Licensed Antibody and Licensed Product so Manufactured to allow
Agenus to test such samples. For the avoidance of doubt, in the event that
Agenus is asked to provide its written approval or written consent pursuant to
this Section 5.2(c), it will be deemed reasonable for Agenus to withhold such
written approval or written consent in the event that Agenus reasonably believes
that the requested modification could compromise the integrity or quality of the
Licensed Antibody or Licensed Product or is inconsistent with the
Specifications.

22

--------------------------------------------------------------------------------

 

(d)

Recordkeeping. Each of the Betta Parties will maintain complete and accurate
batch records, Clinical Trial data, laboratory data, reports and other technical
records relating to the Development and Manufacturing of Licensed Antibodies
and/or Licensed Products (“Records”) in accordance with the applicable
requirement of their respective standard operating procedures, the terms and
conditions of this Agreement, NMPA and all Applicable Law. The Betta Parties
will provide Agenus with the applicable Records upon written request by Agenus
within [*] of such request. All Records will be maintained for the minimum
period required by Applicable Laws.

 

(e)

Audit of Manufacturing. Agenus will have the right to conduct compliance audits
of the Betta Parties to confirm compliance with (i) Section 5.2(c) and (ii) all
Applicable Laws (collectively, the “Manufacturing Standards”) with respect to
the Manufacture of the Licensed Antibodies and Licensed Products by or on behalf
of Betta upon a [*] written notice to Betta. Betta will provide, and will
require the other Betta Parties and Third Party Manufacturers to provide, to
Agenus and its agents access to physical and electronic materials and to their
respective premises in order to facilitate such audit. Agenus will [*] complete
any compliance audit within [*], during business hours, without unreasonable
disruption to the audited party’s normal business operations and in accordance
with such party’s security, safety and other rules and requirements. Agenus may
not conduct ordinary audits more often than once in any [*]; provided, however,
that the frequency, duration and notice requirements in this Section 5.2(e) will
not apply in the event that Agenus has a reasonable belief that Betta is in
material non-compliance with the Manufacturing Standards.

 

(f)

Suspension of Manufacturing. Agenus may terminate or suspend any Betta Party’s
Manufacturing of, and the License with respect to the right of any Betta Party
to Manufacture, one (1) or both Licensed Antibodies on [*] written notice to
Betta in the event that the reference testing conducted pursuant to Section
5.2(c) or the results of an audit conducted in accordance with Section 5.2(e)
demonstrate that the Manufacturing activities of such Betta Party include
material deviations from the Manufacturing Standards and that are not cured
within [*] following Agenus’s written notice of the same to Betta detailing in
reasonable detail such deviations.

 

(g)

Non-Compliance of Manufacturing Process. In the event that a Betta Party
Manufactures a Licensed Antibody that is materially non-compliant with the
Specifications or materially non-compliant with the Manufacturing Standards,
Betta will promptly disclose such non-compliance to Agenus.

 

(h)

Supply for Agenus. Following the Manufacturing Technology Transfer Completion
pursuant to Section 5.2(b), if Agenus wishes that one (1) or both of the
Licensed Antibodies and any Licensed Products be Manufactured by any Betta Party
and/or a Third Party Manufacturer solely for Development and/or
Commercialization outside the Territory, then upon Agenus’ request the Parties
will negotiate [*] toward a supply agreement, pursuant to which such Betta Party
and/or Third Party Manufacturer will [*] supply the Licensed Antibodies or
Licensed Products to Agenus. Such agreement will provide, among other things,
that Licensed Antibodies and/or Licensed Products will be supplied at [*] of
Betta’s Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing
Costs of its Affiliate, Sublicensee or Third Party Manufacturer, as applicable),
plus all logistics, shipping, and any VAT or other applicable transfer taxes,
subject to (i) reasonable forecasting and other typical supply terms and (ii)
Agenus’s procurement of all import

23

--------------------------------------------------------------------------------

 

permits and other approvals needed for such development and commercialization
outside of the Territory where such supply is intended for use. [*].

5.3

Quality Agreement. Prior to commencement of any Clinical Trial or
Commercialization of a Licensed Product by the Betta Parties, Agenus and Betta
will enter into a quality agreement setting forth the responsibilities of the
Parties with respect to compliance with GMP in connection with Development,
Manufacturing and Commercialization of Licensed Products in the Field and in the
Territory and may include additional compliance requirements related to
non-clinical and clinical operations.

ARTICLE 6.

COMMERCIALIZATION

6.1

General. Betta will prepare and present a commercialization plan detailing the
Commercialization activities to be conducted by the Betta Parties in relation to
the Licensed Product in the Field in each region in the Territory (each, a
“Territory Commercialization Plan”) to the JSC as soon as practicable, but no
later than [*], which will be annually updated. Betta will [*], at its own
expense, to Commercialize Licensed Products in the Field and in the Territory in
accordance with the applicable Territory Commercialization Plan. Unless
otherwise agreed by the Parties, no Betta Party will sell or dispose of any
Licensed Antibody or Licensed Product for Value to a Third Party in the Field
and in any region in the Territory without first obtaining the applicable
Regulatory Approval of such Licensed Antibody or Licensed Product in such
region. The Parties, through the JSC, will discuss the strategies and procedures
regarding the Commercialization of the Licensed Products in the Field and in the
Territory.

6.2

Global Branding.

 

(a)

Global Branding Strategy. Agenus will control the global branding strategy
(including global positioning, messages, logo, colors and other visual branding
elements) for the Licensed Antibodies and Licensed Products throughout the world
(the “Global Branding Strategy”). Betta will comply with the Global Branding
Strategy; provided, however, that Betta will be permitted to deviate from the
Global Branding Strategy for a Licensed Product in relation to the Territory to
the extent [*] (such deviations “Permissible Deviations”). Betta will discuss
any Permissible Deviation from the Global Branding Strategy with Agenus and
consider any comments Agenus may have with respect thereto [*].

 

(b)

Product Trademarks.

 

(i)

Subject to obtaining necessary Regulatory Approvals, Betta will Commercialize
Licensed Products in the Field and in the Territory under (1) a
non-Chinese-character product name and related trademarks initially selected by
Agenus or, in the context of a Permissible Deviation, selected by Betta and
approved by the JSC (the “Product Trademarks”); or (2) a Chinese-character
product name and related trademarks selected by Betta and approved by the JSC
(the “Chinese Trademarks”). All uses of the Product Trademarks and Chinese
Trademarks to identify and/or in connection with the Commercialization of,
Licensed Products will be in accordance with the applicable Regulatory
Approvals, all Applicable Law and the Global Branding Strategy. Betta will use
Product Trademarks under which Licensed Products are marketed or sold (other
than Betta’s corporate trademarks or trade names) only pursuant to the terms of
this Agreement to identify, and in connection with the Commercialization of
Licensed Products, and will not use them to identify, or in connection with the
marketing of, any other products. [*] (together with the Product Trademarks and
the Chinese Trademarks,

24

--------------------------------------------------------------------------------

 

the “Product Marks”, [*]. Agenus will grant and hereby grants a non-exclusive,
sublicenseable (subject to Section 2.5), fully paid-up, royalty free,
non-transferrable (subject to Section 14.3) license under the Agenus Product
Marks for Betta to Commercialize the applicable Licensed Product in the Field in
the Territory subject to the terms and conditions in this Section 6.2(b). Betta
will grant and hereby grants a non-exclusive, sublicenseable (subject to Section
2.5), fully paid-up, royalty free, non-transferrable (subject to Section 14.3)
license under the Betta Product Marks for Agenus to Commercialize the applicable
Licensed Product outside the Territory. For the avoidance of doubt, neither
Party will have any right to use the other Party’s or the other Party’s
Affiliates’ corporate names or logos in connection with Commercialization of
Licensed Products.

 

(ii)

Betta will reasonably cooperate with Agenus to enable Agenus to ascertain that
all uses of all of the Product Marks, as permitted hereunder, meet the quality
standards set by Agenus in connection with its existing uses of each of such
Product Mark, including by allowing Agenus and its representatives to make
periodic inspection of Betta’s packaging, inserts, records, documents and other
materials that contain any such Product Mark.

 

(c)

Promotional Materials. Betta will be responsible for the creation, preparation,
production, reproduction and filing with the applicable Regulatory Authorities,
of relevant written sales, promotion and advertising materials relating to
Licensed Products (“Promotional Materials”) for use in the Territory. All such
Promotional Materials will be (A) compliant with Applicable Law, and (B) if
applicable, consistent in all material respects with the Global Branding
Strategy except in relation to the Permissible Deviations. Betta will submit
representative samples of its Promotional Materials to Agenus for review and
comment and will consider Agenus’s comments [*]; provided, however, that Agenus
will have the right to require Betta to remove from any Promotional Materials
any content that Agenus considers is not consistent in all material respects
with the Global Branding Strategy and are not Permissible Deviations.

6.3

Sales and Distribution.

 

(a)

Betta Responsibilities. Betta will be responsible for booking sales and will
warehouse and distribute Licensed Products in the Territory at its sole cost.
Betta will be solely responsible for handling all returns of Licensed Products
sold in the Territory, as well as all aspects of Licensed Product order
processing, invoicing and collection, distribution, inventory and receivables of
Licensed Products sold in the Territory.

 

(b)

Two-Invoice Policy. Prior to Betta providing commercial supply in the Territory,
with respect to the Licensed Products for the PRC for distribution channels in
which the Two-Invoice Policy applies, Agenus will sell Licensed Products for the
PRC exclusively to a single general distributor designated by Betta for
importation into and distribution in the PRC (the “General Distributor”). The
Parties agree that if, under the Two-Invoice Policy and Applicable Laws in a
given Province in the Territory, no Betta Party can, based on their existing
qualifications, distribute the Licensed Products for such Province directly or
indirectly to its distributors for the PRC, or if any distributor for the
Licensed Products for the PRC is required in such Province to have a direct
contractual agreement for the supply of the Licensed Product with the owner of
the Regulatory Approval of the Licensed Product in the country where such
Licensed Product is manufactured, then:

25

--------------------------------------------------------------------------------

 

(i)

The Parties will [*] discuss and agree to alternative arrangements for the
distribution of the Licensed Products in such Provinces that complies with the
Two-Invoice Policy as implemented in such Provinces and that maintains those
responsibilities and economic interests of the Parties as agreed under this
Agreement. The key terms of such alternative arrangements will include pricing,
discounts or allowances arrangements, management of accounts receivable,
collection of distributor data, forecasting and ordering, invoicing, and
management of inventory. [*].

 

(ii)

For the purpose of maintaining the economic interests of the Parties as agreed
under this Agreement, Agenus will pay to Betta the gross margin Agenus receives
from the General Distributor that Betta would have received if Betta directly
sold such Licensed Product to the General Distributor (the “Price Difference”).
Betta will have the right to conduct audits through an independent, certified
public accountant on Agenus’ relevant records to determine the accuracy of the
Price Difference.

 

(iii)

Betta will, and Betta will cause all Betta Parties to, provide to Agenus all
reasonable assistance, facilitation and support for the distribution of the
Licensed Products in the applicable Provinces to comply with the Two-Invoice
Policy. For the avoidance of doubt, in the case that Betta and the General
Distributor directly make an agreement in accordance with this Section 6.3(b),
such agreement will conform to the terms and conditions of this Agreement.

6.4

Recalls, Market Withdrawals or Corrective Actions. In the event that any
Regulatory Authority issues or requests a recall or takes a similar action in
connection with a Licensed Product sold in the Territory during the Term, or in
the event a Betta Party determines that an event, incident or circumstance has
occurred that may result in the need for a recall or market withdrawal in the
Territory, Betta will advise Agenus thereof by telephone, facsimile or e-mail as
promptly as practicable, but at least [*] prior to public disclosure of such
recall, market withdrawal or corrective action conducted, except where such
advisement would reasonably be expected to result in Betta’s non-compliance with
Applicable Law, in which case, Betta will advise Agenus thereof as soon as
reasonably practicable. Except where it would reasonably be expected to result
in Betta’s non-compliance with Applicable Law, Betta, in consultation with
Agenus, will decide whether to conduct a recall, market withdrawal or similar
action in the Territory and the manner in which any such recall will be
conducted. If the Licensed Product that is subject to such recall, market
withdrawal or corrective action was supplied by Agenus, Agenus will make
available all of its pertinent records that may be [*] by Betta in order to
effect a recall in the Territory. Betta will bear all costs and expenses that
may be incurred in connection with any Licensed Product recall or withdrawal in
the Territory; provided, however, that to the extent any such recall or
withdrawal is due to the failure of the Licensed Products supplied by Agenus to
comply with the specifications of the Licensed Product in accordance with the
terms and conditions of the Supply Agreement, Agenus will bear all reasonable
costs and expenses incurred in connection with such recall or withdrawal.

6.5

Ex-Territory Sales. Subject to Applicable Law, Betta will not, and will not
permit any Betta Party or Third Party contractors to, engage in any advertising
or promotional activities relating to any Licensed Product directed primarily to
customers or other buyers or users of such Licensed Product located outside the
Territory, or accept orders for Licensed Products from or sell Licensed Products
outside of the Territory. Betta will require, and will cause Betta Parties to
require, that its legal contracts with distributors of Licensed Products include
restrictions on such distributor’s selling or exporting the Licensed Product out
of the Territory. If Betta Parties receive any order for Licensed

26

--------------------------------------------------------------------------------

Products outside the Territory, it will refer such orders to Agenus. Betta will,
and will ensure that Betta Parties, label Licensed Products to be sold by a
Betta Party as being for sale only in the Territory. Betta will ensure that
Betta Parties do not export any Licensed Products from inside the Territory to
outside of the Territory. Betta will promptly inform Agenus of any exports of
Licensed Products from the Territory, and the actions taken to prevent such
exports. Betta will take reasonable actions requested in writing by Agenus that
are consistent with Applicable Law to prevent exports of Licensed Products from
the Territory.

6.6

Subcontractors. Subject to Section 2.5 for any subcontract that constitutes a
sublicense of the License, Betta may perform any of its Commercialization
obligations relating to the Licensed Products through one or more
subcontractors; provided that (a) Betta remains responsible for the work
allocated to, and payment to, such subcontractors and Sublicensees to the same
extent it would if it had done such work itself; (b) the subcontractor or
Sublicensee undertakes in writing commercially reasonable obligations of
confidentiality and non-use regarding Confidential Information that are
substantially the same as those undertaken by the Parties with respect to
Confidential Information pursuant to ARTICLE 9 hereof; (c) Betta will ensure
that all Inventions discovered, made or conceived by each subcontractor and
Sublicensee in the course of the performance of such activities are assigned to
Betta in a manner consistent with Section 8.1(a) below; provided that, in the
event any such assignment is prohibited by Applicable Law, Betta will ensure
that such Inventions are otherwise Controlled by Betta; and (d) Betta will
require [*] ensure that its subcontractors and Sublicensees comply with all
obligations and covenants to which Betta is subject under this Agreement, as
well as Applicable Laws, including all GDP, GMP, Anti-Corruption Laws and Data
Privacy Laws.

ARTICLE 7.

FINANCIAL TERMS

7.1

Up-Front Payment. Betta will pay to Agenus a one-time, non-refundable,
non-creditable, up-front payment (“Initial Payment”) of Fifteen Million U.S.
dollars ($15,000,000), [*]. Agenus shall invoice Betta for the Initial Payment
immediately upon execution of this Agreement. The Initial Payment shall be
allocated as set forth on Schedule 7.1 hereto.

7.2

Tech Transfer Fee. Betta will pay to Agenus an additional one-time,
non-refundable, non-creditable, and not subject to set-off fee of [*] (“Tech
Transfer Fee”) upon the Manufacturing Technology Transfer Completion pursuant to
Section 5.2(b). Agenus will invoice Betta for the Tech Transfer Fee following
its receipt of Betta’s notice of the Manufacturing Technology Transfer
Completion pursuant to Section 5.2(b) and Betta will make the payment [*]
following receipt of such invoice.

7.3

Milestone Payments. In addition to the Initial Payment and the Tech Transfer
Fee, Betta will pay to Agenus each of the applicable milestone payments provided
for in this Section 7.3 upon the first occurrence of the indicated milestone
event (each a “Milestone Payment”). Each such Milestone Payment will be
non-refundable, non-creditable and not subject to set-off.

 

(a)

Development Milestones. The following Development Milestone Payments will be
paid after the achievement of the specified milestone event, and only once with
respect to all Licensed Products upon the achievement of the corresponding
Development milestone event as follows:

Development Milestone Event

Payment

(i)[*]

[*]

27

--------------------------------------------------------------------------------

(ii)[*]

[*]

(iii)[*]

[*]

 

If the Development milestone event described in clauses 7.3(a)(i) is not
achieved, but the Development milestone event described in clause 7.3(a)(ii) is
achieved, then such earlier skipped Milestone Payment will then be due and
payable together with the Milestone Payment due for the achieved milestone
event. [*] after the achievement of each Development milestone event, Betta will
notify Agenus of such achievement. Agenus will invoice Betta for the Development
Milestone Payment for each Development milestone event achieved following its
receipt of such notice and Betta will make the Milestone Payment [*]following
receipt of such invoice.

 

(b)

Commercial Milestones. Betta will pay to Agenus each of the applicable
Commercialization Milestone Payments in this Section 7.3(b) upon the first time
that the annual Net Sales of all Licensed Products in the Territory (the “Annual
Net Sales”) during the Term achieves the thresholds set forth below
(collectively, the “Commercial Milestones”):

Annual Net Sales of all Licensed Products in the Territory

Payment

(i)[*]

[*]

(ii)[*]

[*]

(iii)[*]

[*]

 

[*] after the end of each calendar year, Betta will notify Agenus if any
Commercial Milestones are achieved (“Commercial Milestones Notice”), provided
that Betta will provide the unaudited Net Sales within [*] after the end of each
calendar year. Agenus will invoice Betta for each Commercial Milestone Payment
for each Commercial milestone achieved following its receipt of the Commercial
Milestones Notice and Betta will make the Milestone Payment within [*] following
receipt of such invoice. For clarity, Betta shall only be obligated to make
payment once for the first time when a Commercial Milestone is achieved and
Betta has no obligation to make further payment if such Commercial Milestone is
achieved again.

7.4

Running Royalties. Betta will pay to Agenus running royalties on Net Sales of
all Licensed Products in the Territory at the applicable royalty rates, as set
forth in the following table:

Annual Aggregated Net Sales of all Licensed Products in the Territory

Royalty Rate

(i)[*]

[*]

(ii)[*]

[*]

(iii)[*]

[*]

(iv)[*]

[*]

28

--------------------------------------------------------------------------------

(v)[*]

[*]

 

 

(a)

Duration of Royalty Obligations. Betta’s obligation to pay royalties under this
Section 7.4 will be in effect during the “Royalty Term” which begins on the date
of First Commercial Sale of a Licensed Product in the Territory and will expire
on a Licensed Product-by-Licensed Product and region-by-region basis upon the
latest of:

 

(i)

the expiration of the last-to-expire Licensed Patent in such region having a
Valid Claim that Covers such Licensed Product;

 

(ii)

the expiration of all Regulatory Exclusivity Periods that apply to such Licensed
Product in such region; or

 

(iii)

the tenth (10th) anniversary of the First Commercial Sale of such Licensed
Product in the Territory.

 

(b)

Additional Provisions Regarding Royalties. Betta’s royalty obligations under
this Section 7.4 will be subject to the following conditions:

 

(i)

only one royalty will be due and payable with respect to the same unit of
Licensed Product;

 

(ii)

royalties when owed or paid hereunder will be non-refundable and non-creditable
and not subject to set-off, except as expressly set forth herein;

 

(iii)

no royalties will be due upon the sale or transfer of Licensed Products among
the Betta Parties, but in such cases the royalty will be due and calculated on a
Betta Party’s Net Sales to the first independent Third Party;

 

(iv)

no royalties will accrue on the disposition of Licensed Products by the Betta
Parties for use in clinical studies conducted by the Betta Parties; and

 

(v)

no royalty anti-stacking, offsets, or reductions of any kind will apply. Betta
will be responsible for [*] ensure non-infringement of the Licensed Products
under third party rights in the Territory in the Field.

7.5

Payment Terms. Unless otherwise stated below, this Section 7.5 will apply to all
payments to be made by one Party to the other hereunder.

 

(a)

Manner of Payment. All payments to be made by one Party to the other Party under
this Agreement will be made in United States dollars and by bank wire transfer
in immediately available funds to such bank account as may be designated in
writing by such Party from time to time. For the purpose of converting the local
currency in which any Net Sales arise into US dollars for purpose of calculating
royalties, the rate of exchange to be applied will be [*].

 

(b)

Royalty Payment Statements. Starting on the date of First Commercial Sale of a
Licensed Product in the Territory, Betta will furnish to Agenus a quarterly
written report for each calendar quarter no later than [*] following completion
of each calendar quarter showing

29

--------------------------------------------------------------------------------

 

all royalty payments due to Agenus pursuant to Section 7.4 (“Royalty Payment
Statement”) for the relevant calendar quarter including:

 

(i)

the gross amount invoiced by the Betta Parties to any Third Party for the sale
to such Third Party of Licensed Products;

 

(ii)

the calculation of Net Sales, including the applicable royalty rate and the type
and amount of all deductions and offsets allocated with respect to such Net
Sales;

 

(iii)

if applicable, the exchange rate, as defined in Section 7.5(a) used for
calculating any royalties; and

 

(iv)

such other particulars as are reasonably necessary for an accurate accounting of
the payments due pursuant to this Agreement.

 

(c)

Royalty Invoicing.

 

(i)

Agenus will invoice Betta for all royalties payable under this Agreement [*]
following receipt of each Royalty Payment Statement for the applicable calendar
quarter.

 

(ii)

With respect to any royalty payment by Betta to Agenus under Section 7.4, Betta
will pay each invoice for such royalty payment [*] after delivery of such
invoice to Betta by Agenus.

 

(d)

Overdue Payments. Any overdue payments to Agenus by Betta under this Agreement
will accrue interest [*] (or the maximum legal interest rate allowed by
Applicable Law, if less) from and after such date and Betta will be responsible
for reasonable legal fees and expenses incurred by Agenus in connection with the
collection thereof.

 

(e)

Records and Audits. Betta will maintain (and will cause all Betta Parties to
maintain) accurate books and records of accounting to document the sales of
Licensed Products and the calculation of royalties payable to Agenus in the
Territory. For a period of [*] following the end of the relevant calendar year,
the relevant books and records will, upon written request by Agenus, be made
reasonably available for inspection by an internationally recognized firm of
independent certified public accountants (to be selected by Agenus/ and
reasonably acceptable to Betta) as reasonably necessary to verify the accuracy
of royalty reports for the relevant period. Access to such books and records
will be during normal business hours and upon reasonable prior notice; provided
that such audits or inspections will not be conducted more frequently than [*].
If the auditors correctly identify any underpayments or overpayments, the amount
of any underpayments will be paid to Agenus by Betta [*] of notification of the
results of such inspection, and any overpayments will be fully creditable
against amounts payable to Agenus in subsequent periods. [*].

 

(f)

Taxes. Betta will be responsible for all withholding, VAT, transfer and other
taxes and fees imposed by any entity in the Territory in connection with the
payments and activities pursuant to this Agreement, none of which would reduce
the payments to Agenus described herein. Agenus will be liable for all U.S.
federal and state income and other taxes (including interest) imposed upon any
payments made by Betta to Agenus pursuant to this Agreement. If Applicable Laws
in the Territory require the withholding of such taxes, Betta will withhold and
deduct the amounts required and pay such amounts to the applicable taxing
authority, and increase any payments due to Agenus to take into account the
withheld or

30

--------------------------------------------------------------------------------

 

deducted amounts such that, after deducting and withholding such amounts
(including for taxes on the additional amounts payable), Agenus receives amounts
equal to the amounts set forth hereunder before any withholdings and deductions;
provided that, in the event that Agenus actually recovers any such withheld or
deducted amounts paid by Betta to the applicable taxing authority, Agenus shall
return, refund, reimburse, or credit any such recovered amounts to Betta. Betta
will submit to Agenus appropriate proof of payment of the withheld or deducted
taxes as well as the official receipts within a reasonable period of time. Each
Party will, upon request, provide the other Party with reasonable assistance in
order to assist such Party in seeking the benefit of any present or future tax
exemptions and/or treaties against double taxation which may apply to any
payments due Agenus under this Agreement.

ARTICLE 8.

INTELLECTUAL PROPERTY

8.1

Ownership of Program Technology.

 

(a)

Agenus will solely own any and all Inventions directed to the composition of
matter of any Licensed Antibody, including improvements thereof, or methods of
use of any Licensed Antibody, including combinations using Licensed Antibody and
improvements thereof (“Product Inventions”) and all patent rights therein
(“Product Invention Patent Rights”); (i) made solely, as between the Parties, by
Representatives of Agenus (“Agenus Improvements”), and any patent rights therein
(“Agenus Improvement Patent Rights”); or (ii) made by Representatives of Agenus
in conjunction with Representatives of Betta (“Joint Improvements”), and any
patent Rights therein (“Joint Improvement Patent Rights”). Betta shall assign
and hereby assigns to Agenus all of its right, title and interest in and to all
of the foregoing.

 

(b)

Betta will own any and all Inventions (other than Product Inventions) made
solely, as between the Parties, by Representatives of Betta (“Betta
Improvements”), and any Patent Rights therein (“Betta Improvement Patent
Rights”).

 

(c)

For clarity, (i) all Product Inventions, Product Invention Patent Rights, Agenus
Improvements, Agenus Improvement Patent Rights, Joint Improvements and Joint
Improvement Patent Rights [*] for the Development, Manufacture or
Commercialization of the Licensed Product in the Field in the Territory will be
included in the Licensed IP and licensed to Betta under the License; and (ii)
all Betta Improvements and Betta Improvement Patent Rights [*] will be included
in the Betta IP and licensed to Agenus under the license granted by Betta to
Agenus under Section 2.4.

 

(d)

Each Party shall promptly notify the other Party of any Invention arising in
connection with this Agreement, including Inventions made by Affiliates or
sublicensees of the Party.

8.2

Ownership Disputes. The Parties will attempt [*] to resolve any disputes
regarding ownership of Inventions, and all Patent Rights and any other
intellectual property rights therein. In the event the Parties are unable to
resolve such dispute through escalation to Executive Officers of the Party, such
dispute will be resolved [*].

8.3

Prosecution, Enforcement and Defense of Patent Rights.

 

(a)

Agenus will have the first right, but not the obligation, at its discretion, to
Prosecute and defend throughout the world any [*]. In any jurisdiction in the
Territory where Agenus chooses not to Prosecute or defend any Licensed Patent
Right, Agenus will notify Betta of

31

--------------------------------------------------------------------------------

 

any decision to cease Prosecution or defense of any Licensed Patent Right in the
Territory at least [*] before any due date for filing, payment or other action
to avoid loss of rights. Upon Betta’s receipt of such notice, or in any
jurisdiction in the Territory where Agenus fails to take or continue any action
to Prosecute or defend any Licensed Patent Right in the Territory within [*]
before any due date for filing, payment or other action to avoid loss of rights,
in each case, Betta will have the second right, but not the obligation, to cause
Agenus to Prosecute and defend such Licensed Patent Right at Betta’s cost;
provided [*]. Agenus will consult with Betta and keep Betta reasonably informed
of the Prosecution or defense of any Licensed Patent Rights in the Territory and
will provide Betta with all material correspondence received from any patent
authority in the Territory in connection therewith. In addition, Agenus will
provide [*]. Agenus [*] will have final decision-making authority under this
Section 8.3(a).

 

(b)

Betta will have the first right, but not the obligation, in its discretion, to
Prosecute and defend throughout the world any [*]. In any jurisdiction outside
the Territory where Betta chooses not to Prosecute any Betta Improvement Patent
Right included within its license to Agenus under Section 2.4, Betta will notify
Agenus of any decision to cease Prosecution or defense of any Betta Improvement
Patent Rights outside the Territory at least [*] before any due date for filing,
payment or other action to avoid loss of rights. Upon Agenus’ receipt of such
notice, or in any jurisdiction outside the Territory where Betta fails to take
or continue any action to Prosecute or defend any Betta Improvement Patent Right
outside the Territory within [*] before any due date for filing, payment or
other action to avoid loss of rights, in each case Agenus will have the second
right, but not the obligation, to cause Betta to Prosecute or defend such Betta
Improvement Patent Right at Agenus’ cost; provided that [*]. Betta will consult
with Agenus and keep Agenus reasonably informed of the Prosecution or defense of
any Betta Improvement Patent Rights outside the Territory and will provide
Agenus with all material correspondence received from any patent authority
outside the Territory in connection therewith. In addition, [*]. Betta [*] will
have final decision-making authority under this Section 8.3(b).

 

(c)

In the Territory, Betta will have, with respect [*], the first right to enforce
Licensed IP. Agenus will have the sole right to enforce Licensed IP outside the
Territory or in the Territory outside the Field. In any jurisdiction in the
Territory where Betta chooses not to enforce [*], Betta will notify Agenus of
such decision at least [*] before any due date for filing, payment or other
action to avoid loss of rights. Upon the earlier of Agenus’ receipt of such
notice or in the event Betta fails to take or continue any action to enforce [*]
of Betta becoming aware of [*] or where Betta fails to take or continue any
action to enforce [*] before any due date for to avoid loss of rights, Agenus
will have the second right, but not the obligation, to enforce [*]. The
non-enforcing Party will provide reasonable assistance in connection therewith,
including by executing reasonably appropriate documents, cooperating in
discovery and [*]. Each Party shall cooperate fully with the other Party in such
action to [*]; provided, however, that if the enforcing Party is Betta, then
such excess recovery will be deemed Net Sales and subject to royalty payments
under Section 7.4.

 

(d)

With respect to the Licensed IP in the Territory or any Betta Improvement Patent
Right included within the license granted to Agenus under Section 2.4, the Party
responsible for Prosecution will consult with and keep the other Party fully
informed of material issues relating to the Prosecution of such Patent Rights,
[*].

32

--------------------------------------------------------------------------------

8.4

Assignments. Each Party will require its Affiliates, and all of its or its
Affiliates’ employees, licensees, sublicensees, independent contractors and
agents [*] to assign all of its or their right, title and interest in or to any
Inventions to such Party. Each Party will, and will cause its Affiliates and all
of its or its Affiliates’ employees, licensees, sublicensees, independent
contractors and agents [*] to cooperate and take all additional actions and to
execute such agreements, instruments and documents as may be reasonably required
to perfect such Party’s right, title and interest in and to Inventions and any
Patent Rights therein.

8.5

Cooperation. Each Party hereby agrees to provide to the other Party all
reasonable assistance and cooperation reasonably necessary to enable such other
Party to undertake Prosecution, enforcement and defense of Patent Rights as
contemplated by this Agreement, including: (a) to cause its employees, and to
use reasonable efforts to cause its licensees, sublicensees, independent
contractors, agents and consultants, to be reasonably available to the other
Party (or to the other Party’s authorized attorneys, agents or representatives);
(b) to endeavor [*] to coordinate its efforts with the other Party to minimize
or avoid interference with the Prosecution, enforcement and defense of the other
Party’s Patent Rights that are subject to this Agreement; (c) to provide any
necessary powers of attorney and executing any other required documents or
instruments required to give effect to the terms of this Agreement; and (d) to
cause its employees, and to use reasonable efforts to cause its licensees,
sublicensees, independent contractors, agents and consultants, to provide any
and all information required for the other Party to comply with its relevant
duties of disclosure as required by Applicable Law in the United States or any
other jurisdiction.

8.6

Licensed Patent Right Challenge. In the event a Betta Party institutes or
actively participates as an adverse party in, or otherwise provides material
support to, institute or actively participate as an adverse party in, or
otherwise provide material support to, any legal action or administrative
proceeding in the Territory to invalidate or limit the scope of any Licensed
Patent Right claim or obtain a ruling that any Licensed Patent Right claim is
unenforceable or not patentable or that any Licensed Antibody or Licensed
Product does not infringe one or more claims of any Licensed Patent Right, then
a “Licensed Patent Right Challenge” will be deemed to have occurred. [*].

8.7

Responsibility. It is understood and agreed that Betta is solely responsible for
searching for, identifying, evaluating or obtaining access to, Patent Rights
Controlled by Third Parties (expressly excluding the Licensed IP) that may be
infringed by Betta’s Development, Manufacture or Commercialization of the
Licensed Antibodies or Licensed Products in the Field in the Territory in
accordance with this Agreement. Agenus will have no responsibility or liability
to Betta with respect to such Third Party Patent Rights. In the event that
either Party receives any notice of potential infringement of any Third Party
Patent Rights as a result of, or otherwise impacting, the Exploitation of the
Licensed Product, it will promptly notify the other Party.

8.8

Patent Term Extension. Agenus and Betta shall each cooperate with one another
and shall [*] in obtaining any available marketing exclusivity and patent term
extension to the extent applicable to the Licensed IP in the Territory.

8.9

Defense Against Claims of Infringement Brought by Third Parties. If a Third
Party brings a claim or asserts against any Party or its Affiliates or
sublicensees that a Patent Right or other right owned or controlled by the Third
Party is or has been infringed by the Development, Manufacture, or
Commercialization of a Licensed Antibody or Licensed Product in the Field in the
Territory (an “Infringement Action”), the Party first obtaining knowledge of
such a claim shall [*] provide the other Party notice of such claim along with
the related facts in reasonable detail. Agenus shall have the right to direct
and control the defense of such Infringement Action, [*]. If Agenus does not

33

--------------------------------------------------------------------------------

exercise its right to direct and control the defense of an Infringement Action,
then Betta shall have such right; [*].

ARTICLE 9.

CONFIDENTIALITY

9.1

Confidential Information.

 

(a)

In connection with the performance of their respective obligations under this
Agreement, each Party (the “Disclosing Party”) may, itself or through its
Affiliates, disclose certain of its Confidential Information to the other Party
(the “Recipient”) or its Affiliates. During the Term and for a period of [*]
thereafter, except as provided herein, the Recipient will maintain all
Confidential Information of the Disclosing Party in strict confidence and will
not use and/or disclose such Confidential Information for any purpose, except
that the Recipient may use and/or disclose or permit the use and/or disclosure
of any such Confidential Information to its Affiliates and/or sublicensees, or
its or their respective directors/board members, officers, employees,
consultants, advisors and agents, who in each case are obligated to maintain the
confidential nature of such Confidential Information on terms no less stringent
than those of this ARTICLE 9 in the exercise of its rights under this Agreement
and solely as necessary for its performance of this Agreement. In addition, the
Recipient may use and/or disclose Confidential Information of the Disclosing
Party (i) in exercising the Recipient’s rights and licenses granted hereunder
(including exercising these rights to discuss with Third Party sublicensing
opportunities) or to fulfill its obligations and/or duties hereunder; provided
that such use and/disclosure is made to a Person who is obligated to
confidentiality and non-use obligations no less rigorous than those of this
Section 9.1 and (ii) subject to Section 9.1(c), in prosecuting or defending
litigation, complying with Applicable Law and/or submitting information to tax
or other Governmental Bodies.

 

(b)

The obligations of confidentiality and non-use set forth above will not apply to
the extent that the Recipient can demonstrate that the relevant Confidential
Information of the Disclosing Party: (i) was publicly known prior to the time of
its disclosure under this Agreement; (ii) became publicly known after the time
of its disclosure under this Agreement other than through acts or omissions of
the Recipient, its Affiliates, potential sublicensees or sublicensees in
violation of this Agreement; (iii) is or was disclosed to the Recipient or any
of its Affiliates at any time, whether prior to or after the time of its
disclosure under this Agreement or any prior confidentiality agreement executed
by the Parties, by a Third Party having no fiduciary relationship with the
Disclosing Party or any of its Affiliates and subject to no obligation of
confidentiality with respect to such Confidential Information; (iv) is
independently developed by the Recipient or any of its Affiliates without access
to such Confidential Information as evidenced by written records; or (v) was
lawfully in the possession of Recipient or any of its Affiliates at the time of
receipt from Disclosing Party or any of its Affiliates as documented by
Recipient’s or any of its Affiliate’s records.

 

(c)

In addition, the Recipient or any of its Affiliates may disclose Confidential
Information of the Disclosing Party to the extent necessary to comply with
Applicable Law or a court or administrative order; provided that the Recipient
provides to the Disclosing Party prior written notice of such disclosure, to the
extent reasonably possible, and that the Recipient takes all reasonable and
lawful actions to obtain confidential treatment for such disclosure and, to the
extent possible, to minimize the extent of such disclosure.

34

--------------------------------------------------------------------------------

 

(d)

Notwithstanding the obligations in Section 9.1(a) and 9.1(c), the Recipient may
disclose (and, in connection therewith, use) Confidential Information of the
Disclosing Party, if such disclosure:

 

(i)

is made to its Affiliates, licensees, sublicensees, agents, consultants,
directors/board members, officers, employees, advisors or other Third Parties
(including service providers) for the Development, Manufacture or
Commercialization of Licensed Antibodies and/or the Licensed Products, or in
connection with a bona fide (A) assignment of this Agreement, (B) a licensing
transaction related to one or more Licensed Antibodies and/or Licensed Products,
(C) a loan, financing or investment, or (D) an acquisition, merger,
consolidation or similar transaction (or for such Persons to determine their
interest in performing such activities or entering into such transactions), in
each case (A) through (D) on the condition that any Third Parties to whom such
disclosures are made agree to be bound by confidentiality and non-use
obligations no less rigorous than those contained in this Agreement;

 

(ii)

consists entirely of Confidential Information previously approved by the
Disclosing Party for public disclosure by the Recipient; or

 

(iii)

in the event that Agenus is the Recipient, is made to an Upstream Licensor or
another sublicensee under an Upstream License Agreement in order to comply with
the terms and conditions under the corresponding Upstream License Agreement or
sublicense agreement; provided that Agenus shall redact any confidential or
proprietary information not required to be disclosed to such Upstream Licensor
or sublicensee.

 

(e)

Each Recipient will be responsible for any breach of the obligations of this
Section 9.1 by any Person to whom such Recipient or its Affiliate disclosed the
Disclosing Party’s Confidential Information.

9.2

Publicity; Attribution; Terms of this Agreement; Non-Use of Names.

 

(a)

Except as required by judicial order or Applicable Law, or as set forth below,
neither Party may make any public announcement concerning this Agreement without
the prior written consent of the other Party, which consent may not be
unreasonably withheld or delayed. The Party preparing any such public
announcement will provide the other Party with a draft thereof at least [*]
prior to the date on which such Party would like to make the public
announcement. Neither Party may use the name, trademark, trade name or logo of
the other Party, its employees, or of [*], in any press release, advertising or
promotional materials without the prior express written permission of the other
Party or, as applicable, [*].

 

(b)

Notwithstanding the terms of this ARTICLE 9, either Party will be permitted to
disclose the existence and terms of this Agreement to the extent required, based
on the advice of such Party’s legal counsel, to comply with Applicable Law,
including the rules and regulations promulgated by the U.S. Securities and
Exchange Commission (“SEC”) or its PRC counterparts, or any other Governmental
Body, at its sole cost and expense.

 

(c)

Either Party may also disclose the existence and terms of this Agreement in
confidence to its attorneys and advisors, and to potential acquirors (and their
respective professional advisors), in connection with a potential merger,
acquisition or reorganization and to existing and potential investors or lenders
of such Party, as a part of their due diligence

35

--------------------------------------------------------------------------------

 

investigations, or to existing and potential sublicensees or assignees or
licensors, including the Upstream Licensors, or to any other Person described in
Section 9.1(d)(i) or Section 9.1(d)(iii), in each case under an agreement to
keep the terms of this Agreement confidential under terms of confidentiality and
non-use substantially no less rigorous than the terms contained in this
Agreement and to use such information solely for the purpose permitted pursuant
to this Section 9.2(c) or Section 9.1(d)(i) or Section 9.1(d)(iii).

 

(d)

For purposes of clarity, either Party may issue a press release or public
announcement or make such other disclosure if the content of such press release,
public announcement or disclosure has previously been made public other than
through a breach of this Agreement by the issuing Party or its Affiliates.

9.3

Publications. The Betta Parties will have the right to make disclosures
pertaining to a Licensed Antibody and/or Licensed Product in recognized
scientific publications or at scientific conferences in accordance with the
following procedure: [*].

9.4

Return of Confidential Information. Subject to Section 10.3, upon the expiration
or termination of this Agreement, upon request, the Recipient will return to the
Disclosing Party or destroy all Confidential Information received by the
Recipient or any of its Affiliates from the Disclosing Party or any of its
Affiliates (and all copies and reproductions thereof). In addition, the
Recipient and its Affiliates will destroy: (a) any notes, reports or other
documents. prepared by the Recipient which contain Confidential Information of
the Disclosing Party; and (b) any Confidential Information of the Disclosing
Party (and all copies and reproductions thereof) which is in electronic form or
cannot otherwise be returned to the Disclosing Party. Nothing in this Section
9.4 will require the alteration, modification, deletion or destruction of
archival tapes or other electronic back-up media made in the ordinary course of
business of the Recipient and its Affiliates; provided that the Recipient and
its Affiliates will continue to be bound by its obligations of confidentiality
and other obligations under this ARTICLE 9 with respect to any of the Disclosing
Party’s Confidential Information contained in such archival tapes or other
electronic back-up media. Any requested destruction of the Disclosing Party’s
Confidential Information will be certified in writing to the Disclosing Party by
an authorized officer of the Recipient supervising such destruction.
Notwithstanding the foregoing, (i) the Recipient and its Affiliates may retain
one copy of the Disclosing Party’s Confidential Information solely for the
purpose of determining the Recipient’s continuing obligations under this ARTICLE
9 and (ii) the Recipient and its Affiliates may retain the Disclosing Party’s
Confidential Information and its own notes, reports and other documents to the
extent reasonably required (A) to exercise the rights and licenses of the
Recipient expressly surviving expiration or termination of this Agreement; (B)
to perform the obligations of the Recipient expressly surviving expiration or
termination of this Agreement; or (C) for regulatory or archival purposes.
Notwithstanding the return or destruction of the Disclosing Party’s Confidential
Information, the Recipient will continue to be bound by its obligations of
confidentiality and other obligations under this ARTICLE 9.

ARTICLE 10.

TERM AND TERMINATION

10.1

Term. The term of this Agreement (the “Term”) will commence on the Effective
Date and will expire upon the expiration of the Royalty Term in all regions for
all Licensed Products, unless earlier terminated by a Party as set forth below
in this ARTICLE 10. On expiration of the Royalty Term for a Licensed Product in
any particular region, absent any prior termination, the License for the
corresponding Licensed Product and its Licensed Antibody and the license granted
to Betta under the Product Marks in accordance with Section 6.2(b) will in such
region become perpetual, fully paid-up, royalty-free, irrevocable and exclusive
in such country.

36

--------------------------------------------------------------------------------

10.2

Termination.

 

(a)

For Convenience. At any time, Betta may elect to terminate this Agreement in its
entirety, or as to a single Licensed Antibody, by providing ninety (90) days’
prior written notice to Agenus; provided that at any time after such notice by
Betta, Agenus may accelerate the effective date of such termination by providing
thirty (30) days’ prior written notice to Betta of such accelerated effective
date.

 

(b)

For Betta’s Abandonment. Agenus may, on written notice to Betta, terminate this
Agreement with respect to either Licensed Antibody and its corresponding
Licensed Products in the event of Abandoned Development or Abandoned
Commercialization of such Licensed Antibody, subject to the provisions of
Section 4.10.

 

(c)

For Material Breach. If either Party believes [*] that the other Party is in
material breach of any material provision of this Agreement, then the
non-breaching Party may deliver notice of such breach to the other Party stating
the cause, and proposed remedy if any. Subject to this Section 10.2(c), the
allegedly breaching Party will have [*] from the date of such notice to cure
such breach (the “Cure Period”). [*]. Notwithstanding the foregoing:

 

(A)

(1) any material breach of Section 11.6 or (2) any breach of any provision in
this Agreement that causes Agenus to materially breach any provision of any
Upstream License Agreement will constitute a material breach of a material
provision of this Agreement and the Cure Period will [*] for such breach; and

 

(B)

the Cure Period will be [*] in the event that a Party materially breaches any of
its payment obligations to the other Party; provided, however, the failure to
make the Initial Payment pursuant to Section 7.1 will be deemed an incurable
material breach of a material provision of this Agreement and Agenus will have
the right to terminate this Agreement in its entirety with immediate effect;

provided that, in each case of (A) and (B) (other than with respect to the
Initial Payment), the breaching Party may remedy such breach during such [*]
Cure Period. If the breaching Party is Betta and the breach relates to Betta’s
failure to enforce any material provisions of a Sublicensee, then following the
Cure Period and operation of the applicable provisions of this Section 10.2(c),
Agenus may terminate this Agreement in whole or in part, or at its option,
solely with respect to such sublicense, and Betta will within [*] of such
termination provide written confirmation to Agenus that such sublicense has been
terminated.

 

(d)

Termination upon Bankruptcy. Each Party will have the unilateral right to
terminate this Agreement at any time during its Term by providing written notice
with immediate effect in the event that: (i) the other Party files in any court
or agency pursuant to any statute or regulation of any state, country or
jurisdiction, a petition in bankruptcy or insolvency or for reorganization or
for an arrangement or for the appointment of a receiver or trustee of that Party
or of all or substantially all of its assets, or (ii) if the other Party is
served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition is not dismissed within [*] after the filing
thereof, or (iii) if the other Party proposes or is a party to any dissolution
or liquidation, or (iv) if the other Party makes an assignment of all or
substantially all of its assets for the benefit of its creditors (an “Insolvency
Event”). All rights and licenses granted under or pursuant to this Agreement by
Betta or Agenus or each of their Affiliates are, and will otherwise be deemed to
be, for purposes of Section 365(n)

37

--------------------------------------------------------------------------------

 

of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as
defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that
the non-insolvent Party (and its Affiliates and sublicensees) as licensees of
such rights under this Agreement, will retain and may fully exercise all of its
rights and elections under the U.S. Bankruptcy Code and any foreign counterparts
thereto.

 

(e)

Other Termination.

 

(i)

Either Party will have the right to terminate this Agreement in connection with
a Force Majeure Event asserted by the other Party, in accordance with Section
14.6.

 

(ii)

[*].

 

(iii)

[*].

10.3

Consequences of Termination. In the event that this Agreement is terminated in
its entirety pursuant to Section 10.2, then, in addition to the other provisions
which survive termination pursuant hereto, the following provisions will apply,
and in the event that a Party terminates this Agreement pursuant to Section 10.2
with respect to a single Licensed Antibody, the following provisions will apply
solely with respect to such Licensed Antibody and the Licensed Products
containing such Licensed Antibody (and this Agreement will continue in full
force and effect with respect to the other Licensed Antibody and the Licensed
Products containing such other Licensed Antibody).

 

(a)

Each Party will comply with the return and destruction obligations with respect
to Confidential Information and any other Know-How of the other Party that are
in its or its Affiliates’, sublicensees’ or Third Party contractors’ possession
or control in accordance with ARTICLE 9.

 

(b)

Betta will deliver all unpaid payments due hereunder within [*] after the
effective date of termination of this Agreement in whole or in part (the
“Termination Date”). All payments made to Agenus prior to termination of this
Agreement will be non-refundable.

 

(c)

As of the Termination Date, all licenses and rights granted by Agenus to Betta
hereunder (including in Section 2.1 and 6.2(b)(i)) will terminate and such
licenses and rights will revert to Agenus (except for those that expressly
survive any such termination hereunder), and the Betta Parties will have no
further rights to use any Licensed IP and Product Marks except to the extent and
for so long as is necessary to permit Betta to finish work-in-progress. With
Agenus written consent, Betta will be permitted to sell any Licensed Product
inventory (“Remaining Inventory”) for a period of [*] following the Termination
Date, and to otherwise perform any responsibilities in connection with any then
ongoing clinical trial or other activity that cannot be terminated as of such
date under Applicable Laws, it being agreed that all such activities and
responsibilities will be discontinued and ceased (unless otherwise agreed or
required under Applicable Laws by transitioning such activities and
responsibilities to Agenus) as promptly as possible, subject to Applicable Laws.
Betta will continue to make any and all applicable payments to Agenus for the
Licensed Product sold or disposed of by any Betta Party, including any royalties
under Section 7.4 for Net Sales of Licensed Product in the Remaining Inventory.
Agenus will have the option of purchasing Remaining Inventory from Betta Parties
at [*] of such Betta Parties’ Fully Burdened Manufacturing Costs of the
Remaining Inventory.

38

--------------------------------------------------------------------------------

 

(d)

Betta will grant, and hereby grants, to Agenus a worldwide, perpetual,
irrevocable, non-exclusive, fully paid, royalty-free, transferable right and
license, with the right to grant sublicenses through multiple tiers, under the
Betta IP and Right of Reference as described in Section 4.7(g), solely for
research and Exploitation of the Licensed Antibodies and/or the Licensed
Products.

 

(e)

At Agenus’ written request and expense, Betta shall assign, and shall cause all
other Betta Parties to assign, to Agenus or its designee, all of Betta’s rights
under Third Party contracts relating to the Development, Manufacture and/or
Commercialization of the Licensed Antibodies and the Licensed Products, to the
extent that such contracts can be assigned without the counterparty’s consent
and, to the extent that such consent is required, Betta will [*] obtain such
consent and, if such consent is obtained, thereafter shall assign, and shall
cause all other Betta Parties to assign, such rights to Agenus; and Agenus will
assume Betta’s obligations under such assigned contracts, except to the extent
such obligations relate to the period of performance prior to assignment or to
any breach of such agreements by a Betta Party.

 

(f)

At Agenus’ written request, Betta will provide Agenus with originals and copies
of all, Regulatory Approval or Regulatory Submission for the Licensed Products.
To the extent any Betta Parties obtained any ownership interest in a Regulatory
Approval or Regulatory Submission, and (i) to the extent permissible under
Applicable Law, Betta shall assign, and shall cause all other Betta Parties to
assign, to Agenus or Agenus’ designee such Regulatory Approval or Regulatory
Submission; or (ii) if such Regulatory Approval or Regulatory Submission cannot
be transferred to Agenus or Agenus’ designee, Betta shall, and shall cause all
other Betta parties to, permit Agenus to cross-reference and rely upon such
Regulatory Approval and Regulatory Submission filed, including submitting to
each applicable Regulatory Authority of a letter or other necessary
documentation (with a copy to Agenus) notifying such Regulatory Authority of the
transfer of such ownership of each Regulatory Approval and Regulatory
Submission. In addition, upon Agenus’ written request, Betta will, at Agenus’s
cost and expense, provide to Agenus copies of all related documentation,
including material non-clinical, preclinical and clinical data that are held by
Betta or reasonably available to Betta Parties.

 

(g)

Betta will, and will cause Betta Parties, to [*] provide assistance, at the cost
of Agenus, to commence or continue Developing or Commercializing the Licensed
Antibodies and Licensed Products in the Territory for a period of no more than
[*] after the effective date of such termination in accordance with a mutually
agreed upon transition plan.

 

(h)

If, as of the Termination Date, Betta Parties are conducting any Clinical
Trials, then, at Agenus’ election on a Clinical Trial-by-Clinical Trial basis:
(i) to the extent permissible under Applicable Law, at Agenus’ cost and expense,
Betta will, and will cause Betta Parties to, cooperate with Agenus to transfer
the conduct of such Clinical Trial to Agenus or its designees and complete such
transfer promptly and, in any case, within [*] after the termination effective
date, and Agenus will assume any and all liability for the conduct of such
transferred Clinical Trial after the date of such election (except to the extent
arising prior to the election date or from any willful misconduct or negligent
act or omission by Betta Parties or their respective employees, agents and
contractors) and (ii) Betta will, at its cost and expense, orderly wind-down the
conduct of any such Clinical Trial that is not assumed by Agenus under clause
(i) above.

39

--------------------------------------------------------------------------------

 

(i)

Except as set forth [*] or as may otherwise be agreed in writing by the Parties,
Betta will be responsible at its own expense for an orderly wind-down, in
accordance with Applicable Laws and accepted pharmaceutical industry norms and
ethical practices, of any then on-going Development, Manufacture and/or
Commercialization activities not transferred in accordance with the foregoing
clauses. [*].

 

(j)

Except where expressly provided for otherwise in this Agreement, termination of
this Agreement will not relieve the Parties of any liability, including any
obligation to make payments hereunder, which accrued hereunder prior to the
effective date of such termination, nor preclude any Party from pursuing all
rights and remedies it may have hereunder or at law or in equity with respect to
any breach of this Agreement, nor prejudice any Party’s right to obtain
performance of any obligation. In the event of such termination, this Section
10.3 will survive in addition to others specified in this Agreement to survive
in such event.

10.4

Effect on Sublicenses. In the event of any termination of this Agreement for any
reason, upon the election of Agenus, any Sublicensee, from the effective date of
such termination, will automatically become a direct licensee of Agenus under
rights and terms equivalent to the sublicense rights and terms which were
previously granted to such Sublicensee by Betta hereunder; provided that, as a
condition of receiving such direct license from Agenus, in the case of a
termination pursuant to Section 10.2(b), Section 10.2(c), Section 10.2(e)(i), or
Section 10.2(e)(ii), such Sublicensee has not contributed in any material
respect to the circumstances that led to the termination.

10.5

Survival in All Cases. Termination or expiration of this Agreement will be
without prejudice to or limitation on any other remedies available to nor any
accrued obligations of either Party. In addition, ARTICLE 1, ARTICLE 8, ARTICLE
9, ARTICLE 12, ARTICLE 13 and Sections 2.4, 7.1, 7.5(e), 10.3, 10.4, 10.5,
11.4(g) (upon expiration, but not upon termination), 11.5(e) (upon expiration,
but not upon termination), 11.8, 14.1, 14.2, 14.5, 14.7 will survive any
expiration or termination of this Agreement.

ARTICLE 11.

REPRESENTATIONS, WARRANTIES, AND COVENANTS

11.1

Mutual Representations and Warranties. Each Party represents, warrants, and
covenants to the other Party that as of the Effective Date:

 

(a)

It is duly organized, validly existing, and in good standing as a corporation or
other entity as represented herein under the laws and regulations of its
jurisdiction of incorporation, organization, or chartering;

 

(b)

it has the full right, power, and authority to enter into this Agreement and to
perform its obligations hereunder;

 

(c)

the execution of this Agreement by its representative whose signature is set
forth at the end hereof has been duly authorized by all necessary corporate
action of the Party and shall not violate (i) such Party’s organizational
documents; (ii) any agreement, instrument or contractual obligation to which
such Party is a party or by which it is bound; (iii) any requirement of any
Applicable Law; or (iv) any order, writ, judgment, injunction, decree,
determination or award of any court or any Governmental Body presently in effect
applicable to such Party;

 

(d)

when executed and delivered by such Party, this Agreement will constitute the
legal, valid, and binding obligation of that Party, enforceable against that
Party in accordance with its

40

--------------------------------------------------------------------------------

 

terms except as enforceability may be limited by bankruptcy, fraudulent
conveyance, insolvency, reorganization, moratorium or other laws relating to or
affecting creditor’s rights generally and by general equitable principles;

 

(e)

as of the Effective Date, it is not currently bound by any agreement with any
Third Party, or by any outstanding order, judgment, or decree of any court or
administrative agency that restricts it from granting to such other Party the
rights and licenses as set forth in this Agreement; and

 

(f)

such Party has valid and sufficient arrangements and agreements with its
directors, officers and employees (which term shall include agents, consultants
and subcontractors) such that ownership of intellectual property rights in and
to any Inventions made by its directors, officers and employees vests in such
Party.

11.2

Betta’s Representations and Warranties. Betta represents and warrants to Agenus
that:

 

(a)

Betta and its Affiliates are not, and Betta will ensure that Betta Parties are
not, required under Applicable Laws to submit scientific data to Governmental
Body controlled databases pursuant to the Chinese State Council’s Scientific
Data Administrative Measures; and

 

(b)

As of the Effective Date, to Betta’s knowledge there is no pending litigation
against Betta or any of its Affiliates relating to, and neither Betta nor any of
its Affiliates has received any written notice from any Third Party asserting,
an allegation that the Development, Manufacturing or Commercialization
activities of Betta or its Affiliates exceed the scope of any license granted by
a Third Party pursuant to an agreement to which Betta or its Affiliates are
currently bound.

11.3

Agenus’ Representations and Warranties. Agenus represents and warrants to Betta
that as of the Effective Date:

 

(a)

Agenus Controls the Licensed IP, and Agenus has executed the Amendment to
Inter-Company Agreements;

 

(b)

Agenus has the full rights, power and authority to grant the License granted
herein, and is not prohibited from doing so by the terms of any agreement to
which it is a party [*], and has the full right, power and authority to deliver
the Licensed IP to Betta, and is not prohibited from doing so by the terms of
any agreement to which it is a party, [*];

 

(c)

The Upstream License Agreements include all agreements between Agenus or its
Affiliates and a Third Party under which Agenus or its Affiliates have licensed
or sublicensed the Licensed IP from a Third Party, and Agenus has provided Betta
with a copy of each Upstream License Agreement, which copy has been redacted to
remove any provisions or terms not necessary to determine Betta’s rights under
the License.

 

(d)

[*];

 

(e)

Agenus’ performance of its obligations under this Agreement does not or will not
cause any breach of any Upstream License Agreements;

 

(f)

Agenus’ right, title and interest to all the Licensed IP are free of any lien or
security interest;

41

--------------------------------------------------------------------------------

 

(g)

Agenus has received no written notice from a Third Party regarding, nor has any
knowledge that any Third Party intends to assert, any claim that the
Exploitation of any Licensed Antibody and/or Licensed Product in the Territory
infringes the intellectual property rights of a Third Party;

 

(h)

there are no written licenses or other agreements to which Agenus or any of its
Affiliates is a party that relate in any material respect to any Licensed
Antibody and/or Licensed Product in the Territory or any Licensed IP relating
thereto, and Agenus has not granted any right or license to any Third Party
relating to any of the intellectual property rights it Controls, which would
conflict or interfere with any of the rights or licenses granted to Betta
hereunder;

 

(i)

neither the execution and delivery of this Agreement nor the performance hereof
by Agenus requires Agenus to obtain any permits, authorizations or consents from
any Governmental Body or from any other person, firm or corporation, and such
execution, delivery and performance will not result in the breach of or give
rise to any right of termination, rescission, renegotiation or acceleration
under, or trigger any other rights under, any agreement or contract to which
Agenus is a party or to which it may be subject that relates to the Licensed IP
or the Licensed Antibody and/or Licensed Product; and

 

(j)

there is no written action, suit, proceeding (other than routine patent office
and regulatory matters), arbitration, or litigation of any nature, civil,
criminal, regulatory or otherwise, in law or in equity, pending, or to its
knowledge, threatened, against Agenus or any of its Affiliates, in each case in
connection with the Licensed IP or the Licensed Antibodies and/or Licensed
Products.

11.4

Covenant by Betta. Betta covenants to Agenus that during the Term:

 

(a)

Betta will not knowingly, and will not permit any Betta Party to, generate
Results or otherwise engage in any activities that use the inventions Covered in
the Licensed IP, the Product Marks, or any other Know-How or Patent Rights
Controlled by Agenus, in a manner that is outside the scope of the license
rights expressly granted to it hereunder;

 

(b)

Betta will perform, and will cause Betta Parties to perform, their
responsibilities and exercise their rights under this Agreement in compliance
with this Agreement (including Section 11.6(b)) and all Applicable Laws,
including all GCP, GLP, GDP, GMP, Anti-Corruption Laws and Data Privacy Laws;

 

(c)

Betta will not, and will not permit Betta Parties to, ship or otherwise make
available Licensed Antibodies or Licensed Products outside of the Territory;

 

(d)

Betta will, and will cause Betta Parties to, maintain complete and accurate
Records, and will ensure that no Records, including any Clinical Trial records
or Manufacturing batch records, are tampered with or improperly modified;

 

(e)

Betta will perform, and will cause Betta Parties and their respective
subcontractors to, perform all necessary or required record filings with, and
obtain all necessary or required licenses, approvals and permits from, all
applicable Governmental Bodies in the PRC (including without limitation the
HGRAC Approvals) for the conduct of activities, including Development activities
and data sharing, under this Agreement, including any record filings or
approvals necessary or required to allow for the access or transfer to or

42

--------------------------------------------------------------------------------

 

use by Agenus or its Affiliates or sublicensees of Clinical Trial data and
records, and provide Agenus with copies of such record filings, licenses,
approvals, and permits;

 

(f)

all employees and officers of Betta or Betta Parties working under this
Agreement shall be under the obligation to assign all right, title and interest
in and to their Inventions, whether or not patentable, if any, to Betta as the
sole owner thereof, and under the obligation to maintain as confidential the
Confidential Information of Betta; and

 

(g)

during the Term and thereafter following its expiration (but not its
termination):

 

(i)

Betta, on behalf of itself and its Affiliates and any other Betta Parties,
hereby covenants that, neither it nor any of its Affiliates or other Betta
Parties shall (i) sue, assert any claim or counterclaim, or take or otherwise
participate in any legal proceeding, petition, allegation or relevant action,
under any Know-How, Patent Rights, or other intellectual property Controlled by
Betta or its Affiliates as of the Effective Date (“Betta Existing IP”), against
Agenus, its Affiliates, or any of its or their sublicensees making any
allegation of infringement, misappropriation, or otherwise by Agenus, its
Affiliates, or any of its or their sublicensees with respect to the research,
development, manufacture, use, commercialization, offer for sale, sale,
distribution, import, export, or other exploitation of any Licensed Antibody or
Licensed Product, or (ii) directly and knowingly cause, assist, support, permit,
authorize or encourage any Third Party in doing any of the foregoing.

 

(ii)

The Betta Parties shall not enable, authorize or license any Third Party to take
any action that would have the effect of allowing such Third Party to take any
action relating to the Betta Existing IP that would be prohibited by this
Section 11.4(g) if taken by a Betta Party.

 

(iii)

If any Betta Party asserts any claim or counterclaim or otherwise participates
in any action, suit or proceeding that would be prohibited by this Section
11.4(g), then Betta shall, and shall use reasonable efforts to cause such
Affiliate or other Betta Party to, (A) withdraw, file a dismissal with
prejudice, or take all actions having similar effect, with respect to any such
claim, counterclaim, action, suit or proceeding [*] of the earlier of (1)
Agenus’s written request, or (2) Betta learning of such claim, counterclaim,
action, suit or proceeding, and (B) if obtained, deliver a copy of such
withdrawal or dismissal with prejudice, or reasonable documentary evidence of
any similar action having similar effect, to Agenus within such [*] period.

11.5

Covenant by Agenus. Agenus covenants to Betta that during the Term:

 

(a)

Agenus will perform its responsibilities under this Agreement in compliance with
this Agreement (including Section 11.6(b)) and all Applicable Laws, including
all Anti-Corruption Laws;

 

(b)

all employees and officers of Agenus or its Affiliates working under this
Agreement shall be under the obligation to assign all right, title and interest
in and to their Inventions, whether or not patentable, if any, to Agenus as the
sole owner thereof, and under the obligation to maintain as confidential the
Confidential Information of Agenus;

43

--------------------------------------------------------------------------------

 

(c)

Agenus shall not, during the Term, grant any right or license to any Third Party
relating to any of the intellectual property rights it Controls which would
conflict or interfere with any of the rights or licenses granted to Betta
hereunder; and

 

(d)

Agenus shall not license, sell, assign or otherwise transfer to any person
(including any Affiliate of Agenus) any Licensed IP, or any of its rights or
obligations thereunder to any person (including any Affiliate of Agenus) in any
manner that would materially conflict with the rights granted or licensed to
Betta under this Agreement.

 

(e)

During the Term and thereafter following its expiration (but not its
termination):

 

(i)

Agenus, on behalf of itself and its Affiliates, hereby covenants that, neither
it nor any of its Affiliates, shall, (i) sue, assert any claim or counterclaim,
or take or otherwise participate in any legal proceeding, petition, allegation
or relevant action, under any patent issuing on PRC patent application number
[*] against any Betta Party making any allegation of infringement by any Betta
Party with respect to the Development, Manufacture, or Commercialization of the
Licensed Products containing Zalifrelimab in the Field and in the Territory, or
(ii) directly and knowingly cause, assist, support, permit, authorize or
encourage any Third Party in doing any of the foregoing.

 

(ii)

Agenus and its Affiliates shall not enable, authorize or license any Third Party
to take any action that would have the effect of allowing such Third Party to
take any action relating to the [*] that would be prohibited by this Section
11.5(e) if taken by Agenus or its Affiliates.

 

(iii)

If Agenus or any Affiliate asserts any claim or counterclaim or otherwise
participates in any action, suit or proceeding that would be prohibited by this
Section 11.5(e), then Agenus shall, and shall use reasonable efforts to cause
such Affiliate to, (A) withdraw, file a dismissal with prejudice, or take all
actions having similar effect, with respect to any such claim, counterclaim,
action, suit or proceeding [*] of the earlier of (1) Betta’s written request, or
(2) Agenus learning of such claim, counterclaim, action, suit or proceeding, and
(B) if obtained, deliver a copy of such withdrawal or dismissal with prejudice,
or reasonable documentary evidence of any similar action having similar effect,
to Betta [*] period.

11.6

Compliance.

 

(a)

No Debarment. Each Party hereby represents, warrants and covenants (on behalf of
itself and its Affiliates) that it nor any of its Affiliates will not and has
not employed or otherwise used in any capacity the services of any person
debarred in performing any activities under or in connection with this Agreement
under Section 335a of Title 21 of United States Code or by the FDA, or under any
analogous laws under the Applicable Laws or by any Regulatory Authority in the
Territory. Each Party will immediately notify the other Party in writing if any
such debarment occurs or comes to its attention, and will, with respect to any
person or entity so debarred, promptly remove such person or entity from
performing any activities related to or in connection with the Territory
Development Plans or this Agreement.

 

(b)

Data Privacy, Anti-Bribery and Anti-Corruption Compliance.

44

--------------------------------------------------------------------------------

 

(i)

Each Party will implement appropriate processes and controls with respect to
technology and work flow methodologies in connection with its activities under
or in connection with this Agreement so as to protect the security and privacy
of personally identifiable information in accordance with Applicable Law in all
material respects.

 

(ii)

Each Party understands and agrees that it has complied and will continue to
comply with all applicable Anti-Corruption Laws in connection with this
Agreement in all material respects.

 

(iii)

To its best knowledge, each Party represents, warrants and covenants that no
payments of money or anything of value have been or will be offered, promised,
or paid, whether directly or indirectly, by any of its directors, officers,
employees, Affiliates, or Third Party representatives to any Government Official
in connection with this Agreement: (A) to influence any official act or decision
of any Government Official; (B) to induce any Government Official to do or omit
to do any act in violation of lawful duty; (C) to secure any improper business
advantage; (D) to obtain or retain business for, or otherwise direct business
to, any Party; or (E) otherwise in violation of Anti-Corruption Laws, in each
case, in connection with this Agreement.

 

(iv)

To its best knowledge, each Party warrants, represents and covenants that, in
connection with this Agreement, the Party, its Affiliates, directors, officers,
employees, and Third Party representatives: (A) have not and will not request,
accept, offer, promise, or give any bribe, kickback, or other corrupt payment to
any person, including any representative of any commercial entity, in violation
of any applicable Anti-Corruption Law; and (B) have not and will not request,
offer, promise, or give any financial or other advantage to induce another
person to perform a function or activity in order to obtain or retain an
improper business advantage, in each case (A) and (B), in any way relating to
this Agreement.

 

(v)

Except as disclosed on Schedule 11.6(b)(v), to its best knowledge, each Party
represents and warrants that, as of the Effective Date, neither it nor any of
its Affiliates nor any of its or their employees, principals, officers, or
directors are currently Public Officials. If any of such Party’s or its
Affiliates’ or its or their employees, principals, officers, or directors is as
of the Effective Date or thereafter becomes a Public Official during the Term,
such Party shall, upon its knowledge, notify the other Party immediately so that
the other Party may, and hereby reserves the right to, take whatever precautions
and actions may be appropriate to assure compliance with applicable
Anti-Corruption Laws. For the purposes of this Section 11.6(b)(v), “Public
Official” means an officer or employee of a Governmental Body; an officer or
employee of any examination and approval authority; an official of the NMPA; an
official of other applicable food and drug administration; a political party
official; a candidate for political office; or an official of public
international organizations. Betta represents and warrants that, as of the
Effective Date, neither it nor any of its Affiliates are directly or indirectly
majority owned by one or more Governmental Bodies.

 

(vi)

Each Party represents and warrants that no formal or informal proceeding,
investigation, or inquiries by or before any Governmental Body involving such

45

--------------------------------------------------------------------------------

 

Party or its Affiliates or, to the best knowledge of such Party, with respect to
any Anti-Corruption Laws is pending or, to the knowledge of such Party, is
threatened.

 

(vii)

Each Party covenants that it will promptly inform the other Party if such Party,
or any of its directors, officers, employees, Affiliates, Third Party
representatives, or sublicensees becomes subject to any investigation relating
to any actual or potential violation of any applicable Anti-Corruption Law in
connection with this Agreement, including any meeting, interview, inspection, or
audit requested by any Governmental Body, upon such Party becoming aware of the
foregoing.

 

(viii)

Each Party will, and will cause its Affiliates performing activities under this
Agreement to, provide reasonable cooperation in connection with any good faith
investigation conducted by the other Party into potential violations of
applicable Anti-Corruption Laws in connection with this Agreement; provided that
such Party will provide the other Party with a written notice at least [*]
before the initiation of such investigation.

 

(ix)

Each Party will, and will cause its Affiliates performing activities under this
Agreement to, adopt, implement, and/or update and, throughout the course of this
Agreement, have, maintain, and enforce an appropriate and risk-based
anti-corruption compliance program designed to reasonably ensure compliance with
the representations, warranties and covenants contained in this Section 11.6(b)
of the Agreement and all applicable Anti-Corruption Laws. Betta further will
cause the Betta Parties to adopt, implement, and/or update such an
anti-corruption compliance program.

 

(x)

On an annual basis following the execution of this Agreement, or as reasonably
requested [*] by Agenus, Betta agrees to submit a compliance certificate to
Agenus which restates the representations, warranties and covenants that are set
forth in this Section 11.6(b) and provides certification by Betta that it and
its Affiliates performing activities under this Agreement has adhered, during
the period covered by the compliance certificate, to such representations,
warranties and covenants.

 

(xi)

Betta shall, and shall cause its Affiliates performing activities under this
Agreement to, keep for a period no less than [*] separate, standalone, complete
and accurate financial records in sufficient detail to properly reflect
activities undertaken for purpose of this Agreement. Betta undertakes, on behalf
of itself and its Affiliates performing activities under this Agreement, that
all such records are kept such that they can be made available to Agenus in any
audit or review procedure for determining compliance with this Section 11.6
initiated by Agenus. Upon the written request of Agenus, Betta shall, and shall
cause its Affiliates performing activities under this Agreement to, permit an
auditor selected by Agenus to have access during normal business hours to such
records as may be reasonably necessary to verify compliance with this Section
11.6.

 

(xii)

Upon request by Agenus, Betta agrees to, and will cause any Affiliate performing
activities under this Agreement to, participate in periodic anti-corruption
training (including but not limited to Anti-Corruption Law training) conducted
by Agenus or persons selected by Agenus.

 

(xiii)

Betta has received, understands and shall comply, and Betta will ensure that its
Affiliates performing activities under this Agreement have received, understand

46

--------------------------------------------------------------------------------

 

and comply, with Agenus’ anti-corruption compliance codes and policies,
including but not limited to Agenus’s Code of Business Conduct and Ethics and
U.S. Foreign Corrupt Practices Act Compliance Memorandum, both of which are
attached hereto as Schedule 11.6(b)(xiii).

 

(c)

Export Controls. Betta acknowledges that the Licensed IP is subject to the
export control laws of the United States. Betta shall not, and will cause its
Affiliates not to, export, report, or otherwise transfer the Licensed IP in
violation of applicable export control laws. Neither Betta Parties nor any of
their directors, officers, employees, or Affiliates is a Restricted Party. In
relation to the activities contemplated by this Agreement, Betta Parties shall
not (a) engage in any dealings or transactions, directly or indirectly, with or
for the benefit of any Restricted Party; (b) violate applicable economic
sanctions or export control laws; or (c) take, or refrain from taking, any
action that foreseeably would cause Agenus to be in violation of applicable
sanctions or export control laws.

11.7

CFIUS. Notwithstanding anything to the contrary in this Agreement, the Stock
Purchase Agreement executed on or about the date hereof, or any other agreement
between the Parties (collectively, the “Transaction Agreements”), Betta shall
neither be permitted nor seek (a) control rights (as defined in 31 C.F.R. §
800.208) in respect of Agenus or any Agenus subsidiary; (b) membership or
observer rights on, or the right to nominate an individual to a position on, the
board of directors or equivalent governing body of Agenus or any Agenus
subsidiary; (c) access to any material nonpublic technical information in the
possession of Agenus or any Agenus subsidiary; or (d) involvement, other than
through voting of shares, in substantive decision making of Agenus or any Agenus
subsidiary regarding: (i) the use, development, acquisition, safekeeping, or
release of sensitive personal data of U.S. citizens maintained or collected by
Agenus or any Agenus subsidiary; (ii) the use, development, acquisition, or
release of critical technologies; or (iii) the management, operation,
manufacture, or supply of covered critical infrastructure (in each case of
(b)-(d), within the meaning of 31 C.F.R. § 800.211(b)). Betta hereby waives any
such rights related to the foregoing to which it may be entitled under the
Transaction Agreements or otherwise.

11.8

DISCLAIMER OF WARRANTIES. EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH PARTY
DISCLAIMS ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR THAT ANY LICENSED
ANTIBODY AND/OR LICENSED PRODUCT DEVELOPED, MANUFACTURED AND/OR COMMERCIALIZED
UNDER THIS AGREEMENT IS FREE FROM THE RIGHTFUL CLAIM OF ANY THIRD PARTY, BY WAY
OF INFRINGEMENT OR THE LIKE, OR THAT ANY PATENT RIGHTS LICENSED HEREUNDER WILL
ISSUE OR BE VALID OR ENFORCEABLE. NEITHER PARTY CAN OR DOES GUARANTEE THAT ANY
LICENSED ANTIBODIES AND/OR LICENSED PRODUCTS WILL BE SUCCESSFULLY DEVELOPED,
MANUFACTURED AND/OR COMMERCIALIZED.

ARTICLE 12.

exclusion of consequential damages

12.1

SUBJECT TO SECTION 12.2, NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY OR SUCH
OTHER PARTY’S AFFILIATES, FOR ANY INJURY TO OR LOSS OF GOODWILL, REPUTATION,
BUSINESS, PRODUCTION, REVENUES, PROFITS, ANTICIPATED PROFITS, CONTRACTS, OR
OPPORTUNITIES (REGARDLESS OF HOW THESE ARE CLASSIFIED AS DAMAGES), OR FOR ANY
CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY, SPECIAL, PUNITIVE, OR ENHANCED
DAMAGES WHETHER ARISING OUT OF BREACH OF CONTRACT, TORT (INCLUDING

47

--------------------------------------------------------------------------------

NEGLIGENCE), STRICT LIABILITY, PRODUCT LIABILITY, OR OTHERWISE (INCLUDING THE
ENTRY INTO, PERFORMANCE, OR BREACH OF THIS AGREEMENT), REGARDLESS OF WHETHER
SUCH LOSS OR DAMAGE WAS FORESEEABLE OR THE PARTY AGAINST WHOM SUCH LIABILITY IS
CLAIMED HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGE, AND
NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL
PURPOSE.

12.2

Nothing in this ARTICLE 12 or any other provision of this Agreement will limit
any Party’s (a) obligations of indemnity for [*] as provided in ARTICLE 13, or
(b) liability for claims arising from such Party’s, its Affiliates’,
sublicensees’, or Third Party contractors’ gross negligence, willful misconduct
or breach of ARTICLE 8, ARTICLE 9, or Section 11.6.

ARTICLE 13.

INDEMNIFICATION

13.1

Indemnification by Betta. Betta will indemnify, defend and hold harmless Agenus,
its Affiliates, and their respective directors, officers, employees and agents
(collectively, “Agenus Indemnitees”) from and against any and all claims,
demands, judgments, losses, damages, liabilities, costs and expenses (including
reasonable attorneys’ fees and expenses) (collectively, “Liabilities”) arising
out of or in connection with any and all [*].

13.2

Indemnification by Agenus. Agenus will indemnify, defend and hold harmless
Betta, its Affiliates, and their respective directors, officers, employees and
agents (collectively, “Betta Indemnitees”) from and against any and all
Liabilities arising out of or in connection [*].

13.3

Procedures. In the event that any Party intends to claim indemnification under
this ARTICLE 13 with respect to a Liability, it will promptly notify the other
Party in writing of any such alleged Liability. The indemnifying Party will have
the right to control the defense thereof with counsel of its choice; provided,
however, that the indemnified Party will have the right to retain its own
counsel, with the fees and expenses to be paid by the indemnifying Party, if
representation by the counsel retained by the indemnifying Party would be
inappropriate due to actual or potential differing interests between the Parties
in such proceeding. The affected Indemnitees will, upon request, cooperate
reasonably with the indemnifying Party and its legal representatives in the
investigation and defense of any action, claim or liability covered by this
ARTICLE 13. Neither Party may settle any claim or action related to a Liability
without the consent of the other Party, if such settlement would (a) impose any
monetary obligation on the other Party (unless the indemnifying Party agreed to
be solely responsible for such monetary obligation), (b) constitute an admission
of guilt or wrong-doing by the other Party, or (c) require the other Party to
submit to an injunction or otherwise limit the other Party’s rights under this
Agreement. Any payment made by the indemnified Party to settle any such claim or
action without the indemnifying Party’s consent will be at indemnified Party’s
own cost and expense.

13.4

Insurance. Each Party will procure and maintain for itself and its Affiliates
during the Term and for a period of [*] thereafter, insurance policies,
including product liability insurance and clinical trial insurance, [*]. Upon
request, each Party will provide the other Party with a certificate of insurance
evidencing the coverage required under this Section 13.4. Each Party will
provide the other Party with prompt written notice of cancellation, non-renewal
or material change in such insurance, and will provide such notice within [*]
after any such cancellation, non-renewal or material change. Each Party will
impose substantially identical obligations on its Affiliates (to the extent not
named insureds under such Party’s coverages) and Sublicensees. It is understood
and agreed that the insurance provided under this Section 13.4 will not be
construed to limit either Party’s liability with respect to its indemnification
or other obligations hereunder.

48

--------------------------------------------------------------------------------

ARTICLE 14.

MISCELLANEOUS

14.1

Governing Law. This Agreement (and any claims or disputes arising out of or
related thereto or to the transactions contemplated thereby or to the inducement
of any Party to enter therein, whether for breach of contract, tortious conduct,
or otherwise and whether predicated on common law, statute or otherwise) will in
all respects be governed by and construed in accordance with the laws of the
State of New York, USA, including all matters of construction, validity and
performance, in each case without reference to any conflict of law rules that
might lead to the application of the laws of any other jurisdiction.

14.2

Dispute Resolution.

 

(a)

Referral of Disputes to the Parties’ Executive Officers. In the event of any
dispute between the Parties arising out of or in connection with this Agreement,
either Party may, by written notice to the other, have such dispute referred to
the Executive Officers for attempted resolution [*].

 

(b)

Arbitration. Subject to Section 14.2(d), any dispute, controversy or claim
arising out of or relating to this Agreement, including the existence,
negotiation, validity, formation, interpretation, breach, performance or
application of this Agreement will be settled by binding arbitration
administered by the AAA in accordance with its Commercial Arbitration Rules (or
the AAA International Arbitration Rules, if recommended under the AAA
guidelines), as such rules may be modified by this Section 14.2(b) or otherwise
by subsequent written agreement of the Parties. The number of arbitrators will
be three (3), of whom the Parties will select one (1) each. The two arbitrators
so selected will select the third (3rd) and final arbitrator. If the arbitrators
selected by the Parties are unable or fail to agree upon the third arbitrator,
the AAA will select the third arbitrator. The place of arbitration will be New
York City, New York, and all proceedings and communications will be in English.
The Parties will have the right to be represented by counsel. Any judgment or
award rendered by the arbitrators will be final and binding on the Parties. The
Parties agree that such judgment or award may be enforced in any court of
competent jurisdiction.

 

(c)

Preliminary Injunctions. Notwithstanding anything to the contrary, a Party may
seek a temporary restraining order or a preliminary injunction from any court of
competent jurisdiction in order to prevent breach or threatened breach of the
scope of the License, ARTICLE 8, ARTICLE 9, Section 11.4(a), Section 11.4(c), or
any other immediate and irreparable injury, loss, or damage on a provisional
basis, pending the decision of the arbitrator(s) on the ultimate merits of any
dispute.

 

(d)

Patent and Trademark Disputes. [*].

 

(e)

Confidentiality. All proceedings and decisions of the arbitrator(s) in
connection with an arbitral proceeding pursuant to this Section 14.2 will be
deemed Confidential Information of each of the Parties and will be subject to
ARTICLE 9.

49

--------------------------------------------------------------------------------

 

14.3

Assignment; Affiliates.

 

(a)

Neither Party may assign its rights and obligations under this Agreement without
the prior written consent of the other Party, except that either Party may make
such assignment, in whole or in party, without the prior written consent of the
other Party to an Affiliate (so long as such Affiliate remains an Affiliate of
such Party). The assigning Party will remain jointly and severally liable with
such Affiliate with respect to all obligations so assigned. Any purported
assignment in contravention of this Section 14.3 will, at the option of the
non-assigning Party, be null and void and of no effect. No assignment will
release either Party from responsibility for the performance of any accrued
obligation of such Party hereunder. This Agreement will be binding upon and
enforceable against the successor to or any permitted assignee from either of
the Parties.

 

(b)

Each Party agrees that, notwithstanding any provisions of this Agreement to the
contrary, including the definition of “Affiliate” in Section 1.2:

 

(i)

Agenus may assign this Agreement in whole or in part to a Third Party in
connection with a Change in Control, subject to Section 14.3(b)(ii).

 

(ii)

In the event that this Agreement is assigned by Agenus in connection with a
Change in Control or Agenus otherwise undergoes a Change in Control, Betta will
not be entitled to any rights or access to Patent Rights or Know-How of the
assignee or acquirer of Agenus, or of any Person who was an Affiliate of such
assignee or acquirer immediately prior to such Change in Control to the extent
that such Patent Rights or Know-How were Controlled by such Person immediately
prior to the consummation of such Change in Control.

14.4

Entire Agreement; Amendments. This Agreement and the exhibits referred to in
this Agreement constitute the entire agreement between the Parties with respect
to the subject matter hereof, and supersede all previous arrangements with
respect to the subject matter hereof, whether written or oral, including (a) the
terms of that certain Confidential Disclosure Agreement, dated as of February 8,
2018, and (b) the binding terms of that certain Agenus-Betta Pharmaceuticals
Non-Binding Term Sheet for Balstilimab and Zalifrelimab Term Sheet, dated as of
April 26, 2020 (together, the “Prior Agreements”). Upon execution of this
Agreement by both Parties hereto, all surviving provisions of the Prior
Agreements are and will be null and void and of no further effect; provided that
a Party’s confidential information under the Prior Agreements will be deemed
Confidential Information under this Agreement. Any amendment or modification to
this Agreement will be made in writing signed by both Parties.

14.5

Notices. All communications, notices, instructions and consents provided for
herein or in connection herewith will be made in writing and be sent to the
address below and will be (a) given in person, (b) sent by registered or
certified mail, return receipt requested, postage prepaid, (c) sent by a
reputable international overnight courier service or (d) sent by electronic mail
or facsimile. Any such communication, notice, instruction or consent will be
deemed to have been delivered: (i) on receipt if given in person; (ii) [*] after
it is sent by registered or certified airmail, return receipt requested, postage
prepaid within the same country or region as the recipient’s address or [*]
after it is sent by registered or certified airmail, return receipt requested,
postage prepaid from another country or region; (iii) [*] after it is sent via a
reputable international overnight courier service; or (iv) upon confirmation of
receipt if sent by electronic mail or facsimile.

Notices to Betta will be addressed to:

 

50

--------------------------------------------------------------------------------

Betta Pharmaceuticals Co. Ltd.

No. 355 Xingzhong Rd. Yuhang District. Hangzhou.

PRC 311100

Attention: Chief Executive Officer

Email: [REDACTED]

Telephone: [REDACTED]

 

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

 

PacGate Law Group

Suite 5501, 55th Floor, Fortune Financial Center, 5 East 3rd Ring Rd., Chaoyang
District,

Beijing, 100020, China

Attention: Eric He

E-mail address: [REDACTED]

 

 

Notices to Agenus will be addressed to:

 

Agenus Inc.

3 Forbes Road

Lexington, Massachusetts 02421-7305, USA

Attention: Chief Executive Officer

Copy to: Legal Department

E-mail address: [REDACTED]

 

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

 

Ropes & Gray LLP

36F, Park Place 1601 Nanjing Road West

Shanghai 200040, China

Attention: Geoffrey Lin

E-mail address: [REDACTED]

 

provided, however, that if either Party will have designated a different address
by notice to the other Party in accordance with this Section 14.5, then to the
last address so designated.

 

14.6

Force Majeure. Failure of any Party to perform its obligations under this
Agreement (except the obligation to make payments when properly due to the
extent a Force Majeure Event does not materially affect such Party’s ability to
make such payments) will not subject such Party to any liability or place them
in breach of any term or condition of this Agreement to the other Party to the
extent (and only to the extent) that such failure is due to fire, explosion,
flood, drought, war, terrorism, riot, sabotage, embargo, strikes or other labor
trouble, failure of suppliers, a national health emergency (including a pandemic
and epidemic), compliance with any order or regulation of any government entity
acting with color of right, or any other cause beyond the reasonable control of
such nonperforming Party and which is not caused by the negligence, intentional
conduct or misconduct of the non-performing Party (each such event or cause
referred to as “Force Majeure Event”). The Party affected will promptly notify
the other Party of the Force Majeure Event and will exert reasonable diligent
efforts to eliminate, cure or overcome any such Force Majeure Event and to
resume performance of its obligations with all possible speed. If a Force
Majeure Event exists for more than [*], the non-affected Party may terminate
this Agreement on an additional [*] written notice to the affected Party.
Notwithstanding the foregoing, the Parties agree that the SARS-

51

--------------------------------------------------------------------------------

CoV-2 / COVID-19 pandemic will not constitute a Force Majeure Event with respect
to Betta’s obligation to pay Agenus [*].

14.7

Use Of Names, Logos Or Symbols. Subject to Section 6.2(b) and ARTICLE 9, and
other than use of a Party’s name, trademarks, trade names in materials prepared
in connection with a bona fide actual or prospective loan, financing or
investment, for which each Party hereby grants the other Party a non-exclusive,
limited right to use, no Party will use the name, trademarks, trade names,
physical likeness, employee names or owner symbol of the other Party for any
purpose, including private or public securities placements, without the prior
written consent of the affected Party. Nothing contained in this Agreement,
except Section 6.2(b) and this Section 14.7, will be construed as granting
either Party any rights or license to use any of the other Party’s trademarks,
trade names or the names of any employees thereof, without separate, express
written permission of the owner of such trademark, trade name or name.

14.8

Independent Contractors. It is understood and agreed that the relationship
between the Parties is that of independent contractors and that nothing in this
Agreement will be construed to create a joint venture or any relationship of
employment, agency or partnership between the Parties to this Agreement. Neither
Party is authorized to make any representations, commitments or statements of
any kind on behalf of the other Party or to take any action that would bind the
other Party. Furthermore, none of the transactions contemplated by this
Agreement will be construed as a partnership for any tax purposes.

14.9

No Implied Waivers; Rights Cumulative. No failure on the part of a Party to
exercise, and no delay by either Party in exercising, any right, power, remedy
or privilege under this Agreement, or provided by statute or at law or in equity
or otherwise, will impair, prejudice or constitute a waiver of any such right,
power, remedy or privilege by such Party or be construed as a waiver of any
breach of this Agreement or as an acquiescence therein by such Party, nor will
any single or partial exercise of any such right, power, remedy or privilege by
a Party preclude any other or further exercise thereof or the exercise of any
other right, power, remedy or privilege.

14.10

Severability. If, under Applicable Law, any provision of this Agreement is
invalid or unenforceable, or otherwise directly or indirectly affects the
validity of any other material provision(s) of this Agreement, this Agreement
will endure except for such invalid or unenforceable provision. The Parties will
consult one another and use good faith efforts to agree upon a valid and
enforceable provision that is a reasonable substitute in view of the intent of
this Agreement.

14.11

Execution In Counterparts. This Agreement may be executed in any number of
counterparts, each of which will be deemed an original, and all of which
together will constitute one and the same instrument. Signatures provided by
facsimile transmission or in Adobe™ Portable Document Format (.pdf) sent by
electronic mail will be deemed to be original signatures.

14.12

No Third Party Beneficiaries. No Person other than Betta and Agenus (and their
respective successors and permitted assignees) will be deemed an intended
beneficiary hereunder or have any right to enforce any obligation of this
Agreement.

14.13

Performance by Affiliates. Either Party may use one or more of its Affiliates to
perform its obligations and duties hereunder and Affiliates of a Party are
expressly granted certain rights herein; provided that each such Affiliate will
be bound by the corresponding obligations of such Party and the Parties will
remain liable hereunder for the prompt payment and performance of all their
respective obligations hereunder.

52

--------------------------------------------------------------------------------

14.14

Exhibits. In the event of inconsistencies between this Agreement and any exhibit
hereto, the terms of this Agreement will control.

14.15

Language. This Agreement is in the English language only, which language will be
controlling in all respects, and all versions hereof in any other language will
be for accommodation only and will not be binding upon the Parties. Unless
otherwise expressly provided, all communications and notices to be made or given
pursuant or relating to this Agreement, and any dispute proceeding related to or
arising hereunder, will be in the English language. If there is a discrepancy
between any translation of this Agreement and this Agreement, this Agreement
will prevail.

14.16

Construction. In construing this Agreement, unless expressly specified
otherwise:

 

(a)

headings and titles are for convenience only and do not affect the
interpretation of this Agreement;

 

(b)

any list or examples following the word “including” will be interpreted without
limitation to the generality of the preceding words;

 

(c)

the terms “hereof”, “hereto”, “hereby”, “herein” and “hereunder” and words of
similar import when used in this Agreement refer to this Agreement as a whole
and not to any particular provision of this Agreement;

 

(d)

references to a Person are also to its successors, heirs and permitted assigns;

 

(e)

except if Business Days are specified, “day” refers to a calendar day;

 

(f)

if a period of time is specified and dates from a given day or Business Day, or
the day or Business Day of an act or event, it is to be calculated exclusive of
that day or Business Day;

 

(g)

references to a law include any amendment or modification to such law and any
rules or regulations issued thereunder, whether such amendment or modification
is made, or issuance of such rules or regulations occurs, before or, only with
respect to events or developments occurring or actions taken or conditions
existing after the date of such amendment, modification or issuance, after the
Effective Date, but only to the extent such amendment or modification, to the
extent it occurs after the date hereof, does not have a retroactive effect;

 

(h)

all references to “Dollars” or “$” herein will mean U.S. Dollars;

 

(i)

the word “will”, when used to indicate an obligation of a Person, will be
construed to have the same meaning and effect as the word “shall” and

 

(j)

each Party represents that it has been represented by legal counsel in
connection with this Agreement and acknowledges that it has participated in the
drafting hereof. In interpreting and applying the terms and provisions of this
Agreement, the Parties agree that no presumption will apply against the Party
which drafted such terms and provisions.

[signature page follows]

 

53

--------------------------------------------------------------------------------

 

 

 

IN WITNESS WHEREOF the Parties, intending to be bound hereby, have caused their
duly authorized representatives to execute this Agreement as of the Effective
Date.

 

BETTA PHARMACEUTICALS CO. LTD.

 

 

/s/ Lieming Ding

Name: Lieming Ding

Title: Chairman & CEO

 

 

AGENUS INC.

 

 

/s/ Garo H. Armen

Name:  Garo H. Armen

Title:    Chairman & CEO