Exhibit 10.1

 

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission.

***Triple asterisks denote omissions.

 

EXCLUSIVE LICENSE AGREEMENT

 

This Exclusive License Agreement (“Agreement”), effective as of June 15, 2019
(Beijing Time, “Effective Date”), is entered into between:

 

(i)Juventas Cell Therapy Ltd., a company duly organized and existing under the
laws of PRC, having its principal office at Building 5, No.8, No.8, Haitai
Development, Huayuan Industrial Zone, Tianjin Binhai High-tech Zone, Tianjin
City, China (hereinafter referred to as “Juventas” or the “Licensor”, which,
unless contrary to the context or meaning thereof, shall include its successors
and assigns); and

(ii)CASI Pharmaceuticals, Inc., a company duly organized and existing under the
laws of Delaware, having its principal office at 9620 Medical Center Drive,
Suite 300, Rockville, Maryland 20850 (hereinafter referred to as “CASI” or the
“Licensee”, which, unless contrary to the context or meaning thereof, shall
include permitted successors and assigns).

 

(Juventas and CASI are each referred hereto as a “Party” and both the
“Parties”.)

 

RECITALS

 

A.           Licensor has acquired, developed and/or accumulated patents,
proprietary technology or formulas, clinical data, know-how and other
confidential information related to the development and manufacturing of one
developed candidate autologous T-cell therapy product with a scFv specifically
binding to CD19.

 

B.           Licensor owns or has the right to license the information,
including the patents, proprietary technology and formulas, clinical data,
know-how and other confidential information associated with the Licensed Product
(as defined below).

 

C.           Licensee desires to obtain, and Licensor has agreed to grant, a
license to offer for sale, market, distribute and sell (collectively,
“Commercialize” or “Commercialization”) the Licensed Product as more
particularly described herein.

 

D.           Subject to the terms and conditions as more particularly described
herein, Juventas or its designated manufacturer will be the exclusive
manufacturer and supplier of the Licensed Product for CASI.

 

AGREEMENT

 

NOW, THEREFORE, in consideration of the foregoing preliminary statements, the
mutual agreements and covenants set out herein, and other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
Parties hereby agree as follows:

 

 1 

 

 

Section I.

Definitions

 

As used in this Agreement, the following capitalized terms shall have the
following meanings:

 

1.1          “Affiliate” means any Person that directly or indirectly controls,
is controlled by or is under common control with a person or entity, but only
for so long as said control shall continue. As used herein, the term “control”
or “controlled by” means: (a) ownership, directly or indirectly, of more than
50% of the voting securities of the applicable party; or (b) possession of the
power to direct or cause the direction of the business, management and policies
of a person whether by ownership, contract or otherwise. Solely for the purpose
of defining “Affiliate” herein, Juventas shall not be deemed as an Affiliate of
CASI.

 

1.2          “Annual Net Sales” means total Net Sales of the Licensed Product in
a particular Calendar Year.

 

1.3          “Calendar Quarter” means a period of three (3) consecutive months
ending on the last day of March, June, September, or December, respectively.

 

1.4          “Commercially Reasonable Efforts” means, with respect to the
efforts to be exerted by a Party to achieve any objective, the reasonable
efforts to accomplish such objective as a similarly situated party in the
pharmaceutical industry would normally use to accomplish a similar objective in
its own interests under similar circumstances.

 

1.5          “Change of Control” means (a) any Person becomes the beneficial
owner, directly or indirectly, of 50% or more of the outstanding equity
interests of a Party, or (b) a Party ceases to own and control, of record and
beneficially, more than 50% of each class of outstanding voting equity interests
of the Party.

 

1.6          “Chairperson” means the chairperson of the JSC or JDC as defined in
Section 4.2 and Section 4.6.

 

1.7          “China Territory” means the People’s Republic of China, and for the
purpose of defining “China Territory” only, including Macau and Taiwan and Hong
Kong.

 

1.8          “Clinical Development” means a human clinical trial of a compound
or product for an indication as required prior to the market of a medical
product.

 

1.9          “CMC” means the regulatory submission for Chemistry, Manufacturing,
and Controls of the Licensed Product as required by the FDA, the EMEA or the
NMPA prior to and during the clinical trials in humans or any comparable
submissions to any Governmental or Regulatory Authority within the Territory.

 

1.10        “Commercialize” or “Commercialization” has the meaning given to such
term in Recitals of this Agreement.

 

 2 

 

 

1.11         “Cost of Goods” or “COGS” means Juventas’ (and/or its contract
manufacturer’s) costs of (i) materials, excipients, packaging and labeling
material (including package insert); (ii) direct line costs, including direct
labor of employees (including basic wages, labor and related payroll taxes and
benefits) incurred or spent in the actual production, filling, packaging and
labeling of the Licensed Product, including without limitation for quality
assurance, purchasing and manufacturing facility operations; (iii) overhead
(including operating expenses, indirect labor and related payroll taxes and
benefits, depreciation, amortization, taxes, insurance, rent, equipment repairs
and maintenance, energy costs and supplies) incurred or spent in support of the
actual production, filling, packaging and labeling of the Licensed Product; and

(iv) any other costs with respect to the manufacture of the Licensed Product.

 

1.12        “Commercialization Plan” has the meaning given to such term in
Section 3.8 of this Agreement

 

1.13        “EMEA” means the European Medicines Agency, or any successor entity
thereto.

 

1.14        “Ex-China Territory” means the rest of the world outside the China
Territory.

 

1.15        “Field” means all therapeutic uses of the Licensed Product.

 

1.16        “FDA” means the U.S. Food and Drug Administration, or any successor
entity thereto.

 

1.17        “First Commercial Sale” means the first sale of the Licensed Product
in any part of the Territory after Regulatory Approval for the Licensed Product
has been granted, or otherwise permitted, by a Regulatory Authority of the
Territory such as NMPA. For the avoidance of doubt, the First Commercial Sale
does not include any sale or supply of any product for the sole purpose of
clinical trials.

 

1.18        “GMP” means current Good Manufacturing Practices as defined in Parts
210 and 211 of Title 21 of the U.S. Code of Federal Regulations, as may be
amended from time to time, or any successor thereto and foreign equivalents
thereof, including, where referring to activities in China, the Guidelines on
Good Manufacturing Practices specific to the Licensed Product, or such practices
as may be as otherwise required by the NMPA, including under the Quality
Administrative Standard for Drug Manufacturing as well as any requirements
issued pursuant to the Regulation of Drug Manufacturing Administrative
Procedures issued by the NMPA.

  

1.19        “GMP Manufacturing Facility” means any manufacturing facility that
meets the GMP.

  

1.20        “Governmental or Regulatory Authority” means: (a) the National
Medical Products Administration of the People’s Republic of China (the “NMPA”)
and any other national, federal, provincial, state, municipal or other
governmental body, (b) any international or multi- lateral body, (c) any
subdivision, ministry, department, secretariat, bureau, agency, commission,
board, instrumentality or authority of any of the foregoing governments or
bodies, (d) any quasi- governmental or private body exercising any regulatory,
expropriation or taxing authority under or for any of the foregoing governments
or bodies, or (e) any international, multi-lateral or multi-national judicial,
quasi-judicial, arbitration or administrative court, grand jury, tribunal,
commission, board or panel.

 

 3 

 

 

1.21        “IND” means any investigational new drug application filed with the
FDA, the EMEA or the NMPA prior to beginning clinical trials in humans or any
comparable application filed with any Governmental or Regulatory Authority
within the Territory.

 

1.22        “Intellectual Property” means all registered patents, patent
applications, inventions or discoveries (whether or not patentable), copyrights,
copyright applications, domain names, Licensed Product specifications, data,
trade secrets, trade dress, know-how and all other intellectual property rights,
and all related documentation or other tangible expressions thereof, including
the proprietary information set forth on Exhibit A attached hereto as will be
updated from time to time, which are necessary to the Commercialization of the
Licensed Product in the Territory, but excluding any intellectual property
solely relating to the development and manufacture of the Licensed Product.

 

1.23        “Improvements” means any inventions, discoveries, know-how, clinical
data or other proprietary information related to any Licensed Product created,
generated or acquired by either Party during the Term of this Agreement.

 

1.24        “JDC” has the meaning given to such term in Section 4.5 of this
Agreement

 

1.25        “JSC” has the meaning given to such term in Section 4.1 of this
Agreement

 

1.26        “Laws” means: (a) all constitutions, treaties, laws, statutes,
codes, ordinances, guidance, orders, decrees, rules, regulations, and municipal
by-laws, (b) all judgments, orders, writs, injunctions, decisions, rulings,
decrees and awards of any governmental, regulatory or judicial authority, and
(c) all policies, practices and guidelines of any governmental or regulatory
authority.

 

1.27        “Licensor Product Liability Claims” means all Product Liability
Claims that arise in the Territory and are attributable to the activities
conducted by the Licensor with regard to the Licensed Product.

 

1.28        “Losses” means any and all claims, liabilities, losses, damages,
fees, penalties, judgments, awards, interest, costs and expenses (including,
without limitation, reasonable attorneys’ fees and expenses and court’s costs)
incurred by a Party to this Agreement, or any Affiliate thereof, resulting from
a third party Proceeding against either Party.

 

1.29        “NDA” means a New Drug Application filed with the FDA, the EMEA, and
the NMPA to obtain approval for commercial sale or use of the Licensed Product
as a pharmaceutical or medicinal product in any formulation or dosage form
(excluding any pricing and reimbursement approvals) or any comparable
application filed with any Governmental or Regulatory Authority within the
Territory.

 

1.30        “Net Sales” means the gross amount invoiced for sales of the
Licensed Product by Licensee, or Affiliates or its permitted sublicensee to any
Third Party in the Territory, less the following amounts: (i) sales taxes or
other taxes separately stated on the Licensed Product invoice; (ii) shipping and
insurances charges separately stated on the Licensed Product invoice; and (iii)
price adjustments, credits, refunds or deductions for returned or defective
Licensed Product, all to the extent reasonably demonstrated by CASI by written
records, provided that such calculation is not in violation of the Generally
Accepted Accounting Principles (GAAP) of the United States. Notwithstanding
anything in this Agreement to the contrary, the transfer of the Licensed Product
between or among CASI and any of its Affiliates and sublicensees will not be
considered a sale.

 

 

 4 

 

 

1.31        “Non-Royalty Sublicense Income” means any and all payments received
from a sublicense by CASI, in consideration of the grant of a sublicense,
including but not limited to upfront and milestone payments, license maintenance
fees and the fair market value of any non- cash consideration, but excluding
payments made by a sublicensee as a royalty on Net Sales of the Licensed Product
sold by such sublicensee.

 

1.32        “Proceedings” means claims, suits, actions, investigations or
proceedings.

 

1.33        “Person” means an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock company,
joint venture, pool, syndicate, sole proprietorship, unincorporated
organization, governmental authority or any other form of entity not
specifically listed herein.

 

1.34        “Licensed Product” means one developed candidate autologous T-cell
therapy product with a scFv specifically binding to CD19, which is identified by
Juventas as an internal reference number CNCT19.

 

1.35        “PRC” means People’s Republic of China, but for the purpose only of
this Agreement, shall exclude Hong Kong Special Administrative Region, Macau
Special Administrative Region and Taiwan.

 

1.36        “Phase II Clinical Trial” means a human clinical trial of a compound
or product for an indication conducted in the PRC, the principal purpose of
which is a determination of safety and efficacy for such indication or
indications in a target patient population over a range of doses and to provide
the rational and provide the basis for the design of phase III clinical trial
studies and the determination of dosing regimens, as more fully defined in
Article 31 of Provisions for

Drug Registration (2007 Revision) (《药品注册管理办法(2007修订)》, or its successor
regulation.

 

1.37        “Product Liability Claim” means any third-party Proceedings
involving any actual or alleged death or bodily injury arising out of or
resulting from the use of Licensed Product.

 

1.38        “Regulatory Approval” means approval or registration by any
Governmental or Regulatory Authority in the Territory as necessary for the
manufacturing, distribution, promotion and sale of the Licensed Product or
otherwise permitting the manufacture or sale of the Licensed Product.

 

1.39        “R&D Plan” has the meaning given to such term in Section 3.7 of this
Agreement.

 

 5 

 

 

1.40        “Restricted Products” has the meaning given to such term in Section
2.8 of this Agreement.

 

1.41        “Supply Agreement” has the meaning given to such term in Section 5.1
of this Agreement.

 

1.42        “Territory” means worldwide.

 

1.43        “Term” has the meaning given to such term in Section 8.1 of this
Agreement.

 

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

 

1.45        “Trademark” means any word, phrase, slogan, design, symbol or
product packaging used or intended to be used to identify the Licensed Product
or distinguish it from competitive or related products. For clarification, the
“Licensor Trademarks” means “合源生物” and “Juventas” and any other trademarks,
logos or branding used by Licensor in connection with the Licensed Product.

 

Section II.

Grant of Exclusive License

 

2.1          Grant of License.

 

(a)          Exclusivity. Subject to the terms and conditions set forth herein,
Licensor hereby grants to Licensee during the Term, an exclusive license (the
“License”) in the Field in the Territory under the Intellectual Property and
Improvements solely to Commercialize the Licensed Product. During the Term of
this Agreement, Licensor and its Affiliates shall not by themselves or through a
third party to Commercialize any Licensed Product. For the sake of clarity,
Juventas has no obligation to provide CASI with any information or material that
is not necessary for Commercialization of the Licensed Product and Parties agree
that Juventas retains the right to use the Intellectual Property to develop and
Commercialize any product other than Licensed Product.

 

(b)          Responsibility of Commercialization. CASI shall use Commercially
Reasonable Efforts, including the use of third-party experts and external
consultants at its own cost, to Commercialize the Licensed Product in the
Territory in which necessary approvals from Governmental or Regulatory
Authorities in such region have been obtained by Juventas for the
Commercialization of the Licensed Product.

 

(c)          Right of First Negotiation. The Parties acknowledge and agree that
during the Term of this Agreement, if one combination of the Licensed Product
with other active drug ingredients will result in a new product from a
regulatory point of view and Juventas intends to grant any third party the
Commercialization rights of such new product, CASI shall have the first right to
negotiate for any Commercialization rights in and to such new product in the
Territory in terms and conditions to be further negotiated by the Parties. In
the event the Parties are unable to reach an agreement on terms within sixty
(60) days from the date that Licensor notifies Licensee that such new product
are available in the Territory, then Licensor may offer such rights in and to
such new product in the Territory to a third party, provided that the terms and
conditions offered to the third party shall not be more favorable than those
offered to Licensee. If Licensor desires to offer such rights to new product on
more favorable terms than those last offered to Licensee, Licensor shall first
offer such terms for the new product to Licensee as set forth herein and the
negotiation period of sixty (60) days shall be renewed and recalculated.

 

 6 

 

 

2.2          Trademarks.

 

(a)          Juventas grants to CASI an exclusive license to use the Licensor
Trademarks in the Territory and solely in connection with the Licensed Product.
CASI shall use the Licensor Trademarks solely in connection with its
Commercialization of the Licensed Product in the Territory. All use of the
Licensor Trademarks by CASI will inure to the purpose of this Agreement. CASI
shall not register or attempt to register any of the Licensor Trademarks in any
jurisdiction in the Territory, or otherwise, without the prior written consent
of Juventas, and in the event that CASI does register any of the Licensor
Trademarks in the Territory (the “Territory Trademarks”), such Territory
Trademarks that are identical to, similarly confusing with or use the Licensor
Trademarks shall be transferred and assigned to Juventas upon expiration or
termination of this Agreement or its earlier request. However, for clarity
purpose, this Section 2.2 does not restrict CASI from developing, creation,
registering or using its own trademarks solely to indicate CASI as a distributor
of the Licensed Product. CASI’s use of the Licensor Trademarks shall comply with
laws and regulations related to labeling and advertising in the Territory and
other applicable Laws.

 

2.3          Right to Sublicense. Licensee shall have the right to sublicense
the licensed rights to its Affiliates, distributors and/or sublicensees or
non-affiliates provided that the Licensor’s prior written consent has been
obtained, which consent shall not be unreasonably withheld. In the event that
Licensee engages any Affiliate, distributor and/or sublicensee in connection
with the Commercialization of the Licensed Product(s), such Affiliate,
distributor and/or sublicensee shall have the right to use the License and the
Licensor Trademarks subject to the terms and conditions herein and solely in
connection with the Licensed Product.

 

2.4          Ownership and Preservation. Licensor retains ownership of, and all
other rights to, the Intellectual Property. Licensor shall use Commercially
Reasonable Efforts to preserve and maintain the Intellectual Property in the
Territory and shall pay any periodic filing or administrative fees associated
therewith. Licensor shall keep Licensee informed regarding the prosecution and
maintenance of licensed patents or patent applications in the Territory, if any,
included in the licensed Intellectual Property. In addition, if the Licensor
fails to preserve or maintain the Intellectual Property in the Territory and
refuses to preserve or maintain the Intellectual Property after receipt of
reminder of Licensee, Licensee may, at its own discretion and cost, take all
necessary actions to ensure such preservation and maintenance.

 

2.5          Improvements. Parties agree that all right, title and interest in
and to the Improvements shall be the sole and exclusive property of Juventas.
CASI shall, and shall cause their employees to make full and prompt disclosure
to Juventas of all Improvements. CASI hereby assign and transfer, without
additional consideration, to Juventas all right, title and interest that CASI
and their employees may have in and to any and all Improvements throughout the
world. CASI shall and shall cause their employees to timely execute, or cause to
be executed, all papers necessary to effect and perfect the assignment and
transfer of all right, title and interest that CASI and their employees may have
in and to any and all Improvements to Juventas.

 

 7 

 

 

2.6          For the avoidance of doubt, nothing in this Agreement shall be
construed to confer any rights upon CASI to modify or reversely engineer the
Licensed Product. Without prior written consent of Juventas, CASI shall not
further develop or file regulatory filing for the Licensed Product. Any and all
information, materials, data and results developed by CASI in violation of this
provision shall be solely owned by Juventas.

 

2.7          Conversion to No-exclusive. Despite anything to the contrary in
this Agreement, any exclusive license granted under this Agreement will
immediately become non-exclusive and any rights to sublicense will immediately
terminate only if [***]. Determinations of total market share shall be made
based on IQVIA market data (formerly IMS Health), or any successor thereto,
calculated on the basis of number of units sold (subject to adjustments for
package sizes, product dosage or strength, and similar factors, as reasonably
determined by the Parties).

 

2.8          Non-competition. CASI irrevocably and unconditionally agrees with
and undertakes to Juventas that, unless with prior written consent of Juventas
or specially permitted by this Agreement, during the Term of this Agreement and
[***] years thereafter, (1) CASI shall not engage in development or
Commercialization of any T-cell therapy product specifically binding to CD19
(“Restricted Products”) other than the Licensed Product; and (2) CASI shall not
market or sell any Restricted Products in the Territory.

 

Section III.

Parties’ Responsibilities

 

3.1          Overview. Subject to this Section III, it is the intent of the
Parties that Juventas will have sole responsibility for the activities related
to preclinical and clinical development of the Licensed Product until the
receipt of Regulatory Approvals required for Commercialization of the Licensed
Product in the Territory, and CASI will have sole responsibility, with
Commercially Reasonable Efforts, for the activities related to the
Commercialization of the Licensed Product in the Territory. Juventas’s
preclinical and clinical development of the Licensed Product shall be subject to
the review and/or approval of JSC as further set out in Section IV. For the sake
of clarity, the Parties shall bear their own costs related to their
responsibilities set out under this Agreement.

 

3.2          Juventas’ Responsibilities. Juventas will be responsible for all
research and development activities for the Licensed Product in the Territory,
in particular:

 

(a)          IND Filings and CMC Development. Upon execution of this Agreement,
Juventas shall continue in IND filings and CMC development in accordance with
the R&D Plan (as defined below), including preparing and submitting relevant
application forms and such other materials as may be required by applicable
Government or Regulatory Authority in the Territory. Juventas will be solely
responsible for compliance with CMC requirements.

 

 8 

 

 

(b)          GMP Manufacturing Facility. Juventas will use Commercially
Reasonable Efforts to establish its own GMP Manufacturing Facility or a
third-party GMP Manufacturing Facility. Upon commencement of manufacturing of
the Licensed Product at the GMP Manufacturing Facility, Licensor shall be solely
responsible for the manufacture and supply of the Licensed Product for
Licensee’s sale and distribution in the Territory. Licensor shall be solely
responsible for all costs and expenses incurred in relation to the GMP
Manufacturing Facility, including development, construction, validation,
equipment, regulatory and operational expenses. Juventas will be solely
responsible for compliance of the GMP Manufacturing Facility with all Applicable
Laws in the Territory.

 

(c)          Clinical Development. Juventas shall be responsible for Clinical
Development of the Licensed Product in the Territory and for all indications by
itself or through a third party and bear all relevant costs and expenses
incurred. Juventas will own and have responsibility and control of the necessary
regulatory submissions to all applicable Government or Regulatory Authority in
the Territory.

 

(d)          NDA Filings. Upon and from the execution of this Agreement,
Juventas shall use Commercially Reasonable Efforts to obtain, control and
maintain NDA approvals in the Territory for the Licensed Product in accordance
with the R&D Plan, including preparing and submitting a product dossier and such
other materials as may be required for classification and approval of the
Licensed Product for the sale and marketing in the Territory by the NMPA or
other applicable Government or Regulatory Authority in the Territory. Juventas
shall bear all costs associated with obtaining and maintaining all Regulatory
Approvals in the Territory, including all costs associated with any regulatory
filings related to the Licensed Product, and any post- marketing studies
necessary to obtain or maintain Regulatory Approval.

 

(e)          Other Responsibilities. In addition to the specified
responsibilities under subsection (a) to (d) above, Juventas shall use
Commercially Reasonable Efforts, including the use of third party experts and
external consultants at its own cost, to complete registration with all
Governmental or Regulatory Authorities in the Territory, as well as other
formalities which may be necessary in order to complete the regulatory and
clinical process for the manufacturing, distribution, marketing and sale of the
Licensed Product in the Territory. The shipping responsibility of the Licensed
Product is subject to a separately Supply Agreement to be further negotiated by
the Parties.

 

3.3          CASI’s Responsibilities. Licensor shall be responsible for the
commercialization, marketing, strategy, pricing, promotion, market targeting,
branding, distribution and sale of the Licensed Product in the Territory, in
particular:

 

(a)          Promotion Efforts. Provided that Licensor has obtained all
Governmental Approvals for the sale and distribution of the Licensed Product,
Licensee shall use Commercially Reasonable Efforts to Commercialize the Licensed
Product in the Territory.

 

 9 

 

 

(b)          Promotion Materials. CASI shall prepare promotion material at its
own cost but shall not use major promotion materials until receipt of Juventas’s
prior consent, which consent shall not be unreasonably withheld. However,
Licensee shall remain solely responsible for such materials’ compliance with
applicable Laws.

 

3.4          Costs of Development. All costs of the development of the Licensed
Product related to activities provided in Section 3.1 shall be the
responsibility of and borne by Juventas, including the cost of the services and
materials provided by Third Parties and the cost of the manufacture and supply
of Licensed Product.

 

3.5          Governmental Correspondence. Licensee shall be responsible to
respond to inquiries, notice or correspondence from Governmental or Regulatory
Authority in relation to the Commercialization of the Licensed Product. Licensor
shall be responsible to respond to all other inquiries, notice or correspondence
from Governmental or Regulatory Authority in relation to the Licensed Product.
Both Parties shall provide reasonable assistance to the other Party for their
provision of such respond.

 

3.6          Regulatory Information. Each Party shall provide the other Party
with all reasonable assistance and take all actions reasonably requested by the
other Party that are necessary to enable the other Party to comply with any Law
applicable to the Licensed Product. Such assistance and actions shall include,
among other things, keeping the other Party informed, commencing within five (5)
business days of notification of any action by, or notification or other
information which it receives (directly or indirectly) from any Governmental or
Regulatory Authority which: (a) raises any material concerns regarding the
safety or efficacy of the Licensed Product; (b) indicates or suggests a
potential material liability for either Party to third parties arising in
connection with the Licensed Product or (c) is reasonably likely to lead to a
field alert report, recall or market withdrawal of the Licensed Product;
provided, that neither Party shall be obliged to disclose information in breach
of any existing contractual restrictions.

 

3.7          Research and Development Plan.

 

(a)          Within six months after the execution of this Agreement, Juventas
shall form a research and development plan that further lays out the
responsibilities and liabilities of Juventas for the research, filing and
production of the Licensed Product (the “R&D Plan”) and submit to JSC for
approval. The R&D Plan shall include (a) a high-level summary of the research
and development activities to be undertaken by Juventas and its Affiliates with
respect to the research and development of the Licensed Product, including the
activities to be taken during the stages of IND filing, CMC development, GMP
manufacturing and NDA and the expected timeline for each stage; and (b) a
detailed provision for divisions of risks and liabilities of the Parties in
different situations.

 

(b)          The R&D Plan shall be updated on a semi-annual basis and amended
from time to time. Any update or amendment shall be submitted to and is subject
to the review and approval by the Joint Steering Committee in accordance with
the procedures provided in Section IV below.

 

 10 

 

 

3.8          Commercialization Plan.

 

(a)          Within six months after the execution of this Agreement, CASI shall
form a Commercialization plan that further lays out the responsibilities and
liabilities of CASI for the Commercialization of the Licensed Product (the
“Commercialization Plan”) and submit to JCC for approval. The Commercialization
Plan shall include a high-level summary of the Commercialization activities to
be undertaken by CASI and its Affiliates with respect to the marketing strategy,
promotion materials and third-party agents.

 

Section IV.

Joint Steering Committee and Joint Development Committee

 

4.1          Joint Steering Committee. The Parties shall establish a joint
steering committee (the “JSC”) to coordinate and oversee activities for which
the Parties collaborate, to oversee the development efforts, to provide a
decision-making structure and to provide a forum for discussion of matters
relating to the development and Commercialization of the Licensed Product.

 

4.2          Membership of JSC. The JSC shall be comprised of an equal number of
representatives from each of CASI and Juventas and unless otherwise agreed such
number shall be two (2) senior representatives from each of CASI and Juventas.
Either Party may replace its respective JSC representatives at any time with
prior notice to the other Party, provided, that such replacement is of
comparable authority and scope of functional responsibility within that Party’s
organization as the person he or she is replacing. CASI shall select one of its
representatives as the chairperson for the JSC (the “Chairperson”) who shall be
responsible for calling meetings, preparing and circulating an agenda in advance
of each meeting (which agenda will include every matter requested by either
Party), and preparing and issuing minutes of each meeting within thirty

(30) days thereafter.

 

4.3          Decisions of JSC. The JSC shall make decisions unanimously. In the
event that the JSC cannot reach an agreement regarding any matter within the
JSC’s authority for a period of twenty (20) days, then the dispute shall
promptly be submitted to the senior executive officers of Juventas and CASI for
resolution. If the dispute remains unresolved for twenty (20) days after
submission to such persons, then the senior executive of Juventas shall have
final decision-making authority on matters related to the R&D Plan; provided,
however, that the senior executive of CASI shall have final decision-making
authority with respect to disputes regarding the Commercialization of the
Licensed Product including pricing and sales force deployment, in the Territory.

 

4.4          Responsibilities of JSC. The JSC shall perform the following
functions, some or all of which may be addressed directly at each meeting of the
JSC:

 

(a)          monitor progress of activities under the R&D Plan;

 

(b)          review and approve amendments to the R&D Plan;

 

(c)          provide a forum for the Parties to keep CASI informed with respect
to Juventas’ material activities under the R&D Plan;

 

(d)          discuss strategy for the preparation, filing, prosecution and
maintenance of the Intellectual Property related to the Licensed Product; and

 

 11 

 

 

(e)          such other responsibilities as may be assigned to the JSC pursuant
to this Agreement or as may be mutually agreed by the Parties from time to time.

 

4.5          Joint Development Committee. The Parties will establish a Joint
Development Committee (the “JDC”) to facilitate cooperation and information
transfer on the development of the Licensed Product. The JDC will provide a
decision-making structure and forum for discussion of matters relating to the
development of the Licensed Product, approve development plans and resources.

 

4.6          Membership of JDC. The JDC shall be comprised of an equal number of
representatives from each of CASI and Juventas and unless otherwise agreed such
number shall be two (2) senior representatives from each of CASI and Juventas.
Either Party may replace its respective JDC representatives at any time with
prior notice to the other Party, provided, that such replacement is of
comparable authority and scope of functional responsibility within that Party’s
organization as the person he or she is replacing. Unless otherwise agreed by
the Parties, the JDC shall have at least one representative with relevant
decision-making authority from each Party such that the JDC is able to
effectuate all of its decisions within the scope of its responsibilities. CASI
shall select one of its representatives as the chairperson for the JDC (the
“Chairperson”) who shall be responsible for calling meetings, preparing and
circulating an agenda in advance of each meeting (which agenda will include
every matter requested by either Party), and preparing and issuing minutes of
each meeting within thirty (30) days thereafter.

 

4.7          Decisions of JDC. In the event that the JDC cannot reach an
agreement regarding any matter within the JDC’s authority for a period of twenty
(20) days, then the dispute shall promptly be submitted to the JSC for
resolution.

 

4.8          Responsibilities of JDC. The JDC shall perform the following
functions, some or all of which may be addressed directly at each meeting of the
JDC:

 

(a)          overseeing, reviewing and monitoring activities under this
Agreement including, without limitation, any clinical trials proposed to be
conducted;

 

(b)          facilitating access to and the exchange of information between the
Parties related to the development of the Licensed Product and

 

(c)          undertaking and/or approving such other matters as are specifically
provided for under the Agreement.

 

Section V.

Supply of Licensed Product

 

5.1          Supply of Licensed Product. Juventas shall by itself or through a
designated manufacturer, completes construction of its GMP Manufacturing
Facility, which is fully functional, and, commences manufacturing of the
Licensed Product pursuant to the terms and conditions of this Agreement. Subject
to the applicable terms in a separate Supply Agreement, Juventas or its
designated manufacturer shall be the exclusive manufacturer and supplier of the
Licensed Product to CASI. Juventas shall promptly notify CASI when the GMP
Manufacturing Facility is complete and operations are ready to commence.
Juventas shall supply the Licensed Product to CASI pursuant to a separate supply
agreement (“Supply Agreement”) to be executed between the Parties within a
reasonable time upon execution of this Agreement. The potential business plan
for CASI to build manufacturing capability of the Licensed Product, if any, will
be discussed by the Parties. If CASI intends to manufacture the Licensed Product
in the Territory, Parties shall negotiate the terms and conditions in good
faith.

 

 12 

 

  

5.2          Supply Price. Juventas shall supply CASI with the Licensed Product
in accordance with this Agreement and a separate Supply Agreement. The supply
price for the Licensed Product from Juventas to CASI will be [***]:

 

[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]

 

[***]

 

Section VI.

Milestone and Royalty Payments

 

6.1          Milestone Payment. A non-refundable and non-creditable milestone
payment of [***] shall be paid to Licensor upon the initiation of the first
Phase II Clinical Trial with the Licensed Product in accordance with the
timeline provided under Section 6.3.

 

6.2          Royalty and Non-Royalty Sublicense Payments.

 

(a)          Licensed Product Royalty. Subject to the terms and conditions set
forth in the remainder of this Section 6.2, CASI shall pay to Juventas the
following royalties on Annual Net Sales of the Licensed Product in the
Territory:

 

A.           China Territory. CASI will pay to Juventas a royalty on Net Sales
of the Licensed Product in the China Territory on an annual basis at the [***].

 

B.           Ex-China Territory: CASI will pay to Juventas a royalty on Net
Sales of the Licensed Product in the Territory on an annual basis at the
following rates:

 

i).           For the portion of aggregate Annual Net Sales of all Licensed
Product in the Ex-China Territory equal to or less than [***] in any calendar
year, [***] of such portion of such Annual Net Sales;

 

 13 

 

 

(ii).         For the portion of aggregate Annual Net Sales of all Licensed
Product in the Ex-China Territory more than [***] but no more than [***] in any
calendar year, [***] of such portion of such Annual Net Sales;

 

(iii).        For the portion of aggregate Annual Net Sales of all Licensed
Product in the Ex-China Territory more than [***] but no more than [***] in any
calendar year, [***] of such portion of such Annual Net Sales; and

 

(iv).        For the portion of aggregate Annual Net Sales of all Licensed
Product in the Ex-China Territory more than [***] in any calendar year, [***] of
such portion of such Annual Net Sales.

 

(b)          Non-Royalty Sublicense Income. If CASI sublicenses its rights under
this Agreement to any Person pursuant to Section 2.3, CASI shall pay [***] of
the Non-Royalty Sublicense Income of such sublicense to Juventas.

 

(c)          Payment Reports. During the Term, following the First Commercial
Sale of the Licensed Product in any country or region in the Territory, CASI
shall furnish to Juventas a written report (each, a “Payment Report”) within
[***] days after the end of each Calendar Quarter showing the Non-Royalty
Sublicense Income, Net Sales of each Licensed Product in China Territory and
Ex-China Territory and the royalties payable under this Agreement, along with
(i) the Non-Royalty Sublicense Income obtained in the Calendar Quarter, (ii)
gross sales of the Licensed Product in China Territory and Ex-China Territory,
(iii) Net Sales in the relevant Calendar Quarter in China Territory and Ex-China
Territory, (iv) all relevant exchange rate conversions in accordance with
Section 6.5, (v) all deductions and (vi) the amount of any payment due from CASI
to Juventas.

 

6.3          Method of Payments. All payments due from CASI to Juventas under
this Agreement shall be paid by CASI or its designated party in RMB by wire
transfer to a bank account designated in writing by Juventas. With respect to
any payment due under this Section VI, Juventas shall provide CASI an original
invoice for the due payment and CASI or its designated party shall make such
payment by the [***] day of the month immediately following receipt of the
original invoice.

 

6.4          Withholding Taxes. Royalties and milestone payments shall be paid
by CASI to Juventas, after deduction of any applicable withholding taxes. Prior
to any payment by CASI to Juventas, CASI shall provide to Juventas any forms
required to attest Juventas’s fiscal domiciliation in order to allow CASI to
claim application of the reduced rate of withholding tax provided for in any
applicable bilateral fiscal convention. Juventas shall promptly return such
forms to CASI. In the event Juventas fails to promptly return such forms duly
filled and signed, CASI shall declare and pay withholding tax at the common law
rate of the applicable corporate income tax, and such tax shall then be deducted
from the corresponding payment by CASI to Juventas. CASI shall pay withholding
tax to the proper taxing authority and proof of payment of such tax shall be
secured and sent to Juventas as evidence of such payment. If, in the opinion of
either Party, the provisions of this Section 6.4 become extremely burdensome,
the Parties agree to meet and discuss such other options as may be available to
them. For the avoidance of doubt, Juventas shall still be solely responsible for
its own compliance with applicable tax law and CASI shall not be liable for any
Juventas’ tax violations in relations to any tax withholdings under this Section
6.4.

 

 14 

 

 

6.5          Currency. With respect to sales of the Licensed Product invoiced in
RMB, the Net Sales and the amounts due hereunder will be expressed in RMB. With
respect to sales of Licensed Product invoiced in a currency other than RMB, the
gross sales, Net Sales and royalties payable shall be expressed in the currency
of the invoice issued by the Party making the sale together with the RMB
equivalent of the royalty payable and the equivalent in the currency used for
calculating the applicable royalty rates, calculated using the rate of exchange
published in the Wall Street Journal for such currency on the last Business Day
of the relevant Calendar Quarter.

 

6.6          Default Payment. In addition to all other rights and remedies
hereunder or at law or in equity, CASI shall pay an interest for any and all
payment defaulted by CASI under this Agreement. The interest shall accrue on the
amount of payment defaulted by CASI, from its due date up to the date of full
payment, at a rate of [***] and shall be paid in RMB by wire transfer to a bank
account designated by Juventas. Such interest shall accrue from day to day and
be computed on the basis of a three hundred and sixty (360) day per year and the
actual number of days elapsed.

 

6.7          Audit. Juventas shall have the right during the Term of this
Agreement and for [***] after termination of this Agreement to engage an
independent auditor that is mutually agreed to by Juventas and reasonably
acceptable to CASI to examine the relevant records from time-to-time, as may be
necessary to verify compliance with the terms of this Agreement. Such audit
shall be requested in writing at least [***] days in advance, and shall be
conducted during CASI’s normal business hours and otherwise in a manner that
minimizes any interference to CASI’s business operations. In order to fulfill
the auditing, the independent auditor so selected shall have the right to
access, examine, review and copy all books or accounts of CASI, relevant
procurement/distribution agreements and other purchase/sales contracts,
purchase/sales orders, operation records, tax paid to local government, and
itemized tax for the Licensed Product, and to discuss the business, operations
and conditions of CASI with its respective directors, officers, employees,
accounts, auditors, financial advisors, legal counsel and investment bankers, to
the extent reasonably deemed by Juventas as necessary for determining the
accuracy of the report provided by CASI pursuant to Section 6.2(c). CASI shall
not unreasonably restrict the independent auditor’s access to premises of CASI
during normal business hours. In the event that any independent auditor
discovers an underpayment, CASI shall promptly pay to Juventas the amount of
such underpayment. The fees charged by such independent auditor shall be paid by
Juventas. However, CASI shall pay such fees, provided that if such auditor
uncovers an underpayment of fees of [***] or more by CASI.

 

 15 

 

 

Section VII.

Representations, Warranties and Covenants

 

7.1          Licensor Representations, Warranties and Covenants. Licensor hereby
represents, warrants and covenants to Licensee, as of the Effective Date, as
follows:

 

(a)          the execution, delivery and performance by Licensor of this
Agreement and the consummation of the transactions contemplated hereby are
within Licensor’s corporate powers and have been duly authorized by all
necessary corporate action on the part of Licensor. This Agreement constitutes
the legal, valid and binding obligation of Licensor, enforceable against
Licensor in accordance with its terms

 

(b)          the execution, delivery and performance of this Agreement by
Licensor will not violate: (i) any Laws or any order of any Governmental or
Regulatory Authority; or (ii) any provision of Licensor’s certificate of
incorporation or other organizational documents;

 

(c)          to the knowledge of Licensor, none of the Intellectual Property
existing as of the Effective Date has been adjudged invalid, unenforceable or
unpatentable by any Governmental or Regulatory Authority of competent
jurisdiction, and all such Intellectual Property existing as of the Effective
Date are valid and enforceable.

 

(d)          To the knowledge of Licensor, (a) the exploitation of Licensed
Product based upon the Intellectual Property as it exists on the Effective Date
does not infringe any issued patent or any pending patent of any person and (b)
the use of the Intellectual Property by Licensee pursuant to the terms of this
Agreement, and Licensee’s exercise of its rights hereunder in connection
therewith, does not infringe, misappropriate or otherwise violate the trade
secret rights or copyrights of any other Person. No written claim or demand of
any Third Party has been made, or to the knowledge of Licensor, is threatened
against Licensor and there is no proceeding, or action, claim (including
regarding infringement of Intellectual Property), complaint, demand, suit,
proceeding, or arbitration brought by a third party, pending, or, to the
knowledge of Licensor, threatened, as of the Effective Date, against Licensor,
and in each case involving any of the Intellectual Property or Licensed Product
existing as of the Effective Date or the exploitation of the foregoing and (i)
challenging any rights of Licensor in any such Intellectual Property or Licensed
Product, (ii) alleging that any issued patent within such Intellectual Property
is invalid or unenforceable, (iii) alleging that the use of any Intellectual
Property existing as of the Effective Date infringes any issued patent of a
third party or infringes, misappropriates or otherwise violates the Intellectual
Property rights of any Person, (iv) challenging the transactions contemplated by
this Agreement or (v) asserting that the manufacture, use, sale, offer for sale
or importation of Licensed Product or the processes used to make Licensed
Product is or was infringing or otherwise violates or violated any Intellectual
Property of any Person.

 

(e)          Licensor is and has been in compliance in all material respects
with all applicable Laws applicable to and in connection with the exploitation
of the Intellectual Property and the Licensed Product. There are no, and there
have not been any issued judicial orders, writs, injunctions, decrees, judgments
or stipulations in force against Licensor with respect to the Intellectual
Property or Licensed Product that would reasonably be expected to have a
material adverse effect on the ability of Licensee to exploit the Licensed
Product in the Field in the Licensee Territory in compliance with all applicable
Laws.

 

 16 

 

 

(f)           To the knowledge of Licensor, no third party has infringed,
misappropriated or otherwise violated any Intellectual Property.

 

(g)          The Intellectual Property owned by Licensor or both controlled by
and prosecuted by Licensor and, to the knowledge of Licensor, the Intellectual
Property controlled but not prosecuted by Licensor have been maintained properly
in accordance with all applicable Laws, including disclosure of all prior art to
the relevant patent authority to the extent required by applicable Laws, and
with all applicable fees due with respect thereto having been paid.

 

(h)          To the knowledge of Licensor, the scientific, technical and other
information relating to the Intellectual Property and Licensed Product disclosed
or made available by Licensor or any of its representatives to Licensee in
writing in the electronic data room has been true and correct in all respects.

 

(i)           Licensor is not currently assisting any third party in preparation
for or in connection with filing an IND with respect to the Licensed Product.

 

(j)           Licensor has the unrestricted right to grant to Licensee the
rights in the Intellectual Property in the Territory that are being granted to
Licensee under this Agreement upon the terms set forth herein. Licensor has
granted any license or sublicense to any rights in the Intellectual Property in
the Territory to any Third Party that are in conflict with the rights granted to
Licensee in this Agreement.

 

(k)          Licensor has taken reasonable and customary measures to maintain
and protect, as applicable, the confidentiality of its or their owned
Confidential Information within the Intellectual Property. Notwithstanding the
foregoing, Licensor and its Affiliates may disclose Confidential Information to
(a) Third Parties under an obligation of confidentiality with respect to such
information, (b) Governmental Authorities or Regulatory Authorities in order to
obtain patents or develop or submit Regulatory Filings for products, and (c) the
extent required by Law.

 

(l)           All employees, consultants, contractors and other persons who have
contributed to the design, creation, conception, reduction to practice or
invention of any Intellectual Property in the Intellectual Property or the
Intellectual Property have entered into written agreements with Licensor
assigning to Licensor all rights relating to such design, conception, reduction
to practice, invention or Intellectual Property.

 

(m)         The Licensor in compliance with all applicable Laws in relation to
the reporting of adverse events in relation to clinical studies of the Licensed
Products.

 

(n)          To the knowledge of Licensor, all clinical studies and nonclinical
studies sponsored by Licensor relating to the Licensed Product have been and are
being conducted in material compliance with applicable Laws, including Laws,
rules, regulations and guidance restricting the use and disclosure of
individually identifiable health information. Licensor has not received any
written notices or other written correspondence from any Governmental or
Regulatory Authority with respect to any ongoing clinical studies and
nonclinical studies relating to the Licensed Product requiring the termination,
suspension or material modification of such clinical studies and nonclinical
studies.

 

 17 

 

 

(o)          Licensor and its employees have never been (i) debarred or (ii)
convicted of a crime for which a Person can be debarred under Section 306(a) of
the U.S. Generic Drug Enforcement Act of 1992 (Section 306(a) or (b)) or similar
Laws of any other jurisdiction.

 

7.2          Licensee Representations, Warranties and Covenants. Licensee hereby
represents, warrants and covenants to Licensor as follows:

 

(a)          the execution, delivery and performance of this Agreement by
Licensee and the consummation of the transactions contemplated hereby are within
the Licensee’s corporate powers and have been duly authorized by all necessary
corporate action on the part of Licensee. This Agreement constitutes the legal,
valid and binding obligations of the Licensee, enforceable against the Licensee
in accordance with its terms;

 

(b)          Licensee will be properly registered, licensed and qualified, and
have all requisite power and authority under its organizational documents and in
accordance with applicable Laws to market and sell Licensed Product in the
Territory, and to conduct its business and perform its obligations hereunder
and, during the Term and any extensions thereof, it shall take all action as may
be required and necessary to obtain and keep current any governmental licenses,
permits, registrations and approvals that are necessary for it to develop, make,
market and sell the Licensed Product and carry out its other activities
hereunder;

 

(c)          the execution, delivery and performance of this Agreement by
Licensee will not violate: (i) any Laws or any order of any Governmental or
Regulatory Authority; or (ii) any provision of Licensee’s certificate of
incorporation or other organizational documents;

 

(d)          Licensee shall carry out its obligations and activities under this
Agreement (including without limitation the marketing, promotion, distribution
and sale of the Licensed Product) in accordance with: (i) the terms hereof and
(ii) all applicable Laws; and

 

(e)          Licensee and its employees have never been (i) debarred or (ii)
convicted of a crime for which a Person can be debarred under Section 306(a) of
the U.S. Generic Drug Enforcement Act of 1992 (Section 306(a) or (b) or similar
Laws of any other jurisdiction.

 

Section VIII.

Term and Termination

 

8.1          Term. Unless terminated in accordance with Section 8.2, the term of
this Agreement shall be as long as CASI or its distributors and/or sublicensees
Commercializes the Licensed Product (the “Term”).

 

8.2          Termination.

 

(a)          Termination for Material Breach. Either Party may terminate this
Agreement for a material breach of this Agreement by the other Party if the
breaching Party fails to cure any such breach within [***] calendar days after
receipt of written notice from the non- breaching Party specifying such breach.
In the event the Supply Agreement is terminated by either Party as the result of
a material breach of the terms of the Supply Agreement by the other Party, this
Agreement shall be deemed to be terminated at the same time.

 

 18 

 

 

(b)          Termination for Insolvency or Bankruptcy. Either Party may
immediately terminate this Agreement upon written notice to the other Party in
the event that: (i) the other Party is declared insolvent or bankrupt by a court
of competent jurisdiction; (ii) a voluntary petition of bankruptcy or
reorganization is filed in any court of competent jurisdiction by such other
Party; (iii) this Agreement is assigned by such other Party for the benefit of
creditors; or (iv) an involuntary petition of bankruptcy or reorganization is
filed against the other Party or its assets and such petition is not dismissed
within [***] days of filing.

 

(c)          Termination for Governmental Action. Either Party may terminate
this Agreement upon [***] days prior written notice in the event that any
Governmental or Regulatory Authority takes any action or raises any objection
that prevents Licensee from making, having made, marketing, promoting,
importing, purchasing or selling Licensed Product, or that has the effect of
making any of the transactions contemplated by this Agreement unlawful.

 

(d)          Termination for Failure to Close under the Investment Agreement.
The Parties entered into an Investment Agreement dated June 15, 2019 with other
parties under which CASI intended to make certain equity investment into
Juventas in the amount of RMB80,000,000 upon Closing (as defined in the
Investment Agreement). Juventas may terminate this Agreement immediately upon
written notice to CASI if, for any reason, the Closing fails to occur.

 

(e)          Termination for Change of Control. Either Party may terminate this
Agreement upon [***] days prior written notice if the other Party is subject to
a Change of Control.

 

8.3          Effect of Termination. On the date of termination or expiration of
this Agreement, (a) all rights and obligations granted under or imposed by this
Agreement will cease and terminate, except as set forth herein and in Section
8.4, (b) all license granted to CASI under this Agreement shall terminate, (c)
CASI shall cease its use and, upon request, within 30 days either return to
Juventas or destroy (and certify as to such destruction) all Juventas’
Confidential Information, including any copies thereof, (d) CASI shall promptly
deliver to Juventas all information, documents and other materials, which belong
to the Improvements or are necessary for Juventas to Commercialize the Licensed
Product and (e) CASI or its Affiliates shall not engage in development,
marketing or sale of the Licensed Product in the Territory before [***]
anniversary after the termination or expiration of this Agreement.
Notwithstanding the foregoing, unless this Agreement was terminated by Licensor
due to Licensee’s breach of this Agreement, Licensee shall have the right to
sell and distribute its existing inventory of Licensed Product, not including
products in process of manufacture, subject to the terms of this Agreement and
payment of applicable royalties to Licensor as set forth in Section 6.2 above.
Such expiration or termination shall not affect any claim, demand, liability or
right of a Party arising pursuant to this Agreement prior to the expiration or
termination hereof. For the avoidance of doubt, termination or expiration of
this Agreement shall not affect a Party’s right to seek damages from the
responsible Party for actions or omissions occurring prior to such termination
or expiration.

 

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8.4          Survival. The following provisions shall survive any termination or
expiration of this Agreement: Section 2.4, Section 2.5, Section 2.8, Section
8.3, Section IX, Section X and Section XI.

 

Section IX.

Confidentiality and Press Releases

 

9.1          Confidential Information. Except to the extent otherwise agreed in
writing, the Parties agree that the receiving Party (the “Receiving Party”)
shall keep confidential and shall not publish or otherwise disclose or use for
any purpose other than as provided for in this Agreement any confidential and
proprietary information and materials, patentable or otherwise, in any form
(written, oral, photographic, electronic, magnetic, or otherwise) which is
disclosed to it by the other Party (the “Disclosing Party”) or is otherwise
received, accessed or developed by a Receiving Party in the course of performing
its obligations under this Agreement, including, but not limited to, all
information concerning the Intellectual Property, Licensed Product(s), the
contents of this Agreement and any other technical and business information of
whatever nature (collectively, “Confidential Information”). Without limiting the
generality of the foregoing, the Receiving Party may disclose the Confidential
Information only to the Receiving Party’s officers, employees, consultants,
agents (the “Representatives”) who have a need to know the Confidential
Information in connection with the transaction contemplated hereby and which
Representatives are contractually or otherwise legally bound to hold and use the
Confidential Information in substantial accordance with the terms herein. The
Receiving Party shall guarantee the full performance by the Representatives of
the confidentiality obligation set forth herein. Intellectual Property and
Improvements shall be the Juventas’ Confidential Information.

 

9.2          Exclusions. The obligations of confidentiality and non-use set
forth in Section 9.1 shall not apply to any portion of the Confidential
Information which the Receiving Party is able to establish by competent proof:
(i) was already legally in the possession of the Receiving Party, at the time of
disclosure by the Disclosing Party; (ii) was generally available to the public
or otherwise part of the public domain at the time of its disclosure to the
Receiving Party; (iii) became generally available to the public or was otherwise
part of the public domain after its disclosure and other than through any act or
omission of the Receiving Party in breach of this Agreement; or (iv) was
disclosed to the Receiving Party by a third party provided that the Confidential
Information was disclosed by such third party in non-violation of any
confidentiality obligation.

 

9.3          Exceptions. The obligations of this Section IX shall not apply to
Confidential Information that: (i) is submitted to a Governmental or Regulatory
Authority to facilitate the issuance of any registrations for the Licensed
Product or the Intellectual Property, provided that the Disclosing Party is
informed of such submission and the required Confidential Information in advance
of the disclosure and reasonable measures shall be taken to assure confidential
treatment of such information where permitted; (ii) is provided by the Receiving
Party to third parties under confidentiality agreements having provisions at
least as stringent as those in this Agreement, and solely for consulting,
funding, merger or acquisition activity, external testing and marketing trials
with respect to any of the subject matter of this Agreement; or (iii) is
otherwise required to be disclosed in compliance with applicable Laws
(including, without limitation and for the avoidance of doubt, the requirements
of any securities regulatory authorities or any stock exchange on which
securities issued by a Party are traded) or order by a court or other
governmental or regulatory authority having competent jurisdiction; provided,
that, if a Party is required to make any such disclosure of the other Party’s
Confidential Information such Party will give reasonable advance written notice
to the other Party of such disclosure requirement and will use its best efforts
to secure confidential treatment of such Confidential Information required to be
disclosed.

 

 20 

 

 

9.4          Remedies. Each Party shall be entitled, in addition to any other
right or remedy it may have, at law or in equity, to seek an injunction from any
court of competent jurisdiction, without the posting of any bond or other
security, enjoining or restraining the other Party from any violation or
threatened violation of this Section IX.

 

9.5          Duration. All obligations of confidentiality, limited use and
non-disclosure imposed by this Section IX with respect to any and all items of
Confidential Information shall expire five years after the termination of this
Agreement, unless a longer period is prescribed by Law.

 

9.6          Press Releases. Except as required by Law (including requirements
of applicable securities administrators or any other stock exchange on which
securities issued by a Party are traded) or any governmental or regulatory
authority, neither Party shall make any press release or other public
announcement relating to the Agreement or the transactions described herein
without the prior written consent of the other Party, which consent will not be
unreasonably withheld. Subject to the foregoing, each Party shall use
Commercially Reasonable Efforts to provide the other Party an opportunity to
review any press release or similar public statement related to this Agreement
or Licensed Product prior to publicly releasing such press release.

 

Section X.

Indemnification

 

10.1        Indemnification by Licensor. Licensor shall defend, indemnify and
hold harmless Licensee, its Affiliates, officers, directors, employees and
agents against any and all Losses arising out of, in connection with or
attributable to: (a) Licensor’s breach of any representation, warranty or
covenant under this Agreement; (b) any negligent or wrongful act or omission on
the part of Licensor, its Affiliates, officers, directors, employees, agents or
representatives except, in each case, to the extent that any such Losses are
caused by the negligence or wrongful act(s) of Licensee, its Affiliates,
officers, directors, employees or agents; and (c) any Licensor Product Liability
Claims except, in each case, to the extent that any such Losses are caused by
the negligence or wrongful act(s) of Licensee, its Affiliates, officers,
directors, employees or agents.

 

10.2        Indemnification by Licensee. Licensee shall defend, indemnify and
hold harmless Licensor, its Affiliates, officers, directors, employees and
agents against any and all Losses arising out of, in connection with or
attributable to: (a) Licensee’s breach of any representation, warranty or
covenant under this Agreement, (b) the promotion, marketing, sale or
distribution of the Licensed Product(s) by Licensee in any part of the Territory
or any negligent or wrongful act or omission on the part of Licensee, its
Affiliates, officers, directors, employees, agents, sublicensees or
representatives except, in each case, to the extent that any such Losses are
caused by the negligence or wrongful act(s) of Licensor, its Affiliates,
officers, directors, employees or agents.

 

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10.3        Procedures. The Party seeking indemnification under this Section X
(the “Indemnified Party”) shall give prompt notice to the Party against whom
indemnity is sought (the “Indemnifying Party”) of the assertion or commencement
of any Proceeding in respect of which indemnity may be sought under this Section
X and will provide the Indemnifying Party such information with respect thereto
that the Indemnifying Party may reasonably request. The failure to give such
notice will relieve the Indemnifying Party of any liability hereunder only to
the extent that the Indemnifying Party has suffered actual prejudice thereby.
The Indemnifying Party shall assume and control the defense and settlement of
any such action, suit or Proceeding at its own expense. The Indemnified Party
shall, if requested by the Indemnifying Party, cooperate in all reasonable
respects in such defense, at the Indemnifying Party’s expense, subject to the
following. The Indemnified Party will be entitled at its own expense to
participate in such defense and to employ separate counsel for such purpose. For
so long as the Indemnifying Party is diligently defending any Proceeding
pursuant to this Section X, the Indemnifying Party will not be liable under this
Section X for any settlement effected without its consent. No Party to this
Agreement shall make any admission, compromise or settlement which includes
terms which adversely impact the other Party without the other Party’s prior
written consent.

 

10.4         Infringement Claims.

 

(a)          Procedure. If either Party learns of or develops a basis for an
infringement, unauthorized use, misappropriation or ownership claim or
threatened infringement or other such claim (an “Infringement”) by or against a
third party with respect to the Intellectual Property or the Licensed Product in
the Territory, such Party shall promptly notify the other Party in writing and
shall promptly provide such other Party with available evidence of such
Infringement. Licensor shall have the first right, but not the obligation, to
institute or defend Infringement actions against or by any such third parties in
the Territory. If, in any such instance, Licensee does not secure actual
cessation of such Infringement or institute or respond to an Infringement
proceeding within 90 days of learning of such Infringement, then Licensor may
institute or defend such Infringement action. Each Party maintaining any such
Infringement action shall keep the other Party reasonably informed as to the
status of such action. Each Party shall execute all necessary and proper
documents, take such actions as shall be appropriate to allow the other Party to
maintain any such Infringement action and shall otherwise cooperate in the
maintenance of any such action (including, without limitation, consenting to
being named as a Party thereto).

 

(b)          Costs and Expenses. The costs and expenses of instituting an
Infringement action (including fees of attorneys and other professionals)
against a third party shall be borne by the Party maintaining the action. The
costs of defending an Infringement action for infringement in the Territory
shall be borne by the Licensor, including any amounts to be paid in settlement
or as finally awarded by a court, unless such action results from unauthorized
Improvements made by Licensee or use of the Intellectual Property other than as
licensed herein.

 

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(c)          Allocation of Award for Third Party Infringement. In the event that
any Infringement action instituted by Licensor and/or Licensee proceeds to
judgment or settlement, any award paid by third parties as a result of such an
Infringement action (whether by way of settlement or otherwise) shall be applied
first to reimburse the costs and expenses incurred by the Parties with respect
to such action and any remaining funds shall be allocated as follows: (i) if
Licensor has maintained such action alone, Licensor shall be entitled to retain
such remaining funds; (ii) if Licensee has maintained such action alone,
Licensee shall be entitled to retain such remaining funds; or (iii) if the
Parties have cooperated in maintaining such action, the Parties shall allocate
such remaining funds between themselves in the same proportion as they have
agreed to bear the expenses of maintaining such action or as otherwise agreed by
the Parties in writing.

 

(d)          Infringement on Third Party Rights; License Required. If, in the
course of any Infringement action by a third party instituted against Licensor
or Licensee, a license to any third party patent becomes necessary in order for
Licensee to enjoy the rights to the Licensed Product contemplated by this
Agreement, then Licensee will be entitled to enter into such a license on terms
and conditions as are required by the third party, and Licensee will be entitled
to deduct from royalties otherwise payable under this Agreement during any
quarter one half of the royalty payments during such quarter to the third party
in respect of such third party’s patent; provided, further, that in no event
shall the royalty rate payable under this Agreement after giving effect to such
credit be reduced by more than twenty five percent (25%). Licensee shall keep
Licensor fully informed of any such license negotiations and the Parties shall
cooperate in good faith to minimize the amounts payable with respect to any such
third-party intellectual property.

 

10.5        Consequential Damages. Neither Party to this Agreement shall be
liable to or otherwise responsible to the other Party hereto for any loss of
profits, diminution in value, or incidental, indirect, consequential, special,
exemplary or punitive damages that arise out of or relate to this Agreement or
the performance or breach hereof or otherwise and whether in contract, tort,
strict liability or otherwise; provided, that, the foregoing limitation shall
not apply: (i) to a Party’s third party indemnification obligations pursuant to
Sections 10.1 and 10.2 above, (ii) to any personal injury or property damage
caused by the grossly negligent or willful misconduct of a Party, or (iii) to
any violation of applicable Law.

 

Section XI.

Miscellaneous

 

11.1        Choice of Law; Jurisdiction. This Agreement shall be governed by and
construed exclusively in accordance with the laws of Hong Kong, without regard
to conflicts of law rules. The language of this Agreement shall be English.
Except as expressly set forth below, any dispute, controversy or claim arising
out of or in relation to this Agreement, or breach hereof, shall be first
settled through amicable negotiations between the Parties. If these negotiations
do not result in an amicable resolution, then arbitration shall be sought in
accordance with Section 11.2 found below.

 

11.2        Arbitration. Any dispute, controversy, difference or claim arising
out of or relating to this contract, including the existence, validity,
interpretation, performance, breach or termination thereof or any dispute
regarding non-contractual obligations arising out of or relating to it shall be
referred to and finally resolved by arbitration administered by the Hong Kong
International Arbitration Centre (HKIAC) under the HKIAC Administered
Arbitration Rules in force when the Notice of Arbitration is submitted. Each
Party shall pay its or his own expenses of such arbitration, and the fees and
expenses of the arbitrator shall be paid by the non-prevailing Party.

 

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11.3        Waiver. The waiver by any Party of a breach of any provision of this
Agreement shall not operate, or be construed, as a waiver of any subsequent
breach.

 

11.4        Modification. No change, modification, or waiver of any terms of
this Agreement shall be valid unless it is in writing and signed by both
Parties.

 

11.5        Entire Agreement. This Agreement constitutes the entire agreement
between the Parties with respect to the subject matter hereof and thereof, and
supersede all prior agreements and understandings, whether oral or written,
between the Parties, it being understood that any information exchanged under a
confidentiality or nondisclosure entered into prior to the date hereof shall be
treated as Confidential Information disclosed under this Agreement.

 

11.6        Force Majeure. If the actual performance of any obligations under
this Agreement is prevented by any act of God (such as fire, flood, earthquake
or other natural cause), terrorist events, riots, insurrections, declared or
undeclared war or national emergency, governmental action or inaction unrelated
to Licensed Product or the Parties’ acts or omissions, or other similar event
outside the reasonable control of a Party, the Party affected by such event (a
“Force Majeure”) shall be excused on a day-by-day basis to the extent of the
prevention; provided, that such Party notifies the other Party as soon as
practicable of the nature and expected duration of the claimed Force Majeure,
uses all Commercially Reasonable Efforts to avoid or remove the causes of
nonperformance and resumes performance promptly after the causes have been
removed. If either Party is unable to perform its obligations under this
Agreement due to a Force Majeure event for a period in excess of 90 days, the
other Party may terminate this Agreement.

 

11.7        Assignment. Licensee shall not be entitled to assign its rights or
delegate its obligations hereunder in whole or in part without the express prior
written consent of Licensor, which consent shall not be unreasonably withheld or
delayed. The foregoing notwithstanding, no consent shall be required for the
assignment of this Agreement in connection with a change in control or a sale of
all or substantially all of the assets of Licensee so long as Licensee is then
in full compliance with the terms of this Agreement and the successor or
assignee agrees in a writing enforceable by Licensor to be bound by the terms of
this Agreement.

 

11.8        Independent Contractor. This Agreement shall not be construed as
constituting a partnership, joint venture or any other form of legal association
that would impose liability upon one Party for the act or failure to act of the
other Party, or as providing either Party with the right, power or authority
(express or implied) to create any duty or obligation of the other Party.

 

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11.9        Headings. The headings have been inserted for convenience only and
are not to be considered when interpreting the provisions of this Agreement.

 

11.10      Counterparts. This Agreement may be executed in multiple
counterparts, each of which will be deemed an original, but all of which
together shall constitute one and the same instrument.

 

11.11      Severability. Each provision of this Agreement will to the extent
possible be interpreted in such manner as to be effective and valid under
applicable law, but if any provision of this Agreement is held to be prohibited
by or invalid under applicable law, such provision will be ineffective only to
the extent of such prohibition or invalidity, without invalidating the remainder
of such provision or the remaining provisions of this Agreement.

 

11.12      Notices. All notices or other communications hereunder shall be
deemed sufficient if given in writing, via registered mail (return receipt
requested), postage paid, or by reputable international delivery service (e.g.
FedEx) or by courier addressed to the appropriate Party at the address set forth
below, or at such other place as such Party may designate in writing to the
other Party.

 

If to Licensor: Juventas Cell Therapy Ltd. Attn: Yiping Deng (邓一平) Address:
1103, Building No.3, Huamao Center, 77 Jianguo Road, Chaoyang District, Beijing,
China 100025 Email: [***] Tel: [***]     If to Licensee: CASI Pharmaceuticals,
Inc. Attn: George Chi Address:

9620 Medical Center Drive, Suite 300

Rockville, Maryland 20850

Email: [***] Tel: [***]

 

All such notices shall be effective upon receipt.

 

11.13      Insurance. Each Party shall have and maintain such types and amounts
of liability insurance covering the manufacture, use and sale of the Licensed
Product as is normal and customary in the pharmaceutical industry generally for
Parties similarly situated, and shall upon request provide the other Party with
a copy of its policies of insurance in that regard, along with any amendments
and revisions thereto.

 

[Signatures on following page]

 

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IN WITNESS WHEREOF, this Exclusive License Agreement has been executed by a duly
authorized officer of each Patty as of the Effective Date.

 

  “Licensor”       JUVENTAS CELL THERAPY LTD.       By: /s/ Lulu Lv   Name: Lulu
Lv   Title: Authorized Representative

 

   

 

  

IN WITNESS WHEREOF, this Exclusive License Agreement has been executed by a duly
authorized officer of each Party as of the Effective Date.

 

  “Licensee”       CASI PHARMACEUTICALS, INC.       By: /s/ George Chi   Name:
George Chi   Title: Chief Financial Officer