Form 8-K
8-K — BeyondSpring Inc.
Accession: 0001171843-26-006273
Filed: 2026-09-29
Period: 2026-09-29
CIK: 0001677940
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Entry into a Material Definitive Agreement
Item: Other Events
Item: Financial Statements and Exhibits
Documents
8-K — f8k_092826.htm (Primary)
EX-1.1 — EXHIBIT 1.1 (exh_11.htm)
EX-5.1 — EXHIBIT 5.1 (exh_51.htm)
EX-10.1 — EXHIBIT 10.1 (exh_101.htm)
EX-99.1 — PRESS RELEASE (exh_991.htm)
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8-K — FORM 8-K
8-K (Primary)
Filename: f8k_092826.htm · Sequence: 1
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0001677940
0001677940
2026-09-29
2026-09-29
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________
FORM 8-K
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of
the Securities Exchange Act of 1934
Date of Report (Date of earliest
event reported): September 29,
2026 (September 28, 2026)
_______________________________
BeyondSpring
Inc.
(Exact name of registrant as specified in its charter)
_______________________________
Cayman
Islands
001-38024
Not Applicable
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(I.R.S. Employer Identification No.)
100
Campus Drive, West Side, 4th Floor, Suite 410
Florham
Park, New
Jersey 07932
(Address of Principal Executive Offices) (Zip Code)
+1 (646)
305-6387
(Registrant's telephone number, including area code)
Not Applicable
(Former name or former address, if changed since
last report)
_______________________________
Check the appropriate box below if
the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section
12(b) of the Act:
Title of
each class
Trading Symbol(s)
Name of each
exchange on which registered
Ordinary Shares, par
value $0.0001 per share
BYSI
The
NASDAQ Stock Market LLC
Indicate by check mark whether the
registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule
12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.01. Entry into a Material Definitive Agreement.
Purchase and Collaboration Agreement
On September 28, 2026, BeyondSpring Inc. (the “Company”)
entered into a Share Purchase and Collaboration Agreement (the “Purchase and Collaboration
Agreement”) with Dalian Wanchunbulin Pharmaceuticals Ltd., a limited liability company incorporated under the laws of the
People’s Republic of China (“China”) and a majority owned indirect
subsidiary of the Company (“Bulin”), and Biolin Investment Limited, a limited
company formed under the laws of Hong Kong (the “Investor” and, together
with the Company and Bulin, the “Parties”) to sell and transfer to the Investor
the entire issued share capital in BeyondSpring Ltd., a BVI business company incorporated under the laws of the British Virgin Islands
and a direct wholly owned subsidiary of the Company that indirectly holds the interests in Bulin (the “Equity
Interests” and, such sale and transfer, the “Sale”).
Pursuant to the terms and subject to the conditions set forth in the Purchase
and Collaboration Agreement, the Parties have established a strategic collaboration with respect to certain development activities involving
the conduct and completion of the China portion of DUBLIN-4, a global Phase 3 trial of Plinabulin in combination with docetaxel for the
treatment of patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations whose
disease has progressed following prior anti-PD-(L)1 antibody therapy and platinum-based chemotherapy (such trial, the “Ongoing
Trial”). The obligation on the part of the Investor to conduct and complete the China portion of the Ongoing Trial, and
to cause Bulin to take certain actions related thereto, constitutes the non-cash consideration for the Sale. No cash consideration will
be paid or payable by the Investor to the Company at the closing of the Sale (the “Closing”).
Pursuant to the terms and subject to the conditions set forth in the Purchase
and Collaboration Agreement, Bulin is required to, among other things, use commercially reasonable efforts to enroll a certain number
of patients in the China portion of the Ongoing Trial that the Company determines, in its sole discretion, is required to satisfy the
Company’s regulatory needs (the “Target Enrollment”) during the three
(3)-year period following the Closing (the “Enrollment Period”). If Bulin
fails to achieve the Target Enrollment prior to the expiration of the Enrollment Period, upon such expiration, among other things, the
Investor must transfer to the Company a proportional portion of the Equity Interests based on the enrollment shortfall; provided
that if the enrollment shortfall is equal to ninety percent (90%) or greater, the Investor must return one hundred percent (100%) of
the Equity Interests to the Company.
Under the Purchase and Collaboration Agreement, Bulin has also agreed to
grant to the Company, and the Company has agreed to receive from Bulin, an exclusive, irrevocable, perpetual, non-terminable, sublicensable,
transferable, fully paid-up, royalty-free license and right to use all data and information generated in connection with the China portion
of the Ongoing Trial for all uses other than certain limited uses, as well as a right of reference in all data related to Plinabulin in
combination with docetaxel. Additionally, Bulin and the Company have agreed to grant to each other certain freedom-to-operate licenses,
all on the terms and subject to the conditions contained in the Purchase and Collaboration Agreement. The Company intends for data generated
by or on behalf of Bulin in connection with the China portion of the Ongoing Trial to form part of an integrated global clinical dataset
in support of the Company’s registration strategy for Plinabulin.
The consummation of the Sale and the other transactions contemplated by
the Purchase and Collaboration Agreement is subject to customary conditions. No regulatory approval is required to effect the Closing.
The Purchase and Collaboration Agreement contains customary representations and warranties of the Company and Bulin, including those relating
to the business and operation of Bulin, and customary representations and warranties of the Investor. The Purchase and Collaboration Agreement
also contains specified termination rights for the Company and the Investor, including a mutual termination right in the event the Closing
has not occurred by such specified date as set forth in the Purchase and Collaboration Agreement and a termination right by the Company
if Bulin fails to achieve the Target Enrollment prior to the expiration of the Enrollment Period or if Bulin takes certain adverse actions
that affect the China portion of the Ongoing Trial.
The foregoing description of the Purchase and Collaboration Agreement and
the transactions contemplated thereby does not purport to be complete and is qualified in its entirety by reference to the Purchase and
Collaboration Agreement, a copy of which is filed as Exhibit 10.1 hereto and incorporated herein by reference.
ATM Program
On September 29, 2026, the Company entered into an Open Market Sale Agreement
(the “Sales Agreement”) with Citizens JMP Securities, LLC, as sales agent
and/or principal (the “Agent”), in connection with the Company’s “at-the-market
offering” program (the “ATM Program”) under which the Company may offer
and sell up to 9,200,000 ordinary shares, par value $0.0001 per share (the “Ordinary Shares”).
Subject to the terms and conditions of the Sales Agreement, the Agent
has agreed to use its commercially reasonable efforts to sell the Ordinary Shares from time to time, based upon the Company’s instructions.
The Agent will be entitled to a commission at a rate of up to 3.0% of the gross proceeds of such Ordinary Shares sold pursuant to the
Sales Agreement. Sales of Ordinary Shares under the Sales Agreement will be made by any method permitted by law that is deemed an “at-the-market
offering” as defined in Rule 415 under the Securities Act of 1933, as amended (the “Securities
Act”). The Sales Agreement contains customary representations and warranties of the parties and indemnification and contribution
provisions under which the Company has agreed to indemnify the Agent against certain liabilities, including liabilities under the Securities
Act. The Agent and the Company have the right, by giving written notice as specified in the Sales Agreement, to terminate the Sales Agreement.
The offering has been registered under the Securities Act pursuant to the
Company’s shelf registration statement initially filed on Form F-3 and subsequently amended on Form S-3 (Registration Statement
No. 333-280153), as supplemented by the Prospectus Supplement dated September 29, 2026 relating to the sale of the Ordinary Shares. This
report shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the Ordinary Shares
in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws
of any such state.
A copy of the Sales Agreement is attached as Exhibit 1.1 hereto and is
incorporated herein by reference. The foregoing description of the Sales Agreement does not purport to be complete and is qualified in
its entirety by reference to such exhibit.
A copy of the opinion of Maples and Calder (Hong Kong) LLP relating to
the validity of the securities to be issued pursuant to the Sales Agreement is filed herewith as Exhibit 5.1.
Item 8.01. Other Events.
On September 29, 2026, the Company issued a press release announcing, among
other things, the transactions described above, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No.
Exhibit
1.1
Open Market Sale Agreement, dated September 29, 2026, by and between BeyondSpring Inc. and
Citizens JMP Securities, LLC.
5.1
Opinion of Maples and Calder (Hong Kong) LLP.
10.1*#
Share Purchase and Collaboration Agreement, dated September 28, 2026, by and among BeyondSpring
Inc., Dalian Wanchunbulin Pharmaceuticals Ltd. and Biolin Investment Limited.
23.1
Consent of Maples and Calder (Hong Kong) LLP (included in Exhibit 5.1).
99.1
Press Release dated September 29, 2026
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
* The schedules and exhibits to this Exhibit have been omitted pursuant to Item 601(a)(5) of
Regulation S-K. The Company agrees to furnish supplementally a copy of such schedules and exhibits, or any section thereof, to the U.S.
Securities and Exchange Commission upon its request.
# Portions of this Exhibit have been omitted pursuant to Item 601(b)(10) of Regulation S-K.
The Company agrees to furnish supplementally an unredacted copy to the U.S. Securities and Exchange Commission upon its request.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report
to be signed on its behalf by the undersigned hereunto duly authorized.
BeyondSpring Inc.
Date: September 29, 2026
By:
/s/ Min Qiu
Min Qiu
Chief Executive Officer
EX-1.1 — EXHIBIT 1.1
EX-1.1
Filename: exh_11.htm · Sequence: 2
EdgarFiling
Exhibit 1.1
OPEN MARKET SALE AGREEMENT
September 29, 2026
Citizens JMP Securities, LLC
c/o Citizens JMP Securities, LLC
1301 Avenue of the Americas, 2nd Floor
New York, NY 10019
BeyondSpring Inc., a Cayman Islands exempted company
(the “Company”), proposes, subject to the terms and conditions stated herein, to issue and sell from time to time through
Citizens JMP Securities, LLC, as sales agent and/or principal (the “Agent”), ordinary shares of the Company, par value
$0.0001 per share (the “Ordinary Shares”), on the terms set forth in this agreement (this “Agreement”).
Section 1.
DEFINITIONS
(a) Certain Definitions. For purposes of this Agreement, capitalized terms used herein and not otherwise
defined shall have the following respective meanings:
“Affiliate” of a Person means another
Person that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, such
first- mentioned Person. The term “control” (including the terms “controlling,” “controlled by” and
“under common control with”) means the possession, direct or indirect, of the power to direct or cause the direction of the
management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise.
“Agency Period” means the period
commencing on the date of this Agreement and expiring on the earliest to occur of (x) the date on which the Agent shall have placed the
Maximum Program Amount pursuant to this Agreement and (y) the date this Agreement is terminated pursuant to Section 7.
“Commission” means the U.S. Securities
and Exchange Commission.
“Exchange Act” means the Securities
Exchange Act of 1934, as amended, and the rules and regulations of the Commission thereunder.
“Floor Price” means the minimum
price set by the Company in the Issuance Notice below which the Agent shall not sell Shares during the applicable period set forth in
the Issuance Notice, which may be adjusted by the Company at any time during the period set forth in the Issuance Notice by delivering
written notice of such change to the Agent and which in no event shall be less than $1.00 without the prior written consent of the Agent,
which may be withheld in the Agent’s sole discretion.
“Issuance Amount” means the aggregate
Sales Price of the Shares to be sold by the Agent pursuant to any Issuance Notice.
“Issuance Notice” means a written
notice delivered to the Agent by the Company in accordance with this Agreement in the form attached hereto as Exhibit A that is
executed by its Chief Executive Officer, President or Chief Financial Officer.
“Issuance Notice Date” means any
Trading Day during the Agency Period that an Issuance Notice is delivered pursuant to Section 3(b)(i).
“Issuance Price” means the Sales
Price less the Selling Commission.
“Maximum Program Amount” means Ordinary
Shares with an aggregate Sales Price of the lesser of (a) the number or dollar amount of Ordinary Shares registered under the effective
Registration Statement (defined below) pursuant to which the offering is being made, (b) the number of authorized but unissued Ordinary
Shares (less Ordinary Shares issuable upon exercise, conversion or exchange of any outstanding securities of the Company or otherwise
reserved from the Company’s authorized capital stock), (c) the number or dollar amount of Ordinary Shares permitted to be sold under
Form S-3 (including General Instruction I.B.6 thereof, if applicable), or (d) the number or dollar amount of Ordinary Shares for which
the Company has filed a Prospectus (defined below).
“Person” means an individual or
a corporation, partnership, limited liability company, trust, incorporated or unincorporated association, joint venture, joint stock company,
governmental authority or other entity of any kind.
“Principal Market” means the Nasdaq
Capital Market or such other national securities exchange on which the Ordinary Shares, including any Shares, are then listed.
“Sales Price” means the actual sale
execution price of each Share placed by the Agent pursuant to this Agreement.
“Securities Act” means the Securities
Act of 1933, as amended, and the rules and regulations of the Commission thereunder.
“Selling Commission” means up to
three percent (3.0%) of the gross proceeds of Shares sold pursuant to this Agreement, or as otherwise agreed between the Company and the
Agent with respect to any Shares sold pursuant to this Agreement.
“Settlement Date” means the first
Trading Day (or any such shorter settlement cycle as may be in effect pursuant to Rule 15c6-1 under the Exchange Act from time to time)
following the date of the Issuance Notice on which Shares are sold pursuant to this Agreement, when the Company shall deliver to the Agent
the amount of Shares sold on such Trading Day and the Agent shall deliver to the Company the Issuance Price received on such sales.
“Shares” shall mean the Company’s
Ordinary Shares issued or issuable pursuant to this Agreement.
“Trading Day” means any day on which
the Principal Market is open for trading.
Section 2.
REPRESENTATIONS AND WARRANTIES OF THE COMPANY
The Company represents and warrants to, and agrees
with, the Agent that as of (1) the date of this Agreement, (2) each Issuance Notice Date, (3) each Settlement Date, (4) each Triggering
Event Date and (5) as of each Time of Sale (each of the times referenced above is referred to herein as a “Representation Date”),
except as may be disclosed in the Prospectus (including any documents incorporated by reference therein and any supplements thereto) on
or before a Representation Date:
(a) Registration Statement. The Company has
prepared and filed with the Commission a shelf registration statement initially on Form F-3 (File No. 333-280153), which was subsequently
amended to provide for registration under Form S-3, that contains a base prospectus (the “Base Prospectus”). Such registration
statement registers the issuance and sale by the Company of the Shares under the Securities Act. The Company may file one or more additional
registration statements from time to time that will contain a base prospectus and related prospectus or prospectus supplement, if applicable,
with respect to the Shares. Except where the context otherwise requires, such registration statement(s), including any information deemed
to be a part thereof pursuant to Rule 430B under the Securities Act, including all financial statements, exhibits and schedules thereto
and all documents incorporated or deemed to be incorporated therein by reference pursuant to Item 12 of Form S-3 under the Securities
Act as from time to time amended or supplemented, is herein referred to as the “Registration Statement,” and the prospectus
constituting a part of such registration statement(s), together with any prospectus supplement filed with the Commission pursuant to Rule
424(b) under the Securities Act relating to a particular issuance of the Shares, including all documents incorporated or deemed to be
incorporated therein by reference pursuant to Item 12 of Form S-3 under the Securities Act, in each case, as from time to time amended
or supplemented, is referred to herein as the “Prospectus,” except that if any revised prospectus is provided to the
Agent by the Company for use in connection with the offering of the Shares that is not required to be filed by the Company pursuant to
Rule 424(b) under the Securities Act, the term “Prospectus” shall refer to such revised prospectus from and after the
time it is first provided to the Agent for such use. The Registration Statement at the time it became effective on August 18, 2025 is
herein called the “Original Registration Statement.” As used in this Agreement, the terms “amendment” or
“supplement” when applied to the Registration Statement or the Prospectus shall be deemed to include the filing by the Company
with the Commission of any document under the Exchange Act after the date hereof that is or is deemed to be incorporated therein by reference.
All references in this Agreement to financial statements
and schedules and other information which is “contained,” “included” or “stated” in the Registration
Statement or the Prospectus (and all other references of like import) shall be deemed to mean and include all such financial statements
and schedules and other information which is or is deemed to be incorporated by reference in or otherwise deemed under the Securities
Act to be a part of or included in the Registration Statement or the Prospectus, as the case may be, as of any specified date; and all
references in this Agreement to amendments or supplements to the Registration Statement or the Prospectus shall be deemed to mean and
include, without limitation, the filing of any document under the Exchange Act which is or is deemed to be incorporated by reference in
or otherwise deemed under the Securities Act to be a part of or included in the Registration Statement or the Prospectus, as the case
may be, as of any specified date.
At the time the Registration Statement was or will
be originally declared effective and at the time the Company’s most recent annual report on Form 10-K was filed with the Commission,
if later, the Company met the then-applicable requirements for use of Form S-3 under the Securities Act. During the Agency Period, each
time the Company files an annual report on Form 10-K the Company will meet the then-applicable requirements for use of Form S-3 under
the Securities Act.
(b) Compliance with Registration Requirements.
The Original Registration Statement and any Rule 462(b) Registration Statement have been declared effective by the Commission under the
Securities Act. The Company has complied to the Commission’s satisfaction with all requests of the Commission for additional or
supplemental information. No stop order suspending the effectiveness of the Registration Statement or any Rule 462(b) Registration Statement
is in effect and no proceedings for such purpose have been instituted or are pending or, to the best knowledge of the Company, are contemplated
or threatened by the Commission.
The Prospectus when filed complied in all material
respects with the Securities Act and, if filed with the Commission through its Electronic Data Gathering, Analysis and Retrieval system
(“EDGAR”) (except as may be permitted by Regulation S-T under the Securities Act), was identical to the copy thereof
delivered to the Agent for use in connection with the issuance and sale of the Shares. Each of the Registration Statement, any Rule 462(b)
Registration Statement and any post-effective amendment thereto, at the time it became effective and at all subsequent times, complied
and will comply in all material respects with the Securities Act and did not and will not contain any untrue statement of a material fact
or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading. As of the date
of this Agreement, the Prospectus and any Free Writing Prospectus (as defined below) considered together (collectively, the “Time
of Sale Information”) did not contain any untrue statement of a material fact or omit to state a material fact necessary to
make the statements therein, in the light of the circumstances under which they were made, not misleading. The Prospectus, as amended
or supplemented, as of its date and at all subsequent times, did not and will not contain any untrue statement of a material fact or omit
to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made,
not misleading. The representations and warranties set forth in the three immediately preceding sentences do not apply to statements in
or omissions from the Registration Statement, any Rule 462(b) Registration Statement, or any post-effective amendment thereto, or the
Prospectus, or any amendments or supplements thereto, made in reliance upon and in conformity with information relating to the Agent furnished
to the Company in writing by the Agent expressly for use therein, it being understood and agreed that the only such information furnished
by the Agent to the Company consists of the information described in Section 6 below. There are no contracts or other documents
required to be described in the Prospectus or to be filed as exhibits to the Registration Statement which have not been described or filed
as required. The Registration Statement and the offer and sale of the Shares as contemplated hereby meet the requirements of Rule 415
under the Securities Act and comply in all material respects with said rule.
(c) Ineligible Issuer Status. The Company is
not an “ineligible issuer” in connection with the offering of the Shares pursuant to Rules 164, 405 and 433 under the Securities
Act. Any Free Writing Prospectus that the Company is required to file pursuant to Rule 433(d) under the Securities Act has been, or will
be, filed with the Commission in accordance with the requirements of the Securities Act. Each Free Writing Prospectus that the Company
has filed, or is required to file, pursuant to Rule 433(d) under the Securities Act or that was prepared by or behalf of or used or referred
to by the Company complies or will comply in all material respects with the requirements of Rule 433 under the Securities Act including
timely filing with the Commission or retention where required and legending, and each such Free Writing Prospectus, as of its issue date
and at all subsequent times through the completion of the issuance and sale of the Shares did not, does not and will not include any information
that conflicted, conflicts with or will conflict with the information contained in the Registration Statement or the Prospectus, including
any document incorporated by reference therein. Except for the Free Writing Prospectuses, if any, and electronic road shows, if any, furnished
to you before first use, the Company has not prepared, used or referred to, and will not, without your prior consent, prepare, use or
refer to, any Free Writing Prospectus.
(d) Incorporated Documents. The documents incorporated
or deemed to be incorporated by reference in the Registration Statement and the Prospectus, at the time they were filed with the Commission,
complied in all material respects with the requirements of the Exchange Act, as applicable, and, when read together with the other information
in the Prospectus, do not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein
or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading.
(e) Exchange Act Compliance. The documents incorporated
or deemed to be incorporated by reference in the Prospectus, at the time they were or hereafter are filed with the Commission, and any
Free Writing Prospectus or amendment or supplement thereto complied and will comply in all material respects with the requirements of
the Exchange Act, and, when read together with the other information in the Prospectus, at the time the Registration Statement and any
amendments thereto become effective and at each Settlement Date, as the case may be, will not contain an untrue statement of a material
fact or omit to state a material fact required to be stated therein or necessary to make the fact required to be stated therein or necessary
to make the statements therein, in the light of the circumstances under which they were made, not misleading.
(f) Statistical and Market-Related Data. The
statistical, demographic and market-related data included in the Registration Statement and the Prospectus are based on or derived from
sources that the Company believes to be reliable and accurate or represent the Company’s good faith estimates that are made on the
basis of data derived from such sources.
(g) Disclosure Controls and Procedures; Deficiencies
in or Changes to Internal Control Over Financial Reporting. The Company has established and maintains disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)), which (i) are designed to ensure that material information relating to the
Company, including its consolidated subsidiaries, is made known to the Company’s principal executive officer and its principal financial
officer by others within those entities, particularly during the periods in which the periodic reports required under the Exchange Act
are being prepared; (ii) have been evaluated by management of the Company for effectiveness as of the end of the Company’s most
recent fiscal quarter; and (iii) are effective in all material respects to perform the functions for which they were established. Based
on the most recent evaluation of its disclosure controls and procedures, the Company is not aware of (i) any significant deficiencies
or material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely
affect the Company’s ability to record, process, summarize and report financial information; or (ii) any fraud, whether or not material,
that involves management or other employees who have a significant role in the Company’s internal control over financial reporting,
in each case except as would not result in a Material Adverse Change. The Company is not aware of any change in its internal control over
financial reporting that has occurred during its most recent fiscal quarter that has materially affected, or is reasonably likely to materially
affect, the Company’s internal control over financial reporting.
(h) This Agreement. This Agreement has been
duly authorized, executed and delivered by, and is a valid and binding agreement of, the Company, enforceable in accordance with its terms,
except as rights to indemnification hereunder may be limited by applicable law and except as the enforcement hereof may be limited by
bankruptcy, insolvency, reorganization, moratorium or other similar laws relating to or affecting the rights and remedies of creditors
or by general equitable principles.
(i) Authorization of the Shares. The Shares
have been duly authorized for issuance and sale pursuant to this Agreement and, when issued and delivered by the Company pursuant to this
Agreement, will be validly issued, fully paid and nonassessable, and the issuance and sale of the Shares is not subject to any preemptive
rights, rights of first refusal or other similar rights to subscribe for or purchase the Shares.
(j) No Applicable Registration or Other Similar
Rights. Except as otherwise disclosed in the Prospectus, there are no persons with registration or other similar rights to have any
equity or debt securities registered for sale under the Registration Statement or included in the offering contemplated by this Agreement,
except for such rights as have been duly waived.
(k) No Material Adverse Change. Except as otherwise
disclosed in the Registration Statement and Prospectus subsequent to the respective dates as of which information is given in the Registration
Statement and the Prospectus: (i) there has been no material adverse change, or any development that could reasonably be expected to result
in a material adverse change, in the condition, financial or otherwise, or in the earnings, business, operations or prospects, whether
or not arising from transactions in the ordinary course of business, of the Company and its subsidiaries, considered as one entity (any
such change is called a “Material Adverse Change”); (ii) the Company and its subsidiaries, considered as one entity,
have not incurred any material liability or obligation, indirect, direct or contingent, not in the ordinary course of business nor entered
into any material transaction or agreement not in the ordinary course of business; and (iii) there has been no dividend or distribution
of any kind declared, paid or made by the Company or, except for dividends paid to the Company or other subsidiaries, any of its subsidiaries
on any class of capital stock or repurchase or redemption by the Company or any of its subsidiaries of any class of capital stock.
(l) Independent Accountants. The independent
registered public accounting firms which have expressed their opinions with respect to the financial statements (which term as used in
this Agreement includes the related notes thereto) filed with the Commission as a part of the Registration Statement and included in the
Prospectus are (i) independent public or certified public accountants as required by the Securities Act and the Exchange Act, (ii) in
compliance with the applicable requirements relating to the qualification of accountants under Rule 2-01 of Regulation S-X; and (iii)
registered public accounting firms as defined by the Public Company Accounting Oversight Board (the “PCAOB”) whose
registration has not been suspended or revoked and who has not requested such registration to be withdrawn.
(m) Preparation of the Financial Statements.
The financial statements filed with the Commission as a part of the Registration Statement and included in the Prospectus present fairly
the consolidated financial position of the Company and its subsidiaries as of and at the dates indicated and the results of their operations
and cash flows for the periods specified. Such financial statements have been prepared in conformity with generally accepted accounting
principles as applied in the United States applied on a consistent basis throughout the periods involved, except as may be expressly stated
in the related notes thereto. No other financial statements or supporting schedules are required to be included in the Registration Statement
or the Prospectus. The financial data set forth in the Prospectus under the captions “Capitalization” fairly present the information
set forth therein on a basis consistent with that of the audited financial statements contained in the Registration Statement and the
Prospectus. No person who has been suspended or barred from being associated with a registered public accounting firm, or who has failed
to comply with any sanction pursuant to Rule 5300 promulgated by the PCAOB, has participated in or otherwise aided the preparation of,
or audited, the financial statements, supporting schedules or other financial data filed with the Commission as a part of the Registration
Statement and included in the Prospectus.
(n) Company’s Accounting System. The Company
and each of its subsidiaries make and keep accurate books and records and maintain a system of internal accounting controls sufficient
to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorization;
(ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting
principles as applied in the United States and to maintain accountability for assets; (iii) access to assets is permitted only in accordance
with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets
at reasonable intervals and appropriate action is taken with respect to any differences.
(o) Incorporation and Good Standing of the Company.
The Company has been duly incorporated and is validly existing as an exempted company in good standing under the laws of the Cayman Islands
and has the power and authority (corporate or other) to own, lease and operate its properties and to conduct its business as described
in the Prospectus and to enter into and perform its obligations under this Agreement. The Company is duly qualified as a foreign corporation
to transact business and is in good standing in each jurisdiction in which such qualification is required, whether by reason of the ownership
or leasing of property or the conduct of business except as would not result in a Material Adverse Change.
(p) Incorporation and Good Standing of the Company’s
Subsidiaries. Each subsidiary of the Company has been duly incorporated or organized, as the case may be, and is validly existing
as a corporation, partnership or limited liability company, as applicable, in good standing under the laws of the jurisdiction of its
incorporation or organization and has the power and authority (corporate or other) to own, lease and operate its properties and to conduct
its business as described in the Prospectus and is duly qualified as a foreign corporation, partnership or limited liability company,
as applicable, to transact business and is in good standing in each jurisdiction in which such qualification is required, whether by reason
of the ownership or leasing of property or the conduct of business except as would not result in a Material Adverse Change. All of the
issued and outstanding capital stock or other equity or ownership interests of each subsidiary have been duly authorized and validly issued,
are fully paid and non-assessable and are owned by the Company, directly or through subsidiaries, free and clear of any security interest,
mortgage, pledge, lien, encumbrance or adverse claim. The Company does not own control, directly or indirectly, any corporation, association
or other entity other than (i) the subsidiaries listed on Exhibit 21.1 to the Company’s most recent annual report on Form 10-K and
(ii) such other entities omitted from Exhibit 21.1 which, when such omitted entities are considered in the aggregate as a single subsidiary,
would not constitute a “significant subsidiary” within the meaning of Rule 1-02(w) of Regulation S-X.
(q) Capitalization and Other Capital Stock Matters.
The authorized, issued and outstanding share capital of the Company is as set forth in the sections of the Registration Statement and
the Prospectus entitled “Description of Share Capital” and “Capitalization” (other than for subsequent issuances,
if any, pursuant to employee benefit plans described in the Prospectus or upon the exercise of outstanding options described in the Registration
Statement or the Prospectus). The Ordinary Shares (including the Shares) conform in all material respects to the description thereof contained
in the Prospectus. All of the issued and outstanding Ordinary Shares have been duly authorized and validly issued, are fully paid and
non-assessable and have been issued in compliance with federal and state securities laws. None of the issued and outstanding Ordinary
Shares was issued in violation of any pre-emptive rights, rights of first refusal or other similar rights to subscribe for or purchase
securities of the Company. There are no authorized or outstanding options, warrants, preemptive rights, rights of first refusal or other
rights to purchase, or equity or debt securities convertible into or exchangeable or exercisable for, any shares in the capital of the
Company or capital stock of any of its subsidiaries other than those accurately described in the Registration Statement or the Prospectus.
The description of the Company’s share option, share bonus and other share plans or arrangements, and the options or other rights
granted thereunder, set forth in the Registration Statement and the Prospectus accurately and fairly presents the information required
to be shown with respect to such plans, arrangements, options and rights.
(r) Stock Exchange Listing. The Ordinary Shares
are registered pursuant to Section 12(b) of the Exchange Act and are listed on the Principal Market and the Company has taken no action
designed to, or likely to have the effect of, terminating the registration of the Ordinary Shares under the Exchange Act or delisting
the Ordinary Shares from the Principal Market, nor has the Company received any notification that the Commission or the Principal Market
is contemplating terminating such registration or listing, other than pursuant to the written notification the Company received from the
Listing Qualifications Department of The Nasdaq Stock Market LLC dated September 17, 2026, as further described in the Company’s
Current Report on Form 8-K filed with the Commission on September 18, 2026.
(s) Non-Contravention of Existing Instruments; No
Further Authorizations or Approvals Required. Neither the Company nor any of its subsidiaries is in violation of its charter or by-laws,
partnership agreement or operating agreement or similar organizational document, as applicable, or is in default (or, with the giving
of notice or lapse of time, would be in default) (“Default”) under any indenture, mortgage, loan or credit agreement,
note, contract, franchise, lease or other instrument to which the Company or any of its subsidiaries is a party or by which it or any
of them may be bound (including, without limitation, any credit agreement, indenture, pledge agreement, security agreement or other instrument
or agreement evidencing, guaranteeing, securing or relating to indebtedness of the Company or any of its subsidiaries ), or to which any
of the property or assets of the Company or any of its subsidiaries is subject (each, an “Existing Instrument”), except
for such Defaults as would not, individually or in the aggregate, result in a Material Adverse Change. The Company’s execution,
delivery and performance of this Agreement, consummation of the transactions contemplated hereby and the issuance and sale of the Shares
(i) have been duly authorized by all necessary corporate action and will not result in any violation of the provisions of the charter
or by-laws, partnership agreement or operating agreement or similar organizational document of the Company or any subsidiary, as applicable;
(ii) will not conflict with or constitute a breach of, or Default under, or result in the creation or imposition of any lien, charge or
encumbrance upon any property or assets of the Company or any of its subsidiaries pursuant to, or require the consent of any other party
to, any Existing Instrument; and (iii) will not result in any violation of any law, administrative regulation or administrative or court
decree applicable to the Company or any subsidiary. No consent, approval, authorization or other order of, or registration or filing with,
any court or other governmental or regulatory authority or agency, is required for the Company’s execution, delivery and performance
of this Agreement and consummation of the transactions contemplated hereby and by the Prospectus, except (i) such as have been obtained
or made by the Company and are in full force and effect under the Securities Act, applicable state securities or blue sky laws and from
FINRA.
(t) No Material Actions or Proceedings. Except
as otherwise disclosed in the Prospectus, there are no legal or governmental actions, suits or proceedings pending or, to the best of
the Company’s knowledge, threatened (i) against or affecting the Company or any of its subsidiaries; (ii) which have as the subject
thereof any officer or director of, or property owned or leased by, the Company or any of its subsidiaries; or (iii) relating to environmental
or discrimination matters, where in any such case (A) there is a reasonable possibility that such action, suit or proceeding might be
determined adversely to the Company, such subsidiary or such officer or director, (B) any such action, suit or proceeding, if so determined
adversely, would reasonably be expected to result in a Material Adverse Change or adversely affect the consummation of the transactions
contemplated by this Agreement or (C) any such action, suit or proceeding is or would be material in the context of the sale of Shares.
Except as otherwise disclosed in the Prospectus, no material labor dispute with the employees of the Company or any of its subsidiaries,
or with the employees of any principal supplier, manufacturer, customer or contractor of the Company, exists or, to the best of the Company’s
knowledge, is threatened or imminent.
(u) Intellectual Property Rights. Except as
otherwise disclosed in the Prospectus, to the Company’s knowledge, the Company and its subsidiaries own, possess, license or have
other rights to use, on reasonable terms, all patents, patent applications, trade and service marks, trade and service mark registrations,
trade names, copyrights, licenses, inventions, trade secrets, technology, know-how and other intellectual property (collectively, the
“Intellectual Property”) necessary for the conduct of the Company’s business as now conducted or as proposed
in the Prospectus to be conducted. Except as set forth in the Prospectus, (a) to the Company’s knowledge, there are no exclusive
rights of third parties to any such Intellectual Property; (b) to the Company’s knowledge, there is no material infringement by
third parties of any such Intellectual Property; (c) there is no pending or, to the Company’s knowledge, threatened action, suit,
proceeding or claim by others, challenging the Company’s rights in or to any such Intellectual Property, and the Company is unaware
of any facts which would form a reasonable basis for any such claim; (d) there is no pending or, to the Company’s knowledge, threatened
action, suit, proceeding or claim by others challenging the validity or scope of any such Intellectual Property; (e) there is no pending
or, to the Company’s knowledge, threatened action, suit, proceeding or claim by others that the Company infringes or otherwise violates
any patent, trademark, copyright, trade secret or other proprietary rights of others, and the Company is unaware of any other fact which
would form a reasonable basis for any such claim; (f) to the Company’s knowledge, there is no U.S. patent or published U.S. patent
application which contains claims that dominate or may dominate any Intellectual Property described in the Prospectus as being owned by
or licensed to the Company or that interferes with the issued or pending claims of any such Intellectual Property; and (g) there is no
prior art of which the Company is aware that may render any U.S. patent held by the Company invalid or any non-provisional U.S. patent
application held by the Company unpatentable which has not been disclosed to or cited by the U.S. Patent and Trademark Office during the
pendency of such patents and applications.
(v) All Necessary Permits, etc. Except as otherwise
disclosed in the Prospectus, the Company and each subsidiary possess such valid and current certificates, authorizations or permits issued
by the appropriate state, federal or foreign regulatory agencies or bodies necessary for the ownership or lease of its properties or the
conduct of its businesses as described in the Registration Statement and the Prospectus, or to permit all clinical and nonclinical studies
and trials conducted by or on behalf of the Company and its subsidiaries, including, without limitation, all necessary U.S. Food and Drug
Administration (the “FDA”), China Food and Drug Administration (“CFDA”) and applicable foreign regulatory
agency approvals; and neither the Company nor any subsidiary has received, or has any reason to believe that it will receive, any
notice of proceedings relating to the revocation or modification of, or non-compliance with, any such certificate, authorization or permit
which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could result in a Material Adverse Change.
(w) Title to Properties. Except as otherwise
disclosed in the Prospectus, the Company and each of its subsidiaries has good and marketable title to all of the real and personal property
and other assets reflected as owned in the financial statements referred to in Section 2(m) above, in each case free and clear
of any security interests, mortgages, liens, encumbrances, equities, adverse claims and other defects, except such as do not materially
and adversely affect the value of such property and do not materially interfere with the use made or proposed to be made of such property
by the Company or such subsidiary. The real property, improvements, equipment and personal property held under lease by the Company or
any subsidiary are held under valid and enforceable leases, with such exceptions as are not material and do not materially interfere with
the use made or proposed to be made of such real property, improvements, equipment or personal property by the Company or such subsidiary.
(x) Tax Law Compliance. The Company has filed
all tax returns that are required to be filed or has requested extensions thereof (except in any case in which the failure to so file
would not individually or in the aggregate, reasonably be expected to have a Material Adverse Change), except as set forth in or contemplated
in the Prospectus and has paid all taxes required to be paid by it and any other assessment, fine or penalty levied against it, to the
extent that any of the foregoing is due and payable, except for any such assessment, fine or penalty that is currently being contested
in good faith or as would not individually or in the aggregate, reasonably be expected to have a Material Adverse Change, except as set
forth in or contemplated in the Prospectus.
(y) Company Not an “Investment Company.”
The Company has been advised of the rules and requirements under the Investment Company Act of 1940, as amended (the “Investment
Company Act”). The Company is not, and will not be, either after receipt of payment for the Shares or after the application
of the proceeds therefrom as described under “Use of Proceeds” in the Prospectus, an “investment company”
within the meaning of Investment Company Act and will conduct its business in a manner so that it will not become subject to the Investment
Company Act.
(z) Insurance. Except as otherwise disclosed
in the Prospectus, each of the Company and its subsidiaries are insured by recognized, financially sound and reputable institutions with
policies in such amounts and with such deductibles and covering such risks as are generally deemed adequate and customary for their businesses
including, but not limited to, policies covering real and personal property owned or leased by the Company and its subsidiaries against
theft, damage, destruction, acts of vandalism and earthquakes and policies covering the Company and its subsidiaries for product liability
claims and clinical trial liability claims. The Company has no reason to believe that it or any subsidiary will not be able (i) to renew
its existing insurance coverage as and when such policies expire; or (ii) to obtain comparable coverage from similar institutions as may
be necessary or appropriate to conduct its business as now conducted and at a cost that would not result in a Material Adverse Change.
Neither the Company nor any subsidiary has been denied any insurance coverage which it has sought or for which it has applied.
(aa) No Price Stabilization or Manipulation; Compliance
with Regulation M. The Company has not taken, directly or indirectly, any action designed to or that might be reasonably expected
to cause or result in stabilization or manipulation of the price of the Ordinary Shares or any other “reference security”
(as defined in Rule 100 of Regulation M under the Exchange Act (“Regulation M”)) whether to facilitate the sale or
resale of the Shares or otherwise, and has taken no action which would directly or indirectly violate Regulation M. The Company acknowledges
that the Agent may engage in passive market making transactions in the Shares on the Principal Market in accordance with Regulation M.
(bb) Related Party Transactions. There are no
business relationships or related-party transactions involving the Company or any of its subsidiaries or any other person required to
be described in the Prospectus which have not been described as required.
(cc) FINRA Matters. All of the information provided
to the Agent or to counsel for the Agent by the Company, its officers and directors and the holders of any securities (debt or equity)
or options to acquire any securities of the Company in connection with letters, filings or other supplemental information provided to
Financial Industry Regulatory Authority, Inc. (“FINRA”) pursuant to FINRA Rules 5110, 5190 and 5121 is true, complete
and correct. The Company meets the requirements for use of Form S-3 under the Securities Act specified in FINRA Rule 5110(h)(1)(C). Neither
the Company nor any of its Affiliates directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is
under common control with, or is a person associated with any member firm of FINRA.
(dd) No Unlawful Contributions or Other Payments.
Except as otherwise disclosed in the Prospectus, neither the Company nor any of its subsidiaries nor, to the best of the Company’s
knowledge, any employee or agent of the Company or any subsidiary, has made any contribution or other payment to any official of, or candidate
for, any federal, state or foreign office in violation of any law or of the character required to be disclosed in the Registration Statement
and the Prospectus.
(ee) Compliance with Environmental Laws. Except
as described in the Prospectus and except as would not, singly or in the aggregate, result in a Material Adverse Change, (i) neither the
Company nor any of its subsidiaries is in violation of any federal, state, local or foreign statute, law, rule, regulation, ordinance,
code, policy or rule of common law or any judicial or administrative interpretation thereof, including any judicial or administrative
order, consent, decree or judgment, relating to pollution or protection of human health, the environment (including, without limitation,
ambient air, surface water, groundwater, land surface or subsurface strata) or wildlife, including, without limitation, laws and regulations
relating to the release or threatened release of chemicals, pollutants, contaminants, wastes, toxic substances, hazardous substances,
petroleum or petroleum products (collectively, “Hazardous Materials”) or to the manufacture, processing, distribution,
use, treatment, storage, disposal, transport or handling of Hazardous Materials (collectively, “Environmental Laws”),
(ii) the Company and its subsidiaries have all permits, authorizations and approvals required under any applicable Environmental Laws
and are each in compliance with their requirements, (iii) there are no pending or threatened administrative, regulatory or judicial actions,
suits, demands, demand letters, claims, liens, notices of noncompliance or violation, investigation or proceedings relating to any Environmental
Law against the Company or any of its subsidiaries and (iv) there are no events or circumstances that might reasonably be expected to
form the basis of an order for clean-up or remediation, or an action, suit or proceeding by any private party or governmental body or
agency, against or affecting the Company or any of its subsidiaries relating to Hazardous Materials or any Environmental Laws.
(ff) Periodic Review of Costs of Environmental Compliance.
In the ordinary course of its business, the Company conducts a periodic review of the effect of Environmental Laws on the business, operations
and properties of the Company and its subsidiaries, in the course of which it identifies and evaluates associated costs and liabilities
(including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with
Environmental Laws or any permit, license or approval, any related constraints on operating activities and any potential liabilities to
third parties). On the basis of such review and the amount of its established reserves, the Company has reasonably concluded that such
associated costs and liabilities would not, individually or in the aggregate, result in a Material Adverse Change.
(gg) ERISA Compliance. Except as would not reasonably
be expected to have a Material Adverse Change, none of the following events has occurred or exists: (i) a failure to fulfill the obligations,
if any, under the minimum funding standards of Section 302 of the United States Employee Retirement Income Security Act of 1974, as amended,
and the regulations and published interpretations thereunder (“ERISA”), with respect to any Plan (as defined below),
determined without regard to any waiver of such obligations or extension of any amortization period; (ii) an audit or investigation by
the Internal Revenue Service, the U.S. Department of Labor, the Pension Benefit Guaranty Corporation or any other federal or state governmental
agency or any foreign regulatory agency with respect to the employment or compensation of employees by any of the Company or any of its
subsidiaries; (iii) any breach of any contractual obligation, or any violation of law or applicable qualification standards, with respect
to the employment or compensation of employees by the Company or any of its subsidiaries; (iv) an increase in the aggregate amount of
contributions required to be made to all Plans in the current fiscal year of the Company and its subsidiaries compared to the amount of
such contributions made in the most recently completed fiscal year of the Company and its subsidiaries; (v) an increase in the “accumulated
post-retirement benefit obligations” (within the meaning of Statement of Financial Accounting Standards 106) of the Company and
its subsidiaries compared to the amount of such obligations in the most recently completed fiscal year of the Company and its subsidiaries;
(vi) any event or condition giving rise to a liability under Title IV of ERISA; or (vii) the filing of a claim by one or more employees
or former employees of the Company or any of its subsidiaries related to their employment. For purposes of this paragraph, the term “Plan”
means a plan (within the meaning of Section 3(3) of ERISA) subject to Title IV of ERISA with respect to which the Company or any of its
subsidiaries would reasonably be expected to have any material liability.
(hh) Brokers. Except as otherwise disclosed
in the Prospectus, there is no broker, finder or other party that is entitled to receive from the Company any brokerage or finder’s
fee or other fee or commission as a result of any transactions contemplated by this Agreement.
(ii) No Outstanding Loans or Other Extensions of
Credit. Except as otherwise disclosed in the Prospectus, since the adoption of Section 13(k) of the Exchange Act, neither the Company
nor any of its subsidiaries has extended or maintained credit, arranged for the extension of credit, or renewed any extension of credit,
in the form of a personal loan, to or for any director or executive officer (or equivalent thereof) of the Company and/or such subsidiary
except for such extensions of credit as are expressly permitted by Section 13(k) of the Exchange Act.
(jj) Compliance with Laws. Except as otherwise
disclosed in the Prospectus, based on the Company’s reasonable belief, the Company and each of its subsidiaries: (A) is and at all
times has been in compliance in all material respects with all statutes, rules, or regulations applicable to the ownership, testing, development,
manufacture, packaging, processing, use, distribution, labeling, storage, import, export or disposal of any product manufactured or distributed
by the Company, including, without limitation the U.S. Food, Drug and Cosmetic Act, the regulations promulgated pursuant to such laws,
including without limitation, regulations relating to Good Clinical Practices and Good Laboratory Practices and all other local, state,
federal, national, supranational and foreign laws and regulations relating to the regulation of the Company (“Applicable Laws”),
except for such non-compliance as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse
Change; (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence
or notice from the FDA or any other court, arbitrator or governmental authority alleging or asserting any material noncompliance with
any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto
required by any such Applicable Laws (“Authorizations”), except for such non-compliance as would not, individually
or in the aggregate, have a Material Adverse Change; (C) possesses all material Authorizations and such Authorizations are valid
and in full force and effect and are not in violation of any material term of any such Authorizations; (D) has not received notice
of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority
or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations and to the knowledge
of the Company, no such proceeding has been threatened by such governmental authority; (E) has not received any written notice that
any governmental authority has taken, is taking or will take action to materially limit, suspend, modify or revoke any Authorizations
and to the knowledge of the Company, no such proceeding has been threatened by any such governmental authority; and (F) has filed,
obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements
or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications,
records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented
by a subsequent submission).
(kk) Dividend Restrictions. Except as disclosed
in the Prospectus, no subsidiary of the Company is prohibited or restricted, directly or indirectly, from paying dividends to the Company,
or from making any other distribution with respect to such subsidiary’s equity securities or from repaying to the Company or any
other subsidiary of the Company any amounts that may from time to time become due under any loans or advances to such subsidiary from
the Company or from transferring any property or assets to the Company or to any other subsidiary.
(ll) Foreign Corrupt Practices Act. Neither
the Company nor any of its subsidiaries nor, to the knowledge of the Company, any director, officer, agent, employee, affiliate or other
person acting on behalf of the Company or any of its subsidiaries is aware of or has taken any action, directly or indirectly, that could
result in a violation or a sanction for violation by such persons of the Foreign Corrupt Practices Act of 1977 or the U.K. Bribery Act
2010, each as may be amended, or similar law of any other relevant jurisdiction, or the rules or regulations thereunder; and the Company
and its subsidiaries have instituted and maintain policies and procedures to ensure compliance therewith. No part of the proceeds of the
offering will be used, directly or indirectly, in violation of the Foreign Corrupt Practices Act of 1977 or the U.K. Bribery Act 2010,
each as may be amended, or similar law of any other relevant jurisdiction, or the rules or regulations thereunder.
(mm) Money Laundering Laws. The operations of
the Company and its subsidiaries are, and have been conducted at all times, in compliance with applicable financial recordkeeping and
reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of all
applicable jurisdictions, the rules and regulations thereunder and any related or similar applicable rules, regulations or guidelines,
issued, administered or enforced by any governmental agency (collectively, the “Money Laundering Laws”) and no action,
suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any of
its subsidiaries with respect to the Money Laundering Laws is pending or, to the best knowledge of the Company, threatened.
(nn) Clinical Studies. All preclinical studies
and clinical trials conducted by or on behalf of the Company that are material to the Company and its subsidiaries, taken as a whole,
have been adequately described in the Registration Statement and the Prospectus in all material respects. The preclinical studies and
clinical trials conducted by or on behalf of the Company were and, if still ongoing, are being conducted in material compliance with all
laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable
to preclinical studies and clinical trials from which data will be submitted to support marketing approval, except where the failure to
be in compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change. The descriptions
in the Registration Statement and the Prospectus of the results of such studies and trials are accurate and complete in all material respects
and fairly present the data derived from such studies. The Company has no knowledge of any well-controlled Phase 2 or Phase 3 clinical
trial the aggregate results of which call into question in any material respect the results of any clinical trial conducted by or on behalf
of the Company that are described or referred to in the Registration Statement and the Prospectus. Except as disclosed in the Registration
Statement and the Prospectus, the Company has not received any written notices or statements from the FDA, the CFDA or any comparable
drug regulatory agency (each, a “Regulatory Authority”) imposing, requiring, requesting or suggesting a clinical hold,
termination, suspension or material modification for or of any preclinical studies or clinical trials that are described or the results
of which are referred to in the Registration Statement, the Prospectus. Except as disclosed in the Registration Statement and the Prospectus,
the Company has not received any notices or statements from any Regulatory Authority, and otherwise has no knowledge that (i) any investigational
new drug application for any potential product of the Company has been rejected or determined to be non-approvable or conditionally approvable;
or (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been,
will be or is reasonably likely to be suspended, revoked, materially modified or limited.
(oo) OFAC. Neither the Company nor any of its
subsidiaries nor, to the knowledge of the Company, any director, officer, agent, employee or affiliate of the Company or any of its subsidiaries
(i) is, or is controlled or 50% or more owned in the aggregate by or is acting on behalf of, one or more individuals or entities that
are currently the subject of any sanctions administered or enforced by the United States (including any administered or enforced by the
Office of Foreign Assets Control of the U.S. Department of the Treasury, the U.S. Department of State or the Bureau of Industry and Security
of the U.S. Department of Commerce), the United Nations Security Council, the European Union, a member state of the European Union (including
sanctions administered or enforced by Her Majesty’s Treasury of the United Kingdom) or other relevant sanctions authority (collectively,
“Sanctions” and such persons, “Sanctioned Persons” and each such person, a “Sanctioned
Person”), (ii) is located, organized or resident in a country or territory that is, or whose government is, the subject of Sanctions
that broadly prohibit dealings with that country or territory (collectively, “Sanctioned Countries” and each, a “Sanctioned
Country”) or (iii) will, directly or indirectly, use the proceeds of this offering, or lend, contribute or otherwise make available
such proceeds to any subsidiary, joint venture partner or other individual or entity in any manner that would result in a violation of
any Sanctions by, or could reasonably be expected to result in the imposition of Sanctions against, any individual or entity (including
any individual or entity participating in the offering, whether as underwriter, advisor, investor or otherwise).
(pp) Dealings with Sanctioned Persons or Sanctioned
Countries. Neither the Company nor any of its subsidiaries has engaged in any dealings or transactions with or for the benefit of
a Sanctioned Person, or with or in a Sanctioned Country, in the preceding three years, nor does the Company or any of its subsidiaries
have any plans to engage in dealings or transactions with or for the benefit of a Sanctioned Person, or with or in a Sanctioned Country.
(qq) Cybersecurity; Data Protection. Except
as disclosed in the Prospectus, (A)(i) the Company has not been notified of, and has not suffered, any security breach or other compromise
of or relating to any of the Company’s information technology and computer systems, networks, hardware, software, data (including,
to the knowledge of the Company, the data of its customers, employees, suppliers, vendors and any third party data maintained by or on
behalf of it), equipment or technology (collectively, “IT Systems and Data”) and (ii) the Company has not been notified
of, and has no knowledge of, any event or condition that would reasonably be expected to result in any security breach or other compromise
to its IT Systems and Data, except in the case of this clause (i) and (ii) as would not, individually or in the aggregate, have a Material
Adverse Change; (B) the Company is presently in compliance in all material respects with applicable laws or statutes and all judgments,
orders, rules and regulations of any court or arbitrator or governmental or regulatory authority, internal policies and contractual obligations
relating to the privacy and security of IT Systems and Data and to the protection of such IT Systems and Data from unauthorized use, access,
misappropriation or modification, except as would not, individually or in the aggregate, have a Material Adverse Change; and (C) the Company
has implemented security, backup and disaster recovery technology consistent with industry standards and practices.
(rr) Sarbanes-Oxley. The Company is in compliance,
in all material respects, with all applicable provisions of the Sarbanes-Oxley Act of 2002 and the rules and regulations promulgated thereunder.
(ss) Duties, Transfer Taxes, Etc. No stamp or
other issuance or transfer taxes or duties and no capital gains, income, withholding or other taxes are payable by the Agent in the United
States or any political subdivision or taxing authority thereof or therein in connection with the execution, delivery or performance of
this Agreement by the Company or the sale and delivery by the Company of the Shares.
(tt) Foreign Private Issuer. The Company is
no longer a “foreign private issuer” within the meaning of Rule 405 under the Securities Act.
(uu) Underwriter Agreements. The Company is
not a party to any agreement with an agent or underwriter for any other “at the market” or continuous equity transaction.
Any certificate signed by any officer or representative
of the Company or any of its subsidiaries and delivered to the Agent or counsel for the Agent in connection with an issuance of Shares
shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate.
The Company acknowledges that the Agent and, for purposes
of the opinions to be delivered pursuant to Section 4(o) hereof, counsel to the Company and counsel to the Agent, will rely upon
the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.
Section 3.
ISSUANCE AND SALE OF ORDINARY SHARES
(a) Sale of Securities. On the basis of the
representations, warranties and agreements herein contained, but subject to the terms and conditions herein set forth, the Company and
the Agent agree that the Company may from time to time seek to sell Shares through the Agent, acting as sales agent, or directly to the
Agent, acting as principal, as follows, with an aggregate Sales Price of up to the Maximum Program Amount, based on and in accordance
with Issuance Notices as the Company may deliver, during the Agency Period.
(b) Mechanics of Issuances.
(i)
Issuance Notice. Upon the terms and subject to the conditions set forth herein, on any Trading Day during the Agency Period on
which the conditions set forth in Section 5(a) and Section 5(b) shall have been satisfied, the Company may exercise its
right to request an issuance of Shares by delivering to the Agent an Issuance Notice; provided, however, that (A) in no event may
the Company deliver an Issuance Notice to the extent that (I) the sum of (x) the aggregate Sales Price of the requested Issuance Amount,
plus (y) the aggregate Sales Price of all Shares issued under all previous Issuance Notices effected pursuant to this Agreement, would
exceed the Maximum Program Amount; and (B) prior to delivery of any Issuance Notice, the period set forth for any previous Issuance Notice
shall have expired or been terminated. An Issuance Notice shall be considered delivered on the Trading Day that it is received by e-mail
to the persons set forth in Schedule A hereto and confirmed by the Company by telephone (including a voicemail message to the persons
so identified), with the understanding that, with adequate prior written notice, the Agent may modify the list of such persons from time
to time.
(ii)
Agent Efforts. Upon the terms and subject to the conditions set forth in this Agreement, upon the receipt of an Issuance Notice,
the Agent will use its commercially reasonable efforts consistent with its normal sales and trading practices to place the Shares with
respect to which the Agent has agreed to act as sales agent, subject to, and in accordance with the information specified in, the Issuance
Notice, unless the sale of the Shares described therein has been suspended, cancelled or otherwise terminated in accordance with the terms
of this Agreement. For the avoidance of doubt, the parties to this Agreement may modify an Issuance Notice at any time provided they both
agree in writing to any such modification.
(iii)
Method of Offer and Sale. The Shares may be offered and sold (A) in privately negotiated transactions with the consent of the Company;
(B) as block transactions; or (C) by any other method permitted by law deemed to be an “at the market offering” as defined
in Rule 415(a)(4) under the Securities Act, including sales made directly on the Principal Market or sales made into any other existing
trading market of the Ordinary Shares. Nothing in this Agreement shall be deemed to require either party to agree to the method of offer
and sale specified in the preceding sentence, and (except as specified in clauses (A) and (B) above) the method of placement of any Shares
by the Agent shall be at the Agent’s discretion.
(iv)
Confirmation to the Company. If acting as sales agent hereunder, the Agent will provide written confirmation to the Company no
later than the opening of the Trading Day next following the Trading Day on which it has placed Shares hereunder setting forth the number
of shares sold on such Trading Day, the corresponding Sales Price and the Issuance Price payable to the Company in respect thereof.
(v)
Settlement. Each issuance of Shares will be settled on the applicable Settlement Date for such issuance of Shares and, subject
to the provisions of Section 5, on or before each Settlement Date, the Company will, or will cause its transfer agent to, electronically
transfer the Shares being sold by crediting the Agent or its designee’s account at The Depository Trust Company through its Deposit/Withdrawal
At Custodian (DWAC) System, or by such other means of delivery as may be mutually agreed upon by the parties hereto and, upon receipt
of such Shares, which in all cases shall be freely tradable, transferable, registered shares in good deliverable form, the Agent will
deliver, by wire transfer of immediately available funds, the related Issuance Price in same day funds delivered to an account designated
by the Company prior to the Settlement Date. The Company may sell Shares to the Agent as principal at a price agreed upon at each relevant
time Shares are sold pursuant to this Agreement (each, a “Time of Sale”).
(vi)
Suspension or Termination of Sales. Consistent with standard market settlement practices, the Company or the Agent may, upon notice
to the other party hereto in writing or by telephone (confirmed immediately by verifiable email), suspend any sale of Shares, and the
period set forth in an Issuance Notice shall immediately terminate; provided, however, that (A) such suspension and termination
shall not affect or impair either party’s obligations with respect to any Shares placed or sold hereunder prior to the receipt of
such notice; (B) if the Company suspends or terminates any sale of Shares after the Agent confirms such sale to the Company, the Company
shall still be obligated to comply with Section 3(b)(v) with respect to such Shares; and (C) if the Company defaults in its obligation
to deliver Shares on a Settlement Date, the Company agrees that it will hold the Agent harmless against any loss, claim, damage or expense
(including, without limitation, penalties, interest and reasonable legal fees and expenses), as incurred, arising out of or in connection
with such default by the Company. The parties hereto acknowledge and agree that, in performing its obligations under this Agreement, the
Agent may borrow Ordinary Shares from stock lenders in the event that the Company has not delivered Shares to settle sales as required
by subsection (v) above, and may use the Shares to settle or close out such borrowings. The Company agrees that no such notice shall be
effective against the Agent unless it is made to the persons identified in writing by the Agent pursuant to Section 3(b)(i).
(vii)
No Guarantee of Placement, Etc. The Company acknowledges and agrees that (A) there can be no assurance that the Agent will be successful
in placing Shares; (B) the Agent will incur no liability or obligation to the Company or any other Person if it does not sell Shares;
and (C) the Agent shall be under no obligation to purchase Shares on a principal basis pursuant to this Agreement, except as otherwise
specifically agreed by the Agent and the Company.
(viii)
Material Non-Public Information. Notwithstanding any other provision of this Agreement, the Company and the Agent agree that the
Company shall not deliver any Issuance Notice to the Agent, and the Agent shall not be obligated to place any Shares, during any period
in which the Company is in possession of material non-public information.
(c)
Fees. As compensation for services rendered, the Company shall pay to the Agent, on the applicable Settlement Date, the Selling
Commission for the applicable Issuance Amount (including with respect to any suspended or terminated sale pursuant to Section 3(b)(vi))
by the Agent deducting the Selling Commission from the applicable Issuance Amount.
(d) Expenses. The Company agrees to pay all
costs, fees and expenses incurred in connection with the performance of its obligations hereunder and in connection with the transactions
contemplated hereby, including without limitation (i) all expenses incident to the issuance and delivery of the Shares (including all
printing and engraving costs); (ii) all fees and expenses of the registrar and transfer agent of the Shares; (iii) all necessary issue,
transfer and other stamp taxes in connection with the issuance and sale of the Shares; (iv) all fees and expenses of the Company’s
counsel, independent public or certified public accountants and other advisors; (v) all costs and expenses incurred in connection with
the preparation, printing, filing, shipping and distribution of the Registration Statement (including financial statements, exhibits,
schedules, consents and certificates of experts), the Prospectus, any Free Writing Prospectus (as defined below) prepared by or on behalf
of, used by, or referred to by the Company, and all amendments and supplements thereto, and this Agreement; (vi) all filing fees, attorneys’
fees and expenses incurred by the Company or the Agent in connection with qualifying or registering (or obtaining exemptions from the
qualification or registration of) all or any part of the Shares for offer and sale under the state securities or blue sky laws or the
provincial securities laws of Canada, and, if requested by the Agent, preparing and printing a “Blue Sky Survey” or
memorandum and a “Canadian wrapper, and any supplements thereto, advising the Agent of such qualifications, registrations, determinations
and exemptions; (vii) the reasonable fees and disbursements of the Agent’s counsel, including the reasonable fees and expenses of
counsel for the Agent in connection with, FINRA review, if any, and approval of the Agent’s participation in the offering and distribution
of the Shares; (viii) the filing fees incident to FINRA review, if any; (ix) the costs and expenses of the Company relating to investor
presentations on any “road show” undertaken in connection with the marketing of the offering of the Shares, including, without
limitation, expenses associated with the preparation or dissemination of any electronic road show, expenses associated with the production
of road show slides and graphics, fees and expenses of any consultants engaged in connection with the road show presentations with the
prior approval of the Company, travel and lodging expenses of the representatives, employees and officers of the Company and of the Agent
and any such consultants, and the cost of any aircraft chartered in connection with the road show; and (x) the fees and expenses associated
with listing the Shares on the Principal Market. Notwithstanding the foregoing, the fees and disbursements of Agent’s counsel shall
not exceed (A) $50,000 in connection with the first Issuance Notice and (B) $5,000 in connection with each Triggering Event Date on which
the Company is required to provide a certificate pursuant to Section 4(o).
Section 4.
ADDITIONAL COVENANTS
The Company covenants and agrees with the Agent as
follows, in addition to any other covenants and agreements made elsewhere in this Agreement:
(a) Exchange Act Compliance. During the Agency
Period, the Company shall (i) file, on a timely basis, with the Commission all reports and documents required to be filed under Section
13, 14 or 15 of the Exchange Act in the manner and within the time periods required by the Exchange Act; and (ii) either (A) include in
its quarterly reports on Form 10-Q and its annual reports on Form 10-K, a summary detailing, for the relevant reporting period, (1) the
number of Shares sold through the Agent pursuant to this Agreement and (2) the net proceeds received by the Company from such sales or
(B) prepare a prospectus supplement containing, or include in such other filing permitted by the Securities Act or Exchange Act (each
an “Interim Prospectus Supplement”), such summary information and, at least once a quarter and subject to this Section
4, file such Interim Prospectus Supplement pursuant to Rule 424(b) under the Securities Act (and within the time periods required by Rule
424(b) and Rule 430B under the Securities Act)).
(b) Securities Act Compliance. After the date
of this Agreement, the Company shall promptly advise the Agent in writing (i) of the receipt of any comments of, or requests for additional
or supplemental information from, the Commission; (ii) of the time and date of any filing of any post-effective amendment to the Registration
Statement, any Rule 462(b) Registration Statement or any amendment or supplement to the Prospectus, any Free Writing Prospectus; (iii)
of the time and date that any post-effective amendment to the Registration Statement or any Rule 462(b) Registration Statement becomes
effective; and (iv) of the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or
any post-effective amendment thereto, any Rule 462(b) Registration Statement or any amendment or supplement to the Prospectus or of any
order preventing or suspending the use of any Free Writing Prospectus or the Prospectus, or of any proceedings to remove, suspend or terminate
from listing or quotation the Ordinary Shares from any securities exchange upon which they are listed for trading or included or designated
for quotation, or of the threatening or initiation of any proceedings for any of such purposes. If the Commission shall enter any such
stop order at any time, the Company will use its best efforts to obtain the lifting of such order at the earliest possible moment. Additionally,
the Company agrees that it shall comply with the provisions of Rule 424(b) and Rule 433, as applicable, under the Securities Act and will
use its reasonable efforts to confirm that any filings made by the Company under such Rule 424(b) or Rule 433 were received in a timely
manner by the Commission.
(c) Amendments and Supplements to the Prospectus
and Other Securities Act Matters. If any event shall occur or condition exist as a result of which it is necessary to amend or supplement
the Prospectus so that the Prospectus does not include an untrue statement of a material fact or omit to state a material fact necessary
in order to make the statements therein, in the light of the circumstances when the Prospectus is delivered to a purchaser, not misleading,
or if in the opinion of the Agent or counsel for the Agent it is otherwise necessary to amend or supplement the Prospectus to comply with
applicable law, including the Securities Act, the Company agrees (subject to Section 4(d) and 4(f)) to promptly prepare, file with the
Commission and furnish at its own expense to the Agent, amendments or supplements to the Prospectus so that the statements in the Prospectus
as so amended or supplemented will not include an untrue statement of a material fact or omit to state a material fact necessary in order
to make the statements therein, in the light of the circumstances when the Prospectus is delivered to a purchaser, be misleading or so
that the Prospectus, as amended or supplemented, will comply with applicable law including the Securities Act. Neither the Agent’s
consent to, or delivery of, any such amendment or supplement shall constitute a waiver of any of the Company’s obligations under
Sections 4(d) and 4(f).
(d) Agent’s Review of Proposed Amendments
and Supplements. Prior to amending or supplementing the Registration Statement (including any registration statement filed under Rule
462(b) under the Securities Act) or the Prospectus (excluding any amendment or supplement through incorporation of any report filed under
the Exchange Act), the Company shall furnish to the Agent for review, a reasonable amount of time prior to the proposed time of filing
or use thereof, a copy of each such proposed amendment or supplement, and the Company shall not file or use any such proposed amendment
or supplement without the Agent’s prior consent, and to file with the Commission within the applicable period specified in Rule
424(b) under the Securities Act any prospectus required to be filed pursuant to such Rule.
(e) Use of Free Writing Prospectus. Neither
the Company nor the Agent has prepared, used, referred to or distributed, or will prepare, use, refer to or distribute, without the other
party’s prior written consent, any “written communication” that constitutes a “free writing prospectus”
as such terms are defined in Rule 405 under the Securities Act with respect to the offering contemplated by this Agreement (any such free
writing prospectus being referred to herein as a “Free Writing Prospectus”).
(f) Free Writing Prospectuses. The Company shall
furnish to the Agent for review, a reasonable amount of time prior to the proposed time of filing or use thereof, a copy of each proposed
free writing prospectus or any amendment or supplement thereto to be prepared by or on behalf of, used by, or referred to by the Company
and the Company shall not file, use or refer to any proposed free writing prospectus or any amendment or supplement thereto without the
Agent’s consent. The Company shall furnish to the Agent, without charge, as many copies of any free writing prospectus prepared
by or on behalf of, or used by the Company, as the Agent may reasonably request. If at any time when a prospectus is required by the Securities
Act (including, without limitation, pursuant to Rule 173(d)) to be delivered in connection with sales of the Shares (but in any event
if at any time through and including the date of this Agreement) there occurred or occurs an event or development as a result of which
any free writing prospectus prepared by or on behalf of, used by, or referred to by the Company conflicted or would conflict with the
information contained in the Registration Statement or included or would include an untrue statement of a material fact or omitted or
would omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances prevailing at
that subsequent time, not misleading, the Company shall promptly amend or supplement such free writing prospectus to eliminate or correct
such conflict or so that the statements in such free writing prospectus as so amended or supplemented will not include an untrue statement
of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances
prevailing at such subsequent time, not misleading, as the case may be; provided, however, that prior to amending or supplementing
any such free writing prospectus, the Company shall furnish to the Agent for review, a reasonable amount of time prior to the proposed
time of filing or use thereof, a copy of such proposed amended or supplemented free writing prospectus and the Company shall not file,
use or refer to any such amended or supplemented free writing prospectus without the Agent’s consent.
(g) Filing of Agent Free Writing Prospectuses.
The Company shall not take any action that would result in the Agent or the Company being required to file with the Commission pursuant
to Rule 433(d) under the Securities Act a free writing prospectus prepared by or on behalf of the Agent that the Agent otherwise would
not have been required to file thereunder.
(h) Copies of Registration Statement and Prospectus.
After the date of this Agreement through the last time that a prospectus is required by the Securities Act (including, without limitation,
pursuant to Rule 173(d)) to be delivered in connection with sales of the Shares, the Company agrees to furnish the Agent with copies (which
may be electronic copies) of the Registration Statement and each amendment thereto, and with copies of the Prospectus and each amendment
or supplement thereto in the form in which it is filed with the Commission pursuant to the Securities Act or Rule 424(b) under the Securities
Act, both in such quantities as the Agent may reasonably request from time to time; and, if the delivery of a prospectus is required under
the Securities Act or under the blue sky or securities laws of any jurisdiction at any time on or prior to the applicable Settlement Date
for any period set forth in an Issuance Notice in connection with the offering or sale of the Shares and if at such time any event has
occurred as a result of which the Prospectus as then amended or supplemented would include an untrue statement of a material fact or omit
to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were
made when such Prospectus is delivered, not misleading, or, if for any other reason it is necessary during such same period to amend or
supplement the Prospectus or to file under the Exchange Act any document incorporated by reference in the Prospectus in order to comply
with the Securities Act or the Exchange Act, to notify the Agent and to request that the Agent suspend offers to sell Shares (and, if
so notified, the Agent shall cease such offers as soon as practicable); and if the Company decides to amend or supplement the Registration
Statement or the Prospectus as then amended or supplemented, to advise the Agent promptly by telephone (with confirmation in writing)
and to prepare and cause to be filed promptly with the Commission an amendment or supplement to the Registration Statement or the Prospectus
as then amended or supplemented that will correct such statement or omission or effect such compliance; provided, however, that if during
such same period the Agent is required to deliver a prospectus in respect of transactions in the Shares, the Company shall promptly prepare
and file with the Commission such an amendment or supplement.
(i) Blue Sky Compliance. The Company shall cooperate
with the Agent and counsel for the Agent to qualify or register the Shares for sale under (or obtain exemptions from the application of)
the state securities or blue sky laws or Canadian provincial securities laws of those jurisdictions designated by the Agent, shall comply
with such laws and shall continue such qualifications, registrations and exemptions in effect so long as required for the distribution
of the Shares. The Company shall not be required to qualify as a foreign corporation or to take any action that would subject it to general
service of process in any such jurisdiction where it is not presently qualified or where it would be subject to taxation as a foreign
corporation. The Company will advise the Agent promptly of the suspension of the qualification or registration of (or any such exemption
relating to) the Shares for offering, sale or trading in any jurisdiction or any initiation or threat of any proceeding for any such purpose,
and in the event of the issuance of any order suspending such qualification, registration or exemption, the Company shall use its best
efforts to obtain the withdrawal thereof at the earliest possible moment.
(j) Earnings Statement. As soon as practicable,
the Company will make generally available to its security holders and to the Agent an earnings statement (which need not be audited) covering
a period of at least twelve months beginning with the first fiscal quarter of the Company occurring after the date of this Agreement which
shall satisfy the provisions of Section 11(a) of the Securities Act and Rule 158 under the Securities Act.
(k) Listing; Reservation of Shares. (a) The
Company will maintain the listing of the Shares on the Principal Market; and (b) the Company will reserve and keep available at all times,
free of preemptive rights, Shares for the purpose of enabling the Company to satisfy its obligations under this Agreement.
(l) Transfer Agent. The Company shall engage
and maintain, at its expense, a registrar and transfer agent for the Shares.
(m) Due Diligence. During the term of this Agreement,
the Company will reasonably cooperate with any reasonable due diligence review conducted by the Agent in connection with the transactions
contemplated hereby, including, without limitation, providing information and making available documents and senior corporate officers,
during normal business hours and at the Company’s principal offices, as the Agent may reasonably request from time to time.
(n) Representations and Warranties. The Company
acknowledges that each delivery of an Issuance Notice and each delivery of Shares on a Settlement Date shall be deemed to be (i) an affirmation
to the Agent that the representations and warranties of the Company contained in or made pursuant to this Agreement are true and correct
as of the date of such Issuance Notice or of such Settlement Date, as the case may be, as though made at and as of each such date, except
as may be disclosed in the Prospectus (including any documents incorporated by reference therein and any supplements thereto); and (ii)
an undertaking that the Company will advise the Agent if any of such representations and warranties will not be true and correct as of
the Settlement Date for the Shares relating to such Issuance Notice, as though made at and as of each such date (except that such representations
and warranties shall be deemed to relate to the Registration Statement and the Prospectus as amended and supplemented relating to such
Shares).
(o) Deliverables at Triggering Event Dates; Certificates.
The Company agrees that on or prior to the date of the first Issuance Notice and, during the term of this Agreement after the date of
the first Issuance Notice, upon:
(A) the filing of the Prospectus or the amendment or
supplement of any Registration Statement or Prospectus (other than a prospectus supplement relating solely to an offering of securities
other than the Shares or a prospectus filed pursuant to Section 4(a)(ii)(B)), by means of a post-effective amendment, sticker or supplement,
but not by means of incorporation of documents by reference into the Registration Statement or Prospectus;
(B) the filing with the Commission of an annual report
on Form 10-K or a quarterly financial report on Form 10-Q (including any Form 10-K/A or Form 10-Q/A containing amended financial information
or a material amendment to the previously filed annual report on Form 10-K or quarterly report filed on Form 10-Q), in each case, of the
Company; or
(C) the filing with the Commission of a current report
on Form 8-K of the Company containing amended financial information that is material to the offering of securities of the Company in the
Agent’s reasonable discretion; (any such event, a “Triggering Event Date”), the Company shall furnish the Agent
(but in the case of clause (C) above only if the Agent reasonably determines that the information contained in such current report on
Form 8-K of the Company is material) with a certificate as of the Triggering Event Date, in the form and substance satisfactory to the
Agent and its counsel, substantially similar to the form previously provided to the Agent and its counsel, modified, as necessary, to
relate to the Registration Statement and the Prospectus as amended or supplemented, (A) confirming that the representations and warranties
of the Company contained in this Agreement are true and correct, (B) that the Company has performed all of its obligations hereunder to
be performed on or prior to the date of such certificate and as to the matters set forth in Section 5(a)(iii) hereof, and (C) containing
any other certification that the Agent shall reasonably request. The requirement to provide a certificate under this Section 4(o)
shall be waived for any Triggering Event Date occurring at a time when no Issuance Notice is pending or a suspension is in effect, which
waiver shall continue until the earlier to occur of the date the Company delivers instructions for the sale of Shares hereunder (which
for such calendar quarter shall be considered a Triggering Event Date) and the next occurring Triggering Event Date. Notwithstanding the
foregoing, if the Company subsequently decides to sell Shares following a Triggering Event Date when a suspension was in effect and did
not provide the Agent with a certificate under this Section 4(o), then before the Company delivers the instructions for the sale of Shares
or the Agent sells any Shares pursuant to such instructions, the Company shall provide the Agent with a certificate in conformity with
this Section 4(o) dated as of the date that the instructions for the sale of Shares are issued.
(p) Legal Opinions. On or prior to the date
of the first Issuance Notice and within five (5) Trading Days of each Triggering Event Date with respect to which the Company is obligated
to deliver a certificate pursuant to Section 4(o) for which no waiver is applicable and excluding the date of this Agreement, a negative
assurances letter and the written legal opinion of Skadden, Arps, Slate, Meagher & Flom LLP, U.S. counsel to the Company, Maples and
Calder (Hong Kong) LLP, Cayman Islands counsel to the Company, Knobbe, Martens, Olson & Bear, LLP, intellectual property counsel to
the Company, each dated the date of delivery, in form and substance reasonably satisfactory to Agent and its counsel, substantially similar
to the form previously provided to the Agent and its counsel, modified, as necessary, to relate to the Registration Statement and the
Prospectus as then amended or supplemented; provided, however, the Company shall be required to furnish no more than one opinion hereunder
per calendar quarter. In lieu of such opinions for subsequent periodic filings, in the discretion of the Agent, the Company may furnish
a reliance letter from such counsel to the Agent, permitting the Agent to rely on a previously delivered opinion letter, modified as appropriate
for any passage of time or Triggering Event Date (except that statements in such prior opinion shall be deemed to relate to the Registration
Statement and the Prospectus as amended or supplemented as of such Triggering Event Date).
(q) Comfort Letter. On or prior to the date
of the first Issuance Notice and within five (5) Trading Days of each Triggering Event Date with respect to which the Company is obligated
to deliver a certificate pursuant to Section 4(o) for which no waiver is applicable and excluding the date of this Agreement, the Company
shall cause CBIZ CPAs P.C. and Marcum LLP, the current and prior independent registered public accounting firm who has audited the financial
statements included or incorporated by reference in the Registration Statement, to furnish the Agent a comfort letter, dated the date
of delivery, in form and substance reasonably satisfactory to the Agent and its counsel, substantially similar to the form previously
provided to the Agent and its counsel; provided, however, that any such comfort letter will only be required on the Triggering Event Date
specified to the extent that it contains financial statements filed with the Commission under the Exchange Act and incorporated or deemed
to be incorporated by reference into a Prospectus. If requested by the Agent, the Company shall also cause a comfort letter to be furnished
to the Agent within ten (10) Trading Days of the date of occurrence of any material transaction or event requiring the filing of a current
report on Form 8-K containing material amended financial information of the Company, including the restatement of the Company’s
financial statements. The Company shall be required to furnish no more than one comfort letter hereunder per calendar quarter.
(r) Management Certificate. On or prior to the
date of the first Issuance Notice and within five (5) Trading Days of each Triggering Event Date, the Company shall furnish the Agent
a certificate executed by the Chief Executive Officer, President or Chief Financial Officer of the Company, signing in such capacity,
dated the date of delivery (i) certifying that attached thereto are true and complete copies of the resolutions duly adopted by the Board
of Directors of the Company authorizing the execution and delivery of this Agreement and the consummation of the transactions contemplated
hereby (including, without limitation, the issuance of the Shares pursuant to this Agreement), which authorization shall be in full force
and effect on and as of the date of such certificate, (ii) certifying and attesting to the office, incumbency, due authority and specimen
signatures of each Person who executed this Agreement for or on behalf of the Company, and (iii) containing any other certification that
the Agent shall reasonably request.
(s) Agent’s Own Account; Clients’ Account.
The Company consents to the Agent trading, in compliance with applicable law, in the Ordinary Shares for the Agent’s own account
and for the account of its clients at the same time as sales of the Shares occur pursuant to this Agreement.
(t) Investment Limitation. The Company shall
not invest, or otherwise use the proceeds received by the Company from its sale of the Shares in such a manner as would require the Company
or any of its subsidiaries to register as an investment company under the Investment Company Act.
(u) Market Activities. The Company will not
take, directly or indirectly, any action designed to or that might be reasonably expected to cause or result in stabilization or manipulation
of the price of the Shares or any other reference security, whether to facilitate the sale or resale of the Shares or otherwise, and the
Company will, and shall cause each of its affiliates to, comply with all applicable provisions of Regulation M.
(v) Notice of Other Sale. Without the prior
written consent of the Agent, the Company will not, directly or indirectly, offer to sell, sell, contract to sell, grant any option to
sell or otherwise dispose of any Ordinary Shares or securities convertible into or exchangeable for Ordinary Shares (other than Shares
hereunder), warrants or any rights to purchase or acquire Ordinary Shares, during the period beginning on the third Trading Day immediately
prior to the date on which any Issuance Notice is delivered to the Agent hereunder and ending on the third Trading Day immediately following
the Settlement Date with respect to Shares sold pursuant to such Issuance Notice; and will not directly or indirectly in any other “at
the market” or continuous equity transaction offer to sell, sell, contract to sell, grant any option to sell or otherwise dispose
of any Ordinary Shares (other than the Shares offered pursuant to this Agreement); provided, however, that such restrictions will not
be required in connection with the Company’s (i) issuance or sale of Ordinary Shares, options to purchase Ordinary Shares or Ordinary
Shares issuable upon the exercise of options or other equity awards pursuant to any employee or director share option, incentive or benefit
plan, share purchase or ownership plan, long-term incentive plan, dividend reinvestment plan, inducement award under Nasdaq rules or other
compensation plan of the Company or its subsidiaries, as in effect on the date of this Agreement, (ii) issuance or sale of Ordinary Shares
issuable upon exchange, conversion or redemption of securities or the exercise or vesting of warrants, options or other equity awards
outstanding at the date of this Agreement, (iii) issuance or sale of Ordinary Shares or securities convertible into or exchangeable for
Ordinary Shares as consideration for mergers, acquisitions, other business combinations, joint ventures or strategic alliances occurring
after the date of this Agreement which are not used for capital raising purposes and (iv) modification of any outstanding options, warrants
of any rights to purchase or acquire Ordinary Shares.
Section 5.
CONDITIONS TO DELIVERY OF ISSUANCE NOTICES AND TO SETTLEMENT
(a) Conditions Precedent to the Right of the Company
to Deliver an Issuance Notice and the Obligation of the Agent to Sell Shares. The right of the Company to deliver an Issuance Notice
hereunder is subject to the satisfaction, on the date of delivery of such Issuance Notice, and the obligation of the Agent to use its
commercially reasonable efforts to place Shares during the applicable period set forth in the Issuance Notice is subject to the satisfaction,
on each Trading Day during the applicable period set forth in the Issuance, of each of the following conditions:
(i) Accuracy of the Company’s Representations and Warranties; Performance by the Company. The
Company shall have delivered the certificate required to be delivered pursuant to Section 4(o) on or before the date on which delivery
of such certificate is required pursuant to Section 4(o). The Company shall have performed, satisfied and complied with all covenants,
agreements and conditions required by this Agreement to be performed, satisfied or complied with by the Company at or prior to such date,
including, but not limited to, the covenants contained in Section 4(p), Section 4(q) and Section 4(r).
(ii) No Injunction. No statute, rule, regulation, executive order, decree, ruling or injunction shall
have been enacted, entered, promulgated or endorsed by any court or governmental authority of competent jurisdiction or any self-regulatory
organization having authority over the matters contemplated hereby that prohibits or directly and materially adversely affects any of
the transactions contemplated by this Agreement, and no proceeding shall have been commenced that may have the effect of prohibiting or
materially adversely affecting any of the transactions contemplated by this Agreement.
(iii) Material Adverse Changes. Except as disclosed in the Prospectus and the Time of Sale Information,
(a) in the judgment of the Agent there shall not have occurred any Material Adverse Change; and (b) there shall not have occurred any
downgrading, nor shall any notice have been given of any intended or potential downgrading or of any review for a possible change that
does not indicate the direction of the possible change, in the rating accorded any securities of the Company or any of its subsidiaries
by any “nationally recognized statistical rating organization” as such term is defined for purposes of Section 3(a)(62) of
the Exchange Act.
(iv) No Suspension of Trading in or Delisting of Ordinary Shares; Other Events. The trading of the Ordinary
Shares (including without limitation the Shares) shall not have been suspended by the Commission, the Principal Market or FINRA and the
Ordinary Shares (including without limitation the Shares) shall have been approved for listing or quotation on and shall not have been
delisted from the Nasdaq Stock Market, the New York Stock Exchange or any of their constituent markets. There shall not have occurred
(and be continuing in the case of occurrences under clauses (i) and (ii) below) any of the following: (i) trading or quotation in any
of the Company’s securities shall have been suspended or limited by the Commission or by the Principal Market or trading in securities
generally on either the Principal Market shall have been suspended or limited, or minimum or maximum prices shall have been generally
established on any of such stock exchanges by the Commission or the FINRA; (ii) a general banking moratorium shall have been declared
by any of federal or New York, authorities; or (iii) there shall have occurred any outbreak or escalation of national or international
hostilities or any crisis or calamity, or any change in the United States or international financial markets, or any substantial change
or development involving a prospective substantial change in United States’ or international political, financial or economic conditions,
as in the judgment of the Agent is material and adverse and makes it impracticable to market the Shares in the manner and on the terms
described in the Prospectus or to enforce contracts for the sale of securities.
(b) Documents Required to be Delivered on each Issuance
Notice Date. The Agent’s obligation to use its commercially reasonable efforts to place Shares hereunder shall additionally
be conditioned upon the delivery to the Agent on or before the Issuance Notice Date of a certificate in form and substance reasonably
satisfactory to the Agent, executed by the Chief Executive Officer, President or Chief Financial Officer of the Company, to the effect
that all conditions to the delivery of such Issuance Notice shall have been satisfied as at the date of such certificate (which certificate
shall not be required if the foregoing representations shall be set forth in the Issuance Notice).
(c) No Misstatement or Material Omission. The
Agent shall not have advised the Company that the Registration Statement, the Prospectus or the Times of Sales Information, or any amendment
or supplement thereto, contains an untrue statement of fact that in the Agent’s reasonable opinion is material, or omits to state
a fact that in the Agent’s reasonable opinion is material and is required to be stated therein or is necessary to make the statements
therein not misleading.
Section 6.
INDEMNIFICATION AND CONTRIBUTION
(a) Indemnification of the Agent. The Company
agrees to indemnify and hold harmless the Agent, its officers and employees, and each person, if any, who controls the Agent within the
meaning of the Securities Act or the Exchange Act against any loss, claim, damage, liability or expense, as incurred, to which the Agent
or such officer, employee or controlling person may become subject, under the Securities Act, the Exchange Act, other federal or state
statutory law or regulation, or the laws or regulations of foreign jurisdictions where Shares have been offered or sold or at common law
or otherwise (including in settlement of any litigation), insofar as such loss, claim, damage, liability or expense (or actions in respect
thereof as contemplated below) arises out of or is based upon (i) any untrue statement or alleged untrue statement of a material fact
contained in the Registration Statement, or any amendment thereto, including any information deemed to be a part thereof pursuant to Rule
430B under the Securities Act, or the omission or alleged omission therefrom of a material fact required to be stated therein or necessary
to make the statements therein not misleading; (ii) any untrue statement or alleged untrue statement of a material fact contained in any
Free Writing Prospectus that the Company has used, referred to or filed, or is required to file, pursuant to Rule 433(d) of the Securities
Act or the Prospectus (or any amendment or supplement thereto), or the omission or alleged omission therefrom of a material fact necessary
in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; or (iii) any act
or failure to act or any alleged act or failure to act by the Agent in connection with, or relating in any manner to, the Common Shares
or the offering contemplated hereby, and which is included as part of or referred to in any loss, claim, damage, liability or action arising
out of or based upon any matter covered by clause (i) or (ii) above, provided that the Company shall not be liable under this clause (iii)
to the extent that a court of competent jurisdiction shall have determined by a final judgment that such loss, claim, damage, liability
or action resulted directly from any such acts or failures to act undertaken or omitted to be taken by the Agent through its bad faith
or willful misconduct, and to reimburse the Agent and each such officer, employee and controlling person for any and all expenses (including
the fees and disbursements of counsel chosen by the Agent) as such expenses are reasonably incurred by the Agent or such officer, employee
or controlling person in connection with investigating, defending, settling, compromising or paying any such loss, claim, damage, liability,
expense or action; provided, however, that the foregoing indemnity agreement shall not apply to any loss, claim, damage, liability or
expense to the extent, but only to the extent, arising out of or based upon any untrue statement or alleged untrue statement or omission
or alleged omission made in reliance upon and in conformity with written information furnished to the Company by the Agent expressly for
use in the Registration Statement, any such Free Writing Prospectus or the Prospectus (or any amendment or supplement thereto), it being
understood and agreed that the only such information furnished by the Agent to the Company consists of the information described in subsection
(b) below. The indemnity agreement set forth in this Section 6(a) shall be in addition to any liabilities that the Company may
otherwise have.
(b) Notifications and Other Indemnification Procedures.
Promptly after receipt by an indemnified party under this Section 6 of notice of the commencement of any action, such indemnified
party will, if a claim in respect thereof is to be made against an indemnifying party under this Section 6, notify the indemnifying
party in writing of the commencement thereof, but the omission so to notify the indemnifying party will not relieve it from any liability
which it may have to any indemnified party for contribution or otherwise than under the indemnity agreement contained in this Section
6 or to the extent it is not prejudiced as a proximate result of such failure. In case any such action is brought against any indemnified
party and such indemnified party seeks or intends to seek indemnity from an indemnifying party, the indemnifying party will be entitled
to participate in, and, to the extent that it shall elect, jointly with all other indemnifying parties similarly notified, by written
notice delivered to the indemnified party promptly after receiving the aforesaid notice from such indemnified party, to assume the defense
thereof with counsel reasonably satisfactory to such indemnified party; provided, however, if the defendants in any such action include
both the indemnified party and the indemnifying party and the indemnified party shall have reasonably concluded that a conflict may arise
between the positions of the indemnifying party and the indemnified party in conducting the defense of any such action or that there may
be legal defenses available to it and/or other indemnified parties which are different from or additional to those available to the indemnifying
party, the indemnified party or parties shall have the right to select separate counsel to assume such legal defenses and to otherwise
participate in the defense of such action on behalf of such indemnified party or parties. Upon receipt of notice from the indemnifying
party to such indemnified party of such indemnifying party’s election so to assume the defense of such action and approval by the
indemnified party of counsel, the indemnifying party will not be liable to such indemnified party under this Section 6 for any
legal or other expenses subsequently incurred by such indemnified party in connection with the defense thereof unless (i) the indemnified
party shall have employed separate counsel in accordance with the proviso to the preceding sentence (it being understood, however, that
the indemnifying party shall not be liable for the fees and expenses of more than one separate counsel (together with local counsel),
representing the indemnified parties who are parties to such action), which counsel (together with any local counsel) for the indemnified
parties shall be selected by the Agent (in the case of counsel for the indemnified parties referred to in Section 6(a) above),
(ii) the indemnifying party shall not have employed counsel satisfactory to the indemnified party to represent the indemnified party within
a reasonable time after notice of commencement of the action or (iii) the indemnifying party has authorized in writing the employment
of counsel for the indemnified party at the expense of the indemnifying party, in each of which cases the fees and expenses of counsel
shall be at the expense of the indemnifying party and shall be paid as they are incurred.
(c) Settlements. The indemnifying party under
this Section 6 shall not be liable for any settlement of any proceeding effected without its written consent, but if settled with
such consent or if there be a final judgment for the plaintiff, the indemnifying party agrees to indemnify the indemnified party against
any loss, claim, damage, liability or expense by reason of such settlement or judgment. No indemnifying party shall, without the prior
written consent of the indemnified party, effect any settlement, compromise or consent to the entry of judgment in any pending or threatened
action, suit or proceeding in respect of which any indemnified party is or could have been a party and indemnity was or could have been
sought hereunder by such indemnified party, unless such settlement, compromise or consent includes an unconditional release of such indemnified
party from all liability on claims that are the subject matter of such action, suit or proceeding.
(d) Contribution. If the indemnification provided
for in this Section 6 is for any reason held to be unavailable to or otherwise insufficient to hold harmless an indemnified party
in respect of any losses, claims, damages, liabilities or expenses referred to therein, then each indemnifying party shall contribute
to the aggregate amount paid or payable by such indemnified party, as incurred, as a result of any losses, claims, damages, liabilities
or expenses referred to therein (i) in such proportion as is appropriate to reflect the relative benefits received by the Company, on
the one hand, and the Agent, on the other hand, from the offering of the Shares pursuant to this Agreement; or (ii) if the allocation
provided by clause (i) above is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative
benefits referred to in clause (i) above but also the relative fault of the Company, on the one hand, and the Agent, on the other hand,
in connection with the statements or omissions which resulted in such losses, claims, damages, liabilities or expenses, as well as any
other relevant equitable considerations. The relative benefits received by the Company, on the one hand, and the Agent, on the other hand,
in connection with the offering of the Shares pursuant to this Agreement shall be deemed to be in the same respective proportions as the
total gross proceeds from the offering of the Shares (before deducting expenses) received by the Company bear to the total commissions
received by the Agent. The relative fault of the Company, on the one hand, and the Agent, on the other hand, shall be determined by reference
to, among other things, whether any such untrue or alleged untrue statement of a material fact or omission or alleged omission to state
a material fact relates to information supplied by the Company, on the one hand, or the Agent, on the other hand, and the parties’
relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission.
The amount paid or payable by a party as a result of
the losses, claims, damages, liabilities and expenses referred to above shall be deemed to include, subject to the limitations set forth
in Section 6(b), any legal or other fees or expenses reasonably incurred by such party in connection with investigating or defending
any action or claim. The provisions set forth in Section 6(b) with respect to notice of commencement of any action shall apply
if a claim for contribution is to be made under this Section 6(d); provided, however, that no additional notice shall be
required with respect to any action for which notice has been given under Section 6(b) for purposes of indemnification.
The Company and the Agent agree that it would not be just and equitable
if contribution pursuant to this Section 6(d) were determined by pro rata allocation or by any other method of allocation which
does not take account of the equitable considerations referred to in this Section 6(d).
Notwithstanding the provisions of this Section 6(d),
the Agent shall not be required to contribute any amount in excess of the agent fees received by the Agent in connection with the offering
contemplated hereby. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall
be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. For purposes of this Section 6(d),
each officer and employee of the Agent and each person, if any, who controls the Agent within the meaning of the Securities Act or the
Exchange Act shall have the same rights to contribution as the Agent, and each director of the Company, each officer of the Company who
signed the Registration Statement, and each person, if any, who controls the Company with the meaning of the Securities Act and the Exchange
Act shall have the same rights to contribution as the Company.
Section 7.
TERMINATION & SURVIVAL
(a) Term. Subject to the provisions of this
Section 7, the term of this Agreement shall continue from the date of this Agreement until the end of the Agency Period, unless
earlier terminated by the parties to this Agreement pursuant to this Section 7.
(b) Termination; Survival Following Termination.
(i) Either party may terminate this Agreement prior to the end of the Agency Period, by giving written notice
as required by this Agreement, upon ten (10) Trading Days’ notice to the other party; provided that, (A) if the Company terminates
this Agreement after the Agent confirms to the Company any sale of Shares, the Company shall remain obligated to comply with Section
3(b)(v) with respect to such Shares and (B) Section 2, Section 6, Section 7 and Section 8 shall survive
termination of this Agreement. If termination shall occur prior to the Settlement Date for any sale of Shares, such sale shall nevertheless
settle in accordance with the terms of this Agreement.
(ii) In addition to the survival provision of Section 7(b)(i), the respective indemnities, agreements,
representations, warranties and other statements of the Company, of its officers and of the Agent set forth in or made pursuant to this
Agreement will remain in full force and effect, regardless of any investigation made by or on behalf of the Agent or the Company or any
of its or their partners, officers or directors or any controlling person, as the case may be, and, anything herein to the contrary notwithstanding,
will survive delivery of and payment for the Shares sold hereunder and any termination of this Agreement.
Section 8.
MISCELLANEOUS
(a) Press Releases and Disclosure. The Company
may issue a press release describing the material terms of the transactions contemplated hereby as soon as practicable following the date
of this Agreement, and may file with the Commission a Current Report on Form 8-K, with this Agreement attached as an exhibit thereto,
describing the material terms of the transactions contemplated hereby, and the Company shall consult with the Agent prior to making such
disclosures, and the parties hereto shall use all commercially reasonable efforts, acting in good faith, to agree upon a text for such
disclosures that is reasonably satisfactory to all parties hereto. No party hereto shall issue thereafter any press release or like public
statement (including, without limitation, any disclosure required in reports filed with the Commission pursuant to the Exchange Act) related
to this Agreement or any of the transactions contemplated hereby without the prior written approval of the other party hereto, except
as may be necessary or appropriate in the reasonable opinion of the party seeking to make disclosure to comply with the requirements of
applicable law or stock exchange rules. If any such press release or like public statement is so required, the party making such disclosure
shall consult with the other party prior to making such disclosure, and the parties shall use all commercially reasonable efforts, acting
in good faith, to agree upon a text for such disclosure that is reasonably satisfactory to all parties hereto.
(b) No Advisory or Fiduciary Relationship. The
Company acknowledges and agrees that (i) the transactions contemplated by this Agreement, including the determination of any fees, are
arm’s-length commercial transactions between the Company and the Agent, (ii) when acting as a principal under this Agreement, the
Agent is and has been acting solely as a principal is not the agent or fiduciary of the Company, or its stockholders, creditors, employees
or any other party, (iii) the Agent has not assumed nor will assume an advisory or fiduciary responsibility in favor of the Company with
respect to the transactions contemplated hereby or the process leading thereto (irrespective of whether the Agent has advised or is currently
advising the Company on other matters) and the Agent does not have any obligation to the Company with respect to the transactions contemplated
hereby except the obligations expressly set forth in this Agreement, (iv) the Agent and its respective affiliates may be engaged in a
broad range of transactions that involve interests that differ from those of the Company, and (v) the Agent has not provided any legal,
accounting, regulatory or tax advice with respect to the transactions contemplated hereby and the Company has consulted its own legal,
accounting, regulatory and tax advisors to the extent it deemed appropriate.
(c) Research Analyst Independence. The Company
acknowledges that the Agent’s research analysts and research departments are required to and should be independent from their respective
investment banking divisions and are subject to certain regulations and internal policies, and as such the Agent’s research analysts
may hold views and make statements or investment recommendations and/or publish research reports with respect to the Company or the offering
that differ from the views of their respective investment banking divisions. The Company understands that the Agent is a full service
securities firm and as such from time to time, subject to applicable securities laws, may effect transactions for its own account or the
account of its customers and hold long or short positions in debt or equity securities of the companies that may be the subject of the
transactions contemplated by this Agreement.
(d) Notices. All communications hereunder shall
be in writing and shall be mailed, hand delivered or telecopied and confirmed to the parties hereto as follows:
If to the Agent:
Citizens JMP Securities, LLC
1301 Avenue of the Americas, 2nd Floor
New York, NY 10019
Email: [***]
Attention: David Kellman and Frankie Beardslee
with a copy (which shall not constitute notice) to:
Ellenoff Grossman & Schole LLP
1345 Avenue of the Americas
New York, NY 10105
Email: capmkts@egsllp.com
Attention: Justin Grossman
If to the Company:
BeyondSpring Inc.
100 Campus Drive, West Side, 4th Floor, Suite 410
Florham Park, New Jersey 07932
Facsimile: [***]
Attention: Min Qiu
with a copy (which shall not constitute notice) to:
Skadden, Arps, Slate, Meagher & Flom LLP
One Manhattan West
New York, NY 10001
Facsimile: [***]
Attention: Michael Hong
Any party hereto may change the address for receipt of communications by
giving written notice to the others in accordance with this Section 8(d).
(e) Successors. This Agreement will inure to
the benefit of and be binding upon the parties hereto, and to the benefit of the employees, officers and directors and controlling persons
referred to in Section 6, and in each case their respective successors, and no other person will have any right or obligation hereunder.
The term “successors” shall not include any purchaser of the Shares as such from the Agent merely by reason of such purchase.
(f) Partial Unenforceability. The invalidity
or unenforceability of any Article, Section, paragraph or provision of this Agreement shall not affect the validity or enforceability
of any other Article, Section, paragraph or provision hereof. If any Article, Section, paragraph or provision of this Agreement is for
any reason determined to be invalid or unenforceable, there shall be deemed to be made such minor changes (and only such minor changes)
as are necessary to make it valid and enforceable.
(g) Governing Law Provisions. This Agreement
shall be governed by and construed in accordance with the internal laws of the State of New York applicable to agreements made and to
be performed in such state. Any legal suit, action or proceeding arising out of or based upon this Agreement or the transactions contemplated
hereby (“Related Proceedings”) may be instituted in the federal courts of the United States of America located in the
Borough of Manhattan in the City of New York or the courts of the State of New York in each case located in the Borough of Manhattan in
the City of New York (collectively, the “Specified Courts”), and each party irrevocably submits to the exclusive jurisdiction
(except for proceedings instituted in regard to the enforcement of a judgment of any such court (a “Related Judgment”),
as to which such jurisdiction is non-exclusive) of such courts in any such suit, action or proceeding. Service of any process, summons,
notice or document by mail to such party’s address set forth above shall be effective service of process for any suit, action or
other proceeding brought in any such court. The parties irrevocably and unconditionally waive any objection to the laying of venue of
any suit, action or other proceeding in the Specified Courts and irrevocably and unconditionally waive and agree not to plead or claim
in any such court that any such suit, action or other proceeding brought in any such court has been brought in an inconvenient forum.
The Company has appointed CT Corporation System, as its authorized agent (the “Authorized Agent”) upon whom process
may be served in any such action arising out of or based on this Agreement or the transactions contemplated hereby which may be instituted
in any Specified Court by the Agent, expressly consents to the jurisdiction of any such court in respect of any such action, and waives
any other requirements of or objections to personal jurisdiction with respect thereto. Such appointment shall be irrevocable. The Company
represents and warrants that the Authorized Agent has agreed to act as such agent for service of process and agrees to take any and all
action, including the filing of any and all documents and instruments, that may be necessary to continue such appointment in full force
and effect as aforesaid. Service of process upon the Authorized Agent and written notice of such service to the Company shall be deemed,
in every respect, effective service of process upon the Company.
(h) General Provisions. This Agreement constitutes
the entire agreement of the parties to this Agreement and supersedes all prior written or oral and all contemporaneous oral agreements,
understandings and negotiations with respect to the subject matter hereof. This Agreement may be executed in two or more counterparts,
each one of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument, and
may be delivered by facsimile transmission or by electronic delivery of a portable document format (PDF) file. This Agreement may not
be amended or modified unless in writing by all of the parties hereto, and no condition herein (express or implied) may be waived unless
waived in writing by each party whom the condition is meant to benefit. The Article and Section headings herein are for the convenience
of the parties only and shall not affect the construction or interpretation of this Agreement.
[Signature Page Immediately Follows]
If the foregoing is in accordance with your understanding
of our agreement, kindly sign and return to the Company the enclosed copies hereof, whereupon this instrument, along with all counterparts
hereof, shall become a binding agreement in accordance with its terms
Very truly yours,
BEYONDSPRING INC.
By:
/s/ Min Qiu
Name: Min Qiu
Title: Chief Executive Officer
The foregoing Agreement is hereby confirmed and accepted by the Agent in
New York, New York as of the date first above written.
CITIZENS JMP SECURITIES, LLC
By:
/s/ David Kellman
Name: David Kellman
Title: Head of Healthcare Investment Banking, Managing Director
EXHIBIT A
ISSUANCE NOTICE
[Date]
Citizens JMP Securities, LLC
c/o Citizens JMP Securities, LLC
1301 Avenue of the Americas, 2nd Floor
New York, NY 10019
Attn: dl-jmp-syndicate@citizensbank.com
Reference is made to the Open Market Sale Agreement between BeyondSpring
Inc. (the “Company”) and Citizens JMP Securities, LLC (the “Agent”) dated as of September [__],
2026. The Company confirms that all conditions to the delivery of this Issuance Notice are satisfied as of the date hereof.
Date of Delivery of Issuance Notice (determined pursuant to Section 3(b)(i)):
Issuance Amount (equal to the total Sales Price for such Shares):
$
Number of days in selling period:
First date of selling period:
Last date of selling period:
Settlement Date(s) if other than standard T+1 settlement:
Floor Price Limitation (in no event less than $1.00 without the prior written
consent of the Agent, which consent may be withheld in the Agent’s sole discretion): $ ____ per share
Comments:
BEYONDSPRING INC.
By:
Name:
Title:
A-1
Schedule A
Notice Parties
The Company
[***]
The Agent
[***]
EX-5.1 — EXHIBIT 5.1
EX-5.1
Filename: exh_51.htm · Sequence: 3
Exhibit 5.1
Our ref VSL/715660-000003/87561500v3
BeyondSpring Inc.
100 Campus Drive, West Side
4th Floor, Suite 410
Florham Park, New Jersey 07932
29 September 2026
Dear Sirs,
BeyondSpring Inc.
We have acted as Cayman Islands legal advisers to BeyondSpring Inc. (the
"Company") in connection with the Company’s registration statement on Form F-3 initially filed with the Securities
and Exchange Commission on 12 June 2024, and subsequently amended on Form S-3 (File No. 333-280153) on 13 August 2025 and declared effective
on 18 August 2025, including all amendments or supplements thereto, filed with the Securities and Exchange Commission (the '"SEC")
under the U.S. Securities Act of 1933 on 12 June 2024, as amended to date (the "Registration Statement") relating to
the offering by the Company of certain ordinary shares of par value US$0.0001 each (the "Shares") and the prospectus
supplement to the Registration Statement dated 29 September 2026 (the "Prospectus Supplement"), relating to the sale
of certain Shares (the “Sale Shares”) by the Company in accordance with the Open Market Sale Agreement dated 29 September
2026 entered into between the Company and the Agent named therein (the "Sale Agreement").
We are furnishing this opinion as Exhibit 5.1 to the Company's current
report on Form 8-K which will be incorporated by reference into the Registration Statement (the "Form 8-K").
1 Documents Reviewed
For the purposes of this opinion, we have reviewed only originals, copies
or final drafts of the following documents:
1.1 The certificate of incorporation of the Company dated 21 November 2014.
1.2 The amended and restated memorandum and articles of association of the Company as conditionally adopted
by a special resolution passed on 24 February 2017 and effective immediately prior to the completion of the Company’s initial public
offering of the Shares (the "Memorandum and Articles").
1.3 The written resolutions of the board of directors of the Company (the "Board") dated
29 May 2024 (the "Board Resolutions") and the written resolutions of the offering committee of the Board dated 29 September
2026 (the "Committee Resolutions").
1.4 A certificate from a director of the Company, a copy of which is attached hereto (the "Director's
Certificate").
1.5 A certificate of good standing dated 17 September 2026, issued by the Registrar of Companies in the Cayman
Islands (the "Certificate of Good Standing").
1.6 The Registration Statement and the Form 8-K.
1.7 The Prospectus Supplement.
1.8 The Sale Agreement.
2 Assumptions
The following opinions are given only as to, and based on, circumstances
and matters of fact existing and known to us on the date of this opinion letter. These opinions only relate to the laws of the Cayman
Islands which are in force on the date of this opinion letter. In giving the following opinions we have relied (without further verification)
upon the completeness and accuracy, as at the date of this opinion letter, of the Director’s Certificate and the Certificate of
Good Standing. We have also relied upon the following assumptions, which we have not independently verified:
2.1 Copies of documents, conformed copies or drafts of documents provided to us are true and complete copies
of, or in the final forms of, the originals, and translations of documents provided to us are complete and accurate.
2.2 All signatures, initials and seals are genuine.
2.3 There is nothing under any law (other than the law of the Cayman Islands), and there is nothing contained
in the minute book or corporate records of the Company (which other than the records set out in paragraphs 1.1 to 1.5 of the opinion letter,
we have not inspected), which would or might affect the opinions set out below.
2.4 The Sale Agreement has been or will be authorised and duly executed and unconditionally delivered by or
on behalf of all relevant parties in accordance with all relevant laws (other than, with respect to the Company, the laws of the Cayman
Islands).
2.5 The Sale Agreement is, or will be, legal, valid, binding and enforceable against all relevant parties
in accordance with their terms under the laws of the State of New York and all other relevant laws (other than, with respect to the Company,
the laws of the Cayman Islands).
2.6 The choice of the laws of the State of New York as the governing law of the Sale Agreement has been made
in good faith and would be regarded as a valid and binding selection which will be upheld by the state and federal courts sitting in the
City of New York, Borough of Manhattan and any other relevant jurisdiction (other than the Cayman Islands) as a matter of the laws of
the State of New York and all other relevant laws (other than the laws of the Cayman Islands).
2.7 The Company has, or will have, sufficient authorized but unissued Shares in its authorized share capital
to enable the Company to issue the Sale Shares.
2.8 The Company will receive money or money's worth in consideration for the issue of the Sale Shares, and
none of such Sale Shares will be issued for less than their par value.
2
2.9 The capacity, power, authority and legal right of all parties under all relevant laws and regulations
(other than, with respect to the Company, the laws and regulations of the Cayman Islands) to enter into, execute, unconditionally deliver
and perform their respective obligations under the Sale Agreement.
2.10 There is no contractual or other prohibition or restriction (other than as arising under Cayman Islands
law) binding on the Company prohibiting or restricting it from entering into and performing its obligations under the Sale Agreement.
2.11 No monies paid to or for the account of any party under the Sale Agreement or any property received or
disposed of by any party to the Sale Agreement in each case in connection with the Sale Agreement or the consummation of the transactions
contemplated thereby represent or will represent proceeds of criminal conduct or criminal property or terrorist property (as defined in
the Proceeds of Crime Act (As Revised) and the Terrorism Act (As Revised), respectively).
2.12 The issue of the Sale Shares under the Sale Agreement will be of commercial benefit to the Company.
2.13 No invitation has been or will be made by or on behalf of the Company to the public in the Cayman Islands
to subscribe for any of the Sale Shares.
3 Opinion
Based upon,and subject to, the foregoing assumptions and
the qualifications set out below, and having regard to such legal considerations as we deem relevant, we are of the opinion that:
3.1 The Company has been duly incorporated as an exempted company with limited liability and is validly existing
and in good standing with the Registrar of Companies under the laws of the Cayman Islands.
3.2 The authorised share capital of the Company is US$50,000 divided into 500,000,000 ordinary shares of a
par value of US$0.0001 each.
3.3 The issue and allotment of the Sale Shares have been duly authorised and when allotted, issued and paid
for as contemplated in the Registration Statement and the Sale Agreement, such Shares will be legally issued and allotted, fully paid
and non-assessable. As a matter of Cayman law, a share is only issued when it has been entered in the register of members (shareholders).
4 Qualifications
The opinions expressed above are subject to the following qualifications:
4.1 To maintain the Company in good standing under the laws of the Cayman Islands, annual filing fees must
be paid and returns made to the Registrar of Companies within the time frame prescribed by law.
4.2 The obligations assumed by the Company under the Sale Agreement will not necessarily be enforceable in
all circumstances in accordance with their terms. In particular:
3
(a) enforcement may be limited by bankruptcy, insolvency, liquidation, reorganisation, readjustment of debts
or moratorium or other laws of general application relating to, protecting or affecting the rights of creditors and/or contributories;
(b) enforcement may be limited by general principles of equity. For example, equitable remedies such as specific
performance may not be available, inter alia, where damages are considered to be an adequate remedy;
(c) some claims may become barred under relevant statutes of limitation or may be or become subject to defences
of set off, counterclaim, estoppel and similar defences;
(d) where obligations are to be performed in a jurisdiction outside the Cayman Islands, they may not be enforceable
in the Cayman Islands to the extent that performance would be illegal under the laws of that jurisdiction;
(e) the courts of the Cayman Islands have jurisdiction to give judgment in the currency of the relevant obligation
and statutory rates of interest payable upon judgments will vary according to the currency of the judgment. If the Company becomes insolvent
and is made subject to a liquidation proceeding, the courts of the Cayman Islands will require all debts to be proved in a common currency,
which is likely to be the "functional currency" of the Company determined in accordance with applicable accounting principles.
Currency indemnity provisions have not been tested, so far as we are aware, in the courts of the Cayman Islands;
(f) arrangements that constitute penalties will not be enforceable;
(g) enforcement may be prevented by reason of fraud, coercion, duress, undue influence, misrepresentation,
public policy or mistake or limited by the doctrine of frustration of contracts;
(h) provisions imposing confidentiality obligations may be overridden by compulsion of applicable law or the
requirements of legal and/or regulatory process;
(i) the courts of the Cayman Islands may decline to exercise jurisdiction in relation to substantive proceedings
brought under or in relation to the Sale Agreement in matters where they determine that such proceedings may be tried in a more appropriate
forum;
(j) we reserve our opinion as to the enforceability of the relevant provisions of the Sale Agreement to the
extent that they purport to grant exclusive jurisdiction as there may be circumstances in which the courts of the Cayman Islands would
accept jurisdiction notwithstanding such provisions;
(k) a company cannot, by agreement or in its articles of association, restrict the exercise of a statutory
power and there is doubt as to the enforceability of any provision in the Sale Agreement whereby the Company covenants to restrict the
exercise of powers specifically given to it under the Companies Act (As Revised), including, without limitation, the power to increase
its authorised share capital, amend its memorandum and articles of association or present a petition to a Cayman Islands court for an
order to wind up the Company; and
4
(l) enforcement or performance of any provision in the Sale Agreement which relates, directly or indirectly,
to an interest in the Company constituting shares, voting rights or ultimate effective control over management in the Company may be prohibited
or restricted if any such relevant interest is or becomes subject to a restrictions notice issued under the Beneficial Ownership Transparency
Act (As Revised).
4.3 Applicable court fees will be payable in respect of the enforcement of the Sale Agreement.
4.4 We express no opinion as to the meaning, validity or effect of any references to foreign (i.e. non-Cayman
Islands) statutes, rules, regulations, codes, judicial authority or any other promulgations and any references to them in the Sale Agreement.
4.5 In this opinion the phrase "non-assessable" means, with respect to shares in the Company, that
a shareholder shall not, solely by virtue of its status as a shareholder and in absence of a contractual arrangement, or an obligation
pursuant to the memorandum and articles of association, to the contrary, be liable for additional assessments or calls on the shares by
the Company or its creditors (except in exceptional circumstances, such as involving fraud, the establishment of an agency relationship
or an illegal or improper purpose or other circumstances in which a court may be prepared to pierce or lift the corporate veil).
Except as specifically stated herein, we make no comment with respect to
any representations and warranties which may be made by or with respect to the Company in any of the documents or instruments cited in
this opinion or otherwise with respect to the commercial terms of the transactions the subject of this opinion.
We hereby consent to the filing of this opinion as an exhibit to the Form
8-K incorporated by reference into the Registration Statement and to the reference to our name under the headings "Enforceability
of Civil Liabilities" and "Legal Matters" and elsewhere in the prospectus included in the Registration Statement and the
Prospectus Supplement. In giving such consent, we do not thereby admit that we come within the category of persons whose consent is required
under Section 7 of the U.S. Securities Act of 1933, as amended, or the Rules and Regulations of the Commission thereunder.
Yours faithfully
/s/ Maples and Calder (Hong Kong) LLP
Maples and Calder (Hong Kong) LLP
Encl
5
EX-10.1 — EXHIBIT 10.1
EX-10.1
Filename: exh_101.htm · Sequence: 4
EdgarFiling
Exhibit 10.1
SHARE PURCHASE AND COLLABORATION AGREEMENT
BY AND AMONG
BEYONDSPRING INC.,
DALIAN WANCHUNBULIN PHARMACEUTICALS LTD.
AND
BIOLIN INVESTMENT LIMITED
Dated as of September 28, 2026
TABLE OF CONTENTS
Page
1
DEFINITIONS
1.1
Definitions
2
2
PURCHASE OF TRANSFERRED EQUITY INTERESTS; CONSIDERATION; CLOSING
2.1
Sale and Purchase of Transferred Equity Interests
2
2.2
Consideration
2
2.3
Closing
2
2.4
Closing Deliveries
2
3
REPRESENTATIONS AND WARRANTIES OF THE SELLER
3.1
Organization
3
3.2
Authorization; Enforceability
3
3.3
Non-Contravention; Consents
3
3.4
Title to Transferred Equity Interests
4
3.5
Intellectual Property
4
3.6
Litigation
4
3.7
Broker’s Fees
4
4
REPRESENTATIONS AND WARRANTIES OF BULIN
4.1
Organization
4
4.2
Authorization; Enforceability
4
4.3
Non-Contravention; Consents
5
4.4
Subsidiary Interests
5
4.5
Bulin Data and Intellectual Property
5
4.6
Regulatory Permits
5
4.7
Litigation
6
4.8
Broker’s Fees
6
5
REPRESENTATIONS AND WARRANTIES OF THE INVESTOR
5.1
Organization
6
5.2
Authorization; Enforceability
6
5.3
Non-Contravention; Consents
6
5.4
Litigation
7
5.5
Broker’s Fees
7
i
5.6
Purchase Entirely for Own Account
7
5.7
Available Funds
7
5.8
Restricted Securities
7
5.9
No Public Market; Limited Rights
8
5.10
Competition
8
5.11
Investor’s Investigation and Reliance
8
6
DEVELOPMENT
6.1
Development Commitment
9
6.2
Development Plan
9
6.3
Performance of Development Plan
9
6.4
Development Records
9
6.5
Target Enrollment
10
6.6
Clinical Trial Data
11
6.7
Regulatory Activities
11
6.8
Manufacturing
13
6.9
No Conditions
13
7
LICENSES
7.1
License to Bulin Data
13
7.2
Freedom-to-Operate License
13
8
CERTAIN COVENANTS
8.1
Further Assurances
15
8.2
Company Register of Members
15
8.3
Bulin Cash
15
8.4
Bulin SEED Shares
16
8.5
Competitive Activity
16
9
CONDITIONS TO CLOSING
9.1
Conditions to Obligations of the Seller and the Investor at the Equity Closing
17
9.2
Conditions to Obligations of the Investor at the Equity Closing
17
9.3
Conditions to Obligations of the Seller at the Equity Closing
17
10
SURVIVAL; LIMITATIONS
10.1
Survival of Representations and Covenants
18
11
TERMINATION OF TRANSFER OF TRANSFERRED EQUITY INTERESTS
11.1
Termination of the Agreement Prior to the Equity Closing
18
11.2
Procedure Upon Termination
19
11.3
Restriction on Termination
19
ii
12
TERMINATION OF COLLABORATION OBLIGATIONS
12.1
Termination of the Agreement After the Equity Closing
19
12.2
Procedure Upon Termination
20
12.3
Effect of Termination
20
13
MISCELLANEOUS
13.1
Notices
21
13.2
Amendments and Waivers
22
13.3
Expenses
22
13.4
Succession and Assignment
22
13.5
Non-Recourse
23
13.6
Third-Party Beneficiaries
23
13.7
Governing Law; Arbitration.
23
13.8
WAIVER OF JURY TRIAL
24
13.9
Counterparts
25
13.1
Entire Agreement
25
13.11
Confidentiality
25
13.12
Severability
26
13.13
Press Release and Announcements
26
13.14
Specific Performance
26
13.15
Certain Interpretive Matters
27
ANNEXES:
Annex I
Definitions
Annex II
Development Plan
EXHIBITS:
Exhibit A
Form of Instrument of Transfer
iii
SHARE PURCHASE AND COLLABORATION AGREEMENT
THIS SHARE PURCHASE AND COLLABORATION AGREEMENT (this
“Agreement”), dated as of September 28, 2026, is made by and among BeyondSpring Inc., an exempted company incorporated
and existing with limited liability under the laws of The Cayman Islands (the “Seller”), Dalian Wanchunbulin Pharmaceuticals
Ltd., a limited liability company incorporated under the laws of the People’s Republic of China (“Bulin”), and
Biolin Investment Limited, a limited company formed under the laws of Hong Kong (the “Investor”). Each of the Seller,
Bulin and the Investor will be referred to herein as a “Party” and, collectively, as the “Parties”.
(A)
The Seller is an exempted company incorporated under the laws of The Cayman Islands, and the Seller directly owns 100% shareholding,
being one issued share with a par value of $1.00 each, in BeyondSpring Ltd., a BVI business company incorporated under the laws of The
British Virgin Islands (the “Company” and, such share, the “Company Equity Interests”);
(B)
The Company directly owns all equity interests in BeyondSpring (HK) Limited, a limited company formed under the laws of Hong Kong,
which in turn owns all equity interests in Wanchun Biotechnology (Dalian) Ltd., a limited liability company incorporated under the laws
of the People’s Republic of China (“WOFE”);
(C)
WOFE directly owns 57.97% of the equity interests in Bulin;
(D)
The Seller desires to sell and transfer to the Investor, and the Investor desires to purchase and acquire from the Seller, the
Company Equity Interests (the “Transferred Equity Interests”), on the terms and subject to the conditions contained
in this Agreement;
(E)
The Parties desire to establish a strategic collaboration with respect to certain development activities involving a certain portion
of the global Phase 3 Clinical Trial of the Seller’s clinical candidate combination therapy of Plinabulin with docetaxel in patients
with non-squamous epidermal growth factor receptor wild-type non-small cell lung cancer who have progressed on PD-1/PD-L1 inhibitor-containing
therapies, known as DUBLIN-4 and, in connection therewith, the obligation on the part of the Investor with respect to conducting and completing
such portion of such Clinical Trial, and causing Bulin to take the actions described herein, shall constitute non-cash consideration for
the purchase of the Transferred Equity Interests, all on the terms and subject to the conditions contained in this Agreement; and
(F)
In connection with the Parties’ strategic collaboration, (i) Bulin desires to grant to the Seller, and the Seller desires
to receive from Bulin, an exclusive, irrevocable, perpetual, non-terminable, sublicensable, transferable, fully paid-up, royalty-free
license and right to use the Bulin Data for any purpose outside of the Territory and (ii) (a) the Seller desires to grant to Bulin, and
Bulin desires to receive from the Seller, and (b) Bulin desires to grant to the Seller, and the Seller desires to receive from Bulin,
in the case of each of clauses (a) and (b), certain freedom-to-operate licenses, all on the terms and subject to the
conditions contained in this Agreement.
NOW, THEREFORE, in consideration of the mutual
covenants and agreements herein set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties agree as follows:
1. DEFINITIONS
1.1 Definitions. Certain capitalized terms used but not defined elsewhere in the text of this Agreement
are defined in Annex I.
2. PURCHASE OF TRANSFERRED EQUITY INTERESTS; CONSIDERATION; CLOSING
2.1 Sale and Purchase of Transferred Equity Interests. On the terms and subject to the conditions set
forth in this Agreement, at the Equity Closing, the Seller shall sell, transfer, convey, assign and deliver to the Investor the Transferred
Equity Interests, free and clear of all Liens (other than restrictions on transfer imposed by applicable securities Laws), and the Investor
shall purchase, acquire and accept from the Seller all of the Seller’s right, title and interest in and to such Transferred Equity
Interests.
2.2 Consideration. As consideration for the Transferred Equity Interests, the Investor shall perform
and comply with all its obligations under Article 6 and Article 8, and cause Bulin to perform and comply with all its
obligations under Article 6, Article 7 and Article 8, in each case in accordance with the terms thereof,
which obligations on the part of the Investor shall be the non-cash consideration for the Transferred Equity Interests. For the avoidance
of doubt, at the Equity Closing, the Investor shall have no obligation to, and shall not, deliver to the Seller any cash as consideration
for the Transferred Equity Interests or the transactions contemplated by this Agreement.
2.3 Closing. The closing of the transactions contemplated by Section 2.1 (the “Equity
Closing”) shall take place by electronic exchange of documents on September 30, 2026, subject to the satisfaction or
waiver of the conditions to the obligations of the Seller and the Investor set forth in Article 9 (other than those conditions
that by their nature are to be satisfied or waived (to the extent permitted by applicable Law) at the Equity Closing), or on such other
date and at such other place as agreed to by the Seller and the Investor in writing, and shall be effective as of 12:01 a.m., New
York City time, on such date. The date on which the Equity Closing actually occurs is referred to herein as the “Equity
Closing Date”.
2.4
Closing Deliveries.
2.4.1 Subject to the terms and conditions of this Agreement, at the Equity Closing the Seller shall deliver
to the Investor:
(a) an instrument of transfer of the applicable Transferred Equity Interests held by the Seller, executed
by the Seller, substantially in the form set forth on Exhibit A hereto;
2
(b) an updated register of members of the Company reflecting the transfer of the Transferred Equity Interests
from the Seller to the Investor, and evidencing the Investor as the holder of such Transferred Equity Interests; and
(c) a certificate executed by an officer of the Seller, in form and substance reasonably satisfactory to the
Investor, confirming the satisfaction of the conditions contained in Section 9.2.1 and Section 9.2.2.
2.4.2 Subject to the terms and conditions of this Agreement, at the Equity Closing Bulin shall deliver to the
Investor a certificate executed by an officer of Bulin, in form and substance reasonably satisfactory to the Investor, confirming the
satisfaction of the conditions contained in Section 9.2.3.
2.4.3 Subject to the terms and conditions of this Agreement, at the Equity Closing the Investor shall deliver
to the Seller a certificate executed by an officer of the Investor, in form and substance reasonably satisfactory to the Seller, confirming
the satisfaction of the conditions contained in Sections 9.3.1 and 9.3.2.
3. REPRESENTATIONS AND WARRANTIES OF THE SELLER
The Seller hereby represents and warrants to the Investor
as follows:
3.1 Organization. The Seller is duly incorporated, formed and validly existing and in good standing
under the Laws of the jurisdiction of its incorporation or formation.
3.2 Authorization; Enforceability. The Seller has all requisite capacity, power and authority, as the
case may be, to enter into, and to consummate the transactions contemplated by, this Agreement. The execution, delivery and performance
by the Seller of this Agreement and the other agreements and documents contemplated hereby to be executed and delivered by the Seller,
and the consummation by the Seller of the transactions contemplated hereby and thereby, have been duly and validly authorized by all necessary
corporate action on the part of the Seller. This Agreement and each of the other agreements and documents contemplated hereby to which
the Seller is or will be a party have been or will be duly and validly executed and delivered by the Seller, and once executed, will constitute
a legal, valid and binding agreement of the Seller, enforceable against the Seller in accordance with their respective terms, subject
to the effect of any applicable bankruptcy, insolvency, reorganization, moratorium or similar Laws affecting creditors’ rights and
remedies generally, and subject, as to enforceability, to the effect of general principles of equity.
3.3 Non-Contravention; Consents.
3.3.1 Assuming the accuracy of the representations made by the Investor in Article 5, the execution,
delivery and performance by the Seller of this Agreement and the other agreements and documents contemplated hereby to which the Seller
is or will be a party, and the consummation of the transactions contemplated hereby and thereby, does not and will not (a) violate
the Organizational Documents of the Seller or (b) violate any applicable Law or Order.
3
3.3.2 The execution, delivery and performance by the Seller of this Agreement and the other agreements and documents
contemplated hereby to which the Seller is or will be a party does not and will not require any clearance, authorization, approval, waiver
or consent from any Governmental Authority.
3.4 Title to Transferred Equity Interests. The Seller owns good and valid title to the Transferred
Equity Interests, free and clear of any and all Liens. Upon transfer of such Transferred Equity Interests in accordance with Article 2,
the Investor shall own good and valid title to such Transferred Equity Interests, free and clear of any and all Liens.
3.5 Intellectual Property. To the knowledge of the Seller, immediately following the Equity Closing
(and, for clarity, after giving effect to the license granted pursuant to Section 7.2.1 hereunder), Bulin shall possess sufficient
rights in Intellectual Property (other than Trademarks) to conduct Bulin’s business with respect to Plinabulin in the Territory
as conducted as of the date hereof, except where a failure to possess such rights would not reasonably be expected to have a material
adverse effect on such business operations.
3.6
Litigation. There is no action, suit, investigation, arbitration or administrative or other proceeding pending or, to the
knowledge of the Seller, threatened against or affecting the Seller, and the Seller is not subject to or bound by any Order, in either
case that would prevent or otherwise interfere with the ability of the Seller to consummate the transactions contemplated by this Agreement.
3.7
Broker’s Fees. There is no investment banker, broker, finder or other intermediary that has been retained by or is authorized
to act on behalf of the Seller or any Affiliate thereof, who might be entitled to any fee or commission in connection with the transactions
contemplated by this Agreement or any other agreements or documents contemplated hereby.
4. REPRESENTATIONS AND WARRANTIES OF BULIN
Bulin hereby represents and warrants to the Investor as follows:
4.1 Organization. Bulin is duly incorporated, validly existing and in good standing under the Laws
of the jurisdiction of its incorporation or formation.
4.2 Authorization; Enforceability. Bulin has all requisite capacity, power and authority, as the case
may be, to enter into, and to consummate the transactions contemplated by, this Agreement. The execution, delivery and performance by
Bulin of this Agreement and the other agreements and documents contemplated hereby to be executed and delivered by Bulin, and the consummation
by Bulin of the transactions contemplated hereby and thereby, have been duly and validly authorized by all necessary corporate action
on the part of Bulin. This Agreement and each of the other agreements and documents contemplated hereby to which Bulin is or will be a
party have been or will be duly and validly executed and delivered by Bulin, and once executed, will constitute a legal, valid and binding
agreement of Bulin, enforceable against Bulin in accordance with their respective terms, subject to the effect of any applicable bankruptcy,
insolvency, reorganization, moratorium or similar Laws affecting creditors’ rights and remedies generally, and subject, as to enforceability,
to the effect of general principles of equity.
4
4.3 Non-Contravention; Consents.
4.3.1 Assuming the accuracy of the representations made by the Investor in Article 5, the execution,
delivery and performance by Bulin of this Agreement and the other agreements and documents contemplated hereby to which Bulin is or will
be a party, and the consummation of the transactions contemplated hereby and thereby, does not and will not (a) violate the Organizational
Documents of Bulin or (b) violate any applicable Law or Order.
4.3.2 The execution, delivery and performance by Bulin of this Agreement and the other agreements and documents
contemplated hereby to which Bulin is or will be a party does not and will not require any clearance, authorization, approval, waiver
or consent from any Governmental Authority.
4.4 Subsidiary Interests. Bulin indirectly owns 2,404,000 Series A-1 Preferred Shares of SEED Therapeutics
as of the date hereof (the “Bulin SEED Shares”), which shares represent approximately 8.88% of the issued and outstanding
equity interests of SEED Therapeutics (and approximately 7.43% on a fully diluted basis).
4.5 Bulin Data and Intellectual Property.
4.5.1 Bulin owns, and shall own, good and valid title to the Bulin Data, free and clear of any and all Liens.
4.5.2 Bulin owns and has good and exclusive title to, or possesses adequate rights to use, each item of Bulin
Intellectual Property, free and clear of any and all Liens. Bulin Intellectual Property, together with the other Intellectual Property
licensed to Bulin (including, as of immediately following the Equity Closing, such Intellectual Property licensed pursuant to Section 7.2.1
hereunder), comprises the material Intellectual Property necessary to conduct Bulin’s business as conducted as of the date hereof.
4.6 Regulatory Permits. Bulin possesses all material Regulatory Permits issued by, has made all material
declarations, filings, registrations and submissions with, and has given all material notices to, the applicable Regulatory Authorities
that are necessary or required for the conduct of its current business, and each such material Regulatory Permit is valid and in full
force and effect, except where the failure to possess, make, give or maintain the same would not, individually or in the aggregate, reasonably
be expected to have a material adverse effect on such business operations. Bulin has not received written notice of any revocation, withdrawal,
suspension, cancellation, termination or material modification of any such Regulatory Permit and, to the knowledge of Bulin, there is
no reason to believe that any such Regulatory Permit will not be renewed in the ordinary course, except to the extent that any of the
foregoing would not, individually or in the aggregate, reasonably be expected to have a material adverse effect on Bulin’s business
operations.
5
4.7 Litigation. There is no action, suit, investigation, arbitration or administrative or other proceeding
pending or, to the knowledge of Bulin, threatened against or affecting Bulin, and Bulin is not subject to or bound by any Order, in either
case that would prevent or otherwise interfere with the ability of Bulin to consummate the transactions contemplated by this Agreement.
4.8
Broker’s Fees. There is no investment banker, broker, finder or other intermediary that has been retained by or is
authorized to act on behalf of Bulin or any Affiliate thereof, who might be entitled to any fee or commission in connection with the transactions
contemplated by this Agreement or any other agreements or documents contemplated hereby.
5. REPRESENTATIONS AND WARRANTIES OF THE INVESTOR
The Investor hereby represents and warrants to the Seller as
follows:
5.1 Organization. The Investor is duly formed, validly existing and in good standing as a limited company
under the Laws of the jurisdiction of its incorporation or formation.
5.2 Authorization; Enforceability. The Investor has all requisite capacity, power and authority, as
the case may be, to enter into, and to consummate the transactions contemplated by, this Agreement. The execution, delivery and performance
by the Investor of this Agreement and the other agreements and documents contemplated hereby to be executed and delivered by the Investor,
and the consummation by the Investor of the transactions contemplated hereby and thereby, have been duly and validly authorized by all
necessary corporate action on the part of the Investor. This Agreement and each of the other agreements and documents contemplated hereby
to which the Investor is or will be a party have been or will be duly and validly executed and delivered by the Investor, and once executed,
will constitute a legal, valid and binding agreement of the Investor, enforceable against the Investor in accordance with their respective
terms, subject to the effect of any applicable bankruptcy, insolvency, reorganization, moratorium or similar Laws affecting creditors’
rights and remedies generally, and subject, as to enforceability, to the effect of general principles of equity.
5.3 Non-Contravention; Consents.
5.3.1 Assuming the accuracy of the representations made by the Seller in Article 3 and made by Bulin
in Article 4, the execution, delivery and performance by the Investor of this Agreement and the other agreements and documents
contemplated hereby to which the Investor is or will be a party, and the consummation of the transactions contemplated hereby and thereby,
does not and will not (a) violate the Organizational Documents of the Investor, (b) violate any applicable Law or Order or (c) violate
or constitute a default under any of the terms, conditions or provisions of any Contract to which the Investor is or is contemplated to
be a party or give rise to a right of termination, cancelation or acceleration or loss of a material benefit under any such Contract.
6
5.3.2 The execution, delivery and performance by the Investor of this Agreement and the other agreements and
documents contemplated hereby to which the Investor is or will be a party does not and will not require any clearance, authorization,
approval, waiver or consent from any Governmental Authority.
5.4 Litigation. There is no action, suit, investigation, arbitration or administrative or other proceeding
pending or, to the knowledge of the Investor, threatened against or affecting the Investor, and the Investor is not subject to or bound
by any Order, in either case that would prevent or otherwise interfere with the ability of the Investor to consummate the transactions
contemplated by this Agreement.
5.5
Broker’s Fees. There is no investment banker, broker, finder or other intermediary that has been retained by or is
authorized to act on behalf of the Investor or any Affiliate thereof, who might be entitled to any fee or commission in connection with
the transactions contemplated by this Agreement or any other agreements or documents contemplated hereby.
5.6 Purchase Entirely for Own Account. The Investor is acquiring the Transferred Equity Interests for
investment for its own account, not as a nominee or agent, and not with a view to the resale or distribution of any part thereof and the
Investor has no intention of selling, distributing or otherwise disposing of any part of the Transferred Equity Interests in a manner
that would violate the registration requirements of the Securities Act. The Investor hereby further represents that the Investor does
not presently have any contract, undertaking, agreement or other arrangement with any Person to sell, transfer or grant participations
to such Person or to any third Person, with respect to any of the Transferred Equity Interests. The Investor has not been formed for the
specific purpose of acquiring the Transferred Equity Interests.
5.7 Available Funds. The Investor has readily available funds sufficient to pay the fees and expenses
of the Investor related to the transactions contemplated hereby. The Investor knows of no circumstances or conditions that could be reasonably
expected to prevent the availability of such funds when required to fulfill the Investor’s obligations under this Agreement following
the Equity Closing pursuant to Article 6 and Article 7.
5.8
Restricted Securities. The Investor understands that the Transferred Equity Interests have not been, and will not be, registered
under the Securities Act, by reason of a specific exemption from the registration provisions of the Securities Act which depends on, among
other things, the bona fide nature of the investment intent and the accuracy of the Investor’s representations as expressed herein.
The Investor understands that the Transferred Equity Interests are “restricted securities” under applicable U.S. federal and
state securities Laws and that, pursuant to these Laws, the Investor must hold the Transferred Equity Interests indefinitely unless they
are registered with the Securities and Exchange Commission and qualified by state authorities, or an exemption from such registration
and qualification requirements is available. The Investor acknowledges that the Company has no obligation to register or qualify the Transferred
Equity Interests for resale. The Investor further acknowledges that if an exemption from registration or qualification is available, it
may be conditioned on various requirements including, but not limited to, the time and manner of sale, the holding period for the Transferred
Equity Interests, and requirements relating to the Company which are outside of the Investor’s control, and which the Company is
under no obligation and may not be able to satisfy.
7
5.9 No Public Market; Limited Rights. The Investor understands that no public market now exists for
the Transferred Equity Interests, and no assurances have been made that a public market will ever exist for the Transferred Equity Interests.
The Investor further understands that the rights and privileges associated with ownership of the Transferred Equity Interests will be
limited by the Organizational Documents of the Company.
5.10 Competition. The Investor is not engaged, directly or indirectly, on its own or together with or
through a third party (including through any partnership, limited liability company, corporation, joint venture or similar arrangement
(whether now existing or formed hereafter)) in drug discovery, research, development, manufacture, commercialization or other exploitation
of any drug products (whether on their own or in combination with other active ingredients) for the treatment of non-small cell lung cancer
(a “Competitor”), not taking into account any financial investment firm or collective
investment vehicle that, together with its Affiliates, holds less than fifty percent (50%) of the outstanding equity of any Competitor
and where the Investor does not, nor do any of its Affiliates, have a right to designate any members of the board of directors of any
Competitor.
5.11
Investor’s Investigation and Reliance. The Investor is a sophisticated purchaser and has made its own investigation, review
and analysis regarding the Company, the Seller and the transactions contemplated hereby. The Investor has been provided with full and
complete access to the Representatives, properties, offices and other facilities, books and records of the Company and other necessary
information that it has requested in connection with its investigation of the Company and the transactions contemplated hereby. The Investor
is not relying, and has not relied, upon any statement, representation or warranty, oral or written, express or implied, made (a) by
the Seller, except as expressly set forth in Article 3 or any certificate delivered by the Seller or (b) by Bulin, except
as expressly set forth in Article 4 or any certificate delivered by Bulin. Neither the Seller nor any of its Affiliates or
Representatives shall have any liability to the Investor or any of its Affiliates or Representatives resulting from the use of any information,
documents or materials made available to the Investor, whether orally or in writing, in expectation of the transactions contemplated
by this Agreement. The Investor acknowledges and agrees that, should the Equity Closing occur, the Investor shall acquire the Transferred
Equity Interests without any representation or warranty as to merchantability or fitness for any particular purpose of their respective
assets, on an “as is” and “where is” basis, except as expressly set forth in Article 3 or any certificate
delivered by the Seller. The Investor acknowledges and agrees that it has no knowledge or reason to believe that any of the representations
or warranties made by the Seller or by Bulin as of the date hereof are untrue, incomplete or inaccurate.
8
6. DEVELOPMENT
6.1
Development Commitment. The Investor shall (a) provide sufficient financial resources, including cash, general funds, capital
funds, working capital and reimbursement for any operating, capital or other losses, to Bulin as may reasonably be required for Bulin
to conduct and complete the portion of the global Phase 3 Clinical Trial of the Seller’s clinical candidate combination therapy
of Plinabulin with docetaxel (such combination therapy, the “Product”) in patients
with non-squamous epidermal growth factor receptor wild-type non-small cell lung cancer who have progressed on PD-1/PD-L1 inhibitor-containing
therapies, known as DUBLIN-4 (such trial, the “Ongoing Trial”), in the People’s
Republic of China (such portion of the Ongoing Trial in the People’s Republic of China, the “Chinese
Territory Ongoing Trial”) and (b) cause Bulin to conduct, and use Commercially Reasonable Efforts to complete,
such Clinical Trial and fulfill its obligations pursuant to this Article 6, Article 7 and Article 8 in
accordance with the terms and conditions of this Agreement.
6.2
Development Plan. A high-level outline of the Development activities currently contemplated by the Parties to be conducted in
support of the Chinese Territory Ongoing Trial, including anticipated timelines, is attached hereto as Annex II (as amended
from time to time in accordance with this Section 6.2, the “Development Plan”).
No later than March 1 of any given calendar year during the term of this Agreement, or more often as the Parties (or the Parties’
respective designees) may agree upon in writing from time to time, the Parties (or the Parties’ respective designees) shall review
and, as appropriate, prepare amendments or other updates to the Development Plan. For clarity, no Party shall have a right under this
Agreement to review any other Party’s activities with respect to products other than the Product.
6.3 Performance of Development Plan. Bulin shall, and the Investor shall cause Bulin to, conduct the
Development activities set forth in the Development Plan, including the Chinese Territory Ongoing Trial, and all other activities reasonably
required to support such Development activities, in each case, in compliance with the terms of this Agreement, GLP, GCP, GMP, all other
applicable Laws and the Development Plan. As between the Parties, the Investor and Bulin shall be responsible for the costs and expenses
incurred by Bulin in the conduct of the Chinese Territory Ongoing Trial and all other activities set forth in the Development Plan.
6.4
Development Records. Bulin shall, and the Investor shall cause Bulin to, maintain complete and accurate records (in the form of
technical notebooks or electronic files where appropriate) of all work conducted by Bulin or its Affiliates, sublicensees or subcontractors
in the Development of the Product and all information resulting from such work, to the extent necessary or useful for the Development
of the Product (such records, “Development Records”). Such Development Records,
including any electronic files where such information may also be contained, shall fully and properly reflect all work done and results
achieved in the performance of the Development of the Product (as applicable) in sufficient detail and in good scientific manner appropriate
for regulatory purposes. In addition to its safety reporting obligations set forth in Section 6.7.3, the Seller shall have
the right to review and copy Development Records maintained by or on behalf of Bulin at reasonable times and to the extent needed for
regulatory purposes, to obtain access to originals, and Bulin shall, and the Investor shall cause Bulin to, promptly provide such access
to the Seller upon the Seller’s reasonable request.
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6.5 Target Enrollment.
6.5.1 Bulin shall, and the Investor shall cause Bulin to, use
Commercially Reasonable Efforts to enroll in, and include in the intent-to-treat population of, the Chinese Territory Ongoing Trial such
number of patients as the Seller determines, in its sole discretion, is required to satisfy the Seller’s regulatory needs (as of
the date hereof, such number is expected to fall within a range of 221–265 patients) (such enrollment and inclusion, the “Target
Enrollment”) in accordance with the applicable Clinical Trial protocol, between the Equity
Closing Date and the three (3)-year anniversary of the Equity Closing Date (such period, the “Enrollment
Period”).
6.5.2 If Bulin fails to achieve (and the Investor fails to cause Bulin to achieve)
the Target Enrollment prior to the expiration of the Enrollment Period, upon the expiration of the Enrollment Period:
(a) As soon as practicable but in no event later than thirty (30) days following the expiration of the Enrollment
Period, the Investor shall transfer to the Seller an ownership percentage of the Company (the “Equity Clawback”) equal
to the product of (i) the total ownership of the Company acquired by the Investor pursuant to this Agreement, as adjusted for any
recapitalization, stock split, reclassification or similar transaction subsequent to the Equity Closing, multiplied by (ii) a
fraction, the numerator of which is the difference between the Target Enrollment and the actual number of subjects enrolled as of the
expiration of the Enrollment Period, and the denominator of which is the Target Enrollment (such fraction, expressed as a percentage,
the “Equity Clawback Percentage”); provided, however, that in the event the Equity Clawback Percentage is equal to
90% (ninety percent) or greater, the Investor shall be obligated to return, and shall deliver, to the Seller 100% of the Company Equity
Interests, as adjusted for any recapitalization, stock split, reclassification or similar transaction subsequent to the Equity Closing.
The Investor shall not (A) issue, redeem, sell, grant, deliver, pledge, transfer, encumber or subject to any Lien (other than restrictions
on transfer imposed by applicable securities Laws) any Transferred Equity Interests, other equity interests of the Company or Bulin SEED
Shares, (B) grant any option, warrant or right to acquire any Transferred Equity Interests, other equity interest of the Company
or Bulin SEED Shares or (C) issue any security convertible into or exchangeable for such securities, in the case of each of clauses (A),
(B) and (C), the effect of which would prevent the Investor from performing and complying with its obligations under this
Agreement, including, without limitation, this Section 6.5.2, except in the case of an Authorized Transferee and subject to
Section 13.4. For the avoidance of doubt, until the achievement of the Target Enrollment or
if the Target Enrollment is not achieved, until the delivery of the Equity Clawback from the Investor
to the Seller, the Company shall have maintained its indirect ownership in SEED Therapeutics; and
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(b) The Seller shall be entitled to terminate this Agreement pursuant to Section 12.1.1.
6.6 Clinical Trial Data.
6.6.1 As between the Parties, Bulin (whether itself or through one or more Affiliates) shall own the right,
title and interest in, to and under all data and information generated in connection with the Chinese Territory Ongoing Trial, including
raw datasets and including case report forms and source data (collectively, the “Bulin Data”).
6.6.2 Following the initiation of the Chinese Territory Ongoing Trial, and at such cadence as is reasonably
agreed upon by the Parties (or the Parties’ respective designees), Bulin shall, and the Investor shall cause Bulin to, (a) transfer
to the Seller copies of all Bulin Data and, upon the Seller’s request, all human genetic resources information generated in connection
with the Chinese Territory Ongoing Trial and (b) provide the Seller with copies of material regulatory correspondence and submissions
with the National Medical Products Administration (“NMPA”) that relate to the
Product (and, as applicable, English-language translations thereof), in each case, in accordance with applicable Laws and at no cost to
the Seller. Without limiting any other obligations under this Agreement, as between the Parties, Bulin and the Investor (themselves or
through one or more of their respective Affiliates) shall be responsible for obtaining all approvals required by applicable Law in connection
therewith at their sole cost and expense. To the extent reasonably necessary under applicable Law in order to effectuate the foregoing
transfer of Bulin Data, human genetic resources information or regulatory correspondence or submissions, the Parties (or the Parties’
respective designees, as appropriate) shall negotiate in good faith and enter into any data processing agreements in connection therewith.
Bulin (itself or through one or more Affiliates) shall, and the Investor shall cause Bulin to, promptly notify the Seller if any transfer
of data, information or materials contemplated by this Agreement is not permitted under any applicable Law, and shall use Commercially
Reasonable Efforts to find alternative means for providing the Seller with such data, information or materials in a manner that is compliant
with applicable Laws.
6.7
Regulatory Activities.
6.7.1 General. As between the Parties, (i) the Investor or its Subsidiaries (for clarity, which
Subsidiaries include, after giving effect to the Equity Closing, Bulin) shall have the sole right to file and maintain, and exclusive
control over filing and maintaining, Regulatory Materials for the Product for use in the Territory, including communicating with Regulatory
Authorities and owning Regulatory Materials for the Product for use in the Territory, and (ii) the Seller or its Subsidiaries shall
have the sole right to file and maintain, and exclusive control over filing and maintaining, regulatory filings for the Product for use
outside the Territory, including communicating with Regulatory Authorities and owning Regulatory Materials for the Product for use outside
the Territory.
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6.7.2 Regulatory Audits, Inspections and Remedial Actions. Bulin shall, and the Investor shall cause
Bulin to, (a) promptly (and in any case, within twenty-four (24) hours) notify the Seller of any clinical hold, audit or inspection
of Bulin or its Affiliates by any Regulatory Authority that relates to or materially adversely affects the Chinese Territory Ongoing Trial
or the Product and (b) promptly comply with all requirements of the applicable Regulatory Authorities in connection therewith. Following
the Seller’s reasonable request, Bulin shall, and the Investor shall cause Bulin to, provide the Seller with all information pertinent
thereto reasonably requested by the Seller.
6.7.3 Safety Reporting and Global Safety Database. As soon as reasonably practicable following written
notice from the Seller, the Seller shall and Bulin shall (and the Investor shall cause Bulin to) mutually agree to and execute an agreement
(a “Pharmacovigilance Agreement”) setting forth each such party’s responsibilities
pertaining to safety data collection, and safety assessment and reporting for the Product in accordance with applicable Laws. In the event
of any inconsistency between the terms of this Agreement and the Pharmacovigilance Agreement, the terms of this Agreement shall govern,
except to the extent such conflicting terms relate directly to the pharmacovigilance responsibilities of the parties thereto (including
the exchange of safety data), in which case the terms of the Pharmacovigilance Agreement shall govern. The Seller shall maintain the global
safety database for the Product by or on behalf of the Parties and their Affiliates. Bulin shall, and the Investor shall cause Bulin to,
maintain a safety database for the Product for the Territory and provide safety reports to the Seller in accordance with the Pharmacovigilance
Agreement.
6.7.4 Collaboration Management. The Seller shall and Bulin shall (and the Investor shall cause Bulin
to), in good faith, work together to coordinate Bulin’s activities with respect to the Chinese Territory Ongoing Trial, data transfer
obligations hereunder and regulatory activities in the Territory with respect to Plinabulin and the Product. To the extent Bulin intends
to take (or fail to take) some action, which action or inaction (i) is inconsistent with Bulin’s obligations under the Agreement
or (ii) adversely affects (or reasonably would be expected to adversely affect) the Ongoing Trial or the Bulin Data (including the
quality thereof) (any such action or inaction, an “Adverse Act”), Bulin shall,
and the Investor shall cause Bulin to, reasonably and in good faith consult with the Seller reasonably in advance of taking (or failing
to take) such action. The Seller shall be entitled to terminate this Agreement pursuant to Section 12.1.2 upon notice to Bulin
and the Investor, if, following reasonable consultation between Bulin and the Seller in accordance with the foregoing sentence, Bulin
undertakes an Adverse Act. For the avoidance of doubt, this Section 6.7.4 does not grant the Seller ordinary-course control
over the management, budget, personnel or operations of Bulin.
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6.7.5 Right of Reference. Effective as of the Equity Closing, Bulin hereby grants and agrees to grant,
and the Investor shall cause Bulin to grant, to the Seller, its Affiliates, sublicensees, subcontractors and its and their successors
and assigns a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any analogous applicable
Law recognized outside of the United States), to all data Controlled by Bulin or its Affiliates, licensees or sublicensees that relates
to the Product, solely for the Seller, its Affiliates, licensees, sublicensees and subcontractors to Develop, manufacture and obtain,
support and maintain Marketing Approvals for Plinabulin (and any combination therapies therewith, including the Product) for use outside
the Territory. The foregoing “Right of Reference” shall be transferable and
sublicensable by the Seller and its Affiliates through multiple tiers. Bulin shall, and the Investor shall cause Bulin to, provide a signed
statement to this effect (in a form reasonably acceptable to the Seller), if requested by the Seller, in accordance with 21 C.F.R. § 314.50(g)(3)
(or any analogous applicable Law outside of the United States), and take such other actions as may reasonably be requested by the Seller
to give effect to the intent of this Section 6.7.5, at no cost to the Seller.
6.7.6 Regulatory Support. Bulin shall, and the Investor shall cause Bulin to, provide the Seller with
any support reasonably requested by the Seller in connection with any regulatory activities conducted by the Seller to the extent relating
to Plinabulin or the Product.
6.8
Manufacturing. For the avoidance of doubt, as between the Parties and subject to Section 6.1, Bulin and the Investor
(themselves or through one or more of their respective Affiliates) shall be responsible for the manufacture and supply of a sufficient
quantity of the Product to conduct the Chinese Territory Ongoing Trial at their sole cost and expense. Bulin shall, and the Investor
shall cause Bulin to, ensure that all Product supplied for use in the Chinese Territory Ongoing Trial shall be manufactured in accordance
with GMP and all other applicable Laws and suitable for use in Clinical Trials as required by applicable Regulatory Authorities.
6.9 No Conditions. For the avoidance of doubt, notwithstanding anything to the contrary in this Agreement,
the Parties expressly acknowledge and agree that the satisfaction of obligations of the Investor and Bulin (as applicable) set forth in
this Article 6 shall not be conditions to the Equity Closing.
7. LICENSES
7.1
License to Bulin Data. On the terms and subject to the conditions contained in this Agreement, effective as of the Equity Closing,
Bulin, on behalf of itself and its Affiliates, hereby grants and agrees to grant to the Seller and its Affiliates an exclusive (even
as to Bulin and its Affiliates), irrevocable, perpetual, non-terminable, sublicensable (through multiple tiers), transferable, fully
paid-up, royalty-free license and right to use the Bulin Data for any purpose, other than the sale of Plinabulin or the Product in the
Territory.
7.2
Freedom-to-Operate License.
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7.2.1 Subject to the terms and conditions of this Agreement, during the term of this Agreement, the Seller,
on behalf of itself and its Affiliates, hereby grants to Bulin a non-exclusive, fully paid-up, royalty-free, non-sublicensable (except
as permitted by Section 7.2.3), non-transferable (except as permitted under Section 13.4) license under the Seller
Intellectual Property, in each case, solely to the extent necessary to manufacture and commercialize Plinabulin (including any combination
therapies, including the Product) in the Territory.
7.2.2 Subject to the terms and conditions of this Agreement, Bulin, on behalf of itself and its Affiliates,
hereby grants to the Seller a non-exclusive, fully paid-up, non-sublicensable (except as permitted by Section 7.2.3), non-transferable
(except as permitted under Section 13.4) license under the Bulin Intellectual Property, in each case, solely to the extent
necessary to manufacture and commercialize Plinabulin (including any combination therapies, including the Product) worldwide other than
in the Territory.
7.2.3
(a) Subject to the terms and conditions of this Agreement, the license granted to Bulin pursuant to the above
Section 7.2.1 shall only be sublicensable by Bulin (through multiple tiers): (A) to its Subsidiaries (provided that such
sublicense shall automatically terminate if such sublicensee ceases to be a Subsidiary of Bulin) and (B) to contract research organizations,
distributors, contract manufacturing organizations and other third-party subcontractors solely for the provision of services with respect
to Bulin’s (or its Subsidiaries’) exploitation of Plinabulin (for clarity, including any combination therapies, including
the Product) (and for clarity, not for the applicable sublicensee to exploit such sublicense for such sublicensee’s independent
benefit); provided that, in the case of each of clauses (A) and (B), such sublicense shall be in writing and,
with respect to any confidential information (including any trade secrets) of the Seller or its Affiliates, contain confidentiality obligations
at least as protective as those set forth in the Confidentiality Agreement. The Investor shall ensure that Bulin and Bulin’s sublicensees
comply with the foregoing limitation.
(b) Subject to the terms and conditions of this Agreement, the license granted to the Seller pursuant to the
above Section 7.2.2 shall only be sublicensable by the Seller (through multiple tiers): (A) to its Affiliates (provided
that such sublicense shall automatically terminate if such sublicensee ceases to be an Affiliate of the Seller), (B) to contract
research organizations, distributors, contract manufacturing organizations and other third-party subcontractors solely for the provision
of services with respect to the Seller’s (or its Affiliates’) exploitation of Plinabulin (for clarity, including any combination
therapies, including the Product) (and for clarity, not for the applicable sublicensee to exploit such sublicense for such sublicensee’s
independent benefit) and (C) to third parties in connection with any sale, transfer, divestiture, disposition, license, sublicense
or other monetization transaction of Plinabulin (for clarity, including any combination therapies, including the Product), or any rights
(including intellectual property) related thereto; provided that, in the case of each of clauses (A) through (C),
such sublicense shall be in writing and, with respect to any confidential information (including any trade secrets) of Bulin, contain
confidentiality obligations at least as protective as those set forth in the Confidentiality Agreement.
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7.2.4 For the avoidance of doubt, the Parties acknowledge and agree that, to the extent that the Bulin Data,
Bulin Intellectual Property or Seller Intellectual Property constitute “intellectual property assets” within the meaning of
The International Tax Co-operation (Economic Substance) Act (As Revised) of the Cayman Islands, (a) no consideration is or shall
be payable from, or in connection with, the exploitation of such Bulin Data, Bulin Intellectual Property or Seller Intellectual Property
under the licenses granted pursuant to the foregoing Sections 7.1, 7.2.1 and 7.2.2, as applicable; and (b) the Seller’s
use of any such Bulin Data or Bulin Intellectual Property shall be solely for the purposes expressly permitted hereunder (including, as
applicable, the Seller’s (or its Affiliates’) development, regulatory and commercial activities in connection with the exploitation
of Plinabulin or the Product) and accordingly no income separately identifiable from any tangible asset in which the Bulin Data, Bulin
Intellectual Property or Seller Intellectual Property subsists shall arise to the Seller therefrom pursuant to this Agreement.
8. CERTAIN COVENANTS
8.1 Further Assurances. From time to time, as and when requested by any Party to this Agreement, any
other Party will execute and deliver, or cause to be executed and delivered, all such documents and instruments and will take, or cause
to be taken, all such further or other actions, as the requesting Party may reasonably deem necessary or desirable to consummate the transactions
contemplated by this Agreement, in any such case, at the requesting Party’s sole cost and expense, except, in the case of the Seller,
for any such requests in connection with (a) Bulin’s performance and compliance with its obligations and (b) the Investor’s
performance and compliance with its obligations, in each case, pursuant to Article 6, Article 7 and Article 8.
8.2
Company Register of Members. As soon as practicable but in no event later than thirty (30) Business Days following the Equity
Closing Date, the Seller shall deliver to the Investor an updated register of members of the Company stamped by the Registry of Corporate
Affairs of The British Virgin Islands, which register of members shall reflect the transfer of the Transferred Equity Interests from
the Seller to the Investor, and shall evidence the Investor as the holder of such Transferred Equity Interests.
8.3 Bulin Cash. For a period commencing on the Equity Closing Date and ending on the earlier of (a) the
consummation of the transactions contemplated by this Agreement (for clarity, including the Investor’s performance and compliance
with its obligations under Article 6) or (b) the valid termination of this Agreement pursuant to Section 12.1, the
Investor shall not, and shall cause Bulin not to, (i) transfer, convey, assign, deliver or distribute any right, title or interest in
or to any cash or cash equivalents held by Bulin as of immediately prior to the Equity Closing (the “Bulin Closing Cash”)
to any past, present or future shareholders of the Investor, its Affiliates or any other party (whether a related party or an Affiliate)
or (ii) utilize the Bulin Closing Cash as payment, funds or financing for any purpose other than (A) the conduct or completion of the
Chinese Territory Ongoing Trial or any other activities set forth in the Development Plan, (B) the satisfaction of Bulin’s or the
Investor’s obligations under this Agreement or (C) Bulin’s operations in the ordinary course of business consistent with past
practice.
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8.4
Bulin SEED Shares. For a period commencing on the Equity Closing Date and ending on the earlier of (a) the consummation of
the transactions contemplated by this Agreement (for clarity, including the Investor’s performance and compliance with its obligations
under Article 6), or (b) the valid termination of this Agreement pursuant to Section 12.1, the Investor
shall not, and shall cause Bulin not to, directly or indirectly, on its own or together with or through a third party,
(i) transfer, convey, assign, deliver or distribute any right, title or interest in or to any Bulin SEED Shares, (ii) encumber
or subject to any Lien (other than restrictions on transfer imposed by applicable securities Laws) any Bulin SEED Shares, (iii) grant
any option, warrant or right to acquire any Bulin SEED Shares or (iv) take any action, or fail to take any action, that would result
in (x) Bulin ceasing to own the Bulin SEED Shares, or (y) the Investor ceasing to continue to indirectly own the Bulin SEED Shares, in
each case, free and clear of any and all Liens (other than restrictions on transfer imposed by applicable securities Laws).
8.5 Competitive Activity. For a period commencing on the Equity Closing Date and ending on the twenty
(20)-year anniversary of the Equity Closing Date:
8.5.1 The Investor shall not, and shall cause Bulin not to, (a) engage, directly or indirectly, on its
own or together with or through a third party (including through any partnership, limited liability company, corporation, joint venture
or similar arrangement), in drug discovery, research, development, manufacture, commercialization or other exploitation of any drug products
(whether on their own or in combination with other active ingredients) for the treatment of non-small cell lung cancer or (b) otherwise
take any action (or abstain from taking any action) that would result in the Investor or Bulin becoming a Competitor, in the case of each
of clauses (a) and (b), outside the Territory without the prior written consent of the Seller, which consent may be
withheld in the Seller’s sole discretion.
8.5.2 The Seller shall not (a) engage, directly or indirectly, on its own or together with or through a
third party (including through any partnership, limited liability company, corporation, joint venture or similar arrangement), in drug
discovery, research, development, manufacture, commercialization or other exploitation of any drug products (whether on their own or in
combination with other active ingredients) for the treatment of non-small cell lung cancer or (b) otherwise take any action (or abstain
from taking any action) that would result in the Seller becoming a Competitor, in the case of each of clauses (a) and (b),
within the Territory without the prior written consent of the Investor.
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9. CONDITIONS TO CLOSING
9.1
Conditions to Obligations of the Seller and the Investor at the Equity Closing. The respective obligations of each Party to consummate
the Equity Closing are subject to the satisfaction or waiver (to the extent permitted by applicable Law) of the following condition:
No provision of any applicable Law, any Order or proceeding shall be in effect that prohibits or prevents the consummation of the Equity
Closing.
9.2 Conditions to Obligations of the Investor at the Equity Closing. The obligations of the Investor
to consummate the Equity Closing are subject to the satisfaction or waiver (to the extent permitted by applicable Law) of the following
conditions:
9.2.1 Representations and Warranties of the Seller. The representations and warranties of the Seller
contained in Article 3 shall be true and correct in all material respects as of the Equity Closing (as if made on and as of
the Equity Closing) (except to the extent such representations and warranties are made as of a specific date, in which case they shall
be true and correct as of such specified date).
9.2.2 Performance of the Seller. The Seller shall have performed and complied in all material respects
with all terms, agreements and covenants contained in this Agreement required to be performed or complied with by the Seller on or before
the Equity Closing Date.
9.2.3 Representations and Warranties of Bulin. The representations and warranties of Bulin contained
in Article 4 shall be true and correct in all material respects as of the Equity Closing (as if made on and as of the Equity
Closing) (except to the extent such representations and warranties are made as of a specific date, in which case they shall be true and
correct as of such specified date).
9.2.4 Officer’s Certificates. (i) The Seller shall have delivered to the Investor a certificate
executed by an officer of the Seller dated as of the Equity Closing Date, confirming the satisfaction of the conditions contained in Section 9.2.1
(Representations and Warranties of the Seller) and Section 9.2.2 (Performance of the Seller) and (ii) Bulin shall have
delivered to the Investor a certificate executed by an officer of Bulin dated as of the Equity Closing Date, confirming the satisfaction
of the conditions contained in Section 9.2.3 (Representations and Warranties of Bulin).
9.3 Conditions to Obligations of the Seller at the Equity Closing. The obligations of the Seller to
consummate the Equity Closing are subject to the satisfaction or waiver (to the extent permitted by applicable Law) of the following conditions:
9.3.1 Representations and Warranties of the Investor. The representations and warranties of the Investor
contained in Article 5 shall be true and correct in all respects as of the Equity Closing (as if made on and as of the Equity
Closing) (except to the extent such representations and warranties are made as of a specific date, in which case they shall be true and
correct as of such specified date).
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9.3.2 Performance of the Investor. The Investor shall have performed and complied in all material respects
with all terms, agreements and covenants contained in this Agreement required to be performed or complied with by the Investor on or before
the Equity Closing Date.
9.3.3 Officer’s Certificate. The Investor shall have delivered to the Seller a certificate executed
by an officer of the Investor dated as of the Equity Closing Date, confirming the satisfaction of the conditions contained in Section 9.3.1
(Representations and Warranties of the Investor) and Section 9.3.2 (Performance of the Investor).
10. SURVIVAL; LIMITATIONS
10.1
Survival of Representations and Covenants. The representations or warranties contained in this Agreement or any certificate delivered
pursuant to this Agreement shall not survive, and shall terminate and be of no further force or effect as of the earlier of the eight
(8)-year anniversary of the Equity Closing Date or the valid termination of this Agreement pursuant to Sections 11.1 or 12.1.
All covenants and agreements set forth in this Agreement that by their terms are required to be performed after the Equity Closing shall
survive the Equity Closing until fully performed in accordance with their respective terms. All other covenants and agreements set forth
in this Agreement shall not survive the Equity Closing and shall terminate at the Equity Closing. No Party shall have any liability to
any Person with respect to any provision of this Agreement or the subject matter thereof following the applicable survival period specified
in this Section 10.1, and no Party shall thereafter assert any claim, cause of action, right or remedy, or any action, with
respect to such provision or the subject matter thereof.
11. TERMINATION OF TRANSFER OF TRANSFERRED EQUITY INTERESTS
11.1 Termination of the Agreement Prior to the Equity Closing. This Agreement may be terminated at any
time prior to the Equity Closing as follows:
11.1.1 by the written consent of the Investor and the Seller;
11.1.2 by either the Seller or the Investor, if the Equity Closing shall not have occurred by December 31, 2026;
provided that the right to terminate this Agreement pursuant to this Section 11.1.2 shall not be available to the Seller
or the Investor, as applicable, if the Equity Closing not having occurred by such time was primarily due to the breach by the Investor
or the Seller, as applicable, of its obligations under this Agreement;
11.1.3 by the Investor, if (i) the Seller shall have breached any of the covenants or agreements contained
in this Agreement to be performed by the Seller such that the condition set forth in Section 9.2.2 would not be satisfied,
(ii) there exists a breach of any representation or warranty of the Seller contained in this Agreement such that the condition set
forth in Section 9.2.1 would not be satisfied or (iii) there exists a breach of any representation or warranty of Bulin
contained in this Agreement such that the condition set forth in Section 9.2.3 would not be satisfied and, in the case of
each of clauses (i)–(iii), such breach has not been cured prior to the earlier of (A) thirty (30) Business
Days from the date that the Seller is notified in writing by the Investor of such breach or (B) the Equity Closing Date; provided
that the right to terminate this Agreement under this Section 11.1.3 shall not be available to the Investor if there has been
a breach or failure to perform by the Investor that gave rise to the failure of the conditions in Section 9.2.1 or Section 9.2.2;
or
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11.1.4 by the Seller, if (i) the Investor shall have breached any of the covenants or agreements contained
in this Agreement to be performed by the Investor such that the condition set forth in Section 9.3.2 would not be satisfied,
or (ii) there exists a breach of any representation or warranty of the Investor contained in this Agreement such that the condition
set forth in Section 9.3.1 would not be satisfied and, in the case of clauses (i) or (ii), such breach has not been cured
prior to the earlier of (A) thirty (30) Business Days from the date that the Investor is notified in writing by the Seller of such
breach or (B) the Equity Closing Date; provided that the right to terminate this Agreement under this Section 11.1.4
shall not be available to the Seller if there has been a breach or failure to perform by the Seller that primarily gave rise to the failure
of the conditions in Section 9.3.1 or Section 9.3.2.
11.2 Procedure Upon Termination. Termination of this Agreement by the Investor or the Seller or both
pursuant to Section 11.1 shall be effected by the delivery of written notice thereof to the other Party, in which case this
Agreement shall terminate without further action or liability by the Investor or the Seller (subject to applicable cure periods); provided,
however, that (a) the Investor will not be released from liability hereunder if this Agreement is terminated and the transactions
abandoned by reason of (i) the willful failure of the Investor to have performed its material obligations under this Agreement (including
any failure of the Investor to proceed with the Equity Closing as required by this Agreement) or (ii) Fraud committed by the Investor,
(b) the Seller will not be released from liability hereunder if this Agreement is terminated and the transactions abandoned by reason
of failure of the Seller to have performed its material obligations under this Agreement and (c) the agreements contained in the
Confidentiality Agreement, to the extent set forth therein, and Sections 3.7, 4.8 and 5.5 and Article 13
shall survive the termination hereof in accordance with their respective terms. Nothing in this Section 11.2 will relieve
either Party of liability for material breach of this Agreement occurring prior to any termination, or for breach of any provision of
this Agreement which specifically survives termination hereunder, subject to the express terms and limitations set forth in this Agreement.
11.3 Restriction on Termination. For the avoidance of doubt, Bulin shall have no right hereunder to
terminate this Agreement at any time prior to the Equity Closing.
12. TERMINATION OF COLLABORATION OBLIGATIONS
12.1 Termination of the Agreement After the Equity Closing.
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12.1.1 Upon the expiration of the Enrollment Period, this Agreement may be terminated by the Seller if Bulin
or the Investor shall have breached or failed to perform any of the covenants or agreements contained in Article 6 or Article
8 of this Agreement to be performed by Bulin or the Investor, respectively; provided that the breach of or failure to perform
by Bulin or the Investor under Article 6 or Article 8 has not been cured prior to six (6) months from the date that Bulin
and the Investor are notified in writing by the Seller of the Seller’s intention to terminate this Agreement pursuant to this Section 12.1.1.
12.1.2 Between the Equity Closing Date and prior to the expiration of the Enrollment Period, this Agreement may
be terminated by the Seller in connection with an Adverse Act pursuant to Section 6.7.4 of this Agreement; provided
that the Adverse Act has not been cured prior to thirty (30) Business Days from the date that Bulin and the Investor are notified in writing
by the Seller of the Seller’s intention to terminate this Agreement pursuant to this Section 12.1.2.
12.2 Procedure Upon Termination. Termination of this Agreement by the Seller pursuant to Section 12.1
shall be effected by the delivery of written notice thereof to Bulin and the Investor, in which case this Agreement shall terminate without
further action or liability by the Seller (subject to applicable cure periods); provided, however, that (a) Bulin will
not be released from liability hereunder if this Agreement is terminated and the transactions abandoned by reason of (i) the failure
of Bulin to have performed its material obligations under this Agreement or (ii) Fraud committed by Bulin, (b) the Investor
will not be released from liability hereunder if this Agreement is terminated and the transactions abandoned by reason of (i) the
failure of the Investor to have performed its material obligations under this Agreement or (ii) Fraud committed by the Investor and
(c) the agreements contained in the Confidentiality Agreement, to the extent set forth therein, and Sections 3.7, 4.8,
5.5, 7.2.3 and 12.3 and Article 13 shall survive the termination hereof in accordance with their respective
terms. Nothing in this Section 12.2 will relieve Bulin or the Investor of liability for material breach of this Agreement
occurring prior to any termination, or for breach of any provision of this Agreement which specifically survives termination hereunder,
subject to the express terms and limitations set forth in this Agreement.
12.3
Effect of Termination. In the event of the termination of this Agreement by the Seller pursuant to Section 12.1:
12.3.1 All licenses granted to Bulin pursuant to Section 7.2.1 shall terminate immediately. For the
avoidance of doubt, the license granted to the Seller pursuant to Section 7.1 shall survive any termination pursuant to Section 12.1;
and
12.3.2 Upon the Seller’s reasonable request, without further consideration, Bulin shall, and the Investor
shall cause Bulin to, reasonably cooperate to provide the Seller with reasonable transition assistance, including with respect to the
Chinese Territory Ongoing Trial to the extent it is not complete upon termination of this Agreement pursuant to Section 12.1.
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13. MISCELLANEOUS
13.1 Notices. All notices and other communications given or made pursuant to this Agreement shall be
in writing and shall be deemed effectively given upon the earlier of actual receipt or (a) personal delivery to the party to be notified,
(b) when sent, if sent by electronic mail during normal business hours of the recipient, and if not sent during normal business hours,
then on the recipient’s next Business Day, (c) three (3) days after having been sent by registered or certified mail, return
receipt requested or (d) one (1) Business Day after deposit with a nationally recognized overnight courier, freight prepaid, specifying
next Business Day delivery, with written verification of receipt, in each case, to the appropriate address set forth below:
To the Seller (or Bulin prior to the Equity Closing Date):
BeyondSpring Inc.
100 Campus Drive, West Side, 4th Floor, Suite 410
Florham Park, NJ 07932
Email: ***
Attention: ***
and
to the Company:
BeyondSpring Ltd.
Vistra Corporate Services Centre, Wickhams Cay II, Road Town, Tortola
British Virgin Islands, VG 1110
Email: ***
Attention: ***
with a copy (which shall not constitute notice) to:
Skadden, Arps, Slate, Meagher & Flom LLP
One Manhattan West
New York, NY 10001
Email: Marie.Gibson@skadden.com; Resa.Schlossberg@skadden.com; Michael.Hong@skadden.com
Attention: Marie Gibson; Resa Schlossberg; Michael Hong
To Bulin (after the Equity Closing Date):
Dalian Wanchunbulin Pharmaceuticals Ltd.
Unit 215, No. 9 Liaohe East Road, Economic and Technological Development Zone
Dalian, Liaoning, China
Email: ***
Attention: ***
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To the Investor:
Biolin Investment Limited
Unit 2201, 22/F, Chung Kiu Commercial Building
47-51 Shan Tung Street
Mong Kok, Hong Kong
Email: ***
Attention: ***
13.2 Amendments and Waivers.
13.2.1 Any provision of this Agreement may be amended, modified or supplemented by an instrument in writing executed
and delivered by each of the Parties hereto. Any amendment or waiver effected in accordance herewith shall be binding upon the Parties.
13.2.2 Except as otherwise provided in this Agreement, any failure of any Party to comply with any obligation,
covenant, agreement or condition herein may be waived by the Party entitled to the benefits thereof only by a written instrument signed
by the Party granting such waiver, but such waiver or failure to insist upon strict compliance with such obligation, covenant, agreement
or condition shall not operate as a waiver of, or estoppel with respect to, any subsequent or other failure. No failure or delay by any
Party in exercising any right, power or privilege under this Agreement will operate as a waiver thereof nor will any single or partial
exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege.
13.3 Expenses. Except as otherwise set forth in this Agreement, each Party shall pay its own costs and
expenses, including the fees and disbursements of counsel, accountants, financial advisors, experts and consultants employed by it in
connection with the transactions contemplated hereby, incurred by it in connection with this Agreement and the transactions contemplated
hereby.
13.4 Succession and Assignment. The provisions of this Agreement
will be binding upon and inure to the benefit of the Parties and their respective successors and assigns. Neither this Agreement nor any
of the rights or obligations under this Agreement may be assigned, delegated or otherwise transferred, in whole or in part, by the Investor
or by Bulin without the prior written consent of the Seller, which consent shall not be unreasonably withheld, conditioned or delayed;
provided, however, that, upon written notice to the Seller, the Investor may delegate, assign or otherwise transfer its
rights or obligations under this Agreement to one or more of its Affiliates; provided, further, that in the case of any
such delegation, assignment or transfer to an Affiliate of the Investor (an “Authorized Transferee”),
(a) the Authorized Transferee shall assume and perform all obligations, covenants and agreements of the Investor under Article 6,
Article 7 and Article 8 of this Agreement, which assumption shall be evidenced in writing, and (b) the
Investor shall remain liable for all of its obligations, covenants and agreements under this Agreement unless otherwise agreed by the
Seller in writing. For purposes of this Section 13.4, failure of the Seller to provide consent shall be deemed reasonable
if, among other matters, the proposed transfer would impede the Seller’s rights under Article 6, Article 7
or Article 8.
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13.5
Non-Recourse. This Agreement may only be enforced against, and any claim, action, suit or other legal proceeding based upon, arising
out of or related to this Agreement, or the negotiation, execution or performance of this Agreement, may only be brought against the
entities that are expressly named as Parties and then only with respect to the specific obligations set forth herein with respect to
such Party. No past, present or future director, officer, employee, incorporator, manager, member, partner, stockholder, Affiliate, agent,
attorney or other Representative of any Party or of any Affiliate of any Party, or any of their successors or permitted assigns, shall
have any liability for any obligations or liabilities of any Party under this Agreement or for any claim or action based on, in respect
of or by reason of the transactions contemplated hereby.
13.6 Third-Party Beneficiaries. This Agreement is for the sole benefit of the Parties and their permitted
assigns and nothing herein expressed or implied will give or be construed to give to any Person, other than the Parties and such permitted
assigns, any legal or equitable rights under this Agreement.
13.7 Governing Law; Arbitration.
13.7.1 This Agreement, including all matters of construction, validity, interpretation, performance and enforceability
and any disputes, claims or controversies (whether in contract, tort, equity or otherwise) directly or indirectly arising out of or relating
to this Agreement, or the negotiation, validity or performance of this Agreement, or the transactions contemplated hereby shall be governed
by and construed and enforced in accordance with the laws of the State of New York without giving effect to any choice or conflict of
laws (whether of the State of New York or any other jurisdiction) that would cause the application of the laws of any jurisdiction other
than the State of New York.
13.7.2 Any dispute, claim or controversy (whether in contract, tort, equity or otherwise) directly or indirectly
arising out of or relating to this Agreement, or the negotiation, validity or performance of this Agreement, or the transactions contemplated
hereby, including all matters of construction, validity, interpretation, performance and enforceability of this Agreement and this agreement
to arbitrate (each, a “Dispute”) 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 (the “Rules”),
except as modified herein.
(a) The law of this arbitration clause shall be Hong Kong law. The seat of arbitration shall be Hong Kong.
The arbitration proceedings shall be conducted in the English language.
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(b) The arbitration shall be conducted by an arbitral tribunal of three arbitrators. The claimant and respondent
shall each designate one arbitrator in the Notice of Arbitration and the Answer to the Notice of Arbitration (as such terms are defined
in the Rules), respectively. If either party fails to designate an arbitrator, HKIAC shall appoint the arbitrator. The two arbitrators
so designated shall, in consultation with the parties, designate the third and presiding arbitrator. Failing such designation within 30
days from the confirmation or appointment of the second arbitrator, HKIAC shall appoint the third and presiding arbitrator.
(c) In addition to monetary damages, the arbitral tribunal shall be empowered to award equitable relief, including,
but not limited to, an injunction and specific performance of any obligation under this Agreement.
(d) By agreeing to arbitration, the Parties do not intend to deprive any court of its jurisdiction to issue
a pre-arbitral injunction, pre-arbitral attachment or other order in aid of arbitration proceedings. Without prejudice to such provisional
remedies that may be granted by a court, the arbitral tribunal shall have full authority to grant provisional remedies, to order a party
to request that a court modify or vacate any temporary or preliminary relief issued by such court, and to award damages for the failure
of any party to respect the arbitral tribunal’s orders to that effect.
(e) The award of the arbitral tribunal shall be final and binding upon the parties thereto, and shall be the
sole and exclusive remedy between the parties regarding any Disputes presented to the arbitral tribunal. Judgment upon any award may be
entered in any court having jurisdiction over any party or any of its assets.
(f) Any arbitration hereunder shall be confidential, and the Parties and their agents agree not to disclose
to any third party (i) the existence or status of the arbitration, (ii) all information made known and documents produced in
the arbitration not otherwise in the public domain and (iii) all awards arising from the arbitration, except and to the extent that
disclosure is required by applicable law or is required to protect or pursue a legal right.
13.8 WAIVER OF JURY TRIAL. EACH PARTY HEREBY WAIVES ITS RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE
OF ACTION ARISING OUT OF OR RELATING TO THIS AGREEMENT, THE OTHER AGREEMENTS OR DOCUMENTS CONTEMPLATED HEREBY OR THE SUBJECT MATTER HEREOF
OR THEREOF. EACH PARTY ALSO WAIVES ANY BOND OR SURETY OR SECURITY UPON SUCH BOND WHICH MIGHT, BUT FOR THIS WAIVER, BE REQUIRED OF SUCH
PARTY. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MIGHT BE FILED IN ANY COURT AND THAT MAY
RELATE TO THE SUBJECT MATTER OF THIS AGREEMENT OR ANY OTHER AGREEMENT OR DOCUMENT CONTEMPLATED HEREBY, INCLUDING ALL COMMON LAW AND STATUTORY
CLAIMS. EACH PARTY FURTHER REPRESENTS AND WARRANTS THAT IT HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL AND THAT IT KNOWINGLY AND VOLUNTARILY
WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH SUCH LEGAL COUNSEL. THIS WAIVER IS IRREVOCABLE, MEANING THAT IT MAY NOT BE MODIFIED
EITHER ORALLY OR IN WRITING, AND THE WAIVER SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, MODIFICATIONS, SUPPLEMENTS OR RESTATEMENTS HEREOF.
IN THE EVENT OF LITIGATION, THIS AGREEMENT MAY BE FILED AS A WRITTEN CONSENT TO A TRIAL BY THE COURT.
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13.9 Counterparts. This Agreement may be executed in three (3) or more counterparts, each of which shall
be deemed an original, but all of which shall constitute one and the same agreement, and the execution of a counterpart of the signature
page to this Agreement shall be deemed the execution of a counterpart of this Agreement. This Agreement may be executed and delivered
by .pdf transmission or other electronic means (including DocuSign, Adobe Acrobat Sign and similar services), each of which shall be deemed
originals.
13.10 Entire Agreement. This Agreement, together with the Confidentiality Agreement and the other agreements
and documents contemplated hereby (including the Schedules, Annexes and Exhibits hereto and thereto) constitute the entire agreement between
the Parties with respect to the subject matter of this Agreement and such other agreements and documents, and is a complete and final
integration thereof. This Agreement and the other agreements and documents contemplated hereby (including the Schedules, Annexes and Exhibits
hereto and thereto) supersede all prior agreements and understandings, both oral and written, between the Parties with respect to the
subject matter hereof (other than the Confidentiality Agreement).
13.11 Confidentiality.
13.11.1 The Investor and its Representatives shall adhere to the terms and conditions of that certain Mutual Confidentiality
and Non-Disclosure Agreement, dated as of August 18, 2026, by and between the Seller and the Investor (the “Confidentiality
Agreement”). The Investor and its Representatives shall, and shall cause each of their Affiliates and Representatives
to, maintain the confidentiality of this Agreement and the other agreements and documents contemplated hereby in accordance with the terms
of the Confidentiality Agreement. In the event of the termination of this Agreement for any reason prior to the Equity Closing, the Confidentiality
Agreement shall continue in full force and effect in accordance with its terms; provided, however, that nothing herein or
in the Confidentiality Agreement shall apply to any disclosure of this Agreement or the other agreements and documents contemplated hereby
by a Party to the extent necessary to enforce any of its rights under this Agreement or the other agreements and documents contemplated
hereby (including in any dispute) and no Party shall be prohibited or required to undertake any process prior to making any such disclosure.
13.11.2 The obligations under this Section 13.11 shall not apply to information which is required
to be disclosed by Law or the rules and regulations of any stock exchange, in which case the Party or an Affiliate making such disclosure
shall use Commercially Reasonable Efforts to allow the other Party reasonable time to comment on such disclosure.
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13.12 Severability. If any provision of this Agreement or the application of any such provision to any
Person or circumstance is held invalid, illegal or unenforceable in any respect by a court of competent jurisdiction, such invalidity,
illegality or unenforceability will not affect any other provision and such invalid, illegal or unenforceable provision will be reformed,
construed and enforced as if such provision had never been contained herein and there had been contained in this Agreement instead such
valid, legal and enforceable provisions as would most nearly accomplish the intent and purpose of such invalid, illegal or unenforceable
provision.
13.13 Press Release and Announcements. The Seller shall issue an initial press release announcing this
Agreement and the transactions contemplated hereby; provided that the Seller and the Investor shall mutually determine and agree
upon the form, nature and content of any such public announcement, press release, media responses or other communications. Thereafter,
no press releases or other public releases of information related to this Agreement or the transactions contemplated hereby will be issued
or released without the prior written consent of the Parties; provided this Section 13.13 shall not apply to public
releases of information required by Law or the rules and regulations of any stock exchange; provided, further, a Party may
make any public announcement or press release without the mutual approval of the other Parties provided that such public announcement
or press release is not inconsistent with the previous public announcement issued by the Seller.
13.14 Specific Performance. Except as otherwise set forth in this Agreement, any and all remedies herein
expressly conferred upon a party will be deemed cumulative with and not exclusive of any other remedy conferred hereby, or by Law or equity
upon such party, and the exercise by a party of any one remedy will not preclude the exercise of any other remedy and nothing in this
Agreement shall be deemed a waiver by any party of any right to specific performance or injunctive relief. The Parties agree that irreparable
damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms
or were otherwise breached. It is accordingly agreed that the Parties shall be entitled to an injunction or injunctions, specific performance
or other equitable relief to prevent breaches or threatened breaches of this Agreement and to enforce specifically the terms and provisions
of this Agreement, without proof of damages or otherwise. Each party agrees that it will not oppose the granting of an injunction, specific
performance and other equitable relief on the basis that the other party has an adequate remedy at law or an award of specific performance
is not an appropriate remedy for any reason at law or in equity. The Parties acknowledge and agree that any party seeking an injunction
or injunctions to prevent breaches or threatened breaches of this Agreement and to enforce specifically the terms and provisions of this
Agreement shall not be required to provide any bond or other security in connection with any such Order or injunction, and the party opposing
such injunction or injunctions hereby agrees that it shall not contest the amount or absence of any such bond or other security requested
or offered by the party seeking such injunction or injunctions.
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13.15
Certain Interpretive Matters. Unless the context requires otherwise, (a) all references herein to Sections, Articles, Annexes
or Schedules are to Sections, Articles, Annexes, or Schedules of or to this Agreement, (b) the headings in this Agreement are for
convenience of reference only and will not control or affect the meaning or construction of any provisions of this Agreement, (c) each
term defined in this Agreement has the meaning assigned to it, (d) words in the singular include the plural and vice versa, (e) all
references to “$” or “dollar” amounts will be to lawful currency of the United States, (f) unless the context
implies otherwise to the extent the term “day” or “days” is used, it will mean calendar days, (g) references
to the masculine, feminine or neuter gender include each other gender, (h) the words “herein,” “hereby,”
“hereof,” “hereunder” and other words of similar import refer to this Agreement as a whole and not to any particular
Section, Article, or other subdivision, (i) the terms “including” and “includes” mean “including or
includes without limitation,” (j) reference to, and the definition of, any document shall be deemed a reference to such document
as it may be amended, supplemented, revised or modified, in writing, from time to time, or (k) reference to any Law shall be construed
as a reference to such Law as re-enacted, redesignated, amended or extended from time to time prior to the date hereof.
[The Remainder of this Page Is Intentionally Left Blank.]
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IN WITNESS WHEREOF, the undersigned Parties
have caused this Share Purchase and Collaboration Agreement to be duly executed by their respective authorized officers as of the day
and year first above written.
INVESTOR:
BIOLIN INVESTMENT LIMITED
By:
/s/ Chan Mak Sun
Name: Chan Mak Sun
Title: Director
[Signature Page to Share Purchase and Collaboration Agreement]
IN WITNESS WHEREOF, the undersigned Parties
have caused this Share Purchase and Collaboration Agreement to be duly executed by their respective authorized officers as of the day
and year first above written.
SELLER:
BEYONDSPRING INC.
By:
/s/ Lan Huang
Name: Lan Huang
Title: Chair of the Board of Directors
[Signature Page to Share Purchase and Collaboration Agreement]
IN WITNESS WHEREOF, the undersigned Parties
have caused this Share Purchase and Collaboration Agreement to be duly executed by their respective authorized officers as of the day
and year first above written.
BULIN:
DALIAN WANCHUNBULIN PHARMACEUTICALS LTD.
By:
/s/ Zhichao Jia
Name: Zhichao Jia
Title: Director and Legal Representative
[Signature Page to Share Purchase and Collaboration Agreement]
ANNEX I
DEFINITIONS
For purposes of this Agreement, the following terms
have the meanings ascribed or referenced in this Annex:
“Adverse Act” has the meaning set
forth in Section 6.7.4.
“Affiliate” means, with respect
to any Person, any other Person directly or indirectly controlling, controlled by or under common control with the first Person. For the
purposes of this definition, “control,” when used with respect to any Person, means the possession, directly or indirectly,
of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities,
by contract or otherwise, and the terms “controlling” and “controlled” have meanings correlative to the foregoing.
“Agreement” has the meaning set
forth in the introductory paragraph.
“Authorized Transferee” has the
meaning set forth in Section 13.4.
“Bulin” has the meaning set forth
in the introductory paragraph.
“Bulin Closing Cash” has the meaning
set forth in Section 8.3.
“Bulin Data” has the meaning set
forth in Section 6.6.1.
“Bulin Intellectual Property” means
all Intellectual Property (other than Trademarks) that is (a) Controlled by Bulin or any of its Affiliates as of the Equity Closing
and (b) necessary for the research, development, manufacture, commercialization or other exploitation of Plinabulin outside the Territory.
“Bulin SEED Shares” has the meaning
set forth in Section 4.4.
“Business Day” means any day other
than (a) a Saturday or Sunday, (b) a day on which the Federal Reserve Bank of New York is closed or (c) a day on which
banks in The British Virgin Islands, The Cayman Islands or Hong Kong are authorized or required by applicable Law to close.
“Chinese Territory Ongoing Trial”
has the meaning set forth in Section 6.1.
“Clinical Trial” means any study
in which human subjects are dosed or treated with an investigational drug product.
“Commercially Reasonable Efforts”
means, with respect to a Party’s obligations under this Agreement, the carrying out of such obligations in a diligent, expeditious
and sustained manner, without undue interruption, pause or delay, consistent with the efforts and resources, including reasonably necessary
personnel and financial resources, that a well-capitalized pharmaceutical company with clinical-stage and commercial-stage products typically
devotes to a priority product or compound of similar market potential, profit potential and strategic value, at a similar stage of its
product life, taking into account issues of safety and efficacy, the competitiveness of the marketplace, and the proprietary position
of the product. Notwithstanding anything to the contrary, amounts to be paid or that may be payable in connection with the performance
of the Investor’s obligations under this Agreement shall not be taken into account in determining Commercially Reasonable Efforts.
“Company” has the meaning set forth
in Recital (A).
“Company Equity Interests” has the
meaning set forth in Recital (A).
“Competitor” has the meaning set
forth in Section 5.10.
“Confidentiality Agreement” has
the meaning set forth in Section 13.11.1.
“Contract” means any legally binding
written contract, agreement, lease, sublease, license, purchase or task order, statement of work, instrument, note, bond, mortgage, indenture
or commitment.
“Control” means with respect to
any Intellectual Property or material, the ability (whether by ownership, license or otherwise, other than a license granted pursuant
to this Agreement) to grant a license or sublicense, provide or provide access or other rights in, to or under such Intellectual Property
or material (as applicable) on the terms and conditions set forth herein, without violating the terms of any agreement or other arrangement
with any third party or any applicable Laws. For clarity, “Controlled” has a correlative meaning.
“Development” means any and all
activities directed to research and non-clinical and clinical development of a drug product, including toxicology, pharmacology, project
management, Clinical Trials, medical affairs studies and other activities reasonably necessary in order to obtain, maintain or expand
Marketing Approval of a drug product. For clarity, “Develop” and “Developing” have a correlative
meaning.
“Development Plan” has the meaning
set forth in Section 6.2.
“Development Records” has the meaning
set forth in Section 6.4.
“Dispute” has the meaning set forth
in Section 13.7.2.
“Enrollment Period” has the meaning
set forth in Section 6.5.1.
“Equity Clawback” has the meaning
set forth in Section 6.5.2(a).
“Equity Clawback Percentage” has
the meaning set forth in Section 6.5.2(a).
“Equity Closing” has the meaning
set forth in Section 2.3.
“Equity Closing Date” has the meaning
set forth in Section 2.3.
“FD&C Act” means the U.S. Federal
Food, Drug and Cosmetic Act.
“FDA” means U.S. Food and Drug Administration
or any successor thereto.
“Fraud” means an actual and deliberate
misrepresentation in the making of a representation or warranty expressly stated in Article 3, Article 4 or Article 5
of this Agreement, as applicable; provided that at the time such representation or warranty was made by such party, (a) such
representation or warranty was materially inaccurate, (b) such party had actual knowledge (and not imputed or constructive knowledge)
of the material inaccuracy of such representation or warranty, (c) in making such representation or warranty such party had the specific
intent to deceive such other party and to induce such other party to enter into this Agreement, and (d) such other party acted in
reasonable reliance on such representation or warranty to its detriment as a result of such reliance and suffered economic loss as a result
thereof. For the avoidance of doubt, (i) any claim for Fraud may only be made against the party committing such Fraud, and (ii) “Fraud”
shall not include any form of constructive fraud, equitable fraud, promissory fraud or any torts (including fraud) based on negligence
or recklessness.
“GCP” means all applicable Laws
and applicable International Council for Harmonisation guidelines including E6(R3) for the design, conduct, performance, monitoring, auditing,
recording, analysis and reporting of Clinical Trials, including (a) in the U.S., 21 C.F.R. Parts 11, 50, 54, 56, 312, 314 and
320 and (b) any analogous applicable Laws in any other countries.
“GLP” means the applicable then-current
standards for laboratory activities for pharmaceuticals or biologics, including as set forth in (a) in the U.S., the then-current good
laboratory practice standards promulgated or endorsed by FDA, as defined in 21 C.F.R. Part 58 and (b) any analogous applicable Laws
in any other countries.
“Good Manufacturing Practices” or
“GMP” means Good Manufacturing Practice and General Biological Products Standards, as promulgated under and in accordance
with (a) in the U.S., the FD&C Act (including 21 C.F.R. Parts 210 and 211) and (b) any analogous applicable Laws in
any other countries.
“Governmental Authority” means any
federal, state, county, city, municipal or other local, foreign, international or multinational government or any subdivision, authority,
department, secretary of state, commission, board, bureau, court, administrative panel or other instrumentality thereof.
“Governmental Authorization” means
any approval, permit, license, certificate, franchise, permission, clearance, consent, registration, qualification or authorization issued,
granted, given or otherwise made available by or under the authority of any Governmental Authority.
“HKIAC” has the meaning set forth
in Section 13.7.2.
“Intellectual Property” means all
intellectual property and rights in confidential information throughout the world, including all U.S. and foreign (a) national, regional
and international patents and patent applications, invention disclosures, and all continuations, continuations-in-part, divisionals, provisionals,
reissues, reexaminations, substitutions, extensions or restorations, including revalidations, reissues, reexaminations and extensions
(including supplementary protection certificates and the like), and patents of addition (“Patent Rights”), (b) copyrights
and copyrightable subject matter, (c) trademarks, service marks, names, corporate names, trade names, domain names, logos, slogans,
trade dress, design rights, and other similar designations of source or origin (“Trademarks”), together with the goodwill
symbolized thereby and (d) technical, scientific, regulatory, business and other information, results, knowledge, techniques and
data, in whatever form and whether or not confidential or patentable (“Know-How”).
“Investor” has the meaning set forth
in the introductory paragraph.
“Law” means any federal, state,
county, city, municipal, foreign or other governmental statute, law, rule, regulation, ordinance, order, code, treaty or requirement (including
pursuant to any settlement agreement or consent decree) and any Permit granted under any of the foregoing, or any requirement under the
common Law, or any other pronouncement having the effect of Law of any Governmental Authority.
“Lien” means with respect to any
property or asset, any mortgage, deed of trust, lien, pledge, hypothecation, assignment, charge, option, preemptive purchase right, easement,
encumbrance, security interest or other adverse claim of any kind in respect of such property or asset. For purposes of this Agreement,
a Person will be deemed to own subject to a Lien any property or asset that it has acquired or holds subject to the interest of a vendor
or a lessor under any conditional sale agreement, capital lease, or other title retention agreement (or any financing lease having substantially
the same economic effect as any of the foregoing) relating to such property or asset.
“Marketing Approval” means approval
by FDA or any foreign counterpart thereof for the commercial marketing and sale (including pricing and reimbursement approval) of a drug
product.
“Marketing Approval Application”
means (a) a New Drug Application (as described in 21 U.S.C. § 355(b)), in the United States or (b) any comparable
submission to the applicable Regulatory Authority in any other country that is necessary to seek Marketing Approval for a drug product
in such country.
“NMPA” has the meaning set forth
in Section 6.6.2.
“Ongoing Trial” has the meaning
set forth in Section 6.1.
“Order” means any writ, judgment,
injunction, ruling, order, or decree (including any consent decree) that is issued, promulgated or entered into by or with a Governmental
Authority, in each case, whether preliminary or final.
“Organizational Documents” means
the certificate of formation, certificate of incorporation, limited liability company agreement, operating agreement, memorandum and articles
of association, bylaws and all other governing documents of an entity, as applicable, in each case as amended.
“Party” or “Parties”
has the meaning set forth in the introductory paragraph.
“Permit” means all approvals, agreements,
authorizations, permits, licenses, easements, orders, certificates, registrations, franchises, qualifications, rulings, waivers, variances
or other form of permission, consent, exemption or authority issued, granted, given or otherwise made available by or under the authority
of any Governmental Authority.
“Person” means an individual, a
corporation, a partnership, a limited liability company, an association, a trust, a joint stock company, a joint venture, an unincorporated
organization, any Governmental Authority, or other entity or organization.
“Pharmacovigilance Agreement” has
the meaning set forth in Section 6.7.3.
“Phase 3 Clinical Trial” means a
Clinical Trial of a product in human subjects that would satisfy the requirements of U.S. 21 C.F.R. § 312.21(c), or analogous
provisions outside the United States, and is sufficient to support submission of a Marketing Approval Application for such product, regardless
of where such Clinical Trial is conducted.
“Plinabulin” means the Seller’s
investigational GEF-H1 agonist, 2, 5-piperazinedione, 3-[[5-(1,1-dimethylethyl)-1H-imidazol-4-yl[methylene]-6-(phenylmethylene)-, (3Z,6Z)
(trivial name t-butyl-dehydrophenylahistin) monohydrate.
“Product” has the meaning set forth
in Section 6.1.
“Regulatory Authorities” means,
with respect to a particular country, the Governmental Authority(ies) responsible for granting Marketing Approval, including FDA in the
U.S.
“Regulatory Materials” means regulatory
applications, submissions, notifications, correspondence, registrations, Marketing Approvals or other filings made to or with, or other
approvals granted by, a Regulatory Authority that are necessary or reasonably useful to Develop, manufacture, commercialize or otherwise
exploit any drug product in a jurisdiction. For clarity, “Regulatory Materials” include Marketing Approval Applications.
“Regulatory Permit” means any Governmental
Authorization issued by any Regulatory Authority relating to the investigation, authorization, marketing, licensure, registration, importation,
distribution or sale of any product of Bulin, including investigational new drug applications, new drug applications, supplemental new
drug applications, establishment registrations and product listings (each as defined under the FD&C Act and the regulations promulgated
thereunder), and all supplements or amendments thereto, and all comparable authorizations from a Governmental Authority in any other jurisdiction.
“Representatives” means, with respect
to any Person, the officers, directors, managers, employees, agents, accountants, advisors, bankers, lenders, investors and other representatives
of such Person.
“Rules” has the meaning set forth
in Section 13.7.2.
“Securities Act” means the Securities
Act of 1933, as amended, and the rules and regulations promulgated thereunder.
“SEED Therapeutics” means SEED Therapeutics
Inc., a British Virgin Islands business company, in which SEED Technology Limited, a British Virgin Islands business company, directly
owns approximately 8.88% of the issued and outstanding equity interests (and approximately 7.43% on a fully diluted basis). SEED Technology
Limited is a direct wholly owned Subsidiary of Bulin.
“Seller” has the meaning set forth
in the introductory paragraph.
“Seller Intellectual Property” means
all Intellectual Property (other than Trademarks) that is (a) Controlled by the Seller or any of its Affiliates as of the Equity
Closing and (b) necessary for the research, development, manufacture, commercialization or other exploitation of Plinabulin in the
Territory.
“Subsidiary” means, with respect
to a Person, any other Person: (a) of which (i) more than fifty percent (50%) of the voting power of the equity securities or
equity interests is owned, directly or indirectly, by such first Person or (ii) an amount of voting securities of or other interests
in such entity that is sufficient to enable such first Person to elect at least a majority of the members of such entity’s board
of directors or other governing body is owned, directly or indirectly, by such first Person; or (b) over which such first Person
directly or indirectly exercises control (including (x) any limited partnership of which such first Person, directly or indirectly,
is the general partner or otherwise has the power to direct or cause the direction of the management and policies thereof and (y) any
limited liability company of which such first Person, directly or indirectly, is the managing member or otherwise has the power to direct
or cause the direction of the management and policies thereof).
“Target Enrollment” has the meaning
set forth in Section 6.5.1.
“Territory” means the People’s
Republic of China, the Hong Kong Special Administrative Region (SAR), Macao Special Administrative Region (SAR) and Taiwan.
“Transferred Equity Interests” has
the meaning set forth in Recital (D).
“U.S.” or “United States”
means the United States of America and its territories and possessions.
“WOFE” has the meaning set forth
in Recital (B).
EX-99.1 — PRESS RELEASE
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EXHIBIT 99.1
BeyondSpring Announces FDA Fast Track Designation for Plinabulin in Post-ICI Non-Squamous NSCLC and Strategic Transaction to Advance Global Phase 3 DUBLIN-4 Trial Toward Planned Interim Analysis
FDA Fast Track designation represents an important regulatory milestone for the Plinabulin and docetaxel combination as an anticancer regimen in 2L/3L advanced or metastatic non-squamous NSCLC without actionable genomic alterations (AGAs) following progression on immune checkpoint inhibitor (ICI) and chemotherapy.
BeyondSpring enters into a strategic transaction to sell its majority equity interest in its Chinese subsidiary to an investor who will fund the China portion of the Phase 3 DUBLIN-4 trial, which is expected to represent approximately 50% of the planned global enrollment of 442 patients.
This non-dilutive transaction provides a financially efficient path toward the next major clinical milestone for Plinabulin, which is DUBLIN-4 interim analysis of 221 Progression-Free Survival (PFS) events.
Management will host a conference call and webcast today at 8:00 a.m. ET to discuss these developments.
FLORHAM PARK, N.J., Sept. 29, 2026 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage company developing innovative therapies for the treatment of cancer and other diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to Plinabulin and docetaxel for the treatment of patients with advanced or metastatic non-squamous non-small cell lung cancer (“NSCLC”) without actionable genomic alterations (AGAs) whose disease has progressed following prior anti-PD-(L)1 antibody therapy and platinum-based chemotherapy, representing patients in the second- or third-line treatment setting. This is the patient population being studied in BeyondSpring’s global Phase 3 DUBLIN-4 trial.
Plinabulin, a first-in-class small molecule agent, has an extensive clinical safety database with more than 700 cancer patients. Its differentiated immuno-modulating mechanism and previously reported encouraging clinical data from DUBLIN-3 and Study 303 support the trial design of DUBLIN-4 in Plinabulin mechanism-targeted post-ICI non-squamous NSCLC patients.
The Company also announced a strategic transaction with Biolin Investment Limited (“Biolin”) relating to the China portion of DUBLIN-4. Under the arrangement, the Company will sell its majority equity interest in its Chinese subsidiary, and Biolin will support DUBLIN-4 clinical development activities in China, which activities are expected to include enrollment of approximately 221 patients. BeyondSpring expects the transaction to substantially reduce its cash requirements for DUBLIN-4 while supporting efficient enrollment and the generation of China clinical data for the global trial.
“We believe the FDA Fast Track designation, an FDA-aligned global Phase 3 strategy, and funding to support China-generated clinical data would meaningfully strengthen our ability to advance Plinabulin and DUBLIN-4 toward the trial’s next major clinical milestone—the prespecified interim analysis at 221 PFS events,” said Min Qiu, CEO of BeyondSpring. “Fast Track designation underscores the significant unmet medical need for the DUBLIN-4 patient population in NSCLC patients whose disease has progressed following ICI and without AGAs, with limited options and docetaxel as the standard of care. Importantly, the strategic transaction provides a time- and capital-efficient approach to executing our global Phase 3 clinical strategy. Positive results from the interim analysis could represent a meaningful value inflection point for BeyondSpring.”
FDA Fast Track Designation
FDA Fast Track designation is designed to facilitate development and expedite review of therapies intended to treat serious conditions with unmet medical needs. The designation provides opportunities for more frequent interactions with the FDA regarding the development program and may allow for rolling review of a future regulatory application. Plinabulin may also be eligible for Priority Review if applicable criteria are met.
DUBLIN-4: Global Registrational Phase 3 Strategy
DUBLIN-4 is a randomized global Phase 3 trial evaluating Plinabulin plus docetaxel versus docetaxel alone in patients with advanced non-squamous NSCLC without actionable genomic alterations following progression on ICI and chemotherapy.
Approximately 442 patients are planned to be randomized 1:1, with overall survival (“OS”) as the primary endpoint and PFS and objective response rate (“ORR”) as secondary endpoints. The trial includes a prespecified interim analysis at 221 PFS events.
Approximately half of the planned trial population is expected to be enrolled at participating sites in China under the strategic arrangement, with the remainder expected to be enrolled through the broader global DUBLIN-4 program, including in the United States and other regions. BeyondSpring intends for data generated across participating regions to form part of an integrated global clinical dataset supporting its registration strategy for Plinabulin.
Strategic Arrangement Supports Global Phase 3 Execution
BeyondSpring has entered into a definitive agreement with Dalian Wanchunbulin Pharmaceuticals Ltd., the Company’s Chinese subsidiary (“Bulin”), and Biolin, pursuant to which BeyondSpring will sell BeyondSpring Ltd., its wholly owned subsidiary that indirectly holds the majority equity interest in Bulin, to Biolin.
Under the arrangement, Biolin will support the funding of clinical development activities conducted by Bulin at participating sites in China, and BeyondSpring will receive access to clinical data generated from the China portion of DUBLIN-4. Patients enrolled in China are expected to represent approximately half of the planned 442-patient global enrollment. Biolin’s obligation to support the funding of the China portion of DUBLIN-4, and to cause Bulin to conduct and use commercially reasonable efforts to complete the trial and perform certain related activities, will constitute the non-cash consideration for the sale of BeyondSpring Ltd.
Following the transaction, BeyondSpring will retain global rights to Plinabulin outside Greater China. The arrangement is expected to substantially reduce BeyondSpring’s cash requirements associated with DUBLIN-4, while China’s large eligible NSCLC patient population is expected to support efficient enrollment.
Conference Call and Webcast Information
BeyondSpring’s management will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss the announcement. The dial-in numbers are 1-877-737-7051 (U.S.) or 1-201-689-8878 (international). The live webcast will be available here. An archived replay of the webcast will be available following the presentation on BeyondSpring’s website www.beyondspringpharma.com under “Events” in the Investor section.
About Plinabulin and the Clinical Rationale for DUBLIN-4 Trial
Plinabulin is a late-stage, first-in-class investigational GEF-H1 agonist with a differentiated mechanism of action that includes dendritic cell maturation, anti-angiogenic activity and mitigation of chemotherapy-induced neutropenia. To date, more than 700 cancer patients have been treated with Plinabulin across multiple clinical programs in various cancer types, demonstrating an extensive clinical safety database.
The post-ICI setting remains difficult to treat, with 12 Phase 3 trials evaluating different treatment approaches against docetaxel, including four involving ADCs, having failed to demonstrate an overall survival benefit over docetaxel.
In the Phase 3 DUBLIN-3 Trial, published in The Lancet Respiratory Medicine in 2024, Plinabulin combined with docetaxel demonstrated a statistically significant improvement in OS in second- and third-line EGFR wild-type NSCLC vs. docetaxel alone (n=559), showing superior OS benefit in non-squamous patients (n=332, OS HR 0.72, p=0.0078). The combination also demonstrated statistically significant improvements compared to docetaxel alone, including doubling 2-year and 3-year survival rates and improvements in PFS and ORR, while also significantly reducing grade 4 neutropenia (p<0.0001).
Importantly, a post hoc analysis of the DUBLIN-3 post-ICI subgroup showed a median OS of 15.8 months with Plinabulin plus docetaxel versus 11.7 months with docetaxel alone (HR 0.55), with ORR of 18.2% versus 8.0%, respectively. These findings support the clinical rationale for Plinabulin’s differentiated dendritic cell maturation mechanism and its further evaluation in DUBLIN-4.
This rationale was further supported by prospective data from the Phase 2 Study 303 (n=47), presented at ASCO 2026. In patients with NSCLC whose disease had progressed following PD-1 inhibitor treatment, the combination of Plinabulin, docetaxel and a PD-1 inhibitor demonstrated encouraging anticancer activity. With a median follow-up of 28.8 months, the Plinabulin combination showed a median PFS of 7.0 months, a disease control rate of 79.5%, and a confirmed ORR of 18.2%, with a 2-year OS rate of 58%, nearly double the historical rate reported with docetaxel in a similar patient population.
About BeyondSpring
BeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies for cancers with high unmet needs. Its lead asset, Plinabulin, has been studied in more than 700 cancer patients and is in late-stage development across multiple cancer indications. Plinabulin’s novel mechanism as a GEF-H1 agonist with dendritic cell maturation benefit supports both anticancer activity and immune modulation, offering a unique approach to resensitizing tumors that have progressed on checkpoint inhibitors. In addition, it has the potential to synergize with chemotherapy, antibody-drug conjugates (ADCs), radiation, and checkpoint inhibitors. BeyondSpring is also an early incubator of and maintains an equity interest in SEED Therapeutics, a clinical-stage targeted protein degradation molecular glue company with investments from Eli Lilly and Eisai. Learn more at beyondspringpharma.com.
Investor Contact: IR@beyondspringpharma.com
Media Contact: PR@beyondspringpharma.com
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge, beliefs, and expectations regarding possible future events and are subject to risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of a number of factors, including, but not limited to, the risk that the conditions to the closing of the transaction may not be satisfied or waived on the expected timeline or at all; the inability of Biolin and Bulin to perform their respective funding, clinical development, data generation and other obligations under the definitive agreement; delays or challenges in enrollment or execution of the China portion of DUBLIN-4; regulatory, data-transfer or human-genetic-resources requirements that may affect the transfer or use of China-generated clinical data; the inability of such data to support regulatory submissions outside Greater China; the possibility that the transaction may not achieve the anticipated financial, operational or strategic benefits; difficulties in raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all; unexpected results from preclinical studies or clinical trials; the possibility that preclinical results may not be predictive of clinical results; delays in, or failure to obtain, regulatory approvals; results that do not meet the Company’s expectations regarding the safety, efficacy, clinical utility, or regulatory pathway of the Company’s product candidates; increased competition in the market; the possibility that Fast Track designation may not result in a faster development or regulatory review process or otherwise provide the anticipated benefits, and the fact that such designation does not increase the likelihood of regulatory approval; the Company’s ability to meet the continued listing requirements of The Nasdaq Stock Market LLC; and other risks described in BeyondSpring’s most recent Form 10-K and subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release, and BeyondSpring undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
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