Document:

Exhibit 10.4

 

RESIGNATION
AND GENERAL RELEASE AGREEMENT

 

This Resignation and
General Release Agreement (“Agreement” ) is made and entered into by and between Jill C. Blumhoff (“Executive”)
and Bioanalytical Systems, Inc., an Indiana corporation (the “Company”).

 

WHEREAS, Executive
has been employed with the Company pursuant to an Employment Agreement dated May 13, 2016, as amended (“Employment Agreement”)
and Executive and the Company are parties to a Key Employee Agreement, dated November 9, 2015 (“Key Employee Agreement”
and, together with the Employment Agreement, the “Existing Agreements”);

 

WHEREAS, Executive
has advised the Board of Directors of the Company of her intention to resign from her position as an officer of the Company and
from her positions as an officer, director or manager of each of the Company's subsidiaries at which she holds any such position;

 

WHEREAS, neither of
the Existing Agreements provides for the payment of severance benefits by the Company to the Executive in the event of her resignation;
and

 

WHEREAS, in recognition
of Executive’s years of dedicated service to the Company and in exchange for a release by Executive of all claims that she
may have against the Company and its directors, officers, employees, shareholders and other persons and entities and her confirmation
that she is bound by the restrictive covenants set forth in the Employment Agreement, the Company has agreed to provide Executive
with certain severance benefits as set forth herein;

 

NOW, THEREFORE, in
exchange for the mutual promises contained herein and other good and valuable consideration, the receipt and sufficiency of which
the parties hereby acknowledge, the parties agree as follows:

 

Section 1.               
Resignation and Retirement. Executive resigns from all positions she currently holds as an officer of the Company
and from all positions she currently holds as an officer, director or manager of each of the Company's subsidiaries, including
without limitation her positions as Vice President - Finance and Chief Financial Officer of the Company, effective as of March
6, 2020 (the “Resignation Date”). Executive will remain an employee of the Company until March 31, 2020 (the
 “Separation Date”). Between the Resignation Date and the Separation Date, Executive shall serve as an advisor
to the interim Chief Financial Officer of the Company and shall have such duties and devote such time and attention to the affairs
of the Company as determined by the Chief Executive Officer of the Company. Between the Resignation Date and the Separation Date,
Executive shall be entitled to receive her base salary at the same rate as in effect on the Resignation Date and will continue
to participate in the employee health and welfare benefit plans offered by the Company to its employees, subject to the terms and
conditions of such plans. After the Resignation Date, Executive shall not participate in any incentive compensation plan offered
by the Company and shall not be entitled to any compensation other than her base salary provided for in this Section 1 with
respect to her service as an employee from the Resignation Date through the Separation Date.

 

     

     

    

 

Section 2.               
Severance Benefits.

 

(a)                 
On the first regular Company payroll date following the Separation Date, the Company shall pay to Executive in accordance
with the Company’s existing payroll practices that portion of Executive’s current base salary which has been earned
but not paid as of the Separation Date, plus the amount of any accrued vacation through the Separation Date, and shall reimburse
Executive for any reimbursable business expenses incurred by Executive with the prior approval of the Chief Executive Officer of
the Company through the Separation Date, but not theretofore reimbursed.

 

(b)                 
The parties anticipate that Executive will have an additional period of employment with the Company after the Resignation
Date of this Agreement and Executive wishes to provide a full release to the Company for all claims and actions through the Resignation
Date. Accordingly, Executive understands and agrees that she will receive the below-described Severance Benefits only if: (x) her
employment is not terminated for Cause (as defined in the Employment Agreement Section 4.3(a), (b), (c) or (e)) prior to the Separation
Date; (y) she signs and returns to the Company the Reaffirmation of Resignation, Retirement and Release Agreement (the “Reaffirmation”),
attached hereto and incorporated herein as Exhibit B; and (z) she does not exercise the revocation right described in the
Reaffirmation. Provided, however, that if Executive dies or suffers a Disability (as defined in the Employment Agreement) which
would prevent her execution of the Reaffirmation between the period of her Resignation Date and Separation Date, the Reaffirmation
may be executed by her authorized Power of Attorney (in the case of a Disability) or the authorized personal representative of
her estate. If Executive meets the foregoing conditions to payment of the Severance Benefits, the Company shall pay or provide
to Executive the following payments and benefits (collectively, the “Severance Benefits”):

 

(i)                
Continued payment of Executive's current base salary for a period of six months following the Separation Date, which shall
be payable in equal bi-weekly installments in accordance with the Company’s existing payroll practices on the Company's regular
payroll dates, commencing on the first regular Company payroll date following the date the Reaffirmation becomes effective (such
effective date, the “Reaffirmation Effective Date”);

 

(ii)             
A cash payment equal to one-half (1/2) of Executive’s target bonus for the Company's fiscal year ended September 30,
2020 ("Fiscal 2020"), to be paid by the Company, if at all, at the same time, under the same terms and subject
to the same limitations and conditions set forth in the applicable plan that would have obtained if Executive were still employed
on the date performance bonuses are paid in respect of performance for Fiscal 2020, which payment shall be subject to, contingent
upon, and compensation for Executive’s compliance with the provisions of the non-competition and non-solicitation provisions
as set forth in the Employment Agreement, which provisions are incorporated by reference herein and made a part hereof as if such
provisions were set forth herein;

 

    	 	2	 

     

    

 

(iii)           
Executive shall be entitled to exercise the 65,000 stock options held by Executive set forth on Exhibit A. All such
stock options shall be considered vested and exercisable as of the Resignation date and shall remain exercisable until the earlier
of June 30, 2020 or the expiration date of such stock options; and

 

(iv)            
If the Executive elects continuation of health coverage pursuant to Section 601 through 608 of the Employee Retirement Income
Security Act of 1974, as amended (“COBRA”), the Company shall reimburse the Executive an amount equal to her monthly
COBRA premiums for a period of six (6) months after the Separation Date; provided that such payments will cease upon the Executive’s
becoming entitled to other health insurance.

 

All stock options and other equity
awards held by Executive but not vested by their terms as of the Resignation Date that are not described in this Section 2 shall
be forfeited effective immediately following the resignation of Executive’s positions as an officer of the Company on the
Resignation Date.

 

Section 3.               
Timing of Payment and Release. 

 

(a)                 
As a condition of receiving from the Company the payments and benefits provided for in Section 2(b) of this Agreement, which
Executive otherwise would not be entitled to receive, Executive must execute (and not revoke) this Agreement.  Executive acknowledges
that she has been advised in writing to consult with an attorney prior to executing this Agreement. All payments made to Executive
hereunder shall be subject to appropriate payroll deductions and other withholdings required by law. In the event of Executive’s
death or Disability (as defined in the Employment Agreement), any payment to be made as part of the Severance Benefits that remains
unpaid as of the date of death or Disability shall be paid to Executive’s estate or spouse, as the case may be, at the same
times and subject to the same terms and conditions as otherwise provided herein.

 

(b)                 
This Agreement shall be construed to comply with Section 409A of the Internal Revenue Code of 1986, as amended (“Code
Section 409A”) or an exemption from the application of Code Section 409A. Notwithstanding anything set forth in this
Agreement, no amount payable pursuant to or as provided in this Agreement which constitutes a “deferral of compensation”
within the meaning of Code Section 409A shall be paid unless and until Executive has incurred a “separation from service”
within the meaning of Code Section 409A. Any payments under this Agreement that may be excluded from Code Section 409A either as
separation pay due to an involuntary separation from service or as a short-term deferral shall be excluded from Code Section 409A
to the maximum extent possible. For purposes of Code Section 409A, to the extent the payment is determined to constitute “nonqualified
deferred compensation” within the meaning of Code Section 409A, each installment payment provided under this Agreement shall
be treated as a separate payment. Further, to the extent Executive is a “specified employee” within the meaning of
Code Section 409A as of the date of Executive’s separation from service, no amount which constitutes nonqualified deferred
compensation which is payable on account of Executive’s separation from service shall be paid to Executive before the date
which is the first day of the seventh month after the date of Executive’s separation from service or, if earlier, the date
of Executive’s death following such separation from service. The aggregate of any payments that would otherwise have been
paid before such date shall be paid to the Participant in a lump sum on such date and thereafter, any remaining payments shall
be paid without delay in accordance with their original schedule.

 

    	 	3	 

     

    

 

(c)                 
In consideration of the Company’s agreement to the payment of the Severance Benefits set forth in Section 2 above
and the other good and valuable consideration indicated herein, Executive (for herself and her personal representatives, heirs
and assigns) RELEASES AND FOREVER DISCHARGES the Released Parties (as defined below) from any and all claims (including, but not
limited to, claims for attorneys’ fees), demands, losses, grievances, damages, injuries (whether personal, emotional or other),
agreements, actions, promises or causes of action (known or unknown) which she now has or may later discover or which may hereafter
exist against the Released Parties, in connection with or arising directly or indirectly out of or in any way related to any and
all matters, transactions, events or other things occurring prior to the date hereof, including all those arising out of or in
connection with her employment or former employment with the Company, or arising out of any events, facts or circumstances which
either preceded or flowed from the termination of her employment, or which occurred during the course of Executive’s employment
with the Company or incidental thereto or arising out of any other matter or claim of any kind whatsoever and whether pursuant
to common law, statute, ordinance, regulation or otherwise. Claims or actions released herein include, but are not limited to,
those based on allegations of wrongful discharge, failure to represent, fraud, defamation, promissory estoppel, and/or breach of
contract; those alleging discrimination on the basis of race, color, sex, religion, national origin, age, disability or handicap
under Title VII of the Civil Rights Act of 1964, the Age Discrimination in Employment Act of 1967 (“ADEA”), the Rehabilitation
Act of 1973, the Equal Pay Act of 1963, the Americans with Disabilities Act of 1990, the Civil Rights Act of 1991, the Family and
Medical Leave Act of 1993, the Fair Labor Standards Act (all as amended) or any other federal, state or local law, ordinance, rule
or regulation; and those arising under the Executive Retirement Income Security Act of 1974, all as amended (except for qualified
retirement or other benefit plans from which Executive is entitled under the terms of such plans to receive future benefits). Executive
agrees and understands that any claims she may have under the aforementioned statutes or any other federal, state or local law,
ordinance, rule, regulation or common law are effectively waived by this Agreement. No claims under the ADEA arising after the
execution of this Agreement are waived hereby.

 

(d)                 
The parties understand and agree that, as used in this Agreement, “Released Parties” means Bioanalytical
Systems, Inc. and its subsidiaries and all of their respective past and present officers, directors, shareholders, employees, trustees,
agents, parent companies, subsidiaries, partners, members, affiliates, principals, insurers, any and all employee benefit plans
(and any fiduciary of such plans) sponsored by the aforesaid entities, and each of them, and each entity’s predecessors,
successors, and assigns, and all other entities, persons, firms, or corporations liable or who might be claimed to be liable, none
of whom admit any liability to Executive, but all of whom expressly deny any such liability. 

 

(e)                 
Except as specifically provided in Section 2 and this Section 3 or required under applicable law,
Executive will not be eligible to receive any salary, bonus or other compensation or benefits with respect to any periods after
the Separation Date; provided, however, Executive shall have the right to receive all compensation and benefits to which she is
entitled under any benefit plans of the Company to the extent she is fully vested as of the Resignation Date pursuant to the terms
and conditions of such employee benefit plans.

 

    	 	4	 

     

    

 

Section 4.               
Covenant Not to Sue.

 

(a)                 
Executive understands that by signing this Agreement, Executive is agreeing that Executive has not and will not file any
claims or lawsuits against the Released Parties with any court or government agency with the exception that this Agreement will
not release (i) any non-waivable rights Executive has, including any claims that arise after the Resignation Date or the Reaffirmation
Effective Date, as applicable; (ii) actions, or rights arising under or to enforce the terms of this Agreement; and/or (iii) vested
benefits under any retirement or pension plan and/or deferred compensation plan.  Further, if Executive is requested to participate
in any lawsuit, other proceeding, or investigation against any of the Released Parties, Executive agrees to immediately notify
the Company. The Parties specifically agree that, to the extent Executive may have any non-waivable rights to file or participate
in a claim, lawsuit, or charge against any of the Released Parties, such as with the Equal Employment Opportunity Commission (EEOC),
the National Labor Relations Board (NLRB), the Department of Labor (DOL), the Occupational Safety and Health Administration (OSHA),
or other government agency, Executive is not giving up such right nor is Executive giving up Executive’ s right to participate
truthfully in any EEOC, NLRB, DOL, OSHA, or other government agency investigation. However, even if Executive has a right to file
or participate in a claim, lawsuit, or charge against any of the Released Parties, Executive agrees that, except for non-waivable
claims, Executive shall not obtain, and hereby waives Executive’ s right to, any relief of any kind from such a claim or
charge.

 

(b)                 
As to any actions or claims that would not be released because of the invalidity or unenforceability of this Agreement,
Executive understands and agrees that, except as prohibited by law, if she asserts or brings any such actions or claims against
the Company, she must repay to the Company the Severance Benefits provided to her pursuant to this Agreement, with legal interest.
Executive and the Company agree that by executing this Agreement, Executive has waived any claim (administrative or otherwise)
she may have under, among other things, the ADEA. If Executive files a charge alleging a violation of the ADEA with any administrative
agency or challenges the validity of this waiver and release of any claim she might have had under the ADEA, she will be required
to repay to the Company the Severance Benefits provided by it pursuant to this Agreement, or pay to the Company any other monetary
amounts (such as attorneys’ fees and/or damages), as a condition precedent to filing such a claim, only if and to the extent
the recovery of any such amounts by the Company is otherwise authorized by law. This Agreement is not to be interpreted by either
party or by any third party as an effort to interfere with the protected right to file a charge or participate in an investigation
or proceeding under the ADEA.

 

Section 5.               
Acknowledgment of No Wages or Payments Owed. Executive and the Company agree that the Company has paid or will pay
Executive all salary, benefits and compensation of any nature (including any and all accrued but unused vacation time), due and
owing in accordance with the payroll schedule in existence at the time of this Agreement. No additional salary, benefits, or compensation
of any nature is payable unless specifically provided for herein.

 

    	 	5	 

     

    

 

Section 6.               
Non-disparagement. In consideration of receipt of the Severance Benefits and the promises made by the Company in
this Agreement, Executive agrees not to make any false, negative or disparaging remarks or comments to any person and/or entity
about the Company; make any statement that may subject the Company to potential embarrassment, humiliation or any other negative
consequence; or make any public statement, including but not limited to, any statement to the media or to any Company employee,
regarding the separation of her employment with the Company, except as specifically approved by the Board of Directors. For its
part, the Company’s agrees that its current directors, officers, and senior leadership team (those holding the title of “Vice
President”) will not make any false or disparaging remarks or comments to any person and/or entity about Executive, including,
but not limited to, not making any statement to the media, internal Company communication, formal or informal, and externally in
print or electronic media, except as agreed in, or consistent with, the press release referenced below. The Company and Executive
acknowledge and agree that nothing in this Section 6 shall be construed to prohibit any truthful statements made in response
to any legal process, required governmental testimony or filings, or administrative or arbitral proceedings (including, without
limitation, depositions in connection with such proceedings).

 

Section 7.               
Continued Cooperation. Executive agrees that (a) she will attend the Company's Annual Meeting of Shareholders to
be held on March 19, 2020 at the Company's offices and, in her role as proxy for Company shareholders, she will vote all Company
shares for which she has been designated as proxy by a Company shareholder as directed by such holder (or, if no direction is given,
for approval) on each and every matter set forth in the Company's proxy statement relating to the Annual Meeting and, with respect
to any matter not set forth in the proxy statement relating to the Annual Meeting that is properly brought before the Annual Meeting,
in accordance with the recommendation of the Board of Directors, and (b) during the period in which Executive is receiving any
of the Severance Benefits set forth in Section 2, Executive shall respond, within a reasonable amount of time, to inquiries
that the Company may have from time to time with regard to matters in which Executive was involved in during the course of her
employment and/or about which Executive has knowledge as a result of her employment with the Company. It is understood and agreed
that such continued cooperation will not unreasonably interfere with Executive’s subsequent employment or responsibilities
outside of any subsequent employment. The Company agrees to be responsible for any reasonable and necessary expenses incurred by
Executive in connection with such continued cooperation.

 

Section 8.               
Return of Property; Termination of Perquisites. Executive hereby certifies that, on or prior to the Separation Date,
she will return to the Company, all of the Company’s property in Executive’s possession or control, including, but
not limited to, any cell phone, computer, equipment, keys, access cards or fobs, passwords, portable computer drives and documents
(electronic or hard copy). On or before the Separation Date, the Company shall remove all Company information from Executive’s
cell phone and thereafter shall return the cell phone to Executive and shall transfer to Executive the telephone number associated
with her cell phone. All perquisites provided by the Company to Executive shall terminate and no longer be provided or paid for
by the Company as of the Separation Date.

 

    	 	6	 

     

    

 

Section 9.               
Confidentiality, Restrictive Covenants and Assignment of Inventions. Executive acknowledges and agrees that her covenants
and obligations and the rights and remedies of the Company regarding confidentiality, restrictive covenants and the assignment
of inventions in Sections 3.1, 3.2, 3.3 and 5.11 of the Employment Agreement continue in full force and effect and such obligations
are incorporated herein by reference as if fully set forth.

 

Section 10.           
Entire Agreement. This Agreement, including the sections of the Employment Agreement incorporated by reference herein
as provided in Section 9 hereof, sets forth the entire agreement between the parties hereto and supersedes the Existing
Agreements and any other prior agreements or understandings between the parties. Executive acknowledges that Executive has not
relied on any representations, promises, or agreements of any kind made to Executive in connection with Executive’ s decision
to accept this Agreement, except for those set forth in this Agreement.

 

Section 11.           
Amendment; Waiver. This Agreement may not be modified, altered or changed except in writing and signed by all parties
hereto. Any waiver by Executive or the Company of a breach of any of the provisions of this Agreement must be in writing and shall
not operate or be construed as a waiver of any of the rights and privileges of Executive or the Company under this Agreement or
of any subsequent breach.

 

Section 12.           
Severability. The provisions of this Agreement are severable, and should any provision be declared invalid or not
enforceable, the remaining provisions of the Agreement shall not be affected thereby unless such reading shall operate to deprive
a party of the overall benefit of the bargain as agreed to herein.

 

Section 13.           
Attorney Fees. Executive agrees that she will be solely and individually responsible for compensating any attorney(s)
for any services they have rendered to or for her in connection with the review of this Agreement or any other matters whatsoever.

 

Section 14.           
Non-Admission of Liability. It is understood and agreed that the Company has denied and continues to deny that it
is liable to Executive on any theory, and that nothing in this Agreement, including, but not limited to, the payment of the Severance
Benefits and other valuable consideration set forth in Section 1 hereof, constitutes an admission by the Company of any
fact, damage or liability to Executive on any theory.

 

Section 15.           
Other Acknowledgments. Executive hereby represents and certifies that Executive: (a) has carefully read all of this
Agreement; (b) has been given a fair opportunity to discuss and negotiate the terms of this Agreement by and through legal counsel;
(c) understands the provisions of this Agreement; (d) has determined that it is in her best interest to enter into this Agreement;
(e) has not been influenced to sign this Agreement by any statement or representation by Company or any of its representatives
not contained in this Agreement; and (f) enters into this Agreement knowingly and voluntarily.

 

Section 16.           
Successors and Assigns. Executive shall not assign or transfer any of her rights or obligations under this Agreement
to any individual or entity.  The Company may assign its rights hereunder to any of its affiliates or to any individual or
entity who or that shall acquire or succeed to, by operation of law, or otherwise, all or substantially all of the assets of the
Company or the Company’s business.  All provisions of this Agreement are binding upon, shall inure to the benefit of,
and are enforceable by or against, the parties and their respective heirs, executors, administrators or other legal representatives
and successors and permitted assigns.

 

    	 	7	 

     

    

 

Section 17.           
Governing Law; Jurisdiction. The laws of the State of Indiana shall govern the validity, performance, enforcement,
interpretation, and other aspects of this Agreement, notwithstanding any state’s choice of law provisions to the contrary.
The parties intend the provisions of this Agreement to supplement, but not displace, their respective obligations and responsibilities
under the Indiana Uniform Trade Secrets Act. Any proceeding to enforce, interpret, challenge the validity of, or recover for the
breach of any provision of, this Agreement shall be filed in the courts of the State of Indiana or the United States District Court
sitting in Indianapolis, Indiana, and the parties hereto expressly waive any and all objections to personal jurisdiction, service
of process or venue in connection therewith.

 

Section 18.           
Right to Revoke Agreement. The parties hereby acknowledge and agree that Executive will have 21 calendar days to
review this Agreement and that this Agreement may be revoked by Executive within 7 calendar days after she signs it. This Agreement
shall not be effective or enforceable until the 7 calendar-day revocation period has expired. Furthermore, the offer to make the
Severance Benefits to Executive and provide the other benefits and consideration set forth herein, shall expire and be deemed automatically
withdrawn by the Company if not accepted and this Agreement signed within 21 calendar days. The parties acknowledge and agree that
any modification to this Agreement proposed or agreed to by the parties shall not restart the 21 calendar day period noted above.

 

Section 19.           
No Impact on Indemnification or Insurance Rights. Nothing in this Agreement shall impair or otherwise affect (a)
Executive’s rights to exculpation from liability, indemnification and advancement of expenses provided to former officers
of the Company under the Company’s Second Amended and Restated Articles of Incorporation, as amended, and Second Amended
and Restated By-laws, as amended (collectively, the “Charter Documents”), or (b) any insurance coverage provided
to former officers of the Company under the Company’s director’s and officer’s insurance policies in force from
time to time; provided that nothing in this Agreement shall prevent the Company from amending its Charter Documents or amending
or canceling any such insurance policies in any respect; and provided, further, that the Company shall not be required to maintain
any specified level of such insurance coverage.

 

[Signatures on next page]

 

    	 	8	 

     

    

 

IN WITNESS WHEREOF,
the parties have executed this Agreement as of the date(s) set forth below.

 

	 	 	BIOANALYTICAL
SYSTEMS, INC.

	 	 	 	 
	/s/ Jill C. Blumhoff	 	By:	/s/ Robert Leasure, Jr.
	Jill C. Blumhoff 	 	 	Robert L. Leasure, Jr., President and Chief Executive Officer
	 	 	 	 
	 	 	 	 
	March 6, 2020	 	March 6, 2020
	Date	 	Date

 

    	 	9	 

     

    

 

Exhibit A

To 

Resignation and General Release Agreement

 

Exercisable Stock Options*

 

	Grant Date	Number of Shares	Exercise Price	
        Expiration Date

         

	09/15/2015	10,000	$1.70	9-14-2025
	05-13-2016	10,000	$0.94	05-12-2026
	10-27-2017	20,000	$1.94	10-26-2025
	02-08-2019	25,000	$1.42	02-8-2029
	 	 	 	 
	Total	65,000	 	 

 

 

*       Options are exercisable
until the earlier of June 30, 2020 or the expiration date of such stock options.

 

    	 	10	 

     

    

 

Exhibit B

To 

Resignation and General Release Agreement

 

To be signed on Executive’s last
day of employment.

 

Reaffirmation of Resignation and General
Release Agreement

 

1.       I,
the undersigned, hereby reaffirm the terms of the Resignation and General Release Agreement, dated *
(“Release Agreement”) previously entered into between Bioanalytical Systems, Inc. (the
 “Company”) and me, which agreement is hereby incorporated by reference into this Reaffirmation of
Resignation and General Release Agreement (“Reaffirmation”). I hereby reaffirm that I have complied with
all the terms of the Release Agreement and that I will continue to do so. I also reaffirm and agree to all the terms of the
Release Agreement. This Reaffirmation shall not apply to rights or claims that may arise after the date the parties sign this
document.

 

2.       By
signing this Reaffirmation, I acknowledge that I have read it and understand it. I understand that I am giving up rights and possible
legal and/or administrative claims by signing it. I agree to all of the terms and conditions contained in the Release Agreement.
I am aware of my right to consult an attorney before signing this Reaffirmation and I acknowledge that the Company has advised
me that I should do so, and that I have done so.

 

3.       I
understand that I have previously been given at least twenty-one (21) calendar days to consider whether I wish to sign this Affirmation.
I understand that I have seven (7) calendar days after signing this Reaffirmation to revoke my release of claims under the Age
Discrimination in Employment Act and the Older Workers Benefit Protection Act pursuant to this Reaffirmation. I have signed this
Reaffirmation knowingly and voluntarily.

 

4.       I
also understand that if I exercise my right not to sign this Reaffirmation or my right to revoke this Reaffirmation, I will not
receive the Severance Benefits described in the Release Agreement, but will instead receive the total gross amount of $10.00 in
consideration of my execution of the Release Agreement.

 

		 	Date: 
	Jill C. Blumhoff	 	 
	 	 	 
	BIOANALYTICAL SYSTEMS, INC.	 	 
		 	 
		 	Date:
	Signature	 	 
	Chief Human Resources Officer	 	 
		 	 
	Title	 	 
	 	 	 
	William D. Pitchford	 	 
	Printed Name	 	 

 

    	 	11Exhibit 10.1

 

Information
in this exhibit identified by [***] is confidential and has been excluded pursuant to Item 601(b)(10)(iv) of Regulation
S-K because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

 

EXCLUSIVE
OPTION AND LICENSE AGREEMENT

 

This
Exclusive Option and License Agreement (this “Agreement”)
is made as of January 3, 2020 (the “Effective Date”), by and between Leap Therapeutics, Inc.,
a corporation organized and existing under the laws of Delaware (“Leap”), having a place of business
at 47 Thorndike Street, Suite B1-1, Cambridge, MA 02141 USA, and BeiGene, Ltd.,
a Cayman Island exempted company incorporated with limited liability (“BeiGene”), having a place of
business at c/o Mourant Ozannes Corporate Services (Cayman) Limited, 94 Solaris Avenue, Camana Bay, PO Box 1348, Grand Cayman
KY1-1108, Cayman Islands. Leap and BeiGene are referred to in this Agreement individually as a “Party” and
collectively as the “Parties.”

 

BACKGROUND

 

A.           Leap
is a biopharmaceutical company that is developing a proprietary antibody known as DKN-01 for the treatment of cancer and controls
certain patents and know-how relating to DKN-01;

 

B.            BeiGene
is a biopharmaceutical company engaged in the research, development and commercialization of pharmaceutical products; and

 

C.            BeiGene
wishes to obtain from Leap an exclusive option to an exclusive license to develop and commercialize DKN-01 in the Field in the
Territory, and Leap is willing to grant such a license to BeiGene, all in accordance with the terms and conditions set forth herein.

 

Now
Therefore, in consideration of the mutual
covenants and agreements contained herein below, and other good and valuable consideration, the sufficiency of which is hereby
acknowledged by both Parties, the Parties agree as follows:

 

Article 1

DEFINITIONS & INTERPRETATION

 

Whenever
used in this Agreement with an initial capital letter, the terms defined in this Article 1 and elsewhere in this Agreement,
whether used in the singular or plural, shall have the meanings specified.

 

1.1          “Acquiring
Entity” means a Third Party that merges or consolidates with or acquires a Party, or to which a Party transfers all
or substantially all of its assets to which this Agreement pertains.

 

1.2          “Active
Ingredient” means [***].1

 

1.3          “Affiliate”
means, with respect to a Person, any other Person controlling, controlled by or under common control with such Person, for so
long as such control exists. For purposes of this Section 1.3 only, “control” means (i) direct or indirect
ownership of fifty percent (50%) or more of the stock or shares having the right to vote for the election of directors of such
corporate entity or (ii) the possession, directly or indirectly, of the power to direct, or cause the direction of, the management
or policies of such entity, whether through the ownership of voting securities, by contract or otherwise.

 

 

 

1
Competitive Information – Technical Information.

 

     

     

    

 

1.4          “Applicable
Laws” means collectively all laws, regulations, ordinances, decrees, judicial and administrative orders (and any license,
franchise, permit or similar right granted under any of the foregoing) and any policies and other requirements of any applicable
Governmental Authority that govern or otherwise apply to a Party’s activities in connection with this Agreement.

 

1.5          [***].2

 

1.6          “BeiGene
Inventions” means all Inventions that are owned solely by BeiGene pursuant to Section 14.1(a).

 

1.7          “BeiGene
IP” means all Patent Rights and Know-How that (i) are Controlled by BeiGene or its Affiliates as of the Effective
Date or (ii) thereafter come into BeiGene’s or its Affiliates’ Control independent of this Agreement, and in
each case, that are generated, used or applied by or on behalf of BeiGene or its Affiliates or sublicensees in the Development,
manufacture or Commercialization of Licensed Products.

 

1.8          “BeiGene
Patent Rights” means all Patent Rights in the BeiGene IP.

 

1.9          “Biosimilar
Product” means, with respect to a Licensed Product in a particular country in the Territory, any pharmaceutical product
that: (a) has received all necessary approvals by the applicable Regulatory Authorities in such country to market and sell
such product as a pharmaceutical product, including any and all required pricing and reimbursement approvals; (b) is marketed
or sold in the Field by a Third Party that has not obtained the rights to market or sell such product as a licensee, sublicensee
or distributor of Leap or BeiGene or any of their respective Affiliates, licensees or sublicensees with respect to such Licensed
Product; and (c) is approved as (i) a “biosimilar” or “bioequivalent” (in the United States)
of such Licensed Product, (ii) a “similar biological medicinal product” (in the EU) with respect to which such
Licensed Product is the “reference medicinal product”, or (iii) if not in the US or EU, the foreign equivalent
of a “biosimilar” or “similar biological medicinal product” or “bioequivalent” of such Licensed
Product; in each case for use in such country pursuant to an expedited regulatory approval process governing approval of generic
biologics based on the then-current standards for regulatory approval in such country (e.g., the Biologics Price Competition
and Innovation Act of 2009 or an equivalent under foreign law) and where such regulatory approval was based in significant part
upon Clinical Data generated by Leap, BeiGene or their respective Affiliates or sublicensees with respect to such Licensed Product.
For purposes of clarity, such a pharmaceutical product will be deemed to be Biosimilar Product for purposes of this definition
if a Licensed Product is used as the reference product in the application or submission made with respect to such pharmaceutical
product under Applicable Laws.

 

1.10        “Business
Day” means a day other than a Saturday, Sunday or any other day on which banking institutions in Boston, Massachusetts
or Beijing, China are authorized or required by Applicable Laws to remain closed.

 

1.11        “Calendar
Quarter” means the period beginning on the Effective Date and ending on the last day of the calendar quarter in which
the Effective Date falls, and thereafter each successive period of three (3) consecutive calendar months ending on March 31,
June 30, September 30 and December 31; provided, that, the final Calendar Quarter shall end on the last day of
the Term.

 

 

 

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    -2-

     

    

 

1.12        “Calendar
Year” means the period beginning on the Effective Date and ending on December 31 of the calendar year in which
the Effective Date falls, and thereafter each successive period of twelve (12) months commencing on January 1 and ending
on December 31; provided, that, the final Calendar Year shall end on the last day of the Term.

 

1.13        “cGMP”
means applicable current Good Manufacturing Practices, including, as applicable, (a) the principles detailed in the U.S.
Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and
Eudralex 4, (c) the principles detailed in the International Conference on Harmonization's Q7 guidelines, and (d) the
Applicable Laws in any relevant country or region corresponding to (a) through (c) above, each as may be amended and
applicable from time to time.

 

1.14        “Clinical
Data” means any and all data (together with all clinical trial reports and the results of analyses thereof) derived
or generated in any Clinical Trial conducted by or on behalf of a Party.

 

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

 

1.16        “Commercialization”
or “Commercialize” means any and all activities directed to the offering for sale and sale of any Licensed
Product, including (a) marketing, promoting, advertising, exhibiting, distributing, detailing, selling (and offering for
sale or contracting to sell) or otherwise commercially exploiting a Licensed Product in the Field in the Territory (including
importing and exporting activities in connection therewith); (b) order processing, handling of returns and recalls, booking
of sales and transporting such Licensed Product for commercial sale; (c) the conduct of any post-approval Clinical Trials
involving such Licensed Product; (d) interacting with Regulatory Authorities regarding the above; and (e) seeking and
obtaining pricing approvals and reimbursement approvals (as applicable) for that Licensed Product in the Territory. For clarity,
Commercialization does not include manufacture.

 

1.17        “Commercially
Reasonable Efforts” means, with respect to a Party’s obligations or activities under this Agreement, the carrying
out of such obligations or activities with a level of effort and resources consistent with the commercially reasonable practices
normally devoted by such Party for the development and commercialization of a pharmaceutical product [***], taking into account
all relevant factors, including but not limited to, [***], [***], [***], associated with the development and commercialization
of such Licensed Product.3

 

1.18        “Confidential
Information” of a Party (a “Disclosing Party”) means, subject to Section 10.2, all Know-How,
which is generated by or on behalf of such Disclosing Party under this Agreement and/or any other technical, scientific, trade,
research, manufacturing, business, financial, marketing, product, supplier, intellectual property, and other non-public or proprietary
data or information that is disclosed by a Disclosing Party or its Affiliates to the other Party or its Affiliates (a “Receiving
Party”) pursuant to this Agreement (including information disclosed prior to the Effective Date pursuant to the Confidentiality
Agreement) or which such Disclosing Party or any of its Affiliates or contractors has provided or otherwise made available to
the Receiving Party or any of its Affiliates or contractors, whether made available orally, in writing, or in electronic form,
including (a) such Know-How comprising or relating to concepts, discoveries, Inventions, data, designs or formulae arising
from this Agreement and (b) any unpublished patent applications disclosed hereunder. For purposes of clarity, unless excluded
pursuant to Section 10.2, (i) all Clinical Data and results generated in any Clinical Trial conducted pursuant to the
Global Development Plan, shall be deemed Confidential Information of Leap, subject to the rights of BeiGene to use and reference
such Clinical Data, without additional consideration, in accordance with Section 5.9; (ii) all Inventions shall be deemed
the Confidential Information of the owning Party as set forth in Section 14.1(a); (iii) any scientific, technical, manufacturing
or financial information, including (except as set forth in (i) above) Clinical Data and information disclosed through an
audit report, Commercialization report, Development report or other report, shall constitute Confidential Information of the Disclosing
Party; (iv) any combination of Confidential Information shall not be considered in the public domain or in the possession
of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the
possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the
Receiving Party; and (v) the existence and terms of this Agreement shall be deemed Confidential Information of both of the
Parties.

 

 

 

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1.19        “Control”
or “Controlled” means with respect to any material, Know-How, or intellectual property right (including Patent
Rights), that a Party has the power (whether by ownership, license, or otherwise other than pursuant to this Agreement) to grant
to the other Party access, a license, or a sublicense (as applicable) to the same on the terms and conditions set forth in this
Agreement without violating any obligations of the granting Party to a Third Party. Notwithstanding the foregoing, a Party will
not be deemed to “Control” any material, Know-How, or intellectual property right (including Patent Rights) that,
(i) prior to the consummation of the merger, consolidation or transfer making such Third Party an Acquiring Entity of such
Party, is owned or in-licensed by (A) a Third Party that becomes an Affiliate of such acquired Party after the Effective
Date as a result of such acquisition transaction or (B) any Person that is an Affiliate of such Third Party prior to the
consummation of such acquisition transaction or (ii) that any Acquiring Entity or any of its Affiliates subsequently develops
without accessing or practicing the Licensed IP or BeiGene IP unless (a) prior to the consummation of such acquisition transaction,
such acquired Party or any of its Affiliates also Controlled such Patent Right or Know-How, or (b) the Know-How or Patent
Rights owned or in-licensed by the applicable Third Party or any of its Affiliates were not used in the performance of activities
under this Agreement prior to the consummation of such acquisition transaction, but after the consummation of such acquisition
transaction, such acquired Party or any of its Affiliates uses any such Patent Rights or Know-How in the performance of its obligations
or exercise of its rights under this Agreement, in each of which cases ((a) and (b)), such Patent Rights or Know-How will
be “Controlled” by such Party for purposes of this Agreement.

 

1.20        “Cover”
means, with respect to a Licensed Product in a particular country that the manufacture, use, sale or importation of such Licensed
Product, as applicable, in such country would, but for the licenses granted herein, infringe a Valid Claim.  Cognates of
the word “Cover” shall have correlative meanings.

 

1.21        “Develop”
or “Development” or “Developing” means all development activities for any Licensed Product
that are directed to obtaining Regulatory Approval(s) of such Licensed Product and to support appropriate usage for such
Licensed Product in the Field, including: (a) all research, non-clinical, preclinical and clinical activities, testing and
studies of such Licensed Product; toxicology, pharmacokinetic, pharmacodynamic, drug-drug interaction, safety, tolerability and
pharmacological studies of such Licensed Product; (b) distribution of such Licensed Product for use in Clinical Trials (including
placebos and comparators); (c) statistical analyses; (d)  the preparation, filing and prosecution of any NDA for such
Licensed Product in the Territory, with respect to Development activities conducted under the Territory Development Plan, and
the preparation, filing and prosecution of any Biological License Application or New Drug Application (each as defined by the
FDA) outside the Territory, with respect to Development activities conducted under the Global Development Plan; (e) all development
activities directed to label expansion (including prescribing information) or obtaining Regulatory Approval for one or more additional
Indications following initial Regulatory Approval; (f) all development activities conducted after receipt of Regulatory Approval
that are required or requested in writing by a Regulatory Authority as a condition of, or in connection with, obtaining or maintaining
a Regulatory Approval; (g) any pharmacoeconomic studies relating to the Indication for which the applicable Licensed Product
is being developed; (h) any investigator- or institution-sponsored studies; and (i) all regulatory activities related
to any of the foregoing. For clarity, Development does not include manufacture.

 

    -4-

     

    

 

1.22        “FDA”
means the United States Food and Drug Administration or any successor entity thereto.

 

1.23        “Field”
means the diagnosis, treatment, palliation or prevention of all indications, diseases and disorders in animals and humans.

 

1.24        “First
Commercial Sale” means, with respect to any Licensed Product in any country or jurisdiction in the Territory, the first
sale of such Licensed Product by BeiGene, its Affiliates, or sublicensees to a Third Party for distribution, use or consumption
in such country or jurisdiction after Regulatory Approvals, as applicable, have been obtained for such Licensed Product in such
country or jurisdiction; provided, that, the following shall not constitute a First Commercial Sale of a Licensed Product: (a) any
sale to an Affiliate or sublicensee for purposes of resale, (b) any use of a Licensed Product in Clinical Trials, pre-clinical
studies or other research or Development activities, or (c) [***].4

 

1.25        “GAAP”
means United States generally accepted accounting principles, consistently applied.

 

1.26        “GCP”
means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses
and reporting of Clinical Trials, including, as applicable (a) as set forth in the International Conference on Harmonization
of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical
Practice (CPMP/ICH/135/95) (the “ICH Guidelines”) and any other guidelines for good clinical practice for trials
on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical
Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations
Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application),
as may be amended from time to time, and (d) the equivalent Applicable Laws in the region in the Territory, each as may be
amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data
and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

 

1.27        “GLP”
means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then-current good laboratory
practice standards promulgated or endorsed by the U.S. Food and Drug Administration, as defined in 21 C.F.R. Part 58, and
the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time.

 

1.28        “Governmental
Authority” means any federal, state, national, state, provincial or local government, or political subdivision thereof,
or any multinational organization or any authority, agency or commission entitled to exercise any administrative, executive, judicial,
legislative, police, regulatory or taxing authority or power, or any court or tribunal (or any department, bureau or division
thereof, or any governmental arbitrator or arbitral body).

 

 

 

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1.29        “Indication”
means a generally acknowledged disease or condition, a significant manifestation of a disease or condition, or symptoms associated
with a disease or condition or a risk for a disease or condition. For the avoidance of doubt, [***] for purposes of this Agreement.5

 

1.30        “Invention”
means any new and useful process, manufacture, or composition of matter, Know-How or other invention that is conceived and first
reduced to practice, constructively or actually, by or on behalf of either Party or jointly by or on behalf of the Parties in
connection with the Development, manufacture and/or Commercialization of Licensed Antibody(ies) and Licensed Products under this
Agreement.

 

1.31        “Know-How”
means all technical information, know-how, data, inventions, discoveries, trade secrets, specifications, instructions, processes,
formulae, methods, protocols, expertise and other technology applicable to formulations, compositions or products or to their
manufacture, development, registration, use or marketing or to methods of assaying or testing them, and all biological, chemical,
pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control, manufacturing,
preclinical and clinical data relevant to any of the foregoing. For clarity, Know-How excludes Patent Rights and physical substances.

 

1.32        “Leap
Inventions” means all Inventions that are owned solely by Leap pursuant to Section 14.1(a).

 

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

 

1.34        “Licensed
Know-How” means all Know-How Controlled by Leap or any of its Affiliates as of the Effective Date or during the Term
of this Agreement that is necessary or useful for BeiGene to Develop, Commercialize, use, import, export, sell, offer for sale,
and have sold the Licensed Antibody(ies) and/or any Licensed Products in the Field in the Territory.

 

1.35        “Licensed
Patent Rights” means all Patent Rights Controlled by Leap or its Affiliates as of the Effective Date or during the Term
of this Agreement that (a) contain one or more claims that cover the composition, manufacture and/or use of the Licensed
Antibody(ies) in the Field in the Territory and/or (b) are necessary or useful for BeiGene to research, Develop, Commercialize,
use, import, export, make, have made, manufacture, use, sell, offer for sale, promote, market, distribute, import and export,
and have sold the Licensed Antibody(ies) and/or any Licensed Products in the Field in the Territory.

 

1.36        “Licensed
Antibody” means any proprietary antibody(ies) of Leap that bind to DKK1, including DKN-01 and any derivatives, fragments
or conjugates thereof.

 

1.37        “Licensed
Product” means any pharmaceutical, formulation or dosage form that contains the Licensed Antibody(ies), whether as its
sole Active Ingredient or in combination with one or more other Active Ingredients, in final finished form.

 

1.38        “Manufacturing
Cost” means, with respect to any Licensed Product supplied by or on behalf of Leap to BeiGene hereunder

 

(a)          if
such Licensed Product (or any precursor or intermediate thereof) is manufactured by a Third Party manufacturer, (i) the [***]
costs of such supply of such Licensed Product (or precursor or intermediate) incurred by Leap or its Affiliate, to the extent
specifically identifiable to the supply of such Licensed Product as determined in accordance with GAAP (including, but not limited
to, [***], the [***] of such Licensed Product (including applicable [***]));6 or

 

 

 

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(b)         if
such Licensed Product (or any precursor or intermediate thereof, including [***] and [***] used in the production of the foregoing)
is manufactured (in the case of [***], generated or otherwise procured) by Leap or its Affiliate, the actual, fully burdened documented
and verifiable direct and indirect costs and expenses incurred and recorded in manufacturing such Licensed Product consisting
solely of (i) the cost of [***], (ii) the reasonable allocation of [***], to such manufacturing operation (including
the allocable costs of [***], if applicable, but excluding [***]; (iii) [***] (including [***] but excluding any allocation
for [***]); (iv) [***]; (v) [***]; (vi) amounts (without markup) that are paid to a Third Party, in connection
with the manufacture of such Licensed Product or any component thereof; and (vii) [***] or [***] and paid (excluding [***]),
in each case ((i) through (vii)), to the extent allocable to the manufacture of such Licensed Product as determined in accordance
with GAAP.7

 

1.39        “NDA”
means a New Drug Application (as defined by the NMPA), or any successor application for Regulatory Approval having substantially
the same function, or its foreign equivalent for approval to market or sell a pharmaceutical product in the Territory.

 

1.40        “Multi-Regional
Clinical Study” means a global Clinical Trial of the Licensed Product which will include Clinical Trial sites in the
[***] and may also include Clinical Trial sites in other countries in the Territory.8

 

1.41        “Net
Sales” means the gross amount invoiced by BeiGene, its Affiliates or sublicensees for sales or other transfers of Licensed
Product less the following deductions:

 

(a)      [***];9

 

(b)      [***],
adjustments arising from [***];10

 

(c)      [***];11

 

(d)      [***]
to the extent relating to the Licensed Product;12

 

(e)      [***]
allowed or paid for [***];13 and

 

(f)       [***],
in each case to the extent not reimbursed.14

 

Each
of the foregoing deductions shall be determined as incurred in the ordinary course of business in type and amount consistent with
good industry practice and in accordance with applicable accounting requirements on a basis consistent with BeiGene’s audited
consolidated financial statements. In the case of any other sale [***], such as [***], other than [***], Net Sales shall be calculated
as above [***], defined as [***].15

 

 

 

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Competitive Information – Commercially Sensitive Terms.

7
Competitive Information – Commercially Sensitive Terms.

8
Competitive Information – Commercially Sensitive Terms.

9
Competitive Information – Financial Provisions.

10
Competitive Information – Financial Provisions.

11
Competitive Information – Financial Provisions.

12
Competitive Information – Financial Provisions.

13
Competitive Information – Financial Provisions.

14
Competitive Information – Financial Provisions.

 

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For
purposes of this Agreement, a “sale” or “transfer” shall mean any transfer or other distribution or disposition,
but shall not include transfers or other distributions or dispositions of Licensed Product at no charge (i) for academic
research, preclinical, clinical, or regulatory purposes (including the use of a Licensed Product in Clinical Trials), (ii) [***]
or (iii) [***].16

 

In
the event a Licensed Product is sold as part of a Combination Product, the Net Sales from the Combination Product, for the purposes
of determining royalty payments, shall be determined by multiplying the Net Sales (as determined above) of the Combination Product,
during the applicable royalty reporting period, by the fraction, A/(A+B), where A is [***] of the Licensed Product when sold separately
in finished form and B is [***]of the other Active Ingredient(s) included in the Combination Product when sold separately
in finished form, in each case during [***]. In the event that such [***] cannot be determined for both the Licensed Product and
all other Active Ingredient(s) included in such Combination Product, Net Sales for the purposes of determining royalty payments
shall be calculated by multiplying the Net Sales of the Combination Product by the fraction of C/(C+D) where C is the fair market
value of the Licensed Product and D is the fair market value of all other Active Ingredient(s) included in the Combination
Product. In such event, the Parties shall negotiate in good faith to determine of the respective fair market values of the Licensed
Product and all other Active Ingredient(s) included in the Combination Product based on the relative value contributed by
each component. “Combination Product” means a Licensed Product comprising the Licensed Antibody in combination
with at least one other active pharmaceutical ingredient, that is either co-formulated or separately formulated and packaged together,
and/or sold together (including as a single unit) for a single price.17

 

1.42       “NMPA”
means the National Medical Products Administration of China, and local counterparts thereto, and any successor agency(ies) or
authority thereto having substantially the same function.

 

1.43       “Patent
Prosecution” means activities directed to (a) preparing, filing and prosecuting applications (of all types) for
any Patent Rights, (b) managing any interference, opposition, re-issue, reexamination, supplemental examination, invalidation
proceedings (including inter partes or post-grant review proceedings), revocation, nullification, or cancellation proceeding
relating to the foregoing, (c) deciding whether to abandon, extend or maintain Patent Rights, (d) listing in regulatory
publications (as applicable), and (e) settling any interference, opposition, reexamination, invalidation, revocation, nullification
or cancellation proceeding, but excluding the defense of challenges to such patent or patent application as a counterclaim in
an infringement proceeding with respect to the particular patent or patent application, and any appeals therefrom. For purposes
of clarity, “Patent Prosecution” will not include any other enforcement actions taken with respect to a patent or
patent application.

 

1.44       “Patent
Rights” means the rights and interests in and to issued patents and pending patent applications (which, for purposes
of this Agreement, include certificates of invention, applications for certificates of invention and priority rights) in any country
or region, including all provisional applications, substitutions, continuations, continuations-in-part, continued prosecution
applications including requests for continued examination, divisional applications and renewals, and all letters patent or certificates
of invention granted thereon, and all reissues, reexaminations, extensions (including pediatric exclusivity patent extensions),
term restorations, renewals, substitutions, confirmations, registrations, revalidations, revisions and additions of or to any
of the foregoing, in each case, in any country.

 

 

 

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16
Competitive Information – Commercially Sensitive Terms.

17
Competitive Information – Financial Provisions and Commercially Sensitive Terms.

 

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1.45       “Person”
means any individual, corporation, company, partnership, association, joint-stock company, trust, unincorporated organization
or government or political subdivision thereof.

 

1.46       “Phase
3 Registrational Clinical Trial” means a controlled or uncontrolled human Clinical Trial of a Licensed Product that
would satisfy the requirements of 21 CFR 312.21(c) or corresponding foreign regulations, regardless of whether such trial
is referred to as a “phase 3 clinical trial,” that is intended (as of the time the Clinical Trial is initiated) to
obtain sufficient data and results to support the filing of an application for Regulatory Approval (but may not include the data
that may be necessary to support the pricing and/or reimbursement approvals). A Phase 3 Registrational Clinical Trial includes
any Clinical Trial that satisfies at least one of the following criteria:

 

(a)       It
would, based on interactions with a Regulatory Authority or otherwise prior to the initiation of such trial, satisfy the requirements
of 21 CFR 312.21(c) or corresponding foreign regulations;

 

(b)       It
is designed in a manner to allow for the addition of patients such that it could satisfy the requirements of 21 CFR 312.21(c) or
corresponding foreign regulations, provided that such Clinical Trial would only be deemed a Phase 3 Registrational Clinical Trial
upon dosing the first patient among such additional patients; or

 

(c)       It
is otherwise intended, at the time of initiation, to support (either alone or together with another Phase 3 Registrational Clinical
Trial) an application for marketing approval of a new product (or an indication or intended use for an already approved product).

 

1.47        “Regulatory
Approval” means all approvals from the relevant Regulatory Authority necessary to initiate marketing and selling a product
(including Licensed Product) in any country. For clarity, to the extent necessary to initiate marketing and selling of a product
in a particular country, Regulatory Approval shall include pricing or reimbursement approval.

 

1.48        “Regulatory
Authority” means any applicable Governmental Authority with authority over the distribution, importation, exportation,
manufacture, production, use, storage, transport, research, non-clinical testing, clinical testing or sale of a pharmaceutical
product (including any Licensed Product), which may include the authority to grant the required reimbursement and pricing approvals
for such sale.

 

1.49        “Regulatory
Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any applicable Regulatory
Authority with respect to a Licensed Product, other than an issued and unexpired Patent Right, including any new chemical entity
exclusivity, pediatric exclusivity or orphan drug exclusivity which grant an exclusive commercialization period during which BeiGene,
its Affiliates or sublicensees have the exclusive right to market and sell such Licensed Product in such country.

 

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

 

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1.51       “Territory”
means Asia (excluding Japan), Australia and New Zealand. “Asia” means [***].18

 

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

 

1.53       “Third
Party In-License Agreement” means the License Agreement between Leap and Eli Lilly and Company, dated as of January 3,
2011, as amended.

 

1.54       “United
States” or “US” means the United States of America and its territories and possessions.

 

1.55       “USD”
means United States dollars.

 

1.56       “Valid
Claim” means a claim of (a) an issued and unexpired patent or (b) a pending patent application, which has
not lapsed or been revoked, abandoned or held unenforceable or invalid by a final decision of a court or governmental or supra-governmental
agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been disclaimed,
denied or admitted to being invalid or unenforceable through reissue, reexamination or disclaimer or otherwise; provided, that,
if a pending patent application has been pending for at least [***] from the date of filing of the initial priority application,
then such corresponding claim in such pending patent application will not be deemed to be a Valid Claim unless and until it subsequently
issues.19

 

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

 

 

 

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Competitive Information – Commercially Sensitive Terms.

19
Competitive Information – Commercially Sensitive Terms.

 

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	Definition	Section
	Accounting
    Firm	9.10(b)(i)
	Agreement	Preamble
	Agreement
    Payments	9.11(a)
	Alliance
    Manager	3.1
	Anti-Corruption
    Laws	12.7(a)(i)
	BeiGene	Preamble
	BeiGene
    Drug	5.1(a)
	BeiGene
    Drug Inventions	14.1(a)
	BeiGene
    Inventions	14.1(a)
	BeiGene
    Indemnitees	13.2
	BeiGene
    Publication	11.1(b)
	Breach
    Notification	15.2(b)(i)
	Claims	13.1
	Clinical
    Supply Agreement	7.3(a)
	CMO	7.2
	Commercialization
    Milestone Event	9.3
	Commercialization
    Milestone Payment	9.3
	Confidentiality
    Agreement	16.13
	Continuing
    Technology Transfer	4.1
	Development
    Milestone Event	9.2
	Development
    Milestone Payment	9.2
	Disclosing
    Party	1.18
	Dispute	16.5(a)
	Effective
    Date	Preamble
	Existing
    Regulatory Materials	12.2(o)
	Excluded
    Claim	16.5(e)
	Executive
    Officers	3.2(f)
	Global
    Development Plan	5.3(a)
	ICC	16.5(a)
	ICH
    Guidelines	1.32
	Indemnified
    Party	13.3
	Indemnifying
    Party	13.3
	Initial
    Technology Transfer	4.1
	Joint
    Patent Rights	14.1(c)
	JCC	3.2(g)
	JDC	3.2(a)
	Leap	Preamble
	Leap
    Inventions	14.1(a)
	Leap
    Indemnitee(s)	13.1
	Leap
    Manufacturing IP	7.2
	Leap
    Publication	11.1(c)
	License	2.2
	Losses	13.1
	Manufacturing
    Technology Transfer	7.2
	Manufacturing
    Technology Transfer Plan	7.2
	Notice
    of Dispute	16.5(a)
	Option	2.1
	Option
    Exercise Fee	5.1
	Party/Parties	Preamble
	POC
    Data Package	5.1
	Product
    Infringement	14.3(a)
	Product
    Marks	14.7
	Public
    Official	12.7(d)
	Publication	11.1(c)
	Receiving
    Party	1.19
	Review
    Period	11.1(b)
	Royalty
    Term	9.5(b)
	Rules	16.5(a)
	Pharmacovigilance
    Agreement	6.4
	SEC	11.4(c)
	Securities
    Regulators	11.4(c)
	Seller	1.40
	Taxes	9.11(a)
	Technology
    Transfer	4.1
	Term	15.1
	Territory
    Development Plan	5.4
	Upfront
    Payment	9.1

 

    -11-

     

    

 

1.58        Interpretation.
The captions and headings to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting
any of the provisions of this Agreement. Unless specified to the contrary, references to Articles, Sections or Exhibits mean the
particular Articles, Sections or Exhibits to this Agreement and references to this Agreement include all Exhibits hereto.
In the event of any conflict between the main body of this Agreement and any Exhibit hereto, the main body of this Agreement
shall prevail. Unless context otherwise clearly requires, whenever used in this Agreement: (a) the words “include”
or “including” shall be construed as incorporating, also, “but not limited to” or “without limitation;”
(b) the word “day” or “year” means a calendar day or year unless otherwise specified; (c) the
word “notice” shall mean notice in writing (whether or not specifically stated) and shall include notices, consents,
approvals and other written communications contemplated under this Agreement; (d) the words “hereof,” “herein,”
 “hereby” and derivative or similar words refer to this Agreement as a whole and not merely to the particular provision
in which such words appear; (e)  the words “shall” and “will” have interchangeable meanings for purposes
of this Agreement; (f) the word “or” shall have the inclusive meaning commonly associated with “and/or”;
(g) provisions that require that a Party, the Parties or a committee hereunder “agree,” “consent”
or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether
by written agreement, letter, approved minutes or otherwise; (h) words of any gender include the other gender; (i) words
using the singular or plural number also include the plural or singular number, respectively; (j) references to any specific
law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments
thereto or any replacement law, rule or regulation thereof; (k) neither Party or its Affiliates shall be deemed to be
acting “under authority of” the other Party.

 

Article 2

OPTION AND LICENSE

 

2.1          Option
Grant to BeiGene. Subject to the terms and conditions of this Agreement, Leap hereby grants to BeiGene an exclusive option
(the “Option”) to an exclusive license under the Licensed IP, to research, develop, use, import, export, make,
have made, manufacture, use, offer for sale, promote, market, distribute, and sell the Licensed Antibody(ies) and/or Licensed
Products in the Field in the Territory as set forth in Section 2.2. BeiGene may exercise the Option at its sole discretion
by written notice to Leap at any time within [***] after Leap delivers to BeiGene the complete POC Data Package (the “Option
Period”). For avoidance of doubt, BeiGene may elect to exercise the Option at its sole discretion at any time prior
to delivery of the complete POC Data Package.

 

2.2          License
Grants to BeiGene. Subject to the terms and conditions of this Agreement, upon exercise of the Option and payment of the Option
Exercise Fee, Leap hereby grants to BeiGene an exclusive (subject to Leap’s retained rights in Section 2.3), royalty-bearing
license, with the right to grant sublicenses, under the Licensed IP, to research, develop, use, import, export, make, have made,
manufacture, use, offer for sale, promote, market, distribute, and sell the Licensed Antibody(ies) and/or Licensed Products in
the Field in the Territory (the “License”).

 

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2.3          Right
to Sublicense.

 

(a)         Subject
to the terms and conditions of this Agreement, BeiGene shall have the right to grant sublicenses under the License through multiple
tiers: (i) to its Affiliates, provided that such sublicense shall automatically terminate if such sublicensee ceases
to be an Affiliate of BeiGene; and (ii) subject to Section 5.10, to contract research organizations, distributors and
other Third Party subcontractors for the sole purpose of performing BeiGene’s obligations hereunder, on BeiGene’s
behalf with respect to the research, Development, (subject to Article 7) manufacture and Commercialization of Licensed Products
in the Field in the Territory, in each case as is set forth in the Global Development Plan or Territory Development Plan; (iii) to
any other Third Party with respect to the Development, manufacture and/or Commercialization of Licensed Products in the Field
in the Territory, subject to Leap’s prior written consent, not to be unreasonably withheld, conditioned or delayed; and
(iv) to contract manufacturers of Licensed Product solely in accordance with Article 7 below. For purposes of clarity,
BeiGene shall have the right, in connection with the grant of a sublicense to any Third Party pursuant to this Section 2.2(a)(ii),
(iii) or (iv), to transfer to such Third Party such quantities of the Licensed Antibody as is reasonably necessary for such
Third Party to conduct Development, manufacture and/or Commercialization activities in accordance with the sublicense grant.

 

(b)         Each
sublicense shall be subject to a written agreement that is consistent with the terms and conditions of this Agreement, and BeiGene
shall ensure that all of its direct or indirect sublicensees comply with the terms and conditions of this Agreement. BeiGene shall
include, or cause to be included, in each sublicense agreement an obligation of the applicable subcontractor or sublicensee to
cease all activities with respect to Licensed Products if BeiGene terminates such sublicense agreement. BeiGene will remain directly
responsible for all its obligations under this Agreement, regardless of whether any such obligation is delegated, subcontracted
or sublicensed to any of its Affiliates or sublicensees. In the event of any material breach by any such subcontractor or sublicensee
of any sublicense granted pursuant to Section 2.3(a) that would be a material breach of this Agreement by BeiGene, BeiGene
shall [***]. BeiGene shall provide, or cause to be provided, to Leap a true and complete copy of each sublicense [***], subject
to the right of BeiGene or the applicable sublicensor to redact any confidential or proprietary information contained therein
that is not necessary for Leap to determine compliance with this Agreement, and if such agreement is not in English, a certified
translation into English thereof within [***] after the execution of such sublicense agreement.20

 

2.4          Leap
Retained Rights. Notwithstanding the exclusive nature of the License, Leap expressly retains the rights to use the Licensed
IP in the Field in the Territory in order to (a) perform its obligations under this Agreement (b) to conduct research
and Development activities that are assigned to Leap under the Global Development Plan and (c) to conduct research, Development,
manufacturing, regulatory activities and otherwise to the extent permitted by this Agreement solely to support research, Development,
manufacturing, regulatory activities or Commercialization outside of the Territory or outside of the Field. For clarity, Leap
retains the exclusive right to practice, license and otherwise exploit the Licensed IP outside the scope of the License.21

 

 

 

20
Competitive Information – Commercially Sensitive Terms.

21
Competitive Information – Commercially Sensitive Terms.

 

    -13-

     

    

 

2.5          License
Grants to Leap. Subject to the terms and conditions of this Agreement, BeiGene hereby grants to Leap:

 

(a)       a
non-exclusive, fully-paid, royalty-free and sublicensable (through multiple tiers) license under the BeiGene Inventions and BeiGene
IP solely to Develop, make, have made and Commercialize Licensed Products outside the Territory;

 

(b)       a
non-exclusive, fully-paid, royalty-free and sublicensable (through multiple tiers) license under the BeiGene IP and BeiGene Inventions
to Develop, make, have made and Commercialize Licensed Products in the Territory solely as necessary for Leap to perform its obligations
under this Agreement and to conduct research and Development activities under the Global Development Plan and in any event solely
to support Development and Commercialization of the Licensed Product outside the Territory.

 

2.6           No
Implied Licenses; Negative Covenants. Except as expressly set forth herein, neither Party shall acquire any license or other
intellectual property interest, by implication or otherwise, under any trademarks, Patent Rights or patent applications of the
other Party. BeiGene shall not, and shall not permit any of its Affiliates or sublicensees to, practice any Licensed IP outside
the scope of the License.

 

2.7           Non-Competition.

 

(a)     During
the Term, BeiGene shall [***].22

 

(b)     During
the Term, Leap shall [***].23

 

Article 3

GOVERNANCE

 

3.1           Alliance
Managers. Each Party shall appoint an individual, who is an employee of such Party, to act as its alliance manager under this
Agreement [***] after the Effective Date (the “Alliance Manager”). The Alliance Managers shall: (a) serve
as the primary points of contact between the Parties for the purpose of providing the other Party with information on the progress
of a Party’s activities under this Agreement; (b) be responsible for facilitating the flow of information and otherwise
promoting communication, coordination and collaboration between the Parties, provided that all communications between the
Parties shall be in English; (c) facilitate the prompt resolution of any disputes; and (d) attend JDC and JCC meetings.
An Alliance Manager may also bring any matter to the attention of the JDC or JCC if such Alliance Manager reasonably believes
that such matter warrants such attention. Each Party may replace its Alliance Manager at any time upon written notice to the other
Party.24

 

3.2          Joint
Development Committee.

 

(a)         Formation.
No later than [***] following the Effective Date, the Parties shall establish a joint development committee (the “JDC”)
to monitor and coordinate the Development and manufacture of Licensed Products in the Field in the Territory and outside of the
Territory. The JDC will be composed of an equal number of representatives from each Party and a minimum of [***] representatives
of each Party. Each representative to the JDC shall be an employee of the applicable Party, unless otherwise agreed by both Parties.25

 

 

 

22
Competitive Information – Exclusivity and Technical Information.

23
Competitive Information – Exclusivity and Technical Information.

24
Competitive Information – Commercially Sensitive Terms.

 

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(b)         Role.
The JDC shall (i) provide a forum for the discussion of the Parties’ activities under this Agreement; (ii) review
and discuss Leap's performance of Development activities under the Initial Development Plan and results and data included in the
POC Data Package; (iii) review and discuss the overall strategy for the Development and manufacture of Licensed Products
in the Field in the Territory; (iv) review and discuss the overall strategy for Development and manufacture of Licensed Products
outside of the Territory; (v) review and discuss the progress of the Regulatory Approvals and Regulatory Submissions for
Licensed Products in the Territory, including discussing relevant CMC information; (vi) review, discuss and approve the Manufacturing
Technology Transfer Plan in accordance with Section 7.2; (vii) establish and oversee the JCC; (vii) to review,
coordinate and approve supply of Licensed Product in accordance with Article 7; (ix) determine whether and when to develop
companion or complementary diagnostic products to be used in connection with Licensed Products; (x) provide a forum for discussion
of summaries of Clinical Trial activities by Leap and its Affiliates for the Licensed Product [***]; and (xi) perform such
other functions as expressly set forth in this Agreement or allocated to the JDC by the Parties’ written agreement.26

 

(c)         Limitation
of Authority. The JDC shall only have the powers expressly assigned to it in this Article 3 and elsewhere in this Agreement
and shall not have the authority to: (i) modify or amend the terms and conditions of this Agreement; (ii) waive either
Party’s compliance with the terms and conditions of this Agreement; or (iii) determine any issue in a manner that would
conflict with the express terms and conditions of this Agreement.

 

(d)         Meetings.
The JDC shall hold meetings at such times as it elects to do so, but shall meet no less frequently than [***] per Calendar
Year until Regulatory Approval of the Licensed Product in the Territory, and thereafter, upon mutual agreement of the Parties,
but no more than [***] per Calendar Year. The first JDC meeting shall be within [***] of the Effective Date. In addition, special
meetings of the JDC may be convened by either Alliance Manager upon not less than [***] (or, if such meeting is proposed to be
conducted by teleconference, [***]) written notice to the other Alliance Manager. The JDC may meet in person or by means of teleconference, Internet
conference, videoconference or other similar communication method; provided that at least [***] each Calendar Year, such
meetings will be conducted in person at locations selected alternatively by Leap and BeiGene or such other location as the Parties
may agree. Each Party shall bear its own expenses related to participation in and attendance at such meetings by its respective
JDC representatives. The Alliance Managers shall jointly prepare and circulate minutes for each JDC meeting within [***] of each
such meeting and shall ensure that such minutes are reviewed and approved by their respective companies within [***] thereafter.
Communications between the Parties pursuant to the JDC meetings shall be in English.27

 

(e)         Non-Member
Attendance. Each Party may from time to time invite a reasonable number of participants, in addition to its representatives,
to attend a meeting of the JDC or JCC (in a non-voting capacity) in the event that the planned agenda for such JDC or JCC meeting
would require such participants’ expertise; provided that if either Party intends to have any Third Party (including
any consultant) attend such a meeting, such Party shall provide prior written notice to the other Party, shall obtain approval
from such other Party for such Third Party to attend, and shall ensure that such Third Party is bound by confidentiality and non-use
obligations consistent with the terms of this Agreement.

 

 

 

 

25
Competitive Information – Commercially Sensitive Terms.

26
Competitive Information – Commercially Sensitive Terms.

27
Competitive Information – Commercially Sensitive Terms.

 

    -15-

     

    

 

(f)          Decision-Making.
All decisions of the JDC shall be made by consensus, with each Party’s representatives having, collectively, one vote.
If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JDC,
the JDC cannot reach consensus as to such matter within [***] after such matter was brought to the JDC for resolution, such matter
shall be referred to the Chief Executive Officer of Leap (or an executive officer of Leap designated by the Chief Executive Officer
of Leap who has the power and authority to resolve such matter) and the Chief Executive Officer of BeiGene (or an executive officer
of BeiGene designated by the Chief Executive Officer of BeiGene who has the power and authority to resolve such matter) (collectively,
the “Executive Officers”) for resolution. If the Executive Officers cannot resolve such matter within [***]
after such matter has been referred to them, then:28

 

 (i)     Subject
to Section 3.2(f)(ii), BeiGene shall have the final decision-making authority for matters within the scope of the JDC’s
decision-making authority with respect to (1) any [***] for Licensed Products in the Field in the Territory, (2) all
[***] with respect to Licensed Products, including [***], in the Field in the Territory; and (3) all [***] activities leading
up to and including the [***] and any [***], as applicable, for Licensed Products in the Field from [***] in the Territory; provided
that: BeiGene shall not exercise its final decision-making authority in a manner that would reasonably be expected to [***].29

 

 (ii)     Leap
shall have the final decision-making authority for matters within the scope of the JDC’s decision-making authority with
respect to any Development, manufacture or Commercialization activities in the Territory that would reasonably be expected to
(y) result in a [***] related to a Licensed Product outside the Territory or outside the Field or (z) otherwise [***];
provided, that, Leap shall not exercise its final decision-making authority in a manner that would: (A) [***] under
this Agreement, including (i) any of BeiGene’s obligations or expenses [***] agreed between the Parties and/or (ii) any
[***] involving a Licensed Product (including a Multi-Regional Clinical Trial), in any case; or (B) [***], without BeiGene’s
written consent, which will not be unreasonably withheld, delayed or conditioned.30

 

(g)         Joint
Commercialization Committee. Not later than [***] prior to the anticipated date of the filing of the first application for
Regulatory Approval for a Licensed Product in the Territory, the Parties shall establish a joint commercialization committee (the
 “JCC”) to review, discuss, coordinate and share information regarding (1) the progress of the Commercialization
of Licensed Products in the Territory; and (2) commercial issues relevant to the Commercialization of Licensed Products in
the Territory and Leap’s commercialization of Licensed Products in other territories outside of the Territory and global
harmonization of such activities. The JCC [***], unless otherwise agreed by the Parties. The JCC and its activities shall be subject
to the oversight of, and shall report to, the JDC and the JDC shall resolve all disputes that arise within the JCC within [***]
after any such matter is brought to the JDC for resolution. In no event shall the authority of the JCC exceed the authority of
the JDC. Each Party shall be responsible for all of its own expenses of participating in the JCC.31

 

(h)         Discontinuation
of Committees. The JDC shall continue to exist until the Parties mutually agree to disband the JDC. Once the JDC is disbanded,
the JDC shall have no further obligations under this Agreement and, thereafter, the Alliance Managers shall be the points of contact
for the exchange of information under this Agreement and decisions of the JDC shall be decisions between the Parties, subject
to the other terms and conditions of this Agreement. The JCC shall disband upon the disbandment of the JDC or earlier, as determined
by the JDC.

 

 

 

28
Competitive Information – Commercially Sensitive Terms.

29
Competitive Information – Commercially Sensitive Terms and Exclusivity Information.

30
Competitive Information – Commercially Sensitive Terms and Exclusivity Information.

31
Competitive Information – Commercially Sensitive Terms.

 

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Article 4

TECHNOLOGY TRANSFER

 

4.1           Technology
Transfer. Within [***] after the Effective Date, Leap will provide and transfer to BeiGene, [***], the Licensed Know-How that
exists on the Effective Date and was not previously provided to BeiGene by providing copies or samples of relevant documentation,
materials and other embodiments of such Licensed Know-How, including data within reports, and electronic files, that exists on
the Effective Date (the “Initial Technology Transfer”). Thereafter, during the Term, Leap shall (a) at
each meeting of the JDC (and, in any event, on [***] if any JDC meeting is not held in a particular [***]), provide BeiGene with
a summary of additional Licensed Know-How, if any, developed since the last meeting of the JDC, (b) transfer any such Licensed
Know-How to BeiGene promptly following BeiGene’s reasonable request, and (c) provide BeiGene with reasonable access
to Leap personnel involved in the research and Development of Licensed Products, either in-person at Leap’s facility or
by teleconference (the “Continuing Technology Transfer,” and together with the Initial Technology Transfer,
the “Technology Transfer”). For the avoidance of doubt, Leap’s personnel shall not be obligated to travel
to BeiGene’s facilities, and Leap’s transfer obligations under this Section 4.1 shall apply solely to the extent
the Licensed Know-How is reasonably necessary to support BeiGene’s Development and Commercialization of the Licensed Product
in the Field in the Territory in accordance with this Agreement. Notwithstanding the foregoing, Leap’s technology transfer
obligations hereunder shall not include the obligation to transfer [***], except as set forth in [***] or unless otherwise mutually
agreed by the Parties in writing.32

 

4.2          Updates
by BeiGene. During the Term, BeiGene shall (a) at each meeting of the JDC (and, in any event, on [***] if any JDC meeting
is not held in a particular [***]), provide Leap with a summary of any BeiGene Inventions and Know-How within the BeiGene IP,
if any, developed since the last meeting of the JDC, (b) transfer any such BeiGene Inventions and Know-How to Leap promptly
following Leap’s reasonable request, and (c) provide Leap with reasonable access to BeiGene personnel involved in the
research and Development of Licensed Products, either in-person at BeiGene’s facility or by teleconference. For the avoidance
of doubt, BeiGene’s personnel shall not be obligated to travel to Leap’s facilities, and BeiGene’s transfer
obligations under this Section 4.2 shall apply solely to the extent the BeiGene Inventions and Know-How within the BeiGene
IP is reasonably necessary to support Leap’s Development and Commercialization of the Licensed Product outside of the Territory.33

 

Article 5

DEVELOPMENT PROGRAM

 

5.1           Initial
Development Responsibility.

 

(a)     [***],
Leap shall be responsible for the Development of the Licensed Products in the Field [***]. Leap shall Develop Licensed Products
in the Field in accordance with a written development plan and timeline attached to this Agreement as Exhibit A (the
 “Initial Development Plan”). Leap will not perform any activities under the Initial Development Plan in the
BeiGene Territory. Leap shall conduct such activities in compliance with all Applicable Laws, including GLP, GCP and cGMP. Upon
completion of its activities under the Initial Development Plan, Leap will provide BeiGene with all results of its activities
under the Initial Development Plan, including all clinical data and analysis thereof, including all of the information agreed
to be included under the Initial Development Plan (the “POC Data Package”) which POC Data Package will be deemed
delivered to BeiGene after BeiGene confirms that the POC Data Package is complete. BeiGene will provide such confirmation within
[***] after receipt of the POC Data Package if BeiGene reasonably determines that such POC Data Package is complete or will provide
written notice to Leap of any missing required information, in which case the [***] will be tolled until Leap provides such missing
information. Leap will not disclose the POC Data Package or any portion thereof to any potential licensees or potential acquirers
of rights to a Licensed Antibody or Licensed Product in the [***] during the Option Period.34

 

 

 

32
Competitive Information – Commercially Sensitive Terms.

33
Competitive Information – Commercially Sensitive Terms.

 

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(b)         Supply
of BeiGene Drug. BeiGene will use Commercially Reasonable Efforts to supply to Leap quantities of [***] (the “BeiGene
Drug”) necessary for performance of the Initial Development Plan according to the terms and conditions of a clinical
supply agreement to be entered into by the Parties within [***] after the Effective Date. Leap agrees to use the BeiGene Drug
for the sole purpose of performing the Initial Development Plan and not to use the BeiGene Drug for any other purpose.35

 

5.2           Diligence
and Responsibilities. [***], BeiGene shall be responsible for the Development of the Licensed Products in the Field in the
Territory in accordance with this Article 5. BeiGene shall use Commercially Reasonable Efforts to (i) [***], and (ii) [***].
BeiGene shall conduct such tasks in compliance with all Applicable Laws, including GLP, GCP and cGMP.36

 

5.3          Global
Development Plan.

 

(a)       The
Parties’ collaborative work to support the global Development of Licensed Products within and outside of the Territory after
BeiGene’s exercise of the Option will be conducted pursuant to a written development plan (as amended from time to time
in accordance with this Section 5.3, the “Global Development Plan”), which the Parties agree may include
one or more additional Multi-Regional Clinical Studies. An initial high-level global development plan is attached to this Agreement
as Exhibit B and will be used by the Parties to create the first Global Development Plan for JDC review and discussion
within [***] after BeiGene’s exercise of the Option. The Global Development Plan shall include (i) [***], (ii) [***],
(iii) [***], (iv) [***], and (v) [***]. From time to time, Leap may make and implement amendments to the then-current
Global Development Plan. To the extent such amendments relate to the Territory or include a combination with an Active Ingredient
Controlled by BeiGene, Leap shall submit such proposed amendments to the JDC for review, discussion and approval before adopting
such amendments. Prior JDC approval shall not be required for amendments to the Global Development Plan that are outside of the
Territory and do not include a combination with an Active Ingredient Controlled by BeiGene.37

 

(b)      BeiGene
shall use Commercially Reasonable Efforts to perform the Development activities assigned to BeiGene under the Global Development
Plan to support the global Development and registration of Licensed Products, [***]. The Parties acknowledge and agree [***].38

 

5.4     Territory
Development Plan. Except for the activities allocated to BeiGene under the Global Development Plan pursuant to Section 5.3,
all Development of Licensed Products in the Territory under this Agreement shall be conducted by BeiGene pursuant to a written
development plan (as amended from time to time in accordance with this Section 5.4 and Section 3.2, the “Territory
Development Plan”). BeiGene shall provide the first Territory Development Plan for JDC review and discussion [***] after
exercise of the Option by BeiGene. From time to time after the Effective Date, but not [***], BeiGene shall propose amendments
to the Territory Development Plan in consultation with Leap and submit such proposed updated or amended Territory Development
Plan to the JDC for review and discussion. For clarity, the Territory Development Plan and amendments thereto shall be consistent
with the Global Development Plan and the Global Development Plan shall take precedent in case of any conflict or inconsistency
between the Territory Development Plan and the Global Development Plan.39

 

 

 

34
Competitive Information – Discovery Information and Commercially Sensitive Terms.

35
Competitive Information – Discovery Information and Commercially Sensitive Terms.

36
Competitive Information – Discovery Information and Commercially Sensitive Terms.

37
Competitive Information – Discovery Information and Commercially Sensitive Terms.

38
Competitive Information – Discovery Information and Commercially Sensitive Terms.

 

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5.5          Development
Costs. Except for the costs and expenses incurred in Leap’s performance of Development activities under the Initial
Development Plan, BeiGene shall be solely responsible for the costs and expenses incurred by BeiGene in the Development of Licensed
Products in the Territory, including [***], not to exceed [***]without BeiGene’s prior written consent. In the event that
Leap and BeiGene agree to conduct Development activities or Clinical Trials that combine a Licensed Product with an Active Ingredient
Controlled by BeiGene, Leap and BeiGene will agree on [***].40

 

5.6          Development
Records. BeiGene shall maintain reasonably complete, current and accurate records of all Development activities conducted
by or on behalf of BeiGene, its Affiliates or its sublicensees pursuant to this Agreement and all data and other information resulting
from such activities, in each case in accordance with all Applicable Laws. BeiGene shall maintain such records during the Term
and for a period of time after the Term consistent with Applicable Laws and reasonable industry practices on record retention
and destruction (which shall not be less than [***]). Such records will be in English (or include complete English translations)
and shall fully and properly reflect all work done and results achieved by or on behalf of BeiGene in the performance of the Development
activities in the Territory hereunder, in good scientific manner appropriate for regulatory and patent purposes. BeiGene shall
document all non-clinical studies and Clinical Trials of the Licensed Product in formal written study reports in accordance with
Applicable Laws and national and international guidelines (e.g., GCP, GLP and GMP). Upon Leap’s request, BeiGene
shall, and shall cause its Affiliates and sublicensees to, provide Leap with copies of such records.41

 

5.7          Clinical
Trial Audits.

 

(a) Upon
reasonable notification by Leap and at Leap’s cost and expense, Leap or its representatives shall be entitled to conduct
an audit of any Clinical Trial sites engaged, or other facilities used, by BeiGene or its Affiliates or sublicensees to conduct
BeiGene’s obligations under the [***]. No later than [***] following the completion of any such audit, Leap will provide
BeiGene with a written summary of Leap’s findings, including any deficiencies or other areas of remediation that Leap reasonably
identifies during the audit, and the Parties shall promptly meet to discuss any such deficiencies or other areas of remediation
identified by Leap. BeiGene will use Commercially Reasonable Efforts to remediate such deficiencies promptly following BeiGene’s
receipt of such report.42

 

(b) BeiGene
will provide Leap with copies of all quality oversight or audit reports, including certified translations into English thereof,
prepared in connection with any audit that BeiGene, its Affiliates or sublicensees conduct of a Clinical Trial site that BeiGene,
its Affiliates or sublicensees have engaged or are evaluating to potentially engage to fulfill BeiGene’s obligations under
the Global Development Plan or the Territory Development Plan no later than [***] after receiving or preparing, as applicable,
any such report.43

 

 

 

39
Competitive Information – Discovery Information and Commercially Sensitive Terms.

40
Competitive Information – Commercially Sensitive Terms.

41
Competitive Information – Commercially Sensitive Terms.

42
Competitive Information – Discovery Information and Commercially Sensitive Terms.

 

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5.8          Development
Reports.

 

(a)         Prior
to exercise by BeiGene of the Option, Leap shall provide BeiGene with [***] written reports, [***], summarizing its, its Affiliates’
and its sublicensees’ Development of Licensed Products, including a summary of the results of such Development, which reports
shall be in English. Without limiting the foregoing, such reports shall contain sufficient detail to enable BeiGene to assess
Leap’s compliance with its Development obligations hereunder. Subject to BeiGene’s right to use and disclose data
and results in accordance with Section 5.9 and the licenses and rights granted to BeiGene in Section 2.2, such reports
shall be Confidential Information of BeiGene pursuant to Article 10.44

 

(b)         BeiGene
shall provide Leap with [***] written reports, [***], summarizing its, its Affiliates’ and its sublicensees’ Development
of Licensed Products, including a summary of the results of such Development, which reports shall be in English. Without limiting
the foregoing, such reports shall contain sufficient detail to enable Leap to assess BeiGene’s compliance with its Development
obligations hereunder. Subject to Leap’s right to use and disclose data and results in accordance with Section 5.9
and the licenses and rights to BeiGene IP and BeiGene Inventions granted to Leap in Section 2.5, such reports shall be Confidential
Information of BeiGene pursuant to Article 10. BeiGene shall promptly respond to Leap’s reasonable requests from time
to time for additional information regarding material Development activities. The Parties shall discuss the status, progress and
results of Development activities at JDC meetings, and Leap shall keep BeiGene reasonably informed through the JDC as to any material
developments with respect to the Development of Licensed Products outside the Territory.45

 

5.9          Data
Exchange and Use. In addition to its adverse event and safety data reporting obligations pursuant to Section 6.4, each
Party shall promptly (but in any event no later than [***] from the other Party’s request) provide the other Party with
copies of and access to all data and results, including all Clinical Data, and all supporting documentation (e.g. protocols, CRFs,
analysis plans) Controlled by such Party or its Affiliates that are generated by or on behalf of such Party or its Affiliates
or sublicensees, if applicable, in the Development of Licensed Products. BeiGene shall have the right to use and reference such
data and results provided by Leap, without additional consideration, for the purpose of obtaining and maintaining Regulatory Approval
and any pricing or reimbursement approvals, as applicable, of Licensed Products in the Field in the Territory. Leap and its designees
shall have the right to use and reference such data and results provided by BeiGene, without additional consideration, for the
purpose of Developing, manufacturing and Commercializing Licensed Products in accordance with the licenses granted under Section 2.5,
filing Patent Rights covering Leap Inventions and obtaining and maintaining Regulatory Approval and any pricing or reimbursement
approvals, as applicable, of Licensed Products outside of the Territory or outside the Field in the Territory. For clarity, any
such data or results that are Inventions will be owned in accordance with Section 14.1 and subject to the licenses, rights
and obligations set forth herein.46

 

 

 

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5.10        Subcontractors.

 

(a)         BeiGene
shall have the right to engage subcontractors for purposes of conducting activities assigned to it under this Agreement or for
which it is responsible under this Agreement, to the extent such subcontractors are set forth in the Territory Development Plan
or the Global Development Plan. BeiGene shall cause any subcontractor engaged by it to be bound by written obligations of confidentiality
and non-use consistent with this Agreement prior to performing any activities. BeiGene shall cause its subcontractors to assign
to BeiGene (or, in the case of academic institutions and Third Party manufacturers, use reasonable efforts to cause such subcontractor
to so assign) all intellectual property made by such subcontractor in the course of performing such subcontracted work. BeiGene
shall remain directly responsible for any obligations under this Agreement that have been delegated or subcontracted to any subcontractor
and shall be directly responsible for the performance of its subcontractors.

 

(b)      Leap
may conduct any activities assigned to it under the Global Development Plan or this Agreement, through one or more Affiliate or
Third Party designees.

 

Article 6

REGULATORY

 

6.1     Regulatory
Responsibilities; Holder of Regulatory Approvals and Regulatory Submissions. After exercise of the Option and payment of the
Option Exercise Fee, BeiGene shall have the sole responsibility, [***], for the conduct of all regulatory activities in Field
in the Territory that are necessary or useful to obtain Regulatory Approval for Licensed Products, including, without limitation,
(i) developing regulatory plans and strategies in support of obtaining such Regulatory Approval, and (ii) preparing,
obtaining, submitting, engaging and maintaining Regulatory Submissions with Regulatory Authorities in the Territory in furtherance
of such Regulatory Approval. BeiGene shall be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products
in the Field in the Territory. Leap shall reasonably cooperate with BeiGene, [***], to enable BeiGene to obtain any or all such
Regulatory Approvals and Regulatory Submissions in the Field in the Territory.47

 

6.2     Review
of Regulatory Submissions.

 

(a)     BeiGene
shall provide to Leap all Regulatory Submissions (including certified English translations thereof) prepared by or on behalf of
BeiGene at least [***] prior to submission and shall consider in good faith any reasonable comments received from Leap with respect
thereto.48

 

(b)     In
addition, each Party shall notify the other Party of any comments or other correspondence regarding any Regulatory Submissions
that are received from any Regulatory Authority in the Territory or, with respect to Multi-Regional Clinical Trials outside the
Territory, and shall provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [***]
of receipt (or such longer time period as may be necessary to obtain translations thereof). Each Party will provide [***] updates,
[***], regarding its activities and progress with respect to all Clinical Trials of the Licensed Product.49

 

(c)     Each
Party shall keep the other Party reasonably informed of regulatory developments related to Licensed Products in the Field in the
Territory and outside the Territory of which it becomes aware and shall promptly notify the other Party in writing of any material
decision by any Regulatory Authority in the Field, in the Territory and outside the Territory, of which it becomes aware regarding
any Licensed Product.

 

 

 

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(d)         Each
Party shall provide the other Party with notice no later than [***] after receiving notice of any meeting or discussion with any
Regulatory Authority in the Territory related to any Licensed Product in the Field. Each Party shall provide the other Party with
a written summary of each such meeting or discussion in English promptly following such meeting or discussion.50

 

6.3          Right
of Reference. Each Party hereby grants to the other Party the right of reference to all Regulatory Submissions pertaining
to Licensed Products in the Field submitted by or on behalf of such Party or its Affiliates, solely to the extent reasonably necessary
for the purposes set forth in this Section 6.3 and requested by such other Party. BeiGene may use such right of reference
to Leap’s Regulatory Submissions solely for the purpose of seeking, obtaining and maintaining Regulatory Approval and any
pricing or reimbursement approvals, as applicable, of Licensed Products in the Field in the Territory. Leap may use the right
of reference to BeiGene’s Regulatory Submissions and Regulatory Approvals solely for the purpose of seeking, obtaining and
maintaining regulatory approval of Licensed Products outside the Territory and with respect to Multi-Regional Clinical Trials
in the Territory. The Party requesting such right of reference shall bear the reasonable costs and expenses of the other Party
associated with providing the right of reference pursuant to this Section 6.3. Each Party will take such actions as may be
reasonably requested by the other Party to give effect to the intent of this Section 6.3 and to give the other Party the
benefit of the rights of reference to the granting Party’s Regulatory Submissions in the other Party’s territory as
provided herein.

 

6.4          Adverse
Events Reporting. Within [***] after the Effective Date, and in no case [***], BeiGene and Leap shall develop and agree in
a written agreement to worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed Products, such
as safety data sharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance
Agreement”).51

 

6.5          Safety
and Regulatory Inspections. BeiGene shall promptly notify Leap of any inspection of BeiGene, its Affiliates, CMOs, sublicenses
or subcontractors (including Clinical Trial sites) by any Regulatory Authority relating to Licensed Products and shall provide
Leap with all information in BeiGene’s Control pertinent thereto. Without limiting the foregoing, BeiGene shall permit Regulatory
Authorities outside the Territory to conduct inspections of BeiGene, its Affiliates, CMOs, sublicenses or subcontractors (including
Clinical Trial sites) relating to Licensed Products, and shall ensure that such Affiliates, sublicensees and subcontractors permit
such inspections. Leap shall have the right, but not the obligation, to be present at and participate in any such inspection described
in this Section 6.5 [***]. BeiGene will provide Leap with a written summary in English of any findings of a Regulatory Authority
relating to Licensed Products following a regulatory audit within [***] following any such audit, and will provide Leap with an
unredacted copy of any report issued by such Regulatory Authority, including if applicable, a certified English translation thereof
[***] following such audit.52

 

6.6          No
Harmful Actions. If either Party reasonably believes that the other Party is taking or intends to take any action with respect
to a Licensed Product in such other Party’s territory that would reasonably be expected to have a material adverse impact
upon the regulatory status of any Licensed Product in the Field in such Party’s territory, then such Party shall have the
right to bring the matter to the attention of the JDC, and the Parties shall discuss in good faith a resolution to such concern.
Without limiting the foregoing, unless the Parties otherwise agree (or unless otherwise set forth herein or in the Global Development
Plan or Territory Development Plan): (a) neither Party shall communicate with any Regulatory Authority having jurisdiction
outside of its respective territory with respect to any Licensed Product, unless required by such Regulatory Authority, in which
case such Party shall notify the other Party of such order within [***] of such communication; and (b) neither Party shall
submit any Regulatory Submissions or seek regulatory approvals for any Licensed Product in the other Party’s respective
territory.53

 

 

 

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6.7     Notice
of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect
to any activity of BeiGene relating to the Licensed Product, then BeiGene shall notify Leap of such notice within [***] of its
receipt thereof. Leap shall have the right to review and comment on any responses to Regulatory Authorities that pertain to a
Licensed Product promptly and in any event [***] of receipt of such proposed response. BeiGene will [***] to a Licensed Product
in the Territory if BeiGene is the holder of Regulatory Approvals and Regulatory Submissions for such Licensed Product in the
Territory and will [***]. The costs and expenses of any regulatory action in the Territory will be borne by BeiGene. In addition,
each Party shall promptly notify the other Party of any information it receives regarding any threatened or pending action, inspection
or communication by or from a Third Party that, in the case of notice to Leap, would reasonably be expected to materially affect
the Development or Commercialization of the Licensed Products, and in the case of notice to BeiGene, would reasonably be expected
to materially affect the Development or Commercialization of the Licensed Products in the Field in the Territory.54

 

Article 7.

MANUFACTURING

 

7.1     Manufacture
of Licensed Product for the Territory. Subject to the terms and conditions of this Article 7 and only after BeiGene’s
exercise of the Option and payment of the Option Exercise Fee, BeiGene shall have the right to (a) purchase Development supply
of Licensed Product from Leap or its Affiliates or Leap’s CMO pursuant to the Clinical Supply Agreement, or (b) exercise
its license under Section 2.2 to manufacture commercial supply of Licensed Product for the Territory itself or have such
Licensed Product manufactured by a Third Party CMO in the Territory agreed upon by the Parties, in each case after successful
completion of the Manufacturing Technology Transfer.

 

7.2     Manufacturing
Technology Transfer. In addition to the Licensed Know-How provided to BeiGene pursuant to the Initial Know-How Transfer, upon
BeiGene’s written request and approximately [***] in advance of the date on which BeiGene intends to commence manufacture
of Licensed Product, Leap will promptly prepare and submit to the JDC, for its review, a plan (“Manufacturing Technology
Transfer Plan”) for the transfer to BeiGene of all Know-How Controlled by Leap with respect to the Manufacture of Licensed
Product (“Leap Manufacturing IP”), and the conduct by Leap of such consultation activities, [***] (as provided
in this Section 7.2), as are necessary to enable BeiGene or any Third Party contract manufacturing organization (the “CMO”)
designated by BeiGene and reasonably acceptable to Leap, such acceptance not to be unreasonably withheld, to manufacture for the
Territory (a) the Licensed Antibody as the Active Ingredient of the applicable Licensed Product and/or (b) the applicable
Licensed Product (such actions, “Manufacturing Technology Transfer”). Following the review and approval by
the JDC of the Manufacturing Technology Transfer Plan, Leap will perform (or cause one or more applicable Third Parties (including,
as applicable, any CMO engaged by Leap to manufacture the Licensed Product) to perform) [***] in accordance with such Manufacturing
Technology Transfer Plan to either BeiGene or to a CMO designated by BeiGene, [***]. Leap will complete the Manufacturing Technology
Transfer for each Licensed Product promptly (and in any event within [***] after agreement by the Parties with respect to the
Manufacturing Technology Transfer Plan and the CMO to receive such transfer, as applicable) following BeiGene’s request
and in accordance with the Manufacturing Technology Transfer Plan. Thereafter during the Term, Leap will provide BeiGene with
additional Leap Manufacturing IP as part of the Continuing Know-How Transfer in accordance with Section 4.1. After completion
of the Manufacturing Technology Transfer to a facility, the use of such facility to manufacture the Licensed Product shall be
subject to the successful completion of any necessary inspections required by applicable Regulatory Authorities. BeiGene may use
Licensed Product manufactured at its facilities or those of the CMO to which the Manufacturing Technology Transfer is made, for
clinical or commercial purposes in the Territory. All Licensed Product manufactured by or on behalf of BeiGene or its CMO shall
be manufactured in compliance with all Applicable Laws and applicable specifications for the Licensed Product. Leap will invoice
BeiGene for any expenses for technology transfer activities under this Section 7.2 [***], for up to [***] for a period of
up to [***], at a rate of [***], prorated to $[***], assuming [***]. BeiGene’s liability for technology transfer activities
under this Section 7.2 will in no event exceed [***] in total.55

 

 

 

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7.3          Clinical
Supply by Leap.

 

(a)         Subject
to, and in accordance with, the terms of this Section 7.3, Leap shall use Commercially Reasonable Efforts, either by itself
or through a Third Party contract manufacturer, to manufacture and supply to BeiGene all Licensed Products required by BeiGene
for Development use in the Territory. Subject to Section 7.2, the Parties shall use Commercially Reasonable Efforts to enter
into an agreement governing the supply by Leap of such Licensed Products for such Development use by BeiGene (“Clinical
Supply Agreement”) within [***] after the Effective Date:56

 

(i)     Leap
shall supply the Licensed Products pursuant to the Clinical Supply Agreement and this Section 7.3(a) at a transfer price
[***]. Leap shall invoice BeiGene for the Licensed Product upon delivery in accordance with Section 7.3(a)(ii) and BeiGene
shall, subject to the terms of the Clinical Supply Agreement, pay the undisputed invoiced amounts within [***] after the date
of such invoice. Notwithstanding the foregoing, in the event Leap incurs [***], Leap may invoice BeiGene for such fee or charge,
[***] and BeiGene shall, pay such invoiced amounts within [***] after the date of such invoice.57

 

(ii)     Delivery
of Licensed Products supplied by Leap for Development will be made [***]. BeiGene shall be responsible for [***]. BeiGene shall
also be responsible for [***].58

 

7.4          Commercial
Supply. BeiGene will be responsible for commercial supply of Licensed Products in the Territory. Upon BeiGene’s request,
Leap will assist BeiGene in negotiating in good faith and executing, a manufacturing and supply agreement pursuant to which Leap’s
Third Party CMO engaged by Leap for the commercial manufacture of the Licensed Products will supply BeiGene with its requirements
of Licensed Products for commercial sale on an exclusive basis in the Territory. BeiGene acknowledges that any agreement regarding
the terms of a manufacturing and supply agreement shall be solely determined by BeiGene and the Third Party CMO and that Leap
shall have no responsibility or authority with respect thereto.

 

 

 

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Article 8

COMMERCIALIZATION

 

8.1          Commercialization
Responsibility.

 

(a)         BeiGene
shall be solely responsible for Commercializing the Licensed Products in the Field in the Territory in accordance with this Article 8
and shall book all sales of such Licensed Product in the Territory. BeiGene shall use Commercially Reasonable Efforts to Commercialize
each Licensed Product that obtains Regulatory Approval in the Field in each country or region in the Territory. BeiGene shall
conduct all Commercialization of Licensed Products in the Field in the Territory in accordance with the Commercialization Plan
for such Licensed Product and all Applicable Laws, [***].59

 

(b)         As
between the Parties, Leap shall have the sole right to Commercialize each Licensed Product outside of the Territory, and to book
all such sales of Licensed Product.

 

8.2          Commercialization
Reports. For [***] following receipt of the first Regulatory Approval for any Licensed Product in any country or region in
the Territory, BeiGene shall provide to Leap [***] within [***] after the end of such [***] a written report that summarizes the
Commercialization activities on a Licensed Product-by-Licensed Product and country-by-country or region-by-region basis, as applicable,
performed by or on behalf of BeiGene, its Affiliates and sublicensees in the Territory since the prior report provided by BeiGene
and shall propose amendments to update to the Commercialization Plan to reflect any changes in such plan. Such reports shall be
Confidential Information of BeiGene, subject to Article 10. BeiGene shall provide updates to any such report or amended Commercialization
Plan at each meeting of the JCC for review and discussion.60

 

8.3          Coordination
of Commercialization Activities.

 

(a)         The
Parties recognize that they may benefit from the coordination of certain activities in support of the Commercialization of Licensed
Products in and outside the Territory. As such, the Parties shall coordinate such activities where appropriate, which may include
[***]. To facilitate coordination, BeiGene shall deliver an initial draft of a Commercialization Plan to the JCC for its review
and discussion not later than [***] to the anticipated date of the first filing of the first Regulatory Approval for a Licensed
Product in the Territory. The Commercialization Plan shall contain in reasonable detail the major Commercialization activities
planned for such Licensed Product in the Territory. Leap shall have the right to comment through the JCC on such Commercialization
Plan.61

 

(b)         BeiGene
shall keep Leap timely informed on the status of any application for pricing or reimbursement approval for Licensed Products in
the Field in the Territory, including any discussion with the applicable Regulatory Authority with respect thereto. Each Party
shall have the right to determine the price of Licensed Products sold in its territory and neither Party shall have the right
to direct, control or approve the pricing of Licensed Products sold by the other Party in such other Party’s territory.

 

8.4          Diversion.
Each Party covenants and agrees that it shall not, and shall ensure that its Affiliates and sublicensees shall not, either
directly or indirectly, promote, market, distribute, import, sell or have sold any Licensed Products, including via the Internet
or mail order, to any Third Party or to any address or Internet Protocol address or the like in the other Party’s territory;
provided that each Party shall have the right to attend conferences and meetings of congresses in the other Party’s
territory and to promote and market Licensed Products to Third Party attendees at such conferences and meetings, subject to this
Section 8.4 and coordination through the JCC. Neither Party shall engage, nor permit its Affiliates or sublicensees to engage,
in any advertising or promotional activities relating to any Licensed Products for use directed primarily to customers or other
buyers or users of Licensed Products located in any country or jurisdiction in the other Party’s territory, or solicit orders
from any prospective purchaser located in any country or jurisdiction in the other Party’s territory. If a Party or its
Affiliate or sublicensee receives any order for Licensed Products for use from a prospective Third Party purchaser located in
a country or jurisdiction in the other Party’s territory, such Party shall immediately refer that order to such other Party
and shall not accept any such orders. Subject to Article 7, neither Party shall, nor permit its Affiliates or sublicensees
to, deliver or tender (or cause to be delivered or tendered) any Licensed Products for use in the other Party’s territory.

 

 

 

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Article 9

PAYMENTS

 

9.1          Option
Fee; Upfront Fee.

 

(a)          In
partial consideration of Leap’s granting of the Option to BeiGene hereunder and Leap’s undertaking of the activities
required under this Agreement, BeiGene shall pay to Leap a one-time, non-refundable non-creditable upfront payment of three million
U.S. dollars (USD 3,000,000) (the “Upfront Payment”) within [***] following the Effective Date.62

 

(b)         In
partial consideration of Leap’s granting of the licenses and rights to BeiGene hereunder and Leap’s undertaking of
the activities required under this Agreement, BeiGene shall pay to Leap a one-time, non-refundable non-creditable upfront payment
of [***] U.S. dollars (USD [***]) (the “Option Exercise Fee”) within [***] following BeiGene’s exercise
of the Option.63

 

9.2          Development
Milestones. Within [***]after the achievement of each milestone event set forth in the table below for each applicable Licensed
Product (each, a “Development Milestone Event”), BeiGene shall make the corresponding milestone payment to
Leap (each, a “Development Milestone Payment”) in accordance with Section 9.4(a). Each Development Milestone
Payment shall be payable [***] of the corresponding Development Milestone Event for the first Licensed Product to achieve such
Development Milestone Event.64

 

	 Milestone
    Event65	Milestone
    Payment66
	Development
    Milestones Events
	 
	Milestone
    Event	Milestone
    Payment (M)
	1.[***]	USD
    [***]
	2.[***]	USD
    [***]
	3.[***]	USD
    [***]
	4.[***]	USD
    [***]
	5.[***]	USD
    [***]

 

 

 

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64
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9.3          Commercialization
Milestones. Upon the [***] of each milestone event set forth in the table below with respect to the first Licensed Product
to achieve such milestone (each, a “Commercialization Milestone Event”), BeiGene shall make the corresponding
milestone payment to Leap (each, a “Commercialization Milestone Payment”) in accordance with Section 9.4(b):67

 

	Milestone
    Event68	Milestone
    Payment69
	Commercial
    Milestones Events
	1.[***]	USD
    [***]
	2.[***]	USD
    [***]
	3.[***]	USD
    [***]
	4.[***]	USD
    [***]

 

For
clarity, each of the foregoing Commercialization Milestone Payments will be payable only [***]. In the event that [***], BeiGene
shall pay Leap [***]. For example, if [***], BeiGene shall pay Leap USD [***] in Commercialization Milestone Payments pursuant
to this Section 9.3.70

 

9.4     Payment
Terms.

 

(a)          Milestone
Payments. BeiGene shall provide Leap with notice of the achievement of each Development Milestone Event within [***] thereafter.
Leap will invoice BeiGene for the corresponding Development Milestone Payment, and BeiGene will make the corresponding Development
Milestone Payment within [***] after receipt of Leap’s invoice.71

 

(b)         Commercialization
Milestone Payments and Royalty Payments. During the Term, following the First Commercial Sale of a Licensed Product, BeiGene
shall furnish to Leap a written report for each Calendar Quarter showing the Net Sales by Licensed Product sold by BeiGene and
its Affiliates and sublicensees during the reporting Calendar Quarter and the Licensed Product royalties payable under this Agreement
in sufficient detail to allow Leap to verify the amount of Licensed Product royalties paid by BeiGene with respect to such Calendar
Quarter. Each such report shall include, [***], and shall specify [***]. Reports shall be due no later than [***] following the
end of each Calendar Quarter. The corresponding Commercialization Milestone Payment(s) and Licensed Product royalties shown
to have accrued by each report provided under this Section 9.4(b) shall be due and payable [***].72

 

 

 

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9.5          Royalty
Payments to Leap.

 

(a)      Royalty
Rates. In further consideration of Leap’s grant of the rights and licenses to BeiGene hereunder, BeiGene shall, during
each applicable Royalty Term, pay to Leap a tiered royalty on aggregate Net Sales of Licensed Products in the Territory for each
Calendar Year (“Annual Net Sales”), at the percentage rates set forth below (subject to Section 9.5(c)):

 

	For
    Annual Net Sales of Licensed Products73	Royalty
    Rate (%)74
	[***]	[***]
	[***]	[***]
	[***]	[***]
	[***]	[***]
	[***]	[***]
	[***]	[***]
	[***]	[***]

 

By
way of illustration, assume in a Calendar Year that (i) Annual Net Sales of Licensed Product in the Territory in US Dollars
total [***] US Dollars ($[***]) and (ii) no adjustments or deductions to payments under Section 9.5(c) apply. The
total royalties due and payable by BeiGene to Leap for such Net Sales would be [***] US Dollars ($[***]), calculated as follows:75

 

$[***]   x
[***]% =     $[***]76

 

$[***]  
x [***]% =     $[***]77

 

$[***]  
x [***]% =     $[***]78

 

$[***]  
x [***]% =     $[***]79

 

	 	$[***]  
    x [***]% =     $[***]80	 

 

Total
Royalty =           $[***]81

 

 

 

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74
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75
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76
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77
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78
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(b)      Royalty
Term. BeiGene’s obligation to make royalty payments will commence on the date of First Commercial Sale of a Licensed
Product in each country in the Territory and continue until the later of (a) ten (10) years following the First Commercial
Sale of such Licensed Product in such country, (b) the expiration of the last-to-expire Valid Claim of any Licensed Patent
Rights that Covers such Licensed Product or its use in such country, or (c) the expiration of Regulatory Exclusivity for
such Licensed Product in such country (the “Royalty Term”).

 

(c)      Royalty
Reductions.

 

 (i)          No
Valid Claim. Subject to Section 9.5(c)(iv), on a Licensed Product-by-Licensed Product and country by country basis, if
there is no Valid Claim within the Licensed Patent Rights that Covers such Licensed Product in a given country in the Territory
and there is no Regulatory Exclusivity for such Licensed Product in such country, then, commencing in the first Calendar Quarter
after the date on which this Section 9.5(c)(i) applies and continuing for each Calendar Quarter thereafter for so long
as there is no Valid Claim that Covers such Licensed Product in such country and there is no Regulatory Exclusivity for such Licensed
Product in such country, the applicable royalty rate that would otherwise be owed on such Net Sales of such Licensed Product in
such country under Section 9.5(a) during any such Calendar Quarter will be reduced by [***] of the rates set forth in
Section 9.5(a).82

 

 (ii)        Biosimilar
Product. If (A) a Licensed Product is generating Net Sales in the Field in a country in the Territory during the applicable
Royalty Term at a time when a Biosimilar Product with respect to such Licensed Product is being sold in such country; and (B) the
market share of the Biosimilar Product(s) in such country [***], then, subject to Section 9.5(c)(iv), the royalty rate
applicable to Net Sales of such Licensed Product in such country in such Calendar Quarter shall be reduced by [***].83

 

 (iii)        Third
Party Payments. If during the Term BeiGene reasonably determines that a license under any Patent Rights controlled by a Third
Party is necessary to avoid infringement of such Patent Rights (including any infringement that may arise from issuance of any
patent application among such Patent Rights) arising from the practice and use of the Licensed IP pursuant to this Agreement in
connection with the manufacture, Development or Commercialization of any Licensed Product in the Field in the Territory, BeiGene
will have the right to acquire rights to such Patent Rights from such Third Party to manufacture, Develop or Commercialize any
such Licensed Product in the Field in the Territory and, subject to Section 9.5(c)(iv), on a Licensed Product-by-Licensed
Product and country by country basis, during any Calendar Quarter, BeiGene may credit against the royalty payments payable to
Leap pursuant to Section 9.5(a) with respect to such Licensed Product in such country in such Calendar Quarter up to
[***] of any upfront payments, milestone payments and royalty payments for which BeiGene is responsible to such Third Party under
the definitive agreement pursuant to which BeiGene acquired rights to such Patent Rights from such Third Party.84

 

 (iv)        Royalty
Floor. In no event will the aggregate amount of royalty payments due to Leap pursuant to this Section 9.5 with respect
to Net Sales for a Licensed Product in a country in the Territory in any given Calendar Quarter during the Royalty Term for such
Licensed Product in such country be reduced (after giving cumulative effect to all reductions provided for under this Section 9.5(c))
to an amount of royalty payments that would be less than [***]; provided, that, BeiGene will be entitled to carry forward
to future Calendar Years any amounts with respect to which BeiGene would have been entitled to make a deduction pursuant to this
Section 9.5(c) but for such maximum annual reduction pursuant to this Section 9.5(c)(iv).85

 

 

 

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9.6          Payments
to Third Parties. Except as expressly set forth herein, each Party shall be solely responsible for any payments due to Third
Parties under any agreement entered into by such Party with respect to the Licensed Product, as a result of activities hereunder.
Without limiting the foregoing, Leap will be solely responsible for any payments due pursuant to the Third Party In-License Agreement.

 

9.7          Payment
Currency; Exchange Rate. All payments to be made under this Agreement shall be made in USD. Payments to Leap shall be made
by electronic wire transfer of immediately available funds to the account of Leap, as designated in writing to BeiGene. If any
currency conversion is required in connection with the calculation of amounts payable hereunder, such conversion shall be made
in a manner consistent with BeiGene’s normal practices used to prepare its audited financial statements for external reporting
purposes; provided that such practices use a widely accepted source of published exchange rates.

 

9.8           Timing
of Royalty Payments. Royalties payable under Section 9.5(a) shall accrue at the time the invoice for the sale of
the Licensed Product is delivered. Royalty obligations that have accrued during a particular Calendar Quarter shall be paid, on
a Calendar Quarter basis, within [***] after the end of each Calendar Quarter during which the royalty obligation accrued, following
the submission of the royalty report for such Calendar Quarter.86

 

9.9          Late
Payments. Any payments or portions thereof due hereunder that are not paid on the date such payments are due under this Agreement
shall bear interest at a rate equal to the lesser of: (a) [***] percentage points above the prime rate as published by The
Wall Street Journal or any successor thereto on the first day of each Calendar Quarter in which such payments are overdue
or (b) the maximum rate permitted by Applicable Laws; in each case calculated on the number of days such payment is delinquent,
[***].87

 

9.10        Records
and Audit Rights.

 

(a)          Records.
BeiGene will keep (and will cause its Affiliates and sublicensees to keep) complete, true and accurate books and records in sufficient
detail for Leap to determine payments due to Leap under this Agreement, including Licensed Product royalty payments. BeiGene will
keep such books and records for at least [***] following the end of the Calendar Year to which they pertain.88

 

(b)          Audit
Rights.

 

(i)          Leap
shall have the right during the [***] period described in Section 9.10(a) to (a) appoint at its expense an independent
certified public accountant of nationally recognized standing (the “Accounting Firm”) reasonably acceptable
to BeiGene to audit the relevant records of BeiGene and its Affiliates to verify that the amount of such payments were correctly
determined and/or (b) require BeiGene to (i) appoint such an Accounting Firm to conduct such an audit of the applicable
sublicensee and (ii) provide the results of such audit to Leap. BeiGene and its Affiliates shall each make its records available
for audit by the Accounting Firm during regular business hours at such place or places where such records are customarily kept,
upon reasonable notice from Leap, solely to verify the payments hereunder were correctly determined. Such audit right shall not
be exercised by Leap more than [***] nor more than once with respect to sales of a particular Licensed Product in a particular
period and may cover a period ending not more than [***] prior to the date of such request. All records made available for audit
pursuant to this Section 9.10(b) shall be deemed to be Confidential Information of BeiGene. The results of each audit,
if any, shall be binding on both Parties. If the amount of any payment hereunder was underreported, BeiGene shall promptly (but
in any event no later than [***] after its receipt of the Accounting Firm’s report so concluding) make payment to Leap of
the underreported amount. Leap shall bear the full cost of an audit that it conducts pursuant to this Section 9.10(b) unless
such audit discloses an under reporting by BeiGene of more than [***] percent ([***]%) of the aggregate amount of the payments
hereunder reportable in any Calendar Year, in which case BeiGene shall reimburse Leap for the reasonable audit fees for such audit,
in addition to paying the underreported amount.89

 

 

 

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Competitive Information – Financial Provisions and Commercially Sensitive Terms.

86
Competitive Information – Commercially Sensitive Terms.

87
Competitive Information – Commercially Sensitive Terms.

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Competitive Information – Commercially Sensitive Terms.

 

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(ii)         The
Accounting Firm will disclose to Leap only whether the payments subject to such audit are correct or incorrect and the specific
details concerning any discrepancies. No other information regarding the results of such audit will be provided to Leap without
the prior consent of BeiGene. BeiGene is entitled to require the Accounting Firm to execute a reasonable confidentiality agreement
prior to commencing any such audit. The Accounting Firm shall provide a copy of its report and findings to BeiGene.

 

9.11        Taxes
and Blocked Currency

 

(a)          Taxes.
Each Party shall be responsible for its own tax liabilities arising under this Agreement. Subject to this Section 9.11,
Leap shall be liable for all of its income and other taxes (including interest) (“Taxes”) imposed upon any
payments made by BeiGene to Leap under this Agreement (“Agreement Payments”). If Applicable Laws require the
withholding of Taxes, BeiGene shall make such withholding payments in a timely manner and shall subtract the amount thereof from
the Agreement Payments. BeiGene shall promptly (as available) submit to Leap appropriate proof of payment of the withheld Taxes
as well as the official receipts within a reasonable period of time. BeiGene shall provide Leap reasonable assistance in order
to allow Leap to obtain the benefit of any present or future treaty against double taxation or refund or reduction in Taxes which
may apply to the Agreement Payments. [***].90

 

(b)         Blocked
Currency. If by Applicable Law in a country or region in the Territory, conversion into USD or transfer of funds of a convertible
currency to the United States becomes materially restricted, forbidden or substantially delayed, then BeiGene shall promptly notify
Leap and, thereafter, amounts accrued in such country or region under this Article 9 shall be paid to Leap (or its designee)
in such country or region in local currency by deposit in a local bank designated by Leap and to the credit of Leap, unless the
Parties otherwise agree.

 

Article 10

CONFIDENTIALITY

 

10.1     Duty
of Confidence. During the Term and for [***] thereafter, all Confidential Information disclosed by a Disclosing Party to a
Receiving Party hereunder, including (a) with respect to BeiGene as Receiving Party, Licensed Know-How and (b) with
respect to Leap as Receiving Party, BeiGene IP, shall be maintained in confidence by the Receiving Party and shall not be disclosed
to any Third Party or used for any purpose, except as set forth herein, without the prior written consent of the Disclosing Party;
provided, however, that with respect to any Confidential Information that is specifically identified at the time
of disclosure to be a trade secret under Applicable Laws, such obligations shall survive the expiration of such [***] period for
so long as such Confidential Information remains a trade secret. The Receiving Party may only use Confidential Information of
the Disclosing Party for purposes of exercising its rights and fulfilling its obligations under this Agreement and may disclose
Confidential Information of the Disclosing Party and its Affiliates to employees, agents, contractors, consultants and advisers
of the Receiving Party and its Affiliates, licensees and sublicensees to the extent reasonably necessary for such purposes; provided
that such persons and entities are bound by confidentiality and non-use of the Confidential Information consistent with the
confidentiality provisions of this Agreement as they apply to the Receiving Party.91

 

 

 

89
Competitive Information – Commercially Sensitive Terms.

90
Competitive Information – Financial Provisions and Commercially Sensitive Terms.

 

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10.2        Exceptions.
The obligations under this Article 10 shall not apply to any information to the extent the recipient Party can demonstrate
by competent evidence that such information:

 

(a)          is
(at the time of disclosure) or becomes (after the time of disclosure) known to the public or part of the public domain through
no breach of this Agreement by the Receiving Party or its Affiliates;

 

(b)         was
known to, or was otherwise in the possession of, the Receiving Party or its Affiliates prior to the time of disclosure by the
Disclosing Party;

 

(c)          is
disclosed to the Receiving Party or an Affiliate on a non-confidential basis by a Third Party that is entitled to disclose it
without breaching any confidentiality obligation to the Disclosing Party or any of its Affiliates; or

 

(d)         is
independently developed by or on behalf of the Receiving Party or its Affiliates, as evidenced by its written records, without
use of or reference to the Confidential Information disclosed by the Disclosing Party or its Affiliates under this Agreement.

 

10.3        Authorized
Disclosures. Subject to this Section 10.3, the Receiving Party may disclose Confidential Information belonging to the
other Party to the extent permitted as follows:

 

(a)         such
disclosure is deemed necessary by counsel to the Receiving Party to be disclosed to such Receiving Party’s attorneys, independent
accountants or financial advisors for the sole purpose of enabling such attorneys, independent accountants or financial advisors
to provide advice to the Receiving Party, on the condition that such attorneys, independent accountants and financial advisors
are bound by confidentiality and non-use obligations consistent with the confidentiality provisions of this Agreement as they
apply to the Receiving Party;

 

(b)         disclosure
by a Receiving Party or its Affiliates to governmental or other regulatory agencies in order to obtain and maintain Patent Rights
consistent with Article 14;

 

(c)         disclosure
by a Receiving Party to any Affiliate, or to its or its Affiliates’ employees, consultants, contractors, subcontractors,
agents or sublicensees on a need-to-know basis in order to enable such Receiving Party to exercise its rights, or to carry out
its responsibilities, under this Agreement including, with respect to BeiGene as the Receiving Party, to any Third Party that
is engaged by BeiGene to perform services in connection with the Development, manufacture and/or Commercialization of the Licensed
Antibody and/or any Licensed Products in accordance with this Agreement; provided, in each case, that such persons and
entities are bound by confidentiality and non-use obligations consistent with those contained in this Agreement as they apply
to the Receiving Party;

 

(d)         disclosure
by BeiGene or a BeiGene Affiliate or sublicensee as reasonably necessary to gain or maintain approval to conduct Clinical Trials
for a Licensed Product, to obtain and maintain Regulatory Approval or to otherwise Develop, manufacture and Commercialize Licensed
Products in the Territory, in accordance with this Agreement;

 

 

 

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(e)         disclosure
by Leap or a Leap Affiliate or sublicensee as reasonably necessary to gain or maintain approval to conduct Clinical Trials for
a Licensed Product, to obtain and maintain Regulatory Approval or to otherwise Develop, manufacture and Commercialize Licensed
Products outside the Territory;

 

(f)          disclosure
by a Party required in connection with any judicial or administrative process relating to or arising from this Agreement (including
any enforcement hereof) or to comply with applicable laws, court orders or governmental regulations (or the rules of any
recognized stock exchange or quotation system); or

 

(g)         disclosure
by a Party to potential or actual investors or potential or actual acquirers or actual or potential sublicensees in connection
with due diligence or similar investigations by such Third Parties; provided, in each case, that any such potential or
actual investor or acquirer or sublicensee agrees to be bound by confidentiality and non-use obligations consistent with those
contained in this Agreement as they apply to the Receiving Party.

 

If
the Receiving Party is required by judicial or administrative process to disclose Confidential Information that is subject to
the non-disclosure provisions of this Article 10, such Receiving Party shall promptly inform the Disclosing Party of the
disclosure that is being sought in order to provide the Disclosing Party an opportunity to challenge or limit the disclosure obligations,
and, if requested by the Disclosing Party, cooperate in all reasonable respects with the Disclosing Party’s efforts to obtain
confidential treatment or a protective order with respect to any such disclosure, at the Disclosing Party’s expense. Confidential
Information that is disclosed as permitted by this Section 10.3 shall remain otherwise subject to the confidentiality and
non-use provisions of this Article 10, and the Party disclosing Confidential Information as permitted by this Section 10.3
shall take all steps reasonably necessary, including obtaining an order of confidentiality and otherwise cooperating with the
other Party, to ensure the continued confidential treatment of such Confidential Information.

 

Article 11

PUBLICATIONS & PUBLICITY

 

11.1        Publications.

 

(a)         BeiGene
acknowledges that some of the Clinical Trials in accordance with the Global Development Plan are part of Multi-Regional Clinical
Studies. Accordingly and notwithstanding anything to the contrary herein, BeiGene shall not publish or present the Clinical Trial
Results, Clinical Data, non-clinical data or any associated results or conclusions of any Clinical Trial from a Multi-Regional
Clinical Study until after the first publication or presentation regarding the overall global study is completed by Leap, such
publication to be at the sole discretion of Leap. Thereafter, BeiGene may publish or disclose Clinical Data, non-clinical data
or any associated results or conclusions of any Multi-Regional Clinical Study in the Territory in accordance with Section 11.1(b).

 

(b)         BeiGene
may publicly present or publish any Clinical Data, non-clinical data or any associated results or conclusions generated by or
on behalf of BeiGene pursuant to this Agreement solely to the extent that such data, results and conclusions are specific to the
Territory and the Field (each such proposed presentation or publication, a “BeiGene Publication”), and subject
to the additional limitations set forth in this Article 11. In the event BeiGene desires to publicly present or publish a
BeiGene Publication in accordance with the foregoing sentence, BeiGene shall provide Leap (including the JDC) with a copy of such
proposed BeiGene Publication at least [***] prior to the earlier of its presentation or intended submission for publication; provided
that in the case of abstracts, this period shall be at least [***] (such applicable period, the “Review Period”).
BeiGene agrees that it will not submit or present any BeiGene Publication (i) until Leap has provided written comments during
such Review Period on the material in such BeiGene Publication or (ii) until the applicable Review Period has elapsed without
written comments from Leap, in which case BeiGene may proceed and the BeiGene Publication will be considered approved in its entirety.
If BeiGene receives written comments from Leap during the applicable Review Period, it shall consider the comments of Leap in
good faith, but will retain the sole authority to submit the manuscript for BeiGene Publication; provided that BeiGene
agrees to (A) delete any Confidential Information of Leap that Leap identifies for deletion in Leap’s written comments,
(B) delete any Clinical Data, non-clinical data results, conclusions or other related information that is not specific to
the Territory or the Field, or the publication of which Leap reasonably determines, in its sole discretion, would conflict with
Leap’s global publication strategy or materially and adversely impact the Licensed Product, and (C) delay such BeiGene
Publication for a period of up to an additional [***] after the end of the applicable Review Period to enable Leap to draft and
file Patent Rights with respect to any subject matter to be made public in such BeiGene Publication and to which Leap has the
applicable intellectual property rights to file such Patent Rights. BeiGene shall provide Leap a copy of the BeiGene Publication
at the time of the submission or presentation. BeiGene agrees to acknowledge the contributions of Leap, and the employees of Leap,
in all BeiGene Publications as scientifically appropriate. BeiGene shall require its Affiliates, sublicensees and contractors
to comply with the obligations of Section 11.1.92

 

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(c)         Without
limiting Section 11.1(a), Leap shall have the right to publicly present or publish any Clinical Trial Results or Clinical
Data, including non-clinical data or any results or conclusions associated therewith (each such proposed presentation or publication,
a “Leap Publication” and, collectively with any BeiGene Publication, a “Publication”), and
subject to the limitations set forth in this Section 11.1(c). In the event Leap desires to publicly present or publish a
Leap Publication that includes data from a Clinical Trial site in the Territory in accordance with the foregoing sentence, Leap
shall provide BeiGene (including the JDC) with a copy of such proposed Leap Publication consistent with the applicable Review
Period. Leap agrees that it will not submit or present any Leap Publication (i) until BeiGene has provided written comments
during such Review Period on the material in such Leap Publication or (ii) until the applicable Review Period has elapsed
without written comments from BeiGene, in which case Leap may proceed and the Leap Publication will be considered approved in
its entirety. If Leap receives written comments from BeiGene during the applicable Review Period, it shall consider the comments
of BeiGene in good faith, but will retain the sole authority to submit the manuscript for Leap Publication; provided that
Leap agrees to (A) delete any Confidential Information of BeiGene that BeiGene identifies for deletion in BeiGene’s
written comments and (B) delay such Leap Publication for a period of up to an additional [***] after the end of the applicable
Review Period to enable BeiGene to draft and file Patent Rights with respect to any subject matter to be made public in such Leap
Publication and to which BeiGene has the applicable intellectual property rights to file such Patent Rights. Leap shall provide
BeiGene a copy of the Leap Publication at the time of the submission or presentation. Leap agrees to acknowledge the contributions
of BeiGene, and the employees of BeiGene, in all Leap Publications as scientifically appropriate. Leap shall require its Affiliates,
sublicensees and contractors to comply with the obligations of this Section 11.1(c).93

 

(d)         Notwithstanding
anything to the contrary in this Section 11.1, the contents of any press release or other publication that has been reviewed
and approved by a reviewing Party in accordance with this Article 11 may be re-released by such reviewing Party or publishing
Party without a requirement for re-approval.

 

11.2        Attorney-Client
Privilege.     In the event of a dispute or potential dispute where the Parties: (a) share a
common legal and commercial interest in such disclosure that is subject to attorney work product protections, attorney-client
privileges or similar protections and privileges; (b) are or may become joint defendants in proceedings to which the information
covered by such protections and privileges relates; (c) intend that such privileges and protections remain intact should
either Party become subject to any actual or threatened proceeding to which the Disclosing Party’s Confidential Information
covered by such protections and privileges relates; and (d) intend that both the Receiving Party and the Disclosing Party
will have the right to assert such protections and privileges, the Parties may negotiate and enter into a common or joint defense
agreement. Notwithstanding the foregoing, nothing in this Section 11.2 will apply with respect to a Dispute between the Parties
(including their respective Affiliates).

 

 

 

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11.3        Publication
and Listing of Clinical Trials. Each Party agrees to comply, with respect to the listing of Clinical Trials or the publication
of Clinical Trial results with respect to Licensed Products and to the extent applicable to its activities conducted under this
Agreement, with (a) the Pharmaceutical Research and Manufacturers of America (PhRMA) Guidelines on the listing of Clinical
Trials and the Publication of Clinical Trial results, and (b) any Applicable Law or applicable court order, stipulations,
consent agreements and settlements entered into by such Party; provided that any listings or publications made pursuant
to this Section 11.3 shall be considered a Publication hereunder and shall be subject to Section 11.1.

 

11.4        Publicity.

 

(a)          The
Parties will agree to a joint press release with respect to this Agreement promptly after the Effective Date. Either Party may
make subsequent public disclosure of the contents of such press release. Subject to the foregoing, each Party agrees not to issue
any press release or other public statement, whether oral or written, disclosing the terms hereof or any of the activities conducted
hereunder without the prior written consent of the other Party (such consent not to be unreasonably withheld, conditioned or delayed),
provided, however, that neither Party will be prevented from complying with any duty of disclosure it may have pursuant
to Applicable Laws or pursuant to the rules of any recognized stock exchange or quotation system, subject to that Party notifying
the other Party of such duty and limiting such disclosure as reasonably requested by the other Party (and giving the other Party
sufficient time to review and comment on any proposed disclosure).

 

(b)         Notwithstanding
Section 11.4(a), to the extent required by Applicable Laws or by any Securities Regulator, Leap has the right to publicly
disclose (i) the achievement of material milestones under this Agreement, (ii) the amount of any payment received by
Leap under this Agreement, and (iii) the commencement, completion, material data and key results of Clinical Trials conducted
under this Agreement. After a publication has been made available to the public, each Party may post such publication or link
to it on its corporate website without the prior written consent of the other party.

 

(c)          The
Parties hereby acknowledge and agree that either Party may be required by Applicable Laws to submit a copy of this Agreement to
the U.S. Securities and Exchange Commission (the “SEC”) or any national or sub-national securities regulatory
body in any jurisdiction (collectively, the “Securities Regulators”). If a Party is required by Applicable
Laws to submit a description of the terms of this Agreement to and/or file a copy of this Agreement with any Securities Regulator,
such Party agrees to consult and coordinate with the other Party with respect to such disclosure and/or the preparation and submission
of a confidential treatment request for this Agreement. Notwithstanding the foregoing, if a Party is required by Applicable Laws
to submit a description of the terms of this Agreement to and/or file a copy of this Agreement with any Securities Regulator and
such Party has (a) promptly notified the other Party in writing of such requirement and any respective timing constraints,
(b) provided copies of the proposed disclosure or filing to the other Party reasonably in advance of such filing or other
disclosure and (c) given the other Party a reasonable time under the circumstances to comment upon and request confidential
treatment for such disclosure, then such Party will have the right to make such disclosure or filing at the time and in the manner
reasonably determined by its counsel to be required by Applicable Laws or the applicable Securities Regulator. If a Party seeks
to make a disclosure or filing as set forth in this Section 11.4(c) and the other Party provides comments within the
respective time periods or constraints specified herein, the Party seeking to make such disclosure or filing will in good faith
consider incorporating such comments.

 

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Article 12

REPRESENTATIONS, WARRANTIES, AND COVENANTS

 

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

 

(a)          it
is a corporation or limited company duly organized, validly existing, and in good standing under the laws of the jurisdiction
of formation;

 

(b)         it
has full corporate power and authority to execute, deliver, and perform this Agreement, and has taken all corporate action required
by Applicable Laws and its organizational documents to authorize the execution and delivery of this Agreement and the consummation
of the transactions contemplated by this Agreement;

 

(c)         this
Agreement constitutes a valid and binding agreement enforceable against it in accordance with its terms (except as the enforceability
thereof may be limited by bankruptcy, bank moratorium or similar laws affecting creditors’ rights generally and laws restricting
the availability of equitable remedies and may be subject to general principles of equity whether or not such enforceability is
considered in a proceeding at law or in equity); and

 

(d)         the
execution and delivery of this Agreement and all other instruments and documents required to be executed pursuant to this Agreement,
and the consummation of the transactions contemplated hereby do not and shall not (a) conflict with or result in a breach
of any provision of its organizational documents, (b) result in a breach of any agreement to which it is a party; or (c) violate
any Applicable Laws.

 

12.2        Representations
and Warranties of Leap. Leap represents and warrants to BeiGene as of the Effective Date that:

 

(a)         Schedule
12.2(a) sets forth a complete and accurate list of all Licensed Patent Rights Controlled by Leap as of the Effective
Date.

 

(b)         Leap
owns or is the exclusive licensee of all right, title, and interest in and to the Licensed Patent Rights set forth on Schedule
12.2(a);

 

(c)         Leap
has the right under the Licensed IP to grant the License to BeiGene, and it has not granted any license or other right under the
Licensed IP that is inconsistent with the License;

 

(d)         Neither
Leap nor any of its respective Affiliates has [***] any [***] of any kind on the Licensed Patent Rights or Licensed Know-How in
the Territory, and the Licensed Patent Rights and Licensed Know-How are [***] of any kind in the Territory, in each case that
would adversely affect the rights granted to BeiGene herein;94

 

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(e)         there
are no claims, judgments or settlements against Leap pending, or to Leap’s Knowledge, threatened that invalidate or seek
to invalidate any Licensed Patent Rights in the Territory;

 

(f)          Leap
is not a party to any agreement with any [***] or an [***] thereof pursuant to which such [***] or such [***] of any of the Licensed
Patent Rights or Licensed Know-How and which gives such [***] or such [***] to any Licensed Patent Rights or Licensed Know-How
that conflicts with, or limits the scope of, the License granted to BeiGene hereunder;95

 

(g)         there
is no pending litigation, nor has Leap received any written notice from any Third Party, asserting or alleging that the Development,
manufacture or Commercialization of the Licensed Product prior to the Effective Date infringed or misappropriated the intellectual
property rights of such Third Party;

 

(h)         to
Leap’s Knowledge, the Licensed IP is not the subject of any interference proceeding, inter partes review or post-grant
review and there is no pending or threatened action, suit, proceeding or claim by a Third Party challenging Leap’s ownership
rights in, or the validity or scope of, any Licensed IP in the Territory;

 

(i)           there
are no pending or, to its Knowledge, no threatened (in writing), adverse actions, suits or proceedings against Leap involving
the Licensed IP or Licensed Product;

 

(j)          to
its Knowledge, the Licensed IP includes all Know-How owned or licensed by Leap or its Affiliates that is necessary or reasonably
useful to Develop, manufacture and Commercialize the Licensed Antibody and/or Licensed Products in the Field in the Territory
as such Development, manufacture and Commercialization is currently being conducted by Leap or contemplated to be conducted by
the Parties hereunder;

 

(k)         to
its Knowledge, Leap has complied with all Applicable Laws applicable to (i) the prosecution and maintenance of the Licensed
Patent Rights and (ii) its Development and manufacture of Licensed Products in the Field;

 

(l)          to
its Knowledge, there are no acts or omissions of Leap that would constitute inequitable conduct, fraud, or misrepresentation to
the applicable patent office with respect to any Licensed Patent Rights;

 

(m)        (i) Leap
has obtained, or caused its Affiliates to obtain, assignments from the inventors of all rights and embodiments in and to the Licensed
IP that is solely owned by Leap or its Affiliates, (ii) to its Knowledge, all such assignments are valid and enforceable,
and (iii) the inventorship of the Licensed Patent Rights that are solely owned by Leap or its Affiliates is properly identified
on each issued patent or patent application in such Licensed Patent Rights;

 

(n)         Leap
and its Affiliates have used reasonable and diligent efforts consistent with industry practices to protect the secrecy, confidentiality
and value of all Licensed Know-How that constitutes trade secrets under Applicable Laws;

 

 

 

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(o)         Leap
has provided to BeiGene all material documentation, data, and information under its control requested by BeiGene relating to the
Licensed Antibody and the use thereof in the Field. Without limiting the foregoing, Leap has made available to BeiGene through
an electronic data room complete and accurate copies of (a) all existing material Regulatory Filings made by Leap or its
Affiliates (the “Existing Regulatory Materials”), and (b) all other material correspondence to/from any
Regulatory Authority and Leap, in each case related to the Licensed Antibody or any Licensed Product. Other than the Existing
Regulatory Materials, neither Leap nor any of its Affiliates has, as of the Effective Date, obtained, or filed, any INDs, CTAs
or any other form of regulatory application with Regulatory Approvals for approval of Clinical Trials, marketing or other purpose,
for the Licensed Antibody or any Licensed Product. The Existing Regulatory Materials are, to the Knowledge of Leap, in good standing,
and neither Leap nor any of its Affiliates has received any notice in writing from any Regulatory Authority that the Existing
Regulatory Materials are not currently in, or may not remain in, good standing with the applicable Regulatory Authority;

 

(p)         Leap
has provided to BeiGene all material adverse event information with respect to the Licensed Antibody or any Licensed Product Known
to Leap or its Affiliates;

 

(q)         all
information and data provided by or on behalf of Leap to BeiGene regarding the Licensed Antibody or Licensed Product on or before
the Effective Date in contemplation of this Agreement or the transactions contemplated hereby was and is as of the Effective Date,
to the Knowledge of Leap, accurate in all material respects, and, to the Knowledge of Leap, Leap has not failed to disclose, or
cause to be disclosed, any material information or data known to Leap that could reasonably be expected to cause the information
and data that has been disclosed by Leap to BeiGene to be misleading in any material respect; and

 

(r)          The
Third Party In-License Agreement is the only agreement by and between Leap and any Third Party that provides for the license to
Leap of any Know-How or Patent Rights that are included as part of the Licensed IP. Without limiting the generality of the foregoing,
the Third Party In-License Agreement is in full force and effect and is the valid and binding obligation of Leap, enforceable
in accordance with its terms and is binding on the parties thereto. Leap has not materially breached and is not currently in material
breach of its obligations under the Third Party In-License Agreement in a manner that has, or would reasonably be expected to
have, a material adverse effect on the rights granted to BeiGene under this Agreement, and to Leap’s Knowledge, the party
to the Third Party In-License Agreement has not materially breached, and is not currently in material breach of, its obligations
under the Third Party In-License Agreement.

 

12.3        Representations
and Warranties of BeiGene. BeiGene represents and warrants to Leap as of the Effective Date that: (a) BeiGene and its
Affiliates is not, and has not been, debarred or disqualified by any Regulatory Authority; and (b) none of BeiGene or its
Affiliates’ employees or contractors who will be involved in the Development, manufacture or Commercialization of the Licensed
Product are, or have been, debarred or disqualified by any Regulatory Authority.

 

12.4        Covenants
of BeiGene. BeiGene covenants to Leap that:

 

(a)          in
the course of performing its obligations or exercising its rights under this Agreement, BeiGene shall comply with all Applicable
Laws, including, as applicable, cGMP, GCP, and GLP standards, and shall not employ or engage any Person who has been debarred
by any Regulatory Authority or is the subject of debarment proceedings by a Regulatory Authority;

 

(b)         BeiGene
will only engage Clinical Trial sites under the Territory Development Plan and the Global Development Plan that conduct all Clinical
Trials in compliance with Applicable Laws, including GCP and the ICH Guidelines, and are approved by the NMPA or the applicable
Regulatory Authority;

 

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(c)         BeiGene
and its Affiliates’ will not use any employees or contractors in the Development, manufacture or Commercialization of the
Licensed Product who are, or have been, debarred or disqualified by any Regulatory Authority; and

 

(d)         except
as otherwise expressly permitted in this Agreement, commencing on the Effective Date and continuing until the end of the Term,
BeiGene and its Affiliates will not (i) assign or otherwise transfer ownership of any BeiGene Inventions outside the Territory,
except to the extent such assignment or transfer does not conflict with or adversely affect any of the licenses granted to Leap
hereunder, or (ii) grant to any Third Party any license rights to any BeiGene Inventions or BeiGene IP outside the Territory
if such license grant conflicts with any of the licenses granted to Leap hereunder.

 

12.5        Covenants
of Leap. Leap covenants to BeiGene that:

 

(a)         in
the course of performing its obligations or exercising its rights under this Agreement, Leap shall comply with all Applicable
Laws, including, as applicable, cGMP, GCP, and GLP standards, and shall not employ or engage any Person who has been debarred
by any Regulatory Authority or is the subject of debarment proceedings by a Regulatory Authority;

 

(b)         Leap
will only engage Clinical Trial sites under the Global Development Plan that conduct all Clinical Trials in compliance with Applicable
Laws, including GCP and the ICH Guidelines, and are approved by the applicable Regulatory Authority;

 

(c)         Leap
and its Affiliates will not use any employees or contractors in the Development or manufacture of the Licensed Product who are,
or have been, debarred or disqualified by any Regulatory Authority;

 

(d)         except
as otherwise expressly permitted in this Agreement, commencing on the Effective Date and continuing until the end of the Term,
Leap and its Affiliates will not (i) assign or otherwise transfer ownership of any Licensed Patent Rights or Leap Know-How
in the Territory, except to the extent such assignment or transfer does not conflict with or adversely affect any of the Licenses
granted to BeiGene hereunder, or (ii) grant to any Third Party any license rights to any Licensed Patent Rights or Leap Know-
How in the Territory if such license grant conflicts with any of the Licenses granted to BeiGene hereunder.

 

12.6        NO
OTHER WARRANTIES. EXCEPT AS EXPRESSLY STATED IN THIS Article 12, (A) NO
REPRESENTATION OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON BEHALF OF LEAP OR BEIGENE; AND (B) ALL OTHER REPRESENTATIONS,
AND WARRANTIES WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE ARE EXPRESSLY EXCLUDED, INCLUDING ANY REPRESENTATIONS AND
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.

 

12.7        Compliance
with Anti-Corruption Laws.

 

(a)          Notwithstanding
anything to the contrary in this Agreement, each Party agrees that:

 

(i)           it
shall not, in the performance of this Agreement, perform any actions that are prohibited by local and other anti-corruption laws
(including the provisions of the United States Foreign Corrupt Practices Act, the “Anti-Corruption Laws”) that
may be applicable to one or both Parties;

 

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(ii)          it
shall adhere to its own internal anti-corruption policies and Leap’s anti-corruption policies and shall not, in the performance
of this Agreement, directly or indirectly, make any payment, or offer or transfer anything of value, or agree or promise to make
any payment or offer or transfer anything of value, to a government official or government employee, to any political party or
any candidate for political office or to any other Third Party with the purpose of influencing decisions related to either Party
or its business in a manner that would violate Anti-Corruption Laws;

 

(iii)         it
will (A) promptly provide written notice to the other Party of any violations of Anti-Corruption Laws by such Party, its
Affiliates or sublicensees, or persons employed by or subcontractors used by such Party or its Affiliates or sublicensees in the
performance of this Agreement of which it becomes aware; and (B) no later than forty-five (45) days following the end of
each Calendar Year, verify in writing that to the best of its knowledge, there have been no violations of Anti-Corruption Laws
by such Party, its Affiliates or sublicensees, or persons employed by or subcontractors used by such Party or its Affiliates or
sublicensees in the performance of this Agreement, or shall provide details of any exception to the foregoing; and

 

(iv)         it
shall maintain records (financial and otherwise) and supporting documentation related to the subject matter of this Agreement
in order to document or verify compliance with the provisions of this Section 12.7, and upon request of the other Party,
up to one time per Calendar Year and upon reasonable advance notice, shall provide the other Party or its representative with
access to such records for purposes of verifying compliance with the provisions of this Section 12.7.

 

(b)         Each
Party represents and warrants that, to its knowledge, neither such Party nor any of its Affiliates, or its or their directors,
officers, employees, distributors, agents, representatives, sales intermediaries or other Third Parties acting on behalf of such
Party or any of its Affiliates:

 

(i)           has
taken any action in violation of any applicable Anti-Corruption Laws; or

 

(ii)          has
corruptly offered, paid, given, promised to pay or give, or authorized the payment or gift of anything of value, directly or indirectly,
to any Public Official, for the purposes of:

 

(1)        influencing
any act or decision of any Public Official in his or her official capacity;

 

(2)        inducing
such Public Official to do or omit to do any act in violation of his or her lawful duty;

 

(3)        securing
any improper advantage; or

 

(4)        inducing
such Public Official to use his or her influence with a government, governmental entity, or commercial enterprise owned or controlled
by any government (including state-owned or controlled veterinary, laboratory or medical facilities) in obtaining or retaining
any business whatsoever.

 

(c)          Each
Party further represents and warrants that, as of the Effective Date, none of the officers, directors or employees of such Party
or of any of its Affiliates or agents acting on behalf of such Party or any of its Affiliates, is a Public Official.

 

(d)         For
purposes of this Section 12.7, “Public Official” means (i) any officer, employee or representative
of any regional, federal, state, provincial, county or municipal government or government department, agency or other division;
(ii) any officer, employee or representative of any commercial enterprise that is owned or controlled by a government, including
any state-owned or controlled veterinary, laboratory or medical facility; (iii) any officer, employee or representative of
any public international organization, such as the African Union, the International Monetary Fund, the United Nations or the World
Bank; and (iv) any person acting in an official capacity for any government or government entity, enterprise or organization
identified above.

 

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Article 13

INDEMNIFICATION

 

13.1        Indemnification
by BeiGene. BeiGene shall indemnify and hold harmless Leap, its Affiliates, and their respective directors, officers, employees,
contractors, agents and assigns (individually and collectively, the “Leap Indemnitee(s)”) from and against
all losses, liabilities, damages and expenses (including reasonable attorneys’ fees and costs) (individually and collectively,
 “Losses”) incurred in connection with any claims, demands, actions or other proceedings by any Third Party
(individually and collectively, “Claims”) to the extent arising from (a) the Development, manufacture
or Commercialization of the Licensed Products by or on behalf of BeiGene or any of its Affiliates or sublicensees, including product
liability Claims, in the Territory, (b) BeiGene’s actions (or omissions) in the performance of its obligations with
respect to Regulatory Submissions and interactions with Regulatory Authorities, in each case, with respect to the Licensed Products
in the Territory, (c)  the gross negligence or willful misconduct of BeiGene or its Affiliates or sublicensees, (d) BeiGene’s
breach of any of its representations or warranties made in or pursuant to this Agreement or any covenants or obligations set forth
in this Agreement, or (e) the failure of BeiGene or its Affiliates or sublicensees to abide by any Applicable Laws, in each
case of clauses (a) through (e) above, except to the extent such Losses or Claims arise out of an Leap Indemnitee’s
gross negligence or willful misconduct, breach of this Agreement, or material failure to abide by any Applicable Laws.

 

13.2        Indemnification
by Leap. Leap shall indemnify and hold harmless BeiGene, its Affiliates, and their directors, officers, employees, contractors,
agents and assigns (individually and collectively, the “BeiGene Indemnitee(s)”) from and against all Losses
incurred in connection with Claims against such BeiGene Indemnitee to the extent arising from (a) the Development, manufacture
or Commercialization of the Licensed Products by or on behalf of Leap or any of its Affiliates or sublicensees (not including
BeiGene or its Affiliates or sublicensees) including product liability Claims, outside the Territory, (b) the Development
or manufacture of the Licensed Products by or on behalf of Leap or any of its Affiliates or sublicensees (not including BeiGene
or its Affiliates or sublicensees) in the Territory as contemplated by this Agreement, (c) Leap’s actions (or omissions)
in the performance of its obligations with respect to Regulatory Submissions and interactions with Regulatory Authorities, in
any case, with respect to the Licensed Products, (d) the gross negligence or willful misconduct of Leap or its Affiliates
hereunder, (e) Leap’s breach of any of its representations or warranties made in or pursuant to this Agreement or any
covenants or obligations set forth in this Agreement, or (f) failure of Leap or its Affiliates to abide by any Applicable
Laws in its performance hereunder, in each case of clauses (a) through (f) above, except to the extent such Losses or
Claims arise out of any of a BeiGene Indemnitee’s gross negligence or willful misconduct, breach of this Agreement or material
failure to abide by any Applicable Laws.

 

13.3        Indemnification
Procedure. If either Party is seeking indemnification under Sections 13.1 or 13.2 (the “Indemnified Party”),
it shall inform the other Party (the “Indemnifying Party”) of the Claim giving rise to the obligation to indemnify
pursuant to such Section within ten (10) Business Days after receiving written notice of the Claim (it being understood
and agreed, however, that the failure or delay by an Indemnified Party to give such notice of a Claim shall not affect the indemnification
provided hereunder except to the extent the Indemnifying Party shall have been actually and materially prejudiced as a result
of such failure or delay to give notice). The Indemnifying Party shall have the right to assume the defense of any such Claim
for which it is obligated to indemnify the Indemnified Party. The Indemnified Party shall cooperate with the Indemnifying Party
and the Indemnifying Party’s insurer as the Indemnifying Party may reasonably request, and at the Indemnifying Party’s
cost and expense. The Indemnified Party shall have the right to participate, at its own expense and with counsel of its choice,
in the defense of any Claim that has been assumed by the Indemnifying Party. Neither Party shall have the obligation to indemnify
the other Party in connection with any settlement made without the Indemnifying Party’s written consent, which consent shall
not be unreasonably withheld, conditioned or delayed. If the Parties cannot agree as to the application of Section 13.1 or
13.2 as to any Claim, pending resolution of the dispute pursuant to Section 16.5, the Parties may conduct separate defenses
of such Claims, with each Party retaining the right to Claim indemnification from the other Party in accordance with Section 13.1
or 13.2 upon resolution of the underlying Claim.

 

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13.4        Mitigation
of Loss. Each Indemnified Party shall take and shall procure that its Affiliates take all such reasonable steps and action
as are reasonably necessary in order to mitigate any Losses (or potential losses or damages) under this Article 13. Nothing
in this Agreement shall or shall be deemed to relieve any Party of any common law or other duty to mitigate any losses incurred
by it.

 

13.5        Limitation
of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT
DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 13.5 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION
RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTIONS 13.1 OR 13.2, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF ITS OBLIGATIONS
HEREUNDER RELATING TO CONFIDENTIALITY.

 

13.6        Insurance.
Each Party shall procure and maintain insurance, including product liability insurance, with respect to its activities hereunder
and which is consistent with normal business practices of prudent companies similarly situated at all times during which any Licensed
Product is being clinically tested in human subjects or commercially distributed or sold in the Territory and/or outside of the
Territory. All such insurance coverage may be maintained through a self-insurance plan that substantially complies with the foregoing
limits and requirements and may be satisfied through one or more policies, including an umbrella policy; provided, however,
that the other Party will provide to the requesting Party a letter(s) affirming appropriate self-insurance and/or a certificate
of insurance evidencing such coverage in accordance with this Agreement. Each Party will maintain such insurance or self-insurance
coverage without interruption during the Term and for a period of [***] thereafter, and, if applicable, will provide certificates
and/or letters evidencing such insurance coverage without interruption as reasonably requested during the period of time for which
such coverage must be maintained. Each Party will be provided at least [***] prior written notice of any cancellation or material
decrease in the other Party’s insurance coverage limits described above. Notwithstanding the foregoing, either Party’s
failure to maintain adequate insurance will not relieve that Party of its obligations set forth in this Agreement.96

 

 

 

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Article 14

INTELLECTUAL PROPERTY

 

14.1        Inventions.

 

(a)         Ownership.
As between the Parties, BeiGene will solely own all Inventions conceived and first reduced to practice solely by employees
or agents of BeiGene or any of its Affiliates (“BeiGene Inventions”) and Leap will solely own all Inventions
conceived and first reduced to practice solely by employees or agents of Leap or any of its Affiliates (“Leap Inventions”).
Inventions conceived and first reduced to practice jointly by employees or agents of BeiGene and Leap or their respective Affiliates
(“Joint Inventions”) will be jointly owned, with each Party having the right to freely practice and license
any such jointly-owned Inventions without accounting to the other, subject to the terms of the Agreement. Notwithstanding the
foregoing, Leap agrees that any Inventions (i) that cover a modification or improvement to the composition of the BeiGene
Drug, or (ii) that cover a new method of using or administering the BeiGene Drug as a single agent or in combination with
any drug (“BeiGene Drug Inventions”) will be and are hereby assigned to BeiGene, and BeiGene shall be the exclusive
owner of any such BeiGene Drug Inventions. Leap will (a) cooperate fully in obtaining patent and other proprietary protection
for any patentable or protectable BeiGene Drug Inventions, in the name of BeiGene and [***]; and (b) execute and deliver
all requested applications, assignments, and other documents and take such other measures as BeiGene reasonably requests, in order
to perfect and enforce BeiGene’s rights in the BeiGene Drug Inventions.

 

(b)         Disclosure.
Each Party shall promptly disclose to the other Party all Inventions, including all invention disclosures or other similar
documents submitted to such Party by its or its Affiliates’ employees, agents, or independent contractors relating thereto,
and shall also promptly respond to reasonable requests from the other Party for additional information relating thereto.

 

(c)          Joint
Inventions. Subject to the rights granted under and the restrictions set forth in this Agreement, it is understood that neither
Party shall have any obligation to account to the other Party for profits, or to obtain any approval of the other Party to license,
assign or otherwise exploit any Joint Inventions (or any Patent Rights claiming the same, “Joint Patent Rights”),
by reason of joint ownership thereof, and each Party hereby waives any right it may have under the Applicable Law of any jurisdiction
to require any such approval or accounting.

 

14.2        Patent
Prosecution.

 

(a)         Licensed
Patent Rights.

 

(i)            Subject
to Section 14.2(c), as between the Parties, Leap shall have the right to control the Patent Prosecution of all Licensed Patent
Rights at Leap’s expense outside of the Territory or outside of the Field, and as between the Parties and subject to Section 14.5,
BeiGene shall have the right to control the Patent Prosecution of all Licensed Patent Rights [***] in the Field in the Territory.97

 

(ii)           BeiGene
shall provide Leap with a reasonable opportunity to consult with BeiGene regarding such Licensed Patent Rights in the Field in
the Territory and keep Leap reasonably informed of the Patent Prosecution of the Licensed Patent Rights in the Field in the Territory.
BeiGene shall provide Leap with a reasonable opportunity to review and comment on material communications from any patent authority
regarding such Licensed Patent Rights in the Field in the Territory and drafts of any material filings or responses to be made
to such patent authorities in advance of submitting such filings or responses. Further, BeiGene shall notify Leap of any decision
to cease Patent Prosecution or maintenance of any Licensed Patent Rights in the Territory. BeiGene will consider Leap’s
comments on Patent Prosecution in good faith but will have final decision-making authority under this Section 14.2(a)(ii).

 

(b)         BeiGene
Patent Rights. As between the Parties, BeiGene shall have the sole right to control the Patent Prosecution of all BeiGene
Patent Rights and Patent Rights in the BeiGene Drug Inventions throughout the world, [***].98

 

 

 

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(c)          Joint
Patent Rights. In the event that any jointly-owned Invention is created hereunder, at either Party’s request, the Parties
shall discuss a mutually acceptable filing and prosecution strategy for any Joint Patent Rights; provided that absent such
agreement, BeiGene shall control the Patent Prosecution of any Joint Patent Rights in the Field in the Territory and Leap shall
control the Patent Prosecution of any Joint Patent Rights outside of the Territory and outside of the Field, as set forth in this
Section 14.2(c). Unless the Parties agree in writing on an alternative arrangement, BeiGene shall be responsible for all
of its costs of Patent Prosecution of Joint Patent Rights in the Field in the Territory and Leap shall be responsible for all
of its costs of Patent Prosecution outside of the Territory or outside of the Field. With respect to Joint Patent Rights to be
filed in the Field in the Territory, BeiGene shall (A) consult with Leap regarding such Joint Patent Rights, and any amendment,
submission or response with respect to such Joint Patent Rights and keep Leap reasonably informed of the Patent Prosecution of
the Joint Patent Rights, and (B) provide Leap with all material correspondence received from any patent authority in connection
therewith in sufficient time to allow for review and comment by Leap. Further, BeiGene shall notify Leap of any decision to cease
Patent Prosecution of any Joint Patent Rights in the Territory. BeiGene will consider Leap’s comments on Patent Prosecution
in good faith but will have final decision-making authority in the Territory under this Section 14.2(c).

 

(d)         Cooperation.
Each Party shall provide the other Party all reasonable assistance and cooperation in the Patent Prosecution efforts under
this Section 14.2, including providing any necessary powers of attorney and executing any other required documents or instruments
for such prosecution.

 

(e)          Abandonment.
If BeiGene decides to cease the Patent Prosecution, or to allow to lapse, any Licensed Patent Rights in the Field in the Territory
or any Joint Patent Rights in the Field in the Territory, BeiGene shall inform Leap of such decision promptly and, in any event,
so as to provide Leap a reasonable amount of time to meet any applicable deadline to establish or preserve such Patent Rights
in such country or region. Leap shall have the right, but not the obligation, to assume responsibility for continuing the Patent
Prosecution of such Patent Rights in Leap’s name (or both Parties’ names, with respect to Joint Patent Rights), [***],
through patent counsel or agents of its choice and, to the extent that Leap assumes such responsibility, BeiGene shall promptly
deliver to Leap copies of all necessary files related to any Patent Rights with respect to which responsibility has been transferred
and shall take all actions and execute all documents reasonably necessary for Leap to assume such Patent Prosecution activities,
at Leap’s request and expense.99

 

14.3        Patent
Enforcement.

 

(a)          Notice.
Each Party shall notify the other within [***] of becoming aware of any alleged or threatened infringement by a Third Party
of (i) any of the Licensed Patent Rights or Joint Patent Rights in the Territory or (ii) any of the BeiGene Patent Rights
in the Territory, which infringement of such BeiGene Patent Rights adversely affects or is reasonably expected to adversely affect
any Licensed Product in the Field in the Territory, and, in each case, any related declaratory judgment or equivalent action alleging
the invalidity, unenforceability or non-infringement of any Licensed Patent Rights or Joint Patent Rights in the Field in the
Territory or any such BeiGene Patent Rights in the Territory (collectively “Product Infringement”). For clarity,
Product Infringement excludes any adversarial Patent Prosecution proceedings.100

 

 

 

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(b)         Enforcement
Rights.

 

(i)           BeiGene
shall have the first right to bring and control any legal action to enforce Licensed Patent Rights or Joint Patent Rights against
any Product Infringement in the Territory [***] as it reasonably determines appropriate; provided, that: (A) BeiGene shall
discuss with Leap such Product Infringement, the enforcement of Licensed Patent Rights or Joint Patent Rights against any Product
Infringement in the Field in the Territory and any reasonable rationale that Leap may have for BeiGene not pursuing such enforcement
action and BeiGene shall consider in good faith the interests of Leap in such enforcement of the Licensed Patent Rights and/or
Joint Patent Rights; (B) BeiGene shall keep Leap reasonably informed about such enforcement; (C) BeiGene shall not take
any position with respect to, or compromise or settle, any such Product Infringement in any way that materially and adversely
affects the scope, validity or enforceability of any Licensed Patent Rights or Joint Patent Rights in the Territory, without the
prior consent of Leap, which consent shall not be unreasonably withheld, delayed or conditioned; and (D) if BeiGene does
not intend to prosecute or defend a Product Infringement, or ceases to diligently pursue an enforcement with respect to such a
Product Infringement, it shall promptly inform Leap in such a manner that such enforcement will not be prejudiced and Section 14.3(b)(ii) shall
apply.101

 

(ii)          If
BeiGene or its designee fails to abate such Product Infringement in the Field in the Territory or to file an action to abate such
Product Infringement in the Field in the Territory within [***] after a written request from Leap to do so, or if BeiGene discontinues
the prosecution of any such action after filing without abating such Product Infringement, then Leap shall have the right to enforce
the Licensed Patent Rights or Joint Patent Rights, as applicable, against such Product Infringement in the Field in the Territory
at its sole expense as it reasonably determines appropriate and shall keep BeiGene reasonably informed with respect to any such
enforcement action; provided that (A) if BeiGene provides a reasonable rationale for not pursuing or continuing to
pursue such Product Infringement (including a substantive concern regarding counter-claims by the infringing Third Party), Leap
shall not pursue any action against such Product Infringement, and BeiGene and Leap shall discuss in good faith whether to consider
the appropriate steps to be taken to address BeiGene’s concerns as well as the effect of such Product Infringement on Leap
and (B) Leap shall not enter into any settlement admitting the invalidity of, or otherwise impairing, any Licensed Patent
Rights or Joint Patent Rights in the Field in the Territory without the prior written consent of BeiGene, which consent shall
not be unreasonably withheld, delayed or conditioned.102

 

(iii)         BeiGene
shall have the sole right to bring and control any legal action to enforce BeiGene Patent Rights against any Product Infringement
in the Territory [***] as it reasonably determines appropriate, and shall keep Leap reasonably informed with respect to any such
legal action.103

 

(iv)         BeiGene
shall not have the right to enforce any Licensed Patent Rights or Joint Patent Rights outside of the Territory or outside the
Field. Leap shall have the sole right to enforce any Licensed Patent Rights or Joint Patent Rights outside of the Territory or
outside of the Field.

 

(c)         Cooperation.
At the request of the Party bringing an action related to Product Infringement, the other Party shall provide reasonable assistance
in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party
to the action if required by Applicable Laws to pursue such action, at each such Party’s sole cost and expense.

 

(d)         Recoveries.
Any recoveries resulting from an enforcement action relating to a claim of Product Infringement in the Territory will first
be applied to costs and expenses incurred by each Party in connection with such action (including, for this purpose, a reasonable
allocation of expenses of internal counsel) (provided that if the amount of such recovery is not sufficient to cover all such
costs and expenses of each Party, then the amount of the recovery will be proportionately shared by the Parties based on the amount
of such costs and expenses incurred by each Party); and with respect to any remaining proceeds, (i) the Parties shall negotiate
in good faith an appropriate allocation of such remaining proceeds to reflect the economic interests of the Parties under this
Agreement with respect to such Product Infringement and (ii) unless otherwise agreed in subsection (i), [***] of such remaining
proceeds will be allocated to the enforcing Party and [***] of such remaining proceeds will be allocated to the non-enforcing
Party.104

 

 

 

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102
Competitive Information – Commercially Sensitive Terms.

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14.4        Infringement
of Third Party Rights.

 

(a)         Notice.
If any Licensed Product used or sold by BeiGene, its Affiliates or sublicensees becomes the subject of a Third Party’s
claim or assertion of infringement of any Patent Rights or other intellectual property rights in the Territory that are owned
or controlled by such Third Party, BeiGene shall promptly notify Leap within [***] after receipt of such claim or assertion and
such notice shall include a copy of any summons or complaint (or the equivalent thereof), including, if applicable, a certified
translation into English, received regarding the foregoing. Thereafter, the Parties shall promptly meet to consider the claim
or assertion and the appropriate course of action and may, if appropriate, agree on and enter into a “common interest agreement”
wherein the Parties agree to their shared, mutual interest in the outcome of such potential dispute. The Parties shall assert
and not waive the joint defense privilege with respect to any communications between the Parties in connection with the defense
of such claim or assertion.105

 

(b)         Defense.
In the event that a claim is brought against either Party alleging the infringement, violation or misappropriation of any
Third Party intellectual property right based on the manufacture, use, sale or importation of the Licensed Products in the Field
in the Territory, the Parties shall promptly meet to discuss the defense of such claim, and the Parties shall, as appropriate,
enter into a joint defense agreement with respect to the common interest privilege protecting communications regarding such claim
in a form reasonably acceptable to the Parties; provided, that, unless otherwise agreed by the Parties, BeiGene will have the
sole right, but not the obligation, to defend and dispose (including through settlement or license) such claim at [***]; provided
that (i) BeiGene will discuss in good faith and coordinate with Leap in connection therewith and BeiGene will consider in
good faith and reasonably address Leap’s input and comments with respect thereto and (ii) BeiGene will not, without
the consent of Leap, enter into any such settlement, consent judgment or other disposition of any action or proceeding that would
(A) impose any liability or obligation on Leap, (B) include the grant of any license, covenant or other rights to any
Third Party that would conflict with or reduce the scope of the rights of Leap with respect to the Licensed Products outside of
the Territory or outside of the Field, or (C) otherwise adversely affect the rights of Leap with respect to the Licensed
Products outside of the Territory or outside of the Field. Notwithstanding the foregoing, Leap shall have the right to participate,
at its sole cost and expense and with counsel of its choice, in the defense of any claim that is controlled by BeiGene pursuant
to this Section 14.4(b).106

 

14.5        Patent
Rights Licensed from Third Parties. Each Party’s rights under this Article 14 with respect to the prosecution and
enforcement of any Licensed Patent Rights that is licensed by Leap from a Third Party, including under the Third Party In-Licensing
Agreement, shall be subject to the rights of such Third Party to prosecute and enforce such Patent Rights.

 

14.6        Patent
Term Extensions. BeiGene will reasonably cooperate with Leap, including providing reasonable assistance to Leap in its efforts
to seek and obtain patent term restoration or supplemental protection certificates or the like or their equivalents in any country
in the Territory, where applicable to Licensed Patent Rights, including as may be available to the Parties under the provisions
of the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 or comparable laws outside the United States of America,
in each case, in connection with any Licensed Product. Notwithstanding anything to the contrary contained herein, if elections
with respect to obtaining such patent term restoration or supplemental protection certificates or the like or their equivalents
in the Territory are to be made in connection therewith, the Parties will mutually agree upon the election. In the event that
the Parties are unable to agree upon the election, Leap shall have the right to make the election in its discretion.

 

 

 

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Competitive Information – Commercially Sensitive Terms.

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14.7        Product
Trademarks. Subject to Section 8.3(c), BeiGene shall have the right to brand Licensed Products in the Territory using
trademarks, logos, and trade names it determines appropriate for such Licensed Products, which may vary by country or region or
within a country or region (the “Product Marks”); provided, however, that BeiGene shall provide
Leap with a reasonable opportunity to review and provide comments on each proposed Product Mark, shall give due consideration
to Leap’s comments before selecting any Product Mark, and shall not use any trademarks or house marks of Leap (including
Leap’s corporate name) or any trademark confusingly similar thereto without Leap’s prior written consent. BeiGene
shall own all rights in the Product Marks in the Territory (excluding any such marks that include, in whole or part, any corporate
name or logos of Leap or its Affiliates or sublicensees) and shall register and maintain the Product Marks in the Territory that
it determines reasonably necessary, [***].107

 

14.8        Patent
Marking. BeiGene shall mark all Licensed Products in accordance with Applicable Laws, including the applicable patent marking
laws, and shall require all of its Affiliates and sublicensees to do the same. To the extent permitted by Applicable Laws, BeiGene
shall indicate on the product packaging, advertisement and promotional materials that such Licensed Product is in-licensed from
Leap.

 

Article 15

TERM AND TERMINATION

 

15.1        Term.
This Agreement shall be effective as of the Effective Date, and shall continue in effect until the earlier of: (i) [***]
after the end of the Option Period, if BeiGene has not exercised the Option and paid the Option Exercise Fee by such date; and
(ii) on a country-by-country and Licensed Product-by-Licensed Product basis, the expiration of the Royalty Term applicable
to such Licensed Product in such country (the “Term”). On a country-by-country basis, upon the expiration of
the Royalty Term, the License in such country shall become fully paid-up, royalty-free, perpetual, irrevocable and non-exclusive;
provided, that, any remaining Development Milestone Events or Commercialization Milestones Events that are achieved with respect
to a Licensed Product after such expiration shall be and remain subject to BeiGene’s obligation to pay the corresponding
Development Milestone Payments or Commercialization Milestone Payments (as applicable) in accordance with Section 9.2 and
9.3, which shall survive such expiration.108

 

15.2        Termination

 

(a)          Termination
by BeiGene for Convenience. At any time, BeiGene may terminate this Agreement by providing written notice of termination to
Leap, which notice includes an effective date of termination at [***] after the date of the notice.109

 

(b)         Termination
for Material Breach.

 

 

 

107
Competitive Information – Commercially Sensitive Terms.

108
Competitive Information – Commercially Sensitive Terms.

109
Competitive Information – Commercially Sensitive Terms.

 

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(i)            If
either BeiGene or Leap is in material breach of any obligation hereunder, the non-breaching Party may give notice to the breaching
Party specifying the claimed particulars of such breach (a “Breach Notification”). If the Party receiving a
Breach Notification fails to cure, or fails to dispute, that material breach on or before [***] from the date of the Breach Notification,
the Party delivering the Breach Notification may terminate this Agreement.110

 

(ii)           If
the allegedly breaching Party disputes in good faith the existence, materiality, or cure of the applicable material breach and
provides written notice of such dispute to the other Party within the [***] period set forth above, then the matter will be addressed
under the dispute resolution provisions in Section 16.5 and the termination will not become effective unless and until it
has been determined under Section 16.5 that the allegedly breaching Party is in material breach of any of its obligations
under this Agreement and has failed to cure the same. During the pendency of such a dispute, all of the terms of this Agreement
will remain in effect and the Parties will continue to perform all of their respective obligations hereunder.111

 

(c)          Termination
for Patent Challenge. Leap may terminate this Agreement upon [***] written notice to BeiGene in the event that BeiGene
or its Affiliates challenges or contests, or materially assists any other person to challenge or contest, the validity or enforceability
of any of the Licensed Patent Rights, unless, prior to the expiration of such [***], BeiGene or its Affiliates withdraws such
challenge or contest; provided, however, that Leap shall not be entitled to terminate this Agreement if BeiGene or its Affiliates
so challenges the Licensed Patent Rights in connection with defense, cross-claim or counterclaim to an action brought by Leap
or its Affiliates with respect to a product other than a Licensed Product; and further provided that Leap shall not be entitled
to terminate this Agreement if the challenge was initiated by an Affiliate of BeiGene prior to such Affiliate being an Affiliate
of BeiGene (e.g., through an acquisition or other change of control).112

 

(d)         Termination
for Insolvency. Each Party shall have the right to terminate this Agreement upon delivery of written notice to the other Party
in the event that (a) such other Party files in any court or agency pursuant to any statute or regulation of any jurisdiction
a petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment
of a receiver or trustee of such other Party or its assets, (b) such other Party is served with an involuntary petition against
it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within [***] of its filing, or
(c) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors.113

 

(e)          Full
Force and Effect During Notice Period. This Agreement shall remain in full force and effect until the expiration of the applicable
termination notice period. For clarity, if any milestone event is achieved under Section 9.2 or 9.3 or royalty payments become
payable under Section 9.5 during the termination notice period, the corresponding milestone payment or royalty payment, as
applicable, is accrued and BeiGene shall remain responsible for the payment of such milestone payment or royalty payment, as applicable,
even if the due date of such milestone payment or royalty payment, as applicable, may come after the effective date of the termination.

 

 

 

110
Competitive Information – Commercially Sensitive Terms.

111
Competitive Information – Commercially Sensitive Terms.

112
Competitive Information – Commercially Sensitive Terms.

113
Competitive Information – Commercially Sensitive Terms.

 

    -48-

     

    

 

  

15.3     Effect
of Termination. Except as provided in Section 15.4, if this Agreement is terminated the following shall apply:

 

(a)     License
Grant to BeiGene. The License and all other rights granted by Leap to BeiGene under the Licensed IP pursuant to this Agreement
shall terminate.

 

(b)     License
Grants to Leap. The licenses granted by BeiGene to Leap pursuant to Section 2.4 shall continue following the effective
date of termination and, except as otherwise provided in this Section 15.3, all other rights and licenses granted by BeiGene
to Leap pursuant to this Agreement shall terminate.

 

(c)     Sublicenses.
If the License granted to BeiGene terminates as a result of a termination of this Agreement with respect to one or more Licensed
Products or in its entirety, the terms of this Section 15.3(c) will apply with respect to any sublicense agreement existing
as of the effective date of such termination, but only if the applicable sublicensee did not contribute to any material breach
of this Agreement that was the cause of the termination by Leap of this Agreement and is not otherwise in material breach of the
applicable sublicense agreement at such time: (i) all of such sublicensee’s obligations under the applicable sublicense
agreement to BeiGene will remain in effect as obligations to Leap and will be enforceable solely by Leap as a third party beneficiary,
and, in the case of any sublicensee that is not a party to a sublicense agreement with BeiGene, all of such sublicensee’s
obligations under the applicable sublicense agreement with the applicable sublicensor of such sublicensee shall remain in full
force and effect in accordance with their respective terms; (ii) such sublicensee’s rights under the sublicense agreement
that do not exceed and are consistent with Leap’s obligations to BeiGene under this Agreement, whether in scope, duration,
nature or otherwise, will survive termination; provided, that, the foregoing will in no way be interpreted to increase
the scope, duration, territory or other aspect of the rights sublicensed to such sublicensee; and (iii) all of BeiGene’s
rights under such sublicense agreement will remain in effect, may be exercised solely by Leap and will inure to the exclusive
benefit of Leap.

 

(d)     Negotiation
of License. [***].114

 

(e)     Regulatory
Submissions. Upon Leap’s written request to the extent delivered on or before the effective date of termination or within
[***] thereafter, BeiGene shall provide Leap with copies of all Regulatory Submissions for Licensed Products in the Territory.
To the extent permissible under Applicable Law and commercially feasible, BeiGene shall assign to Leap or shall provide Leap with
a right of reference with respect to such Regulatory Submissions, as Leap determines at its reasonable discretion, [***]. In addition,
upon Leap’s written request, BeiGene shall, [***], provide to Leap copies of all material related documentation, including
material non-clinical, preclinical and clinical data that are held by or reasonably available to BeiGene, its Affiliates or sublicensees.
The Parties shall discuss and establish appropriate arrangements with respect to safety data exchange, provided that Leap
will assume all safety and safety database activities no later than [***] after termination.115

 

(f)     Trademarks.
BeiGene shall transfer and assign, and shall ensure that its Affiliates transfer and assign, to Leap, at no cost to Leap,
all Product Marks relating to any Licensed Product and any applications therefor (excluding any such marks that include, in whole
or part, any corporate name or logos of BeiGene or its Affiliates or sublicensees). Leap and its Affiliates and licensees shall
have the right to use other identifiers specific to any Licensed Product (e.g., BeiGene compound identifiers). BeiGene shall also
transfer to Leap any in-process applications for generic names for any Licensed Product.

 

 

114
Competitive Information – Commercially Sensitive Terms.

115
Competitive Information – Financial Provisions and Commercially Sensitive Terms. 

 

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(g)     Inventory.
At Leap’s election and request, BeiGene shall transfer to Leap or its designee some or all inventory of Licensed Products
(including all final product, bulk drug substance, intermediates, works-in-process, formulation materials, reference standards,
drug product clinical reserve samples, packaged retention samples, and the like) then in the possession or control of BeiGene,
its Affiliates or sublicensees; provided that, Leap will pay BeiGene a price [***] for such transferred Licensed Products
(if manufactured by Leap) or at BeiGene’s Manufacturing Cost (if manufactured by BeiGene).116

 

(h)     Wind
Down and Transition. BeiGene shall be responsible, [***], for the wind-down of BeiGene’s and its Affiliates’ and,
subject to Section 15.3(c), its sublicensees Development, manufacture and Commercialization activities for Licensed Products.
BeiGene shall, and shall cause its Affiliates and, subject to Section 15.3(b), its sublicensees to, reasonably cooperate
with Leap to facilitate orderly transition of the Development, manufacture and Commercialization of Licensed Products to Leap
or its designee, including (i) [***] or, to the extent any such [***]; and (ii) [***] (i), [***].117

 

(i)     Ongoing
Clinical Trial. If, at the time of such termination, BeiGene or its Affiliates are conducting any Clinical Trials, then, at
Leap’s election on a Clinical Trial-by-Clinical Trial basis to the extent delivered on or before the effective date of termination
or within the [***] period immediately thereafter: (i) [***]; and (ii) [***] under clause (i) above.118

 

(j)     Return
of Confidential Information. At the Disclosing Party’s election, the Receiving Party will return (at Disclosing Party’s
expense) or destroy all tangible materials comprising, bearing, or containing any Confidential Information of the Disclosing Party
relating to any Licensed Product that are in the Receiving Party’s or its Affiliates’ possession or control and provide
written certification of such destruction (except to the extent any information is the Confidential Information of both Parties
or to the extent that the Receiving Party has the continuing right to use the Confidential Information under this Agreement);
provided, that, the Receiving Party may retain one copy of such Confidential Information for its legal archives. Notwithstanding
anything to the contrary set forth in this Agreement, the Receiving Party will not be required to destroy electronic files containing
such Confidential Information that are made in the ordinary course of its business information back-up procedures pursuant to
its electronic record retention and destruction practices that apply to its own general electronic files and information.

 

15.4     Termination
by BeiGene for Breach.

 

(a)     Notwithstanding
anything to the contrary in this Article 15, if BeiGene has the right to terminate this Agreement pursuant to Section 15.2(b) then,
at BeiGene’s option (which may be exercised by BeiGene by written notice to Leap within [***] of the date of delivery by
BeiGene of the notice of termination), (i) BeiGene may elect [***], in which case the rights and obligations of the Parties
under this Agreement shall [***], including the License granted by Leap to BeiGene pursuant to Section 2.2, and BeiGene shall
have the right to off-set any actual damages that BeiGene suffered as a direct result of the uncured material breach by Leap described
in the Breach Notification against the right of Leap to receive the milestone and royalty payments pursuant to Article 9;
provided that Leap’s rights and BeiGene’s obligations under Sections 3.2 and 8.3 [***]; or (ii) BeiGene may elect
to [***], in which case (A) Leap will be responsible for the [***]; (B) the licenses granted by BeiGene to Leap pursuant
to Section 2.4 shall terminate, and (C) the provisions of Section 15.3(d) shall terminate. In the case of
Subsection (a)(ii) above, BeiGene will invoice Leap [***] for the [***] incurred by or on behalf of BeiGene in such [***],
and Leap will pay the invoiced amounts within [***] after the date of any such invoice.119

 

 

116
Competitive Information – Financial Provisions and Commercially Sensitive Terms.

117
Competitive Information – Commercially Sensitive Terms.

118
Competitive Information – Financial Provisions and Commercially Sensitive Terms. 

 

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15.5     Survival.
Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration
or termination. Without limiting the foregoing, the provisions of Article 1 (as applicable), Article 10, Article 11,
Article 13, Article 14 and Article 16 (as applicable), and Sections 2.6, 5.9 (with respect to Leap’s use
rights), 5.10 (with respect to responsibility for subcontractors), 6.3 (with respect to Leap’s right of reference thereunder),
9.10, 12.6, 15.1, 15.3, 15.4, 15.5 and 15.6 shall survive the expiration or termination of this Agreement.

 

15.6     Termination
Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether or not termination is effected and notwithstanding
anything contained in this Agreement to the contrary, all other remedies shall remain available except as agreed to otherwise
herein.

 

Article 16

MISCELLANEOUS

 

16.1     Assignment. Except
as provided in this Section 16.1, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation
hereunder be assigned or transferred, by either Party without the consent of the other Party; provided, however,
that (and notwithstanding anything elsewhere in this Agreement to the contrary) either Party may, without the written consent
of the other Party, assign this Agreement and its rights and obligations hereunder in whole or in part to an Affiliate of such
Party and (a) BeiGene may, without the written consent of Leap, assign this Agreement and its rights and obligations hereunder
(or under a transaction under which this Agreement is assumed) in connection with the transfer or sale of all or substantially
all of its assets or business, or in the event of its merger or consolidation or similar transaction; and (b) Leap may, without
the written consent of BeiGene, assign this Agreement and its rights and obligations hereunder (or under a transaction under which
this Agreement is assumed) in connection with the transfer or sale of all or substantially all of its assets or business related
to the subject matter of this Agreement, or in the event of its merger or consolidation or similar transaction. Any attempted
assignment not in accordance with this Section 16.1 shall be void. Any permitted assignee shall assume all assigned obligations
of its assignor under this Agreement. Any permitted assignment of this Agreement shall not operate to release the assigning Party
from any of its obligations under this Agreement unless the Parties otherwise agree in writing.

 

16.2     Extension
to Affiliates. Except as expressly set forth otherwise in this Agreement, each Party shall have the right to extend the
rights and obligations granted in this Agreement to one or more of its Affiliates by providing written notice to the other Party.
All applicable terms and provisions of this Agreement, except this right to extend, shall apply to any such Affiliate to which
this Agreement has been extended to the same extent as such terms and provisions apply to the Party extending such rights and
obligations. The Party extending the rights and obligations granted hereunder shall remain primarily liable for any acts or omissions
of its Affiliates.

 

16.3     Severability. Should
one or more of the provisions of this Agreement become void or unenforceable as a matter of Applicable Laws, then this Agreement
shall be construed as if such provision were not contained herein and the remainder of this Agreement shall be in full force and
effect, and the Parties will use their best efforts to substitute for the invalid or unenforceable provision a valid and enforceable
provision which conforms as nearly as possible with the original intent of the Parties.

 

16.4     Governing
Law; English Language. This Agreement shall be governed by and construed in accordance with the laws of the State of
New York and the patent laws of the United States without reference to any rules of conflict of laws. This Agreement was
prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this
Agreement.

 

 

119
Competitive Information – Commercially Sensitive Terms. 

 

    -51-

     

    

 

16.5     Dispute
Resolution.

 

(a)     If
any dispute, claim or controversy of any nature arising out of or relating to this Agreement, including any action or claim based
on tort, contract or statute, or concerning the interpretation, effect, termination, validity, performance or breach of this Agreement
(each, a “Dispute”), arises between the Parties and the Parties cannot resolve such Dispute through good faith
discussions, within [***] of a written request by either Party to the other Party (“Notice of Dispute”), either
Party may refer the Dispute to senior representatives of each Party for resolution. Each Party, within [***] after a Party has
received such written request from the other Party to so refer such Dispute, shall notify the other Party in writing of the senior
representative to whom such dispute is referred. If, after an additional [***] after the Notice of Dispute, such representatives
have not succeeded in negotiating a resolution of the Dispute, and a Party wishes to pursue the matter, each such Dispute, controversy
or claim that is not an “Excluded Claim” (defined below) shall be finally resolved by binding arbitration administered
by the International Chamber of Commerce (“ICC”) (or any successor entity thereto) pursuant to its arbitration
rules and procedures then in effect (the “Rules”), as modified in this Section 16.5.120

 

(b)     The
arbitration shall be conducted by a tribunal of arbitrators experienced in the business of pharmaceuticals (including biologicals).
The tribunal shall be compromised of three (3) arbitrators, one of whom shall be nominated by each Party and a third of whom,
who shall serve as the presiding arbitrator, shall be nominated by mutual agreement of the two party-nominated arbitrators. If
the two party-nominated arbitrators do not nominate the third arbitrator within [***] of the second arbitrator’s appointment,
then the third arbitrator shall be appointed by the ICC Court. If the issues in dispute involve scientific, technical or commercial
matters, the arbitrators chosen hereunder shall engage experts that have educational training or industry experience sufficient
to demonstrate a reasonable level of relevant scientific, medical and industry knowledge, as necessary to resolve the dispute.
Within [***] after initiation of arbitration, the Parties shall select the arbitrators. The place of arbitration shall be New
York City, New York, and all proceedings and communications shall be in English.121

 

(c)     Prior
to the arbitrators being selected, either Party, without waiving any remedy under this Agreement, may seek from any court having
jurisdiction any temporary injunctive or provisional relief necessary to protect the rights or property of that Party until final
resolution of the issue by the arbitrator or other resolution of the controversy between the Parties. Once the arbitrators have
been selected, either Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered
or the controversy is otherwise resolved, and either Party may apply to a court of competent jurisdiction to enforce interim injunctive
relief granted by the arbitrators. Any final award by the arbitrators may be entered by either Party in any court having appropriate
jurisdiction for a judicial recognition of the decision and applicable orders of enforcement. The arbitrators shall have no authority
to award punitive or any other type of damages not measured by a Party’s compensatory damages. Each Party shall bear its
own costs and expenses and attorneys’ fees and an equal share of the arbitrators’ fees and any administrative fees
of arbitration, unless the arbitrators agree otherwise.

 

(d)     Except
to the extent necessary to confirm an award or as may be required by law, neither a Party nor the arbitrators may disclose the
existence, content, or results of an arbitration without the prior written consent of both Parties. In no event shall an arbitration
be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would
be barred by the applicable New York statute of limitations.

 

 

120
Competitive Information – Commercially Sensitive Terms.

121
Competitive Information – Commercially Sensitive Terms. 

 

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(e)     As
used in this Section 16.5, the term “Excluded Claim” means any dispute, controversy or claim that concerns
(a) the validity, enforceability or infringement of any patent, trademark or copyright, or (b) any antitrust, anti-monopoly
or competition law or regulation, whether or not statutory. Any Excluded Claim may be submitted by either Party to any court of
competent jurisdiction over such Excluded Claim.

 

16.6     Force
Majeure. Neither Party shall be responsible to the other for any failure or delay in performing any of its obligations
under this Agreement or for other nonperformance hereunder (excluding, in each case, the obligation to make payments when due)
if such delay or nonperformance is caused by strike, fire, flood, earthquake, accident, war, act of terrorism, act of God or of
the government of any country or of any local government, or by any other cause unavoidable or beyond the control of any Party
hereto. In such event, the Party affected will use reasonable efforts to resume performance of its obligations and will keep the
other Party informed of actions related thereto. If any such failure or delay in a Party’s performance hereunder continues
for more than [***], the other Party may terminate this Agreement upon written notice to the delayed Party.122

 

16.7     Waivers
and Amendments. The failure of any Party to assert a right hereunder or to insist upon compliance with any term or condition
of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term
or condition by the other Party. No waiver shall be effective unless it has been given in writing and signed by the Party giving
such waiver. No provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives
of each Party.

 

16.8     Relationship
of the Parties.  Nothing contained in this Agreement shall be deemed to constitute a partnership, joint venture, or legal
entity of any type between Leap and BeiGene, or to constitute one as the agent of the other. Each Party shall act solely as an
independent contractor, and nothing in this Agreement shall be construed to give any Party the power or authority to act for,
bind, or commit the other.

 

16.9     Notices. 
All notices, consents or waivers under this Agreement shall be in writing and will be deemed to have been duly given when (a) scanned
and converted into a portable document format file (i.e., pdf file), and sent as an attachment to an e-mail message, where,
when such message is received, a read receipt e-mail is received by the sender (and such read receipt e-mail is preserved by the
Party sending the notice), provided further that a copy is promptly sent by an internationally recognized overnight delivery
service (receipt requested)(although the sending of the e-mail message shall be when the notice is deemed to have been given),
or (b) the earlier of when received by the addressee or five (5) days after it was sent, if sent by registered letter
or overnight courier by an internationally recognized overnight delivery service (receipt requested), in each case to the appropriate
addresses and e-mail addresses set forth below (or to such other addresses and e-mail addresses as a Party may designate by notice):

 

If
to Leap:Leap Therapeutics, Inc.

47 Thorndike Street, Suite B1-1

Cambridge,
MA 02141 USA

Attention:
[***]123

Tel:
[***]124

 

 

122
Competitive Information – Commercially Sensitive Terms.

123
Personal Information – Contact Information.

124
Personal Information – Contact Information. 

 

    -53-

     

    

 

E-mail
address: [***]125

  

With
a copy to:

 

[***]126

 

Morgan
Lewis & Bockius L.L.P.

 

One
Federal Street

 

Boston,
MA 02110

 

If
to BeiGene:

 

BeiGene, Ltd.

 

c/o     Mourant
Ozannes Corporate Services (Cayman) Limited

 

94
Solaris Avenue

 

Camana
Bay

 

PO
Box 1348

 

Grand
Cayman, KY1-1108,

 

Cayman
Islands

 

Attention:
[***]127

 

Fax:
[***]128

 

E-mail
address: []

 

With
copies to:

 

BeiGene, Ltd.

 

55
Cambridge Parkway, Suite 700W

 

Cambridge,
MA 02142

 

Attn:
[***]129

 

Tel:
[***]130

 

E-mail
address: [***]131

 

16.10     Further
Assurances.  BeiGene and Leap hereby covenant and agree without the necessity of any further consideration, to execute,
acknowledge and deliver any and all documents and take any action as may be reasonably necessary to carry out the intent and purposes
of this Agreement.

 

16.11     Compliance
with Law.  Each Party shall perform its obligations under this Agreement in accordance with all Applicable Laws. No Party
shall, or shall be required to, undertake any activity under or in connection with this Agreement which violates, or which it
believes, in good faith, may violate, any Applicable Laws.

 

16.12     No
Third Party Beneficiary Rights.  This Agreement is not intended to and shall not be construed to give any Third Party
any interest or rights (including any Third Party beneficiary rights) with respect to or in connection with any agreement or provision
contained herein or contemplated hereby, except as otherwise expressly provided for in this Agreement.

 

 

125
Personal Information – Contact Information.

126
Personal Information – Contact Information.

127
Personal Information – Contact Information.

128
Personal Information – Contact Information.

129
Personal Information – Contact Information.

130
Personal Information – Contact Information.

131
Personal Information – Contact Information. 

 

    -54-

     

    

 

16.13     Entire
Agreement.  This Agreement sets forth the entire agreement and understanding of the Parties as to the subject matter
hereof and supersedes all proposals, oral or written, and all other communications between the Parties with respect to such subject
matter. The Parties acknowledge and agree that, as of the Effective Date, all Confidential Information disclosed pursuant to the
Confidentiality Agreement by a Party or its Affiliates shall be included in the Confidential Information subject to this Agreement
and the Confidentiality Agreement is hereby superseded in its entirety; provided, that the foregoing shall not relieve
any Person of any right or obligation accruing under the Confidentiality Agreement prior to the Effective Date. “Confidentiality
Agreement” means the Mutual Confidentiality Agreement between Leap and BeiGene dated [***].132

 

16.14     Counterparts. 
This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.

 

16.15     Expenses. 
Each Party shall pay its own costs, charges and expenses incurred in connection with the negotiation, preparation and completion
of this Agreement.

 

16.16     Binding
Effect.  This Agreement shall be binding upon and inure to the benefit of the Parties and their respective legal representatives,
successors and permitted assigns.

 

16.17     Construction. 
The Parties hereto acknowledge and agree that: (a) each Party and its counsel reviewed and negotiated the terms and provisions
of this Agreement and have contributed to its revision; (b) the rule of construction to the effect that any ambiguities
are resolved against the drafting Party shall not be employed in the interpretation of this Agreement; and (c) the terms
and provisions of this Agreement shall be construed fairly as to all Parties hereto and not in a favor of or against any Party,
regardless of which Party was generally responsible for the preparation of this Agreement.

 

16.18     Cumulative
Remedies.  No remedy referred to in this Agreement is intended to be exclusive unless explicitly stated to be so, but
each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

 

16.19     Export. 
Each Party acknowledges that the laws and regulations of the United States restrict the export and re-export of commodities and
technical data of United States origin. Each Party agrees that it will not export or re-export restricted commodities or the technical
data of the other Party in any form without appropriate United States and foreign government licenses.

 

16.20     Notification
and Approval.  In the event that this Agreement or the transaction(s) set forth herein are subject to notification
or regulatory approval in one or more countries, then development and commercialization in such country(ies) will be subject to
such notification or regulatory approval. The Parties will reasonably cooperate with each other with respect to such notification
and the process required thereunder, including in the preparation of any filing. BeiGene will be responsible for any and all costs,
expenses, and filing fees associated with any such filing.

 

[Remainder
of page left blank intentionally.]

  

 

132
Competitive Information – Commercially Sensitive Terms. 

 

    -55-

     

    

 

IN
WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives.

 

 

	LEAP
    THERAPEUTICS, INC.	 
	 	 
	By:	/s/
    Christopher Mirabelli	 
	Name:
    Christopher Mirabelli, Ph.D.	 
	Title:
    President and Chief Executive Officer	 
	 	 
	BEIGENE, LTD.	 
	 	 
	By:	/s/
    Scott A. Samuels	 
	Name:
    Scott A. Samuels, Esq.	 
	Title:
    Senior Vice President, General Counsel	 

  

    -56-

     

    

 

List
of Exhibits

 

	Exhibit A:	Initial
    Development Plan

 

	Exhibit B:	Global
    Development Plan

 

	Schedule
    12.2(a)	Licensed
    Patent Rights

  

    Exhibit A-1 

     

    

 

EXHIBIT A

INITIAL DEVELOPMENT PLAN

 

[***]133

  

 

133
Competitive Information – Discovery Information and Technical Information. 

 

     

     

    

 

EXHIBIT B

GLOBAL DEVELOPMENT PLAN

 

[***]134

 

 

134
Competitive Information – Discovery Information and Technical Information. 

 

     

     

    

 

Schedule
12.2(a)

 

LICENSED
Patent RIghts

 

[***]135

 

 

135
Competitive Information – Technical Information and Exclusivity Information.

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