Exhibit 10.1


*** text omitted
and filed separately


confidential treatment
requested


under 17 c.f.r.
§§ 200.80(b)(4) and 240.24b-2 







 


LICENSE
Agreement


 


 


This License
Agreement (the “Agreement” or the “License Agreement”) is effective as of July 12, 2012 (the “Effective
Date”) by and between RegeneRx Biopharmaceuticals, Inc., a company organized and existing under the laws of the state
of Delaware, with offices at 15245 Shady Grove Road, Suite 470, Rockville, Maryland, U.S.A. (hereinafter “Licensor”),
and Lee’s Pharmaceutical (HK) Limited, a Hong Kong registered company with its principal place of business at Unit 110-111,
Bioinformatics Centre, No. 2 Science Park West Avenue, Hong Kong Science Park, Shatin, Hong Kong (hereinafter “Licensee”),
each a “Party” and, collectively, the “Parties.”


 


Recitals


 


WHEREAS,
Licensor is engaged in the business of developing biopharmaceutical products, including the clinical development of drug candidates
referred to as RGN-137, RGN-259 and RGN-352, which utilize Tβ4 (as defined herein) as the biologically active ingredient;


 


WHEREAS,
Licensee is engaged in the business of developing, marketing, manufacturing, and distributing biopharmaceutical products including
in China, Hong Kong, and Macau;


 


WHEREAS,
Licensee wishes to obtain the rights to develop, manufacture and commercialize the Licensed Product in the Field (as each such
term is defined herein) in China, Hong Kong, Macau and Taiwan and Licensor wishes to grant such rights, in each case upon the
terms and conditions set forth herein; and


 


WHEREAS,
Licensor and Licensee wish to specify certain terms relating to the manufacture of the Licensed Product by Licensee or relating
to the supply of the Licensed Product and/or the API (as defined herein) in the event that respectively Licensor elects to supply
commercial quantities of the Licensed Product and/or the API to Licensee and Licensee elects to buy commercial quantities of the
Licensed Product and/or the API.


 


NOW,
THEREFORE, in consideration of the premises and other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the Parties agree as follows:


 


 


Section
1. Definitions


 


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


 


“Affiliate”
shall mean, with respect to a Person, any Person that Controls, is Controlled by or is under common Control with such first Person.
For purposes of this definition only, “Control” means (a) to possess, directly or indirectly, the power to
direct the management or policies of a Person, whether through ownership of voting securities, by contract relating to voting
rights or corporate governance, or (b) to own, directly or indirectly, at least fifty percent (50%) of the outstanding voting
securities or other ownership interest of such Person. 


 






    	 



    	 	



    
 


 


“Agreement”
shall have the meaning given such term in the preamble.


 


“API”
shall mean Tβ4 in the form of an active ingredient to be utilized as a component in the Licensed Product.


 


“Challenge” shall
have the meaning given such term in Section 8.8(b).


 


“Change of Control”
shall mean, with respect to a Party, the occurrence of any of the following:


 


(a) any consolidation,
merger, recapitalization or reorganization of a Party with or into any Third Party, or any other corporate reorganization involving
a Third Party (“Merger”), as long as the stockholders of such Party immediately prior to the Merger own less
than fifty percent (50%) of the surviving entity’s voting power immediately after the Merger;


 


(b) a change in
the beneficial ownership of more than fifty percent (50%) of the voting securities of any Party (whether in a single transaction
or series of related transactions) where, immediately after giving effect to such change, the legal or beneficial owner of more
than fifty percent (50%) of the voting securities of such Party is a Third Party, excluding any equity investment by venture capitalists
or investment banks or other nonstrategic investors, who alone or with their Affiliates, are not themselves in the business of
developing and commercializing pharmaceutical products; or


 


(c) the sale,
transfer, lease, license or other disposition to a Third Party of all or substantially all of a Party’s assets in one or
a series of related transactions.


 


“Commercialization
Plan” shall have the meaning given such term in Section 4.1.


 


“Commercially
Diligent Efforts” shall mean, with respect to the development and commercialization by Licensee of at least one Licensed
Product, the level of efforts and resources generally used by similarly situated pharmaceutical companies marketing compounds
or products throughout the Territory (including internally developed, acquired and in-licensed compounds or products) with similar
commercial potential at a similar stage in their lifecycle (assuming continuing development of such product). 


 


“Confidential
Information” shall mean any and all information, data, results, Inventions, trade secrets, techniques, material, or
compositions of matter of any type or kind, including without limitation all Know-How and all other scientific, pre-clinical,
clinical, regulatory, manufacturing, marketing, personnel, financial, legal and commercial information or data, whether communicated
in writing, orally or by any other method, that a Party treats or identifies as confidential and, in each case, is disclosed by
one Party to the other Party under this Agreement.


 






    	2*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    
 





“Control”,
“Controls” and “Controlled” shall mean, with respect to a particular item of information
or intellectual property right, that the applicable Party or any Affiliate of such Party owns or has a license to such item or
right and has the ability to grant to the other Party access to and a license or sublicense (as applicable) under such item or
rights as provided for herein without violating the terms of any agreement or other arrangement with any Third Party existing
as of the Effective Date or thereafter.


 


“Development
Plan” shall have the meaning given such term in Section 3.1.


 


“Disclosing
Party” shall have the meaning given such term in Section 9.1.


 


“Distributor”
shall mean any Third Party appointed by Licensee to distribute, market and sell Licensed Product purchased from Licensee or any
of its Affiliates (regardless of whether such Third Party has the right or obligation to provide packaging or labeling services
with respect to such Licensed Product) that: (i) is not required to make royalty or other similar payment to Licensee or any of
its Affiliates with respect to any Licensed Patent or Licensed Know-How related to the Licensed Product; and (ii) has no right
to market such Licensed Product under its own trademark or trade name.


 


“Effective
Date” shall have the meaning given such term in the preamble.


 


“Expiry
Date” shall have the meaning given such term in Section 12.1.


 


“Extended
Term” shall have the meaning given such term in Section 12.1.


 


“FDA”
shall mean the United States Food and Drug Administration or any successor U.S. governmental agency performing similar functions.


 


“Field”
shall mean the diagnosis, prevention and treatment of all human and animal diseases and conditions, provided, however, that “Field”
shall not include any use of the Licensed Product incorporated into the form of any type of cosmetic or food product.


 


“First
Commercial Sale” shall mean the initial sale of Licensed Product by or on behalf of Licensee, its Affiliates or Sublicensees
in exchange for cash or some equivalent to which value can be assigned for the purpose of determining Net Sales in the Territory
following Regulatory Approval of the Licensed Product in the Territory. For clarity, First Commercial Sale shall not include transfers
of Licensed Product at or below cost by or on behalf of Licensee, its Affiliates or Sublicensees in connection with compassionate
use, emergency use, treatment INDs, or the like authorized by the FDA, the SFDA, or any corresponding Governmental Authorities.


 


“GAAP”
shall mean, in the case of the Licensor, Generally Accepted Accounting Principles recognized in the United States, and in the
case of the Licensee, Generally Accepted Accounting Principles recognized in Hong Kong.


 






    	3*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


“Generic
or Branded Generic” shall mean a drug product containing the same active ingredients as Licensed Products and is subject
to the regulations of the governments of countries where they are dispensed and is comparable to brand/reference listed drug product
in dosage form, strength, route of administration, quality and performance characteristics, and intended use.


 


“GCP”
shall mean the then current good clinical practices as defined in U.S. Regulations 21 C.F.R. §§ 50, 54, 56, 312 and
314, the International Conference of Harmonization (ICH) E6 “Good Clinical Practice: Consolidated Guidance,” and in
any successor regulation or any official guidance documents issued by a Governmental Authority.


 


“GLP”
shall mean the then current good laboratory practice standards as defined by the FDA pursuant to 21 C.F.R. Part 58, and in any
successor regulation or any official guidance documents issued by a Governmental Authority.


 


“GMP”
shall mean the then current good manufacturing practices as defined by the FDA pursuant to 21 C.F.R. §§ 210 and 211
and in any successor regulation or any official guidance documents issued by a Governmental Authority.


 


“Governmental
Action” shall have the meaning given such term in Section 12.2 (c).


 


“Governmental
Authority” shall mean: (i) any national, federal, provincial, state, municipal or other governmental body in any jurisdiction
in the Territory, the United States or elsewhere, (ii) any international or multi-lateral body, (iii) any subdivision, ministry,
department, secretariat, bureau, agency, commission, board, instrumentality or authority of any of the foregoing governments or
bodies, (iv) any quasi-governmental or private body exercising any regulatory, expropriation or taxing authority under or for
any of the foregoing governments or bodies, or (v) any international, multi-lateral, or multi-national judicial, quasi-judicial,
arbitration or administrative court, grand jury, tribunal, commission, board or panel, in each case having jurisdiction over the
United States or any jurisdiction in the Territory.


 


“Hong
Kong” shall mean the Hong Kong Special Administrative Region of the People’s Republic of China.


 


“IND”
shall mean an investigational new drug application filed with the FDA, or the equivalent in any jurisdiction in the Territory.


 


“Indemnified
Party” shall have the meaning given such term in Section 11.3.


 


“Indemnifying
Party” shall have the meaning given such term in Section 11.3.


 


“Initial
Term” shall have the meaning given such term in Section 12.1


 


“Intellectual
Property” shall mean any Inventions, Patents, patent rights, utility models, copyrights, trade secrets, Trademarks,
service marks, Know-How, technical information and all other intellectual property rights.


 






    	4*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    
 


 


“Invention”
shall mean any process, method, use, composition of matter, article of manufacture, discovery, finding, or invention, whether
or not patentable.


 


“Joint
Development Committee” shall have the meaning given such term in Section 3.4.


 


“Joint
Inventions” shall have the meaning given such term in Section 8.2(c).


 


“Know-How”
shall mean all tangible and intangible (i) techniques, technology, practices, trade secrets, methods, knowledge, know-how, skill,
experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and
quality control data, results or descriptions, software and algorithms, and (ii) compounds, compositions of matter, and physical,
biological or chemical material.


 


“Laws”
shall mean (i) all constitutions, treaties, laws, statutes, codes, ordinances, guidance, orders, decrees, rules, regulations,
and municipal by-laws, whether domestic or international, anywhere in the Territory or as may otherwise be agreed in writing between
the Parties, (ii) all judgments, orders, writs, injunctions, decisions, rulings, decrees and awards of any Governmental Authority,
and (iii) all policies, practices and guidelines of any Governmental Authority.


 


“Licensed
Know-How” shall mean Know-How owned or Controlled by Licensor that exists as of the Effective Date or at any time thereafter
during the Term, in each case that is necessary or useful for the development, registration, manufacture, promotion, marketing,
distribution, or sale of the Licensed Product in the Field in the Territory.


 


“Licensed
Patents” shall mean the Patents owned or Controlled by Licensor as of the Effective Date (as listed in Exhibit A
hereto), to the extent that such Patents disclose or claim the Licensed Product as well as any future Patents owned or Controlled
by Licensor or its Affiliates during the Term, to the extent that such future Patents disclose or claim the Licensed Product.


 


“Licensed
Product” shall mean any product containing any Licensor’s drug candidates including, without limitation, those
referred to as RGN-137, RGN-259 and RGN-352, that utilize Tβ4 as at least one of the biologically active ingredients and/or
improvements thereto developed or acquired by or on behalf of Licensor for the Field in the Territory, in each case to the extent
such improvements are owned or Controlled by Licensor. The term “Licensed Product” shall include both clinical and
commercial applications of any such product.


 


“Licensee”
shall have the meaning given such term in the preamble.


 


“Licensee
Inventions” shall have the meaning given such term in Section 8.2(a).


 


“Licensee
Product Data” shall have the meaning given such term in Section 12.3 (b) (i)


 


“Licensor”
shall have the meaning given such term in the preamble.


 


“Licensor
Inventions” shall have the meaning given such term in Section 8.2(b).


 


 



    	5*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


“Losses”
shall have the meaning given such term in Section 11.1.


 


“Macau”
shall mean the Macau Special Administrative Region of the People’s Republic of China.


 


“Marketing
Approval” shall mean all approvals, licenses, registrations, or authorizations of a Regulatory Authority in any jurisdiction
of the Territory necessary for the manufacture, use, storage, marketing, importation or sale of the Licensed Product in such jurisdiction.


 


“Marketing
Year” shall mean the period commencing on the date that Marketing Approval in the PRC is obtained and ending on December
31 of the same year. Thereafter, and for the duration of this Agreement, each subsequent Marketing Year will correspond to a calendar
year period (i.e., from January 1 to December 31).


 


“Net
Sales” shall mean the gross receipts for sales made by Licensee and/or its Affiliates and Sublicensees of the
Licensed Product to other independent buyer(s), including, without limitation, to Distributors in bona fide arm’s length
transactions, less the following deductions with respect to such sale, to the extent applicable to the Licensed Product and to
the extent actually allowed and taken: (i) quantity and/or cash discounts actually allowed or taken to the extent customary; (ii)
customs, duties, excise taxes, if any, directly related to the sale of the Licensed Product and actually paid; (iii) amounts allowed
by reason of rejections and return of goods; (iv) Third-Party rebates related to the sale of the Licensed Product; and (v) import
tax, value-added tax and other similar sales taxes related to the sale of the Licensed Product, all to the extent in accordance
with GAAP as consistently applied across all products of Licensee. No deductions shall be made for commissions paid to individuals,
whether with independent sales agencies or regularly employed by Licensee, its Affiliates or Sublicensees, and on its payroll,
or for the cost of collections. On sales made in other than in arm’s length transaction, the value of Net Sales attributed
to such a transaction shall be that which would have been received in an arm’s length transaction, based on sales of like
quantity and quality products on or about the time of such transaction.


 


“Panel”
shall have the meaning given such term in Section 13.8(c)(i).


 


“Parties”
and “Party” shall have the meanings given such terms in the preamble.


 


“Patents”
shall mean any and all patents and/or patent applications, and any patents issuing on such patent applications, as well as
any continuations, divisions, reissues and re-examinations of any of the foregoing.


 


“Person”
shall mean an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity
or organization, including a government or political subdivision, department or agency of a government.


 


“PHS”
shall mean the National Institutes of Health, the Centers for Disease Control, and/or the FDA, agencies of the United States Public
Health Service within the Department of Health and Human Services.


 


 



    	6*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


“PHS
License” shall mean the Patent License Agreement, dated as of February 6, 2001, between PHS and Licensor, attached hereto
as Exhibit B.


 


“Product
Liability Claim” shall mean any Third Party proceedings involving any actual or alleged death or bodily injury arising
out of or resulting from the use of the Licensed Product sold by Licensee or its Sublicensees.


 


“Prohibited
List” shall mean (a) the HHS/OIG List of Excluded Individuals/Entities (available through the Internet at http://www.oig.hhs.gov);
(b) the General Services Administration’s List of Parties Excluded from Federal Programs (available through the Internet
at http://www.epls.gov); and (c) the FDA Debarment List (available through the Internet at http://www.fda.gov/ora/compliance_ref/debar/).
-


 


“PRC”
shall mean the People’s Republic of China, excluding Hong Kong and Macau.


 


“Prosecute”
shall have the meaning given such term in Section 8.5(a).


 


“Receiving
Party” shall have the meaning given such term in Section 9.1.


 


“Regulatory
Approval” shall mean any and all approvals (including, to the extent necessary, pricing approvals), licenses, registrations
or authorizations of any Governmental Authority, necessary for the promotion, development (including without limitation the conduct
of clinical trials), marketing, distribution, manufacture, sale or importation of a Licensed Product.


 


“Regulatory
Authority” shall mean any applicable Governmental Authority in any jurisdiction in the Territory from which Regulatory
Approval is required to be obtained, including the State Food and Drug Administration in the PRC, the Trade and Industry Department
and the Department of Health in Hong Kong, and any local counterparts.


 


“Regulatory
Laws” shall mean all applicable Laws governing (i) marketing approval or clearance, import, export, testing, investigation,
development, manufacture, packaging, labeling, handling, storage, distribution, installation, servicing, marketing, or sale, (ii) recordkeeping
and reporting obligations, (iii) recalls, or (iv) similar regulatory matters, with respect to the Licensed Product.


 


“Relevant
Period” shall mean, on a Licensed Product by Licensed Product basis, the period starting from the Effective Date and
ending on the expiration of the last-to-expire valid and applicable Licensed Patent within the Territory or ten (10) years from
the First Commercial Sale of each Licensed Product in the PRC, whichever is later.


 


“Renewal
Options” shall have the meaning given such term in Section 12.1


 


“Royalty
Term” shall mean the period commencing on the First Commercial Sale and ending at the expiration of or the effective
date of termination of this Agreement.


 






    	7*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


“Semester”
shall have the meaning January 1 through June 30 and July 1 through December 31 of each calendar year.


 


“SFDA”
shall mean the State Food and Drug Administration in the PRC.


 


“Sublicensee”
shall mean any Affiliate or Third Party to whom Licensee sublicenses any rights as permitted by Section 2.1(c).


 


“Sublicense
Participation Fee” shall mean any non-refundable consideration, including, but not limited to, up-front licensing fees,
development, commercial, advance royalty, or other milestone payments received by Licensee from a Sublicensee pursuant to an agreement
in connection with the development and commercialization of a Licensed Product in the Territory. 


 


“Supply
Agreement” shall have the meaning given such term in Section 5.2.


 


“Taiwan”
shall mean the Republic of China.


 


“Tβ4”
shall mean the 43 amino acid peptide commonly referred to as Thymosin Beta 4.


 


“Territory”
shall mean the PRC, Hong Kong, Macau and Taiwan.


 


“Third
Party” shall mean any Person other than Licensor, Licensee, and Affiliates of either Party.


 


“Trademark”
shall mean any trademark, trade dress, brand mark, trade name, brand name, logo, business symbol or other similar indicia of origin.


 


“ICC
Rules” shall have the meaning given such term in Section 13.8(c).


 


“Valid
Claim” shall mean a claim of an issued and unexpired Licensed Patent, that has not been revoked or held unenforceable
or invalid by a decision of a court or other Governmental Authority of competent jurisdiction, and that is not appealable or has
not been appealed within the time allowed for appeal, and that has not been abandoned, disclaimed, denied or admitted to be invalid
or unenforceable through reissue, re-examination, disclaimer or otherwise.


 


 


Section
2.  License Grant and Other Rights


 


2.1License
Grants to Licensee


 


(a)Non-Exclusive
License. Subject to the terms of this Agreement, Licensor hereby grants to Licensee a non-exclusive, irrevocable (except as
otherwise provided for in this Agreement and the PHS License), royalty-free license to use the Licensed Patents and the Licensed
Know-How to develop the Licensed Product in the Field in the Territory.


 


(b)Exclusive
License. Subject to the terms of this Agreement, Licensor hereby grants to Licensee an exclusive irrevocable (except as otherwise
provided for in this Agreement and the PHS License) royalty-bearing license to use the Licensed Patents and the Licensed Know-How
to manufacture, offer to sell, sell and import the Licensed Product in the Field in the Territory.


 






    	8*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


(c)Sublicensing.


 


(i)Licensee
shall be entitled to sublicense any or all of the rights granted to Licensee pursuant to Section 2.1(a) or 2.1 (b) to any
of its Affiliates or Third Party upon thirty (30) days’ prior written notice to Licensor, which notice shall include the
identity of such Affiliate or Third Party..


 


(ii)All
sublicenses granted to Affiliates or Third Parties pursuant to Section 2.1(c)


(i) above shall be subject to all terms, conditions, obligations and covenants
of this Agreement and all applicable provisions of the PHS License. No sublicense shall relieve Licensee of any of its obligations
hereunder.


 


(d)No Further
Licenses. Except for the licenses granted to Licensee pursuant to Sections 2.1(a)


  and 2.1 (b), no further rights or licenses are granted to Licensee
in or under this Agreement, whether expressly or by implication.


 


(e)Licensor’s
Retained Rights. Notwithstanding the rights granted to Licensee in Sections 2.1(a) and 2.1(b) and without limiting the generality
of Section 2.1(f), Licensor retains the rights to:


 


(i)conduct
or have conducted clinical trials and other studies involving the Licensed Product in the Territory for the generation of data
in support of regulatory submissions to the Regulatory Authorities outside the Territory; or


 


(ii)conduct
activities in the Territory with respect to the manufacture, formulation and processing of the Licensed Product for use and commercialization
outside the Territory, provided that Licensor shall first give Licensee the opportunity to manufacture, formulate and process
the Licensed Product for commercialization outside the Territory. If Licensee chooses not to provide such activities to Licensor,
or is unable to perform such activities for whatever reason, or the price or timing for such activities is unacceptable to Licensor,
Licensor shall be free to choose an alternative source in the Territory for such activities.


 


(f)Negative
Covenant. Licensee covenants that it will not, and it will not permit any of its Affiliates to, use or practice any Licensed
Patents and Licensed Know-How outside the scope of the license granted to it under Sections 2.1(a) and 2.1(b) above.


 


2.2Transfer
of Licensed Know-How. Upon the reasonable request of Licensee and at no cost to Licensee, Licensor shall promptly provide
Licensee with such tangible embodiments of the Licensed Know-How as are in Licensor’s possession or control so as to permit
Licensee to enjoy the licenses granted to it pursuant to Sections 2.1(a)


  and 2.1 (b).


 






    	9*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


2.3Use
of Affiliates. At Licensor’s option, any of Licensor’s rights under this Agreement may be exercised by any Affiliate
of Licensor. Further, at Licensor’s option, any of Licensor’s obligations under this Agreement may be performed by
any Affiliate of Licensor, and such obligations will be deemed satisfied upon performance by such Affiliate.


 


2.4PHS
Reserved Rights. Notwithstanding anything contained in Section 2.1


to the contrary, Licensee:


 


(a)acknowledges
that PHS has retained certain rights and interests in the Licensed Patents pursuant to the PHS License;


 


(b)agrees
that the provisions of the PHS License contained in Exhibit C shall be binding on Licensee and its successors as if Licensee
or its successors were the licensee under the PHS License; and


 


(c)shall assist
Licensor in complying with Licensor’s obligations under the PHS License.


 


 


Section
3. Development


 


3.1Development
Plan.


 


(a)Initial
Development Plan. Licensee shall carry out all development activities with respect to the Licensed Product in the Territory
in accordance with a development plan as agreed upon in writing by the Parties (the “Development Plan”).


 


(b)Development
Activities. For purposes of this Agreement, development activities shall mean all activities that are reasonably required
to obtain Regulatory Approval of the Licensed Product in the Territory, including without limitation toxicology, in vitro testing,
in vivo testing, in silico testing, stability testing, statistical analysis and report writing, packaging and regulatory affairs,
preclinical studies and clinical trials.


 


3.2Content
of Development Plans. The Development Plan (as amended after the Effective Date) shall include, to the extent applicable,
(i) the identity of the Licensed Product to be developed, (ii) a description of the overall program of development for such Licensed
Product through Regulatory Approval in the Territory, (iii) a description of the development activities including preclinical
studies, pharmacology, toxicology, formulation, clinical pharmacology studies, clinical studies and regulatory plans and other
key elements necessary to obtain Regulatory Approval for the Licensed Product, (iv) specific plans and protocols for clinical
studies, including Licensee’s good faith forecast of the quantity of clinical supplies of API that Licensee will require,
(v) a schedule for all such activities, and (vi) specific tentative deadlines for meeting specified regulatory milestones.


 


3.3Updates
and Amendments to the Development Plan. The Parties shall amend the Development Plan at least once every twelve (12) months
to expand and refine the description of the activities specified in the initial Development Plan or other then current Development
Plan and to add other development activities, and the anticipated schedule and budgets for all such activities. Such amended Development
Plan shall become effective only upon the approval of the Joint Development Committee. If the Parties fail to update the Development
Plan as required by this Section 3.3 the most recently approved Development Plan shall continue in effect until such time as an
amended Development Plan becomes effective.


 






    	10*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


3.4Joint
Development Committee. Within one hundred eighty days (180) days from the Effective Date, the Parties shall establish a joint
development committee (the “Joint Development Committee”) to coordinate and oversee the development of the
Licensed Product in the Territory.


 


(a)Composition
of the Joint Development Committee. The Joint Development Committee shall be comprised of an equal number of representatives
from each Party, initially two persons, each of whom has relevant experience and skill appropriate for service on the Joint Development
Committee, such as heads of clinical, manufacturing, and commercial development. The Parties may establish and later change the
number of representatives that each Party has on the Joint Development Committee, as long as an equal number of representatives
from each Party is maintained (unless such Party desires to have fewer representatives). Each Party may change any of its representatives
on the Joint Development Committee at any time upon notice to the other Party.


 


(b)Decisions
of the Joint Development Committee. Except as otherwise provided in this Agreement, in the event that the Joint Development
Committee cannot reach a decision in any matter properly before it, Licensee shall have final decision-making authority with respect
to such matter, including approval and amendments of the Development Plan; provided, however, that any such matter under dispute
shall first be referred to the Parties’ respective Presidents or chief executive officers, for attempted resolution by good
faith negotiations within fourteen (14) days; further provided, that any final decision made by Licensee shall (i) be consistent
with the terms of this Agreement (including Licensee’s diligence obligations hereunder); (ii) not materially affect the
rights and obligations of Licensor under this Agreement without Licensor’s consent; (iii) not materially affect the development,
manufacture or commercialization of the Licensed Products outside the Field and/or outside the Territory, as reasonably determined
by Licensor.


 


(c)Activities
of the Joint Development Committee. The Joint Development Committee shall be responsible for establishing and approving the
Development Plan.


 


(d)Meetings
of the Joint Development Committee. The Joint Development Committee shall hold its first meeting within one hundred eighty
days (180) days after the Effective Date and shall meet thereafter on a schedule and at locations mutually determined by the Parties.
Ad hoc meetings of the Joint Development Committee may be called by either Party upon reasonable advance notice to the other.
Subject to the Parties mutual agreement, regular and ad hoc meetings may be face-to-face or by teleconference or videoconference.


 






    	11*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


(e)Joint
Development Committee Expenses. Each Party shall bear the expense of the participation of its representatives on the Joint
Development Committee and in Joint Development Committee meetings.


 


3.5Clinical
Trials. Licensee shall be responsible for conducting or having conducted all clinical trials of the Licensed Product in the
Territory and for paying all fees, costs and other expenses associated therewith.


 


3.6Regulatory
Approvals. Licensee shall be responsible for obtaining and maintaining all Regulatory Approvals necessary to conduct such
clinical trials, including without limitation any Certificate for Clinical Trial and Medicinal Test in Hong Kong, and for paying
all fees, costs and other expenses associated therewith.


 


3.7Licensor’s
Cooperation. As reasonably requested by Licensee, Licensor shall cooperate with and assist Licensee in obtaining any Regulatory
Approvals necessary to conduct clinical trials of the Licensed Product in the Territory. In connection therewith, Licensor shall
provide Licensee upon request with copies of any regulatory materials and/or data as are reasonably necessary for these purposes.


 


3.8Clinical
Supply of Licensed Product.


 


(a)Clinical
Supply. Licensor shall supply Licensee with such quantities of the API, as appropriate, as are required by Licensee in order
to conduct development activities in accordance with the Development Plan, including clinical trials of the Licensed Product.
Licensor shall supply such API on the schedule and subject to such forecasting, pricing, and other ordering and delivery procedures
as are mutually agreed upon in writing by the Parties.


 


(b)Clinical
Supply Costs. Subject to the other provisions hereof, Licensor shall supply at its cost sufficient supply of API for a Phase
II dry eye clinical trial required by Licensee pursuant to Section 3.8(a)


. Licensee shall reimburse Licensor for Licensor’s fully-allocated manufacturing
costs for any API required by Licensee for all other clinical development, including clinical trials. In all cases, Licensee shall
be responsible for the cost of formulating, filling and finishing Licensed Product in accordance with applicable Laws in the relevant
jurisdiction.


 


3.9Diligence.
Notwithstanding anything specified in any Development Plan, Licensee shall at all times exert no less than Commercially Diligent
Efforts to develop at least one Licensed Product in the Territory, including seeking Regulatory Approval and Marketing Approval
of the Licensed Product in the Territory. Licensee shall require any Affiliates, Sublicensees, and/or Third Parties it uses to
develop the Licensed Product to use such efforts on Licensee's behalf.


 






    	12*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


Section
4. Commercialization of Licensed Product 


 


4.1Commercialization
Plan.


 


(a)Initial
Commercialization Plan. Licensee shall carry out all commercialization activities with respect to the Licensed Product in
the Territory in accordance with a commercialization plan provided for by Licensor (the “Commercialization Plan”).
The initial Commercialization Plan shall be provided to Licensor within ninety (90) days from the expected First Commercial Sale
date with respect to PRC.


 


(b)Commercialization
Activities. For purposes of this Agreement, commercialization activities shall mean all appropriate activities undertaken
before and after Regulatory Approval relating specifically to the marketing, sale and distribution of the Licensed Product in
the Territory, including, without limitation, (i) sales force detailing, advertising, education, planning, marketing, sales force
training and distribution, (ii) scientific and medical affairs, and (iii) pricing and related terms for the Licensed Product.


 


4.2Content
of Commercialization Plan.


 


(a)Description
of Activities. The Commercialization Plan (as amended, if needed) shall include a reasonable description of the activities
that Licensee shall undertake in order to market the Licensed Product in the Territory, including, but not limited to, (i) media
marketing plans, promotional activities and similar matters, including detailed budgets, and (ii) the identity of intended major
Distributors and Sublicensees, if any.


 


(b)Net
Sales Targets. The Parties acknowledge that, as of the Effective Date, specific Net Sales targets in any Marketing Year are
difficult to determine. The Commercialization Plan shall specific a broad range of Net Sales targets that will be refined and
updated in amendments to the Commercialization Plan as the Licensed Product in the Territory approaches Regulatory Approval.


 


4.3Amendments
to the Commercialization Plan. The Parties shall amend the Commercialization Plan at least once every twelve (12) months after
the First Commercial Sale date with respect to the PRC to refine the description of the activities specified in the initial Commercialization
Plan and any subsequently amended Commercialization Plan, and to add other commercialization activities, to update the anticipated
schedule and budgets for all such activities, and to update the Net Sales targets. Such amended Commercialization Plan shall comply
with the provisions of Section 4.2. If the Parties fail to update the Commercialization Plan as required by this Section 4.3,
the most recently approved Commercialization Plan shall continue in effect until such time as an amended Commercialization Plan
becomes effective pursuant to this Section 4.3.


 


4.4Diligence.
Licensee shall at all times exert no less than Commercially Diligent Efforts to promote, market and distribute at least one Licensed
Product in the Territory. Licensee shall require any Affiliates, Sublicensees, Distributors, and/or other Third Parties it uses
to promote, market and distribute the Licensed Product to use such efforts on Licensee's behalf.


 






    	13*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


4.5Notification
of Benchmarks and Milestones. Licensee shall report in writing to Licensor the date of the First Commercial Sale in each country
of the Territory and the achievement of any milestone specified in this Agreement within thirty (30) days of such occurrences.


  


Section
5. Manufacture and Supply of Licensed Product 


 


5.1Supply
Obligation. Upon Licensee’s written request and subject to the terms of a definitive supply agreement to be negotiated
by the Parties, Licensor shall manufacture and supply to Licensee (i) API at no charge for a Phase 2 ophthalmic clinical trial
aimed at studying the Licensed Product in patients affected by dry eye in quantities and timeframes to be agreed; and (ii) API
at Licensee’s cost for other clinical trials to be conducted by Licensee in the Territory.


 


5.2Supply
Terms. Licensee shall at all times be entitled to manufacture or source API from suppliers of its choice. Upon Licensee’s
written request, Licensee may purchase all or part of its commercial requirements of API from Licensor at a cost plus price to
be discussed and agreed upon by the Parties, subject to Licensor’s ability to deliver required amounts of API pursuant to
the terms of a commercial supply agreement to be negotiated by the Parties.


 


5.3Manufacturing
License. Licensor grants to Licensee the rights under the Licensed Patents and Licensed Know-How as may be necessary in order
for Licensee to manufacture or have manufactured by an Affiliate or by a Third Party the API and the Licensed Product in the Territory
for the sole purpose of exercising the licenses granted to Licensee pursuant to Sections 2.1(a) and
(b).


  


Section
6. Royalties and Payments 


 


6.1Royalties.



 


(a)During
the Royalty Term, on an annual basis, Licensee shall pay Licensor royalties equal to [***]% of aggregate annual Net Sales up to
U.S. $[***] for all Licensed Products, [***]% of aggregate annual Net Sales for all Licensed Products between U.S. $[***] and
U.S. $[***], and [***]% of aggregate annual Net Sales for all Licensed Products above U.S. $$[***]. Each such payment shall be
due and payable no later than sixty (60) days after the end of the Semester in which the applicable Net Sales were made. In case
any Generic/Branded Generic of any Licensed Product by any Third Party enter the market without a direct or indirect agreement
with the Licensee, its Affiliates or their Sublicensees or Distributors for the Licensed Product and during the applicable Semester
, on a country-by-country basis and product-by-product basis, such Generic/Branded Generic taken in the aggregate have according
to IMS or similar data source a market share (measured in US dollars) in such country of at least 30% (thirty percent), then the
royalties’ rate applicable in such market will be reduced by fifty percent (50%).


 


(b)If it is
necessary for Licensee to obtain a license from a Third Party under any Patent in a particular country in the Territory in order
to use, make, or sell a Licensed Product and Licensee obtains such a license, Licensee may deduct, from the royalty payment that
would otherwise have been due pursuant to Section 6.1(a) with respect to Net Sales of the applicable Licensed Product in such
country in a particular applicable Semester an amount equal to fifty percent (50%) of the royalties paid by Licensee to such Third
Party pursuant to such license on account of the sale of such Licensed Product in such country during such applicable Semester.


 






    	14*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


(c)If Licensee
wishes to pursue the development, promotion, marketing, distribution and sale of the Tβ4 fragment LKKTETQ, which product
was licensed for certain uses by Licensee from the National Institute of Health of the United States of America prior to the signing
of this Agreement, and if such development, promotion, marketing, distribution and sale would infringe upon any Valid Claim of
any issued patents or future patents owned or Controlled by Licensor in the Territory (hereinafter, «Licensor LKKTETQ Patent »),
then the license grant and other rights granted from Licensor to Licensee according to Section 2 of this Agreement shall be automatically
expanded to include also the Licensee’s right to exploite such Licensor LKKTETQ Patent. In such a case, the Parties will
negotiate in good faith an appropriate royalty on the Net Sales obtained by Licensee in the Territory with the LKKTETQ containing
product whose sales infringe any Valid Claim as referred to above. In no event such royalty will be greater than seventy percent
(70%) of the royalty rates provided for in Section 6.1(a) above. Furthermore, in this case, there will be no License Fees nor
Milestone Payments nor Sublicense Participation Fees owed by Licensee to Licensor in connection with the sales of such LKKTETQ
containing product.


 


6.2Licensee
Fee.


 


(a)On March
28, 2012 Licensee paid Licensor U.S. $200,000 pursuant to the terms set forth in the Binding Term Sheet that was executed between
the Parties on March 27.


 


(b)Licensee
shall promptly pay to Licensor U.S. $200,000 upon execution of this License Agreement.


 


(c)Licensor
shall be obligated to promptly return to Licensee U.S. $200,000 if License Agreement is not executed.


 


6.3Milestone
Payments.


 


(a)Licensee
shall promptly pay to Licensor a non-refundable sum of U.S. $500,000 upon initiation of First Commercial Sale of the first Licensed
Product in the PRC.


 


(b)Licensee
shall promptly pay to Licensor a non-refundable sum of U.S. $1,500,000 upon obtaining U.S. $50,000,000 of aggregate, cumulative
commercial Net Sales in the Territory.


 


(c)Licensee
shall promptly pay to Licensor a non-refundable sum of U.S. $1,600,000 upon obtaining U.S. $80,000,000 of aggregate, cumulative
commercial Net Sales in the Territory.


 






    	15*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


6.4Sublicense
Participation Fees. Licensor shall be entitled to an amount equal to thirty percent (30%) of any Sublicense Participation
Fees received by Licensee, provided that any amounts already paid to Licensor under Section 6.2 and 6.3 above with respect to
such Licensed Product shall be creditable against the amount payable under this Section 6.4.


 


6.5Royalty
Reports. Licensee shall furnish to Licensor, within sixty (60) days following the end of each Semester during the Royalty
Term, a complete, detailed and accurate written report for such Semester showing (i) the gross amount of sales, on a unit-by-unit
basis, of Licensed Products by Licensee and Sublicensees to independent buyers (whether an end-user, wholesaler or otherwise)
in bona fide arm’s length transactions; (ii) the adjustments resulting from the deductions in the definition of “Net
Sales; (iii) total Net Sales and (iv) the conversion into United States Dollars, pursuant to Section 6.7, of any
such Net Sales made in another currency; and (v) the calculation of royalties due.


 


6.6Manner
of Payments. All payments due Licensor under this Agreement shall be payable in United States Dollars by wire transfer of
immediately available funds to such bank account(s) as Licensor shall designate, or by such other method as Licensor may reasonably
designate.


 


6.7Exchange
Rate. When converting any amount in another currency into United States Dollars, Licensee shall use an exchange rate
equal to New York foreign exchange rate quoted in the Wall Street Journal on the business day prior to the date a payment
under this Agreement is due.


 


6.8Interest
on Late Payments. Any payment not paid within thirty (30) calendar days from the date such payment is due under this Agreement
shall be subject to interest from and including the date such payment is due through and including the date such payment is actually
made at an annual rate equal to the sum of two percent (2%) plus the annual prime rate of interest quoted in the Money Rates Section of
the Wall Street Journal calculated daily on the basis of a 365-day year, or similar reputable data source, or, if lower,
the highest rate permitted under applicable law. The payment of such interest shall not limit Licensor from exercising any other
rights it may have as a consequence of the lateness of any payment.


 


6.9Records;
Audit Rights.


 


(a)Records.
Licensee shall maintain, and shall require its Affiliates and Sublicensees to maintain, during the Term of this Agreement and
for a period of five (5) years thereafter, complete, detailed and accurate books and records in connection with the sale of Licensed
Product as necessary to allow the accurate determination of any and all financial and accounting information relevant to either
Party’s payment obligations hereunder, including without limitation as necessary for the calculation of the royalties due
to Licensor hereunder and any fees payable pursuant to Section 12.3(d)


 


(b)Audit
Rights.


 






    	16*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    
 


 


(i)Licensor
or its representative shall have the right to annually audit Licensee’s, its Affiliates’ and its Sublicensees’
records as set forth in this Section 6.9


. Licensee shall permit Licensor or its representative to have access during
normal business hours to such records of Licensee, its Affiliates and its Sublicensees as may be reasonably necessary to verify
the accuracy of the royalty reports hereunder for any Semester during a Marketing Year ending not more than one (1) year prior
to the date of such request, provided that if Licenseee or its Sublicensee as defined herein restates any of its financial statements,
or if there are any financial irregularities reported, or if during the audit of Licensee’s records under this Section 6.9(b)(i)
material discrepencies are found with regard to royalties owed to Licensor, Licensor shall be able to audit the Licensee’s
or Sublicensee’s records for most recently ended Marketing Year and any Marketing Year ending not more than three (3) years
prior thereto. Annual audits can take place no more often than once per each calendar year. Notice of Licensor’s intent
to conduct an audit must be provided within 30 days of the later of: (i) Licensor’s receipt of the periodic royalty report
reflecting full yearly sales of Licensed Product or (ii) Licensee’s filing of its official report in accordance with the
Hong Kong Stock Exchange regulations. Except as otherwise provided in Section 6.9(b)(ii), each Party shall be responsible
for its own costs and expenses relating to any audit conducted under this Section 6.9(b)(i). Licensee shall cause its Affiliates
and Sublicensees to agree to make their records available for audit by Licensor or its representative as set forth in this Section 6.9.


 


(ii)If any
audit conducted by Licensor or its representative shows an underpayment of royalties to Licensor, Licensee shall remit to Licensor
the amount of such underpayment within thirty (30) days after its receipt of Licensor’s request therefor. If an underpayment
in royalties exceeds five percent (5%) of the total amount owed for the period then being audited, Licensee shall be responsible,
and promptly shall reimburse Licensor, for Licensor’s reasonable out-of-pocket costs for conducting the audit. If any audit
conducted by Licensor or its representative shows an overpayment of royalties to Licensor, then at Licensor’s option, such
overpayment shall either be refunded to Licensee promptly or be credited against amounts payable by Licensee in subsequent Semesters.


 


(c)Confidentiality.
Licensor shall treat all financial information of Licensee, its Affiliates and Sublicensees that Licensor reviews in connection
with any audit conducted under this Section 6.9 as Confidential Information of Licensee
subject to the provisions of Section 9 of this Agreement.


  


Section
7. Regulatory Matters


 


7.1Regulatory
Approvals. Licensee shall have the sole authority and responsibility to obtain in its own name and maintain any Regulatory
Approvals and Marketing Approvals with respect to the Licensed Product in the Territory. Licensor shall, promptly after the Effective
Date, provide Licensee with a copy of any relevant data related to the Licensed Product owned by Licensor that have been filed
with the FDA. Subject to the prevailing applicable Regulatory Law in the Territory, Licensor shall retain the sole right, but
not the obligation, to be designated as the sponsor of any and all clinical trials of Licensed Product conducted by Licensee,
and Licensor shall have the sole right to decide, to the extent permitted by the applicable Regulatory Law in the Territory, whether
any clinical trials shall be conducted under an IND issued by the FDA or under an IND issued by the SFDA. Irrespective of the
exercise of such rights, Licensee shall at all times be responsible for ensuring that any and all clinical trials are conducted
in compliance with all applicable Regulatory Laws and other requirements of any Regulatory Authority in the Territory, and all
Regulatory Laws and other requirements of any Governmental Authority (including any promulgated by the FDA) that would be applicable
if such clinical trials were sponsored under Licensor’s IND or otherwise subject to the jurisdiction of the FDA.


 






    	17*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


7.2Contact
with Governmental Authorities. Subject to the other provisions of this Section 7.2, Licensee shall be solely responsible
for responding to all inquiries, notices of violation, warning letters, inspectional observations, and other actions from or by
Governmental Authorities in the Territory, in each case to the extent related to the Licensed Product in the Territory. Licensor
and Licensee shall immediately forward to each other copies of any material correspondence from any Governmental Authority that
it receives in respect of the Licensed Product. Notwithstanding the other provisions of this Section 7.2, Licensee shall
not respond to any inquiries or other correspondence from a Governmental Authority with respect to the Licensed Product in the
Territory without first providing Licensor with a copy of its proposed response, and incorporating any reasonable comments of
Licensor in such response. Licensor shall cooperate with Licensee in responding to any inquiry or other correspondence from a
Governmental Authority in a timely manner, including by promptly responding to all inquiries of Licensee relating thereto.


 


7.3Regulatory
Information. Each Party agrees to provide the other Party with all reasonable assistance and take all actions reasonably requested
by the other Party that are necessary or desirable to enable the other Party to comply with any Law or other requirement of any
Governmental Authority applicable to the Licensed Product. Such assistance and actions shall include, among other things, (a) informing
the other Party, within five (5) business days, of receiving notice of any action by, or notification or other information which
it receives (directly or indirectly) from any Governmental Authority that: (i) raises any material concerns regarding the safety
or efficacy of the Licensed Product; (ii) indicates or suggests a potential material liability for either Party to Third Parties
arising in connection with the Licensed Product; or (iii) is reasonably likely to lead to a field alert report, recall or market
withdrawal of the Licensed Product; provided, that neither Party shall be obliged to disclose information in breach of any contractual
restriction; and (b) Licensee immediately reporting to Licensor the occurrence of any adverse reaction (including without
limitation death) or other incident during any clinical trial or medicinal exam and any other information so as to enable Licensor
to fulfil its reporting obligations to any Governmental Authority, as further specified by the Safety Agreement.


 


7.4Official
Documentation. Licensee shall provide to Licensor one exact copy of any official registration and/or importation documents
supplied by the relevant Regulatory Authorities immediately upon issuance. In case of early termination of this Agreement, Licensee
shall provide to Licensor any original versions of such registrations and/or documents that are not otherwise in Licensor’s
possession as per Section 12.3(a).


 






    	18*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


7.5Clinical
Trial Reports. Without limiting any of Licensee’s obligations under this Agreement, Licensee shall be responsible for
preparing the clinical trial yearly progress reports, clinical trial final report and any other reports as may be required by
a Regulatory Authority in connection with clinical trials of the Licensed Product; provided, however that Licensee shall provide
drafts of such reports for Licensor’s knowledge prior to submission to the applicable Regulatory Authority and provide all
final reports submitted to applicable Regulatory Authorities.


 


7.6Unknown
Side Effects; Adverse Reactions


 


(a)Reporting
Unknown Side Effects and Adverse Reactions. Each Party shall provide promptly to the other Party any information and data
relating to any serious or previously unknown side effects or adverse reactions relating to the Licensed Product that the providing
Party receives from any source, as further specified in the Safety Agreement.


 


(b)Safety
Agreement. Promptly after the Effective Date and before the date that Licensee commences any clinical trials of the
Licensed Product in the Territory, the Parties shall enter into a separate written safety agreement containing
(i) appropriate provisions addressing safety issues relating to the Licensed Products, (ii) a description of the
types of side effects and reactions that must be reported pursuant to Section 7.6(a) and any other complaints or
information requests that must be reported, and (iii) such cooperative working procedures as are reasonably necessary to
ensure that satisfactory systems and processes are in place to ensure the effective exchange of safety and other medical
information relating to the Licensed Product (the “Safety Agreement”).


 


Section
8.  Intellectual Property


 


8.1Trademarks.
Licensee shall be free to use Licensee’s Trademarks or any other Trademark(s) owned by the Licensee in the Territory for
the Licensed Product.


 


8.2Ownership
of Inventions.


 


(a)Licensee
Inventions. Subject to any licenses granted to Licensor herein, Licensee shall own all Inventions having as inventors only
employees, consultants or contractors of Licensee (“Licensee Inventions”). Licensee shall have written agreements
in place with its employees, consultants, and contractors giving Licensee all rights and authority necessary to grant the license
in Section 8.3(a).


 


(b)Licensor
Inventions. Subject to any licenses granted to Licensee herein, Licensor shall own all Inventions having as inventors only
employees, consultants or contractors of Licensor (“Licensor Inventions”). Licensor shall have written agreements
in place with its employees, consultants, and contractors giving Licensor all rights and authority necessary to grant the license
in Section 8.3(b).


 


(c)Joint
Inventions. Licensee and Licensor shall own jointly all Inventions having as inventors employees, consultants or contractors
of both Licensee and Licensor (“Joint Inventions”). The Parties will agree on a case-by-case basis the appropriate
allocation of cost and control concerning matters regarding the prosecution, maintenance, defense and infringement of Patents
for such Joint Inventions.


 






    	19*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


8.3Licenses
to Certain Inventions. 


 


(a)License
Grant to Licensor. To the extent that any Licensee Invention or any Joint Invention relates to the development, promotion,
marketing, distribution, manufacturing or sale of the Licensed Product, Licensee hereby grants to Licensor, and Licensor hereby
accepts, an exclusive, perpetual, transferable, sublicensable (through multiple tiers), royalty-bearing license under Licensee’s
rights in such Licensee Invention or Joint Invention, as applicable, to research, develop, promote, market, distribute, manufacture,
have manufactured, sell, offer for sale or import the Licensed Product outside the Territory and/or outside the Field. The foregoing
license shall include a right of reference (transferable by Licensor to its Affiliates and sublicensees) to all regulatory filings
made by Licensee in the Territory and all data from any clinical trials conducted by Licensee pursuant to this Agreement for the
development, manufacture and commercialization of any Licensed Product outside the Territory and/or outside the Field. Licensee
shall promptly disclose all Licensee Inventions and Joint Inventions in writing to Licensor. If Licensor desires to use any such
Licensee Invention and/or Joint Invention for the development, manufacture and commercialization of the Licensed Products outside
the Territory and/or outside the Field, Licensor shall notify Licensee in writing. Following Licensee’s receipt of such
notice, the Parties shall negotiate in good faith and on a case-by-case basis the terms and conditions of such license, including
commercially reasonable royalty rates; provided that such royalty shall in no event exceed 4% on relevant net sales. If the Parties
are unable to agree on the terms and conditions for such license within ninety (90) days of commencemcent of negotiations, the
matter shall be resolved in accordance with Section 13.8.


 


(b)License
Grant to Licensee. To the extent that any Licensor Invention or any Joint Invention relates to the development, promotion,
marketing, distribution, or sale of the Licensed Product, then such Licensor Invention or Licensor’s interest in such Joint
Invention, as applicable, shall be deemed a Licensed Patent and shall be subject to the licenses granted to Licensee pursuant
to Sections 2.1(a) and 2.1(b).


 


8.4Patent
Marking. Licensee shall, and shall cause its Affiliates, Sublicensees and Distributors to mark all Licensed Products sold
or otherwise distributed pursuant to this Agreement in accordance with the applicable patent statutes and other relevant regulations
in the jurisdiction of the Territory in which such Licensed Product is manufactured, sold or otherwise distributed.


 


8.5Prosecution
and Maintenance of Licensed Patents in the Territory.


 


(a)Prosecution.
As between Licensor and Licensee, Licensor shall have the right, but not the obligation, to prepare, file, prosecute, and maintain
the Licensed Patents in the Territory, and to pursue any proceeding (including interferences, re-examinations, examinations, protests,
reissues, opposition proceedings and the like) relating to any of the Licensed Patents (collectively “Prosecute”)
in the Territory, such costs and expenses shall be shared equally by the Parties. The Parties agree to utilize Licensee’s
local intellectual property counsel and counsel shall promptly provide Licensor with all information related to such prosecution.
In the event that Licensor decides not to Prosecute any Licensed Patent, Licensor shall notify Licensee of its decision and the
reason therefor, and subject to Licensor’s consent (which will not be unreasonably withheld or delayed), Licensee shall
have the right to Prosecute such Licensed Patent in the Territory at its expense.


 






    	20*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


(b)Cooperation.
In connection with any of Licensor’s activities to Prosecute any of the Licensed Patents, Licensee shall cooperate fully
and provide Licensor with any information or assistance that Licensor reasonably requests, including executing such documents
as may be necessary with respect to such prosecution activity. If Licensee becomes aware of any patent, information, proceeding
or other matter that may affect the preparation, filing, prosecution, or maintenance of any of the Licensed Patents or that may
adversely impact the validity, scope, title or enforceability of any of the Licensed Patents, Licensee shall promptly notify Licensor
of such patent, information, proceeding, or matter.


 


8.6Infringement
by Third Parties.


 


(a)Notice.
If Licensee learns of any actual or possible infringement of any Licensed Patent in the Territory, or any actual or possible misappropriation
or misuse of Licensed Know-How, Licensee shall promptly notify Licensor of such infringement, misappropriation or misuse.


 


(b)Right
to Bring Suit in the Territory.


 


(i)As between
Licensor and Licensee, Licensor shall have the right but not the obligation, to bring and control any legal action or proceeding
with respect to any infringement of Licensed Patents or any misappropriation or misuse of Licensed Know-How by Third Parties in
the Territory, at its own expense and using counsel of its own choice.


 


(ii)In the
event that Licensor declines to take legal action with respect to any infringement of the Licensed Patents, Licensee shall have
the right, after giving Licensor ten (10) working days’ prior notice of its intent to do so, to take such legal action at
its own expense, with the concomitant right to choose legal counsel reasonably acceptable to Licensor and to determine legal strategy.
Licensor shall have the right to participate in any such legal action using its own counsel, at its own expense. Licensee may
not settle or compromise any such controversy with any Third Party without the prior written approval of Licensor, which shall
not be unreasonably withheld or delayed.


 


(iii)For
any action or proceeding brought by Licensor pursuant to this Section 8.6


, if Licensor is unable to initiate or prosecute such action solely in its
own name, then Licensee shall join such action voluntarily and shall execute all documents necessary to initiate litigation to
prosecute and maintain such action-


 






    	21*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    
 


 


(iv)In connection
with any action or proceeding brought by Licensor pursuant to this Section 8.6, Licensee shall cooperate fully and will provide
Licensor with any information or assistance that Licensor reasonably requests.


 


8.7Certifications.
Each Party shall inform the other Party of any certification related to the Licensed Product regarding any Licensed Patents it
receives pursuant to either 21 U.S.C. §§ 355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or its successor provisions,
or any equivalent regulations in any jurisdiction of the Territory, and shall provide the other Party with a copy of such certification
within five (5) days of receipt by such Party. Licensor’s and Licensee’s rights with respect to the initiation
and prosecution of any legal action as a result of such certification or any recovery obtained as a result of such legal action
shall be as set forth in this Section 8.


 


8.8Defense
of Third Party Claims.


 


(a)Notice.
If either Party learns that a Third Party has commenced or plans to commence, either as a claim, a counterclaim, or an action
for declaratory judgment, an action or proceeding challenging any of the Licensed Patents in any jurisdiction of the Territory,
such Party shall promptly provide the other Party with notice thereof.


 


(b)Licensor’s
Right to Defend. As between Licensor and Licensee, Licensor shall have the right, but not the obligation, to defend and control
any claim, counterclaim or other action initiated by a Third Party challenging any of the Licensed Patents in any jurisdiction
of the Territory (each a “Challenge”), at its own expense and using counsel of its own choice.


 


(i)For the
defense of any Challenge pursuant to this Section 8.8, if Licensor is unable to initiate or prosecute such defense solely
in its own name, then Licensee (subject to any necessary approval of the relevant court) shall join such action voluntarily and
shall execute all documents necessary to initiate litigation to prosecute and maintain such action. -


 


(ii)In connection
with the defense of any Challenge brought by Licensor pursuant to this Section 8.8, Licensee shall cooperate fully and will
provide Licensor with any information or assistance that Licensor reasonably requests.


 


8.9Awards
and Recovery. Any recovery obtained by Licensor in connection with or as a result of any action contemplated by Section 8.6
or 8.8, whether by settlement of otherwise, shall be shared by the Parties as follows:


 


(a)such recovery
shall first be allocated to Licensor for reimbursement in respect of its respective out-of-pocket costs and expenses incurred
in connection with such action; and


 


(b)any remaining
amounts after such reimbursement shall be split equally by the Parties.


 



    	22*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


Section
9. Confidentiality and Press Releases


 


9.1Confidential
Information. Except to the extent expressly authorized by this Agreement, or otherwise agreed in writing by the Parties, the
Parties agree that the receiving Party (the “Receiving Party”) shall keep confidential and shall not publish
or otherwise disclose or use for any purpose other than as provided for in this Agreement any Confidential Information which is
disclosed to it by the other Party (or an Affiliate thereof) (each, a “Disclosing Party”), except to the extent
that the Receiving Party can demonstrate by competent written evidence that such Confidential Information:


 


(a)was already
legally in the possession of the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure
by the Disclosing Party;


 


(b)was generally
available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;


 


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


 


(d)was disclosed
to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing
Party not to disclose such information to others; or


 


(e)is independently
discovered or developed by the Receiving Party without the use of Confidential Information provided by the Disclosing Party.


 


9.2Exceptions.
The obligations of this Section 9 shall not apply to Confidential Information that:


 


(a)is submitted
to Governmental Authorities by the Receiving Party to facilitate the issuance of any Regulatory Approval for the Licensed Product,
or to obtain, maintain, enforce or defend Patents (in each case only to the extent permitted by this Agreement; provided that
(A) such disclosure may be only to the extent reasonably necessary to obtain Regulatory Approvals or Patents, as applicable, and
(B) the Receiving Party shall take reasonable measures to assure confidential treatment of such information to the extent applicable;


 


(b)is provided
by the Receiving Party to Third Parties (including, in the case of Licensee, to its Affiliates, Sublicensees or Distributors)
under written confidentiality agreements having provisions at least as stringent as those in this Agreement, for consulting, development,
external testing, marketing trials and other similar activities to the extent that such Receiving Party is permitted to conduct
such activities pursuant to this Agreement; or


 






    	23*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    
 


(c)is otherwise
required to be disclosed by the Receiving Party in compliance with Laws (including, without limitation and for the avoidance of
doubt, the requirements of the U.S. Securities and Exchange Commission, the American Stock Exchange, the Hong Kong Stock Exchange,
and any other stock exchange on which securities issued by a Party are traded) or order by a court or other Governmental Authority
having competent jurisdiction; provided, however, that the Receiving Party shall first give written notice to the Disclosing Party
in order to allow the Disclosing Party the opportunity to seek confidential treatment of the Confidential Information. Confidential
Information that is disclosed pursuant to Law or an order by a court or other Governmental Authority shall remain otherwise subject
to the confidentiality and non-use provisions of this Section 9, and the Party disclosing Confidential Information pursuant to
a Law or order by a court or other Governmental Authority shall take all reasonable steps necessary, including without limitation
obtaining an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information.


 


9.3Disclosure
to PHS. Licensor may disclose certain Confidential Information of Licensee to PHS in order to comply with the PHS License.
In such event, such Confidential Information shall be subject to the applicable confidentiality provisions of the PHS License.


 


9.4Return
of Confidential Information Upon Expiration or Termination of Agreement. Within thirty (30) days after any expiration
or termination of this Agreement, each Party shall destroy (and certify to the other Party such destruction) or return (as requested
by the other Party) all Confidential Information provided by the other Party except as otherwise set forth in this Agreement,
and except that each Party may retain a single copy of the Confidential Information in its confidential legal files for the sole
purpose of ascertaining its ongoing rights and responsibilities regarding the Confidential Information and for defending or enforcing
its legal rights.


 


9.5Written
Agreements. The Receiving Party shall have in effect or obtain written agreements from each of its employees, consultants
and contractors who have access to Confidential Information of the Disclosing Party, which agreements shall obligate such persons
to similar obligations of confidentiality, and to assign to the Receiving Party all Know-How, information and Inventions conceived,
made or reduced to practice by such persons during the course of performing the Receiving Party’s obligations under this
Agreement. Each Party will notify the other Party promptly upon discovery of any unauthorized use or disclosure of the Confidential
Information of the other Party.


 


9.6Remedies.
Each Party shall be entitled, in addition to any other right or remedy it may have, at law or in equity, to seek an injunction,
without the posting of any bond or other security, enjoining or restraining the other Party from any violation or threatened violation
of this Section 9.


 


9.7Prior
Confidentiality Agreement. The Confidential Disclosure Agreement, dated as of July 2, 2005, between Licensor and Licensee
shall remain in effect with respect to disclosures made thereunder prior to the Effective Date.


 


9.8Press
Releases. Except as required by Law (including, without limitation and for the avoidance of doubt, the requirements of the
U.S. Securities and Exchange Commission, the American Stock Exchange, the Hong Kong Stock Exchange, and any other stock exchange
on which securities issued by a Party are traded) or any Governmental Authority, neither Party shall make any press release or
other public announcement relating to this Agreement or the transactions described herein without the prior written consent of
the other Party.


 


 



    	24*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


Section
10. Representations, Warranties and Covenants


 


10.1Licensor
Representations, Warranties and Covenants. Licensor hereby represents, warrants and covenants to Licensee as follows:


 


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


 


(b)the execution,
delivery and performance of this Agreement by Licensor will not violate any Law or any order of any Governmental Authority;


 


(c)except
as may be required to permit the sale or exportation of Licensed Product into the Territory from time to time during the Term,
the execution, delivery or performance of this Agreement by Licensor will not require Licensor to obtain any permits, authorizations
or consents from any Governmental Authority, and such execution, delivery and performance will not result in a material breach
of or give rise to any termination of any agreement or contract to which Licensor is a Party;


 


(d)Licensor
has the right and authority to grant the licenses granted in Section 2


of this Agreement; and


 


(e)Licensor,
its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) debarred
or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) of the Generic Drug Enforcement
Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensor, its Affiliates, and its and their
respective employees, agents, contractors and consultants have never been (i) threatened to be debarred or (ii) indicted
for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b) of the Generic
Drug Enforcement Act of 1992 or similar Laws of any other jurisdiction. Licensor shall promptly notify Licensee upon learning
of any such debarment, conviction, threat or indictment.


 


10.2Licensee
Representations, Warranties and Covenants. Licensee hereby represents, warrants and covenants to Licensor as follows:


 


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


 






    	25*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


(b)Licensee
will be at all times properly registered, licensed and qualified, and have all requisite power and authority under its organizational
documents and in accordance with the Laws of the Territory to develop (including without limitation the conduct of clinical trials),
promote, market, distribute, import, export and sell the Licensed Product in the Territory, and to conduct its business and perform
its obligations hereunder and, during the Term, it shall take all action as may be required and necessary to obtain and keep current
any governmental licenses, permits, registrations and approvals (including without limitation Regulatory Approvals) that are necessary
or advisable for it to carry out its activities hereunder;


 


(c)the execution,
delivery and performance of this Agreement by Licensee will not violate any Law or any order of any Governmental Authority;


 


(d)except
for Regulatory Approvals and as may be required to permit the sale or importation of Licensed Product from time to time into the
Territory during the Term, the execution, delivery or performance of this Agreement by Licensee will not require Licensee to obtain
any permits, authorizations or consents from any Governmental Authority, and such execution, delivery and performance will not
result in a material breach of or give rise to any termination of any agreement or contract to which Licensee is a Party;


 


(e)Licensee,
its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) debarred
or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) of the Generic Drug Enforcement
Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensee, its Affiliates, and its and their
respective employees, agents, contractors and consultants have never been (i) threatened to be debarred or (ii) indicted
for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b) of the Generic
Drug Enforcement Act of 1992 or similar Laws of any other jurisdiction. Licensee shall promptly notify Licensor upon learning
of any such debarment, conviction, threat or indictment;


 


(f)Licensee
and its Affiliates and its and their respective employees, agents, contractors and consultants shall not use any Person on a Prohibited
List in connection with the performance of any of its obligations or activities under this Agreement;


 


(g)Licensee
shall carry out its obligations and activities under this Agreement, including the development, promotion, marketing, distribution
and sale of Licensed Products, in accordance with: (i) the terms hereof, (ii) all applicable Laws and Regulatory Laws, including
without limitation the Pharmacy and Poisons Ordinance (Chapter 138 of the Laws of Hong Kong), the Dangerous Drugs Ordinance (Chapter
134 of the Laws of Hong Kong) and any subsidiary legislation thereunder; and (iii) GCP, GLP, and, to the extent Licensee manufactures
or has manufactured any Licensed Products pursuant to Section 5.2


, GMP;


 






    	26*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


(h)As of the
Effective Date, Licensee believes in good faith that it will have sufficient financial resources available to carry out, or to
have carried out, all of its obligations and activities contemplated under this Agreement;


 


(i)Licensee
and its Affiliates shall not develop, promote, market, distribute, or sell during the Initial Term and the Extended Term any product
in the Field that utilizes or otherwise contains Tβ4 or any derivatives, analogs or fragments thereof without Licensor’s
prior written approval, with the exception of peptide LKKTETQ that Licensee has licensed from the National Institute of Health
of the United States of America prior to the signing of this Agreement. The development, promotion, marketing, distribution and
sale of such peptide LKKTETQ by Licensee is subject to the provisions of 6.1(c); and


 


(j)Licensee
shall not reverse engineer or otherwise deconstruct any API or component part of finished Licensed Product for the purpose of
developing a product that would compete with the Licensed Product in the Field. 


 


10.3Disclaimer
of Warranties. EXCEPT AS SET FORTH IN THIS AGREEMENT, NEITHER PARTY GIVES ANY OTHER WARRANTY, EXPRESS OR IMPLIED REGARDING
THE LICENSED PRODUCTS, THE LICENSED KNOW-HOW, THE LICENSED PATENTS, OR THE SCOPE OR VALIDITY THEREOF. ALL OTHER WARRANTIES, INCLUDING,
WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT ARE EXPRESSLY DISCLAIMED.


 


 


Section
11. Indemnification


 


11.1Indemnification
by Licensor. Licensor shall defend, indemnify and hold harmless Licensee, its Affiliates, and its and their respective officers,
directors, employees and agents from and against any and all losses, liabilities, claims, damages, penalties, fines, costs and
expenses (including reasonable legal fees and other litigation costs, regardless of outcome) (collectively “Losses”)
arising as a result of any Product Liability Claims or mandatory or voluntary recall of the Licensed Product in any jurisdiction
of the Territory, in each case solely if and to the extent that such Losses are caused by (i) failure of any Licensed Product
provided by Licensor to conform to the relevant specifications therefor as specified with any clinical supplies provided to Licensee;
or (ii) any willful act or negligence of Licensor and/or its manufacturer of clinical supplies in relation to the Licensed
Product; provided, however, that Licensor shall have no obligation under this Section 11.1 if Licensee or any of its Affiliates,
Sublicensees or Distributors has been negligent, whether in testing, storing, handling or otherwise dealing with the Licensed
Product, or in case such Losses arise out of or are attributable to any breach of this Agreement by Licensee.


 


11.2Indemnification
by Licensee. Licensee shall defend, indemnify and hold harmless Licensor, its Affiliates, and its and their respective officers,
directors, employees and agents from and against any and all Losses arising as a result of any and all Third Party claims if and
to the extent that such Losses are caused by Licensee’s and/or any Affiliate’s, Sublicensee’s or Distributor’s
manufacture, storage, development, use, promotion, marketing, distribution, and sale of the Licensed Product, provided, however,
that Licensee shall have no obligation under this Section 11.2 if Licensor and/or its manufacturer have been negligent, whether
in manufacturing, testing, storing, handling or otherwise dealing with the Licensed Product, or in the case said claims arise
out of or are attributable to any breach of this Agreement by Licensor.


 






    	27*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    
 


 


11.3Procedures.
The Party seeking indemnification under this Section 11 (the “Indemnified Party”)
shall give prompt notice to the Party against whom indemnity is sought (the “Indemnifying Party”) of the assertion
or commencement of any claim for indemnification pursuant to this Section 11, and shall provide the Indemnifying Party such information
with respect thereto that the Indemnifying Party may reasonably request. The failure to give such notice will relieve the Indemnifying
Party of its indemnification obligations hereunder only to the extent that the Indemnifying Party has suffered actual prejudice
thereby. The Indemnifying Party shall assume and control the defense and settlement of any such action, suit or proceeding at
its own expense. The Indemnified Party shall, if requested by the Indemnifying Party, cooperate in all reasonable respects in
such defense, at the Indemnifying Party’s expense, subject to the following. The Indemnified Party will be entitled at its
own expense to participate in such defense and to employ separate counsel for such purpose. For so long as the Indemnifying Party
is diligently defending any action, suit or proceeding pursuant to this Section 11, the Indemnifying Party will not be liable
under this Section 11


for any settlement effected without its consent. No Party shall enter into
any compromise or settlement which commits the other Party to take, or to forbear to take, any action without the other Party’s
prior written consent.


 


11.4Consequential
Damages. NEITHER PARTY SHALL BE LIABLE TO OR OTHERWISE RESPONSIBLE TO THE OTHER PARTY HERETO FOR ANY LOSS OF PROFITS,
DIMINUTION IN VALUE, OR INCIDENTAL, INDIRECT, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES THAT ARISE OUT OF OR
RELATE TO THIS AGREEMENT OR THE PERFORMANCE OR BREACH HEREOF OR OTHERWISE AND WHETHER IN CONTRACT, TORT, STRICT LIABILITY OR
OTHERWISE; PROVIDED, THAT, THE FOREGOING LIMITATION SHALL NOT APPLY: (I) TO A PARTY’S INDEMNIFICATION OBLIGATIONS
PURSUANT TO SECTIONS 11.1 AND 11.2 ABOVE; (II) TO ANY GROSSLY NEGLIGENT ACT OR WILLFUL MISCONDUCT OF A PARTY; OR (III)
TO A PARTY’S BREACH OF ITS CONFIDENTIALITY OBLIGATIONS PURSUANT TO SECTION 9 HEREOF.


 


11.5Insurance.



 


(a)General
Liability. Each Party shall maintain as and when available comprehensive general liability insurance, including blanket contractual
liability insurance through the Term and for five (5) years thereafter, which insurance shall afford limits of not less than $5,000,000
for each occurrence for bodily injury liability, personal injury liability, products liability, property damage liability, contractual
liability and completed operations liability. Each Party shall ensure that such insurance will include coverage for defense costs.


 






    	28*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


(b)Product
Liability. Each Party shall maintain as and when available and thereafter throughout the Term product liability insurance
on commercially standard terms for the pharmaceutical manufacturing industry, with a reputable insurer, in an amount not less
than $5,000,000 per occurrence and $5,000,000 in the annual aggregate.


 


(c)Certificate
of Insurance. Each Party will provide, upon request and as and when available, the other with certificate(s) of insurance
evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date and
the limits of liability. Each Party shall cause its insurance policy to name the other Party hereto as an additional insured.
Each Party’s general liability insurance policy shall contain a waiver of subrogation rights which that Party’s insurer(s)
may have against the other Party.


  


Section
12. Term and Termination


 


12.1Term
and Rules Post Expiration:


 


(a)This Agreement
shall enter into full force and effect at the Effective Date and subject to the renewal options (the “Renewal Options”)
as provided under this Section 12, the initial term of this Agreement shall be three (3) years from the Effective Date (the “Initial
Term”). Licensor hereby irrevocably grants the Renewal Options to the Licensee, which shall be solely exercisable by
the Licensee at its own discretion, to renew this Agreement on the same terms and conditions under this Agreement for another
extended term of three (3) years (the “Extended Term”), and such Renewal Options can be exercised by the Licensee
for not more than six (6) times on each of the date falling immediately before the expiry date of the Initial Term (for the first
time of the exercise of the Renewal Option) or the expiry date of each of the Extended Term (for the second time of the exercise
of the Renewal Option and onward). The Parties hereto acknowledge and agree that the exercise of the Renewal Option by the Licensee
shall, where applicable, be subject to further independent shareholder approval and any other requirements under the Listing Rules
at each time when the Renewal Option is exercised. This Agreement shall remain in force on a country-by-country basis and on a
Licensed Product-by-Licensed Product basis until the expiration of the Initial Term (if the Renewal Options are not exercised
by the Licensee) or the expiration of the Extended Term (if the Renewal Options are exercised by the Company) (the “Expiry
Date”). For the avoidance of doubt and subject to the provisions of Section 12.3 below, Licensor shall have no right
to refuse to renew this Agreement if the Licensee chooses to exercise the Renewal Options. The Parties hereto hereby confirm that
if the Licensee exercises its Renewal Options no renewal agreement is required to be entered into, and the terms of this Agreement
shall remain in full force and effect during the Extended Term(s).


 


(b)If the
Initial Term and the Extended Term cover the entire Relevant Period with respect to any given Licensed Product, the Licensee shall,
upon the expiration of the Relevant Period, have, with respect to such Licensed Product, a royalty-free, fully paid up, perpetual
and irrevocable license, with the right to sublicense and/or assign, for the use of the Licensed Patents and the Licensed Know-How.
For the avoidance of doubt, on a Licensed Product-by-Licensed Product basis, the Licensee shall be entitled to retain in full
all profits generated from the Licensed Patents and the Licensed Know-How after expiration of the Relevant Period.


 






    	29*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


12.2Termination
and Rules Post Termination:


 


(a)In the
event either Party is in breach of any material obligation hereunder (the “Breaching Party”), the non
breaching Party may give written notice to the Breaching Party specifying the claimed particulars of such breach, and in the event
such material breach is not cured, within sixty (60) days following the date of such written notification, without prejudice to
any other rights and remedies available at any time to the non breaching Party, the non breaching Party shall have the right thereafter
to terminate this Agreement by giving thirty (30) days prior written notice to the Breaching Party to such effect.


 


(b)Termination
for Governmental Action. Either Party may terminate this Agreement upon ten (10) days’ prior written notice in
the event that any Governmental Authority takes any action or raises any objection (“Governmental Action”)
that prevents Licensee, for a period of not less than one hundred eighty (180) days, from importing, exporting, purchasing or
selling the Licensed Product in the Territory, or that has the effect of making Licensor’s manufacture of the Licensed Product
unlawful.


 


(c)Termination
by Licensor for Patent Challenge. Licensor may terminate this Agreement in its entirety immediately upon written notice to
Licensee if Licensee or its Affiliates or Sublicensees (directly or indirectly, individually or in association with any person
or entity) challenges the validity, enforceability or scope of any Licensed Patents anywhere in the world.


 


(d) Termination
or Conversion Pursuant to the PHS License. In the event that PHS terminates the PHS License under Article 13 therein or rescinds
a Licensed Field of Use (as that term is defined in the PHS License) that includes any portion of the Field in which Licensee
is licensed hereunder, Licensee may, at its option:


 


(i)terminate
this Agreement; or


 


(ii)convert
this Agreement to a license between Licensee, on the one hand, and Licensor and PHS, on the other hand, with such conversion subject
to the approval of PHS, which shall not be unreasonably withheld, and contingent upon Licensee’s acceptance of all of the
provisions of the PHS License.


 


(e)Termination
for Bankruptcy. To the extent permitted under applicable Law, if at any time during the term of this Agreement, an Event of
Bankruptcy (as defined below) relating to either Party (the “Bankrupt Party”) occurs, the other Party (the “Other
Party”) shall have, in addition to all other legal and equitable rights and remedies available hereunder, the option to
terminate this Agreement upon sixty (60) days written notice to the Bankrupt Party. It is agreed and understood that if the Other
Party does not elect to terminate this Agreement upon the occurrence of an Event of Bankruptcy, except as may otherwise be agreed
with the trustee or receiver appointed to manage the affairs of the Bankrupt Party, the Other Party shall continue to make all
payments required of it under this Agreement as if the Event of Bankruptcy had not occurred, the Bankrupt Party shall not have
the right to terminate any license granted herein. The term “Event of Bankruptcy” means: (i) filing in any court or
agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization
or for an arrangement or for the appointment of a receiver or trustee of the Bankrupt Party or of its assets; (ii) proposing a
written agreement of composition or extension of a Bankrupt Party’s debts; (iii) being served with an involuntary petition
against the Bankrupt Party, filed in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days
after the filing thereof; (iv) proposing or being a party to any dissolution or liquidation when insolvent; or (v) making an assignment
for the benefit of creditors. Without limitation, the Bankrupt Party’s rights under this Agreement shall include those rights
afforded by 11 U.S.C. § 365(n) of the United States Bankruptcy Code (the “Bankruptcy Code”) and any successor
thereto. If the bankruptcy trustee of a Bankrupt Party as a debtor or debtor-in-possession rejects this Agreement under 11 U.S.C.
§ 365(o) of the Bankruptcy Code, the Other Party may elect to retain its rights licensed from the Bankrupt Party hereunder
(and any other supplementary agreements hereto) for the duration of this Agreement and avail itself of all rights and remedies
to the full extent contemplated by this Agreement and 11 U.S.C. § 365(n) of the Bankruptcy Code, and any other relevant laws.






    	30*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


12.3Effects
of Termination.


 


(a)Return
of Material. In the event of early termination of this Agreement for any reason: (i) all rights and licenses granted to Licensee
under this Agreement shall terminate (including all rights and licenses with respect to Licensed Patents and Licensed Know-How),
and (ii) Licensee shall transfer to Licensor all data, files, records, information and other materials (including clinical supplies
of Licensed Product and including the originals of any registrations and/or importation documents as specified in Section 7.4)
in its possession or control relating to, containing or comprising the Licensed Product, including Licensor’s Confidential
Information.


 


(b)Transfer
of Materials. In the event of early termination of this Agreement in accordance with Section 12.2 ( c ) above:


 


(i)to the
extent not transferred pursuant to Section 12.3(a), Licensee shall provide to Licensor a copy of any and all documentation and
data owned by Licensee and in tangible form at the time of termination of the Agreement that has been generated with respect to
the Licensed Product and is necessary to enable Licensor to continue development of a Licensed Product and the commercialization
thereof in the Territory (collectively, the “Licensee Product Data”), and Licensor may use such Licensee Product
Data at its discretion on an exclusive basis, to the extent necessary to enable Licensor, its Affiliates and Third Parties on
behalf of Licensor or its Affiliates to continue to develop and commercialize a Licensed Product in the Territory; and


 


(ii)if such
termination occurs after a Licensed Product has received Regulatory Approval, Licensee shall, if permitted under applicable Law,
promptly transfer and deliver to Licensor original copies of any and all Regulatory Approvals obtained in connection with the
Licensed Product in the Territory (including any and all official registrations, licenses, permits, certificates, and/or importation
documents issued by Regulatory Authorities in the Territory), as well as any and all regulatory documentation and applications
for Regulatory Approval submitted to Regulatory Authorities in the Territory in connection with the Licensed Product; Licensor
shall pay Licensee’s direct, out-of-pocket costs for compliance with this Section 12.3(b)(ii); and


 


 



    	31*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



 


(iii)to
the extent that any Regulatory Approval is issued in the name of Licensee, its Affiliates, Sublicensees or other designee, Licensee
shall, to the extent permitted by applicable Law, promptly assign or procure the assignment to Licensor (or its designee) such
Regulatory Approvals, and in the event assignment is not permitted under applicable Law or cannot be carried out for any other
reason, the Licensee shall take all steps that are necessary and/or desirable to assist Licensor to obtain such Regulatory Approvals
in the name of Licensor (or its designee) in the Territory, with such actions including without limitation coordinating with the
applicable Regulatory Authority, furnishing all necessary information and documents in respect thereof, and promptly cancelling
and terminating (as necessary) all Regulatory Approvals held by the Licensee, its Affiliate(s), Sublicensee(s) and/or other designee(s)
which are not otherwise assignable or transferable to the Licensor (or its designee); Licensor shall pay Licensee’s direct,
out-of-pocket costs for compliance with this Section 12.3(b)(iii); and


 


(iv)Licensee
shall assign (or cause its Affiliates to assign) to Licensor all agreements with any Third Party with respect to the conduct of
clinical trials for the Licensed Product, including agreements with contract research organizations, clinical sites and investigators,
unless expressly prohibited by any such agreement or unless such agreement covers clinical trials for products in addition to
the Licensed Products (in which case Licensee shall cooperate with Licensor in all reasonable respects to secure the consent of
such Third Party to such assignment or to the conclusion of a new agreement between the Licensor and the Third Party on terms
substantially similar to the agreement between Licensee and the Third Party), and Licensor shall assume all obligations under
all such agreements.


 


(c)Survival
of Sublicenses. All sublicenses granted by Licensee to Sublicensees shall survive termination of this Agreement, and Licensor
shall assume all such sublicenses as the Licensor thereunder in accordance with the terms of such sublicenses; provided, however,
that Licensor may elect to terminate any such sublicenses, and Licensor shall not be required under this Section 12 to assume
obligations under any such sublicense that are greater in scope than those set forth in this Agreement.


 


(d)Remedies
for Termination. Expiration or termination of this Agreement by either Party shall not affect any claim, demand, liability
or right of a Party arising pursuant to this Agreement prior to such termination or expiration hereof.


 


12.4Survival.
The following provisions shall survive the termination or expiration of this Agreement: Sections 6 (with respect to Net Sales
made prior to expiration or termination of this Agreement), 7.3, 7.6(a), 9, 11, 12.3, 12.4, 13, and all provisions of the PHS
License that are binding on Licensee and are specified in the PHS License as surviving the expiration or termination thereof.


 


 



    	32*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    



Section
13. Miscellaneous


 


13.1Waiver.
The waiver by any Party of a breach of any provision of this Agreement shall not operate, or be construed, as a waiver of any
subsequent breach.


 


13.2Modification.
No change, modification, or waiver of any term of this Agreement shall be valid unless it is in writing and signed by both Parties.


 


13.3Entire
Agreement. This Agreement (including all exhibits and attachments hereto, all of which are incorporated herein by reference)
constitutes the entire agreement between the Parties (and their Affiliates) with respect to the subject matter hereof and thereof,
and supersedes all prior agreements and understandings, whether oral or written, between the Parties, except for the Confidential
Disclosure Agreement described in Section 9.7.


 


13.4English
Language. This Agreement is written and executed in the English language. Any translation into any other language shall not
be an official version of this Agreement and in the event of any conflict in interpretation between the English version and such
translation, the English version shall prevail.


 


13.5Assignment.
Licensor and Licensee shall be entitled to assign its rights or delegate its obligations hereunder to any of its Affiliates or
to a Third Party upon (30) thirty days’ prior written notice to Licensor. All sublicenses granted to Affiliates or Third
Parties pursuant to this Section 13.5 shall be subject to all terms, conditions, obligations and covenants of this Agreement
and all applicable provisions of the PHS License. In addition, each Party hereby consents to the other Party’s assignment
of its rights and obligations under this Agreement in connection with a Change of Control of such Party. No such assignment
shall remove or mitigate the obligations or liability of the assigning Party unless otherwise agreed in writing by the non-assigning
Party. For clarity, if Licensor is involved in a Change of Control with a Third Party: (a) the intellectual property rights of
such Third Party existing as of the date of closing of such Change of Control or developed outside of any activities under this
Agreement (if such Third Party becomes the assignee of this Agreement); or (b) the intellectual property rights of such Third
Party (if such Third Party remains an Affiliate of Licensor), shall be automatically excluded from the definitions of Licensed
Patents and Licensed Know-How licensed to Licensee under this Agreement.


 


13.6Independent
Contractor. This Agreement shall not be construed as constituting a partnership, joint venture or any other form of legal
association that would impose liability upon one Party for the act or failure to act of the other Party, or as providing either
Party with the right, power or authority (express or implied) to create any duty or obligation of the other Party.


 


13.7Third
Party Beneficiaries. Any sublicense granted by Licensee to an Affiliate or Third Party pursuant to Section 2.1(c) is
intended by the Parties to be a third party beneficiary of this Agreement; provided that such Sublicense is in compliance
with all of its obligations under any such sublicense to the extent that such obligations are required under this Agreement.
Except as expressly provided in this Section 13.7, the Parties do not intend, nor will any Section of this Agreement be
interpreted, to create for any person any third party beneficiary rights.


 






    	33*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    
 


 


13.8Disputes.
Disputes regarding the scope, validity or enforceability of Patents are excluded from this Section 13.8.


 


(a)Good
Faith Negotiations by Officers. In the event of disputes between the Parties arising out of or relating to this Agreement,
or the breach, termination (other than termination for convenience in accordance with Sections 12.2(a) and 12.3(d)) or invalidity
thereof, a Party seeking to resolve such dispute will, by written notice to the other, have such dispute referred to their respective
chief executive officers, for attempted resolution by good faith negotiations within fourteen (14) days after such notice is received.


 


(b)Mediation.
In the event that the Parties are unable to resolve a dispute through good faith negotiations pursuant to Section 13.8(a)


, the Parties agree to submit such dispute to non-binding mediation using
an industry expert mutually acceptable to the Parties. The costs of any such mediation shall be shared by the Parties equally.


 


(c)Arbitration.
If all good faith attempts to resolve a dispute through negotiations and mediation pursuant to Sections 13.8(a) and (b) have failed
after sixty (60) days from notice provided pursuant to Section 13.8(a), then upon the request of either Party, the dispute shall
be finally resolved by binding arbitration administered by I.C.C. Arbitration (the “ICC Rules”).


 


(i)The arbitration
shall be conducted by a panel of three neutral arbitrators (the “Panel”) appointed in accordance with the ICC
Rules.


 


(ii)The
arbitration proceedings shall take place in Geneva, Switzerland. The arbitral proceedings and all pleadings shall be in the English
language. Any written evidence originally in a language other than English shall be submitted in English translation accompanied
by the original or true copy thereof.


 


(iii)The
Panel shall have the power to decide all questions of arbitrability.


 


(iv)At the
request of either Party, the Panel will enter an appropriate protective order to maintain the confidentiality of information produced
or exchanged in the course of the arbitration proceedings.


 


(v)The Panel
is empowered to award any remedy allowed by law, including monetary damages, prejudgment interest and punitive damages, and to
grant final, complete, interim or interlocutory relief, including injunctive relief.


 


(vi)The
Parties may apply to a court of competent jurisdiction within the Hong Kong, or the United States for a temporary restraining
order, preliminary injunction, or other interim or conservatory relief, as necessary, without breach of this arbitration agreement
and without any abridgment of the powers of the arbitrators. Judgment on the award rendered by the Panel may be entered in any
court having jurisdiction thereof. Each Party hereby waives any defenses it may have to the personal jurisdiction and venue of
such courts to resolve such disputes, including without limitation the defense of forum non conveniens, and each Party
agrees not to file any motion to seek any relief under any forum non conveniens defense.


 


 






    	34*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    
 


 


(vii)Each
Party shall bear its own legal fees arising in connection with the dispute. The Panel may assess costs, fees and expenses of the
ICC and the Panel to the Parties in the manner the Panel deems appropriate under the circumstances.


 


13.9Notices.
Except as otherwise provided herein, all notices or other communications hereunder shall be deemed sufficient if given in writing,
via registered mail (return receipt requested), postage paid, or by reputable high speed delivery service (e.g., FedEx)
or by courier addressed to the appropriate Party at the address set forth below, or at such other place as such Party may designate
in writing to the other Party.


 


	 

        If
        to Licensor:
	RegeneRx Biopharmaceuticals,
        Inc.

        15245 Shady Grove Road

        Suite 470

        Rockville, Maryland 20850

        U.S.A.

        Attn:  President
        and CEO

        Phone: 301.208.9191

        Fax:  (301) 208-9191

	 	 
	With
    a copy to:	Ken
        Krisko, Esq.

        Cooley LLP

        One Freedom
        Square

        Reston Town Center 

        11951 Freedom Drive

        Reston, VA  20190-5656
        

        Direct: (703) 456-8187

        Fax: (703)
        456-8100

	 	 
	If
    to Licensee:	Lee’s
        Pharmaceutical (HK) Limited

        Unit 110-111, Bioinformatics
        Center

        No. 2 Science Park West
        Avenue

        Hong Kong Science Park

        Shatin, Hong Kong

        Attn: Benjamin Li

        Fax.: 00852 23141708

	 	 


All such notices
shall be effective upon receipt.


 


13.10Governing
Law. This Agreement shall be governed and construed in accordance with the laws of New York, USA without regard to
its principles of conflict of laws. The Parties agree to exclude the application to this Agreement of the United Nations Convention
on Contracts for the International Sale of Goods.


 






    	35*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    
 


 


13.11Severability.
The provisions of this Agreement are severable. If any item or provision of this Agreement shall to any extent be invalid or unenforceable,
the remainder of this Agreement shall not be affected thereby, and each term and provision of this Agreement shall be valid and
shall be enforced to the fullest extent permitted by law. The Parties will use diligent good faith efforts to revise this Agreement
as and to the extent reasonably necessary to effectuate their original intent and purpose under this Agreement.


 


13.12Jurisdiction
and Venue. In connection with any dispute arising hereunder or in connection with the subject matter hereof
that is not settled in accordance with Section 13.8


, each of the Parties hereby consents to the exclusive jurisdiction and venue
of the courts of Geneva, Switzerland. Each Party hereby irrevocably waives any right that it may have to assert that any such
court lacks jurisdiction or that such forum is not convenient.


 


end
of page

[signatures appear on following page]


 






    	36*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




    	 



    
 


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


 


 





	 	 	Lee’s Pharmaceutical (HK) Limited
	 	 	 
	 	 	 
	 	 	By:  /s/ Benjamin Li
	 	 	Name: Benjamin Li
	 	 	Title: Chief Executive Officer
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	RegeneRx Biopharmaceuticals, Inc.
	 	 	 
	 	 	 
	 	 	By:  /s/J.J. Finkelstein
	 	 	Name: J.J. Finkelstein
	 	 	Title: President & CEO




 


 






    	 



    	 



    
  


Exhibits


 


 


 


Exhibit A - Licensed
Patents: to be filled by Regenerx


Exhibit B - PHS
License: to be filled by Regenerx


Exhibit C - PHS
License Terms Applicable to Licensee


 


 






    	 



    	 



    
   


Exhibit
A


 


LICENSED
PATENTS


 


 


	Application No.	Title	Case Status	Country
	05106874.3 (Patent No. HK1074577)	METHODS OF TREATING DISORDERS OF THE EYE AND SURROUNDING TISSUE WITH THYMOSIN BETA 4, ANALOGUES, ISOFORMS AND OTHER DEVICES	Granted	Hong Kong
	 	 	 	 
	08109146.6	METHODS OF TREATING DISORDERS OF THE EYE AND SURROUNDING TISSUE WITH THYMOSIN BETA 4, ANALOGUES, ISOFORMS AND OTHER DEVICES	Published	Hong Kong
	 	 	 	 
	04108302.2	METHODS OF HEALING OR PREVENTING INFLAMATION, DAMAGE AND OTHER CHANGES THAT OCCUR PRIOR TO, DURING OR IMMEDIATELY AFTER A MYOCARDIAL EVENT	Published	Hong Kong
	 	 	 	 
	01108257.0 (Patent No. HK1038307)	THYMOSIN BETA 4 PROMOTES WOUND REPAIR	Granted	Hong Kong
	 	 	 	 
	06105092.0	THYMOSIN BETA 4 PROMOTES WOUND REPAIR	Published	Hong Kong
	 	 	 	 
	11111350.8	THYMOSIN BETA 4 PROMOTES WOUND REPAIR	Published	Hong Kong
	 	 	 	 
	06112825.0	EXTRACELLULAR MATRIX BUILD-UP	Published	Hong Kong
	 	 	 	 
	07102111.3	METHOD OF TREATING AND PREVENTING BIOLOGICAL OR IMMUNOLOGICAL RESPONSES TO A REACTIVE CHEMICAL OR BIOLOGICAL OR TOXIC AGENT	Published	Hong Kong
	 	 	 	 
	08105152.5	METHOD OF TREATING OR PREVENTING TISSUE DETERIORATION, INJURY OR DAMAGE DUE TO A NEURO-MUSCULAR-, OR NEURO-MUSCULAR-DEGENERATIVE DISEASE, OR RESTORE TISSUE ADVERSELY AFFECTED BY SAID DISEASE OF RESPIRATORY TISSUE	Published	Hong Kong
	 	 	 	 
	09103362.5	METHODS OF TREATING OR PREVENTING TISSUE DAMAGE CAUSED BY INCREASED BLOOD FLOW	Published	Hong Kong
	 	 	 	 
	08112090.6	METHOD OF TREATING OR PREVENTING TISSUE DETERIORATION, INJURY OR DAMAGE DUE TO CONGESTIVE HEART FAILURE	Published	Hong Kong
	 	 	 	 
	08110517.5	LKTTET AND/OR LKKTNT PEPTIDE COMPOSITIONS AND METHODS	Published	Hong Kong
	 	 	 	 
	10100178.2	Method of Downregulating NF-kappaB OR Suppressing NF-kappaB-Mediated Actions	Published	Hong Kong
	 	 	 	 
	11105917.6	IMPROVED BETA THYMOSIN FRAGMENTS	Published	Hong Kong
	 	 	 	 
	200780003219.5	METHODS OF TREATING OR PREVENTING TISSUE DAMAGE CAUSED BY INCREASED BLOOD FLOW	Published	China
	200680027388.8	METHOD OF TREATING OR PREVENTING TISSUE DETERIORATION, INJURY OR DAMAGE DUE TO CONGESTIVE HEART FAILURE	Published	China
	 	 	 	 
	200680021662.0	LKTTET AND/OR LKKTNT PEPTIDE COMPOSITIONS AND METHODS	Published	China
	 	 	 	 
	200980117938.9	IMPROVED BETA THYMOSIN FRAGMENTS	Published	China
	 	 	 	 
	201080013941.9	Methods for Improving Neurological Outcome After Neural Injury and Neurodegenerative Diseases	Published	China
	 	 	 	 







 


 


 


 



    	A-1



    	 



    

Exhibit B


 


PHS LICENSE


  





 



    	B-1



    	 



    





    	B-2



    	 



    





    	B-3



    	 



    





    	B-4



    	 



    





    	B-5



    	 



    





    	B-6



    	 



    





    	B-7



    	 



    





    	B-8



    	 



    





    	B-9



    	 



    





    	B-10



    	 



    




    	B-11



    	 



    






    	B-12



    	 



    





    	B-13



    	 



    



    	B-14



    	 



    





    	B-15



    	 



    





    	B-16



    	 



    





    	B-17



    	 



    




    	B-18



    	 



    





    	B-19



    	 



    





    	B-20



    	 



    





    	B-21



    	 



    





    	B-22



    	 



    





    	B-23



    	 



    





    	B-24



    	 



    





    	B-25



    	 



    





    	B-26



    	 



    





    	B-27



    	 



    





    	B-28



    	 



    





    	B-29



    	 



    





    	B-30



    	 



    





    	B-31



    	 



    




    	B-32



    	 



    




    	B-33



    	 



    





    	B-34



    	 



    





    	B-35



    	 



    







 



    	B-36



    	 



    

Exhibit C


 


PHS LICENSE
TERMS


APPLICABLE
TO LICENSEE


 


For the purposes of this Exhibit C
only, terms in bold have the meanings given such terms in the PHS License.


 


 


		5.01	PHS reserves on behalf of the
                                                             Government an irrevocable, nonexclusive, non-transferable,
                                                             royalty-free license for the practice of all inventions licensed
                                                             under the Licensed Patent Rights throughout the world by or
                                                             on behalf of the Government and on behalf of any foreign government
                                                             or international organization pursuant to any existing or future
                                                             treaty or agreement to which the Government is a signatory.
                                                             Prior to the First Commercial Sale, Licensee agrees
                                                             to provide PHS reasonable quantities of Licensed Products
                                                             or materials made through the Licensed Processes solely
                                                             for PHS research use and not for purposes of commercial development,
                                                             manufacture or distribution, at a price equal to Licensee’s
                                                             cost of such.



 


		5.02	Licensee agrees that products
                                                             used or sold in the United States embodying Licensed Products
                                                             or produced through use of Licensed Processes shall be
                                                             manufactured substantially in the United States, unless a written
                                                             waiver is obtained in advance from PHS.



 


		5.03	Licensee acknowledges that
                                                             PHS may enter into future Cooperative Research and Development
                                                             Agreements (CRADAs) under the Federal Technology Transfer Act of
                                                             1986 that relate to the subject matter of this Agreement.
                                                             PHS agrees to notify Licensee, as soon as is practical
                                                             of any proposed CRADA that relates to the subject matter of this
                                                             Agreement. Licensee agrees not to unreasonably deny
                                                             requests for a Research License from such future collaborators
                                                             with PHS when acquiring such rights is necessary in order
                                                             to make a Cooperative Research and Development Agreement (CRADA)
                                                             project feasible. As of the effective date of this Agreement,
                                                             Licensee requests that Licensee have an opportunity
                                                             to join as a party to any proposed Cooperative Research and Development
                                                             Agreement (CRADA).



 


		5.04	In addition to the reserved license
                                                             of Paragraph 5.01 above, PHS reserves the right to grant such
                                                             nonexclusive Research Licenses directly or to require Licensee
                                                             to grant nonexclusive Research Licenses on commercially
                                                             reasonable terms. The purpose of this Research License is
                                                             to encourage basic research, whether conducted at an academic or
                                                             corporate facility. In order to safeguard the Licensed Patent
                                                             Rights, however, PHS shall consult with Licensee
                                                             before granting to commercial entities a Research License
                                                             or providing to them research samples of Licensed Products
                                                             or materials made through the Licensed Processes, provided
                                                             however that PHS will not provide materials obtained from
                                                             Licensee under Paragraph 5.01 above to third parties, except
                                                             with Licensee’s prior written consent, which shall not
                                                             be unreasonably withheld.



 






    	C-1



    	 



    



 


		8.01	Licensee agrees to keep accurate
                                                             and correct records of Licensed Products made, used, sold,
                                                             or imported and Licensed Processes practiced under
                                                             this Agreement appropriate to determine the amount of royalties
                                                             due PHS. Such records shall be retained for at least five
                                                             (5) years following a given reporting period and shall be available
                                                             during normal business hours upon five (5) business days prior written
                                                             notice from PHS to Licensee for inspection at the expense
                                                             of PHS by an accountant or other designated auditor selected
                                                             by PHS for the sole purpose of verifying reports and payments
                                                             hereunder. The accountant or auditor shall only disclose to PHS
                                                             information relating to the accuracy of reports and payments
                                                             made under this Agreement. If an inspection shows an under reporting
                                                             or underpayment in excess of five percent (5%) for any twelve (12)
                                                             month period, then Licensee shall reimburse PHS for
                                                             the cost of the inspection at the time Licensee pays the unreported
                                                             royalties, including any late charges as required by Paragraph 9.08
                                                             of this Agreement. All payments required under this Paragraph
                                                             shall be due within thirty (30) days of the date PHS provides
                                                             Licensee notice of the payment due.



 


		10.01	Licensee shall use its
                                                              reasonable best efforts to bring the Licensed Products and
                                                              Licensed Processes to Practical Application. “Reasonable
                                                              best efforts” for the purposes of this provision shall include
                                                              substantial adherence to the Commercial Development Plan
                                                              at Appendix F and substantial performance of the Benchmarks
                                                              at Appendix E as may be amended from time to time by mutual written
                                                              consent. The efforts of sublicensees and Affiliates shall be considered
                                                              the efforts of Licensee. To the extent that the Benchmarks
                                                              or development obligations set forth in Appendix E differ from
                                                              or conflict with those set forth in the Commercial Development
                                                              Plan in Appendix F, Appendix E shall be considered to supersede
                                                              Appendix F and the Commercial Development Plan in Appendix F shall
                                                              be amended to be consistent with Appendix E.



 


		10.02	Upon the First Commercial Sale,
                                                              until the expiration of this Agreement, Licensee shall
                                                              use its reasonable best efforts to make Licensed Products
                                                              and Licensed Processes reasonably accessible to the United
                                                              States public.



 


		12.05	Licensee shall indemnify and
                                                              hold PHS, its employees, students, fellows, agents, and consultants
                                                              (the “Indemnified Parties”) harmless from and
                                                              against all liability, demands, damages, expenses, and losses, including
                                                              but not limited to death, personal injury, illness, or property
                                                              damage (the “Indemnified Losses”) suffered by
                                                              an Indemnified Party in connection with or arising out of
                                                              a) the use by or on behalf of Licensee, its sublicensees,
                                                              directors, employees, or third parties of any Licensed Patent
                                                              Rights, or b) the design, manufacture, distribution, or
                                                              use of any Licensed Products, Licensed Processes or
                                                              materials by Licensee, or other products or processes developed
                                                              in connection with or arising out of the Licensed Patent Rights.
                                                              Licensee agrees to maintain a liability insurance program
                                                              consistent with sound business practice. Notwithstanding any other
                                                              provision to the contrary, Licensee shall have no obligation
                                                              to indemnify an Indemnified Party from an Indemnified
                                                              Loss in connection with or arising out of the design, manufacture,
                                                              distribution or use of any Licensed Product or Licensed
                                                              Process by or on behalf of the Indemnified Party.



 






    	C-2



    	 



    
 


 


		13.05	PHS shall specifically have
                                                              the right to terminate or, with Licensee’s consent,
                                                              modify, at its option, this Agreement, if PHS determines
                                                              that the Licensee: 1) is not using its reasonable best
                                                              efforts to effectuate the Commercial Development Plan submitted
                                                              with its request for a license and the Licensee cannot otherwise
                                                              demonstrate to PHS’s satisfaction that the Licensee
                                                              has taken, or can be expected to take within a reasonable time,
                                                              effective steps to achieve Practical Application of the Licensed
                                                              Products or Licensed Processes; 2) has not used
                                                              its reasonable best efforts to achieve the Benchmarks as
                                                              my be modified under Paragraph 9.02; 3) has wilfully made a
                                                              false statement of, or wilfully omitted, a material fact in the
                                                              license application or in any report required by this Agreement;
                                                              4) has committed a material breach of a covenant or agreement
                                                              contained in the license; 5) is not keeping Licensed Products
                                                              or Licensed Processes reasonably available to the public
                                                              after commercial use commences; 6) cannot reasonably satisfy
                                                              unmet health and safety needs; or 7) cannot reasonably justify
                                                              a failure to comply with the domestic production requirement of
                                                              Paragraph 5.02 unless waived. In making this determination, PHS
                                                              will take into account the normal course of commercial development
                                                              programs conduct with sound and reasonable business practices and
                                                              judgment and the annual reports submitted by Licensee under
                                                              Paragraph 9.02. Prior to invoking this right, PHS shall give
                                                              written notice to Licensee providing Licensee specific
                                                              notice of, and a ninety (90) day opportunity to respond to, PHS’s
                                                              concerns as to the previous items 1) to 7). If Licensee
                                                              fails to alleviate PHS’s concerns as to the previous
                                                              items 1) to 7) or fails to initiate corrective action to PHS’s
                                                              reasonable satisfaction, PHS may terminate this Agreement.



 


		13.07	PHS reserves the right according
                                                              to 35 U.S.C. § 209(1)(4) to terminate or modify this Agreement
                                                              if it is determined that such action is necessary to meet requirements
                                                              for public use specified by federal regulations issued after the
                                                              date of the license and such requirements are not reasonably satisfied
                                                              by Licensee.



 


		13.08	Within thirty (30) days of receipt
                                                              of written notice of PHS’s unilateral decision to modify
                                                              or terminate this Agreement, Licensee may, consistent
                                                              with the provisions of 37 C.F.R. 404.11, appeal the decision by
                                                              written submission to the designated PHS official. The decision
                                                              of the designated PHS official shall be the final agency
                                                              decision. Licensee may thereafter exercise any and all administrative
                                                              or judicial remedies that may be available.



 


		13.09	Within ninety (90) days of expiration
                                                              or termination of this Agreement under this Article 13, a
                                                              final report shall be submitted by Licensee. Any royalty
                                                              payments, including those incurred but not yet paid (such as the
                                                              full minimum annual royalty), and those related to patent expense,
                                                              due to PHS shall become immediately due and payable upon
                                                              termination or expiration. If terminated under this Article 13,
                                                              sublicensees may elect to convert their sublicenses to direct licenses
                                                              with PHS and Licensee pursuant to Paragraph 4.03.





 






    	C-3